GLOBAL STANDARD

CONSUMER PRODUCTS
PERSONAL CARE AND HOUSEHOLD
INTERPRETATION
GUIDELINE

ISSUE 4
GLOBAL STANDARD
CONSUMER PRODUCTS ISSUE 4
PERSONAL CARE AND HOUSEHOLD
INTERPRETATION
GUIDELINE

BRC Global Standards 2017

LIABILITY
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The Global Standard for Consumer Products Issue 4 Personal Care and Household Interpretation Guideline and the terms of the
disclaimer set out above shall be construed in accordance with English law and shall be subject to the non-exclusive jurisdiction
of the English Courts.

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© BRC Global Standards 2017

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PART II
REQUIREMENTS
FOR
FOUNDATION
AND HIGHER
LEVELS

1 SENIOR MANAGEMENT
COMMITMENT
1.1 Senior management commitment and
continual improvement 3
1.2 Organisational structure, responsibilities
and management authority 9

2 PRODUCT RISK
MANAGEMENT
2.1 Legislation and safety requirements 11
2.2 Product risk assessment 15
2.3 Product labelling and claims 19
2.4 Packaging materials 20

3 
PRODUCT SAFETY AND
QUALITY MANAGEMENT
3.1 Product safety and quality management
system 22
3.2 Documentation control 22
3.3 Record completion and maintenance 23
3.4 Internal audit 25
3.5 Supplier approval and performance
monitoring 28
3.6 Specifications and technical files 32
3.7 Corrective and preventive action 34
3.8 Control of non-conforming materials 35
3.9 Traceability 36
3.10 Complaint handling 38
3.11 Management of incidents, product
withdrawal and product recall 39

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4 
SITE STANDARDS
4.1 External standards 44
4.2 Security 45
4.3 Layout, product flow and segregation 46
4.4 Building interiors 49
4.5 Staff facilities 50
4.6 Housekeeping and hygiene 52
4.7 Waste and waste disposal 54
4.8 Pest control 56
4.9 Product storage, dispatch and transport 58

5 
PRODUCT INSPECTION
AND TESTING
5.1 Product inspection and laboratory
testing 59
5.2 Quantity control 63
5.3 Product sample control 64

6 
PROCESS CONTROL
6.1 Control of operations 67
6.2 Equipment and equipment maintenance 72
6.3 Product contamination control 74
6.4 Calibration and control of measuring and
monitoring devices 77
6.5 Final product packing and control 79
6.6 Stock control and product release 80

7 
PERSONNEL
7.1 Training and competency 82
7.2 Protective clothing 83
7.3 Hygiene practices 84

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PART II

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

REQUIREMENTS FOR
FOUNDATION AND HIGHER
LEVELS
1 SENIOR MANAGEMENT COMMITMENT

1.1 SENIOR MANAGEMENT COMMITMENT AND CONTINUAL IMPROVEMENT

FUNDAMENTAL
The site’s senior management shall demonstrate they are fully committed to the implementation of the
requirements of the Global Standard for Consumer Products and to processes which facilitate continual
improvement of product safety and quality management.

Interpretation
The statement of intent for this clause is a fundamental requirement. Without commitment from the site’s senior management,
which has the authority to allocate budget and resources and set site policies, it is not possible to properly implement the
Standard. A department manager or quality manager may think it is a good idea to adopt the Standard and try to address matters
on their own initiative, but many of the requirements need support from different parts of the site and demand commitment at the
highest level. The requirement encompasses a need to effect continual improvement as consumer quality and safety
expectations rise and legal requirements become more complex. Site standards from 20 years ago would not be
acceptable today.

Example
At the opening meeting, none of the site’s senior management is present. The quality manager informs the auditor that the site’s
senior management is dealing with an important client and has authorised the quality manager to deputise. The auditor also
notices that none of the site’s senior managers were present at the opening meeting last year. The auditor asks the quality
manager to ensure that the site’s senior manager is available, but this is not possible.

Senior management does not understand the importance of its commitment. If the senior management was unavailable due to
exceptional circumstances, then the audit visit should have been postponed. The auditor will decide whether to continue with the
audit after consultation with the certification body, if necessary, and depending on the conditions of business between the
certification body and the site.

CLAUSE FOUNDATION HIGHER

1.1.1 The site shall have an implemented policy which

demonstrates the site’s intention to meet its
obligation to produce safe and legal products to
the specified quality and its responsibility to its
customers. This shall be:

• authorised by the person with overall

responsibility for the site
• communicated to all staff.
Interpretation
The site’s senior management is required to establish a policy that is understood by all of the employees. This policy needs to
address product safety, legality and quality as well as any customer or customer-specific requirements. At the fundamental level
the policy may or may not be in a readily documented format, although it needs to be something the site’s senior management can
endorse. This could be achieved through a training programme.

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Example
During the audit of a site making toilet-rim blocks, the auditor questions one of the line operatives to determine their
understanding of the site’s policy. The employee replies that they are not aware of any such policy and a further review of the
employee’s training record shows that they were not trained in understanding the policy during their induction.

This would result in a non-conformity as the employee is unaware of the site’s policy.

CLAUSE FOUNDATION HIGHER

1.1.1 The site shall have a documented policy which

states the site’s intention to meet its obligation to
produce safe and legal products to the specified
quality and its responsibility to its customers. This
shall be:

• authorised and signed by the person with

overall responsibility for the site
• communicated to all staff.
Interpretation
The site’s senior management is required to document a policy that is understood by all of the employees. This policy needs to
address the product safety, legality and quality as well as any customer or customer-specific requirements. At the higher level the
policy must be in readily accessible, documented format authorised by the site’s senior management. In addition, this should be
included in a training programme to ensure that there is a full understanding of the requirement.

Example
During the audit of a site making wet wipes, the auditor questions one of the line operatives to determine their understanding of
the site’s policy. The employee replies that they are not aware of any such policy and the policy is not displayed anywhere on site.
A further review of the employee’s training record shows that they were not trained in understanding the policy during their
induction.

This would result in a non-conformity as the employee is unaware of the site’s policy.

CLAUSE FOUNDATION HIGHER

1.1.2 The site’s senior management shall ensure that clear objectives are defined to maintain safety and
legality and improve the quality of products manufactured, in accordance with the site’s product safety
and quality policy and commitment to implementing the requirements of this Standard. These objectives
shall be clearly communicated to relevant staff and monitored, and results reported at least annually to
site senior management.

Interpretation
The site’s senior management needs to set objectives concerning legality, safety and quality so that the workforce can
understand what is required of them. Setting such objectives also enables the allocation of suitable budgets and resources.
Auditors will be looking for evidence that this has been done and communicated to the appropriate staff. Objectives may include,
for example:

• reducing customer complaints

• fewer non-conforming products
• better customer satisfaction scores
• fewer lots rejected by customers
• improving on-time, in-full delivery
• the introduction of Lean principles such as Six Sigma (6∑)
• increased production efficiencies (uptime or downtime).
There are many other objectives that could be included here. In each case, the objective should be measurable and documented.
It is then possible to review success or failure. The objective is to show a coherent relationship between the objectives and the
policy which will subsequently be examined at the management review. This will then help to deliver continuous improvement.

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Examples

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

A detergent company has set objectives for the level of customer complaints each year and can demonstrate that it has diligently
monitored the complaint levels for the past five years. There is no evidence that actions have been taken to address the failure to
meet objectives.

This would result in a non-conformity. Effort is being made to collect data but it is not being used effectively.

The quality manager of a toy manufacturer shows the auditor a document stating that there are documented key performance
indicators (KPIs) set for the level of customer rejects. When the auditor visits the site, none of the operators is aware of this
document and there is no evidence that the rejects are being monitored. The auditor is told this is done by ‘George’ who is away
on holiday.

A non-conformity would be raised, as there is no evidence that the KPIs are monitored.

A wet-wipe manufacturer has set an objective to reduce the amount of solution rework to less than 1% of production within two
years and has set KPIs for various departments in order to achieve this. The auditor is shown monitoring charts from the various
departments and the results of the KPIs to support the objective. In addition, there are a number of projects in place to reduce
errors at various stages in the manufacturing process. The projects are assigned to designated persons who have the backing of
senior management.

The auditor would consider this acceptable.

CLAUSE FOUNDATION HIGHER

1.1.3 The site shall have a programme of management

meetings which enable product safety, legality or
quality issues to be brought to the attention of
senior management for resolution.
Records of the minutes from these meetings shall
be maintained.

Interpretation
The site’s senior management needs to determine that the systems and procedures are effective in delivering the results required
in relation to product safety, legality and quality. The meetings are also to determine progress against the set objectives, setting
new ones and determining who is responsible within certain timescales. The meetings are required to be undertaken at regular
intervals, possibly monthly or quarterly. The evidence that such meetings occur would be minutes of the meetings and diarised
future meetings.

Example
The auditor is shown handwritten minutes from a meeting with senior management present. The minutes detail the progress
being made with the KPIs from the objectives set at the beginning of the year. The last agenda item is the date of the next meeting
at the beginning of the next quarter.

The auditor would accept the evidence.

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 CLAUSE FOUNDATION HIGHER

1.1.3 Management review meetings attended by the

site’s senior management shall be undertaken at
appropriate planned intervals, at least annually, to
review the site’s performance against the Standard
and the objectives set out in clause 1.1.2. The
review process shall include the evaluation of:

• previous management review action plans and

timeframes
• results of internal, second-party and/or
third-party audits (relevant to the scope of this
Standard)
• customer complaints and results of any
customer feedback
• product safety and quality incidents, corrective
actions, out-of-specification results and
non-conforming materials
• management review of the systems for product
risk assessment, changes in legal requirements
and process performance
• resource requirements.
Records of the meetings shall be documented and
used to revise the objectives. The decisions and
actions agreed within the review process shall be
effectively communicated to appropriate staff and
actions implemented within agreed timescales.

Interpretation
The management review process is an important part of the system. It usually takes place annually, although other shorter time
periods are acceptable. The review should be a specific meeting with a defined agenda. Topics discussed during other events,
such as a brief mention of safety matters in a weekly management meeting, do not constitute a review.

Note that this clause gives a list of aspects to be covered. All the bulleted points should be addressed. It is acceptable to consider
additional points relevant to the review, but not to omit any of the points listed in the Standard.

Second- and third-party audits are audits done by, or on behalf of, customers, or audits carried out by independent bodies (such
as a BRC audit).

Example
A company has not discussed resource requirements at a meeting because the senior manager does not think that financial and
staff information should be disclosed to the technical team.

It is a requirement to discuss resource needs. There is nothing in the Standard to say that detailed financial information has to be
revealed and the manager could have withheld sensitive information while still addressing the topic.

A non-conformity would result.

CLAUSE FOUNDATION HIGHER

1.1.4 The site’s senior management shall provide sufficient human and financial resources required to
produce and improve products safely and in compliance with the requirements of this Standard.

Example
The auditor notes that the quality manager has not attended the last risk assessment meeting, the internal audit programme is
behind schedule, and the pH meter normally used to measure the incoming raw material is out for repair (hence no tests are being

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undertaken). The quality manager explains to the auditor that she is really busy and does not have time to do the audits. Not only

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

this, but money is tight and there is no budget for a new pH meter.

The auditor will raise non-conformities against this clause concerning the goods-in process and the internal audit process as they
are not in line with the requirements.

CLAUSE FOUNDATION HIGHER

1.1.5 Where the site is certificated to the Standard, it shall ensure that announced recertification audits occur
on or before the audit due date indicated on the certificate.

Interpretation
A number of situations may arise when a late audit is acceptable. For example:

• the area around the factory is closed due to government restrictions

• the site is not operational as it is flooded or there has been a fire
• the auditor cannot travel due to severe weather
• there is a war in the region and the auditor is advised not to travel.
It is the responsibility of the site to adhere to the audit date and it would not be acceptable if the quality manager was ill or the
management team had other appointments.

Example
The site is overdue for the audit by one week and the management has no explanation for the lateness.

The auditor will raise a non-conformity during the subsequent visit.

CLAUSE FOUNDATION HIGHER

1.1.6 The site shall have a genuine hard copy or electronic version of the current Standard available with a
position statement and be aware of any changes to the Standard or protocol that are published on the
BRC website.

Interpretation
The site could subscribe to BRC Participate which would address the requirement to be aware of BRC publications and make the
Standard available in an electronic format. The site could also download a copy free of charge from the BRC Bookshop.

Example
The auditor asks to see the site’s copy of the Standard and is shown a printed copy. The auditor then asks to see where the
Standard came from and is directed to the BRC Participate website, to which the quality manager has access.

The auditor would accept the evidence.

CLAUSE FOUNDATION HIGHER

1.1.7 Where required by legislation, the site shall be registered with or approved by the appropriate
government agency and evidence of this shall be available.

Interpretation
This clause does not apply to all products. It refers to the requirement for some sites to be registered concerning the safe
production of their products. Auditors will expect to see evidence of up-to-date registration for the correct range of products. A
number of products require the licensing of the site and/or the product itself, while other products are subject to voluntary codes.

Cosmetics
Each cosmetic product must be notified to the European Commission using the Cosmetic Product Notification Portal (CPNP)
prior to placing the product on the market.

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The Food and Drug Administration (FDA) does not license cosmetics firms. However, state or local authorities may require
licensing or have other requirements you need to know about. The Voluntary Cosmetic Registration Program (VCRP) is an FDA
post-market reporting system for use by manufacturers, packers and distributors of cosmetic products that are commercially
distributed in the United States.

Medical devices
If you place certain medical devices on the EU market, you or your authorised representative (agent) must be registered with the
competent authority (national health regulator) in the EU state where you have an office or place of business. In the UK, the
Medicines and Healthcare Products Agency (MHRA) is the competent authority for the registration of medical devices. MHRA
will only register manufacturers or authorised representatives that have a place of business in the UK.

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and
distribution of medical devices intended for use in the United States are required to register annually with the FDA. This process is
known as establishment registration.

CLAUSE FOUNDATION HIGHER

1.1.8 A system shall be in place to close out non-

conformities raised with consideration of the root
cause.

Interpretation
Within the management team there needs to be an understanding of the techniques used to determine root cause when a
non-conformity is raised during a third-party audit. Normally there are 28 days (90 days for a first audit) to close out the issue
raised (corrective action) and in addition the site must determine the long-term corrective action in order to prevent recurrence.

CLAUSE FOUNDATION HIGHER

1.1.8 The site’s senior management shall ensure that the

root causes of non-conformities identified at the
previous audit against the Standard have been
effectively addressed to prevent recurrence.
A system shall be in place to close out non-
conformities raised at internal, second-party and
third-party audits, with consideration of the root
cause.

Interpretation
Within the management team there needs to be an understanding of the techniques used to determine root cause when a
non-conformity is raised during a third-party audit. Nominally there are 28 days (90 days for a first audit) to close out the issue
raised (corrective action) and in addition the site must implement the long-term corrective action in order to prevent recurrence.
The site’s senior management team is also required to review the effectiveness of the action taken.

Example
Applies at both foundation and higher levels
During the audit the auditor raises a non-conformity because a production record is incomplete.

Twenty days later the auditor is sent details of the closure of the non-conformities raised during the last audit. This includes a copy
of the internal audit of the production records which shows that all records were completed following a toolbox talk (an informal
group discussion that focuses on a specific issue). In addition, the site also sends information regarding the toolbox talk and a
‘five whys’ document showing the root cause of the issue, which was that the paperwork was used by several of the personnel,
some of whom took the paperwork to the processing area in order to record the data. This meant that on occasions the
paperwork was not available to the other team members and they sometimes forgot to add the data after the event.

The toolbox talk was not just a retraining exercise but the demonstration of a new way to capture the data for all staff using a
personal digital assistant (PDA).

The auditor would accept the evidence provided.

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1.2 O
 RGANISATIONAL STRUCTURE, RESPONSIBILITIES AND MANAGEMENT

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

AUTHORITY
The site shall have a clear organisational structure and lines of communication to enable effective management of product
safety, legality and quality.

Interpretation
If an organisation is well-structured with clear roles, reporting lines and responsibilities, it is much simpler to communicate with
staff and manage the site. This requirement applies to any type of site, whether small or large, and whether making simple low-risk
products or more complex items. In all cases the same principle applies, even though the actual structures needed may be more
complex in some cases.

CLAUSE FOUNDATION HIGHER

1.2.1 The site shall have an up-to-date organisation chart for key staff demonstrating the management
structure of the company. The responsibilities for the management of activities which ensure product
safety, legality and quality shall be clearly allocated and understood by the managers responsible. There
shall be clear evidence of who deputises in the absence of the responsible person.

Interpretation
There is a requirement for an organisation chart. The Standard specifies a chart, so text describing the organisation will not be
sufficient. Additionally, the site must clearly state who deputises for whom. This also implies that the deputy should understand
the requirements of the job they are deputising for. There may be more than one person deputising for another. Production, and
any associated problems, will continue when people are off sick or on holiday. It is unacceptable to produce unsafe products
because someone was absent, and action on withdrawals or recalls cannot usually be delayed until someone returns to work.
Even on a small site, written procedures that make arrangements to cover absence are required to remove any doubt as to who is
responsible for what – for example, by appointing deputies. It is particularly important that the site provides cover for the individual
with nominated responsibility for safety and quality. This is another indication of management commitment.

CLAUSE FOUNDATION HIGHER

1.2.2 The site’s senior management shall ensure that all employees are aware of their responsibilities. Where
documented work instructions exist for activities undertaken, the relevant employees shall have access
to these and be able to demonstrate that work is carried out in accordance with the instructions.
A senior member of staff should be identified with responsibility and authority to stop production, if
required.

Interpretation
This clause requires that there are instructions for general work duties, which are communicated in addition to information
concerning particular product productions or individual items of equipment. Many general procedures – such as those for
methods of work, housekeeping and site systems – can contribute to the assurance of safe products and could, therefore, be
detailed. These general requirements may sometimes be part of a job description or contained in a general site manual.

Detailed instructions on how to carry out specific tasks may be recorded in work instructions. These documents contain the
practical details of how to carry out tasks in a form easily understood by the employee. They can be pictorial, diagrammatic, in text
format or a combination of all three.

Examples
A company cleaner is provided with detailed instructions about cleaning duties. The site has a cleaning procedure covering
general requirements but the cleaner’s work instructions include:

• details of the area to be cleaned

• schedule to be followed
• how to clean – what materials to use
• how to dispose of waste materials
• how to fill in a log book to show that work has been completed.
The instructions are provided in simple text and in a language that the cleaner understands.

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The auditor would consider this to be satisfactory.

Production-line workers in a cosmetics factory have work instructions in the form of flow charts and diagrams, provided at each
station. These clearly show how to mix ingredients together, and include:

• how to check the formulation being made

• the order of adding chemicals
• how to transfer chemicals to the vat and control quantity
• mixing time
• mixing temperature and how to record it
• what to do when batch mixing is complete, and how to sign off
• how to record the batch production.
The instructions provided are referenced, approved and dated. The individual formulations are also recorded and approved and
have to be checked by a supervisor before production begins.

The auditor would check that all aspects of the batch-mixing production are properly included and can be understood by the
employees.

Production-line workers in a television factory have work instructions in the form of flow charts and diagrams, provided at each
station. These clearly show how to assemble the components, and include:

• how to check the circuits

• the order of assembly
• how to ensure that there is no possibility of static
• solder bath temperatures
• Hi Pot test parameters
1

• what to do in the event of Hi Pot failure

• how to record the batch production.
The instructions provided are referenced, approved and dated. The individual specifications are also recorded and approved and
have to be checked by a supervisor before production begins.

1 Hi Pot stands for high potential. A Hi Pot test is used to test the insulation of a product far beyond the voltages it would normally encounter.

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2 PRODUCT RISK MANAGEMENT

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

FUNDAMENTAL
The site shall have a management process in place to ensure that a risk assessment is completed on each product
group to ensure safety, legality and quality in the regions of intended sale, where known.

Interpretation
This fundamental clause is about the management of the scheme and ensuring that information is available to support full risk
assessments. It stresses that the management must be comprehensive and systematic, so the availability of a few isolated risk
reports on a small proportion of products would not be deemed sufficient. The concept of risk should be integral to the whole
operation. This is a fundamental clause because an understanding of risk and management of the procedures and processes
using a risk-based approach is essential to the implementation of the Standard. Auditors will look for systematic product and
process risk assessments, and decisions made on the basis of risk.

The whole clause has been deemed fundamental, rather than individual subclauses, because each part is important to the
operation of a site in conformity with the Standard.

In order to decide whether a product is likely to cause injury it is helpful to review past injury data. Finding information and data
about injuries that have occurred can be difficult. Sites may have their own information resulting from customer complaints (or lack
of complaints), and information may be available from the authorities. Details provided with product recalls may also highlight
injuries that are known to have occurred.

The USA has a website which gives detailed injury reports: www.cpsc.gov/LIBRARY/neiss.html

The European injury database also gives some information on types of injury: https://webgate.ec.europa.eu/idb

2.1 LEGISLATION AND SAFETY REQUIREMENTS

CLAUSE FOUNDATION HIGHER

2.1.1 The site shall have a system to demonstrate knowledge of all applicable legislation, product standards
and product safety issues in the place of production and regions of intended sale of each product. This
may be within the company or by use of external expertise.

Interpretation
The site may have access to applicable websites such as:

• http://eur-lex.europa.eu/
• http://www.legislation.gov.uk/
• https://www.usa.gov/
• http://www.lawinfochina.com/
An affiliation with test houses, trade associations and consultants will also support the information requirements.

Examples
Set out below are some examples of legislation for different products from around the globe. Legislation changes on a regular
basis, and although great care has been taken to ensure this is correct at the time of issue, the legislation will need to be reviewed
to ensure it is up to date. Also, you should refer to the general legislation and/or product-specific legislation as well as codes of
practice.

United Kingdom and Europe

In the UK the Sale of Goods Act 1979 requires that all products must be ‘fit for purpose’, of satisfactory quality and fit their
description. This means that your products must fulfil the purpose the customer has been led to expect and the reasons that led
them to buy it. Consumers are protected by the Consumer Rights Act 2015.

In the EU, the General Product Safety Directive (GPSD) 2001/95/EC refers to products that do not have specific regulation.

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The Waste Electrical and Electronic Equipment Directive (WEEE Directive) is the European Community directive 2012/19/EU on
waste electrical and electronic equipment (WEEE). This, together with the RoHS Directive 2002/95/EC, became European law in
February 2003.

In Europe the consolidated version of the Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the
registration, evaluation, authorisation and restriction of chemicals (REACH) sets out, among other things, that AZO dyes (which
may release one or more of the 22 aromatic amines in detectable concentrations, above 30 ppm in the finished articles or in the
dyed components) may not be used in textile and leather articles that may come into direct and prolonged contact with the
human skin or oral cavity.

Since Annex XVII of REACH came into force in 2009, the AZO Directive 2002/61/EC has been replaced by the REACH regulation.
AZO dyes are now on the REACH restriction list.

Washing powders and detergents are regulated by EC Regulation EC No 648/2004 on detergents. The regulation establishes
common rules to enable detergents and surfactants to be sold and used across the EU, while providing a high degree of
protection to the environment and human health. The 2012 amendment introduced new limits to reduce the damage phosphates
from detergents may have on ecosystems and water quality, which is a phenomenon known as ‘eutrophication’.

For cosmetics in Europe, the following legislation applies:

• EU Cosmetics Directive 76/768/EEC

• New Cosmetic Products Regulation (EC)1223/2009.
CE marking applies to a range of products, from electrical equipment to toys and from civil explosives to medical devices.
CE marking is covered by the following legislation:

• 2001/95/EC: (New) General Products Safety Directive

• 93/68/EEC: ‘CE Marking’ Directive
• 93/465/EEC: Conformity Assessment Procedures & CE Marking Rules.
Even if your product is manufactured outside the EEA, you must ensure that it bears CE marking if it comes under the scope of a
directive requiring CE marking. Not all products sold in the EU need to bear CE marking.

The following categories of product require CE marking if you wish to sell them within the EU or member states of the EEA:

• toys
• electrical products
• construction products
• pressure vessels
• telecommunications equipment
• medical devices
• machinery, equipment and safety components
• personal protective equipment
• satellite station equipment
• gas appliances
• pressure equipment
• appliances (other than gas)
• non-automatic weighing instruments and equipment
• measuring instruments
• recreational craft
• lift machinery
• equipment and protective systems for explosive atmospheres
• in vitro diagnostic medical devices
• marine equipment
• safety components and subsystems for incorporation into cableway installations
• cableway equipment (ski tows etc.).

12 WWW.BRCGLOBALSTANDARDS.COM
China

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

In China the Restriction of Hazardous Substances (RoHS), officially known as the Administrative Measure on the Control of
Pollution Caused by Electronic Information Products, is a Chinese government regulation to control certain materials, including
lead. There are currently six substances considered environmentally hazardous by the China RoHS directive:

• lead
• mercury
• cadmium
• hexavalent chromium
• polybrominated biphenyls
• polybrominated diphenyl ethers.
The China RoHS does not allow any technology exemptions, unlike the EU RoHS 2 Directive.

The product quality law of the People’s Republic of China consists of two articles:

• Article 1 This law is enacted for the purposes of strengthening the supervision and administration of product quality,
improving product quality, determining the liability of product quality, protecting the legal rights and interest of consumers, and
safeguarding the social economic order.
• Article 2 Those who undertake the production and sale of products within the territory of the People’s Republic of China must
abide by this law.

United States of America

In the US consumers are protected by the Federal Trade Commission (FTC), which maintains and pursues law enforcement
through federal and state legislatures, including US and international government agencies. The Consumer Product Safety
Commission (CPSC) imposes new testing and documentation requirements and sets new acceptable levels for several
substances. Those affected include manufacturers of apparel, shoes, personal care products, accessories and jewellery, home
furnishings, bedding, toys, electronics and video games, books, school supplies, educational materials and science kits.

Toys and children’s products sold in the US are covered by HR 4040, the Act known as the Consumer Product Safety
Improvement Act of 2008. The sections that apply are as follows:

• 101 Children’s products containing lead; lead paint rule

• 102 Mandatory third party testing for certain children’s products
• 103 Tracking labels for children’s products
• 104 Standards and consumer registration of durable nursery products
• 105 Labeling requirement for advertising toys and games
• 106 Mandatory toy safety standards
• 107 Study of preventable injuries and deaths in minority children related to consumer products
• 108 Prohibition on sale of certain products containing specified phthalates.
Specific import–export provisions include:

• 221 Export of recalled and non-conforming products

• 222 Import safety management and interagency cooperation
• 223 Substantial product hazard list and destruction of noncompliant imported products
• 224 Financial responsibility
• 225 Study and report on effectiveness of authorities relating to safety of imported consumer products.
In the US the Lacey Act Amendments of 2008 prohibit the sale of certain animal-derived products, such as feathers, and wooden
products. It requires that no Lacey Act ‘prohibited species’ is sold and that the retailer shows ‘due care’. This means that a person
facing a particular set of circumstances must undertake certain steps that a reasonable person would take to do their best to
ensure that they do not violate the law. They should also check botanical resources, such as the Germplasm Resources
Information Network (GRIN) taxonomy, to confirm:

• the validity of any scientific names

• the geographic distribution.

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Additional non-Lacey regulations apply for products imported to the US.

Composite wooden products are also required to meet CARB-ATCM 91320/S.1660-formaldehyde emission from composite
wood products.

For cosmetics in the US, the following legislation applies:

• Safe Cosmetics Act of 2011 (H.R. 2359)

• California Safe Cosmetics Act (SB 484).
For cosmetics in Canada:

• Canadian Environmental Assessment Regulations

• Canadian New Substances Notification (NSN) Regulations.
CLAUSE FOUNDATION HIGHER

2.1.2 If the site relies on information concerning product safety, quality and legality provided by their customer
or a third party, it shall have a process in place to validate the credibility of the provider of the information
and retain evidence of this validation.

Interpretation
On large sites there may be a team which has the sole responsibility of following product safety information. Small sites, on the
other hand, may have no such specialist team and may just view safety as something that ‘gets in the way’ of production.

In many cases, sites rely on information supplied by their customers or independent consultants. This may take the form of a
customer quality or safety manual, or may be more specific to an order – such as, ‘We need a test report showing compliance
with … standard before we will accept this order’. Such information is helpful and forms a good basis, but the following should also
be considered:

• Customer information should be systematically stored and acted upon. It builds into a knowledge system about product
requirements.
• Customer manuals must be the current versions and checked frequently for updates.
• Customers are not always right. They may ask for the wrong tests or miss something important. Don’t assume they are right
and check from another source whenever possible.
• Back up any information from more than one source, such as trade association certification body newsletters, legislative
portals and websites.

When sites wish to sell their products in diverse geographical markets, often working in languages that they don’t understand,
this becomes more difficult. Whatever the system, it is vital to update it frequently as new issues emerge, and changes in
legislation and standard updates regularly occur.

The site can review the government sites (examples below) in order to ensure that the information is correct:

• Electronic Code of Federal Regulations (E-Cfr)

• legislation.gov.uk
• europa.eu/eu-law/index_en.htm
Example
A small giftware company has little expertise on product safety so it has signed up for safety updates from two independent test
houses and also to receive notification of all product recalls in its sector. The administrator is tasked with routinely checking this
information. The administrator has been on a short training course to help them understand the issues and has a contact at the
test house to consult for more information. The administrator is also responsible for logging any client requests concerning safety.

The auditor should find this satisfactory. A system appropriate to the level of the operation is in place and as information is from
various sources, cross-checking is also evident.

14 WWW.BRCGLOBALSTANDARDS.COM
 PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS
CLAUSE FOUNDATION HIGHER

2.1.3 The company’s senior management shall have a system in place to ensure that the site is kept informed
of and reviews:

• changes in legislation
• scientific and technical developments
• industry codes of practice
• new risks to raw materials, components, packaging and finished product.
Any changes shall be implemented in a timely and controlled manner or as defined by legal
requirements.

Interpretation
The best system of information gathering is of no use if the information is not acted upon. This clause ensures that any changes
are adopted in a timely manner. Most changes allow a reasonable time for implementation before they are enforced, and they may
require:

• additional cost
• redesign of product
• sourcing of new materials
• training of staff
• new packaging or labelling.
Procedures should be in place to ensure changes are adequately considered within an appropriate timescale.

CLAUSE FOUNDATION HIGHER

2.1.4 Copies of applicable legislation, standards, codes of practice and similar documents shall be available
to relevant staff.

Interpretation
The legislation may be accessible through the internet as long as the relevant personnel can have access to the documents.
Codes of practice may come directly from the customer and these should be implemented into the systems and procedures. Any
changes should be reflected through the system.

2.2 PRODUCT RISK ASSESSMENT

CLAUSE FOUNDATION HIGHER

2.2.1 The company shall ensure that a product hazard and risk assessment is undertaken for each product or
product group. The assessment shall be documented and include:

• a description of the product assessed (for example, approved samples or mock-ups, sample
drawings, computer graphics, photographs, specification)
• the intended use of the product and foreseeable abuse conditions
• the hazards, the risk level for each hazard and whether the risk is acceptable
• the date performed, name of the person responsible and the evidence from which the assessment
was derived.
If the assessment indicates that a product may present an unacceptable risk to consumers, that product
shall not be produced by the site. If the product requires modification, a new risk assessment shall be
completed on the modified design.

Interpretation
This clause ensures that proposed designs and materials allow for the production of safe and legal products. A risk assessment of
the product design and materials is essential to ensure a safe and legal product. This assessment should address matters
such as:

• the materials used in the make-up – to ensure that they have the correct mechanical properties such as strength and durability
• the chemical composition of materials – to ensure that toxic or dangerous substances are not used
WWW.BRCGLOBALSTANDARDS.COM 15
• the assembly of the parts – to ensure that the materials work together (for example, the correct type of adhesive)
• the mechanical assembly – for example, screwing or gluing
• the technical features of the design – such as the shape of moulds or the fit of components.
It is likely that the assessment will be carried out over different stages, starting with the concept drawings and continuing until the
first pre-production samples are produced. Assessment of the product design should then continue based on feedback
obtained from all sources.

Once a site is in routine production, it may not be necessary to carry out a complete assessment for every variant. However,
changes should not be made without an assessment of the new parts or materials, and the likely effect on the product.

Sites may be concerned about sharing confidential information, formulations and design details with the auditor. Auditors must be
able to view sufficient information to ensure that the site has made a complete risk assessment. All audits are confidential between
the site and the auditor. No proprietary or design/formulation information is released on the audit report and the site can decide
whether to allow its report to be viewed by third parties.

It may be that the product design is supplied to a site and that the site has no input into the risk assessment of the product. In these
situations, a site sometimes thinks that the risk assessment process is not relevant, and that all it needs to do is produce items to
the specification it has been given. This misconception has caused a number of unsafe products to reach the marketplace.

When the product design is supplied to the site it is essential that the site:

• has a formal written specification

• is provided with a validated copy of the risk assessment, if this exists
• is able to carry out an assessment or commission an assessment if one does not exist. If an assessment is commissioned the
site must validate the capability of the external party to conduct the risk assessment
• has formally agreed to abide by the content
• has a system in place for communicating key information to the workforce and back to the specifier, if necessary
• has a procedure for taking the design risk assessment and producing a process risk assessment, establishing any key control
points in the process.

It is not acceptable for a site to produce an unsafe or illegal product because it was supplied with a faulty design brief.

Example
A candle maker has a design of candle which it has made and sold successfully and safely for many years in a range of colours. It
decides to add a dark red colour to the range and assumes it will be satisfactory because of its record.

The company receives several complaints about candles flaring up, and is informed of one fire incident. On investigation, it is
found that the red pigment affects the burning characteristics of the wax, giving rise to high, smoky flames and unstable burning.
A check of the pigment characteristics or a test burn following a risk assessment of the change to the original product may have
avoided these problems.

A hair dye manufacturer has developed a system which it has made and sold successfully and safely for many years in a range of
colours. It decides to add a dark red colour to the range and assumes it will be satisfactory because of its record.

The company receives several complaints about skin irritation, and is informed of one serious skin complaint. On investigation, it
is found that the red pigment affects the characteristics of the product, giving rise to higher sensitivity in some users. A skin trial of
the pigment characteristics following a risk assessment of the change to the original product may have avoided these problems.

CLAUSE FOUNDATION HIGHER

2.2.2 The risk assessment shall be produced by suitably trained and competent internal or external resources.
Evidence of this shall be available unless the risk assessment is provided by the customer.

Staff with responsibility for decision-making shall be trained to ensure they understand risk assessment
procedures or outcomes necessary for their activity.

16 WWW.BRCGLOBALSTANDARDS.COM
Interpretation

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

In order to conduct a satisfactory risk assessment, the manager in charge (risk assessment team leader) must be competent and
the rest of the team should understand the principles that are used. Methods of risk assessment could include:

• Design Failure Mode Effect Analysis

• Fishbone or Ishikawa diagram
• Hazard Analysis Critical Control Point (HACCP).
It is very unusual for one person to be able to carry out the entire assessment; it is likely that a team of people will be required. For
example, an engineer who can evaluate the strength of a moulding may not be able to evaluate the toxicity of the materials used to
make the product.

A suitable team should be assembled to cover all aspects and there should be a designated responsible person of sufficient
authority to approve the outcomes. The team must have the commitment of senior management.

This does not mean that a whole range of staff has to be employed for the purpose. While this may be appropriate for very large,
complex operations, it is more likely that the duties will form just a part of someone’s job, or external resources will be used. There
are numerous third parties that provide risk assessment services, but they must be correctly briefed about the site’s products and
processes. The final responsibility for the risk assessment will rest with the site producing the items and, at the very least, a staff
member at the site should coordinate and be responsible for the assessment.

For a product risk assessment, the team is likely to include some of (but is not limited to) the following:

• designers
• chemists
• materials scientists
• human factors specialists, such as ergonomics experts or child psychologists
• engineers
• quality assurance staff
• line operatives
• hygiene staff
• legal staff.
CLAUSE FOUNDATION HIGHER

2.2.3 The site shall determine and maintain up-to-date information about the legislation and mandatory
standards applicable to each product and to the materials from which it is made, relevant in the regions
of intended sale.

CLAUSE FOUNDATION HIGHER

2.2.4 The risk assessment shall be reviewed at least annually, and following any significant complaints or
incidents, to ensure that the assessment remains up to date, and reflects any changes in specification,
manufacturing process and legislation.

Interpretation
A regular review is necessary because new safety information may have been published, there may have been recalls of similar
products or the legislation may have changed. In general, consumers’ expectations of safety increase over time. A good example
is passenger cars, which originally did not have seat belts and, until recently, did not have air bags. Electrical equipment was
purchased in the past without a ‘plug top’ whereas today all electrical items come with a plug top fitted, thus reducing the
incidence of electrocution due to poorly fitted plug tops.

Reviews can be carried out more frequently if required. Where products are made for less than a year and the risk assessment is
no longer relevant to production, there is no need to conduct a full review but any complaints or incidents relating to products no
longer in production should still be part of a review process. The review should be carried out by those responsible for risk
assessments and a summary reported to senior management as part of the overall system review.

WWW.BRCGLOBALSTANDARDS.COM 17
Examples
A company has a good system and most of the documentation is in order. The auditor finds that the risk assessment has not been
reviewed following a change of supplier for a component.

Following further investigation, although the component has had no detrimental effect on the product, the auditor is likely to raise
a minor non-conformity. The company needs to take care that the system is operated correctly but there are no real concerns that
there is a breakdown of the system or that product safety is compromised.

A company has some risk assessments documented but they are not signed or dated. It is not completely clear whether
assessments have been reviewed in the past 12 months.

This would warrant a major non-conformity as the Standard is systematically not being adhered to. It is not a critical non-
conformity as some aspects of the Standard are in place and the auditor does not consider that the lapse will result in an unsafe or
illegal product.

A factory has a team responsible for carrying out a risk assessment of product design. There are representatives from the design,
production, quality assurance and management teams and all team members have had training in risk assessment. Each product
idea is passed to the team at each stage of development and a full report produced and signed by the team leader. Any additional
external resources or information are included in the documented risk assessment pack along with the team findings.

Procedures have been followed correctly and an auditor would be satisfied by this approach.

CLAUSE FOUNDATION HIGHER

2.2.5 Where there is a legal requirement to do so or when it is necessary to confirm its safety or legality, a
representative product should be submitted for testing to a suitably qualified and, where applicable, an
accredited laboratory (internal or external). The results of the test should form part of the risk
assessment.

Interpretation
This clause addresses the specific cases when testing of a product that is representative of overall production must be carried out
because of legislation.

It will often be the case that the allowed test organisations are also specified. This would be true, for example, of a toy, a cosmetic
product or children’s clothing, or indeed any product requiring CE marking.

Example
The two most important laws pertaining to cosmetics marketed in the United States are the Federal Food, Drug, and Cosmetic
Act (FD & C Act) and the Fair Packaging and Labeling Act (FPLA). The FDA regulates cosmetics under the authority of these laws.
The FDA advises manufacturers to use whatever testing is necessary to ensure the safety of their products and ingredients. The
companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their
products.

CLAUSE FOUNDATION HIGHER

2.2.6 Where legally required, the identity, competence, qualifications and/or licence of the person producing
the safety review or risk assessment shall be documented and verified.

Interpretation
A competent person is someone who has sufficient training, experience, knowledge and other qualities that allow them to assist
the site properly. The level of competence required will depend on the complexity of the situation and the particular help needed.

Examples
In US law, competence concerns the mental capacity of an individual to participate in legal proceedings or transactions, and the
mental condition a person must have to be responsible for his or her decisions or acts. Competence is an attribute that is
decision-specific.

18 WWW.BRCGLOBALSTANDARDS.COM
In Europe the Cosmetics Products Regulation (EC) 1223/2009 requires there to be a ‘responsible person’. This is the person or

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

business within the EU who places a cosmetic product on the market. It may be any one of the following persons:

• the manufacturer (if based within the EU)

• a representative of the manufacturer appointed under a written mandate
• the importer of the product into the EU
• a representative appointed under written mandate by the importer into the EU
• a distributor who modifies a product already on the market or by applying its own name or trade mark to the goods (i.e. own
branding).

2.3 PRODUCT LABELLING AND CLAIMS

CLAUSE FOUNDATION HIGHER

2.3.1 The site shall verify that information shown on primary (consumer) package labels and outer cartons is
correct and meets the regulatory and safety requirements of the region of intended sale.

Interpretation
Because consumers usually receive products in some type of packaging, the specification of the packaging can be as important
as the product itself. For many products there are regulatory requirements about the amount of packaging that can be used, its
composition, and labelling or marking requirements. The site should assess and document its packaging in this respect.

Mislabelling is a common problem. Labels should be stored appropriately and separated to prevent confusion. This is particularly
important when different language versions of a similar label are being used. Care should also be taken to use labels in order of
production so as to prevent old, out-of-date stock remaining and being inadvertently used. Likewise, products and labelling need
to be carefully monitored during changeover periods to ensure that the correct labels are applied.

Sites should ensure that the responsibility for all language versions of label copy is clearly defined. It is expected that this
information would be part of the technical file.

Examples
Cosmetics
The two most important laws pertaining to cosmetics marketed in the US are the Federal Food, Drug, and Cosmetic Act (FD &
C Act) and the Fair Packaging and Labeling Act (FPLA). The FDA regulates cosmetics under the authority of these laws.

Household products
A site produces bleach. It sells the item in a bottle with a child-proof opening but it considers that there is still a small risk of
someone ingesting the bleach.

It has labelled the bottle with instructions on what to do if someone does swallow the bleach and provided an emergency helpline.
The bottle also has raised labelling in Braille so visually impaired people know its contents.

This would be acceptable to the auditor.

Nappy sacks
A site producing nappy sacks will need to take into account the risk of suffocation to babies where a sack has not been properly
disposed of. Appropriate packaging must be labelled with clear warnings.

CLAUSE FOUNDATION HIGHER

2.3.2 The site shall have a process in place to ensure that any claims made about a product shall be fully
validated to ensure that products meet the stated claim.

Interpretation
The claims made most frequently for a product are about size, weight, volume or quantity. Sites need documented procedures to
check that any claims made are accurate.

The tolerable negative error is related to the nominal quantity. It varies between 9% on pre-packages nominally of 50 g or 50 ml or
less than 1.5% on packages nominally of 1 kg or 1 litre or more.

WWW.BRCGLOBALSTANDARDS.COM 19
In the US, the Fair Packaging and Labeling Act (FPLA or Act), enacted in 1967, directs the Federal Trade Commission and the FDA
to issue regulations requiring that all ‘consumer commodities’ be labelled to disclose net contents, identity of commodity, and
name and place of business of the product’s manufacturer, packer or distributor. The Act authorises additional regulations where
necessary to prevent consumer deception (or to facilitate value comparisons) with respect to descriptions of ingredients, slack fill
of packages, use of ‘cents-off’ or lower-price labelling, or characterisation of package sizes. The Office of Weights and Measures
of the National Institute of Standards and Technology, US Department of Commerce, is authorised to promote to the greatest
practicable extent uniformity in State and Federal regulation of the labelling of consumer commodities.

Sometimes sites make particular claims about products – for example, ‘washable-ink pens’, ‘suitable for children 3 to 6 years’, ‘sun
protection factor 10’, etc. Whenever a claim is made, there should be evidence to substantiate that it is correct and justified. This
evidence must be documented and reviewed at intervals, and the methods determined.

Examples
A suntan lotion company has rated a product as factor 10. It has done this on the basis of copying a competitor’s formulation and
has no evidence to show that the factor is correct.

The auditor would find this to be a non-conformity and, depending on the technical information about the formulation, could
decide that the product was unsafe.

A company claims that its washing machine is the ‘quietest on the market’. Although this was true several years ago, the company
has not kept up to date with research. Several models are now available that are quieter; the claim is no longer valid and should be
removed.

An auditor may be aware of the situation and challenge the claim.

CLAUSE FOUNDATION HIGHER

2.3.3 Where applicable, the site shall ensure that product-in-use evaluation (internal or external), reliability
trials and shelf-life tests are validated. It shall be verified that the production of a safe and legal product is
maintained, taking account of the category of consumers at risk.

Interpretation
For products that claim a certain level of performance there needs to be evidence that they actually meet such claims. Products
such as cosmetics usually have a ‘best before end’ or ‘use after opening’ date on them and stability trails must be conducted to
ensure that the product is usable within these time periods.

For fabricated products, tests are usually necessary to establish that a product is fit for purpose and likely to endure for a suitable
(or guaranteed) use period – for example, light bulbs are tested to establish their minimum life.

It is expected that a site would provide documentary evidence to substantiate any statement regarding shelf life or minimum
durability, taking into account environmental conditions or usage that the product would need to withstand during the stated
period.

Example
A company producing shampoo labels the bottles with the net weight. The weight is described using the European average
weight system. The company is obliged to check a defined number of products and to record that the average weights are within
the defined acceptable tolerances.

The auditor is likely to ask to see an example of the records and, if they are not available, a non-conformity would be raised.

2.4 PACKAGING MATERIALS

CLAUSE FOUNDATION HIGHER

2.4.1 Packaging shall be assessed for fitness for purpose and found suitable with regard to:

• protecting the product from damage

• maintaining product integrity
• protecting the consumer from injury
• preventing contamination.
20 WWW.BRCGLOBALSTANDARDS.COM
Interpretation

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

Because consumers usually receive products in some type of packaging, the specification of the packaging can be as important
as the product itself. For many products there are regulatory requirements about the amount of packaging that can be used, its
composition, and labelling or marking requirements. The site should assess and document its packaging in this respect.

Additionally, the packaging must be suitable for its purpose in protecting the product from damage or contamination and itself
being safe when handled by consumers. The packing process must not increase the risk of producing an unsafe product. In this
respect there is legislation regarding the levels of heavy metals. This is enacted in the UK by The Packaging (Essential
Requirements) Regulations 2015 and in Europe the Council Directive on Packaging and Packaging Waste (94/62/EC).

The aggregate heavy metal limits apply to cadmium, mercury, lead and hexavalent chromium in packaging or packaging
components. They require that the total by weight of such metals should not exceed 100 ppm (subject to some exemptions).

Auditors will look for evidence of rejected packaging materials and will examine how the rejected material is treated. Such material
should be subject to the process for non-conforming products and suitably recorded, segregated, disposed of and reworked as
necessary.

Example
A company includes sachets of silica gel in its packing in order to keep products dry. The silica gel is contaminated with an irritant
chemical that causes injury to customers. The company is made aware of this through a product safety information sheet and
takes action to use a different material. It has documented the actions and removed the contaminated packets from stock items.

The auditor is satisfied that the company took appropriate action on packaging once the information became available.

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3 PRODUCT SAFETY AND QUALITY MANAGEMENT

3.1 PRODUCT SAFETY AND QUALITY MANAGEMENT SYSTEM

The site’s processes and procedures to meet the requirements of this Standard shall allow consistent application, facilitate
training, and support due diligence in the production of a safe and legal product to agreed quality.

CLAUSE FOUNDATION HIGHER

3.1.1 The site shall have an established quality management system (QMS) in place which is appropriate to
the size of business and risk associated with the products.
The QMS shall be fully implemented, collated in a navigable and readily accessible way, and translated
into appropriate languages if necessary.

Interpretation
Documentation may be produced and stored in several different ways, including electronic copies, databases, intranet systems,
photographs and diagrams. Records must be permanent (or at least have a defined lifetime) and therefore adequate storage or
back-up systems will be necessary.

This Standard does not specifically demand a quality manual, although there are many instances where documentation is
required and many sites will find it easiest to collate this into some kind of manual. If a manual is used it must be readily accessible
to those who need it.

3.2 DOCUMENTATION CONTROL

The site shall operate an effective document control system to ensure that only the correct approved versions of documents,
including recording forms, are available and in use.
Interpretation
When a document is changed, a record needs to be made of the change and the reason for it. This can be achieved by keeping a
copy of the previous version with the reason for change written on it, or by keeping a ‘history of amendments’ log.

In order to be useful, documents must be available where and when they are needed, and controlled so that there is no confusion
between different versions of the same document, out-of-date requirements, alterations made by writing unauthorised notes on
the margins of specifications, and other similar issues.

The method the site uses to control documents should be documented as a procedure or work instruction, so that any member of
staff producing documents understands the system and operates in the same way.

Examples
An auditor notices a print worker adding thinner to an ink and consulting a piece of paper that appears to give mixing proportions.
The piece of paper has no identification or date. When consulted, the print worker says that they had been given the instructions
by the person who ran the machine previously, and that this was always used to make sure the press ran smoothly.

A document that is important to the correct functioning of the process should be controlled and authorised. A non-conformity
would be raised.

An auditor notices that throughout the factory all documents appear suspiciously clean and new. Because they are in such good
condition, the auditor is unconvinced that people are actually using the documents. However, when the staff are consulted, the
auditor finds that they use the documents and are well informed, and that the quality assurance manager produced new copies of
everything the day before the audit to create a good impression.

This is acceptable and would not result in a non-conformity, although the extra work was unnecessary. The auditor expects to see
a working site and not a showcase. As long as the system is operating well, a little wear and tear is to be expected.

22 WWW.BRCGLOBALSTANDARDS.COM
 PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS
CLAUSE FOUNDATION HIGHER

3.2.1 The site shall be able to demonstrate that key The site shall have a document control procedure
documents which form part of the product safety to ensure that all key documents which form part
and quality system are identified with a version of the product safety and quality system are
number and issue date. effectively managed.
This shall include a list of controlled documents This shall include:
indicating the last version number.
• a list of all controlled documents indicating the
latest version number
• the method for the identification and
authorisation of controlled documents
• a record of the reason for any changes or
amendments to documents
• the system for replacement of existing
documents when these are updated.
Documents which are in electronic form shall be
suitably protected to prevent loss or malicious
intervention.

Interpretation
Applies at both foundation and higher levels
Documents need to be identified by, for example, an identification number, issue date, version number, author and approval
authority. Documents should show page numbers and the total number of pages (for example, page 4 of 7). A method for
rescinding previous versions, in part or in whole, should also be in place.

Note that the system for document control extends to the issuing of external documents, such as copies of standards (including
the Global Standard), customer specifications and legal information.

Examples of documents that need to be controlled include:

• product specifications
• procedures, such as those for supplier approval, or for selecting reference samples
• work instructions
• forms
• records
• other similar documents.
3.3 RECORD COMPLETION AND MAINTENANCE
The site shall maintain original, accurate, timely and legible records to demonstrate the effective control of product safety,
legality and quality.
Interpretation
Senior management is responsible for the procedures relating to overall control of records. It must ensure that the data is properly
collected, used, stored, reviewed and maintained.

Example
Loss of records often occurs as a result of wider changes in a company. A textile company is about to move to new premises and
the managing director decides to have a clear-out. Many old record boxes are sent for disposal by the site services manager,
without considering their content. The company installs a new computer system in its new premises. Unfortunately, some of the
record files use old software no longer compatible with the new system. Important records are lost by both actions.

This would result in a non-conformity. It highlights the importance of management commitment to, and understanding of, the
requirements of the Standard.

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 CLAUSE FOUNDATION HIGHER

3.3.1 Records shall be maintained in good condition and retrievable. Any alterations to records shall be
authorised and justification for alteration shall be recorded. Where records are in electronic form these
shall be suitably backed up to prevent loss.

Interpretation
Records are documents that contain evidence about past effects. They provide information to act upon and data to help with
continuous improvement. There should be a clear understanding of why records are to be kept and what purpose the information
will serve. In order to be useful, they must be legible and genuine. It is also essential that they are signed, dated and authorised so
that the person making the record can be identified and consulted as necessary.

Records relating to the safety, legality or quality of the products must be kept securely and in good condition so that they can be
consulted if necessary. There is no point recording every detail if, when needed, the records are found to have been lost,
destroyed or damaged.

Records are documented information about measurements or events. Examples include:

• a signed checklist to show each time pest control stations have been checked
• a control chart of tests done to check the strength of a seam
• the product release form from a goods-in department showing when each product was signed for release
• documented evidence of employee training.
There will always be occasions when mistakes are made and records need to be amended. Such amendments must be clear and
identified – for example, by simply crossing out a result, recording the correct one and initialling the change. If appropriate, a brief
reason for the change can also be included. The use of pencil (which can be erased) and correction fluid (which obscures the
original) is not acceptable for records. Records that store results electronically, whether by manual or automatic processes,
should have suitable security systems to prevent unauthorised changes. Auditors will ask for a demonstration of this.

Records must be true observations of the event at the time and should not be completed after, or even before, the event.

Data can be backed up in many different ways such as by having a cloud server or using a daily, weekly or monthly back-up to a
disc or tape from a mainframe server; usually these are kept off site.

Examples
An operator on a line producing fabric conditioner has a record sheet on which to enter the results of half-hourly pH checks. The
auditor notes that the operator has pre-initialled the column used to authorise results for the whole day, even though only two
readings have been taken.

This is a non-conformity and also may encourage the auditor to investigate whether similar methods are used by others.

An auditor is shown a data logger attached to a viscosity gauge in the same factory. The auditor asks the operator about an
unusual result. The operator says that it must have been a ‘rogue’ result, and deletes it.

A non-conformity would be raised as the record was changed with no evidence or authorisation.

A factory has a record of all knives, to whom they have been distributed, and when. The records also include evidence that all
broken parts of a knife are returned before a new one is issued. The record is signed by the distributor and receiver of the knives.

This is a satisfactory record and acceptable to the auditor.

CLAUSE FOUNDATION HIGHER

3.3.2 Records shall be retained for a defined minimum period with consideration given to:

• legal requirements
• the shelf life of the product
• customer requirements.

24 WWW.BRCGLOBALSTANDARDS.COM
Interpretation

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

The length of time for which a record needs to be kept (known as the retention period) depends on a number of criteria:

• Legal requirements in the country/regions of sale Some countries have minimum periods, especially related to product
liability laws.
• Customer requirements Some customers demand a minimum period. For example, baby diapers/nappies are stamped
with manufacturing date and, in some countries, an expiry date.
• Product lifetime This is a reasonable approach but may be difficult to determine in practice. An estimation of the lifespan of a
product should be part of a risk assessment.
• Time for any effects to have been realised For some products, this is simple. For example, once a piece of kitchen paper
has been used, there is not likely to be any further effect, but for some products, particularly chemical products with potential or
even unknown long-term effects, this can be very difficult. For example, some of the chemicals previously used in hair dyes are
no longer acceptable. In such situations, it is recommended that industry best practice is consulted, or records are kept for as
long as possible.

3.4 INTERNAL AUDIT

The company shall be able to demonstrate that it verifies the effectiveness of the product safety and quality requirements
implemented from the Global Standard for Consumer Products.
Interpretation
It is important to check periodically that any system is functioning and working as expected. This is why internal audits are
necessary and crucial in providing evidence that the site is committed to its safety and quality goals.

The BRC has published a separate guideline, Internal Auditing, which may be useful for those requiring more information.

CLAUSE FOUNDATION HIGHER

3.4.1 The internal audit shall consist of a scheduled

programme of recorded inspections by trained
staff to ensure that the factory environment and
processing equipment is maintained in a suitable
condition for production of safe and legal product
against GMP guidelines.

Interpretation
The internal audit schedule should be prepared in advance so that different areas or activities are scheduled throughout the year.
A single internal audit of all areas on a single day is not sufficient to cover the full requirements of an internal audit programme as it
will not provide the depth of assessment or level of confidence required.

Guidance on the internal audit process, as well as an example of an internal audit plan, is provided in the BRC’s best-practice
guideline, Internal Audit (Issue 2). The plan includes areas that need auditing along with a proposed schedule for completion. The
example also highlights that the frequency of internal audits may vary; activities in key areas such as hygiene, good manufacturing
practice, foreign body risks and critical control points (CCPs) need to be audited more frequently than those in some other areas.

How often an area is audited may be influenced by risk, known issues within the company, best practice or customer
requirements. However, all activities should be covered at least once a year. The clause requires that documented inspections are
undertaken to investigate any contamination risk from the equipment or building structure, and takes account of areas such as
overhead beams, ceiling fittings, void areas, equipment contact surfaces and areas where dirt might accumulate and could easily
be missed from routine cleaning cycles.

The Standard does not specify a frequency for such inspections; this would depend on the site structure as well as the types of
product being produced. The auditor is likely to ask for a justification of the frequency chosen if they have doubts as to the
effectiveness of the inspections.

A record of inspections should be kept. Actions that are said to have been completed should be verified to prove that they have
been done and that they successfully address the non-conformity. It is essential that audits and follow-up actions are recorded
clearly and completely. If matters are not recorded, it is not possible for an auditor to verify that the work has been done, nor for the
site to refer to issues at a later date.

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 CLAUSE FOUNDATION HIGHER

3.4.1 There shall be a scheduled programme of internal

audits throughout the year with a scope which
covers the implementation of the process risk
assessment, GMP and documented procedures
to achieve this standard. The scope and frequency
of the audits shall be established in relation to the
risks associated with the activity and previous
audit performance.

Interpretation
The Standard requires that internal audits are scheduled and the scopes defined. This ensures that aspects of the Standard do
not get missed or glossed over and that, over a 12-month period, all departments and processes are covered.

Examples
A new quality manager is appointed in an electric toothbrush factory and enthusiastically sets up an ambitious and frequent
internal audit programme. Several months into the job, the quality manager realises the programme is unrealistic and cuts back
because some of the audits are not necessary. Unfortunately the change is not documented, nor is a new schedule devised.
When the auditor reviews the audits they discover that some aspects have been audited many times but others have not been
covered at all.

This results in two non-conformities: one because the documented audit procedure has not been followed, and two because
aspects of the Standard have not been audited.

Blades on a cutting machine have to be checked and cleaned or replaced weekly. An internal audit is scheduled at six-monthly
intervals to confirm that the records have been correctly completed. It shows, through interview, that the operative has been
following the procedure. At the same time, the operative’s training records are examined to demonstrate their competence. The
auditor records that the operative had the correct version of the procedure, followed it and was adequately trained. The auditor
also notes that the records of machine maintenance had been completed correctly since the last audit.

This is satisfactory.

CLAUSE FOUNDATION HIGHER

3.4.2 Internal audits shall be carried out by appropriately

trained, competent auditors. Auditors shall be
independent (i.e. not audit their own work).

Interpretation
Auditors are expected to have received training (internal or external) on how to audit and what the process entails. They will also
need to know how to report findings.

Many skills of internal auditing do not depend on technical knowledge of the process, but sometimes this will be required. It can
be difficult to source such knowledge from someone who is independent of the operation being audited. Internal auditors should
never audit their own work, since it will not be possible to remain objective, or the audit will not be viewed as objective. If this
situation arises, then the person responsible for internal auditing may need to seek external independent resources to assist with
the audit.

Example
A small company produces household cleaning materials and needs to carry out an internal audit of the use of dangerous
chemicals. This is carried out by the company engineer who finds that assessments have been made and a procedure is in place,
but still feels unable to evaluate whether the justifications for using dangerous chemicals are adequate.

There are several ways to handle this situation. The internal auditor should first check whether the evaluation has been validated
by another competent person. If not, the auditor could contact the trade association for further information, seek help from
another staff member or possibly employ an external resource for this matter. The company engineer should not just accept the
findings and hope that they are correct.

26 WWW.BRCGLOBALSTANDARDS.COM
A company has a documented procedure for how to calibrate a balance before use. An internal auditor can check that an

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

employee is following the requirements even if they do not actually know how to use the balance themselves.

This is satisfactory.

CLAUSE FOUNDATION HIGHER

3.4.3 The inspection programme shall be fully

implemented, and the results shall be reported to
a suitable person. Records of any non-
conformities and corrective actions shall be
available within agreed timescales and completion
verified.

CLAUSE FOUNDATION HIGHER

3.4.3 The internal audit programme shall be fully

implemented and tracked. Internal audit reports
shall identify conformity as well as non-conformity
and the results shall be reported to the personnel
responsible for the activity audited. Corrective
actions and timescales for their implementation
shall be agreed and completion of the actions
verified.

Interpretation
The audit programme may be scheduled according to department, procedures or by sections of the standard. Either way, the
system needs to be divided into manageable elements, then the trained independent auditors can be assigned to each element
at appropriate intervals and the frequency determined according to risk. The system needs to be kept up to date according to the
schedule. The results of the internal audit must demonstrate the positive points – for example, those areas that work well –
although any actions required need to be agreed. The timescale for implementation should ensure that corrections are actually
done and it should be clear who is responsible. It sets an expectation that can be reviewed against the actual result achieved.

A record of audits should be kept. Actions that are said to have been completed should be verified to check that they have been
done and that they successfully address the non-conformity. It is essential that audits and follow-up actions are recorded clearly
and completely. If matters are not recorded, it is not possible for an auditor to verify that the work has been done, nor for the site to
refer to issues at a later date.

Examples
A company has an audit schedule which it keeps to. Audit reports are available, but they only list the non-conformities found.

This results in a non-conformity and highlights the need for better training or procedures for audit reporting.

It is not possible to judge from the reports whether all aspects have been considered during the audits, since positive aspects are
not included in the report.

Following an internal audit, the site supervisor of a cosmetics factory has agreed to improve cleaning in the packing area. They
revise the cleaning schedule for walls and windows and document a new procedure within a month. The internal audit
subsequently contains an update note that the action has been delayed by a week due to illness. The action was implemented a
week later but was found to be satisfactory.

This would be acceptable. Although the deadline was missed, it was carried through in a reasonable period and the reason for the
delay was clear.

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3.5 SUPPLIER APPROVAL AND PERFORMANCE MONITORING
3.5.1 MANAGEMENT OF SUPPLIERS OF RAW MATERIALS, COMPONENTS AND PACKAGING
The site shall have an effective supplier approval and monitoring system to ensure that any potential risks from raw materials,
components or packaging to the safety, legality and quality of the final product are understood and managed.
Interpretation
This clause sets out the requirement for sites to control their purchasing of anything that affects product safety, legality and quality.
This includes not only raw materials but also components, subcontracted work, packaging materials, instruments, machinery and
possibly processing aids if they can result in unsafe products being produced. It is essential that potential suppliers are evaluated.

CLAUSE FOUNDATION HIGHER

3.5.1.1 The site shall have a defined and implemented

process for supplier approval, including a list of
approved suppliers of raw materials, components
and packaging impacting product safety, legality
or quality.
The approval of these suppliers shall be based on
at least one or a combination of the following:

• supplier questionnaire
• certificate of analysis
• supplier audits
• supplier certification with a scope covering the
products supplied
• historical evidence of good supply.
Interpretation
It is essential that sites work with reliable suppliers and that they know the basis on which they have chosen their suppliers. It is
increasingly necessary in some product sectors to be assured that suppliers not only supply to specification but also maintain
adequate traceability systems.

The precise methods of supplier approval are not prescribed and may vary depending on the items to be purchased and the level
of associated risk, as well as the supplier’s experience of working with the site. Whichever method is used, a documented
procedure is required. This should set out the procedures to be followed, whether a risk assessment has been conducted, the
records to be kept, the criteria for approval and how exceptions are to be handled.

CLAUSE FOUNDATION HIGHER

3.5.1.1 The site shall have a documented procedure for

supplier approval, including a list of approved
suppliers for products, materials and services
impacting product safety, legality or quality.
The approval of these suppliers shall be based on
at least one or a combination of the following:

• supplier questionnaire
• certificate of analysis
• supplier audits
• supplier certification with a scope covering the
products supplied.

Interpretation
Every new supplier of goods (or services) that could affect the safety and quality of the final product needs to be formally
evaluated to ensure that it is able to reliably deliver the specified products. Sites can either have a formal documented supplier-
approval system and checklist, or adopt a case-by-case approach. Either is satisfactory provided the key issues are addressed
and suppliers are reviewed at intervals to ensure that they continue to meet the criteria used for their initial approval and that their
products meet requirements.

28 WWW.BRCGLOBALSTANDARDS.COM
This performance review should include an assessment of how complaints are handled, their customer service in case of

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

problems, and the actual supply record.

CLAUSE FOUNDATION HIGHER

3.5.1.2 Documented procedures shall be established

which include clear criteria for ongoing
assessment of the standards of performance
required. Ongoing assessment may employ one
or more of the following or other acceptable
methods:

• in-house checks
• certificate of conformity
• supplier audits
• traceability checks.
Records of this monitoring shall be retained with
consideration given to legal requirements,
product shelf life and customer requirements.

Example
A company is purchasing paint with which to decorate baby cots. It has approved the supplier based on the fact that the supplier
has current ISO 9000 certification.

The auditor would not accept this without further research. Unless the factory is carrying out its own testing on each batch of paint
supplied, the approval process is unlikely to be sufficient. It would be more usual to insist that batches of paint are delivered with
certificates of analysis.

CLAUSE FOUNDATION HIGHER

3.5.1.3 Documented procedures shall define how

exceptions are handled; for example, the use of
products where audit or monitoring has not been
undertaken.
Based on a batch or delivery basis, the procedure
may involve the assessment of certificates of
analysis.

Interpretation
Only approved suppliers should be used, but as an exception a site may find that it either requires materials at short notice, or is
not in a position to wait for materials; for example, when an approved supplier has unexpected problems with delivery. If such a
situation might occur, the site must have a procedure in place to determine how to handle it and in what circumstances an
unapproved supplier can be used. Any instances when an unapproved supplier is used must be documented.

Example
A cosmetics company sources its perfumes from two approved suppliers but finds that both are having trouble supplying a
particular fragrance. Rather than stop production it sources from a third company, following its procedure for unapproved
suppliers. This requires the supplying company to fill in a self-assessment evaluation, for the batch of material to be tested before
use and a small trial run to be carried out.

An auditor would find this approach satisfactory.

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3.5.2 CONTROL AND ACCEPTANCE OF INCOMING RAW MATERIALS, COMPONENTS AND PACKAGING
MATERIALS

FUNDAMENTAL
The company shall have an effective process to ensure that incoming raw materials, components and packaging
materials are suitable for use and do not adversely affect the safety, legality or quality of the finished product.

Interpretation
Sites carry out internal product inspections at various points in production; this includes an inspection programme for incoming
components, subcontracted work or home work.

The requirements of the Standard mean that inspections are carried out on a defined and rational basis and that, in any
subsequent investigation, it can be seen whether the inspection checked the parameter in question and whether the sampling
programme was sufficient to highlight the levels of defects subsequently detected.

Further details of the requirements and technical details of inspection and sampling procedures are available in the international
standard ISO 2859 Sampling Procedures for Inspections by Attributes. Other similar, commonly used standards include Mil
Standard 105, ANSI Z1.4 and BS 6001.

Example
A company is producing skin lotion; it has carried out an assessment and established that if the water quality is not controlled,
there is a risk of product contamination. A further assessment shows that both the incoming quality of the water and the
cleanliness of interior pipes are important and that monitoring is required.

An auditor would look for the actions that have been put in place as a result of this evaluation.

CLAUSE FOUNDATION HIGHER

3.5.2.1 Raw materials, components and packaging shall

be checked on arrival to ensure they conform to
agreed specifications and any agreed acceptance
criteria, e.g. certificates of analysis.

Interpretation
It is vital that the correct raw materials and components are used for products. If the wrong materials are used, it is very unlikely
that products can be corrected at a later stage of production. This clause is therefore a fundamental requirement for all sites.

Incoming materials and components can be controlled in a number of ways, depending on the situation. They may require
testing, checking of certificates of analysis or conformity, visual inspection or other checks.

It is usual that accepted product can be identified in some way to help traceability, and to prove that it has been through an
acceptance procedure. Items and materials that are stored pending acceptance should be segregated so there is no possibility of
their being confused with accepted products. Similarly, any rejected goods must be labelled and segregated.

CLAUSE FOUNDATION HIGHER

3.5.2.1 Raw materials, components and packaging shall

have documented approval procedures to ensure
they conform to agreed specifications and
requirements, and documented positive batch
release.
Incoming goods, including materials returned to
site from subcontractors (and home workers), shall
be subject to a documented positive batch release
procedure.

30 WWW.BRCGLOBALSTANDARDS.COM
Interpretation

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

It is vital that the correct raw materials and components are used for products. If the wrong materials are used, it is very unlikely
that products can be corrected at a later stage of production. This clause is therefore a fundamental requirement for all sites.

Incoming materials and components can be controlled in a number of ways, depending on the situation. They may require
testing, checking of certificates of analysis or conformity, visual inspection or other checks, which should be described in a
documented procedure. The procedure should also specify the means of release of acceptable raw materials and components
and any labelling or recording requirements.

It is usual that accepted product can be identified in some way to help traceability, and to prove that it has been through an
acceptance procedure. Items and materials which are stored pending acceptance should be segregated so there is no possibility
of their being confused with accepted products. Similarly, any rejected goods must be labelled and segregated.

Any materials likely to affect the safety, quality and legality of a product must have written approval procedures.

It is a requirement that a positive release system is in place – i.e. someone has to check the delivery and approve it. The rationale
on which they make that decision should be clear. They might need to check that it is accompanied by a test report or they might
need to physically inspect it for size, colour or another parameter.

Example
A company has been using a chemicals supplier for a long time with no problems. The supplier is supposed to supply surfactants
with certificates of analysis but this is no longer checked, as there have never been any problems in the past.

This is not acceptable. If the approval procedure states this should be checked as goods come in, then that should be done and
documented. If this is inappropriate, the procedure should be reviewed, and a new approach documented and validated before
changes are allowed. This would result in a non-conformity.

CLAUSE FOUNDATION HIGHER

3.5.2.2 The company shall have a process to ensure that The company shall have a documented procedure
raw materials, components and packaging used to ensure that raw materials, components and
by home workers (when used and if authorised by packaging used by home workers (when used
the customer) are approved. and if authorised by the customer) are approved.

Interpretation
Applies at both foundation and higher levels
Work produced by home workers and the material they use must be controlled in the same way as work produced on site,
because the same safety or quality problems may occur. Home workers should have documented work instructions and any
equipment they use must be subjected to maintenance procedures and calibration as necessary. Home workers shall be made
aware of any issues concerning product safety that are pertinent to their work – for example, avoiding foreign-body contamination
or control of knives.

CLAUSE FOUNDATION HIGHER

3.5.2.3 The company shall have in place a process to The company shall have in place a documented
ensure the authenticity of raw materials, procedure to ensure the authenticity of raw
components and packaging to prevent fraud. materials, components, packaging and
documentation to prevent fraud.

Interpretation
Applies at both higher and foundation levels
This may necessitate some form of risk assessment, such as Vulnerability Assessment Critical Control Point (VACCP) or Threat
Assessment Critical Control Point (TACCP).

Further information on risk assessments is given in the publicly available specification PAS 96:2014 (free of charge) and ISO/IEC
27001:2013 (ISO 27001) for information security management systems (ISMS). See also the Global Standard for Food Safety
Issue 7: Understanding Vulnerability Assessment (UK).

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An assessment should be undertaken of what types of products are bought from where to determine whether there is a likelihood
of substitution or fraud. This should be followed by actions such as enhanced supplier approvals, shortening the supply chain,
mass balance exercise or extra audits of the supply chain. These actions may be supported by ‘horizon scanning’ to see if similar
products or materials have been affected.

Example
Applies at both foundation and higher levels
The auditor is shown a project undertaken on manuka honey used in a face cream. The data and research showed this product to
be vulnerable to substitution. Previously the site had bought this product through an agent but since discovering the issue has
now approved a source from a broker who purchases directly from the farm in New Zealand.

This would be accepted by the auditor.

3.6 SPECIFICATIONS AND TECHNICAL FILES

A system shall be in place to manage specifications and technical data for raw materials, components and packaging materials.
Interpretation
This clause covers two important but different needs:

• to have information about the materials and components used to make the product
• to keep all the technical information about the product itself.
It requires such information to be accurate and accessible within a reasonable period of time to those employees who need to use
it. The Standard refers to the collection of product information as the ‘technical file’.

In some product sectors there is a formal legal requirement to maintain a technical file. For example, in cosmetics it is referred to as
the product information file (PIF); this clause would also apply to such files. It does not mean that all the information has to be
physically available on one file at all times, but it has to be available for each product; it can be assembled from different sources if
necessary.

In some countries and for some products (for example, electrical products in the EU) there is a legal requirement to produce such
a file for the authorities within a defined timescale and in a language they can understand. It is therefore advisable to test and
ensure that a technical file can be assembled from the available information if it is stored in a variety of locations.

Some industry sectors call these collections of data ‘product information packages’ or ‘job bags’. It does not matter what the
information is called, as long as the content is correct. The site must be aware of what comprises its technical file, even if it is not in
one place. This can be achieved, for example, by keeping a list of documents considered to form the file and their location.

CLAUSE FOUNDATION HIGHER

3.6.1 Suitably detailed and accurate specifications shall be held for all raw materials, components, packaging
materials and finished products to ensure compliance with relevant safety, legislative, quality and
customer requirements. The specifications shall be accessible to relevant staff and the company shall
seek formal agreement of specifications with relevant parties.

Interpretation
The correct materials and components are essential to the safety and quality of the product. If items are not clearly specified or
bought on well-defined specifications, it is likely that they may be unsuitable for the purpose. The supplier cannot be responsible
for supplying the wrong grade of material if it has not been correctly specified. The use of inadequate components and raw
materials has caused many product failures and safety issues.

The specification must relate to the safety and quality and not just the performance or physical characteristics of the product. If
the site is manufacturing a customer’s own-label product it is essential that there is a documented agreement regarding the
specification of the finished product and the materials used.

32 WWW.BRCGLOBALSTANDARDS.COM
 PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS
CLAUSE FOUNDATION HIGHER

3.6.2 A specification shall be available for each finished product and shall have been verified to ensure it is fit
for purpose, meets customer requirements and is compliant with relevant safety and legislative
requirements in the regions of intended sale.

• As a minimum, the specification may include the following, although this is not an exhaustive list:
• product name and description
• composition
• physical and/or chemical parameters
• assembly diagrams
• packaging
• labelling
• intended shelf life
• warnings
• instructions for use.
Examples
A qualified, board-registered toxicologist has assessed a cosmetic for safety and produced a favourable report. The American
company produces the material and ships it to another state. On the way, many of the bottles explode, contaminating products
and leaving sharp plastic parts in the boxes.

The toxicologist’s review was concerned with chemical safety. The site did not consider the physical problems of overfilling
bottles, or the build-up of pressure due to volatile components within the specification.

Auditors will expect to see that all aspects have been addressed by the risk assessment.

CLAUSE FOUNDATION HIGHER

3.6.3 Companies shall maintain the data in a technical file that is accessible to relevant staff containing all
relevant data (or details of where such data is located) to ensure that products meet the requirements of
the specification and legislative and customer requirements.
Relevant data may include:

• bill of materials
• safety data sheets on all chemicals used where relevant to the safety, legality or quality of the product
• risk assessment(s)
• description of the conformity assessment procedure
• test reports
• inspection reports
• list of the legislation and product standards with which the products are manufactured to comply
• production control procedures and charts
• approvals by any government body (if applicable)
• declarations of conformity to legal requirements (if applicable)
• self-inspection reports
• corrective actions.
Interpretation
The technical file should be the source of all technical information about the product. The list provided in the Standard is only
given to suggest the type of information required and is not exhaustive or compulsory. The actual information will depend on the
type of product being produced and specific requirements in the regions of intended sale. It should be treated as a ‘living’
document, updated when necessary by adding information as it becomes available. It is not something to set up at the beginning
of production and then forget about. The auditor will expect to see evidence that the technical file is being used.

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3.7 CORRECTIVE AND PREVENTIVE ACTION
FUNDAMENTAL
The site shall be able to demonstrate that it uses the information from identified failures in the product safety and
quality management system to make necessary corrections and prevent recurrence.

Interpretation
There are many different ways in which non-conformities are discovered, both internal and external – for example:

• Problems may be noticed internally by inspection, or quality assurance staff or operators working at the packing lines.
• Evidence may come via internal audits or routine reviews.
• Externally, non-conformities may be found during customer or third-party audits, customer complaints, or actions of
enforcement agencies.

A site needs to have an efficient means of recording and investigating actual and potential non-conformities and reporting the
findings. Even if, on investigation, there is no actual non-conformity, the investigation should still be recorded and it may help if the
problem recurs.

The Standard requires issues to be investigated in a ‘timely’ way. It does not define ‘timely’, but auditors would expect the site to
have some requirements or guidelines in place that specify the timescales appropriate to the level of risk to the consumer.

CLAUSE FOUNDATION HIGHER

3.7.1 The company shall operate an effective system for

the capture, recording and timely corrective
actions of non-conformities or matters reported as
possible non-conformities critical to product
safety, legality or quality.

CLAUSE FOUNDATION HIGHER

3.7.1 The company shall operate an effective

documented process for the capture, recording
and timely investigation of non-conformities or
matters reported as possible non-conformities
critical to product safety, legality or quality.

Interpretation
It is essential that sites have good systems in place to discover, record and investigate cases where their products or procedures
fall short of requirements. Sites failing to demonstrate that they have a robust system will not be certified because they will not be
able to give the auditor confidence in their ability to reliably place safe and legal products of agreed quality onto the market.

CLAUSE FOUNDATION HIGHER

3.7.2 An appropriate staff member shall be identified

and assigned the responsibility and accountability
for each corrective action. This shall be
documented.

Interpretation
The Standard requires that a named individual is responsible for each identified corrective action. This has been found to be one
of the most reliable ways of ensuring that actions are completed, and avoids any confusion. It does not mean that one person has
to do all the work to correct the non-conformity; in many cases this is likely to be a team effort. The responsible person must,
however, be documented and held accountable for the successful completion of the corrective action.

Agreement of the actions is required, along with the timescale for implementation, to ensure that corrections actually get done
and that it is clear who is responsible. It sets an expectation and can be reviewed against the actual result achieved.

34 WWW.BRCGLOBALSTANDARDS.COM
Example

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

The site supervisor of a cosmetics factory has agreed to improve cleaning in the packing area. They revise the cleaning schedule
for walls and windows and document a new procedure within a month. The internal audit subsequently contains an update note
that the action has been delayed by a week due to illness. The action was implemented a week late but found to be satisfactory.

This would be acceptable.

Although the deadline was missed, it was carried out in a reasonable period and the reason for delay was clear.

CLAUSE FOUNDATION HIGHER

3.7.3 The company shall ensure that corrective actions The company shall ensure that effective corrective
prevent recurrence of the problem and shall actions are taken to prevent recurrence of the
monitor and record their completion. problem and shall monitor and record their
completion within an appropriate timescale.

Interpretation
Applies at both foundation and higher levels
The Standard requires sites to investigate non-conformities in order to understand the root cause of the problem and to put in
place a sustainable solution that will prevent recurrence. This clause also requires the completed action to be carried out within an
appropriate timescale, and to be recorded.

Example
A wet-wipe manufacturer has found a non-conformity during an internal audit. The liquid solution pH was found to be not to
specification which meant that there was a risk that the product would be vulnerable to mould growth. The problem was
investigated and it was found that the mix setting had been altered. The setting was corrected, checked and the non-conformity
was signed off.

The company is surprised to receive a non-conformity for this, because everything had been properly documented. However, it
did not address the part that prevents recurrence (root cause). The company did not try to find out why the setting had been
changed and how this could be prevented, and therefore did not try to discover the root cause of the issue.

CLAUSE FOUNDATION HIGHER

3.7.4 The company shall review its processes at least

annually and adopt preventive measures as they
become available.

Interpretation
This clause is self-explanatory and requires an annual review to ensure that appropriate measures are adopted and new ideas
taken up when appropriate. Sites would be expected to review the recurrence of similar issues and take action to investigate the
causes, rather than just deal with issues as they occur.

A summary of this data, any obvious trends and the effectiveness of corrective actions taken as a result of it, should be part of the
annual management review.

3.8 CONTROL OF NON-CONFORMING MATERIALS

The company shall ensure that non-conforming raw materials, packaging, components and products are clearly identified,
labelled, quarantined, investigated and documented.
Interpretation
Auditors will look for evidence of rejected packaging materials and how the rejected material is treated. Such material should be
subject to the process for non-conforming products and suitably recorded, segregated, disposed and reworked as necessary. It
is vital that non-conforming products or materials cannot be mixed up with ‘good’ items. All non-conforming raw materials,
components, products and packaging must be identified, segregated and investigated. Non-conforming materials include any
items that do not meet the stated specification and are not just those that are considered to give rise to a safety or legal problem.

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 CLAUSE FOUNDATION HIGHER

3.8.1 Clear procedures for the control of non-conforming materials and products, including customer returns,
shall be in place and understood by all relevant, authorised personnel. These shall include effective
identification and quarantining before a decision has been made on the final disposition of the non-
conforming product by rejection, acceptance by concession or regrading for an alternative use.

Interpretation
Procedures are required so that employees know what to do when a non-conforming material is discovered. If the actions
required are not clearly stated, there may be a tendency to ignore the problem.

In some cases, a non-conforming material may be suitable for an alternative use – for example, a plasticiser unsuitable for
children’s toys may be satisfactory for adult products. In other cases, a material that falls slightly outside the agreed tolerance may
still be usable without a major problem – for example, a plastic master batch for a bucket manufacturer that is the wrong colour.

If concessions are made to allow use, there must be a written procedure for this and all concessions documented and authorised.
The reason for the existence of all non-conforming materials must be investigated, ideally to prevent recurrence. Reduction in
rework should inform a site’s KPIs and should be reviewed as part of an internal audit. Procedures are also required to ensure that
the subsequent use, return or disposal of non-conforming materials is handled and documented correctly. The product to be
reworked must be subject to the methods and inspection or testing requirements that are in place for production.

A procedure for the disposal of unsafe or non-conforming material must be available and fully implemented.

If unsafe or non-conforming products are allowed to be removed from a site without proper disposal, there is a risk of their
reaching the consumer or being confused with good products. It is possible to use products as ‘seconds’, provided there is no
safety or legal issue and that it is not a breach of customer requirements. Any such products must, however, be identified
separately from ‘good’ products.

In cases where it is warranted, auditors would expect to see that disposal had been observed and signed off by a site
representative or suitable independent third party, or carried out by an approved professional contractor.

Example
A company has rejected some plastic mouldings because the shape is incorrect. The items are segregated and sent to be ground
up. The material is to be used as ‘regrind’ and added into the mix for another product at 8% of the total. Before the material is used,
it is subjected to testing to ensure that the content of toxic elements is within the allowed limits. Pre-production samples of the
product are prepared to ensure that the physical performance is appropriate. The material is also checked for homogeneity. All
the procedures are documented.

The auditor finds this acceptable. The auditor also reviews the records and test results for the products made with this material to
ensure that they conform to specification.

3.9 TRACEABILITY
FUNDAMENTAL
The site shall be able to trace all raw materials, components and packaging from its suppliers through all stages of
processing and dispatch to its primary customers, and from the customer back to the supplier.

Interpretation
It is worth remembering that a good traceability system makes sound business sense and prevents or limits the scope of recalls or
withdrawals of product. The best traceability systems incorporate a tool, such as mass balance, for reconciling quantities of
bought-in raw materials, components and packaging with finished product. To this end, the auditor will need to see not just
traceability from the customer to the supplier and from the supplier to the customer, but also where else a component or material
has been used.

Additionally, Global Standards auditors are required to carry out a full vertical audit which entails reviewing each and every step of
the production process following the traceability of a product.

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 PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS
CLAUSE FOUNDATION HIGHER

3.9.1 The site shall have a system in place which has the ability to trace and follow all raw materials,
components and packaging materials from the supplier through all stages of processing and
distribution of the finished product, and vice versa, in a timely manner.

Interpretation
This is a fundamental requirement because it is vital that stock can be traced in order to take appropriate action. There are two
aspects to consider:

• tracing back to suppliers’ raw materials and components used within the site to produce the products
• tracing forward finished products to the initial customers (i.e. retailers or wholesalers who have purchased the items). In some
cases, it will be a legal or customer requirement that products (for example, motor cars) can be further traced, perhaps even to
the final consumer.

It is worth remembering that a good traceability system usually makes sound business sense and prevents or limits the scope of
unnecessary recalls or withdrawals of product.

Example
A company sources bottles for its children’s sunscreen products from three separate suppliers and places them all in a single
storage bin. It is subsequently informed by one supplier that one of the batches of bottles did not pass a migration test. The
company has to withdraw all the production as it cannot identify which bottles have been used with which products.

The company will receive a non-conformity because it did not have a system in place. The company will have also wasted time
and money recalling good products because it cannot distinguish them from bad ones.

CLAUSE FOUNDATION HIGHER

3.9.2 Identification of lots/batches of raw materials, including packaging, processing aids, intermediate/
semi-processed products, part-used materials, rework, finished products and materials pending
investigation, shall be sufficient to ensure traceability.

Interpretation
Lots or batches are easier to define in some industries than others. For example, a curtain manufacturer making curtains from one
roll of fabric might easily define that as a batch. On the other hand, a computer manufacturer assembling thousands of different
parts, all from different batches or even different suppliers, may need a more sophisticated process. If each product has a serial
number that uniquely identifies it, then it may become a batch of one. When products are made by a continuous production
technique, the site may need to adopt an empirical approach and define the batch in such a way as to limit the damage from any
issues that occur – for example, by using a date or hour code. The auditor may ask the site to explain the rationale behind the
selection of a batch.

CLAUSE FOUNDATION HIGHER

3.9.3 Finished product shall be identified with a unique Finished product shall be identified with a unique
code such as a batch code applied to the product code such as a batch code applied to the product
or packaging where legally required or specified or packaging.
by the customer.
Documented procedures must be in place to trace
Procedures must be in place to trace a finished a finished product back to the batch of raw
product back to the batch of raw materials or materials or packaging used.
packaging used.

CLAUSE FOUNDATION HIGHER

3.9.4 Subcontracted manufacture of products or components shall have prior customer approval and shall be
traceable to a level appropriate to the risk.

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Interpretation
‘Outer packaging’ is defined in the glossary of the Standard as the packaging visible when the product is released from the site. It
is likely to be, for example, a cardboard box or multipack rather than an individual consumer product unit. The Standard does not
require individual products to be marked unless this is a legal or customer requirement.

CLAUSE FOUNDATION HIGHER

3.9.5 The system shall be tested to ensure traceability can be determined from raw-material receipt to finished
product and vice versa. This shall occur at a predetermined frequency, at least annually, and results shall
be retained. The time taken to complete the exercise shall be measured and recorded.

CLAUSE FOUNDATION HIGHER

3.9.6 The need for extended traceability through the chain should be established on the basis of risk and any
legal or specific customer requirements. Where required, extended traceability shall be implemented.

Interpretation
The BRC publishes a best-practice guideline, Traceability, which gives more detail for those requiring further information. It
includes examples of methods to be used and case studies. Therefore, this guideline does not address each subclause of section
3.9 in detail but offers further clarification on subclauses 3.9.2 and 3.9.4.

3.10 COMPLAINT HANDLING

The company shall operate an effective system for the capture, recording and investigation of product complaints at all levels of
severity.
Interpretation
This clause of the Standard covers customer complaints about safety, quality or legal issues. The system for recording complaints
may be much wider and may include issues such as delivery, value and customer service. In this case, it must be possible to
extract the complaints relevant to the scope of the Standard.

Customer complaints, especially for larger producers, are likely to be received from a wide range of sources. A defined system
and staff training are likely to be required to ensure that an effective capture system exists and that complaints are well managed.

For sites needing more guidance on complaint handling, the BRC produces a best-practice guideline, Complaint Handling.

CLAUSE FOUNDATION HIGHER

3.10.1 All complaints shall be recorded, investigated using root analysis and the results of the investigation
recorded where sufficient information is provided. Actions appropriate to the seriousness and frequency
of the problems identified shall be carried out to reduce the likelihood of recurrence.

Interpretation
This clause simply requires that appropriate actions are carried out by suitably trained staff. It should be noted that the frequency
of problems identified is mentioned; sites would therefore be expected to review the recurrence of similar issues and take action
to investigate the causes rather than just deal with issues as they occur.

Corrective action plans must be clearly documented, giving details of the investigation and actions taken to prevent a recurrence.

In some ways complaint handling is very similar to dealing with non-conformities. The site needs to ensure that complaints are
captured and recorded effectively. Depending on the nature of the business, it is likely that complaints are received from a wide
range of sources and delivered to a number of people – for example, individual consumers calling customer service lines,
comments made to sales people during business development meetings, letters sent to the chief executive, and product returns
from unsatisfactory deliveries. Whatever the source, the site needs a system to capture and collate the information.

Many sites will record product safety and quality complaints along with a much wider range of issues. This is quite acceptable
provided that quality and safety issues can be identified and are routed to an appropriate person for investigation in a timely
manner. For sites of all sizes, it is important that a customer is made aware of information relevant to their products, whether the
information is positive or whether there is a problem or issue. For higher-risk products, where such information could relate to

38 WWW.BRCGLOBALSTANDARDS.COM
safety or legal matters, the Standard requires that individuals are responsible for customer communication. This does not mean

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

that a person has to be employed solely for this task, or that the same person has to be responsible for all communication, but it
does mean that a system has to be in place, people have to be aware of their responsibilities and any communication has to be
found to be effective.

In complex supply chains, customer complaints may be delegated to third parties such as agents or importers.

In such cases, the allocation of responsibilities must be clear and documented in advance. It is important that problems do not
arise because of the unclear division of responsibility, or because people think that someone else is handling the issue. It is also
important that the third party knows the extent of their authority when offering remedial actions or refunds. In these
circumstances, clear communication with the provider of this service is essential to ensure that information is captured
appropriately and that a management system is in place.

The effectiveness of this system should be checked and reviewed. There are a number of ways to do this – for example, follow-up
calls or visits, customer surveys, reviewing complaints, logging customer contact and feedback – but the Standard is not
prescriptive.

CLAUSE FOUNDATION HIGHER

3.10.2 The company shall have a process in place to respond in a timely manner to consumers and customers
regarding complaints.

Interpretation
Complaints are an important source of information concerning business performance and customer satisfaction. It is important
that this information can be recorded accurately and that it is not hidden or lost because people are worried about the implications
of reporting negative comments. Complaints should be seen as opportunities for improvement. It is a requirement of the Standard
that the complaint data is analysed and used to drive continuous improvement. A summary of this data, any obvious trends and
the effectiveness of corrective actions taken as a result of it should be part of the annual management review.

Example
A company has a procedure for logging complaints and a simple form on the company’s intranet site where all employees can
record information. The system is explained to an employee as part of their initial training. Each section manager is responsible for
reviewing the input to the system on a monthly basis and a customer services manager has overall responsibility to review the
complaints and follow up on any necessary actions. When complaints concern safety, quality or legality, they are coded so that
the quality manager also receives the complaint immediately and can review the urgency of any action to be taken.

An auditor reviews the complaints on the intranet system and selects one example. They follow the trail of the complaint to ensure
that all parties have carried out the required actions and that the correct information has been logged. During this investigation,
the auditor takes the opportunity to question staff about the system and finds it to be well understood and used.

The auditor is satisfied with the process.

CLAUSE FOUNDATION HIGHER

3.10.3 Complaint data shall be analysed for significant

trends. This analysis shall be made available to
relevant staff.

3.11 M
 ANAGEMENT OF INCIDENTS, PRODUCT WITHDRAWAL AND PRODUCT
RECALL
The company shall have a plan and system in place to manage incidents effectively and enable the withdrawal and recall of
products should this be required.
Interpretation
A product recall system is a fundamental component of a company’s product safety management system. EU legislation
stipulates an obligation to all sectors of the supply chain to ensure effective systems are in place to minimise safety risks to
consumers. This risk must be controlled by the introduction, implementation and maintenance of effective and efficient product
recall processes.

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The BRC has developed Product Recall, a guideline that gives an insight into what is involved in a product recall, as well as
guidance and advice on creating or improving product recall processes.

Example
A company produces a depilatory cream. It has a problem with complaints of rashes and has decided to carry out a recall.
It identifies the faulty batch and recalls all products from 40 customer sites. The system details the requirements for the staff and
the contact details of the responsible people in the process. In addition, the procedure enables the rapid identification of the
customers and sites involved so that contact can be made and accurate information given. The certification body is notified within
3 days of the decision.

This would be deemed acceptable by the auditor.

CLAUSE FOUNDATION HIGHER

3.11.1 The site shall have a system in place to monitor The site shall determine and provide written or
issues which could result in the need to withdraw other guidance to relevant staff regarding the type
or recall products including consumer complaints, of event that would constitute an incident or
product rejections and feedback from customers. emergency situation that impacts product safety,
There should be a process in place to notify senior legality or quality, and a documented reporting
management of an incident or emergency that procedure shall be in place which shall include
may affect the legality, safety and quality of a informing their customers in a timely manner.
product.

Interpretation
Applies at both foundation and higher levels
A product recall is from the market place where the product is in the hands of or available to the consumer, whereas in a
withdrawal the product is still within the distribution network and under the control of the site.

An incident could be as a result of an issue recognised internally or as a result of a customer or even a consumer complaint.

For example:

• Someone has had an allergic reaction to the new hair dye developed.
• The bottles received at a store are leaking from the cap.
• A non-production glass jar was broken in the filling area.
Equally it could be as a result of a similar product being recalled or withdrawn from sale.

Any of these issues needs to be fully investigated and resolved to ensure that there is not a potential for a product recall.

CLAUSE FOUNDATION HIGHER

3.11.2 The site shall have a documented procedure in place to effectively manage product withdrawals and
recalls. Procedures shall exist to ensure that customers are notified immediately on issues of
significance to the customer or consumer in terms of product safety, quality or legality.

Examples
A company recalls a mascara because of potential Bacillus cereus, Staphylococcus epidermidis and Staphylococcus warneri
contamination. It also instigates a voluntary recall of certain shampoo, body lotion, conditioner and shower gel products due to
microbial contamination from bacteria.

Having received five reports regarding consumers who were seriously burned after applying a flammable, continuous-spray sun
care product, a manufacturer voluntarily withdrew its products from US markets because they could cause the skin to catch fire if
a person came into contact with an ignition source before the product was completely dry.

40 WWW.BRCGLOBALSTANDARDS.COM
 PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS
CLAUSE FOUNDATION HIGHER

3.11.3 The documented product withdrawal and recall procedures shall include as a minimum:

• identification of key staff constituting the incident management team and their key responsibilities
• an up-to-date list of key contacts, with details of agencies providing advice and support
• a list of persons who can initiate a recall.
CLAUSE FOUNDATION HIGHER

3.11.4 The site shall have written technical and quality

agreements in place with agents and distributors
and other parties in the supply chain where these
are necessary to ensure effective withdrawal/
recall.

Interpretation
The agreement should detail the traceability requirements and contact details in order to initiate an effective recall or withdrawal.

CLAUSE FOUNDATION HIGHER

3.11.5 In the event of a product recall, the certification body issuing the current certificate and the appropriate
enforcement authorities shall be informed in a timely manner. The company shall be aware of and adhere
to any legal reporting obligations in the regions of sale.

Interpretation
This part of the Standard ensures that there are adequate procedures in place should unsafe or illegal products be distributed
beyond the site. In Europe, the term usually means the physical return of the product either for replacement or repair. The systems
a site has in place to deal with the issue should reflect the regions in which its products are available for sale. However, they should
all include the need to contact the certification body which issued the BRC certificate.

Product withdrawal refers to actions taken for products that have not reached the consumer, such as those in retailer stores,
storage depots and distribution points.

The BRC has produced a best-practice guideline, Product Recall, which may help those requiring more detail. Authorities such as
the Consumer Product Safety Commission (CPSC) in the US and the Directorate-General for Health and Consumer Affairs
(DG Santé) in the EU also produce information and guidance.

The reason for the requirement to inform the certification body of any recalls is so that it can investigate whether there is any need
for a re-audit and whether the recall casts doubt on the certification. The BRC does not require any definite action to be triggered
on its behalf and the certification body may feel that actions have been carried out in accordance with defined procedures and
therefore no further work is needed.

It is also courteous to inform the certification body in case its audit is called into question following the recall.

Example
A company discovers that one of its sun cream products contains a chemical that is not allowed in the country of sale even though
it is acceptable in the home market. It immediately informs the US and European authorities and posts recall notices. It also
informs its certification body, which seeks information as to the cause of the problem and how it has been addressed. The
company has established that bought-in perfume contained the banned substance even though it had been supplied with a
certificate of conformity. The company has reviewed and improved its supplier-approval policies and instigated additional test
procedures.

The certification body decides that the incident has been dealt with correctly and that there is no need to revisit or suspend the
certification.

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 CLAUSE FOUNDATION HIGHER

3.11.6 Products which are to be disposed of on safety grounds, as the result of a recall or withdrawal or as
substandard trademarked materials, shall be disposed of securely. This may be delegated to a specialist
in secure waste disposal. Records of such material destruction or disposal shall be maintained.

Interpretation
It is vital that, having determined that a component, product or even product packaging is illegal, unsafe, or of a quality that
requires it to be destroyed, it does not make its way back on to the market.

Guidance could come from BS EN 15713:2009, which provides a framework of key conditions to be adhered to by companies
who destroy confidential information on behalf of their customers.

Checks as to whether a licensed waste disposal company could securely dispose of product might include:

• video surveillance
• background checks on all employees
• secure facility
• chain-of-custody procedures
• alarm-monitored facility.
Example
In the US, lead-painted toys fall under the category of products that would need to be destroyed or properly disposed of,
according to the Consumer Product Safety Commission. They cannot be exported for resale.

Disposal is therefore determined as part of recall negotiations with the CPSC, in accordance with state and federal environmental
laws.

CLAUSE FOUNDATION HIGHER

3.11.7 The product recall and withdrawal procedures

shall be tested at least annually.

CLAUSE FOUNDATION HIGHER

3.11.7 The product recall and withdrawal procedures

shall be regularly tested, at least annually, in a way
that ensures their effective operation. Results of
the test shall include timings of key activities and
shall be retained.
The company’s senior management shall ensure
that results of this test shall be used to implement
improvements as necessary.

Interpretation
This is not to be confused with the traceability test. Certainly the test requires that traceability is effective, but it needs a much
wider-ranging evaluation. Product recalls can cost millions or even billions of pounds, so this activity is worth practising, rather like
a fire drill to ensure that everyone (including deputies) is well versed in the activity, which it is hoped will never happen.

A product recall system is a fundamental component of a company’s product safety management system. EU legislation
stipulates an obligation to all sectors of the supply chain to ensure effective systems are in place to minimise safety risks to
consumers. This risk must be controlled by the introduction, implementation and maintenance of effective and efficient product
recall processes.

Improvements from the test may include timings or ensuring that phone numbers are updated. The test should ensure that the
system works even when the site is at its most vulnerable; for example, just before or during a major holiday, or at a time when
senior management is away from the site.

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 PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS
CLAUSE FOUNDATION HIGHER

3.11.8 The company shall develop contingency planning

for business continuity in the event of major
incidents such as:

• disruption to key services (e.g. water, energy,

staff availability)
• events such as flood, fire and natural disaster
• malicious contamination or sabotage.
Interpretation
This requirement is in place to ensure that business processes continue if unexpected events occur. The Standard is concerned
only that guidance is in place concerning product safety and legality, although a full business continuity plan is likely to cover a
much wider scope of activities.

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4 SITE STANDARDS

4.1 EXTERNAL STANDARDS

Sites used for manufacturing, storage or distribution shall be of suitable size, location, construction and design to facilitate
maintenance, prevent contamination and enable the production of safe and legal products.
Interpretation
This part of the Standard is one of the most straightforward. It requires that sites are fit for purpose, both externally and internally,
and requires that operations are conducted in an orderly fashion so as not to jeopardise the safety or quality of the product. For
many products, the external conditions around a site will have no effect, but there are some situations when they can have a
substantial impact on the products being manufactured. In all cases, it is important to ensure that the site is of adequate size and
construction to produce the stated products safely.

Example
A company stores cardboard boxes in an outbuilding, in an area of high rodent population. This could have an impact on the
products, but the company keeps the area around the outbuilding as clear as possible and has good pest control. There is no
evidence of rats entering the building.

The auditor considers that this is satisfactory and that practical steps have been taken. It is not necessary or cost-effective to
move the store but the site should continue to monitor the situation.

CLAUSE FOUNDATION HIGHER

4.1.1 The site to be included in the audit shall be clearly

defined, and shall be located and maintained so as
to allow the production of safe and legal products.
The external areas and surroundings shall be
maintained in good order.

Interpretation
The site needs to be well defined with boundaries clearly marked – partly so that the auditor is clear about the premises to be
audited, and partly so that proper consideration can be given to the state and suitability of the location. As part of the audit visit,
the auditor will look around the exterior site to establish the suitability of the location, the possibility of contamination and any
other potential problems that may be caused by a lack of clarity about the responsibility for shared or communal areas. Auditors
understand that conditions are not always ideal and that sites and their surroundings often develop over time. They will
understand that some buildings may be old or that new methods have had to be accommodated in buildings for which they were
not intended. The auditor will need to be satisfied that any shortcomings in this regard do not pose a risk to the safety and quality
of the product.

CLAUSE FOUNDATION HIGHER

4.1.1 The site to be included in the audit shall be clearly

defined, and shall be located and maintained so as
to allow the production of safe and legal products.
The external areas and surroundings shall be
maintained in good order.
A site plan shall be retained and readily available.

Example
A company produces bath and shower gel products in a purpose-built unit. The auditor observes that part of the site is not named
on the factory plan, and establishes that this area has been sublet to a separate chemical formulation research company.

Because the area is not clearly separate from the main operation, the auditor would want to determine that there is no risk to the
production site from the use or disposal of chemicals from the sublet unit. The auditor would investigate how the company
controlled the sublet area, any areas of overlap, common services, etc., and ask to see copies of documented procedures, as well
as observing the activities on the factory floor.

44 WWW.BRCGLOBALSTANDARDS.COM
Since it is probable that the company would not be able to control the activity of the sublet operation sufficiently, it is likely that the

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

auditor would issue a non-conformity.

CLAUSE FOUNDATION HIGHER

4.1.2 Consideration shall be given to local activities and

the site environment and measures shall be taken
to prevent contamination.
Where measures have been put into place to
protect the site (from potential contaminants,
flooding, etc.), they shall be regularly reviewed in
response to any changes.

Interpretation
This clause requires a site to consider its external environment. In most cases there will be no concerns, but if measures have to
be taken the site must demonstrate that it checks these measures and ensures that they are still adequate.

Example
A cosmetics factory producing mouthwash is in a rural setting and initially the site was not surrounded by anything more than a
few houses and open fields that were used for grazing horses and sheep. In recent years some of the land has been turned over to
a pig farm and the rest to arable farming.

The auditor would raise a non-conformity as the site has not taken any action regarding the changing environment and the
potential for pesticides and odours contaminating the products.

4.2 SECURITY
Security shall be maintained to prevent access of unauthorised persons to production and storage areas.

CLAUSE FOUNDATION HIGHER

4.2.1 Access to the site by employees, contractors and visitors shall be controlled and a visitor-reporting
system shall be in place.

Interpretation
Access to sites should be controlled in order to prevent any accidental or malicious damage to the product or materials.

Care should be taken that the system for site security is maintained during shift work and any shutdown periods.

CLAUSE FOUNDATION HIGHER

4.2.2 Contractors involved in maintenance or repair shall

be qualified or supervised and a member of staff
shall oversee their activities.

CLAUSE FOUNDATION HIGHER

4.2.2 Contractors involved in maintenance or repair shall

be qualified or supervised, and a nominated staff
member shall be responsible for their activities
with regard to potential effects on the safety,
legality or quality of products.

Interpretation
A large percentage of all incidents and accidents are as a direct result of contractor activity on site. Contractors should be suitably
qualified and supervised, when appropriate. Whether or not continual supervision is appropriate, a nominated staff member
should be designated as responsible for any contractors on site and ensure that appropriate procedures are respected.

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Example
The maintenance manager of a factory producing washing-up liquid has arranged for the back flushing of the newly installed water
treatment plant. This process involves the introduction of a strong saline solution to the plant thus reactivating the resin bed. The
maintenance manager has failed to inform the quality manager or the production manager of the activity. During the operation a line
QC check is conducted and it is discovered that the washing-up liquid is the wrong density. Further investigation reveals that during
the back-flushing operation the main water feed to the line had not been isolated and as a result a full batch of product is wasted.

The auditor would raise a non-conformity against such activity.

4.3 LAYOUT, PRODUCT FLOW AND SEGREGATION

FUNDAMENTAL
The factory layout, flow of processes and movement of personnel shall be adequate to prevent the risk of product
contamination and mix-ups and to comply with relevant legislation.

Interpretation
The layout of a plant is fundamental to an efficient production process.

CLAUSE FOUNDATION HIGHER

4.3.1 The layout process flow of machinery and equipment shall be arranged to minimise the risk of product
contamination and damage.

Interpretation
This clause is far more important in some industries than others. It is especially relevant when the product is likely to become
contaminated or damaged by being placed in contact with other stages of production. It is particularly likely to be relevant to
continuous-flow sites where dead space in pipes or potential mixing with the wrong components may give rise to non-compliant
products.

Any site should be able to produce a plan of its process. The auditor can, to some extent, use this as a site guide. Care should be
taken to include all relevant processes. This should cover not only the main production area but also ancillary storage or mixing
facilities, and their relationship with the main process.

Example
A company produces sachets of liquid laundry detergents. The product has to be adjusted to the right pH at the end of the line.
Any cross-contamination with earlier stages of mixing will result in a potentially contaminated product. The factory is arranged so
that the final stage of mixing is at the end of the production line and has an automatic check immediately prior to the form fill seal
process, removing any possibility of cross-contamination.

The auditor would find this satisfactory provided the automatic check is adequately calibrated and tested at suitable intervals.

CLAUSE FOUNDATION HIGHER

4.3.2 Premises shall allow sufficient working space and storage capacity to enable all operations to be carried
out and, if necessary, in hygienic conditions. The necessary level of hygiene shall be maintained for each
product.

Interpretation
It is self-evident that if a site is too cramped, the quality of the operation is likely to suffer. Auditors will wish to evaluate the work
pattern and discuss how peaks in demand are dealt with. It is essential that equipment is located with sufficient space to allow
easy access for operating, cleaning and maintenance.

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 PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS
CLAUSE FOUNDATION HIGHER

4.3.3 The location of facilities and services, including

toilets, cleaning and catering facilities, shall be
segregated and separated from production areas
and shall not jeopardise the integrity of the
product.

Interpretation
This applies to products where it is important not to risk the product integrity by possible microbiological or chemical
contamination caused by workers or their food and personal effects.

Example
An auditor observes staff eating their lunch on a table situated adjacent to a production line. There is the potential for staff
members to spill food into the product being assembled.

This is unsatisfactory and would result in a non-conformity. All staff facilities should be located so that product contamination is
not possible.

CLAUSE FOUNDATION HIGHER

4.3.4 When critical to product safety, legality, quality or

customer requirements, controls shall be in place
to ensure that raw materials, work in progress,
rework, waste materials, packaging, components
and finished products of different specifications
are not inadvertently mixed and are effectively
segregated.

CLAUSE FOUNDATION HIGHER

4.3.4 There shall be effective segregation to minimise

the risk of product cross-contamination taking into
account the flow of product, nature of materials,
equipment, personnel, waste, airflow, air quality
and utilities.
Documented control procedures shall be in place.

Interpretation
It may be necessary to segregate a product for many different reasons – for example, to prevent microbial contamination or to
ensure that products for different geographical locations do not mix.

Example
A factory is producing perfumed talcum powder on the same equipment as it uses to produce baby powder which is unperfumed.
The production schedule starts the week with the baby powder and ends the week with the perfumed powder. The perfume is
injected through a separate system directly into the flow of powder. There are no additional recipe materials. At the weekend the
equipment is cleaned out and an initial charge of unperfumed powder is put through the machine; this is monitored to ensure that
there is no residual perfume, and retained to be added back into the first run of the perfumed powder. Once the quality control
supervisor is certain that there is no smell, a sample is taken to the laboratory to verify the finding. If the laboratory determines that
there is residual perfume, a further sample is taken and all prior production is added back to the first perfumed batch. If a second
sample fails then the line is stopped and another full clean is carried out.

The auditor would deem that this was sufficient if there was also evidence that tests had been carried out to ensure that the first
containers of fragrance-free powder did not contain any traceable perfume.

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 CLAUSE FOUNDATION HIGHER

4.3.5 Where materials or products require special handling procedures to be in place, these shall be
maintained to ensure product safety, quality and legality are not compromised.

Interpretation
It is essential that products are not accidentally mixed – for example, when a product is legal in one country but not another, or
where a product contains materials unsuitable for some consumers (such as when products are separated for older and younger
children). It may also be necessary to separate raw materials or components carefully so that there is no chance of their being
used in the wrong products; for example, making sure that paints containing toxic metals are separated from those that are
suitable for use on children’s products, or separating products that contain fragrances from those that do not.

The Standard is not prescriptive about how separation is done, only that it is considered and carried out effectively if found to be
necessary.

CLAUSE FOUNDATION HIGHER

4.3.6 The company shall determine whether allergenic or sensitising materials are used and, if so,
documented policies shall exist for the handling of such materials including:

• physical or time segregation from other products

• use of identified, dedicated equipment if necessary
• adequate labelling of final products.
Interpretation
This clause relates to the specific cases of handling allergenic or sensitising materials. In these cases, careful handling is
important for several reasons, including:

• to avoid cross-contamination of products

• to make sure that the correct warning labels are placed on the products with the potential allergens
• to ensure ingredients are not confused
• to enable good traceability of such materials.
It is also necessary to ensure that the subsequent use, return or disposal of non-conforming materials is handled and
documented correctly. The product to be reworked must be subject to the methods and inspection or testing requirements that
are in place for production.

The auditor will assess whether the segregation is adequate.

Example
A company is producing a fragranced liquid handwash that contains a number of allergenic compounds. There is a requirement
for these chemicals to be listed on the product label. The company has a system for separating out products at the end of the
packing line into a discrete area.

The auditor finds this to be acceptable but wishes to establish how cross-contamination is avoided in the mixing area. The
company needs to demonstrate a suitable cleaning and checking programme.

CLAUSE FOUNDATION HIGHER

4.3.7 Materials and products requiring segregation (e.g. materials intended for different geographical regions)
shall have documented control procedures in place to ensure that product integrity is maintained.

Interpretation
Care needs to be taken to ensure that products are not inadvertently mixed. In the case of Forest Stewardship Council (FSC)
paper, for example, the chain of custody needs to be maintained. Segregation may be physical or by time, although clear
identification is the important control.

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

documented correctly. The product to be reworked must be subject to the methods and inspection or testing requirements that
are in place for production.

The auditor will assess whether the segregation is reliable.

4.4 BUILDING INTERIORS

The interior of the site, buildings and facilities shall be suitable for the intended purpose.
Interpretation
Buildings should be adequate to allow products to be made safely and of the quality required. The exact requirements will change
depending on product type. A site needs to consider which factors may affect its products and whether it has taken reasonable
steps to avoid or control the risks from these factors, particularly with regard to appropriate cleaning measures.

CLAUSE FOUNDATION HIGHER

4.4.1 The site shall be maintained to minimise potential for product contamination The quality and finish of site
buildings and facilities, including any pipework and drainage, shall be suitable for the intended purpose
with due regard to the risk to product safety, legality and quality, and shall be maintained to an
appropriate standard. This shall include, as defined by the risk assessment:

• a clean, tidy and organised factory

• adequate lighting
• adequate ventilation
• walls, floors, windows, doors and ceilings maintained in a good condition to prevent foreign body
risks
• suitable and sufficient removal of any by-products and contaminants.
Interpretation
Judging whether a site is sufficiently clean, tidy and in good repair is subjective, but auditors will be considering the condition of
the site with regard to the potential for any adverse effects on production. Auditors will expect to see a working environment rather
than showcase conditions, but will raise non-conformities for unnecessarily dirty or untidy sites as well as for unreasonably
cramped or congested locations. A generally clean and tidy site, relative to the product group, may be seen as a reflection of
management commitment and worker safety.

CLAUSE FOUNDATION HIGHER

4.4.2 Suitable and sufficient lighting shall be provided for correct operation of processes, inspection of
products, and effective cleaning.

Interpretation
In a textile site, for example, the exact quality and intensity of light may be specified and important for colour- and pattern-
matching. At a site making plumbing fittings, on the other hand, as long as it is well lit and operatives can see clearly to work, no
further requirements would be necessary. As a guide, the auditor will want to understand the importance the site places on
lighting crucial to the product and, at the very least, be reassured that eyestrain is avoided.

Particular industries will have their own detailed requirements and the clauses in this section reflect the more stringent needs for
sites making products with potential cleanliness issues or within particular environmental settings.

CLAUSE FOUNDATION HIGHER

4.4.3 The site shall be assessed for any particular requirements relevant to the products being produced, such
as temperature, humidity and electrostatic discharge. Any identified requirements shall be adopted,
calibrated, documented, monitored and regularly reviewed.

Interpretation
An assessment should be made to first establish whether any control is needed. Many products are made satisfactorily in the
ambient conditions of the location and do not need further control. Some products, however, are susceptible to variations in
conditions and need to be produced in conditions where temperature and humidity are controlled. If so, the requirements must

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be met and compliance with these requirements monitored. The site should have contingency plans for any failures to meet the
required conditions.

Examples
A site manufactures a variety of household products including some aerosol products with a high alcohol content. The alcohol-
containing products are produced in a separate part of the factory. At the entrance all personnel are required to undertake a static
check and if they fail they are required to wear a wristband and attach themselves to an earthing cable. The area is enclosed and
has been assessed for possible ignition sources including lighting and mechanical devices.

An auditor in the UK would also wish to see that the site has carried out an assessment in accordance with The Dangerous
Substances and Explosive Atmospheres Regulations 2002 (DSEAR) requirement (employers are required to control the
risks to safety from fire, explosions and substances corrosive to metals) and may want to see the alcohol licence issued from
HM Revenue and Customs.

A factory produces toilet tissue. If the humidity is not controlled, it is difficult to prevent mould growth and/or there is a dust
problem. The site has installed humidifiers in the production areas and the area is checked daily to confirm that a humidity of
50–60% is achieved. The humidifiers spray a fine mist that helps to keep the dust down.

Provided the company can show that the level of control is sufficient to prevent mould growth, this action would be considered
satisfactory.

CLAUSE FOUNDATION HIGHER

4.4.4 Where water quality presents a risk to the final product it shall comply with the required specification (as
defined in the region of intended product sale), suitably treated to prevent contamination and regularly
monitored.

Interpretation
These requirements apply to sites producing goods that need to avoid microbiological contamination.

A site would be expected to demonstrate how it controls the quality of water used on site, and its knowledge of the requirements
for water quality specified for the product in the country of sale. Auditors would normally expect to see evidence of water sampling
and testing for chemical and/or microbiological contamination done at appropriate frequencies.

4.5 STAFF FACILITIES

Staff facilities shall be sufficient to accommodate the required number of personnel, and shall be designed and operated to
minimise the risk of product contamination. The facilities shall be maintained in a good and clean condition.
Interpretation
This clause focuses on staff facilities, from the perspective of eliminating product contamination. There may be other
requirements relating to the health, safety and wellbeing of employees but these are not part of the scope of the Standard.

CLAUSE FOUNDATION HIGHER

4.5.1 Staff facilities such as washrooms and break areas must be provided and maintained in a clean condition
and segregated from production areas to prevent product contamination.
Where a site provides food service the food preparation areas must be clean and fit for purpose and
adequately segregated from production areas.

Interpretation
The requirement is not for any specific design or type of facility but to ensure that product contamination is minimised.
This generally means that break activities, such as eating, should be in a place physically removed from any production or
packing area.

Example
A customer complaint shows that a customer has received part of a sandwich inside a package they have purchased containing
washing powder.

50 WWW.BRCGLOBALSTANDARDS.COM
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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

the box.

The auditor would look to see that procedures are now in place that do not allow for the eating of food near production areas, and
that these procedures are effectively monitored – otherwise a non-conformity would result.

CLAUSE FOUNDATION HIGHER

4.5.2 Where smoking or use of electronic cigarettes is allowed under national law, it shall only be permitted in
designated controlled smoking areas which shall be isolated from production and storage areas and
fitted with air extraction to the exterior of the building. Adequate arrangements for dealing with smokers’
waste shall also be provided at smoking facilities, both inside buildings and at external locations.

Interpretation
Smokers’ waste, such as cigarette ends, matches, ash, snuff and chewing tobacco, can become a source of product
contamination and so must be controlled. External waste should also be controlled to prevent it from being transferred inside
the site.

CLAUSE FOUNDATION HIGHER

4.5.3 Storage facilities of sufficient size to accommodate all reasonable personal items shall be provided for all
personnel who work in areas where they are unable to keep possessions with them.

Interpretation
If staff are not allowed to bring their possessions with them into production areas, because of possible product contamination,
they must be provided with adequate and safe storage for their items. This is so that staff do not try to carry items with them for fear
of their being lost, damaged or stolen. The Standard is not prescriptive on this matter and any solutions suitable to the size and
complexity of the site are acceptable.

CLAUSE FOUNDATION HIGHER

4.5.4 Based on risk assessment, the site shall determine The site shall use risk assessment to determine
and provide workwear as required and make where a change to workwear in different areas is
provisions for changing areas for all personnel: required. Any required changing facilities shall be
staff, visitors and contractors. provided for all personnel: staff, visitors and
contractors. Changing areas should be sited to
allow direct access to the production, packing or
storage areas without exposure to any external
area. Where this is not possible, the site shall use
the risk assessment to help determine the
activities required to mitigate any risk. This
procedure shall be documented.

Interpretation
Applies to both foundation and higher levels
This is intended to prevent general as well as microbiological contamination. Once staff have changed into their workwear they
should be able to enter the production site without the risk of recontaminating it on their journey from the changing facilities. This
is equally important for others (such as maintenance staff or visitors) entering the site.

In some cases, the design of the site may not allow direct access to the production area from the changing facilities. If so, the
person responsible for the quality, safety and legality of the product must carry out an assessment to gauge the risk of
contamination. It may be necessary to define a specific procedure (or route) to reach the production area. If the assessment
reveals that it is not possible to reach the production area without a risk of contamination, then the facilities will need to be
redesigned.

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 CLAUSE FOUNDATION HIGHER

4.5.5 Suitable and sufficient hand-cleaning facilities shall be provided at access to production areas, and at
other appropriate points within these areas, based on appropriate risk.

Interpretation
The risk assessment should determine whether hand cleaning is required in order to protect the product from contamination due
to contact from hands. This is more relevant after eating, drinking, smoking or visiting the toilet.

Where hand cleaning is essential, facilities must be provided in washrooms and other appropriate points, such as entrances. It is
also a requirement that signs or notices are placed near the washing points. These act as a reminder and should also contain
information about how the cleaning shall be done. It is often appropriate to include pictures or diagrams rather than a lot of text.

4.6 HOUSEKEEPING AND HYGIENE

FUNDAMENTAL
Housekeeping and cleaning systems shall be in place which ensure appropriate standards of hygiene are
maintained at all times and the risk of product contamination is minimised.

Interpretation
No matter what types of products are being made, a clean, tidy site prevents unnecessary contamination and ensures that the
work is carried out in an orderly fashion.

Example
A site has installed a new paint storage section in a previously disused area. The cleaning protocol is modified to include more
frequent cleaning, removal of any paint spillages using a proprietary specialist cleaner, and checking drain filters to ensure there
are no blockages.

The auditor observes the paint store, which appears clean and well organised, and is satisfied the procedure is operating.

CLAUSE FOUNDATION HIGHER

4.6.1 Equipment, production and storage areas shall be maintained in a state of cleanliness appropriate to the
operations undertaken. Cleaning practices shall be completed so as to minimise risk of contamination
and records kept.

Interpretation
No matter what types of products are being made, a clean, tidy site prevents unnecessary contamination and ensures that the
work is carried out in an orderly fashion.

The cleaning carried out shall be effective and not cause any product contamination.

Both routine and exceptional cleaning (such as that needed for new equipment, after a close-down or after maintenance) should
be appropriate and of adequate frequency. The use of suitable tools, which do not in themselves cause contamination, should be
considered – for example, not using cloths or mops that are prone to leave threads, or employing colour-coded materials and
equipment for use in different areas. Dedicated, colour-coded equipment can be used for certain areas; for example, red
for toilets.

Example
The auditor asks questions regarding the housekeeping and hygiene equipment and is shown to a cupboard under the stairs.
The cleaner is called and they open the cupboard door to reveal the contents. Inside there are a number of cleaning chemicals
and a book in which there is a material safety data sheet (MSDS) for each one. The chemicals are not perfumed and are suitable
for the cleaning tasks. The equipment is colour-coded as follows:

• red for toilets

• yellow for offices
• blue for production.

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

conformity as there is a possibility of cross-contamination from the mops.

CLAUSE FOUNDATION HIGHER

4.6.2 Suitable cleaning chemicals shall be identified, clearly labelled and controlled to prevent the risk of
product contamination. Chemicals shall not be decanted unless into properly labelled and identified
containers. Adequate storage facilities shall be provided and sited so as not to compromise the safety,
legality and quality of the product.

Interpretation
The chemicals used should be chosen carefully so as to leave no taint or smell. Cleaning materials often contain potentially
dangerous chemicals which may become hazardous if mixed with other materials. All chemicals used on site should be
adequately labelled and securely stored. This clause is included here because the primary use of chemicals on many sites is for
cleaning, but the requirements also apply to any other chemicals used, such as pest control chemicals, weed killers and machine
lubricants. It is not good practice to decant chemicals into other containers, especially if the shapes are associated with other
liquids (for example, decanting a colourless solvent into a ‘soft drink’ bottle). If liquids have to be decanted, they must be clearly
labelled with as much of the original information as possible, in particular any safety or warning information and any instructions
for use.

Example
A small unlabelled plastic spray bottle is on top of a printing press. The bottle contains solvent to thin the ink on the press if it
becomes sticky.

The auditor will raise a minor non-conformity. The bottle should be labelled with the contents, warnings and instructions for use.

CLAUSE FOUNDATION HIGHER

4.6.3 If cleaning services are outsourced, the service providers shall have signed a contract which identifies
the scope and frequency of the work, and records shall be maintained. A defined company
representative shall be responsible for ensuring that the work is carried out satisfactorily.

Interpretation
It is recognised that the cleaning of sites is often carried out by a third-party company. This clause ensures that the responsibility
for a clean, tidy site is not abdicated by the site management and that the cleaning company used is committed to following
suitable methods at a defined frequency.

The clause contains a requirement for a log book to be maintained. This can be done in any format (for example, signed-off work
sheets or computer entries) as long as the information is recorded, ‘signed’ and dated.

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 CLAUSE FOUNDATION HIGHER

4.6.4 Documented cleaning procedures shall be in

place, validated and maintained for the building,
utilities, plant and all equipment. Where more than
basic cleaning is required, cleaning procedures
shall include the following information as a
minimum:

• responsibility for cleaning

• item/area to be cleaned
• frequency of cleaning
• method of cleaning
• cleaning materials to be used
• cleaning records and responsibility for
verification.
Cleaning and housekeeping shall be carried out
by trained personnel in accordance with
documented procedures, and records shall be
maintained.

Interpretation
Specified cleaning procedures are needed; the Standard outlines the minimum details to be covered. Additional information
should be added as necessary in order to define the cleaning adequately. Cleaning personnel should also be trained with regard
to the cleaning practices. Training is likely to take the form of practical demonstrations as well as checks to ensure that the
protocols and procedures are understood. This requirement also applies to any temporary or third-party staff that may be used.

CLAUSE FOUNDATION HIGHER

4.6.5 The standard of cleaning shall be appropriate to

the product being manufactured and shall be
verified and documented and, where relevant,
agreed with the customer. Corrective actions shall
be documented.
Cleaning procedures shall be revalidated following
building work, maintenance, changes to
equipment or new product introduction.

Interpretation
In areas where cleanliness is vital, the effectiveness of the cleaning must be confirmed. There are a number of ways to achieve this
and the site would need to assess the most appropriate means for its own operation. Examples of controls might include:

• swabbing to check microbiological cleanliness

• confirmation of times and temperature used during steam cleaning
• visual and/or olfactory inspection
• verification that the surface is free from residue
• audit of the full cleaning procedure.
4.7 WASTE AND WASTE DISPOSAL
Waste disposal shall be managed in accordance with legal requirements and to prevent accumulation, mix-up, risk of
contamination and the attraction of pests.
Interpretation
This clause is a general requirement for a system to be in place. It does not define the type of system but does require it to prevent
the use of unfit or defective materials. Auditors will observe the production or packaging site to identify any possible areas where
waste may be misused or is poorly controlled.

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 PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS
CLAUSE FOUNDATION HIGHER

4.7.1 Waste disposal shall be managed in accordance with legal requirements and to prevent accumulation,
mix-up, risk of contamination and the attraction of pests.

Interpretation
Waste material allowed to accumulate in a site may be a source of product contamination, become confused with satisfactory
products or materials, and present a risk of materials being misused.

Example
A company has left a number of drums of rejected plastic stabilising solution outside the factory for disposal. An employee has
been on holiday for a week and does not know they have been rejected. Thinking they can be used, the employee takes the
drums to the production area, without first checking with the supervisor.

The site should have procedures in place to identify this error before the material is used. Normally the drums should be clearly
labelled as rejected product. If no such procedures are in place, the company will receive a non-conformity as there is the
possibility of an out-of-specification product being produced.

CLAUSE FOUNDATION HIGHER

4.7.2 Where legally necessary, waste shall be removed by identified, licensed contractors, and records of
disposal shall be maintained by the site.

Interpretation
There are a number of reasons why waste may need to be categorised and segregated. Examples include:

• disposal of toxic waste

• disposal of highly flammable waste
• segregation for recycling purposes, such as plastic or paper
• measurement of weight or volume of some waste, such as batteries.
Some countries have legal requirements covering the waste measures indicated above, as well as others.

In some cases, particularly those concerning toxic waste, disposal may be carried out only by registered and licensed operators.
If so, the site must demonstrate that appropriate contractors were identified and evaluated through the site’s supplier-approval
scheme. The site must also demonstrate that appropriate records are maintained and include information such as:

• identification of material disposed

• quantity (volume, weight, number as appropriate)
• type and number of containers
• date and time of disposal
• signature of waste contractor (or responsible staff member if in-house).
CLAUSE FOUNDATION HIGHER

4.7.3 Waste materials shall be controlled, clearly

labelled and where necessary quarantined to
ensure that they are not reintroduced into non-
waste production flows.

Interpretation
If waste material is not separated from good stock it is likely to become confused. A variety of quarantine methods, appropriate to
the site, can be used and may include:

• separate storage areas

• defined and colour-coded/fenced-floor areas
• separate bins or containers.

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If unsafe or illegal products have been identified, they must be disposed of securely to ensure that they cannot re-enter the supply
chain. The site may also have specific customer requirements for products that do not meet their specifications. In such cases,
disposal must be carried out securely and the disposal/destruction validated and recorded. This work is often subcontracted to
specialists. These specialists must have been evaluated under the supplier-approval procedure.

Any evidence that ‘destroyed’ product has re-entered the supply chain shall be rigorously investigated.

Example
A company has sent a lot of branded disposable rubber gloves for disposal as the finish does not meet the customer
requirements and the customer has requested that they are destroyed. A batch of rubber gloves is for sale on the internet, which
appears to match the description of the ‘destroyed’ samples. An investigation reveals that an employee took a carton from the
premises, because they thought it was wasteful to destroy them.

A site would be expected to deal with this on a number of levels, and to review.

CLAUSE FOUNDATION HIGHER

4.7.4 External waste collection containers and

compactors shall be managed in such a manner
as to minimise risk to the product if necessary.

Interpretation
This clause is self-explanatory and requires that the containers are managed so as not to present a risk to the product.

4.8 PEST CONTROL

The whole site shall have an effective preventive pest control programme in place to minimise the risk of pests. Sufficient
resources shall be available to respond rapidly to any issues that occur, in order to prevent risk to products.
Interpretation
Sites need some form of pest control to ensure that products are not damaged or contaminated. Even when the product itself is
unlikely to be damaged by pests, customers may still have pest control requirements so as to avoid the problem of infestation in
the warehouses or transport.

There are many publications providing further detail on pest control, including the BRC best-practice guideline, Pest Control.

Example
A site manufactures facial tissues impregnated with balm. The audit has been scheduled for the two days immediately prior to a
national holiday. The factory manager has requested that all of the factory/good manufacturing practice elements are undertaken
on the first day of the audit with the paperwork/office side being audited on the second day. During the visit the auditor asks to
review the pest control system on site and is shown a risk assessment that determines an electronic system will suffice to deter
any unwanted pests. Reading the data supplied by the manufacturer, the auditor learns that the system emits a sine wave that
resonates in the heads of small mammals, therefore discouraging them from staying on site.

On the second day the auditor asks to revisit the production area. They are informed that all staff have gone home and the area is
empty. Still the auditor asks to see something on the shop floor and is taken down to the production area.

Upon entry to the area the manager switches on the electricity to the production hall. The auditor enquires if this switch includes
the mains plugs, into which the pest control system is plugged, and is informed that it is.

The auditor raises a non-conformity as the pest control device will be off for the duration of the holidays.

CLAUSE FOUNDATION HIGHER

4.8.1 The pest control programme shall be based on a documented risk assessment which should include the
product, the material included, the location and type of premises, the possible types of pest, and the
process.
The pest control provider shall be a specialist or a trained employee.
The pest control programme shall include a documented inspection schedule.

56 WWW.BRCGLOBALSTANDARDS.COM
Interpretation

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

The important factor is to identify the target pest. This will vary from region to region; in some countries lizards and snakes are
prevalent, and in others, mammals. Additionally, some products attract specific pests that will require specialist treatment. In the
rare cases where a site considers that no pest control is required, it must justify its reason for the decision and review it every year.

Note that a site is responsible for managing the risk from pests even if it subcontracts the activity.

Typically, the annual control programme for rodents in the UK would be eight technician visits and one field biologist visit.

CLAUSE FOUNDATION HIGHER

4.8.2 The company shall either have a clearly defined contract with external contractors which reflects the
activities of the site, or have trained staff.
During each visit activity/action reports shall be completed. These should include observations of pests
or evidence of pest activity and recommendations for action by the site.

Interpretation
Pest control is often subcontracted to external companies, which may need to be licensed or approved by the authorities. Where
contractors are used, the signed contract must clearly define the scope and level of activity to be provided. If it is handled
in-house, responsible employees must have undergone formal training and have demonstrated their competence.

The activity found and any actions undertaken must be recorded so that any trends can be reviewed. Trends may be seasonal, or
there may be a particular ‘hot spot’ on the site.

A nominated manager is required so that the site’s management team is aware of any issues.

CLAUSE FOUNDATION HIGHER

4.8.3 When necessary, materials or products shall be fumigated, and records of this process shall be kept.
Fumigated goods may not be supplied to customers without full professional safety clearance and
correct clearance documentation. All fumigation operations shall be controlled by staff with appropriate
professional qualifications and/or training.

Interpretation
The fumigation certificate, in respect of international shipping of sea freight (also referred to as a pest control certificate), is the
proof that any wooden packing materials used in international sea freight shipping, such as pallets, crates or wood, have been
fumigated or sterilised prior to the international shipment.

In general, manufacturers of wooden packaging must meet the International Standards for Phytosanitary Measures 15 (ISPM15),
as this is the standard most commonly used around the world.

If you are dispatching goods to another country within the EU there are no additional controls or standards, other than the
presumption that any packaging made from wood produced in EU member states automatically complies with European
Community internal plant health regulations.

Exporters to Portugal are encouraged to use ISPM15-compliant wood packaging to enable its subsequent reuse outside of
Portugal. This is because of emergency measures against the spread of pine wood nematode present there.

The US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) regulates the importation of wood and
wood products. APHIS requires wood and wood products to undergo certain phytosanitary procedures prior to importation in
order to eliminate the risk of introducing non-native pests and diseases into the United States.

CLAUSE FOUNDATION HIGHER

4.8.4 Full material safety data sheets for all chemical pest control agents used shall be controlled, available to
relevant staff at all times and kept in a designated place.

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Interpretation
The report should contain details of what chemicals were used in which trap. Additionally, MSDS should be readily available to the
site; for example, in the case of accidental poisoning.

4.9 PRODUCT STORAGE, DISPATCH AND TRANSPORT

Facilities for the storage and transportation of products shall be suitable for purpose and minimise the risk of product
contamination, damage and malicious intervention.
Interpretation
Products are at risk from contamination during storage and when they are being moved around a site or transported off site.
Off-site transport is often outside the control of the production site but, where it has responsibility for such transport, it must not
introduce hazards. The individual requirements listed in this clause are self-explanatory. Concerns to be considered include:

• storage temperature
• protection from rain or dust
• stacking limitations
• handling procedures – manual and via pallet truck, etc.
• cross-contamination of materials
• security.
CLAUSE FOUNDATION HIGHER

4.9.1 All materials, work in progress and product shall be properly identified and protected during storage by
appropriate packaging to protect the product from contamination.

CLAUSE FOUNDATION HIGHER

4.9.2 Where storage of raw materials, components, packaging, intermediate or finished product is necessary
it shall be maintained in good condition and be securely protected from contamination, deterioration
and damage.
All handling operations during storage shall be managed to prevent product damage.

CLAUSE FOUNDATION HIGHER

4.9.3 Vehicles or containers used for transportation and dispatch of product shall be inspected prior to
loading to ensure that they are fit for purpose. Records of inspection shall be maintained.

CLAUSE FOUNDATION HIGHER

4.9.4 Documented procedures to maintain product

safety and quality during loading and
transportation shall be developed and
implemented.

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4.9.5 Where product is vulnerable to weather damage, vehicles and containers for transportation shall be
loaded and unloaded so as to protect the product.

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4.9.6 Where a third-party haulage contractor is used, all the requirements shall be defined within a contract
and effectively managed.

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5 PRODUCT INSPECTION AND TESTING

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

5.1 PRODUCT INSPECTION AND LABORATORY TESTING
FUNDAMENTAL
The company shall have a programme for product inspection and testing to control products during and after
production to ensure that products are safe, legal and meet the quality specification.

Interpretation
Inspection includes the measures aimed at checking, measuring, or testing of one or more product characteristics and to relate
the results to the requirements in order to confirm compliance.

Testing is generally carried out using a laboratory to verify product parameters.

This clause addresses the general quality control testing and specific cases when testing of a product representative of overall
production must be carried out because of legislation. The test laboratories are also often specified. Although this is a
fundamental requirement, if a site is making simple, low-risk products, testing may not be necessary. The site is required to
consider this matter, document why no testing is needed and relate this to the product risk, if any. Once this has been done, the
remaining clauses of the section are not applicable. Sites should expect an auditor to challenge their decision and be able to
justify it.

CLAUSE FOUNDATION HIGHER

5.1.1 There shall be a scheduled product-testing programme according to risk for each product or product
group as defined in the specifications. This shall be based on information such as:

• the outcome of the product and process risk assessments

• any legal requirements for testing in the regions(s) of intended sale
• the site’s requirements for demonstrating the production of safe products.
The methods, frequency and specified limits of testing shall be clearly defined.

Interpretation
The testing programme must be established, taking account of the range of factors listed in the Standard. Usually the programme
should be determined before production starts, although there may be occasions where the need for additional testing is
determined at a later date – for example, as a result of complaints, in order to improve features, or to take account of the need to
substitute one or more raw materials.

It is good practice to ensure that products meet the requirements of defined product standards in the countries or regions of
intended sale. For some products this will be a mandatory requirement but, even when the standards are voluntary, compliance is
usually the most straightforward way to show that the product meets the requirements of the intended market.

Sites should note that some specifiers have their own product standards, which may contain additional requirements. A site is
advised to check if this is the case and, if it is, to make sure that it or its testing organisation has copies of the most up-to-date
requirements.

The test programme must relate to all parts of in-process production and product where testing is required. It includes tests on
raw materials, component parts and products during production as well as final products. The programme may include testing
carried out by third-party laboratories as well as in-house testing, if this is necessary. When raw materials are specified to be
supplied with test reports, this should also be documented as part of the programme. A test programme is not complete unless it
details how and when samples are selected, by what criteria the results should be assessed, and who is responsible for checking
and accepting the results.

Example
A company produces pepper mills made with plastic and metal parts. Its test programme comprises the following:

• Polycarbonate bodies are purchased with a requirement for a test certificate on each batch to show the product meets the
safety of materials in contact with food requirements. The actual tests and test methods are defined and all tests must be

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 carried out in a laboratory accredited to ISO 17025 for the defined methods. There is a procedure in place for checking
certificates before accepting goods.
• The company has decided that it is foreseeable that these items will be placed in a dishwasher so it has conducted
dishwashing tests to a defined product standard to check suitability. This test has been carried out by a company experienced
in the testing but not accredited.
• The company carries out ‘stress-cracking’ tests on initial samples to confirm that the design does not have inherent
weaknesses, and on a random but defined basis. Quality assurance is responsible for testing and analysing results.
• In-process testing is carried out to ensure that the screws are assembled to the correct torque. There is an internal procedure
which defines the method and equipment to be used for this check. Each operator checks a sample hourly and records the
result on a production control chart. The chart has clearly defined action and warning limits and there is an established
procedure for the operator.
• The final product is subject to a performance test to grind 50 g of pepper. The conditions and procedure for this test are
defined. The test is carried out by the quality assurance department.
• Every six months a sample of final production is sent to an independent third-party accredited laboratory to check for
compliance with legislation. The precise legislation is defined.
• The factory has a procedure for use-testing of the mills at home by volunteers, and records of the performance are kept on a
defined chart. The quality assurance manager reviews this information.

An auditor would accept this as an appropriate test programme. Auditors are experienced in the product categories and may
have specific comments to make about any tests that are missing or inappropriate. Note that the test programme covers quality
and performance issues as well as safety and legality.

CLAUSE FOUNDATION HIGHER

5.1.2 The testing programme shall be implemented and records kept of all test results. Results which are
outside the defined specification shall be reviewed promptly by an authorised competent person. The
need for corrective action shall be assessed and documented, and any action carried out as necessary.

Interpretation
The stages at which a product is tested depends on the product type, and any legal and customer requirements. It is usually more
cost-effective to carry out tests relating to design issues as early on in the process as possible, so that errors may be corrected
before high costs are incurred.

For many higher-risk products, a ‘type test’ needs to be carried out by an approved third-party laboratory. This is a test to ensure
that the model is made in conformity with the appropriate legal requirements. Once the product passes this test it is the site’s
responsibility to ensure that the ongoing production continues to match the tested sample. Even if there is no legal requirement
for a type test, sites should ensure that the general production samples meet the same standards as tested products.

Note that a site needs to be cautious when accepting testing of raw materials packaging and components as an alternative to
final-product testing. It may be that all individual components and materials are satisfactory, but that there is an interaction
between them or the way they in which they are used, which means that the final product is unsafe. It is industry best practice to
test the final product randomly to ensure that the product going to the consumer is satisfactory.

Example
A company uses a solvent-based glue to assemble a product. The glue and the plastic materials being assembled have both
been tested and comply with legal requirements and the specification. When assembled, the solvent from the glue affects
another component adjacent to the glued area, causing it to weaken and break under some conditions.

Testing of the final product would have revealed this issue therefore the auditor would have raised a non-conformity.

CLAUSE FOUNDATION HIGHER

5.1.3 Where the company undertakes or subcontracts analyses which are critical to product safety or legality,
the laboratory or subcontractors shall have gained recognised laboratory accreditation or operate in
accordance with the requirements and principles of ISO/IEC 17025.
Documented justification shall be available where accredited methods are not undertaken.

60 WWW.BRCGLOBALSTANDARDS.COM
Interpretation

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

There are many things to consider when deciding where testing is to be performed and who will carry it out.

It is essential to use accredited laboratories only for tests critical to safety or legality that are not also validated by additional tests.
For example, a strength test carried out on the site does not need to be accredited if some random samples are also sent to a
third-party laboratory for verification of the results.

An accredited laboratory is one which has been audited by the appropriate national accreditation service to check that it operates
in accordance with ISO 17025. There are other accreditation schemes in some countries but these generally follow the same
principles. If a laboratory is working to an alternative scheme, this can be accepted provided it has been audited by a competent
and independent third party and can show that it follows the requirements of ISO 17025.

Sites should note the following important points about accreditation:

• Each accredited laboratory has a scope of accreditation, which is publicly available. Only those tests listed on the scope are
accredited.
• A laboratory is unlikely to be accredited for all the tests it performs. This does not mean that it is performing other test work to
a lower standard but it may indicate that it performs the testing less frequently, does not have exactly the right equipment or
has not found accreditation to be cost-effective. If in doubt, a site should ask the laboratory why it is not accredited for a
particular test.
• When an accredited laboratory is not available for some tests, the site wishing to test products should confirm that its chosen
laboratory is working to the principles of ISO 17025. An auditor would ask for justification of the use of such a laboratory if the
test was key to safety or legality.
• The Standard is not prescriptive about this, as long as testing is carried out competently and meets customer and legal
requirements. The following should be considered when planning testing:
• Customers may have preferred or required test laboratories.
• Testing the final product in the country of origin may give faster response times and make it easier to discuss results, but
testing in the country of sale may be more acceptable to the customer.
• Some ‘type tests’ must be carried out by laboratories approved by the authorities.
• Even if capabilities exist in-house, it is sometimes useful to have independent verification of key results both as a benchmark
and to reassure clients.
• Some test results are subject to interpretation and differing opinions. It can be useful to get more than one view on tests for
important projects.

Sites should always be satisfied that testing is carried out by competent and trained staff.

CLAUSE FOUNDATION HIGHER

5.1.4 Procedures shall be in place to ensure reliability of test results, other than those critical to safety and
legality. These shall include:

• use of recognised test methods and reference standards, where available

• documented testing procedures
• ensuring staff are suitably qualified and/or trained and competent to carry out the analysis required
• use of a system to verify the accuracy of test results (e.g. ring or proficiency testing)
• use of appropriately calibrated and maintained equipment.
Interpretation
It is essential that inaccurate results are not relied on. It is also important that the test methods used are precise, accurate and can
meet the required detection limits for the substance being measured. Likewise, the correct level of discrimination must be
possible.

Part of the assessment to ISO 17025 is that the laboratory uses suitably validated test methods and has the right quality assurance
procedures in place. Even when tests are being carried out by non-accredited entities, it is still important that test results are
accurate and robust. The Standard suggests a number of possible ways to do this but the list is not exhaustive. For
straightforward tests and measurements, very simple means may be available (for example, cross-checking a measurement with
two different makes of measuring rule), but in other cases more complex work will be required.

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The advantage of using recognised test methods, published in national or international standards or similar documents, is that the
methods have already been validated and checked so sites can use them with confidence and just have a procedure in place for
ensuring the quality of their own performance. If a site wishes to use a method that is not recognised or is an in-house method, it
will need to record and document the data justifying its validity.

Example
A company uses a spring-loaded micrometer gauge to measure the thickness of plastic sandwich bags. The results are quoted to
an accuracy of 0.001 mm but when checked the instrument is only accurate and calibrated to 0.01 mm.

Auditors will check the validity of results. In this case a non-conformity would result as the bag thickness has not been correctly
checked.

CLAUSE FOUNDATION HIGHER

5.1.5 Test and inspection results shall be reviewed regularly to identify trends. The significance of external
laboratory results must be understood and acted upon accordingly.
Appropriate actions shall be implemented promptly to address any unsatisfactory trends.

Interpretation
The Standard requires that all results falling outside the defined specification are reviewed and actioned by the responsible
person. It is essential that such results are not ignored until the annual review. It may be appropriate, depending on the risk, to
define a maximum length of time before reviewing the relevant procedures.

It is also possible that a nominated deputy will need to be assigned to this task. Although this is not a specific requirement of the
Standard, it is good practice for the responsible person to also review a selection of results that are in specification, since errors
can be made with false pass results as well as failures. This review should form a part of the internal audit for the department
responsible.

CLAUSE FOUNDATION HIGHER

5.1.6 Where testing is submitted to third parties, the

required testing shall be clearly defined, including
reference to the number, date and version of the
test standard or method to be used.
In cases where the company relies on the
expertise of third-party testing organisations to
determine appropriate test requirements, the
company shall ensure that the third party receives
a clear written briefing on the purpose of the test
and that the testing programme is formally agreed
and documented.

Interpretation
A test programme should be defined as precisely as possible to remove ambiguities. For example, if the tests required are
referenced by a product standard, the edition and section of that standard should be clearly stated. Sites often rely on their test
houses to advise on the appropriate requirements, as test houses have more expertise in this area. This is quite acceptable but
the site must ensure that the laboratory receives a written brief as to the requirements. Examples of this would be:

• defining the countries of intended sale

• clarifying any testing which is not required – for example, chemical testing of components
• indicating any user or usage information – for example, the intended age range for children’s products
• explaining any limitations to the sample – for example, the final product will be in a different colour
• the availability or unavailability of more samples – so that the laboratory knows whether it has to do all tests on the product
provided.

The individual responsible for the testing programme and follow-up must be clearly identified.

62 WWW.BRCGLOBALSTANDARDS.COM
5.2 QUANTITY CONTROL

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

The company shall operate a quantity control system which conforms to the legal requirements in the country where the
product is sold and any additional customer requirements.
Interpretation
For many product types, and in many countries, product quantity labelling is a legal requirement and the accuracy of information
on this labelling is defined. The method and frequency of validating the information may also be legally set. Sites should be aware
of, and abide by, any such requirements.

Example
A company producing shoe polish for the European market labels the bottles with the net weight. The weight is described using
the European average weight system. The company is obliged to check a defined number of products and to record that the
average weights are within the defined acceptable tolerances.

The auditor is likely to ask to see an example of the records and, if they are not available, a non-conformity would be raised.

CLAUSE FOUNDATION HIGHER

5.2.1 Where necessary the company shall operate a quantity control system which conforms to legal
requirements and/or specified customer requirements in the region where the product is available
for sale.
Documentary evidence shall be available on site to substantiate claims.

Interpretation
Documentary evidence must be available on site to substantiate any quantity claims, such as net weight or average contents.
These are governed by legislation such as the following:

• UK The Weights and Measures (Packaged Goods) Regulations 2006

• USA The Fair Packaging and Labeling Act (FPLA)
• Canada Weights and Measures Act (RS 1985).
CLAUSE FOUNDATION HIGHER

5.2.2 Where quantity checking is required, the frequency and methodology used based on valid sampling
plans shall meet the minimum requirements of any legislation governing quantity verification.

Interpretation
In Europe, quantity checking is governed by Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of
the member states relating to the making-up by weight or by volume of certain pre-packaged products.

In the UK it is enacted by the Weights and Measures (Packaged Goods) Regulations 2006. These regulations set out three rules
with which packers and importers must comply:

• The contents of the packages must not be less on average than the nominal quantity.
• The proportion of packages that are short of the stated quantity by more than a defined amount (the ‘tolerable negative error’)
should be less than a specified level.
• No package should be short by twice the tolerable negative error.
This statement is taken from the regulations themselves and it simply means that on average the average of the average must not
be less than the nominal stated average.

The regulations provide protection for consumers against short measures.

Packers and importers must ensure that packaged goods are labelled with the quantity. The information must be visible, indelible,
easy to read and not able to be damaged.

In Canada the Consumer Packaging and Labelling Act and Regulations (RSC, 1985, c. C-38) apply. There are three principles that
must be met to comply with the accuracy requirements of the Consumer Packaging and Labelling Act and Regulations:

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• The declared quantity on a package should accurately reflect the quantity being supplied, so the average net contents of the
packages in a lot (batch) may not be less than the declared quantity.
• The control over production should be such that the individual packages are within allowable tolerances. No more than 2.5% of
the lot may have a negative error larger than the tolerance.
• The number of packages that may have excessive negative errors is limited. Not more than one package may contain less than
twice the permitted tolerance. For example, if tolerance 1 (T1) is set at 5 g then a single unit with less than 10 g (T2) is illegal.

5.3 PRODUCT SAMPLE CONTROL

The site shall ensure that procedures are in place for the selection, handling, storage, approval and use of reference samples
taken from pre-production, subcontracted and finished production in accordance with customer requirements.
Interpretation
It is helpful if a site keeps a sample of the product it intends to make. It may also be useful to keep subassemblies or components if
there are a number of variations to the same model.

A site will often operate a final approved sample system with its customers. If so, a documented procedure, in which samples are
matched with first examples from the production line, should be in place to ensure compliance with customer requirements.

Example
A company makes a number of slight variations on a basically similar insect repellent spray. It decides to keep one complete
sample and samples of various components of packaging to cover the entire range. For each style, a full specification and parts
list (of the aerosol components) are generated.

The auditor will be satisfied with the approach provided that the company can demonstrate that all variants of assembly and
manufacture are covered.

CLAUSE FOUNDATION HIGHER

5.3.1 Where legally required or specified by a customer,

a reference sample of the product which has been
approved by the customer or a representative of
the agreed specification shall be retained.

Interpretation
Sites must determine how samples are to be selected, taking into account whether samples are kept at various stages before
production – for example, first model, ‘looks like, works like’ model or final pre-production sample. They should also consider how
samples are identified and selected, and who approves the sample. Any known differences between the sample and production
should be noted.

Customers often have their own requirements concerning samples. If so, a copy of their requirements should be available and the
site procedure should detail how these requirements are implemented and reviewed. These are often referred to as ‘red’, ‘black’ or
‘gold’ sealed samples.

CLAUSE FOUNDATION HIGHER

5.3.1 Where legally required or specified by a customer,

a sample of the product which has been approved
by the customer or a representative of the agreed
specification shall be retained.
The company shall document a process to
identify, select and categorise reference samples.
If customers have a defined system of sealed
samples referring to different stages of sample
approval, the customer’s procedure shall be
documented and followed.

64 WWW.BRCGLOBALSTANDARDS.COM
Interpretation

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

Sites must have a written procedure to explain how samples are selected, which takes into account whether samples are kept at
various stages before production – for example, first model, ‘looks like, works like’ model and final pre-production sample. The
procedure should include how samples are identified and selected, and who approves the sample. Any known differences
between the sample and production should be noted.

Customers often have their own requirements concerning samples. If so, a copy of their requirements should be available and the
site procedure should detail how these requirements are implemented and reviewed. These are sometimes referred to as ‘red’ or
‘bronze’ for pre-production samples or ‘green’ or ‘gold’ sealed samples for production.

CLAUSE FOUNDATION HIGHER

5.3.2 Reference samples shall be stored and recorded in suitable environmental conditions to maintain their
original status for a specified period.

Interpretation
It is helpful if a site keeps a sample of the product it intends to make. It may also be useful to keep subassemblies of materials or
components if there are a number of variations to the same product. A site will often operate a final approved sample system with
its customers. If so, a documented procedure, in which samples are matched with first examples from the production line, should
be in place to ensure compliance with customer requirements. Samples must be stored correctly; where an investigation of a
production issue is necessary, it will be unhelpful to find the reference sample rotten, faded or otherwise deteriorated.

Requirements usually concern keeping products at the right temperature and/or humidity, but other aspects, such as light or
freedom from magnetism, can be important in some cases. If the site does not know what storage conditions are suitable for its
products, it should examine the samples at suitable intervals to determine whether any deterioration is noticeable.

The site would be expected to understand the impact of storage conditions on the quality of stored product, and apply suitable
controls.

Example
A company makes a number of slight variations on a basically similar washing-up liquid. It decides to keep one filled, labelled
bottle and samples of labels and manufactured liquid to cover the entire range. For each variant a recipe and bill of materials are
generated.

The auditor will be satisfied with the approach provided that the company can demonstrate that all issues of manufacture and
filling are covered.

CLAUSE FOUNDATION HIGHER

5.3.3 A secure and tamper-evident system shall be in

place for the storage of samples. A sample-
tracking process shall be in place and temporary
removal of samples shall be managed.

CLAUSE FOUNDATION HIGHER

5.3.3 A secure and tamper-evident system shall be in

place for the storage and tracking of samples, with
access by authorised personnel.
The removal and return of samples to storage shall
be documented and authorised by a designated
responsible person.

Interpretation
Storage of sealed, pre- and post-production samples must be secure. If samples are not controlled it is not possible to say
whether they have been substituted, left in unsuitable conditions, modified or otherwise changed. Samples may also be removed
or lost without secure storage. The level of such a system, and whether each product needs to be controlled or if it is sufficient to
keep products in a locked room or cupboard with controlled entry, will depend on the type of product, the site and any customer

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requirements. The auditor will be looking for a system which gives confidence that the samples are reliable reflections of the
pre-production model.

This requirement is not intended to prevent samples being used or examined but to ensure that such events take place in a
controlled way and with an appropriate procedure in operation.

Examples
A small company is manufacturing disposable tableware products. It labels an example of each type with a numbered paper label
and stores it in a locked cupboard. The label issue is controlled on a spreadsheet detailing the product by label number.

This is appropriate for the activity and an auditor would find it an acceptable approach.

A large factory manufactures baby nappies (diapers) with a variety of designs used on the elasticated waistbands for the
high‑street retailers. The customer requires that each design is sealed in a bag with a tamper-proof seal and a log signed by the
responsible person. If the bag is opened or the seal broken, the factory has to contact the customer.

The auditor would check that the process had been followed and look for evidence of missing samples or samples with damaged
seals. If any evidence is found and the customer has not been informed, then a non-conformity would be raised.

CLAUSE FOUNDATION HIGHER

5.3.4 Documented procedures shall be in place to

determine the retention time for samples. This
should normally be the foreseeable lifetime of the
product unless otherwise justified.

66 WWW.BRCGLOBALSTANDARDS.COM
6 PROCESS CONTROL

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

6.1 CONTROL OF OPERATIONS
FUNDAMENTAL
The site’s programme of process and quality controls to ensure the production of safe and legal products of
consistent quality shall be based on a risk assessment of the production process and the potential for product
contamination.

Interpretation
This is a fundamental requirement because, without proper control of the site’s process, safe products that are fit for purpose
cannot be consistently achieved.

There are various aspects to product safety, quality and legality:

• designing a product
• selecting materials that are capable of resulting in a safe, quality product
• ensuring that the manufacturing process is controlled so that this is achieved on a consistent basis
• packaging products appropriately
• ensuring that products contain suitable warnings and adequate instructions.
The risk assessment should consider the whole programme from new product development through to dispatch. It should take
into account all components, including packaging and the legal requirements for the country in which the product is to be sold.

6.1.1 PROCESS RISK ASSESSMENT

CLAUSE FOUNDATION HIGHER

6.1.1.1 A hazard and risk analysis shall be carried out by a A hazard and risk analysis shall be carried out by a
multi-disciplinary team or demonstrably multi-disciplinary team including representatives
competent manager. who are experienced in the particular activities
undertaken by the site. The team members shall
In the event of the site not having appropriate
have knowledge of the hazard and risk analysis
in-house knowledge, external expertise may be
principles.
sought but the day-to-day management of the
system shall remain the responsibility of the site.

Interpretation
Applies at both foundation and higher levels
For a comprehensive hazard and risk analysis to be established and maintained, it needs to be managed by a nominated team
with relevant skills and experience. The number of team members needs to be appropriate to the size and structure of the
company, as the team will include representatives of each department with responsibility for the operation of the Standard. There
will always be more than one person, since a single person does not constitute a team. The team needs knowledge of the types of
operations that are carried out at the site and the hazards these operations may present to the product.

It is good practice to document the team members within the study, with a summary of their roles within the company.
Membership of the team needs to be reviewed and, when necessary, updated (e.g. when job responsibilities change or
personnel leave or join the company).

The team leader must be able to demonstrate competency and experience in using the HARA tools and processes. This can be
shown by:

• the quality of the plan

• documented evidence of the team leader’s qualification (e.g. successful completion of an industry-recognised risk
assessment training course)
• demonstrable, extensive experience in implementing or training (e.g. FMEA, HACCP, HARPC, nomograms, ISO 31000:2009
or AS/NZS 4360:2004).

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Training records (see clause 7.1) need to demonstrate that adequate training has been given to all HARA team members. This may
be achieved through either an external course or internal training.

Senior management commitment (see clause 1.1) is required to support the HARA team. This may be demonstrated by the
presence of senior management within the team, policy statements referring to HARA, or evidence within management review
meetings that HARA issues are discussed and reviewed. The results of the HARA plan must be integrated into the product safety
and quality management system.

CLAUSE FOUNDATION HIGHER

6.1.1.2 The person responsible for leading the hazard

analysis shall receive sufficient training to be able
to demonstrate competence in the understanding
of hazard and risk management principles and
their application.
In the event of the site not having appropriate
in-house knowledge, external expertise may be
sought but the day-to-day management of the
system shall remain the responsibility of the site.

Interpretation
The team leader must be able to demonstrate competency and experience in using the HARA tools and processes; this can be
shown by:

• the quality of the plan

• documented evidence of the team leader’s qualification (e.g. successful completion of an industry-recognised risk
assessment training course)
• demonstrable, extensive experience in implementing or training (e.g. FMEA, HACCP, HARPC, nomograms, ISO 31000:2009
or AS/NZS 4360:2004).

Training records (see clause 7.1) need to demonstrate that adequate training has been given to the HARA team leader. This may
be achieved through either an external course or internal training.

CLAUSE FOUNDATION HIGHER

6.1.1.3 Where the hazard and risk analysis study has been undertaken centrally by the head office, accurate
flow diagrams shall be available on site.
It must be possible to demonstrate that a central hazard and risk analysis has been verified to meet the
specific activities of the local operation. Verification activities include internal audits and complaints
analysis.

Interpretation
The flow diagram should include all of the inputs to the manufacturing process, from new product development to delivery.

CLAUSE FOUNDATION HIGHER

6.1.1.4 The scope of the hazard and risk analysis shall be defined in terms of the products and processes that
are covered.
The site shall establish precise process flow diagrams identifying each step in the production of the
products.

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 PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS
CLAUSE FOUNDATION HIGHER

6.1.1.5 The site shall consider the potential product safety

and quality issues which could occur at each
process stage.
Each potential issue shall be assessed to
determine the level of risk and suitable controls
established to reduce or eliminate the risk.

CLAUSE FOUNDATION HIGHER

6.1.1.5 The site shall consider the potential product safety

and quality issues which could occur at each
process stage. This should include:

• physical or chemical product contamination

• microbiological contamination
• product quality or safety issues as appropriate
to the products manufactured.
The results of this assessment shall be
documented.

Interpretation
See the interpretation guidance given for clause 6.1.1.6: higher.

CLAUSE FOUNDATION HIGHER

6.1.1.6 An analysis of any identified issues shall be

undertaken in order to decide which need to be
controlled. The following should be considered:

• the likely occurrence of the issue

• the severity of the hazard (e.g. injurious to
health, potential to cause, rejection or a product
recall)
• existing activities that effectively prevent or
reduce the issue to acceptable limits.

Interpretation
The site needs to identify the hazards that might be introduced if production is not adequately controlled. Hazards may be
contamination issues or indeed poor controls leading to poor performance. They can be introduced in a number of ways,
including:

• poor control of equipment settings

• use of incorrect parameters, such as time or temperature
• malfunctioning equipment
• use of unsuitable raw materials
• contamination from machinery, buildings, other products, etc.
• poor or ineffective quality checks.
A site should carry out and document the assessment even if, subsequently, no additional hazards or control points are required.

CLAUSE FOUNDATION HIGHER

6.1.1.7 Where any significant product safety or quality

issues are controlled by process monitoring the
process parameters shall be defined and records
retained of checks of the process.

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 CLAUSE FOUNDATION HIGHER

6.1.1.7 For each issue which requires control, control

points shall be reviewed to identify those that are
critical to prevent, eliminate or reduce a significant
issue to acceptable limits.

Interpretation
Process monitoring shall be established and adequately controlled to ensure products are produced within the required process
specification.

Which parts of the process (if any) need to be monitored is established following the assessment of potential hazards and
required process control. Monitoring may be needed on the product itself (for example, pH or viscosity measurements) or the
environmental conditions. In all cases the parameter to be measured should be clearly defined as well as the acceptable
tolerance, frequency of measurement, measuring equipment and means of recording results.

It is likely that auditors will ask to view some of these records, such as control charts filled in by operators, or automated
electronic records.

Examples
A cosmetics company has to control the temperature settings on the mixing machines to ensure a consistent mix with no lumps.
The process is monitored by automatic temperature checks, visual examination, filtration and viscosity testing on site. All results
are plotted on control charts with defined process limits. Photographs are available to compare acceptable results
against rejects.

This is a good example of the appropriate action being taken.

A household chemical company is manufacturing a toilet bleach. It has carried out a risk assessment and knows that if the
product becomes contaminated with aluminium, aluminium hydroxide would form causing a hazard, as the bottle could expand
and leak or even explode. In order to avoid this, the site measures the levels of contamination in the finished product.

By comparing the levels of contamination with the maximum safety level, the company knows whether the products easily satisfy
requirements or are close to the limit. This may determine whether the manufactured product is suitable for bottling.

A company is producing skin lotion; it has carried out an assessment and established that if the water quality is not controlled,
there is a risk of product contamination. A further assessment shows that both the quality of the incoming water and the
cleanliness of interior pipes are important and monitoring is required.

An auditor would look for the actions that have been put in place as a result of this evaluation.

CLAUSE FOUNDATION HIGHER

6.1.1.8 If there are identified critical control points (CCPs) where product safety and legality require control
measures to be in place, then for each CCP the site shall:

• establish and validate critical limits

• establish a system to monitor control of the CCPs
• establish the corrective action to be taken when monitoring indicates that a particular CCP is not
under control
• establish procedures of validation and verification to confirm that the system is working effectively,
including auditing of the system
• establish appropriate documentation concerning all procedures and records.
Interpretation
Critical control points (CCPs) are those points at which a parameter must be controlled and monitored in order to prevent critical
problems occurring in the process. This is usually recognised as the last point in the process which can be detected and
monitored; as a result there can be no subsequent step that will eliminate or reduce the effect. There would not normally be many
of these points, since there are usually only a few really critical steps. Other points that need to be controlled, but are not critical to
the product integrity, are called control points and may well be controlled through monitoring programmes.

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The monitoring at a CCP should be something that can be done and recorded in order to detect problems. The control points

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

should have defined monitoring and set limits outside of which action must be taken.

A common misperception is that the complete product safety test represents a CCP; in fact this is unlikely to be the case. This is
because a CCP reflects many different aspects of manufacturing, usually takes several days, and the result is only known when
production is complete. Unless there is a positive release system in place, then this is not a control as the product could be sold
before the safety test results are known.

Examples
A company is making children’s SPF 50 washable sun cream. It is important that the product meets all safety requirements so the
company has set a CCP that it has to pass in order to meet the product standard for Regulation (EC) No 1223/2009. It has one
product per batch tested to this standard by an external laboratory from a production of 20,000 bottles.

The test is important but it is not a CCP. It is not a test that gives an indication of where a critical production issue has to be
controlled. A more realistic CCP might be an online check to ensure that the total viable count of micro-organisms is below the
required specification and/or that the laboratory analysis of the sun cream pH is as the specification. This can be checked,
recorded and action taken if it is outside the allowed tolerance.

A company is monitoring the pH of a skin cream as a CCP. Records show that the pH was outside of the specification on several
occasions but no actions were documented and it did not appear that any action had been taken.

This would result in a major or even critical non-conformity since control at this point has been designated as critical to the
process, but no action has been taken.

CLAUSE FOUNDATION HIGHER

6.1.1.9 Corrective action shall be taken in the event of deviation of the process from specification. This shall be
recorded.

CLAUSE FOUNDATION HIGHER

6.1.1.10 The hazard and risk analysis shall be reviewed whenever new product types are manufactured or
significant changes are made to production methods.

Interpretation
Once the HARA has been developed it must be reviewed if anything in the process changes. This could include buying raw
materials from a different source or developing a new product or processing method. The HARA must be reviewed to establish
that no new risks have been introduced. Failures of the product or similar products in service might also trigger this review as they
may indicate some hitherto underlying issue that has yet to be discovered.

Other factors may include changes in legislation; some legislation, such as REACH, has been updated on a regular basis. As a
result, a chemical in use now may not be acceptable in the future. For example, on 6 April 2016 the results of 48 substances
evaluated under the Community Rolling Action Plan (CoRAP) were released by the European Chemicals Agency (ECHA). Since
1 September 2016 companies must apply for the approval of active substances in biocidal products that used to be outside the
scope under the previous directive but now fall within the scope of the Biocidal Products Regulation. This regulation concerns
two groups of substances:

• active substances in food-contact materials for surface action; for example, antimicrobial substances used on plastic
chopping boards to give them an antimicrobial surface (product type 4, disinfection of material which may have contact
with food)
• in situ-generated active substances with precursors that were not in the scope of the directive because they were not placed
on the market, or because no claim was made that these precursors could be used for a biocidal purpose. For example, ozone
generated from oxygen from the air (product type 5, disinfection of drinking water), which may be used in drinks dispensers.

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 CLAUSE FOUNDATION HIGHER

6.1.1.11 The hazard and risk analysis shall also be formally

reviewed at least annually and this review shall be
documented.

6.1.2 LINE CLEARANCE AND IN-PROCESS CHECKS

CLAUSE FOUNDATION HIGHER

6.1.2.1 Before the start of any manufacturing operation

and following changes of product, checks shall be
made to ensure that the production line has been
cleared and made ready for use.
All work instructions, raw materials, components
and packaging with the necessary equipment
shall be available for use.

CLAUSE FOUNDATION HIGHER

6.1.2.1 Before the start of any manufacturing operation,

documented checks shall be carried out to ensure
that the production line and the relevant areas
around it have been cleared and, where
necessary, cleaned, to avoid mixing with materials
from the previous operations.
All documentation, raw materials, components
and packaging with the necessary equipment
shall be available for use.
It shall be possible to identify the production line
with its name or identifying code as determined by
the risk assessment.

Interpretation
It is vital that all previous production materials are cleared away, including labels and packaging as well as components and
chemicals. This is to avoid inadvertent mixing. Additionally, any instructions on manufacture or assembly should also be removed
so that there is no possibility of confusing them in any way.

6.2 EQUIPMENT AND EQUIPMENT MAINTENANCE

Equipment shall be suitable for the intended purpose and shall be used in such a way as to minimise the risk of contamination
of product.
Interpretation
Equipment used to manufacture product should be specified prior to commissioning. The equipment must be fit for purpose;
even if it has been altered to manufacture a product, it must perform in a way that does not compromise product safety, quality or
legality. For example, if the product is a low-pH cleaner then the plant, including pipework, mixing vessels and filling heads,
should be constructed of non-reactive materials that will not leach chemicals into the product and will not fail because it
becomes brittle.

CLAUSE FOUNDATION HIGHER

6.2.1 All equipment shall be fit for purpose and constructed of appropriate materials.
The design and placement of equipment shall ensure it can be effectively cleaned and maintained.

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Interpretation

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

Equipment used to manufacture product should be specified prior to commissioning. The equipment must be fit for purpose;
even if it has been altered to manufacture a product, it must perform in a way that does not compromise product safety, quality or
legality. For example, if the product is made of injection-moulded plastic, the plant, including pipework, mixing vessels and filling
heads, should be constructed of non-reactive materials that will not leach chemicals into the product and will not fail because of
erosion.

CLAUSE FOUNDATION HIGHER

6.2.2 In the case of equipment failure, procedures shall be in place to establish the safety and legal status of
the product prior to release.

Interpretation
Steps must be taken to ensure the product is still safe, legal and of the right quality in the event of plant or equipment failure. This is
especially important in the case of in-line testing equipment, coding equipment or parameter monitoring/controlling equipment
for a CCP.

CLAUSE FOUNDATION HIGHER

6.2.3 An implemented maintenance programme

covering all items of equipment and plant which
are critical to product safety, legality and quality
shall be in place.

CLAUSE FOUNDATION HIGHER

6.2.3 A documented planned preventive maintenance

programme based on risk assessment and
covering all items of equipment and plant which
are critical to product safety, legality and quality
shall be in place.

Interpretation
Planned preventive maintenance (PPM) and planned maintenance (PM) are forms of scheduled maintenance to any item of
equipment. This can be carried out by on-site engineers or by a subcontractor on a scheduled service visit to ensure that an item
of equipment is operating correctly and therefore avoiding any unscheduled breakdowns and downtime. Such maintenance must
be carried out according to the manufacturer’s recommendations or legislation.

Example
In the UK, a fork lift truck is legislated for under the Lifting Operations and Lifting Equipment Regulations 1998 (LOLER), which
requires the truck to be serviced (dependent upon use – approximately twice per year) by a competent service engineer. Other
mechanical equipment, such as a power press, is legislated for under the Provision and Use of Work Equipment Regulations 1998
(PUWER) (SI 1998/2306) which implement the provisions of the Use of Work Equipment Directive (89/655/EEC) and Directive
95/63/EC on the Amended Use of Work Equipment. Once again, the frequency of servicing is determined and whilst it is not
concerned with productivity, some safety maintenance activities will also have production benefits.

The auditor will review the equipment during the site tour and may ask to see more details of the specifications or maintenance
schedules. An auditor might also examine production control records to establish whether the equipment is capable of
consistently producing products which meet specification.

CLAUSE FOUNDATION HIGHER

6.2.4 Materials (e.g. chemical lubricating oils and paints) used for equipment and plant maintenance shall be
assessed to establish whether they pose a risk by direct or indirect contact with raw materials,
intermediates, components, packaging and finished products. If necessary, they shall be suitably
identified for the intended use and controlled.

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Interpretation
In the UK, the Control of Substances Hazardous to Health Regulations 2002 (COSHH) require employers to either prevent or
reduce their workers’ exposure to substances that are hazardous to their health. Safety data sheets (SDSs) provide information on
all chemical products to help users of those chemicals make a risk assessment. They describe the hazards the chemical presents,
and give information on handling, storage and emergency measures in case of accident.

In the US, the Occupational Safety and Health Act of 1970 (OSH Act) (29 USC §651 et seq.; 29 CFR Parts 1900 to 2400) requires
manufacturers and importers of hazardous materials to conduct hazard evaluations of the products they manufacture or import. If
a product is found to be hazardous under the terms of the standard, the manufacturer or importer must so indicate on containers
of the material, and the first shipment of the material to a new customer must include a material safety data sheet (MSDS).
Employers must use these MSDSs to train their employees to recognise and avoid the hazards presented by the materials.

In Australia, the Work Health and Safety Regulations (WHS) require the manufacturer or importer of a hazardous chemical to
prepare an SDS for the chemical. Additionally, a supplier must provide the manufacturer’s or supplier’s current SDS for the
hazardous chemical on first supply to a workplace and upon request.

If a chemical was to pose a risk to a worker, then that chemical would possibly pose a risk to the end-consumer.

CLAUSE FOUNDATION HIGHER

6.2.5 Repairs or servicing of equipment shall be completed by competent maintenance personnel.

CLAUSE FOUNDATION HIGHER

6.2.6 When possible, equipment shall be positioned so as to give access beneath, inside and around it for
ease of cleaning and servicing.

6.3 PRODUCT CONTAMINATION CONTROL

Appropriate facilities and procedures shall be in place to control the risk of foreign body, chemical or biological contamination.
Interpretation
The site must identify the level of control that is required. There are various kinds of foreign-body detection but this clause most
commonly applies to metal detectors. The BRC best-practice guideline, Foreign Body Detection, gives guidance for those
seeking further information.

6.3.1 IDENTIFICATION AND PREVENTION OF RISK OF PRODUCT CONTAMINATION

CLAUSE FOUNDATION HIGHER

6.3.1.1 The site shall ensure that all necessary steps are taken to identify and prevent the risks of foreign body,
chemical and biological contamination as identified by risk assessment. This shall include any
contamination potentially introduced by raw materials, components or packaging.

6.3.2 CHEMICAL AND BIOLOGICAL CONTROL

CLAUSE FOUNDATION HIGHER

6.3.2.1 Processes shall be in place to manage the use, storage and handling of non-production chemicals and
biological materials to prevent contamination. These shall include as a minimum:

• a list of approved chemicals for purchase

• availability of material safety data sheets
• the labelling and/or identification of containers of chemicals and biological materials at all times
• a designated storage area with access restricted to authorised personnel.

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6.3.3 METAL CONTROL

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

CLAUSE FOUNDATION HIGHER

6.3.3.1 Tools and other sharp metal implements including knives, cutting blades, needles, perforation blades
and wires used in production shall be controlled where there is a risk of product contamination. Methods
such as, but not limited to, the following may be used:

• tools permanently attached to equipment to prevent loss

• items controlled by an issue listing and registration procedure
• recovery of all parts of broken needles before the issue of a replacement needle.
Snap-off-blade knives shall be prohibited.

CLAUSE FOUNDATION HIGHER

6.3.3.2 Staples, paper clips and drawing pins shall not be used in open product areas.
Where staples or other items are present as packaging materials or closures, appropriate precautions
shall be taken to minimise the risk of product contamination.

Interpretation
There should be clear controls in the case where staples are used to close boxes, or metal closures are used for banding. This is
important both with regard to the loose staples or closures and to the quality of the form so that there are no sharp edges or other
hazards.

6.3.4 GLASS, BRITTLE PLASTIC, CERAMICS, WOOD AND SIMILAR MATERIALS CONTROL
CLAUSE FOUNDATION HIGHER

6.3.4.1 Glass or other brittle materials shall be excluded or protected against breakage in areas where there is a
risk of product contamination.

Interpretation
Breakages need to be controlled. There should be a process for ensuring all of the sharp material is accounted for in the event of a
breakage. In some cases this may involve reconstructing the broken item to see if anything is missing. As well as cleaning up the
broken items, some companies will use dedicated or disposable equipment to prevent the spread of small particles.

CLAUSE FOUNDATION HIGHER

6.3.4.2 Where there is a potential risk to product all glass, ceramic, wood and brittle-plastic items in production
areas (except where the item is part of the product) shall be included in the risk assessment and listed in
a register. Documented procedures for handling these materials shall include:

• regular checks of the condition of these materials carried out at specified intervals and recorded
• recording of all breakages in an incident report
• segregation of contaminated product
• recording details of cleaning or replacement to minimise potential for product contamination.
Interpretation
It is important to assess the risk to the product from any non-production glass, ceramics or indeed any material that could
become sharp when broken. The risk is obvious in the case of a glass window in a production hall, but may be considerably less
obvious for a changing-room mirror.

Examples
During the audit the auditor notices that the mirror in the ladies’ changing room is cracked. Upon investigation the site quality
manager tells the auditor that they had not considered the changing rooms to be an area where the glass needs to be monitored
and it is not mentioned in the register. The auditor reviews the risk assessment and confirms that the site thought that the mirrors
and windows in the changing areas were far enough away from the production hall to be of little or no risk to the product.

The auditor would accept this argument if the consideration was reasonable. However, if there was a possibility of glass fragments
being transferred into the production areas on the staff’s workwear, the auditor would raise a non-conformity.

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During the audit the auditor notices that the reed diffuser filling line and the candle line both have glass receptacles. The process
is defined and in the event of glass breakage the line operatives are required to use a disposable broom and dustpan system. The
equipment is colour-coded yellow and is thrown away following the clear-up.

This would be acceptable.

6.3.5 FOREIGN BODY DETECTION AND REMOVAL EQUIPMENT

The risk assessment shall identify the potential use of equipment to detect or remove foreign body contamination.
6.3.5.1 Filters and sieves
CLAUSE FOUNDATION HIGHER

6.3.5.1.1 Filters and sieves used for foreign body control shall be of a specified mesh size or gauge and designed
to provide the maximum protection that is practical for the product. Material retained or removed by the
system shall be examined and recorded to identify risks.

CLAUSE FOUNDATION HIGHER

6.3.5.1.2 Filters and sieves shall be regularly inspected and Filters and sieves shall be regularly inspected and
tested for damage. tested for damage at a documented frequency
determined by the risk assessment.
Defective sieves and filters shall be segregated
and appropriate action taken to replace them. Defective sieves and filters shall be segregated
and appropriate action taken to replace them.
Records shall be maintained.
Records shall be maintained.

6.3.5.2 Metal detectors and X-ray equipment

CLAUSE FOUNDATION HIGHER

6.3.5.2.1 Where a metal or other foreign body detector is required based on risk assessment, the company shall
establish documented procedures specifying the methods and frequency of testing, critical limits for
detection, and recording of test results.

CLAUSE FOUNDATION HIGHER

6.3.5.2.2 The metal detector or X-ray equipment shall incorporate one of the following:

• an automatic rejection device

• a belt stop system with an alarm where the product cannot be automatically rejected (e.g. for very
large packs)
• in-line detectors which identify the location of the contaminant to allow effective segregation of the
affected product.

CLAUSE FOUNDATION HIGHER

6.3.5.2.3 Systems shall be in place to segregate product rejected by the metal detector to prevent accidental
reintroduction and allow investigation of the source of the metal contaminant.

CLAUSE FOUNDATION HIGHER

6.3.5.2.4 The company shall examine product rejected by There shall be a documented procedure to
the metal detector and retain any metal examine product rejected by the metal detector
contaminant. and to retain any metal contaminant.
The source of the contamination shall be The source of the contamination shall be
investigated and appropriate corrective action investigated and appropriate corrective action
taken to minimise the risk of further contamination. taken to minimise the risk of further contamination.
Records shall be maintained. Records shall be maintained.

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6.3.5.3 Magnets

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

CLAUSE FOUNDATION HIGHER

6.3.5.3.1 The type, location and strength of magnets shall be recorded in a register.
Documented procedures shall be in place for inspection, cleaning, strength testing and integrity checks.
Records of all checks shall be maintained.

CLAUSE FOUNDATION HIGHER

6.3.5.3.2 Optical sorting equipment shall be checked on the basis of the manufacturer’s instructions or
recommendations.
Records of all checks shall be maintained.

6.4 CALIBRATION AND CONTROL OF MEASURING AND MONITORING DEVICES

Measuring equipment used to monitor product safety, quality and legality shall be calibrated and of suitable accuracy for its
intended purpose.
Interpretation
This section requires equipment to be properly identified, listed and calibrated at an appropriate frequency by suitably qualified
staff. It is easy to believe test results, but if the equipment being used to take the measurements is incorrect this can lead to a false
sense of security and unsafe products being produced.

The clauses require that equipment is not adjusted by untrained operators and that each piece is suitably labelled with its
calibration status. Auditors will wish to see calibration certificates.

The calibration range and discrimination are very important. For example, if a thermometer has been calibrated as accurate
between 10°C and 100°C, it cannot be reliably used for measurements of 150°C. If a balance has been confirmed as accurate for
weighing between 10 g and 100 g at an accuracy of 0.1 g, it cannot be used to record weights to the nearest 0.001 g.

Example
A factory has a number of balances with which it check-weighs products to ensure that they are to specification. It also operates
within temperature- and humidity-controlled environments, which are monitored. None of the equipment has been calibrated
over the past year. The auditor is told that the calibration laboratory has increased its prices and the site cannot afford to maintain
calibration. A representative of the site says they are sure that the equipment will still be acceptable, because it was in calibration
when it was last checked.

This would not only raise a non-conformity about the calibrations but would also highlight a lack of provision of resources for a
key task.

CLAUSE FOUNDATION HIGHER

6.4.1 The site shall have a list of equipment used to make measurements relevant to product safety, legality
and quality.

Interpretation
Although this sounds relatively simple, in some industries where the process is steamy or oily the labels may simply not stick. A
good deal of research may therefore be needed to find a system that works. In many cases where gauge use is high, the system
used is colour-coded to show the calibration status of the gauge.

CLAUSE FOUNDATION HIGHER

6.4.2 The equipment used to accept or reject a product shall be calibrated to a specified accuracy and
precision at a defined frequency (or before use).

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Examples
A laboratory uses a pH meter and calibrates it every day. The results of the calibration are reviewed by the auditor, who notes that
the readings show two points at which the meter is calibrated: pH 4.0 and pH 7.0. The recorded calibration readings show a
record of pH 4.0 and pH 7.0 for every calibration. The auditor asks to see the calibration being performed and watches the
technician follow the procedure, press the calibration button and record the reading after calibration.

The auditor raises a non-conformity as there is no record of the ‘as-found measurement’, without which it is not possible to
determine whether once a day is the correct frequency.

The auditor asks to see the micrometer used by a sheet metal worker. On examination the auditor holds the gauge up to the light
and discovers that the spindle of the gauge is not parallel to the frame. As a result it does not sit squarely on the anvil. The worker
admits to having dropped it the previous week.

The auditor raises a non-conformity as the gauge is no longer in calibration and the incident had not been reported.

CLAUSE FOUNDATION HIGHER

6.4.3 The calibration of identified equipment shall be

traceable to a recognised national standard.
Where such a standard does not exist, the basis
by which calibration is declared shall be verified.

Interpretation
A calibration check may be carried out in-house, as long as it is performed to a documented method by competent staff, using
appropriate reference standards/equipment. The reference standards/equipment will need to be calibrated by a laboratory that
can demonstrate competence, measurement capability and traceability. For example, in the UK this would be a UKAS-accredited
calibration laboratory (ISO 17025); in the US, the National Institute of Standards and Technology (NIST); in India, the National
Accreditation Board for Testing and Calibration Laboratories (NABL).

As a guide, any instrument or reference standard should have an accuracy 10 times greater than that of the device being
calibrated.

Example
A device having a ±0.5% tolerance might be calibrated using a standard having an uncertainty of ±0.05%. There may, however,
be exceptions to this rule where a factor of 2 or 5 may be acceptable.

This science is known as metrology and is used for the determination of accurate gauges measuring optical and ionising radiation
and properties that are:

• dimensional
• electromagnetic
• environmental
• mechanical
• thermodynamic
• time- and frequency-dependent.
Some gauges are not traceable to a national standard (e.g. pH or the classification of a steel type according to ISO/TS 4949:2003)
so standards have been set up by which comparisons can be made.

CLAUSE FOUNDATION HIGHER

6.4.4 Records of the results of calibration and

verification shall be maintained for a suitable
period, taking account of the life of the products
being produced.

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 PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS
CLAUSE FOUNDATION HIGHER

6.4.5 Adjustment of identified equipment by

unauthorised staff shall be prevented and the
equipment shall be marked to show its calibration
status and period of validity.
A process shall be in place for actions to be taken
if equipment is found not to be operating within
specified tolerances and/or limits.

CLAUSE FOUNDATION HIGHER

6.4.5 Adjustment of identified equipment by

unauthorised staff shall be prevented and the
equipment shall be marked to show its calibration
status and period of validity.
Procedures shall be in place for actions to be
taken if equipment is found not to be operating
within specified tolerances and/or limits.

Interpretation
Gauges such as thermometers can be reset to zero at any point so this requirement needs to be controlled by access and
authority.

If a gauge is found to be out of calibration for whatever reason it is usual to refer to the last time the equipment was in calibration,
then recheck the results from that point until now.

6.5 FINAL PRODUCT PACKING AND CONTROL

The company shall ensure that products are packed in accordance with customer-specified requirements and any relevant
safety criteria, quality and legal requirements.
Interpretation
Even if a product has been made successfully, it can be unsafe or not of the right quality if it is not packaged correctly or put in the
wrong box. The site needs to have a procedure in place to ensure that this cannot happen. In the case of quantities, it may well be
a legal requirement that suitable checks are in place.

Examples
A company making hair dye does not have an appropriate final pack procedure. It packs the wrong colour dye into the wrong
boxes. Many consumer complaints are received.

The same company corrects the error but packs the wrong language edition of the instruction sheet into the boxes. Customers
cannot understand the instructions and are at risk of damaging their hair or even injuring themselves through incorrect
application.

Both these actions would result in a non-conformity, and highlight the importance of proper control at the packing stages.

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6.5.1 Before the start of the packaging operation and Before the start of the packaging operation,
following changes of product, checks shall be documented checks shall be carried out to ensure
carried out to ensure that the packing line has that the packing line and the relevant areas around
been cleared and made ready for packing. it have been cleared, and where necessary
cleaned, to avoid mixing with materials from the
All work instructions and packaging materials shall
previous operations.
be available for use.
All documentation and packaging materials shall
be available for use.
The packing line shall be identifiable by its name
or identifying code as determined by the risk
assessment.

Interpretation
Applies at both foundation and higher levels
Almost a third of all product recalls are as a result of ‘the wrong item in the box’. One way this can occur is when the line changes
over and the previous packaging (including insertions) is still available. Some companies have adopted a just-in-time approach
where the product and packaging are brought to the line only when they are needed.

CLAUSE FOUNDATION HIGHER

6.5.2 The company shall ensure that product packing is The company shall have a validated, documented
effectively managed to ensure that it meets procedure for the packing of products taking
customer-specified packing requirements for the particular account of customer requirements.
product.
This shall include methods of ensuring that the
This shall include methods of ensuring that the correct product(s) and components are correctly
correct product(s) and components are correctly packaged and placed in the correct outer
packaged and placed in the correct outer packaging.
packaging.

CLAUSE FOUNDATION HIGHER

6.5.3 The quantity of product should match the quantity markings, which should be accurate, verified and in
accordance with the legal requirements in the country of sale.

6.6 STOCK CONTROL AND PRODUCT RELEASE

The company shall ensure that stock and finished product are not released unless all agreed procedures have been followed
and the release is suitably controlled.

CLAUSE FOUNDATION HIGHER

6.6.1 Controls shall be in place to ensure correct stock rotation and that materials and products are used in the
correct order and within the allocated shelf or usage life as applicable.

Interpretation
This section of the Standard addresses stock rotation. This is obviously important if products have a limited shelf life, but it is
generally good practice to ensure that stock is shipped in the order of production. Even products that do not deteriorate with age
should be considered because information such as addresses, phone numbers or instructions can become out of date.
Companies should be able to demonstrate how they control the organisation of the dispatch process.

CLAUSE FOUNDATION HIGHER

6.6.2 The company shall ensure that product brought in from off-site subcontractors shall be included in the
product release procedure.

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

Sites often have problems with subcontracted work as they do not control it as rigorously as work produced on site. This clause
ensures that any subcontracted work is subject to the same level of control as work produced on site.

There shall be a procedure for the selection and instruction of subcontractors and for the acceptance of products received from
subcontractors. This may include documentation checks, inspection, testing or a combination of these. The products shall be
subject to an authorised positive release system. Subcontractors may be subject to the same KPIs as the site of major
manufacture. This clause includes work produced by home workers and the material they use, which must be controlled in the
same way as work produced on site, because the same safety or quality problems may occur. Home workers should have
documented work instructions and any equipment they use must be subjected to maintenance procedures and calibration as
necessary. Home workers must be made aware of any issues concerning product safety that are pertinent to their work – for
example, avoiding foreign-body contamination and control of sewing needles.

CLAUSE FOUNDATION HIGHER

6.6.3 Only products conforming to specification and

agreed quality requirements are to be released for
dispatch.
If no such control is conducted, the company shall
have a full justification for its absence documented
in the customer agreement, which shall be
reviewed at least annually.

CLAUSE FOUNDATION HIGHER

6.6.3 A documented procedure shall be in place to

ensure that only products conforming to
specification are released for dispatch.
Procedures may include, but are not limited to:

• positive final release by authorised staff

• online test methods
• automatic rejection process (which shall be
validated and monitored).
If a risk assessment determines that no such
control is required, the company shall have a full
justification for its absence, which is documented
in the customer agreement and shall be reviewed
at least annually.

Interpretation
Once products have been produced, the final stage is to control the dispatch so that no substandard products are released. The
Standard requires a robust system to be in place. It does not specify the procedure to be used but suggests some common
methods.

The most usual method is by ‘positive release’, where products have to be approved for release by a suitable person authorised to
do so. This means that products do not just get sent out and only stopped when or if there is a problem, but that every batch is
checked and positively agreed to be satisfactory before it can be shipped. For example, a mascara may be held until the
microbiology results are available.

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7 PERSONNEL

7.1 TRAINING AND COMPETENCY

FUNDAMENTAL
The company shall ensure that personnel performing work that affects product safety, legality and quality are
demonstrably competent to carry out their activity, through training, work experience or qualification.

Interpretation
In order to produce anything successfully, it is important that employees are competent, well trained and understand their duties.
Auditors will expect sites to be able to show that staff meet these requirements, and they will probably interview and observe staff
to judge the extent to which this requirement has been met.

Auditors are likely to focus mainly on production, quality and technical staff but any others who could influence the products
should also be considered, such as dispatchers, cleaners and administrators taking orders. It is a requirement that those carrying
out the risk assessment (to ensure products are safe and legal) have some formal training. The training types and methods are not
specified because different levels and types of training will be appropriate in different industries. However, it is likely that the
auditor will challenge staff’s understanding of risk methods. If the auditor is in any doubt as to the staff’s understanding of a
process or is unconvinced by the results of risk assessments, they will evaluate the training.

Note that the requirements of this section apply to general duties as well as to specific job training. Basic understanding of a site’s
procedures is as important as specialist knowledge. Misunderstanding the site procedures (relating, for example, to storing
products in the wrong places, not using the correct tools, or not understanding the site requirements for hand-washing) may have
a deleterious effect on safety.

Example
An auditor is visiting a factory producing first-aid kits and asks an operative what their duties are with regard to packing the
cartons into outer boxes. The operative does not appear to understand and is not packing the same way as operatives on other
lines. The auditor seeks clarification from the supervisor and is told that the operative, whose first language is not used on the site,
is new and has been sent by an agency as temporary staff to help with a backlog of work.

The auditor raises a non-conformity. The site must have a way of ensuring that all staff are competent and clearly understand their
job. In this case, some hands-on training, followed by sign-off after the operative had demonstrated competence, would be
appropriate.

CLAUSE FOUNDATION HIGHER

7.1.1 The company shall ensure that all employees are

able to demonstrate competence with regard to
their activity.

CLAUSE FOUNDATION HIGHER

7.1.1 The company shall ensure that all employees are

able to demonstrate competence with regard to
their activity.
The company shall:

• identify the need for training

• document training procedures and records to
demonstrate that training is effective and
regularly reviewed
• ensure that training includes both general
information on the company and specific job
training
• retain all training records.

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

The auditor will judge the competency of staff through records, observation and interview. They will look for job descriptions and
ensure that they correspond with staff’s own views of their roles. They will also look for evidence that any necessary training has
been carried out and its success evaluated. The need for training and records does not mean that experienced personnel without
formal qualifications are not acceptable. Their experience can be evaluated and documented and ‘grandparent rights’ may be an
acceptable assessment in some cases.

CLAUSE FOUNDATION HIGHER

7.1.2 Training records shall be stored in such a way as to ensure privacy of personnel is protected and legal
compliance with data protection laws in the country of operation are respected, while also allowing
auditors access to necessary information. Training shall be traceable to an individual employee.

Interpretation
A training record should be traceable to an individual, and should cover all their relevant responsibilities, taking account of any
privacy laws that apply. The site should give due attention to refresher training.

The auditor will wish to review training procedures and records on part of their site tour. For example, they will observe how staff
have been trained to use a new piece of equipment, or how they are made aware of the requirements of a new customer. The
auditor does not want to see payroll information, tax details or health details; this type of information can be divulged only with the
employee’s express permission.

Examples
A factory operative is asked by the auditor about methods of adjusting a computer-controlled cutting machine. The operative
does not appear to know. When asked, the supervisor produces evidence that the operative was sent on an external course to
learn about the machine. On further questioning it appears that the operative did not understand the course, they did not go back
for the second day of instruction, and no evaluation or questionnaire about the course had been completed.

The operator could not demonstrate competence or adequate training and so a non-conformity would be raised.

The test laboratory in a factory has just bought a new piece of equipment to test its products for toxic metals. The laboratory
supervisor used a similar machine several years ago but other staff are not familiar with it. An in-house training session has been
arranged with the supplier, and all staff will complete the training before commissioning the new equipment. The laboratory has
also signed up to a correlation trial to ensure that its results are reliable.

This is a satisfactory way of addressing an issue when no-one on site has the required competence to carry out training.

A qualified supervisor has carried out some basic hygiene training for shift workers. Unfortunately, although the training has been
minuted and dated, it is not possible to check which operators were present at the time.

The auditor would raise a non-conformity, although the problem could easily have been solved if each operative had signed an
attendance sheet, which was then filed with the record of the training.

7.2 PROTECTIVE CLOTHING

The company’s standards shall be documented and adopted by all personnel, including contractors and visitors to the
production facility.
Interpretation
Any clothing provided as protection shall not, itself, present a contamination risk to the products. In many industries there are no
particular requirements, but even so, appropriate controls should be in place, such as using only approved laundry companies. If,
for example, protective clothing is required, the laundering methods (including frequency and suitability) shall be documented
and assessed. When staff are responsible for their own laundry, the site should have clear procedures on the process that should
be used, to ensure that product safety and quality are maintained.

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 CLAUSE FOUNDATION HIGHER

7.2.1 The company shall use risk assessment to determine the need for protective clothing.
Where a need for protective clothing has been identified by the risk assessment, this shall not pose a
contamination risk to the product.

CLAUSE FOUNDATION HIGHER

7.2.2 Based on the assessment of risk to the product

integrity, suitable footwear shall be worn within the
factory environment.

CLAUSE FOUNDATION HIGHER

7.2.3 Protective clothing, where provided, shall be

effectively laundered at an appropriate frequency.
Disposable protective clothing, if used, shall be
subject to adequate control to avoid product
contamination.

7.3 HYGIENE PRACTICES

Standards of hygiene shall be applied with due regard to the risk of product contamination.
Interpretation
This clause encompasses good manufacturing practices and requirements for HARA. It is very important in high-risk product
areas such as nursery accessories, cosmetics and medical devices.

It is necessary not only to meet the requirements but also to monitor whether they are being implemented and take action on any
lapses. The auditor will observe whether this requirement is being complied with throughout the course of the audit.

CLAUSE FOUNDATION HIGHER

7.3.1 Where the risk has been identified, the company The company shall have a policy to control the
shall have a policy to control the wearing of wearing of jewellery so that it poses no risk of
jewellery so that it poses no risk of product product contamination.
contamination.

CLAUSE FOUNDATION HIGHER

7.3.2 All cuts and grazes on exposed skin shall be covered by a contrasting coloured plaster that is issued and
monitored by the site, to avoid contamination of product.

CLAUSE FOUNDATION HIGHER

7.3.3 Where metal foreign body detection is in place,

detectable plasters shall be used and shall be
regularly tested through the detector.

CLAUSE FOUNDATION HIGHER

7.3.4 Hand-cleaning shall be performed at a suitable frequency to maintain hygienic conditions.

CLAUSE FOUNDATION HIGHER

7.3.5 Eating, drinking or smoking shall only be permitted within designated areas and where there is no risk of
contamination of products.

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CLAUSE FOUNDATION HIGHER

7.3.6 The company shall use risk assessment to determine

the need for all head and facial hair to be covered and
fully contained to prevent product contamination.

Interpretation
It is estimated that 50–150 head hairs per day fall out and if you run your fingers through your hair, five or six can be dislodged.
Information on beard shedding is not as readily available. Comment groups suggest that beards may shed hair at a somewhat
lesser rate but it would appear that the longer the beard, the more similar the rate is to head hair. If it is determined that hair
covering is required, then the wearing of the hairnet/beard snood must cover all hair and not allow any hair to be exposed.

CLAUSE FOUNDATION HIGHER

7.3.7 Where there is a risk to product safety and quality,

fingernails shall be kept short, clean and unvarnished.
False fingernails shall not be permitted.

CLAUSE FOUNDATION HIGHER

7.3.8 Where there is a risk to product safety and legality,

the site should have a procedure for the
notification by personnel, including temporary
personnel, visitors and contractors, of any relevant
infectious diseases or conditions which they may
have been in contact with or be suffering from.

CLAUSE FOUNDATION HIGHER

7.3.8 The site shall have a documented procedure for

the notification by personnel, including temporary
personnel, visitors and contractors, of any relevant
infections, diseases or conditions which they may
have been in contact with or be suffering from.

Interpretation
Certain infectious diseases can be passed on; therefore high-risk products are commonly tested for the following bacteria:

• Staphylococcus aureus – found in the nose

• Escherichia coli – found in the lower intestine
• Pseudomonas aeruginosa – found on the skin
• Candida albicans – found in the mouth and on nails
• Aspergillus niger – found on fruits and vegetables.
The notification can be in the form of a voluntary declaration; however, there is legal protection for the non-disclosure of sensitive
information, such as:

• religious beliefs
• health
• ethnic background
• age
• sexual health
• criminal records
• political opinions.
In Europe this is Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free
movement of such data. In the US it is the Privacy Act of 1974.

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