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Participant Workbook-IsO 9001 - 2015-Issue 03 Rev 03 Jan 2024

The document is a Participant Work Book for the ISO 9001:2015 Auditor/Lead Auditor Course scheduled from December 16 to December 24, 2024, in Dubai, UAE. It includes instructions for participants, a list of exercises for daily auditing, and sections for documenting personal information, qualifications, and expectations from the course. The workbook emphasizes the importance of active participation, teamwork, and adherence to course requirements for successful completion.
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0% found this document useful (0 votes)
524 views51 pages

Participant Workbook-IsO 9001 - 2015-Issue 03 Rev 03 Jan 2024

The document is a Participant Work Book for the ISO 9001:2015 Auditor/Lead Auditor Course scheduled from December 16 to December 24, 2024, in Dubai, UAE. It includes instructions for participants, a list of exercises for daily auditing, and sections for documenting personal information, qualifications, and expectations from the course. The workbook emphasizes the importance of active participation, teamwork, and adherence to course requirements for successful completion.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 51

Participant Work Book

ISO 9001:2015 Auditor / Lead Auditor Course

Course Registration Number: 18130 Dates of Course: 16/12/2024 To 24/12/2024

Venue of the Course: United Arab Emirates City: Dubai Country: UAE

Participant Name (IN CAPITALS): SHEBEER MATTOLAVALAPPIL Signature:

INSTRUCTIONS FOR PARTICIPANTS

1) This Workbook shall be given to you on the first day and shall be taken back at the end of each day
before you depart & finally compiled on day 5 before the test begins.

2) This workbook dully filled ones shall, be used for your continuous Audit on every day. Please ensure
that you submit this workbook to the tutor(s), for daily continuous Audit at the end of each day.

3) On the last day, please return the course feedback forms (dully filled in by you – for our reference
and improvements) and the IRCA written answer papers for the course.

4) Tips for SUCCESSFUL COMPLETION OF THE COURSE:

 Be attentive and be present on all days all modules must be attended.


 The course evaluation shall consider two aspects – your daily performance shall be monitored by
the tutors and continuous Audit and your score in written examination shall be considered for
your result of your success.
 Please clarify all doubts from the tutors during breaks as well.
 Your active participation is desired – throughout the course.
 While working in groups, please do not be dominating to demonstrate leadership, rather listen
to every member and your team performance shall be judged on your consensus & joint
decisions – individual differences be avoided during demonstration of the team performance
(will lead to score deductions).
 Before each “Group Exercise”, the group should select the Group Leader for that exercise and
note it in this workbook. Every member should lead team in rotation for different group
exercises.

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Following is the List of Exercises:

# Exercise Marks # Exercise Marks


Obtained Obtained

Introduction of Participants Documentation Audit -


1 10
(Interviewing) Improvements

Audit Report Preparation- Stage 1


2 Process Approach 11
Document Review

3 Terms & Definitions pertaining to Quality 12 Audit Plan Preparation

Documentation Audit – Context of


4 13 Audit Preparation- Audit Checklist
Organization

5 Documentation Audit – Leadership 14 Recording Non-conformities

Documentation Audit – Planning &


6 15 Role play (Interview Process)
Review of Risk and opportunities

Keywords approach to understand


7 Documentation Audit – Support 16
ISO 9001 requirements

Audit Report Preparation- Stage 2


8 Documentation Audit – Operation 17
On-site At

Documentation Audit – Performance


9 18 Audit Follow up – NC Closures
Evaluation

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Exercise 1 Introduction of Participant Exercise – 15 Minutes


Note: No row should be left blank because it carries marks.
YOUR PARTNER’S NAME  Shebeer Mattolavalappil

Qualifications  BSC Environmental Science (AZTECA International University Programs


accredited by AIU & ASIC)
 HSE Manager (July 2024 – Present)
Working Organization, Designation &
Role  AL FARES INTERNATION AL TENTS & METAL CONSTRUCTION, DUBAI
INDUSTRIAL CITY
 ISO 9001:2015 is a global standard for Quality Management Systems (QMS),
ensuring consistent quality, customer satisfaction, and continual
Knowledge of ISO 9001:2015: improvement. Ranked by importance: Context of the Organization (1)
identifies internal/external issues, Leadership (2) emphasizes management's
And Rank 1(Minimum) to
role, Planning (3) addresses risks and objectives, Support (4) ensures
5(Maximum) resources and competence, and Operation (5) focuses on delivering quality
outcomes. Performance evaluation and continual improvement further
strengthen the QMS framework.
 Saudi Aramco Marjan Increment Program – Tanajib Gas Plant Projects (PK-09
& PK-11): Served as Management Representative (MR) during the OSHAD-SF
external audit and conducted the 1st Annual Internal Audit for the Abu Dhabi
Branch Fabrication Shop.
 ADNOC Al Dabb’iya Surface Facilities Project, Phase III: Performed internal
Any I/II/III Party Audit Experience:
audits to assess subcontractors' HSE performance across offshore clusters.
 ADCO Wellhead Piping and Flowline Installation Project: Conducted internal
Rank 1(Minimum) to 5(Maximum) audits to evaluate subcontractors' HSE performance in Abu Dhabi.
 ADCO Abu Dhabi Crude Oil Pipeline Project: Monitored subcontractors' HSE
performance through internal audits.
 Heritage Grand Hotel Mega Civil Project, Doha, Qatar: Acted as MR during the
certification audit for the mega civil project.
 Understand the ISO 9001:2015 Standard:
 Develop Audit Skills and Techniques:
Objective of attending this course:  Gain Competence as a Lead Auditor:
 Enhance Process Improvement Knowledge:
 Prepare for Certification and Professional Growth:
 Comprehensive Understanding of ISO 9001:2015 Requirements:
 Practical Application of QMS Concepts:
 Feminization of Audit Process and Techniques:
Expectations from the course:
 Improved Analytical and Problem-Solving Skills:
 Leadership and Team Collaboration Skills:
 Awareness of Documentation and Record-Keeping:
 With over 13 years of experience in oil and gas, civil and mechanical works,
and HSSE roles across the Middle East, I am a Graduate Member of IOSH and
hold TSP status from BCSP-USA. I am also a Certified Lead Auditor (ISO
45001:2018), a NEBOSH IGC holder, an OSHAD Practitioner, and possess a
Level 6 Diploma in Occupational Health & Safety (NCFE-UK). My expertise
Any additional Information spans oil and gas field development, wellhead installation, flowline projects,
(something interesting of yourself): high-voltage line installations, pipe fabrication, HSE management, behavior-
based safety, training, audits, emergency management, and incident
investigations with root cause analysis. Additionally, I bring excellent
communication and interpersonal skills.

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Exercise 2 Process Approach


Group Exercise – 45 Minutes

(a) Give the following information in the spaces provided for this bottling line (examples):
1. The inputs
2. Outputs RESOUCES & METHODS
3. Monitoring & Measuring opportunities
4. Efficiency & Effectiveness

BOTTLING OPERATION LINE


INPUTS OUTPUTS

MONITORING & MEASUREMENTS

INPUTS Resources Methods Process parameters OUTPUTS Criteria for Effectiveness &
(Monitoring & Efficiency
Measurements)
Raw materials Juice concentrate, Procurement, Juice quality (pH, brix, Bottled juice - Juice meets quality standards (pH, brix,
water, bottles, quality checks, temperature) (sealed, labeled,
taste)
Equipment caps, labels inventory control - Bottle cleanliness and packaged)
- Accurate fill levels
- Cap and label quality
- Defect-free bottles
Manpower Filling machines, Preventive Efficient bottling
- Minimal material wastage
cappers, labelers, maintenance, Machine speed process and
Utilities conveyors calibration - Downtime frequency production
Maximum production output (bottles/hour)
schedules - Accuracy of filling levels reports
- Low downtime and breakdowns
Operators, - Seal tightness
- Accurate machine calibration
technicians, quality Training, SOPs, Smooth operation
inspectors quality assurance - Operator efficiency and consistent
Skilled and efficient workforce
- Training completion product quality
- Minimal human errors
Electricity, water, Supply monitoring, - Inspection performance
- Timely completion of tasks
compressed air energy control Utility-supported
- Energy consumption operation
Optimal energy and resource usage
- Water flow/pressure
- Minimal waste of utilities
- Air pressure for capping

Tutor Marking: 1 mark for each Column min. 2 correct answers. 5 marks max. For part a.

(b) System approach to Management –

Give the list of outputs of each department in general


Marketing Design Purchase Production
Design Output: Product drawings, Approved purchase orders Finished goods (sealed, labeled,
Marketing Output: Customer technical specifications, prototypes, Supplier contracts and packaged products)
requirements, product and approved designs. Material specifications and Quality inspection reports
specifications, market trends, and requirements Waste or scrap records
sales forecasts. Delivery schedules Production performance data
(e.g., production rates,
downtime)

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Tutor Marking: 1 mark for each Column min. 2 correct answers. 5 marks max. for part b.

Exercise 3 Terms & Definitions pertaining to Quality Exercise – 30 Minutes

# Mapping Quality # Quality Term


Description
Terms
1 Demonstrated ability to apply knowledge &
Competence 1 QUALITY
skills
2 A set of interrelated and interacting QUALITY MANAGEMENT
Process 2
activities SYSTEM
3 An action to eliminate the cause of detected
Corrective Action 3 PROCESS
non-conformity
4 Result of a process Output 4 QUALITY IMPROVEMENT
5 Degree to which inherent characteristics
Quality 5 REQUIREMENTS
fulfills requirements
6 Need or expectation that is stated or implied Requirement 6 QUALITY PLAN
Customer’s perception to which the Customer
7 7 CORRECTIVE ACTION
customer’s requirements have been fulfilled Satisfaction
Part of quality management focused on
8 providing confidence that quality Quality Assurance 8 CAPABILITY
requirements have been fulfilled
Part of quality management focused on Quality
9 9 GRADE
increasing the ability to fulfill improvements Improvement
Category or rank given to diff. quality
10 requirements of product, processes or Grade 10 CUSTOMER SATISFACTION
systems having same functional use
Relation between the results achieved and
11 Efficiency 11 NON-CONFORMITY
resourced used
Quality
Management system to direct and control
12 Management 12 MONITORING
an organization about Quality
System (QMS)
Part of Quality Management focused on
13 Quality Control 13 PREVENTIVE ACTION
fulfillment of quality requirement
14 Fulfillment of a requirement Conformity 14 MEASUREMENT
Ability of an organization, system, or
15 processes to realize a product that will fulfill Capability 15 CONFORMITY
the requirement of the product
16 QUALITY ASSURANCE
17 COMPETENCY
Tutor Marking: 1 mark for each correct 18 EFFICIENCY
answer. 10 marks for 10 or more correct 19 PRODUCT
answers. 20 QUALITY CONTROL

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Exercise 4 Documentation – Stage 1 Audit Group Exercise – 45 Minutes


Read the QMS Apex Documented Information of Good Glass Company Context of the Organisation [please refer
Annex. 9001] and identify clause 4

A) Complete the following:

1. State 3 Internal issues and 3 externals issued Internal issue


for GGC 1 Availability of reliable, qualified and competent
workforce.
2, Stability of workforce
3,Availablity of Raw materials

External Issue
1. External provider’s competence and availability.
2, External inspections/audits External
3,Transportation

2. State 3 Interested parties and their needs & 1, Customers – Value of money, High Quality, Quick
expectations from GGC response.

2,Bank/Finance - Good financial performance and


cash flow

3,Employees – Employment security and work


relationship

3. State at least 3 considerations while 1. Organizational Context and Objectives (Clause


determining the scope of QMS in any 4.1 and 4.2): Understand the internal and
organization external factors affecting the organization, its
interested parties, and its strategic goals to align
the QMS with these elements.
2. Processes and Activities (Clause 4.4): Identify
Exclusion: Clause 8.3
the relevant processes and their boundaries,
including what is within the scope of the QMS
and what is excluded.
3. Regulatory and Compliance Requirements
(Clause 4.3): Ensure the QMS complies with
applicable legal, regulatory, and industry-
specific requirements.

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4. Evaluate appropriateness of the scope stated Outsourced Processes Controls


in Apex Documented Information of Good Calibration Regional, National and International
Glass company. Traceability

5. State 4 evidence to be verified for Internal audit, customer complaints, roles and
conformity of QMS in an organization. responsibilities, training and awareness.

B) Choose the appropriate sub-clause out of clause 4 for Context of Organization:

# Term Clause

1. Internal Resources Clause 4.1.1

Clause 4.3 -
Determining
Scope to be maintained as documented information the scope of
2.
the quality
management
system
Road condition from seaport to Good Glass company Clause 4.1
3.
Clause 4.2 of
Supplier’s requirements for details of product to be supplied
4. ISO
9001:2015,
Contractual relationship for fulfilment of their needs 4.2
5.
Competence of people in the organization 4.1/7.2
6.
Legal Issues as needs od interested parties 4.1
7.

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1 mark for each answer. Max 5 marks for 5 or more correct answers

Exercise 5 Documentation – Stage 1 audit Group Exercise – 45 Minutes

Read the QMS Apex Documented Information of Good Glass Company Leadership and identify sub-Clause out of
Clause 5

A) Choose the appropriate clause for each statement:

# Statement Sub-Clause

1. QMS Policy shall be maintained as documented information. Clause 5.2.1 - Establishing the
Quality Policy
2. Ensuring processes deliver their intended output Clause 4.4 - Quality
Management System and its
Boundaries
3. Promoting continual Improvement of QMS QMS is Clause 10.3 - Continual
Improvement.

5.1.1 I
4. Integrity of QMS is maintained when changes are planned in QMS
5.3
5. Roles & Responsibilities are assigned & communicated. Roles and responsibilities is
Clause 5.3 - Organizational
roles, responsibilities, and
authorities.
6. Commitment to satisfy applicable requirements Commitment to satisfy
applicable requirements is
Clause 5.1.1 - Leadership and
Commitment.

1 mark for each answer. Max 5 marks for 5 or more correct answers

B) State examples from Gold Glass company:

1. Review the QMS Policy of Good Glass company and find out areas of concern, if any:

Insufficient focus on continuous improvement: Without clear goals or mechanisms for


improvement, the QMS could stagnate.

2. Select and state 4 Roles & Responsibilities for QMS to be communicated within the organization.

1. Top Management

 Responsibility: Ensure the QMS aligns with strategic objectives, leads continual improvement,

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and ensures customer satisfaction.


 Communication: Communicate commitment to quality and provide necessary resources.

2. Quality Manager
o Responsibility: Oversee QMS implementation, maintenance, and improvement.
o Communication: Share process performance, audit results, and corrective actions with all
departments.
3. Process Owners/Department Heads
o Responsibility: Ensure their processes meet quality objectives and customer needs.
o Communication: Set performance targets and ensure teams understand their roles in
achieving quality outcomes.
4. Employees
o Responsibility: Follow QMS procedures, report issues, and contribute to improvements.
o Communication: Receive training on their roles and understand how they contribute to
quality.

3 marks for each answer. Max 5 marks for both correct answers

Exercise 6 Documentation – Stage 1 audit Group Exercise – 45 Minutes

Read the QMS Apex Documented Information of Good Glass Company Planning and identify sub clauses
out of Clause 6

A) State examples from Gold Glass Company:

1. List at least 3 reasons for addressing  Ensure QMS effectiveness: Maintain consistent
risks and opportunities. product/service quality.
 Increase customer satisfaction: Prevent issues affecting
delivery or quality.
 Drive continuous improvement: Improve processes and
reduce failures
2. Find out & state 3 options to address  Risk Mitigation: Preventive measures to reduce impact,
risks. e.g., better training.
 Risk Transfer: Outsource or insure against risks, e.g.,
third-party suppliers.
 Risk Acceptance: Monitor and accept low-impact risks if
mitigation costs are high.
3. Establish at least 3 QMS objectives for  Risk Mitigation: Preventive measures to reduce impact,
the GGC. e.g., better training.
 Risk Transfer: Outsource or insure against risks, e.g., third-
party suppliers.
 Risk Acceptance: Monitor and accept low-impact risks if
mitigation costs are high.

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3 marks for each correct answer. Max 5 marks for 2 or more correct answers
3 marks for each answer. Max 5 marks for both correct answers
B) Choose the appropriate Sub-clause out of Clause 6 for each statement:

# Statement Clause

1. Determination of Risk & Opportunities that need to be addressed to achieve Clause 6.1: Actions to
continual improvement. address risks and
opportunities
2. The performance of the organization needs to be considered for addressing Clause 6.1: Actions to
Risk & Opportunities. address risks and
opportunities
3. Evaluation of effectiveness of actions to address risks and opportunities Clause 6.2: Quality
objectives and planning to
achieve them
4. How to integrate & implement the actions into business processes. Clause 6.1: Actions to
address risks and
opportunities
5. Actions to address risks and opportunities need to be proportionate to the Clause 6.1: Actions to
impact on product quality address risks and
opportunities

1 mark for each answer. Max 5 marks for 5 or more correct answers
Tutor Marking: 2.5 marks for each non-conformity as in answers. 10
max. marks for entire exercise.
Exercise 7 Documentation – Stage 1 audit Group Exercise – 45 Minutes

Read the QMS Apex Documented Information of Good Glass Company for Clause 7-Support and identify

A) State examples from Gold Glass company:

1. Determine & state 3 internal & Internal Communications:


3 external communications 1. Employee Training Sessions: Internal communication about
examples 3 from GGC. training schedules, new safety protocols, and quality updates.
2. Internal Newsletters/Notices: Regular updates on policies,
performance, and project status within the company.
3. Team Meetings: Department meetings to discuss operational
matters, project progress, and quality control.

External Communications:
4. Supplier Communication: Communication of quality standards and
delivery requirements to suppliers.
5. Customer Feedback: Communicating with customers about
product feedback, complaints, and satisfaction surveys.
6. Regulatory Authorities: Communication with government agencies
to ensure compliance with industry regulations.

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2. Give three examples of 1. Workplace Safety Environment: Safe working conditions with
environment for operation of protective equipment and signage.
processes 2. Production Area Layout: Organized layout for efficient
manufacturing and product flow.
3. Technology Infrastructure: Availability of necessary IT systems
and software to monitor and manage processes.

3. State at least 5 controls to be 1. Document Approval: Documents must be reviewed and


exercised for documented approved by authorized personnel before use.
information control. 2. Version Control: Track document versions with version
numbers and change logs.
3. Access Control: Limit document access to authorized
personnel only.
4. Document Retention: Maintain a system for retaining
documents for the required time frame.
5. Document Review and Update: Periodic review and updates to
ensure relevance and compliance with current standards.

3 marks for each correct answer. Max 5 marks for 2 or more correct answers
3 marks for each answer. Max 5 marks for both correct answers
B) Choose appropriate Sub-clause out of Clause 7 for each statement:

# Statement Clause

1. Review and approval for suitability & adequacy of created documented Clause 7.5.3: Control of
information. documented information

2. Availability of training records including its effectiveness. Clause 7.2: Competence

3. Activities for control of documented Information. Clause 7.5.3: Control of


documented information
4. Measuring equipment shall be calibrated or verified, or both, at specified Clause 7.1.5: Monitoring
intervals, and prior to use. and measuring resources
5. Documented Information shall be controlled to ensure its availability. Clause 7.5.3: Control of
documented information
6. Consider the capabilities of, and constraints on, existing internal resources. Clause 7.1.2: People and
resources
7. Maintain the infrastructure necessary for the QMS. Clause 7.1.3:
Infrastructure

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1 mark for each answer. Max 5 marks for 5 or more correct answers
Tutor Marking: 2.5 marks for each non-conformity as in answers. 10 max.
marks for entire exercise.

Exercise 8 Documentation – Stage 1 Audit Group Exercise – 45 Minutes

Read the QMS Apex Documented Information of Good Glass Company for Clause 8- Operation and
identify

A) Choose appropriate Sub-clause out of Clause 8 for each statement:

# Term Clause

1. In determining the stages and controls for design and development consider 8.3.2 –© Design and
required verification and validation activities development control

2. Customer’s requirements shall be confirmed by the organization before 8.2.3 - Communication


acceptance, when the customer does not provide a documented statement of with customers
their requirements.

3. Organization shall control the unique identification of the outputs when 8.5.2 - Identification and
traceability is a requirement traceability
4. Establish criteria for the processes and acceptance of products and services 8.7.1-d - Control of
nonconforming outputs
5. Review of the requirements specified by the customers 8.2.3.1 - Determining
requirements for
products and services
6 Changes to requirements for products and services 8.2.4 - Change of
requirements for
products and services
7 when the property of a customer is lost, damaged, or otherwise found to be 8.5.3 - Property
unsuitable for use, the organization shall report this to the customer belonging to customers
or external providers
8 Determine and apply criteria for the evaluation, selection, monitoring of 8.4.1 - General
performance, and re-evaluation of external providers requirements

9 Contamination control during storage of the product 8.5.4 - Preservation of


products
10 Maintain documented information for release of the products 8.6.2 - Release of
products and services

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1 mark for each answer. Max 5 marks for 5 or more correct answers

B) State examples from Gold Glass company:

1. Determine & briefly describe at  Late Deliveries: Delivering products later than promised, causing
least 3 potential scenarios that problems for customers.
may result in customer dis-  Defective Products: Products with cracks or defects that don't
satisfaction in the GGC. meet quality standards.
 Wrong Products: Products that don’t match the customer's
order or needs.
2. List at least 4 areas/processes in GGC & QMS operational controls required in each area.

Area/Process QMS operational Controls

 Production Process  Quality checks to ensure products meet standards.


 Machine monitoring to prevent defects.
 Regular maintenance to keep equipment running smoothly.

 Customer Order Management  Review orders to confirm details.


 Confirm orders with customers to avoid mistakes.
 Ensure timely delivery of products.

 Supplier Management  Evaluate suppliers for quality.


 Inspect raw materials on arrival.
 Monitor supply chain for timely deliveries

 Product Storage and Handling  Control storage conditions to avoid damage.
 Track inventory regularly.
 Prevent contamination during storage.

 Production Process  Quality checks to ensure products meet standards.


 Machine monitoring to prevent defects.
 Regular maintenance to keep equipment running smoothly.

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3 marks for each correct answer. Max 5 marks for both correct answers

Exercise 9 Documentation – Stage 1 Audit Group Exercise – 40 Minutes

Read the QMS Apex Documented Information of Good Glass Company Performance Evaluation and
identify clause 9

A) Choose appropriate Sub-clause out of Clause 9 for each statement:


1. Statement Clause
a) Results of analysis shall be used to evaluate conformity of products and services 9.1.3 (a) Analysis
and Evaluation
b) organization shall conduct internal audits at planned intervals 9.2.1 Internal
Audit
c) Internal Audit program shall be established considering importance of processes & results of 9.2.2 Internal
previous Audit. Audit Program
d) Ensure impartiality & objectivity of auditing process. 9.2.2 (c) Internal
Audit Program
e) Management review is conducted to ensure suitability & adequacy of QMS. 9.3.1 General
Requirements for
Management
Review
f) Management review shall be planned and carried out taking into consideration the changes in 9.3.2 (b) Inputs to
external and internal issues that are relevant to the QMS Management
Review

1 mark for each answer. Max 5 marks for 5 or more correct answers
Tutor Marking: 2.5 marks for each non-conformity as in answers. 10 max.
B) State examples from Gold Glass company:
marks for entire exercise.
1. Determine & state at least 5 items in QMS that need to be monitored and measured in the Good Glass
Company.
 Product Quality: Thickness, clarity, and strength tests.
 Customer Satisfaction: Feedback, complaints, and delivery performance.
 Production Efficiency: Yield rates and equipment downtime.
 Supplier Performance: Material quality and delivery reliability.
 Compliance: Adherence to ISO standards and safety regulations
2 Prepare a checklist for auditing internal audit process of GGC:
1. Defined audit schedule and scope,
2. Independent auditors assigned,
3. Processes reviewed systematically.
4. Findings documented with evidence,
5. Audit report prepared promptly,
6. Findings categorized (e.g., observations, non-conformities).,
7. Corrective actions identified and tracked,
8. Follow-up audits conducted, Audit records maintained, Auditors trained and qualified.
3 State at least 4 retained documents information to audit performance evaluation of QMS.
 Internal audit reports.
 Management review minutes.
 Customer feedback records.
 Quality performance KPIs.

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5 marks for each correct answer. Max 5 marks for 2 or more correct answers

Exercise 10 Documentation – Stage 1 Audit Group Exercise – 45 Minutes

Read the Quality Apex Documented Information of Gold Glass Company Improvements and identify
clause 10

A) Choose appropriate Sub-clause out of Clause 10 for each statement:

1. Statement Clause

a) React to the non-conformity & take actions to correct it. 10.2.1 (A) 1 Corrective action

b) Determine if similar non-conformity exist or could occur. Clause: 10.2 .1 (B) 3


Corrective action
c) Causes of non-conformity are to be determined by auditee. Clause: 10.2 .1 (B)
2Corrective action
d) Retain documented information as evidence of results of corrective action. Clause: 10.2 .2 Corrective
action

1.5 marks for each answer. Max 5 marks for 4 or more correct answers
B) State examples from Gold Glass company:
2. Give examples of Clause 9.1 (Monitoring & Evaluation):
opportunities for GGC could use advanced analytics tools to track production efficiency
improvements in QMS of GGC and product quality, identifying trends and areas for improvement.
with reference to
performance evaluation. Clause 9.1 (Monitoring & Evaluation):
(Clause 9.1/9.2/9.3) GGC could use advanced analytics tools to track production efficiency
and product quality, identifying trends and areas for improvement.

Clause 9.3 (Management Review):


GGC could involve more diverse feedback from all departments during
management reviews to get a comprehensive view of QMS performance.
3. Define correction and Correction:
corrective actions, with Immediate action to eliminate a detected non-conformity.
example for GGC processes
Example: Fixing or throwing away or disposed based on industrial
requirements, glass products that are damaged during inspection.

Corrective Action:
Long-term solution to address the root cause of a non-conformity.

Example: Adjusting the furnace temperature and training workers to


avoid future glass defects.

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3 marks for each correct answer. Max 5 marks for both correct answers

Exercise 11 Audit Report- Stage 1 Document Review Time – 45 Minutes

AUDIT REPORT
Name of Company (Organization): GGC-Good glass Company
Accreditation: (NABCB/JAZ-ANZ/IAS/EIAC)
Address of the company:
Contact Person: John Fred Position: Operation Manager
SCOPE (4.3):
The organization shall determine the 4.1 Internal and External Issues
boundaries and applicability of the
quality management system to (a) Internal Issues:
establish its scope. When determining The industrial cleaning equipment's suction system and filters are not
this scope, the organization shall Functioning effectively, resulting in glass dust particles in the glass cutting area.
consider:
a) the external and internal issues (b) External Issues:
referred to in 4.1
The municipality issued a memo to GGC due to the failure to obtain a Permit
b) the requirements of relevant
To Work (PTW) while performing excavation for maintenance. The excavation
interested parties referred to in 4.2
Area passes over municipal utility lines.
c) The products and services of the
organization. 4.2 Understanding the Needs and Expectations of Interested Parties
The organization shall apply all the
requirements of this International (c)
Standard if they are applicable within
the determined scope of its quality
 The organization is required to monitor and review information
management system.
regarding the needs and expectations of interested parties, as specified
The scope of the organization’s quality
in Clause 4.2. However, during the audit, it was found that customer
management system shall be available
equity was not fully recorded in the Customer Enquiry Register.
and be maintained as documented
information.
The scope shall state the types of Product and Service Information Availability
products and services covered and
provide justification for any  Detailed product and service information is not clearly available on the
requirement of this International company website as required. Customers must contact the company for
Standard that the organization each piece of information, which is inconvenient and could lead to
determines is not applicable to the dissatisfaction.
scope of its quality management
system. Opportunity for Improvement (OFI):
Conformity to this International
Standard may only be claimed if the  Records of internal and external communications are not being
requirements determined as not being effectively tracked. These records should be systematically
applicable do not affect the reviewed and monitored at regular intervals to ensure better
organization’s ability or responsibility to communication and compliance.
ensure the conformity of its products
and services and the enhancement of
customer satisfaction.

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QUALITY MANAGEMENT SYSTEM (4.4)

4.4.1 The organization shall establish,


implement, maintain, and continually
improve a quality management
system, including the processes
needed and their interactions, in
accordance with the requirements of
this International Standard. The
organization shall determine the
processes needed for the quality
management system and their
application throughout the
organization, and shall: Non-Compliances:
a) determine the inputs required and 1. Process Interaction and Sequence (4.4.1.b)
the outputs expected from these  No documented process flow or interaction map.
processes  Impact: Risk of inefficiencies and unclear responsibilities.
b) determine the sequence and 2. Monitoring and Measurement (4.4.1.c)
interaction of these processes  No KPIs or performance indicators for process control.
c) determine and apply the criteria and  Impact: Difficult to measure process effectiveness and take
methods (including monitoring, corrective actions.
measurements, and related 3. Resource Allocation (4.4.1.d)
performance indicators) needed to  No formal resource planning or allocation.
ensure the effective operation and
 Impact: Potential delays and quality issues due to insufficient
control of these processes
resources.
d) Determine the resources needed for
4. Risk and Opportunity Management (4.4.1.f)
these processes and ensure their
 No clear process for addressing risks and opportunities.
availability.
 Impact: Missed improvement opportunities and unforeseen
e) assign the responsibilities and
issues.
authorities for these processes
5. Process Evaluation and Improvement (4.4.1.g & 4.4.1.h)
f) address the risks and opportunities
 No regular evaluations or improvement actions for processes.
as determined in accordance with the
 Impact: Inefficiencies and decreased process effectiveness.
requirements of 6.1
g) evaluate these processes and 6. Documented Information (4.4.2)
 Inadequate documentation to support process operations.
implement any changes needed to
ensure that these processes achieve  Impact: Inconsistent processes and potential non-compliance.
their intended results
h) Improve the processes and the
quality management system.

4.4.2 To the extent necessary, the


organization shall:
a) maintain documented information
to support the operation of its
processes
b) Retain documented information to
have confidence that the processes are
being carried out as planned.

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POLICY (5.2)

5.2.1 Establishing the quality policy Top Positive observation.


management shall establish, implement, and
maintain a quality policy that: A clear statement showing the organization’s dedication to maintaining and improving quality.
a) is appropriate to the purpose and context of Emphasis on continuous improvement of processes, products, and services to boost performance
the organization and supports its strategic and effectiveness. A statement confirming the company follows all applicable legal,
direction Regulatory, and industry standards.
b) provides a framework for setting quality
objectives
c) includes a commitment to satisfy applicable
Opportunity for Improvement (OFI):
requirements The policy does not clearly define roles and responsibilities. There should be a recognition
d) Includes a commitment to continual of the responsibility of top management, employees, and teams in contributing to quality
improvement of the quality management Management.
system.

Positive Observation:
 The quality policy is available and maintained as documented information. It is
communicated, understood, and applied throughout Good Glass Company (GGC).
Additionally, it is made available to relevant interested parties as appropriate: Page: 08.

5.2.2 Communicating the quality policy the Observation:


quality policy shall:
 GGC has clearly communicated the quality policy to their interested parties, as required
a) be available and be maintained as
and appropriate. The policy is effectively communicated, understood, and applied
documented information
throughout the organization, ensuring alignment with the company’s quality objectives
b) be communicated, understood, and applied
and standards.
within the organization
c) Be available to relevant interested parties, as
appropriate. Opportunity for Improvement (OFI):
 The quality policy should be displayed in a prominent location and, if necessary, in
Different languages to accommodate the diverse workforce and ensure better
understanding by all employees.

 This will enhance awareness, understanding, and application of the policy across all levels
of the organization.

ADDRESSING RISK AND OPPORTUNITIES (6.1):


Clause 6.1.1: Addressing Risk and Opportunities
6.1.1 When planning for the quality Summary of Non-compliances (Minor NC):
management system, the organization shall a. No risk management plan for ensuring that the QMS achieves its intended results.
consider the issues referred to in 4.1 and the b. No action plan for capitalizing on improvement opportunities (e.g., enhancing product
requirements referred to in 4.2 and determine quality).
the risks and opportunities that need to be c. Lack of preventive measures to address risks like safety or product quality issues.
addressed to: d. No documented process for continuous improvement or measurement of QMS
Performance.
a) give assurance that the quality management
system can achieve its intended result(s)
b) enhance desirable effects
c) prevent, or reduce, undesired effects
d) Achieve improvement. OFI (Opportunity for Improvement):
 Action Integration: Better integrate risk actions into specific QMS processes (e.g., audits,
6.1.2 The organization shall plan: supplier evaluations).
a) actions to address these risks and  Effectiveness Evaluation: Formalize the process to evaluate the effectiveness of actions
opportunities with measurable KPIs.
b) how to:
1) integrate and implement the actions into its Major NC (Non-compliance):
quality management system processes (see 4.4)  No Action Plan: No clear actions to address risks affecting product/service conformity.
2) Evaluate the effectiveness of these actions.  No Integration in QMS: Actions not integrated into QMS processes.
Actions taken to address risks and opportunities

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shall be proportionate to the potential impact Minor NC (Non-compliance):


on the conformity of products and services.  Weak Evaluation: Evaluation of action effectiveness is informal.

 Disproportionate Actions: Actions are not proportional to the impact on conformity.

Good Observation:
 Risk and Opportunity Addressed: GGC has identified and taken actions (e.g., improving
supplier evaluation, training) to address risks and opportunities.
QUALITY OBJECTIVES AND PLAN (6.2): OFI (Opportunity for Improvement):
 Communicating Objectives: Improve how quality objectives are communicated to
6.2.1 The organization shall establish quality everyone in the organization.
objectives at relevant functions, levels and  Updating Objectives: Set up a clearer process for updating objectives when needed.
processes needed for the quality management Major NC (Non-compliance):
system. The quality objectives shall:  Objectives Not Measurable: Some quality objectives (Achieve a product defect rate) are
a) be consistent with the quality policy not measurable or don’t match the quality policy.
b) be measurable  No Documentation: There is no documented information to support the quality objectives.
c) consider applicable requirements Good Observation:
d) be relevant to conformity of products and  Clear Responsibility: Resources, responsibilities, and deadlines are defined for meeting
services and to enhancement of customer quality objectives.
satisfaction
e) be monitored
f) be communicated
g) be updated as appropriate.
The organization shall maintain documented
information on the quality objectives.
a) What will be done:
6.2.2 When planning how to achieve its quality  Observation: Most quality objectives have defined actions, but some lack specific,
objectives, the organization shall determine: actionable steps.
a) what will be done  OFI: Ensure that all quality objectives have detailed action plans with clear steps.
b) what resources will be required b) Resources required:
c) who will be responsible  Observation: Resources (personnel, equipment, etc.) are identified for many
d) when it will be completed objectives, but not consistently for all.
e) How the results will be evaluated.  OFI: Document resource requirements for all quality objectives, ensuring no gaps.
c) Who will be responsible:
 Observation: Responsibility is assigned for most objectives, but some lack clear
ownership.
 OFI: Assign clear responsibility for all quality objectives to ensure accountability.
d) When it will be completed:
 Observation: Deadlines are provided for most objectives, but some lack specific
completion dates.
 OFI: Include clear and specific deadlines for all quality objectives.
e) How the results will be evaluated:
 Observation: Evaluation methods are defined, but some objectives lack measurable KPIs.
 OFI: Define measurable evaluation criteria (KPIs) for all quality objectives to track progress
effectively.
7.1.1Has the organization determined and
provided the resources needed for the 7.1.1 - OFI and Observations
establishment,
Implementation, maintenance and continual
 a) Internal Resources:
improvement of the quality management
system.
The organization has considered:  Observation: The organization has considered existing internal resources, but
a) the capabilities of, and constraints on, resource limitations may not be fully assessed.
existing internal resources;  OFI: Conduct a more detailed review of internal resource capabilities and
b) what needs to be obtained from external constraints.
providers
 b) External Providers:

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 Observation: The organization has identified external providers and their


resources but could improve the process for evaluating their capacity.
 OFI: Strengthen the evaluation and selection process for external providers to
ensure consistent quality.

7.1.2 People
Has the organization determined and provided 7.1.2 - OFI and Observations
the persons necessary for the effective Observation: The organization has provided the necessary personnel for the effective
implementation of its quality management implementation and operation of the QMS. However, some roles may not be fully defined or
system and for the operation and control of its documented, leading to potential confusion in process control.
processes. OFI: Ensure clear role definitions, responsibilities, and qualifications for all personnel involved in the
QMS to enhance the effectiveness of process implementation and control.

7.1.3 Infrastructure 7.1.3 - OFI and Observations


Has the organization determined, provided and  Observation: The organization has provided necessary infrastructure, but logistics and
maintain the infrastructure necessary for the fleet management plans are not fully implemented or maintained as required.
operation of its processes and to achieve  OFI: Implement and regularly review logistics and fleet management plans to meet
conformity of products and services. evolving operational needs.

7.1.4 Environment for the operation of 7.1.4 - OFI and Observations


processes  Observation: The organization has provided the necessary environment for processes and
Has the organization determined, provided and product/service conformity, but some areas (like safety or ergonomics) may need
maintained the environment necessary for the improvement.
operation of its processes and to achieve  OFI: Regularly review and improve the work environment to support processes and ensure
conformity of products and services. conformity.

7.1.5 Monitoring and measuring resources 7.1.5 - OFI and Observations


Has the organization determined and provided  Observation: The organization has resources for monitoring and measuring conformity,
the resources needed to ensure valid and but the documentation may not always be up to date.
reliable  OFI: Keep the documentation updated and take action if measuring equipment is found
results when monitoring or measuring is used unfit to ensure accurate results.
to verify the conformity of products and
services to
Requirements.
Has the organization retained appropriate
documented information as evidence of fitness
for purpose of the monitoring and
measurement resources?
Has the organization determined if the validity
of previous measurement results has been
adversely affected when measuring equipment
is found to be unfit for its intended purpose,
and take appropriate action as necessary?

7.1.6 Organizational knowledge 7.1.6 - OFI and Observations


Has the organization determined the  Observation: The organization has identified the knowledge needed for its processes and
knowledge necessary for the operation of its product/service conformity, but there may be gaps in sharing or retaining this knowledge.
processes and to  OFI: Improve how knowledge is shared and stored to ensure it is always available for the
Achieve conformity of products and services. organization.

Competence (7.2):

The organization shall:


a) determine the necessary competence of 7.2 - OFI and Observations
person(s) doing work under its control that
affects the performance and effectiveness of
the quality management system  Observation: The organization has identified the required skills for staff, but there might

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b) ensure that these persons are competent be gaps in training records or competence evaluations for equipment operator roles.
based on appropriate education, training, or  OFI: Improve tracking of training and competence to ensure all staff have the necessary
experience skills and maintain proper documentation.
c) where applicable, take actions to acquire the
necessary competence, and evaluate the
effectiveness of the actions taken
d) Retain appropriate documented information
as evidence of competence.

Communication (7.4):
7.4 - OFI and Observations
The organization shall determine the internal
and external communications relevant to the  Observation: The organization has identified key communications for the QMS but needs
quality management system, including: a clearer structure on who communicates, when, and how.
a) on what it will communicate
 OFI: Create a clear communication plan to specify what, when, how, and who
b) when to communicate
communicates for better clarity and efficiency.
c) with whom to communicate
d) how to communicate
e) who communicates

Documented Information (7.5)


General 7.5 - OFI and Observations
Verify that the organization’s Quality
management system includes:  Observation: The organization has the required documents for its QMS, but may need
a) Documented information required by this better control over external documents and updates.
International Standard.
 OFI: Improve the process for creating, updating, and controlling both internal and external
b) documented information determined by the
documents for better consistency and access.
organization as being necessary for the
effectiveness of the environmental
management system

Creating and Updating


Verify how organization plans to create and
update documented information.

Control of documented information


Verify how organization plans to control
documented information includes documented
information of external origin.

Operational Planning and Control (8.1)


8.1 - OFI and Observations
The organization shall plan, implement, and
control the processes (see 4.4) needed to meet  Observation: Processes are in place, but some criteria and control measures, like
the requirements for the provision of products document reviews, need clearer updates.
and services, and to implement the actions  OFI: Implement regular document reviews and updates to ensure processes meet
determined in Clause 6, by: requirements.
a) determining the requirements for the
products and services; b) establishing criteria
for:
1) the processes
2) the acceptance of products and
services
c) determining the resources needed to achieve
conformity to the product and service
requirements
d) implementing control of the processes in

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accordance with the criteria; e) determining,


maintaining, and retaining documented
information to the extent necessary:
1) To have confidence that the
processes have been carried out as
planned.
2) To demonstrate the conformity of
products and services to their
requirements.
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements for
products and services 8.2 - OFI and Observations
8.2.3 Review of the requirements for products
and services-The organization shall retain  Observation: The organization communicates effectively with customers, but some
documented information, as applicable: product and service requirements (e.g., glass panels, installation, and warranty) need
a) on the results of the review clearer documentation during the review process.
b) On any new requirements for the products  OFI: Ensure that the requirements for glass panels, installation, and warranty are clearly
and services. documented and regularly reviewed.

8.3 Design and development of products and Observation:


service-  8.3.1: Design process in place, but lacks clear milestone tracking.
8.3.1-The organization shall establish,  8.3.2: Planning is established, but timelines and resources need clearer definition.
implement, and maintain a design and  8.3.3: Inputs are documented, but customer feedback and environmental factors are not
development process that is appropriate to fully integrated.
ensure the subsequent provision of products  8.3.4: Design controls are in place but not consistently documented.
and services.  8.3.5: Outputs are documented but need better alignment with initial requirements.
8.3.2-Design and development planning  8.3.6: Design changes are recorded, but impact analysis could be more thorough.
8.3.3 Design and development inputs-The
organization shall retain documented OFI (Opportunity for Improvement):
information on design and development inputs  8.3.1: Improve milestone tracking in the design process.
8.3.4- Design and development controls-  8.3.2: Define timelines and resources more clearly.
Documented information of these activities is  8.3.3: Integrate customer feedback and environmental factors.
retained.  8.3.4: Strengthen documentation of design controls.
8.3.5-Design and development outputs- The
 8.3.5: Ensure outputs align with requirements.
organization shall retain documented
 8.3.6: Conduct thorough impact analysis for design changes.
information on design and development
outputs.
8.3.6- Design and development changes- The
organization shall retain documented
information on:
a) design and development changes
b) the results of reviews
c) the authorization of the changes
d) The actions taken to prevent adverse
impacts.
8.4 Control of externally provided processes, Observation:
products and services-The organization shall  The organization has criteria for evaluating external providers, but re-evaluation needs
determine and apply criteria for the evaluation, improvement.
selection, monitoring of performance, and re-  Documentation is available but lacks detail on actions taken.
evaluation of external providers, based on their OFI:
ability to provide processes or products and  Improve the re-evaluation process with clear guidelines.
services in accordance with requirements.  Ensure thorough documentation of evaluations and actions.
The organization shall retain documented
information of these activities and any
necessary actions arising from the evaluations.
8.5 Production and service provision Observation:
Control of production and service provision  The organization maintains documented information on the review of changes, product
Identification and traceability release, and non-conforming outputs.
Property belonging to customers or external

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providers  However, some documented information on non-conformity, including action taken and
Preservation authority decision, needs to be more detailed.
Post-delivery activities OFI:
Control of changes-The organization shall retain  Ensure that all non-conformity records are fully detailed, including the actions and
documented information describing the results authority decision.
of the review of changes, the person(s)  Strengthen traceability and evidence for the release of products and services.
authorizing the change, and any necessary
actions arising from the review.
Release of products and services-The
organization shall retain documented
information on the release of products and
services. The documented information shall
include:
a) evidence of conformity with the acceptance
criteria
b) Traceability to the person(s) authorizing the
release.

Control of nonconforming outputs-The


organization shall retain documented
information that:
a) describes the nonconformity
b) describes the actions taken
c) describes any concessions obtained
d) identifies the authority deciding the action in
respect of the non-conformity
Performance Evaluations (9): Clause 9.1: Monitoring, Measurement, Analysis, and Evaluation
Monitoring, Measurement, Analysis and Observation:
Evaluation (9.1) The organization has monitoring processes in place, but some methods and schedules are unclear.
Verify the processes how the organization OFI:
determines:  Document methods more clearly for consistency.
a) what needs to be monitored and measured  Define and schedule monitoring and evaluation times.
b) the methods for monitoring, measurement,
analysis, and evaluation needed to ensure valid
results
c) when the monitoring and measuring shall be
performed
d) When the results from monitoring and
measurement shall be analyzed and evaluated.
The organization shall retain appropriate
documented information as evidence of the
results.
9.1.2 Customer satisfaction Clause 9.1.2: Customer Satisfaction
Has the organization monitored customers’ Observation:
perceptions of the degree to which their needs The organization monitors customer satisfaction but lacks a defined method for regularly reviewing
and customer feedback.
expectations have been fulfilled and OFI:
determined the methods for obtaining,  Implement a more structured process to gather and analyze customer feedback
Monitoring and reviewing this information. consistently.
 Develop a formal review system to ensure customer satisfaction is continually assessed.

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9.1.3
9.1.3 Analysis and evaluation
Whether organization has analyzed and
evaluated appropriate data and information
arising from monitoring and measurement.
a) conformity of products and services; Clause 9.1.3: Analysis and Evaluation
b) the degree of customer Observation:
The organization analyzes data on product/service conformity and customer satisfaction. However,
there is no customer complaint and evaluation tracker in place.
OFI:
Implement a customer complaint and evaluation tracker to systematically monitor and assess
customer feedback and ensure continuous improvement.
satisfaction;
c) the performance and effectiveness of the
quality management system;
d) if planning has been implemented Clause 9.2: Internal Audit
effectively;
e) the effectiveness of actions taken to address 1. Internal Audit Program:
risks and opportunities; The organization has a documented internal audit program covering frequency, methods,
f) the performance of external providers; responsibilities, planning requirements, and reporting. Audits are planned for
g) The need for improvements to the quality production, HR, procurement, logistic and defined timelines (24th Aug-2024 to 27th Aug-
management system. 2024)
2. Audit Criteria and Scope:
Confirm the organization has clear audit criteria (ISO QMS-9001) and defined scope
(evaluating and checking QMS standards are met and properly implemented). Ensure
Internal Audit (9.2) alignment with organizational and regulatory needs.
3. Auditor Selection Criteria and Impartiality:
Verify that the organization has established that auditor selection includes competence and impartiality. Ensure auditors are
internal audit program including the frequency, independent of the areas they audit.
methods, responsibilities, planning 4. Reporting Audit Results:
requirements and reporting Check that audit results are reported to relevant management with findings, conclusions,
and corrective actions. Ensure reports are timely.
Verify the organization has 5. Retention of Audit Records:
- Defined the audit criteria and scope Verify retention of audit records (plans, reports, findings) according to retention policies.
- Auditor selection criteria and 6. Dates of Audits:
impartiality of the audit process Confirm that internal audits are conducted as per the planned dates and schedule.
- Plans to ensure that the results of the
audits are reported to relevant
management.
Plans to retain documented information as
evidence of the implementation of the audit
program and the audit results

Dates of internal audit conducted or planned

Management Review (9.3)


Verify processes for management review by top
management at planned intervals
Verify Management review inputs and
necessary Management review outputs
Dates of management review conducted or
planned
Verify plans for retaining documented
information as evidence of the results of
management review.

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 OFI-1: Expand customer research to anticipate future needs and enhance product
10.1 General features.
Whether organization has determined and  OFI-2: Introduce AI chatbots or self-service options for faster customer support.
select opportunities for improvement and
implement any
necessary actions to meet customer
requirements and enhance customer
satisfaction including
a) improving products and services to meet
requirements as well as to address future needs
and
expectations;
b) correcting, preventing or reducing undesired
effects;
c) Improving the performance and effectiveness
of the quality management system.

Clause 10.1: General - Opportunities for Improvement and Corrective Actions


Improvement (Nonconformity and corrective
action) (10.2):  Establish a formal process to gather and analyze customer feedback regularly.
 Implement automated customer support tools to improve response times.
Verify the processes for retaining documented
information as evidence of:
I) The nature of the nonconformities and any Minor NC:
subsequent actions taken.
ii) the results of any corrective action
 Minor NC-1: No formal method for consistent customer feedback collection.
Verify the plans for corrective actions to be
appropriate to the significance of the effects of  Correction: Implement a structured feedback process.
the nonconformities encountered, including the
environmental impact(s).  Minor NC-2: Inconsistent corrective action tracking across departments.

10.3 Continual improvement Clause 10.3: Continual Improvement


Whether organization has continually improved
the suitability, adequacy and effectiveness of OFI:
the quality management system and has
considered the results of analysis and
evaluation, and the outputs from management  Formalize the process for evaluating QMS effectiveness against strategic goals.
review, to determine if there are needs or  Ensure management review outputs are systematically acted upon.
opportunities  Use performance data and customer feedback to drive QMS improvements.

Minor NC:

 Minor NC-1: Inconsistent use of management review outputs for QMS improvements.

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AUDIT CONCLUSION

RECOMMENDATION FOR CONDUCT OF REGISTRATION AUDIT


We are pleased to recommend for the conduct of Registration Audit as per the Audit Plan (B004) as per the following
sheet attached:

It is required that action to be taken by review and revision of documents for the areas of concern
mention above.

Details of Additional Locations or Sites and Activities for certification (If applicable)
Location 1 No additional location and sites

Activity N/A

*Add Rows for more

Following phrase is applicable in case of multi-site organization only


Stage 2 Audit Plan for each site will be prepared after considering the processes/activities to be audited on that site
(mentioned in the above table). Assessor will confirm that the Stage 2 audit team has the required competence.
Recommendation for Supplementary PR Audit
(Write NA if this sheet if not applicable)
1.The following have been considered as major concerns during this Audit visit:

2. A recommendation for next stage cannot be made until the nonconformities have been cleared, following the
corrective action plan being submitted and a Supplementary PRA being satisfactorily completed.

Scope Assessed:

3. Immediate action is required to investigate the underlying cause of these non-conformities and implement
effective, corrective, and preventive action. A plan to determine actions, time scales and responsibilities must be
prepared and submitted to Chief Executive for review, no later than ----/-----/----------.

4. Team recommends a Supplementary PR Audit for --- Audit Day(s). The same could be conducted by ----/----/------
-, upon satisfactory corrective action plan submitted by client to BSCIC’s Chief Executive.

5. Client to inform their readiness to BSCIC’s Chief Executive for the further Audit as in 4 above so that the same
could be satisfactorily planned & conducted.

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DECLARATION OF NON-CONFLICT OF INTEREST


I confirm that I / My Team has no consultancy or other commercial association with M/S_ GGC-Good glass
Company during the last two years other than activities conducted under the direction of BSCIC.

BSCIC Progress Review Audit Report Acceptance


The Progress Review Audit of M/S GGC-Good glass Company was completed.

BSCIC through its Team Leader / Lead Auditor confirms the Confidentiality of the information received,
Observed and Reported by the Team BSCIC.

Team Leader / Lead Auditor by signing this sheet confirm the Non-Conflict of Interests with the
Organization.

This report and its full contents are completely understood and accepted.

Please sign below confirming acceptance of the Audit report’s contents

(Audit Report Number): BSCIC-QMS-CA-2024-008

Signed for & on behalf of BSCIC Signed for on behalf of the client
Name: Shebeer Mattolavalappil Name: Mr. Fares Baddad
Date: 30-December-2024 Date:

Group Exercise – 60 Minutes


Exercise 12 Audit Plan Preparation 15 Min. for Presentation

Considering the Quality Manual of Good Glass Company, prepare an audit plan, as per following
guidelines:

1. Total audit days are determined based on the number of employees and complexity of the organization and
guidelines given in IAF MD5 2019 Annex A to C. For this exercise we will consider Total audit days = Four
(minimum) [One audit day = 8 hrs. starting at 9am).
2. Use all the personnel in your group as auditors (you can use auditor – 1, 2, etc.) as references, rather than actual
names.
3. Avoid if possible two people going for same process area audit.
4. Cover one Installation site also in the audit plan as they do execution as well.
5. The audit plan shall contain basic information as under:
a) The start and time of each process area and the auditor allotted for that specific process area.
b) Allot 5 minutes as auditor’s brush up time in middle for effective smooth continuity and effective audit, for
information sharing and judgment on audit proceedings.
c) You can do this in two ways…one plan accommodating all process areas and auditors or separate plan for
each auditor, with distributing the process areas.

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For tutor: The tutor to Scan the flip charts and send to the BSCIC. In case Scanning is not possible send
photographs.

Audit Plan Date: 22-12-2024


Organization: Good Glass Company UAE
Scope: Certification audit

The objective of the Audit: To assess the conformity of the quality management system (QMS) w.r.t ISO
9001:2015.

Criteria ISO 9001:2015 System Quality Manual Issue 01, Dt. Feb. 2023,
Documentation: Procedures Manual Issue 01, Dt. Feb. 2023
Team Leader: Shabeer Mattola Audit Start Date 22-12-24 Opening 9:30 am
(1) Meeting
Team Member: John Green (2) Audit End Date 24-12-2024 Closing 05:00 PM -05:30 PM
Ajeesh (3) Meeting
Thomas(4)

Audit Schedule
Date Client Function Auditor Time (Hrs.)
22-12-2024 Opening Meeting (all auditors shall available in opening meeting as required) Team 9:30 AM - 10:00
Leader AM
(Shabeer
Mattola)
Process Area 1: Quality Management (ISO 9001) Auditor 2 1.0
(John 10:00 AM-11:00
Green) AM
Process Area 2: Production Process (Manufacturing) 1) Shabeer 1.0
Mattola 11:00 AM-12:00
PM
Process Area 3: Installation Site (Execution) 3- 1.0
10:00 AM-11:00
AM
Auditor's Brush Up Time All Auditors 1:05 PM- 1:30
PM
Process Area 4: Customer Feedback & Complaint Handling Auditor 1 1.0
(John 1:30 PM- 2:30
Green) PM
Process Area 5: Procurement & Supplier Management Auditor 2 1.0
2:30 PM- 3:30
PM
Process Area 6: HR & Competency Management Auditor 3 1.0
3:30 PM- 4:30
PM
Process Area 7: Internal Audits & Corrective Actions Auditor 4 1.0
4:30 PM- 5:00
PM
Closing Meeting ( all the auditor) 1)Team 0.5
Leader 5:00 PM- 5:30
(Shabeer PM
Mattola)

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Tutor Marking: 10 max. Mark for right presentation of audit plan. Deduct 1 mark for any
important area missing or short duration less than 8 hours in total.

Exercise 13 Preparation of Audit Checklist Group Exercise – 60 Minutes

Considering the Quality Manual of Good Glass Company, and using the organization structure, prepare an Audit Checklist for a
process area (department), allotted to you by the trainer.

Note: As you are aware, the word shall mean “MANDATORY” and all the requirements after shall are action points to be
verified in an audit…take this as a tip in preparing Audit Checklist

Clause # CHECK POINT (For Verification) Conclusion Evidence for


(Compliance NC
/ NC)
Context of the Organisation
Refer - Risk and
Opportunity
Management
(4.4.1.f)
Non-
compliance: No
documented
4.1 Understanding the process flow or
organization and its Is the company aware of external and internal factors that interaction
context impact the quality management system? NC map.
Documented
Information
(4.4.2)
Non-
compliance:
Inadequate
4.2 Understanding the documentation
needs and expectations to support
of Has the company identified the needs and expectations of process
interested parties customers, suppliers, and other stakeholders? NC operations.

Does the quality system cover all necessary products, services,


4.3 Scope and areas? Compliance
4.4 Quality Management System and its processes
Quality Management
System and its processes Are the company’s processes clearly defined and controlled? Compliance
Leadership Areas
Is top management involved in the quality management
5.1.1 General system? Compliance
Does the company understand customer needs and meet their
5.1.2 Customer Focus expectations? Compliance
Is there a quality policy, and is it communicated to all
5.2 Policy employees? Compliance
5.3 Organizational roles, Are roles and responsibilities clearly defined and
responsibilities and communicated? Compliance

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authorities

Planning / Risks and Opportunities


Risk
Management
(Clause 6.1.1)

No
documented
process for
continuous
improvement
or
measurement
6.1 Actions to address Has the company identified risks and opportunities, and taken of QMS
risks and opportunities action? NC performance.
6.2 Quality objectives
and planning to achieve Are clear quality objectives set, and is there a plan to achieve
them them? Compliance
6.3 Planning of changes Are changes affecting the QMS planned and managed? Compliance
Support Areas
Clause # CHECK POINT (For Verification) Conclusion Evidence for
(Compliance / NC
NC)

Internal Resources: Does the organization conduct a detailed


review of internal resource capabilities and constraints to
7.1.1 General ensure sufficient resources for QMS implementation? Compliance
Human
Resources
(Clause 7.1.2)

evaluating and
selecting
external
providers
available but
selection
criterial not
reviewed as
External Providers: Is there a defined process for evaluating well
7.1.2 People and selecting external providers (e.g., suppliers, contractors)? Minor NC

Infrastructure: Is the infrastructure required for the effective


operation of the QMS in place, including physical resources
7.1.3 Infrastructure (buildings, equipment, etc.)? Compliance

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Infrastructure
and
Environment
(Clause 7.1.3 &
7.1.4)
Infrastructure
is in place, but
logistics and
fleet
7.1.4 Environment for Are environmental factors (e.g., cleanliness, noise, and management
the operation of lighting) regularly reviewed to ensure product and process Minor non plans need
processes conformity? compliances improvement.
Monitoring
and Measuring
Resources
(Clause 7.1.5)

Observation:
Resources for
monitoring and
Are the necessary resources for monitoring and measuring measuring
product conformity identified and maintained? conformity are
available but
Minor non may not always
7.1.5.1 General compliances be up-to-date.
Are measurement devices regularly calibrated, and is the
7.1.5.2 Measurement documentation kept up to date?
traceability Compliance
Observation:
Knowledge
needed for
processes and
conformity is
Knowledge: Is there a process to identify the knowledge identified, but
necessary to support the QMS and ensure conformity to gaps may exist
product/service requirements? in sharing or
7.1.6 Organizational Minor non retaining
knowledge compliances knowledge.

7.2 Competence the Are personnel responsible for QMS processes competent
organization based on education, training, skills, and experience? Compliance
Is there defined process of employee mobilization awards and
7.3 Awareness the awareness session are properly recorded. Compliances
Is there a defined process for internal and external
7.4 Communication communication relevant to the QMS? Compliances
7.5.1 Documented Is the communication structure clear, including what is
information communicated, when, by whom, and how? Compliances
7.5.2 Creating and Does the organization have a defined procedure for controlling
updating documented information? Compliances
7.5.3 Control of Has the organization identified all external documents needed
documented information for the effective operation of the QMS? Compliances
Operation Areas
8.1 Operational planning Does the organization plan, implement, and control the
and control processes needed to meet product/service requirements? Compliances

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Effective
communication
with
customers, but
product and
service
requirements
(e.g., glass
panels,
installation,
warranty) need
Is there a process in place for communicating with customers clearer
8.2.1 Customer regarding product/service requirements, complaints, and documentation
communication feedback? NC during review
8.2.2 Determining the
requirements for Are customer requirements identified and documented before
products and services accepting any order Compliance
8.2.3 Review of the Review
requirements for Does the organization review product/service requirements records, signed
products and services before commitment? Compliance agreements

8.2.4 Changes to
requirements for Are changes to product/service requirements reviewed and
products and services communicated to relevant personnel? Compliance
Design process
is in place but
Are there controls in place to ensure that the design and lacks milestone
8.3.1 General development process meets requirements? OFI tracking.
Planning is
established,
but timelines
and resources
need clearer
8.3.2 Design and Are there? Planning is established and set timelines and definition.
development planning resources. OFI
8.3.3 Design and
development inputs Are inputs reviewed for adequacy and completeness? Compliance
8.3.4 Design and Are there controls in place to ensure that the design and
development controls development process meets requirements? Compliance
8.3.5 Design and Are design outputs clearly documented and meet the
development outputs requirements of the design inputs? Compliance
Design controls
are in place but
not
8.3.6 Design and Are changes to design and development controlled and consistently
development changes documented? OFI documented.

8.4.1 General
8.4.2 Type and extent of Does the organization determine the type and extent of
control control for external processes, products, and services? Compliance
Does the organization provide external providers with the
8.4.3 Information for necessary information for them to deliver products and
external providers services? Compliance

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8.5.1 Control of
production and service Are processes for production and service provision planned
provision and controlled to ensure conformity to requirements? Compliance
8.5.2 Identification and Is identification and traceability of products and services
traceability ensured throughout production? Compliance
8.5.3 Property belonging
to customers or external Is property belonging to customers or external providers
providers protected while under the organization’s control? Compliance
Is there a process for preserving product/service conformity
8.5.4 Preservation during production, delivery, and storage? Compliance
8.5.5 Post-delivery Are post-delivery activities (e.g., warranty, support) planned
activities and carried out as needed?
Performance evaluation Areas
Has the organization determined what needs to be measured
and monitored to ensure the effective functioning of the
9.1.1 General Quality Management System (QMS)? Compliance
There is a
process to
collecting
customer
satisfaction
data, but the
data were not
found properly
9.1.2 Customer Does the organization have a process for collecting customer documented
satisfaction satisfaction data (e.g., surveys, feedback)? OFI and tracked.
Is there a documented process for evaluating and analyzing Compliance
9.1.3 Analysis and the performance of the QMS, including product and service
evaluation quality?
Are audit findings documented and communicated to relevant Compliance
9.2 Internal audit personnel?
Are the reviews aligned with organizational objectives and Compliance
9.3.1 General regulatory requirements?
9.3.2 Management review Does the organization evaluate changes in external and Compliance
inputs internal issues that could affect the QMS during the review?
Compliance
9.3.3 Management review Are resources and timelines allocated for actions identified
outputs during the management review?

Improvement Areas
Are improvements tracked and monitored to ensure they are Compliance
10.1 General effective and lead to sustained benefits?
10.2 Nonconformity and Are corrective actions taken promptly when non-conformities are Compliance
corrective action identified, and are they proportional to the risk and impact?
The QMS is
reviewed by
management at
regular
intervals, but
the impact has
not been
10.3 Continual Does management regularly review the results of continual effectively
improvement improvement efforts and their impact on the QMS? OFI observed.

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Tutor Marking: 10 max. Mark for right presentation of audit checklist. Award one mark each for each good
question including clause no. Deduct 0.5 mark for not mentioning clause no.

Recording Non-conformities Group Exercise – 60 Minutes


Exercise 14
15 Minutes for presentation
15 Minutes for Tutor Review
Please read the following cases and judge as under – please note you are an auditor assessing.
This situation, that means you are standing there in the case and performing interview while auditing.

1. If you think there is a sufficient objective evidence of nonconformity, then complete the non-conformity
notes provided in section “A” and categorize the same as “Major” or “Minor”.

2. If you think there is not sufficient objective evidence of nonconformity, then state the reasons in the section
“B”. In the reasoning, also state what must be further investigated before concluding your decision wither it is
conforming or non-conforming.

Incident 1
In ABC Catering Company, once customer complaint was received as under:

“Our contract says that the quality of rice to be used for rice-based dishes should be an “Indian Basmati rice only” and
you would be giving proof of calories should comply with specs. Sheet “ABC_SPEC 212 issue 2 dt. 12 Jan 2010” and
you would be giving us an III Party laboratory test report every quarter of the year…. we have not received any
evidence till now. Last month we performed a system audit and were surprised to note that the audit team raised the
same issue in the form of Non-conformance report (NC – 15 Dt. 21 Dec.2010) which is not yet closed. Please note the
following:

1. Since our contract is for five years and one year has passed. We need to ensure that for next balance four
years you would be providing us the evidence of compliance of the same, for past three consignments and
shall ensure that, you will continue to adhere to the contractual requirements.
2. In the eventuality to adhere to requirements of point 1. Above soon, as per the discretion of our
management, there may be a possibility that we may not continue business with you as per the contract
times.

We are taking a stand on this, as need to submit this evidence to all our customer’s and all of them are concerned on
this issue. We cannot afford to lose our clients, as they are prestigious international airlines. This is very important for
our business standards and reputation. Hope you realize the criticality of the situation and comply to the
requirements, ASAP.”

On this, ABC Company responded in the following manner:

“We have been faxing all the evidence to the number as defined in the contract. Yes, we did not confirm whether you
received or not. We have all the evidence of the faxes sent to you in our files and were shown to your auditors when
they were here to perform the II party audits. Please let us know if the fax is working or not or it has changed or any
other issue. Anyhow now onwards we shall be emailing the evidencing the same to your Quality department.
And we shall be uploading all these evidence in our internal Intranet and giving you the password for access (only to
authorized personnel only - as identified by you), to avoid such issues occurring again.

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The NCR – 15 clearly mentions that one report is missing. Which we agreed and responded back to your closures
(after rectifying our recording system) for closure and requested you to formally close the NCR. Which is pending
from your side for acceptance of the actions and close out.
We always assure you the best of services to come. We thank you for this opportunity for improvement which we feel
that without you pointing this, our communication system would not have improved.”

Incident 2
While doing the audit of Sheet Metal components for various industry sectors, you found that one of the gauges (GO
– NOGO) for final inspections of circular product, was found to be broken from one of the sides. On asking the
inspector using the gauge, replied that it was supplied by the client & would be returned to the client with the last
consignment. On verification of the Quality Manual, you also detected that this company where you are presently
auditing, had sought exclusion for Customer Property.

Incident 3
A company manufacturing compasses for pleasure crafts. During the audit you observed that, to do the inspections of
centricity of pin (The arrow in the compass which points to north), the person lifts a liver to lift the pin up & visually
verifies the parallel level of the pin with the surface. You as an auditor observed that the person doing the job is
wearing thick glasses and hands shaking. On enquiry you came to know that the person is the senior most person & in
the company since last 20 years & very experienced in Compasses – the only inspector - his hands shake because of
illness. Through the complaints register you also establish that nearly 3% of the consignments on an average, comes
back from the market and are replaced by the company free of cost. It was further established by you that on re-
verification of some of the samples from the stock, ready to delivery revealed that they also have problems of
centricity.

Note: A pleasure craft (speed boat) moves very fast in water compared to big ships which, even turns very slowly. The
precision and swiftness of the compass indications are the key quality norms for acceptability.

Incident 4
While review of Management Review Meeting minutes, recorded the issue as - The brand retail business started
operations in one country and due to local laws, they had to recruit local manpower, but their English was not good
enough to sell the products to prospective customers…mainly foreigners. This was identified during interview process
also. Human Resources developed competency matrix and details job descriptions and translated to local languages.
These local personnel had no problems in selling products to local community but failed to sell products to foreign
guests, due to problem in communication. As per the law there is a restriction in law that female employees will not
interact with males & vice versa. HR & Operational Management had this problem but was not able to balance the
law and business requirements, for nearly a year due to which the business targets were not able to meet business
objectives (sales & branding). This aspect was taken up for discussions in Management Review and it was recorded in
the minutes of meeting that local regulatory labor authorities would be contacted for solutions.

Incident 5
While auditing the Management Representative area (internal audit process), you noticed that one of the internal
audit NC reveals the fact of - the internal audits frequency was annually and 70% of the three internal audit results
revealed that 70% of the non-conformities were on Product Quality. You also noted that there were no changes in the
quality plan, inspection sampling plan & no trainings imparted in quality inspections.

Incident 6
The results of one of the student (with Slr. #: 098701) of a computer institute has appeared in the Final Evaluation for
ORACLE 8 (Five months diploma course). During the audit you as a member of audit team towards ISO 9001:2015, you
were to verify the records of this students. Following were the facts which were revealed from the records (soft &
hard copy) :

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 The approved marks allotted on practical exercises test on computer were not traceable (nor hard copy not in
soft copy form).
 The answers for the test revealed that they were correct in the soft copy and the hard copy – the Srl.# is correct
but the name was different on the record.
 There was also a letter from the student dated four months back (after the test) mentioning that his marks
were not disclosed by the institute and his new prospective employer wanted to verify the certificate and
marks obtained – No corrective action records evidenced.
 One of the objectives of the institute was “TO BUILD CARRIERS OF ATLEAST 75 % OF THE PASSED STUDENTS OF
EACH BATCH THROUGH THEIR PLACEMENT CELL.”

Questions in this section are designed to test student’s ability to analyse audit situations, evaluate audit evidence and apply knowledge of
the audit criteria correctly.
Students are also required to demonstrate their ability to write a well- constructed nonconformity statement that clearly describes the
weakness or failure of the management system, the audit evidence and the requirement(s) of the standard.
Note to marker:
To raise a nonconformity report when there is not sufficient audit evidence should be penalized and markers should normally award zero
mark.
To complete an audit investigation where there is sufficient evidence to report nonconformity can often be supported and be given
marks, normally up to a maximum of 7 marks from a possible 10 marks.
To be awarded marks a student must clearly state their reason for thinking there is not yet sufficient evidence to report the findings as a
nonconformity and describe the investigation they would follow to determine conformity or nonconformity; including audit trails and audit
evidence they would seek and for what purpose, quoting relevant ISO 9001 clause numbers.
Exceptionally, where there was some obvious ambiguity in the description of the audit situation or the student demonstrates logical argument,
knowledge of the subject and the answer shows an ability to make a reasoned judgement leading to a clear determination of conformity or
nonconformity marks up to the maximum available may be given.

Typical solutions for nonconformities follow a standard method of presentation: ie failure in the system (3 marks for identifying the failure),
audit evidence (3 marks for identifying the audit evidence) and requirements (1 mark for identifying the ISO 9001 clause and requirement).
Alternative structure or presentation of the nonconformity by a student is acceptable provided these three components of the nonconformity
are clearly present and the distribution of marks adhered to.

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NON-CONFORMITY NOTE Incident: 1

ISO 9001:2015 CLAUSE No: _____________

Company documents Area unit involved


MAJOR / MINOR
ABC Catering Company [Strike out as required]
Requirement:
 Quality of Rice: Only Indian Basmati rice should be used for rice dishes.
 Calorie Compliance: The rice must meet the standards described in the document "ABC_SPEC 212 issue 2 dated 12 Jan
2010."
 Proof of Compliance: A third-party lab must test the rice, and reports should be sent every three months to prove it
meets the standards.
Failure (Nonconformity):
 The contractual requirement of providing proof of compliance with specifications (“ABC_SPEC 212 issue 2 dt. 12 Jan
2010”) and quarterly III-party lab test reports was not fulfilled.
 An unresolved non-conformance report (NC-15 Dt. 21 Dec. 2010) from a previous audit remains open, indicating
systemic failure in addressing nonconformities promptly.
 ABC Catering failed to verify whether the customer received the faxed evidence, demonstrating inadequate
Evidencecommunication practices.
(reference of Process/Personnel/Documents):

Auditor (Shabeer Mattolavalappil) Auditee (Jhon green) Date 22-12-2024

Comments:

The nonconformity relates to ABC Catering's failure to provide the required quarterly third-party lab test reports for rice
quality, as specified in "ABC_SPEC 212 issue 2 dated 12 Jan 2010." Additionally, an unresolved non-conformance report (NC-15)
from a previous audit remains open, showing a lack of timely corrective actions. The failure to verify if the customer received
the faxed evidence indicates poor communication practices.
Immediate corrective actions are needed to submit the lab reports on time, close the open non-conformance, and improve
communication with the customer to ensure compliance.

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NON-CONFORMITY NOTE Incident: 2

ISO 9001:2015 CLAUSE No:

Company documents Area unit involved MAJOR / MINOR


[Strike out as required]
Requirement:

ISO 9001:2015 Clause No:

Clause 8.5.3 – Control of Production and Service Provision

Failure (Nonconformity):

 A broken GO-NOGO gauge was found during final inspection of circular products.
 The inspector stated the gauge was provided by the client and would be returned with the last shipment.

 However, the Quality Manual shows the company sought an exclusion for customer property, which should align with actual
practices. The broken gauge was not properly maintained, affecting the inspection process.
Evidence (reference of Process/Personnel/Documents):

Broken GO-NOGO gauge found during inspection.

Quality Manual (exclusion for customer property).

Auditor Auditee Date


Shebeer Mattolavalappil Jhon Green Date 22-12-2024

NON-CONFORMITY NOTE Incident: 3

ISO 9001:2015 CLAUSE No:

Company documents Area unit involved MAJOR / MINOR


[Strike out as required]
Requirement:
ISO 9001:2015 CLAUSE No:
Clause 7.1.5 – Monitoring and Measuring Resources
Clause 8.6 – Release of Products and Services

Failure (Nonconformity):
 The inspector’s shaking hands due to illness likely affected the accuracy of the centricity check on the compass pins.
 3% of consignments were returned for replacement, indicating quality issues with centricity.
 Samples from stock also showed centricity problems, highlighting a recurring issue.

Evidence (reference of Process/Personnel/Documents):


 Complaints register showing returns.
 Inspector’s condition and inspection records.
 Re-verification of compass samples.

Auditor Auditee Date


Shebeer Mattolavalappil Jhon Green Date 22-12-2024

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NON-CONFORMITY NOTE Incident: 4

ISO 9001:2015 CLAUSE No:

Company documents Area unit involved MAJOR / MINOR


[Strike out as required]

Requirement:

ISO 9001:2015 CLAUSE No:


Clause 7.2 – Competence
Clause 10.2 – Nonconformity and Corrective Action

Failure (Nonconformity):

 The business was unable to meet sales and branding targets for nearly a year due to communication problems caused by local
manpower's lack of English proficiency.

 Cultural and legal restrictions (female employees unable to interact with male customers and vice versa) were not addressed
effectively, leading to a failure to balance legal requirements and business objectives.

 Despite HR creating a competency matrix and job descriptions, the operational management could not resolve the
communication and legal issues promptly, resulting in the business not meeting its targets for nearly a year.

Evidence (reference of Process/Personnel/Documents):

 Minutes from the Management Review Meeting documenting the issue.

 HR Competency Matrix and job descriptions.

 Interviews and reports from HR and Operations regarding the competency and legal restrictions.
Auditor Auditee Date
Shebeer Mattolavalappil Jhon Green Date 22-12-2024

NON-CONFORMITY NOTE Incident: 5

ISO 9001:2015 CLAUSE No:

Company documents Area unit involved MAJOR / MINOR


[Strike out as required]
Requirement:

ISO 9001:2015 CLAUSE No:


Clause 9.2 – Internal Audit
Clause 10.2 – Nonconformity and Corrective Action
Failure (Nonconformity):
 The internal audit frequency was only annual, and 70% of the non-conformities identified were related to product quality.
 Despite these findings, there were no updates to the quality plan, inspection sampling plan, or training programs for quality
inspections.
 This lack of action indicates a failure to adequately address recurring product quality issues identified in audits.
Evidence (reference of Process/Personnel/Documents):

Auditor Auditee Date


Shebeer Mattolavalappil Jhon Green Date 22-12-2024

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NON-CONFORMITY NOTE Incident: 6

ISO 9001:2015 CLAUSE No:

Company documents Area unit involved MAJOR / MINOR


[Strike out as required]

Requirement:

ISO 9001:2015 CLAUSE No: 7.5.3 - Control of Documented Information

Failure (Nonconformity):

 Untraceable Marks:
The marks for the practical exercises test were missing in both hard and soft copies.
 Incorrect Student Name:
The correct serial number was listed, but the student’s name was incorrect in the records.
 Unresolved Student Complaint:
A student letter, dated four months ago, mentioned unreported marks, but no corrective actions were taken.
 Placement Objective Impacted:
The lack of proper documentation may hinder achieving the placement goal of 75% of students.

Evidence (reference of Process/Personnel/Documents):

 Documents: Student evaluation records (soft and hard copies), student letter

 Personnel: Evaluation and administrative staff

 Audit Process: Review of student records and correspondence

Auditor Auditee Date


Shebeer Mattolavalappil Jhon Green Date 22-12-2024

Role Play – Interview Process Group Exercise –


Exercise 15 60 Minutes for study of GGC & referring the previous
exercises outcome (exercises 5, 6, 7, 8 & 12)
60 Min. for Role Play
30 Minutes for presenting audit findings
15 Minutes for Tutor Review
Process Area (Department):
# CHECK POINT (For Verification) Conclusion Evidence for NC
(Compliance / NC) (Page # of Manual)
1 Clear job description available for all roles. Compliance Page # 45
Interview panel follows a standardized NC
2 Page # 52
interview process.
Candidate evaluation is documented and NC
3 Page # 60
recorded.
Interview panel members must be NC
adequately trained and competent to
4 conduct interviews in accordance with the Page # 67
company's recruitment process and ISO
9001:2015 Clause 6.2.2
Candidate feedback is collected after Compliance / NC
5 Page # 75
interviews.
Proper documentation of selection Compliance / NC
6 Page # 80
decisions.
New hires receive proper orientation Compliance / NC
7 Page # 88
before joining.

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Interview process includes a reference
8 Compliance / NC Page # 93
check step.

Write NCRs for any Four in the prescribed format on subsequent pages

Questions in this section are designed to test student’s ability to analyse audit situations, evaluate audit evidence and apply knowledge of
the audit criteria correctly.
NON-CONFORMITY
Students are also required to demonstrate their ability to write aNOTE (Role Play)
well- constructed NC: 1 statement that clearly describes the
nonconformity
weakness or failure of the management system, the audit evidence, and the requirement(s) of the standard.
Note to marker: ISO 9001:2015 CLAUSE No: _____________

To raise a nonconformity report when there is not sufficient audit evidence should be penalized and markers should normally award zero
Company documents Company documents MAJOR / MINOR
mark.
[Strike out as required]
To complete an audit investigation where there is sufficient evidence to report nonconformity can often be supported and be given
marks, normally up to a maximum of 7 marks from a possible 10 marks.
Requirement:
To be awarded marks a student must clearly state their reason for thinking there is not yet sufficient evidence to report the findings as a
nonconformity and describe the investigation they would follow to determine conformity or nonconformity; including audit trails and audit
evidence they would seek and for what purpose, quoting relevant ISO 9001 clause numbers.
Exceptionally,
Failure where there was some obvious ambiguity in the description of the audit situation or the student demonstrates logical
(Nonconformity):
argument, knowledge of the subject and the answer shows an ability to make a reasoned judgement leading to a clear determination of
conformity or nonconformity marks up to the maximum available may be given.

Typical solutions for nonconformities follow a standard method of presentation: ie failure in the system (3 marks for identifying the failure),
Evidence (reference
audit evidence of Process/Personnel/Documents):
(3 marks for identifying the audit evidence) and requirements (1 mark for identifying the ISO 9001 clause and requirement).
Alternative structure or presentation of the nonconformity by a student is acceptable provided these three components of the
nonconformity are clearly present and the distribution of marks adhered to.

Auditor Auditee Date


Shebeer Mattolavalappil Jhon Green Date 22-12-2024

NON-CONFORMITY NOTE (Role Play) NC: 2


 ISO 9001:2015 CLAUSE No: ISO 9001:2015 CLAUSE No: 8.5.1 – Control of Production and Service
Provision

Company documents Area unit involved MAJOR / MINOR


[Strike out as required]
Requirement:

 ISO 9001:2015 CLAUSE No: 8.5.1 – Control of Production and Service Provision
 Company Documents: Recruitment Process Manual, Candidate Interview Forms
 Area/Unit Involved: HR Department, Recruitment Team
Failure (Nonconformity):

The interview process was not properly documented. Key steps, such as candidate feedback collection and selection decisions, were
missing or not recorded, resulting in a lack of transparency and the inability to justify hiring decisions.

Evidence (reference of Process/Personnel/Documents):

 Incomplete candidate evaluation records


 Missing feedback documentation after interviews

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ISO 9001:2015 Auditor / Lead Auditor Course
Auditor Auditee Date
Shebeer Mattolavalappil Jhon Green Date 22-12-2024

NON-CONFORMITY NOTE (Role Play) NC: 3

ISO 9001:2015 CLAUSE No: 7.5.3 – Control of Documented Information

Company documents Area unit involved MAJOR / MINOR


[Strike out as required]

Requirement:

ISO 9001:2015 CLAUSE No: 7.5.3 – Control of Documented Information


Company Documents: Interview Guidelines, Candidate Evaluation Forms, Recruitment Records

Failure (Nonconformity):

The interview documentation, including candidate evaluation forms and feedback records, was not properly controlled. Some
documents were missing, and others were not properly dated or signed, indicating a lack of proper control over documented
information.

Evidence (reference of Process/Personnel/Documents):

 Missing or incomplete interview evaluation forms

 Disorganized recruitment documentation


Auditor Auditee Date
Shebeer Mattolavalappil Jhon Green Date 22-12-2024

NON-CONFORMITY NOTE (Role Play) NC: 4

ISO 9001:2015 CLAUSE No: _____________

Company documents Area unit involved MAJOR / MINOR


[Strike out as required]

Requirement:
Interview panel members must be adequately trained and competent to conduct interviews in accordance with the company's
recruitment process and ISO 9001:2015 Clause 6.2.2.

Failure (Nonconformity):

There was no documented evidence that all members of the interview panel had received proper training or were assessed for
competence in conducting interviews, which could lead to inconsistencies or bias during the hiring process.

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Evidence (reference of Process/Personnel/Documents):

 Missing or incomplete training records for interview panel members


 Lack of a formal competency assessment process

Auditor Auditee Date


Shebeer Mattolavalappil Jhon Green Date 22-12-2024

Exercise 16
Keywords Approach to understand ISO 9001 requirements Time: 75 Minutes

Find and State keywords in the clauses of ISO 9001:2015.

Clause No. Keywords


4.1 Understanding the organization, external and internal issues, context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the QMS, boundaries, applicability
4.4 QMS and its boundaries, integration into business processes
5.1 Leadership, commitment, customer focus, quality policy
5.2 Quality objectives, planning, alignment with strategic direction
5.3 Organizational roles, responsibilities, authorities
6.1 Actions to address risks and opportunities, planning
6.2 Quality objectives and planning to achieve them, measurable
6.3 Planning of changes, consideration of consequences
7.1.1 Resources, general requirements, adequate provision of resources
7.1.2 People, competence, roles, responsibility, authority
7.1.3 Infrastructure, physical facilities, equipment, IT systems
7.1.4 Environment for operation, work conditions, workplace
7.1.5 Monitoring and measuring resources, calibration, accuracy
7.1.6 Organizational knowledge, knowledge management, information systems
7.2 Competence, training, awareness, qualifications
7.3 Awareness, communication, quality objectives, customer focus
7.4 Communication, internal and external communication channels
7.5 Documented information, control of documents and records
8.1 Operational planning and control, managing operations
8.2 Requirements for products and services, review, acceptance criteria
8.2.1 Customer communication, order review, customer requirements
8.2.2 Determining requirements, customer feedback, legal and regulatory needs
8.2.3 Review of changes, changes in requirements, impact assessment
8.3.1 Design and development planning, process stages, milestones
8.3.2 Inputs, design inputs, customer needs, regulations
8.3.3 Design and development controls, review, verification, validation
8.3.4 Design changes, impact assessment, revised outcomes
8.3.5 Design and development outputs, specifications, documents, release

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8.3.6 Design and development review, process assessment


8.4.1 Control of externally provided processes, suppliers, outsourcing
8.4.2 Type and extent of control, monitoring of supplier performance
8.5.1 Control of production and service provision, product specifications
8.5.2 Identifications and traceability, product status
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation of product, during production and delivery
8.5.5 Post-delivery activities, warranty, customer support
8.5.6 Control of changes, revision control, product changes
8.6 Release of products and services, verification, acceptance
8.7.1 Control of nonconforming outputs, management of deviations
8.7.2 Corrective actions, corrective action plans, resolution of nonconformities
9.1.1 Monitoring, measurement, analysis, evaluation of performance
9.2.1 Internal audit, auditing, compliance, effectiveness review
9.2.2 Internal audit program, scope, frequency, results analysis
9.3 Management review, strategic direction, performance, continuous improvement
10.1 Nonconformity and corrective action, actions to address, prevent recurrence
10.2 Continual improvement, actions to improve the QMS, performance
10.3 Change management, improvement processes, adapting to changes

1 Mark for each clause or part of a clause. Max 10 marks for all correct answers

AUDIT REPORT PREPARATION- Group Exercise – 60 Minutes for report preparation


Exercise 17
On- site Audit- stage2 30 Minutes for the report’s presentation
15 Minutes for tutor feedback
Based on the audit done and findings recorded, please prepare Audit Report as below:
(A flipchart can be used in addition to the workbook)

AUDIT REPORT (B003)


Name of Company (Organization): Good Glass Company

Address: Al Marrakesh Street


10303 Dubai,
United Arab Emirates
Contact Person: Fares Al Baddad Position: MD
Alternate Contact Person: Hussain al Baddad Position: Operation Head
Registration Scope:

Registration No.: 23/675 No. of Employees: 250 No. of Shifts: 2


Company’s Documentation Reference: ISO 9001:2015 Quality Management System (QMS)

Management Standard: ISO 9001:2015 Quality management system


Audit Type: Stage 2 Audit
Audit Commencement Date: 22-12-2024 Audit Completion Date: 24-12-2024

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Audit Team:
Name: Status
Shebeer Mattolavalappil (Lead Auditor)
John Green (Team Member)
Robert Green (Team Member)
Max Pacher (Team Member)
Audit days: 2 day
Nonconformities raised during Audit
NCR Ref. No. NC-01, NC-02
Minor/Major Minor
Nonconformities raised during last visit
NCR Ref. No. N/A
Closed/Open 0

Context of the organisation


Good Glass Company operates in the competitive glass manufacturing industry, serving both residential and
commercial sectors. Committed to high-quality products and ISO 9001:2015 standards, the company prioritizes
customer satisfaction, operational efficiency, and continuous improvement to meet evolving market demands.

Context of the organisation


Good Glass Company operates in a competitive market within the glass manufacturing industry, catering to both
residential and commercial sectors. The company is committed to producing high-quality products and ensuring
compliance with international standards such as ISO 9001:2015. The organization has made efforts to maintain a
consistent focus on customer satisfaction, operational efficiency, and continuous improvement, while responding to
evolving market demands.
Leadership
The leadership at Good Glass Company is dedicated to fostering a culture of quality. The Management Team is highly
engaged in the Quality Management System (QMS) and supports employees in achieving organizational goals. There
is a clear communication line from top management to staff members regarding the importance of compliance with
the QMS standards and objectives.
Planning
Good Glass Company has demonstrated effective planning practices, including the establishment of clear objectives
for quality management. The company has set out long-term goals for growth and quality improvement, which are
reflected in both strategic and operational plans. Risk management is part of the company's strategic planning,
allowing the organization to address potential challenges proactively.
Support
The organization ensures that all necessary resources are available for maintaining and improving its QMS. Adequate
training programs are in place to ensure that employees are well-equipped to perform their duties. The company also
maintains effective communication channels with suppliers and other stakeholders to ensure quality standards are
met.
Operation
The operational processes at Good Glass Company are well-documented and consistently monitored for compliance
with the ISO 9001:2015 standards. Key operations include glass production, quality control, packaging, and
distribution. The company has well-established processes to ensure that all products meet customer requirements
and regulatory standards.

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Performance Evaluation
The company monitors and evaluates its performance regularly, with a focus on customer feedback, internal audits,
and key performance indicators (KPIs). Regular reviews of the QMS are conducted to ensure that the organization
continues to meet its quality objectives.
Improvement
Good Glass Company maintains a culture of continuous improvement, identifying areas of potential enhancement
through regular audits, customer feedback, and performance reviews. Corrective actions are taken promptly, and
preventive measures are integrated into operational processes to minimize recurrence of issues.

AUDIT CONCLUSION (B007)

Based on the findings during the Stage 2 Audit, Good Glass Company has shown a strong commitment to quality
management and ISO 9001:2015 standards. While a few minor nonconformities were identified, the organization
demonstrates effective management practices in leadership, planning, support, operations, and performance
evaluation. The company is recommended for ISO 9001:2015 certification, provided that the identified
nonconformities are addressed within the agreed-upon timeframes.

NONCONFORMITY REPORT Client Representative:


NCR Reference Details of nonconformity Management Standard/
Document Reference
NC-01 Inconsistent documentation of internal audits for the past year ISO 9001:2015 Clause 9.2
(Internal Audit)
NC-02 Missing evidence of risk management review for the last quarter ISO 9001:2015 Clause 6.1
(Actions to Address Risks and
Opportunities)
*Add more rows if required

RECOMMENDATION FOR CERTIFICATION(B006)


Congratulations, we are pleased to recommend certification for the scope detailed in Audit Report, subject
to submission and approval of corrective action plan within 20 days for each of the two Minor NC’s detected
during this audit along with complete evidence.

Subsequently this Audit Report Pack along with your satisfactory Corrective Action Plan and
Objective evidence (if applicable) shall be reviewed independently with in BSCIC. Once the recommendations are
found as sound, BSCIC will be pleased to issue a Certificate of Registration. This will come along with the BSCIC Logo
and Accreditation Mark. The conditions for use of BSCIC Logo
And Accreditation Mark have been stipulated and the same will be provided to you.

BSCIC believes in value added partnership with its clients, and we will be pleased to revisit your company for the
Surveillance Audit for a visit every
Year for 2 Audit Days per visit.

Details of Additional Locations and Activities for certification (If applicable)

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Location 1 Good glass company facility

Activity Glass manufacturing

Recommendation for Supplementary /Re-assessment


1.The following have been considered as major concerns during this Audit visit:

2. This Audit is based on random samples therefore nonconformities may exist which have not been
identified.
For Registration Audits:
3. A recommendation for certification cannot be made until the nonconformities have been cleared,
following the corrective action plan being submitted and a limited/full re audit being satisfactorily
completed.
Scope Assessed:
4. The non-conformities identified indicate a breakdown in the management system to effectively control
the activities for which it was intended.
Immediate action is required to investigate the underlying cause of these non-conformities and implement
effective, corrective, and preventive action. A plan to determine actions, time scales and responsibilities
must be prepared and submitted to Chief Executive for review, no later than 24/01/2024

5. Team recommends a Limited Supplementary Audit for 1 audit day(s) or a full Re-assessment for 2 audit
day(s). The same could be conducted by 25/01/2025, upon satisfactory corrective action plan submitted
by client to BSCIC’s Chief Executive.

6. Client to inform their readiness to BSCIC’s Chief Executive for the further Audit in 4 above so that the
same could be satisfactorily planned & conducted.

SURVEILLANCE AUDIT(SA) PROGRAMME


SA. Fréquence 1 Year
S.A. Conduct Number SA1 SA2 REA
Re Assess.
Audit day(s) 2 2 3.5

01 / 2025,2026

Functions/ Areas / Site


Management   
M.R. Functions   
Marketing Process/Function  
Purchasing Process/Function  
Production Process/Function  
Service Provision Process/Function
Plant Maintenance Process/Function  

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Quality Assurance Process/ Function  


Calibration Process/ Function  
Storage / Warehousing  
HR / Training Process/ Function  
Management Review   
QMS Documents & Changes   
Internal Audit   
Complaints Management   
Previous NCR & Corrective Actions   
Use of BSCIC Logo & Marks   
Re-Audit (Tick ) 
Legal (QMS specific)

Notice: 1. this plan may subject to change based on circumstances


2. Assessor to Pl.  in boxes indicating a full plan. This is required to be updated upon each Surveillance Audit. Please cutoff in ink
if Not Applicable.

DECLARATION OF NON-CONFLICT OF INTEREST


I confirm that I have no consultancy or other commercial association with M/S Good Glass Company during
the last two years other than activities conducted under the direction of BSCIC.

BSCIC RA e-Report – Report Acceptance

The onsite Registration Audit of M/S Good Glass Company was completed.

BSCIC through its Team Leader / Lead Auditor confirms the Confidentiality of the information received, Observed and
Reported by the Team BSCIC.

Team Leader / Lead Auditor by signing this sheet confirms the Non-Conflict of Interests with the Organization.

This report and its full contents are completely understood and accepted.

Please sign below confirming acceptance of the Audit report’s contents

(Audit Report Number): GGC/RA/06/22

Signed for & on behalf of BSCIC Signed for on behalf of the client Co.

Name: Mr.Shebeer Mattolavalappil Name: MR. Fares Badad


Date: 24th Dec , 2024 Date: 24th Dec , 2024

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Group Exercise – 30 Minutes for preparation


Exercise 18 Audit Follow-up NC Closures
30 Minutes for reviewing & decision making
15 Minutes for presentation
15 Minutes for tutor feedback

Review the closure submitted by auditee and judge weather this closure is acceptable or not, for
the below three cases.
NON-CONFORMITY NOTE - 1
PROCESS ACTIVITY ISO 9001:2015 CLAUSE
Production Drilling Machine 7.6
DETAILS OF NON-CONFORMITY [A]
The dial gage no. 45 does been used on Drilling machine does not have calibration status (as per
procedure ABC_7.6 Rev 1) and on asking the operator replied that he does not know what
A
calibration is.
U
Requirement of the standard: D
Where necessary to ensure valid results, measuring equipment shall I
T
d) be identified to enable the calibration status to be determined;
O
AUDITOR: DATE: 24-12-2024 R
NAME: Shebeer SIGN ___________
ROOT CAUSE PROPOSED ACTION
1. Operator did not understand the auditor The system of identification shall be [B]
2.. The system had stickers which came off replaced A
U
Target Date: 24th Dec 2025
D
Responsibility: QA Manager
I
ACTION TAKEN T
The sticker system is replaced by two paints. Red spot indicates the instrument has errors and E
user must consider the error factors and green spot indicates that the instrument has no errors. E
All have been trained on this new identification system with the error factors communicated to
users.

VERIFICATION OF ACTION TAKEN – □ Closed □ Not Closed [C]


A
Verification and Action Taken: U
The reference to Clause 7.6 is incorrect; it should be Clause 7.5.3 (Identification and D
Traceability). The standard requirement should be verified under Clause 7.1.5.2 I
(Measurement Traceability, sub-clause (b)). T
O
R
The non-conformity was due to an incompetent operator, but the root cause analysis
incorrectly mentions a misunderstanding with the auditor. The issue was the drilling
machine lacking a calibration certificate, yet the action taken was to replace the sticker
system with two paint marks.

Action should include training for all operators, proper traceability of calibration status,
and stronger preventive maintenance and inspection processes.

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NON-CONFORMITY NOTE - 2
PROCESS ACTIVITY ISO 9001:2015 CLAUSE
Designing Validations of trainings 7.3.6
[A]
DETAILS OF NON-CONFORMITY
The validation records for the Design of training module # 76 (training security sniffer dogs) not A
evidenced as defined in the Design procedure. STAR_D_007 Rev.3 U
D
I
Requirement of the standard:
T
Records of the results of validation and any necessary actions shall be maintained (see 4.2.4) O
R
AUDITOR: DATE: 24th Dec 2024
NAME: Anita Gonzalvis SIGN ___________
ROOT CAUSE PROPOSED ACTION
1. It is difficult to validate Solution for this validation shall be [B]
analyzed and action taken A
U
ACTION TAKEN D
After many analyses the management (with help of external specialist) it was concluded it is I
difficult to validate. For such training modules where it would be difficult to validate, and an T
exclusion for 7.5.2 has been approved. The changes in Para 1.2 Application chapter of the E
manual is modified with exclusions and justification given. The procedure for Design E
STAR_D_007 Rev. 4 is released. Evidence enclosed for perusal: The Revised Manual &
Procedure.

VERIFICATION OF ACTION TAKEN – □ Closed □ Not Closed [C]


A
ISO Quality Management Systems — Requirements: U
D
Clause 7.3.6 is not part of ISO 9001:2015. I
T
The issue of missing validation records for training module #76 should be considered an
O
opportunity for improvement rather than a non-conformity, according to STAR_D_007 Rev.3.
R

Clause 4.2.4 is incorrect and requires justification.


The root cause analysis is insufficient, as it only states that validation is difficult.
The proposed action is inadequate; a solution should be analyzed, and responsibilities clearly
defined.

The root cause and proposed action do not align. Therefore, the action needs to be reviewed and
is deemed inappropriate. It has not been closed.

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NON-CONFORMITY NOTE - 3
PROCESS ACTIVITY ISO 9001:2015
Human Resources Induction Training for New Recruits CLAUSE [A]
6.2.2
DETAILS OF NON-CONFORMITY A
The induction training records for all five security guards for level 5 (recruited 20 days’ back) are not U
evidenced as required by procedure MLS_HR_008 Rev.5 Paragraph 5.5. e) Which states that all new D
recruits would be undergoing induction training program for minimum 2 days, within one week of I
their joining. T
O
Requirement of the standard:
R
The organization shall:

AUDITOR: DATE: 24th Dec 2024


NAME: Shebeer Mattolavalappil SIGN ___________
ROOT CAUSE PROPOSED ACTION
The recruitment was wrongly done, as for level 5 people should have 5 The recruitment procedure [B]
yrs. experience in special task force (s per recruitment procedure) but and induction training shall A
U
they have only 3.5 yrs and on recommendations by ministry of be modified to make the
D
defense, they were recruited. Management thinking what to do since system more effective and
I
20days as this may require policy change meaningful, to consider T
these unique cases. Without E
compromising quality E
requirements.
ACTION TAKEN
The procedures have been modified and re-issued and in future these would be applicable. These
procedures are enclosed for reference:
1. The recruitment procedure has been modified with options in competency requirements, to
make it more practical
2. Induction training conducted to all the new 5 personnel, and it shall be ensured that
inductions are done within one week of joining, in future. The records of these trainings are
enclosed.

VERIFICATION OF ACTION TAKEN – □ Closed □ Not Closed [C]


A
U
D
I
T
O
R

Tutor marking: 3.3 mark for each correct CAP acceptance. 10 max. Marks for the entire exercise.

conformity.

Issue 03 Rev 03 Jan 2024 Page 51 of 51

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