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AMETEK HDR POWER SYSTEMS
QUALITY POLICY MANUAL
Reviewed and Approved:
en (ahi uxhle
Steve Wetta, Directof of HDR
Lea appr
Ethan Salsbury, Quallly Manager
521 Lakeview Plaza Boulevard, Worthington, Ohio 42085AMETEK’ QUALITY POLICY
I in NSN
Revision: H
Effective Date: 12/1/2017
INTRODUCTION
QUALITY POLICY STATEMENT
The purpose of our business is to provide precise control of electrical power to help
businesses grow and prosper. We do this by helping clients solve their power problems
‘with custom solutions that create the most economical long-term results
To accomplish this purpose, it is Ametek HDR Power Systems’ (HDR) endeavor to focus
con both internal and external client satisfaction and satisfy client expectations every time;
every employee and supplier working for continuous improvement in every way, in
‘manufacturing, in engineering, in finance, in sales and other administrative areas. We
‘must prevent losses and errors by using problem solving tools and data, taking action on
the information that is developed to continually improve performance. Prevention is the
key to ongoing success, where the organization works to develop solutions for both
product and process that are the most economical inthe long term and eliminate waste.
(Our goat is full implementation of World Class Quality Management concepts that utilize a
risk based thinking. This concept recognizes that quality is inherent in all phases of the
‘company operation and that control and coordination of these many facets is a necessity
for worid class success. This quality program policy provides the structure in support of
these objectives. Involvement of al the people in the company is a key ingredient for the
success of this program.
‘This quality program has been developed and implemented to meet ISO 9001:2015
Quality Management Systems Requirements. HDR's quality program is dynamic in order
to satisfy special client or product requirements,
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References
International / National
ANSVISOASQ Q9001 Quality Management Systems ~ Requicements
ANSISOIASQ 29000 Qualty nlanagement Systems ~ Fundamentals and
Vocabulary
ANSIASOIASQ @9004 Qualty Management Systems ~ Guidelines for
Performance Improvements,
Iso 19011 Guidelines for Auditing Management Systems
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QUALITY ASSURANCE REQUIREMENTS MATRIX
run, 10 9001:2008 180 9401:2015
Intoction
2 (QA Progam a 44,84
4 Design Contal a 8
s Document nd Data Control 42 1s
6 Purcasing 1" ea
1 CComrol of Cet Supplied 8 8s
8 Product Ientfication and Traceability 1s Bsa
9 Proce Conta 18 es
10, Inspection & Testing 15 Bs
u Control of inspetion, Measuring ane
‘Test Equipment 6 mus
2 Inspection, Tes, nd Opertng State 1 Bs
. Nonconforing Mates, Parts nd Components 3 87,102
4 Comestive & Preventive Action as 102
Is Hanling, Slorage ad Shipping 1s 8s
i CConrol of Quality Records a2 1s
n. Intemal Quai Audis sa 92
in Peloing 62 73,13
, Servicing 18 BS
20. Sita Tehniques ut 94
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Revision History
Revision A ~ Original program itation
Revision B - Update Requirements
Revision C - Remove references to ISO revision date and general editorial changes
Revision D ~ Correct the Index, page numbers in error
Revision E ~ Change the cover sheet to Jim Lichtenberg, New Director
Revision F ~ Intoduetion modification
Rovision G — Update Frequency of Management Review, Change Quality Policy Quilty
Approval Requirements, Update Head of Quality on cover sheet
Revision H ~ Updates to meet ISO 9001:2015 standard, Management Updates, Address
Correction
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CONTENTS
Fi Acac Ree ai
2 QualtyAstwane Pop Qty Sym
4 DesenCatt
Sree an a Col tn,
9. et Can Cae Of Spc Poet
Coating, Meme nt Te pi
2 peti ean Opting Sat
16 Caaf Gai Rete
eal ay Ai, aig
opt
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QUALITY POLICY
oeAMETEK’ QUALITY POLICY
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1.0 MANAGEMENT RESPONSIBILITY
14 Scope:
‘This policy defines company objectives for quality and its commitment to quay
1.2 Reference:
1S0 9001:2008; Section 5.5
180 9001:2015, Section 5.0
1.3. Quality Policy
‘The quality policy is stated in the company’s Quality Statement, which has been
developed and agreed to by the Senior Management of the company, The Quality
Policy Manual represents the approach that Ametek HDR Power Systems takes in
addressing the requirements ofthe International Standard ISO 9001:2015.
This Quality Policy Manual not only meets the provisions of ISO 8001, but permits
and directs compliance with requirements of other ANSI, IEEE and IEC and other
recognized and appropriate codes, standards, requirements and practices where
directed to do so by client specifications and requirements,
‘Ametek HDR Power Systems ensures that this policy is understood, implemented
‘and maintained at all levels throughout the organization. Quality objectives and
‘commitments pertaining to key elements of quality are documented,
1.4 Organization
Responsibility and Authority
‘The interrelation of all personnel who manage, perform and verify work affecting
duality are defined in the organization chart found in Appendix "S*. The quality job
descriptions, including quality responsibilties and authority of these individuals are
listed in Append "A". 1.5.
Resources
‘Ametek HDR Power Systems identifies in-house resource requirements and
provides adequate resources including the assignment of trained personnel for
performance of work and verification activities including intemal quality audits.
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Verification activities include inspection, test and monitoring of the design,
production and servicing processes. Design reviews and audits ofthe quality
systems and processes are carried out by personnel independent of those having
direct responsibilty for the work being performed.
1.6 Management Representative
The management representative has the authority and responsibility for promoting
awareness as well as ensuring that the Quality System is established,
implemented and maintained in accordance with the Standard. Further, the
‘management representative is responsible for and preparing information for
management review of the quality system. This includes records of
‘nonconformances identified, cient complaints received, intemal quality audits
performed and reported and corrective and preventive actions taken to ensure the
system is functioning and continuous improvement is possible.
1.7 Management Review
‘[Link] functional (Leadership) Executive Staff group monitors ongoing
development and implementation of the quality system, ensures that the system
continues to be effective, efficient and suitable in satisfying the requirements of
1S0 9001:2015 and Ametek HDR Power Systems’ quality policy and objectives,
The Management Representative presents information on the status of the quality
R] system during an annual management review of the quality system. Quality plans
involving the implementation, maintenance and continuous improvement of a
‘quality system are initiated, reviewed and approved.
Internal quality system audits are scheduled and performed. Minutes of GSM.
meetings are retained as quality records,
1.8 Document(s) implementing this Policy
Quality Statement
Management Responsibility Procedure No, H1-090010
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2.0 QUALITY SYSTEM
24 Scope
‘This policy defines the Quality Management System operated by Ametek HOR
Power Syetome to encure that our products and cervicee conform to epecifiod
requirements
2.2 Reference
180 9001:2008, Section 4.4
180 9001:2018, Section 4.0
28° Policy
Quality Policy Manual
‘The Quality Policy Manual outlines our quality management system and is based
Upon the international standard ISO/DIS 10013 - Guidelines for Developing Quality
Policy Manuals. The Quality Policy Manual also contains our Quality Policy,
Organization Chart and the quality responsibilty of persons on that chart. The
Quality Policy Manual references and is supported by the Systems Management
Procedures and Department Procedures that can be found separately.
‘Systems Management Procedures
‘Ametek HDR Power Systems quality systems have been set up based on
international standard ISO 9001. The organization and outline of the quality
system is contained in Appendix °C" of this Quality Policy Manual. The Quality
Policy Manual is supported by the Systems Management Procedures and
Department Procedures, which contain the procedures for the processes which
affect the quality of our products and services. Each procedure lists the qually
records that ensures effective implementation ofthe applicable quality systems
and identifies retention times for said records,
‘The Quality System embraces product engineering, sales, operations, testing,
‘quality assurance and logistics in addition to our quality control system,
Procedures for these functions can be found in the Systems Management
Procedures and Department Procedures and are presented in the form of
‘documented procedures, work instructions, process charts, and/or training
requirements. This Quality System provides consistency to our practices; andi is
the foundation that facilitates our continuous improvernent,
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Quality Planning
‘Ametek HDR Power Systems prepares quaity plans to meet specified
Fequirements for our products, projects or contracts. Quality planning typically
includes:
~ identification and acquisition of any resources (Le. controls, processes,
equipment & skills) needed to achieve the required quality,
= ensuring compatibility regarding product design, production, installation and
servicing,
~ updating existing quality control (inspection or testing techniques) and/or
quality assurance (quality systems or processes) if needed,
~ Carifcation of any specific (new or nonstandard) acceptance criteria,
~ Identification and preparation of any (new or non-standard) quality records,
Note: The Quality System structure and contents of Systems
Management Procedures and Department Procedures are
‘outlined in Appendix "C ofthis document
24 Responsibilties
‘The Management Representative bears the prime responsiblity for establishing,
implementing, and maintaining an effective and economic quality management
system,
All Department Managers are responsible for implementing and maintaining the
Systems Management Procedures and Department Procedures required for
implementing the quality management system in their areas.
2.5 Document(s) implementing this Policy
‘Systems Management Procedure No. H1-090020
‘Systems Management Procedures and Department Procedures
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3.0 CONTRACT REVIEW
3.1 Scope
‘This policy defines the methodology by which clients' requirements are established
and reviewed.
3.2 Reference
ISO 9001:2008, Section 7.2
180 9001:2016, Section 8.2
3.3 Policy
Before acceptance of a sales order or a tender, the requirements requested by the
client are reviewed to ensure they are clearly defined and documented. At this
time, any differences with the cient are resolved and the commitment to a sales
‘order is given if all aspects are met. Amendments to existing contracts are
‘communicated to the appropriate departments through revisions to the existing
sales order,
Records of the orders and, if applicable, reviews with clients are kept on file
3.4 Responsibilities
‘The Sales Manager, Engineering Manager and designates have the prime
responsibilty to ensure that the client's requirements are clearly defined and
documented.
Executive Secretary (ES) has the responsibilty to keep record of all sales orders
and transactions for hardware and Client support has tesponsibilty for service
contracts,
3,8 Document(s) Implementing this Policy
Contract Review Procedure No. H1-090030,
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4.0 DESIGN CONTROL
41 Scope
‘This policy defines the methodologies and tools for control of design and
development to satisfy client requirements, and to achieve company objectives.
42 Reference
180 9001:2008, Section 7.3
180 9001:2015, Section 8.3
43° Policy
General
Documented procedures have been established defining the product design
process to ensure that it meets internal, client, and regulatory requirements.
Design and Development Planning
Plans are drawn up that identify the responsibility for each design and
development activity. The plans describe andlor reference these activities and are
updated as the design evolves. Design and development activities are planned
and assigned to qualified personnel equipped with adequate resources.
Organizational Interfaces
Organizational and technical interfaces between different groups are identified and
the necessary information documented, transmitted and regularly reviewed.
Design Input
Design input requirements relating to the product, including applicable statutory
and regulatory requirements, are identified and documented and their selection
reviewed for adequacy. Incomplete, ambiguous, or conflicting requirements are
resolved with those responsible for imposing these requirements. The results of
‘any contract reviews are taken into consideration using risk based thinking.
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Design Output
Design output is documented and expressed in terms of requirements that are
verified and validated against design input requirements. In addition to meeting
the input requirements, the output document makes reference to acceptance
criteria and identifies characteristic that are crucial to safe and proper functioning
of the product
Design Review
Reviews at each stage of design are planned and conducted and where
appropriate, cross-functional representatives are present. Records of reviews are
maintained,
Dasign Verification
‘Ametek HDR Power Systems plans, establishes, documents and assigns to
‘competent personnel functions for verifying the design. Design verification
establishes that design output meets the design input requirements by means of
design control measures. To ensure continuity, Ametek HDR Power Systems
uses the same subcontractors, tooling, and processes during verification that wil
be used in production wherever possible. Performance testing activities are
tracked to monitor timely completion and conformance to requirements.
Design Validation
‘Ametek HDR Power Systems ensures its! products conform to clients requirements
by performing design validation.
Design Changes
‘Ametek HDR Power Systems established and maintains procedures for the
Identification, documentation and appropriate review and approval of all changes
and modifications. Changes are submitted for written client approval when
appropriate,
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Design Analysis
Measures shall be provided for design analysis in such areas as compatiilty of
materials, thermal qualifications, accessibilty for in-service inspection,
maintenance and repair. Acceptance criteria for inspections and tests are
submited to the client for review and approval when necessary.
Measures shal be taken to provide for the selection and review for suitability of
application of materials, parts and equipment that are essential for the proper
functioning of the system or component
Adequacy of Design:
‘Adequacy of design shall be shown by:
Designs previously proven in like applications and usage.
Performance testing shall demonstrate adequacy of performance under the most
adverse design conditions. If testing indicates that modifications to the item are
necessary to obtain acceptable performance, the item shall be modified and
retested as necessary to assure satisfactory performance,
44 — Responsibilities
Product Engineering has the prime responsiblity for product planning, design,
verification, and validation. Product Engineering is also responsible for change
control for specific client requests and regulatory requirements.
The Quality Assurance function ensures that both internal and extemal design and
development activities are audited in accordance with company procedures.
45 Document(s) implementing this Policy
Design Control Procedure No. H1-090040
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5.0 DOCUMENT and DATA CONTROL
5.1 Scope
This policy defines the way in which quality system documentation and related
documents are controlled,
52 Reference
180 9001:2008, Section 4.2
180 9001:2018, Section 7.5
53 Policy
‘Ametek HDR Power Systems has established and maintains procedures to control
all documents and data that relate to the requirements of ISO 9001 and applicable
‘extemal standards. These documents are reviewed and approved for adequacy
by authorized personnel prior to Issue, This control ensures that:
a) The pertinent issues of appropriate documents, which include documents
referenced by client drawings or specifications, are available at al locations where
‘operations essential to the effective functioning of the quality system are
performed.
b) Obsolete documents are promptly removed from all points of issue or use.
©) Obsolete documents, where noted, may be retained for legalknowledge
purposes and if so are suitably identified
54 Document and Data Changes
Changes to documents are reviewed and approved by the same
functions/organizations that performed the original review and approval unless
specifically designated otherwise. Where practicable, the nature of the changes is
identified in the document or the appropriate attachments
‘Amaster lst or equivalent document control procedure has been established to
Identify the current revision of documents in order to preclude the use of non:
applicable documents
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5.5 Responsibilities
The Management Representative has responsibilty to review, revise and control
this Quality Policy Manual. The Business Manager and Head of Quality are
responsible for approving the original and changes to this Quality Policy Manual,
Systems Management Procedures are prepared, reviewed and revised by
appropriate managers, and approved and controlled by the Management
Representative
Department Procedures are prepared by department managers or designates, and
approved and controlled by department management.
Product engineering department is responsible for drawings, specifications and
‘other documents. Change of these items is through the ECO process defined at
the procedure level
5.6 Document(s) implementing this Poliy
Document and Data Control Procedure No. H1-090050
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6.0 PURCHASING
UALITY POLICY
6.1 Scope
‘This policy defines the controls on the purchase of materials and services used in
the manufacture of Ametek HDR Power Systems’ products.
62 Reference
180 9001:2008, Section 7.4
180 9001:2015, Section 8.4
63 Policy
Evaluation of Sub-Contractors
‘Selection ofall sub-contractors is based on their ability to meet product and
service requirements at a total cost that provides the best value. Acceptable
citeria may be based on past performance, quality, price, location and timeliness
Cf dolivery. A list of approved sub-contractors!vendors is maintained for each
product in the product specification. Where our client has an approved
subcontractor list, Ametek HDR Power Systems purchases the relevant materials
from subcontractors on that ls.
PROGRAM REQUIREMENTS:
‘The program shall include provisions, as required, for:
1. Source evaluation and selection;
2. Objective evidence of quality furnished by the supplier or contractor;
3. Source inspection, audit, or surveilance; and
4. Examination of items or services upon delivery
‘The selection and evaluation of suppliers is based on one or more of the following
criteria
1. On-site survey
2. Past history of reliability
3. Client approved or designated supplier
4. Product or service being supplied (importance, complexity and quantity.
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5
Engineering Evaluation - The capacity and competency of the suppliers
Product Design and Quality program will be evaluated by Engineering
personnel.
Source surveying of parts purchased,
a. Asuppliers survey is made of new suppliers and established suppliers
as deemed necessary by purchasing and quality assurance.
b. Measures are established to verify suppliers’ performance at intervals
consistent with the importance, complexity and quality of the item or
service.
Purchasing Data
Purchase orders are clear and concise as to type, class, style, andlor part number
and reference acceptable criteria or other information, where applicable. Raw
materials, components, and supplies used in the manufacture of our products must
meet all requirements, stated, or referenced, on the Purchase Order.
Content of Procurement Documents - Include the following provisions as
applicable for the item being purchased:
a)
by
4
°)
4)
9
hy
‘Scope of work
‘Technical requirements-including reference to specifications, codes,
standards, regulations, test, inspection and acceptance requirements
Right to access the supplies facilities for the purpose of inspection and or
audits of materials and quality system used to control materials included in
the purchase order, at the supplier's plant, if required by contract.
Documentation requirements as applicable
Nonconformance reporting as applicable, and
Spare/replacement part identiication as applicable.
‘Subcontracts and associated reference data are available for review, when
appropriate.
Applicable client requirements as contained in client specifications are carried
orward to the suppliers through their insertion on purchase orders and HOR
‘specifications to suppliers.
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‘Changes and/or revisions to subcontracts and/or purchase orders follow the same
process and review as the original order.
Materials used in our processes satisfy environmental, health, and safety
mandates.
Verification of Purchased Product
Where Ametek HDR Power Systems chooses to verify product at our sub-
contractor(s) premises, Ametek HDR Power Systems wil specify the general
arrangements and the methods in the Purchase Order.
Where specified in a contract, Ametek HDR Power Systems’ clients have the right
to verify product at Ametek HDR Power Systems sub-contractor(s) premises and
‘Ametek HDR Power Systems’ premises. However, this does not absolve the sub-
contractor(s) of effective quality control
6.4 Responsibilities
“The Logistics function is responsible for ensuring that the procedures established
for the control ofthe purchasing activities are implemented and maintained and
that purchasing documents are reviewed and approved prior to release
“The Engineering function is responsible for ensuring that material specifications
will allow product specifications to be met
‘The Engineering/Qualty function will determine the extent ofthe receiving
inspection activity required, and will coordinate the assessment of vendors
6.5 Document(s) implementing this Policy
Purchasing Procedure No. H1-090060
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7.0 CONTROL OF CLIENT SUPPLIED PRODUCT
71 Scope
‘This policy defines the way in which client supplied product is controled.
72 Reference
1S0 9001:2008, Section 7.5
1S0 9001:2015, Section 8.5
73 Polley
Documented procedures are established and maintained for the receipt, inspection
where necessary, storage, and use of client supplied product. Problems
associated with client supplied product are communicated back to the client.
74 Responsibilities
The Sales or Service/Test functions are responsible for identifying client supplied
product during contract review activity, and for communicating such information to
the appropriate company personnel.
7.8 Document(s) implementing this Policy
Control of Client Supplied Product Procedure No. H1-090070
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8.0 PRODUCT IDENTIFICATION AND TRACEABILITY
8.1 Scope
‘This policy defines how product identification and traceability is maintained.
82 Reference
180 9001:2008, Section 7.5
180 9001:2015, Section 8.5.2
83 Policy
Procedures are established, where appropriate, for identifying products from
receipt and during all stages of production, delivery, and installation. ‘These
procedures aim at ensuring that product can be identified throughout the entire
process.
Where traceability is a requirement, Ametek HDR Power Systems establishes and
maintains documented procedures,
‘When required by codes, standards, or specifications, the program provides
traceability of materials, parts, or components to specific inspection or test records.
84 Responsibility
Allpersonnel are responsible for observing the requirements of the procedure that
implements this policy.
8. Document(s) Implementing this Policy
Product Identification & Traceability Procedure No. H1-090080
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9.0 PROCESS CONTROL
94 Scope
This policy defines the way in which manufacturing processes are controled.
0.2 Reference
ISO 9001:2008, Section 7.5
180 9001:2018, Section 8.5.1
93° Policy
Procedures are established to control processes that affect quay and to ensure
that the processes are caried out under controlled conditions. Controled
conditions are achieved (where applicable) by
utlizing documented work instructions
monitoring process and product characteristics
‘complying with internal, client, or regulatory requirements
Using suitable production equipment and working environment
approving process and equipment where appropriate:
providing workmanship criteria
verifying job set-up
‘complying with client special characteristics requirements
utlizing a planned total preventive maintenance system
maintaining an infrastructure that ensures product conformity,
‘These procedures, in conjunction with the appropriate training of personnel,
ensure the manufacturing of products in a controlled process, Where applicable,
certification of skils is required
Special processes refer to processes that cannot be fully verified by subsequent
inspection or testing. These processes are identified in the respective
departmental procedures. Records are maintained for qualified processes,
equipment and personnel, as appropriate,
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9.4 Responsibilities
The Manufacturing function is responsible for establishing workmanship standards
and process instructions,
The Manufacturing operators/process owners are responsible for monitoring
processes and product characteristics.
The Scheduling Function establishes schedules to meet delivery commitments to
clients.
‘The Plant Engineering function is responsible for developing and maintaining a
preventive maintenance function,
‘The Quality Assurance function is responsible for ensuring that quality instructions
adequately specify requirements.
9.5 Document(s) implementing this Policy
Process Control Procedure No. H1-090090
‘Systems Management Procedures and Department Procedures
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10.0 INSPECTION AND TESTING
10.1 Scope
‘This policy defines the conduct of inspection and testing activities to verity
conformance to specified requirements.
10.2 Reference
1S0 9001:2008, Section 7.5
10 9001:2015, Section 8.5
10.3 Policy
Receiving Inspection and Testing
Incoming inspection procedures verify consistency for purchased raw material,
components, and/or supplies from sub-contractors prior to release into production,
Incoming inspection practices and procedures will be carried out and documented
by qualified personnel within the quality system. The extent and level of inspection
criteria is planned according to quantity and complexity of the parts and by the
amount of control atthe sub-contractor's premises and recorded evidence of
conformance, Product is not released into production unless it has been
inspected, except in the following event: Where incoming product is released for
Urgent production purposes, its positively identified and recorded in order to
permit immediate recall and replacement in the event of nonconformance to
specified requirements.
In Process Inspection
‘Ametek HDR Power Systems doos:
4) Inspect, test and identily product as required by the quality plan or documented
procedures:
») Hold product until the required inspection and tests have been completed or
necessary reports have been received and verified except when product is
released under positive recall procedures (see 10.3). Release under positive
recall procedures does not preclude the activities outlined in a, above.
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Final Inspection and Testing
“The quality plan or documented procedures for final inspection and testing does
Tequire that all specified inspection and tests, including those specified either on
receipt of product or in-process, have been carried out and that the data meets
‘specified requirements.
‘Ametek HDR Power Systems carries out all final inspection and testing in
‘accordance with the quality plan or documented procedures to complete the
‘evidence of conformance of the finished product to the specified requirements.
No product is dispatched unti al the activities specified in the quality plan or
documented procedures have been satisfactorily completed and the associated
data and documentation is available and authorized
Inspection and Test Records
Records shall be maintained to support product acceptance. Procedures for
‘handling product that fails to pass inspection and test are outlined in section 13.0
of this Manual
‘Test Procedures:
Contain the prerequisites, as required, to accomplish any specific provision or
objectives of the test. The test personnel shall assure that the prerequisites have
been accomplished before proceeding with the test. Prerequisites may include
environmental conditions, instrument calibration, appropriate equipment, trained
personnel, test equipment condition, provisions for data collection, and the iter to
be tosted.
1. Test procedures are written and shall include or reference requirements and
‘acceptance limits as contained in applicable documents.
2. Test procedures include qualification test, proof tests, pre-operational and
operational tests, as appropriate t6 demonstrate satisfactory performance
during operation
3. Special test requirements and special acceptance criteria are provided by
the client and so stated in their specifications.
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4. Test results are documented and evaluated by responsible authority to
assure that all requirements have been met,
5. Test reports are maintained in the Job Files.
6 Test records shall identty item tested, date tested, test technician, type of
observation. results. person evalualing test results, and any action resulting
from a deviation,
10.4 Responsibilties
‘The Production function is responsible for in-process visual inspection and specific
testing as identified in process documentation.
‘The Testing function is responsible for ensuring that detailed testing procedures
and instructions are provided where necessary, as an aid to personnel responsible
for conducting such.
‘The Operations function is responsible for receiving, the Final Testing function is
responsible for authorizing release to shipping and Operations is responsible for
pre-shipping and final inspections.
The operating procedures supporting this policy identify the authority forthe final
release of product,
10.5 Document(s) implementing this Policy
Inspection and Testing Procedure No. H1-080100
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11.0 INSPECTION, MEASURING AND TEST EQUIPMENT
114 Scope
This policy defines the control of inspection, measuring and test equipment used
by Ametek HDR Power Systems
11.2 Reference
10 9004:2008, Section 76
180 9001:2015, Section 7.1.5
143 Polo
‘Ametek HDR Power Systems controls/maintains inspection, measuring and test to
demonstrate the conformance of product to the specified requirements.
Equipment is used in a manner that ensures that measurement uncertainty is.
known and is consistent with the requited measurement capability,
Control procedures.
Inspection, measuring and test equipment used to verity product is controlled via
an equipment recall process and is verified and/or calibrated on site by an
approved certified lab for periodic testing and calibration,
‘Ametek HDR Power Systems
a) Determines the measurements to be made, the accuracy required and
selects the appropriate inspection, measuring and test equipment and
‘ensures the equipment is capable of the accuracy and precision necessary;
b) Identifies inspection, measuring and test equipment with a suitable indicator
or approved identification record to show the calibration status;
©) Maintains calibration records for inspection, measuring and test equipment;
d) Assesses and documents the validity of previous inspection and test results
‘when inspection, measuring and test equipment is found to be out of
calibration;
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©) Ensures that the environmental conditions are suitable for the inspections,
‘measurements and tests being carried out;
1) Ensures that the handling, preservation and storage of inspection,
‘measuring and test equipment is such that the accuracy and fitness for use
is maintained,
‘TEST EQUIPMENT NOT USED FOR ACCEPTANCE TESTING:
(Equipment that is not used for acceptance testing may not be calibrated to
the NIST)
1, Test equipment not in calibration is tagged "Not to be used for
Acceptance Testing’
2, Test equipment not used for acceptance testing is tagged "Not to be
used for Acceptance Testing)
Where test hardware (e.g. jigs, fxtures, templates, pattems) or test software is
used as suitable forms of inspection, they are checked to prove that they are
capable of verifying the acceptability of product prior to release for use during
production and are rechecked at prescribed intervals. Ametek HDR Power
‘Systems has established the extent and frequency of such checks and does
‘maintain records as evidence of control. Measurements of design data are made
available, when required by the client or his representative, for verification that itis
functionally adequate.
114° Responsibilties
‘The Test function is responsible for coordinating calibration activity with
Purchasing functions for ensuring that the on-going needs for inspection,
‘measuring, and test equipment are identified and assigned accordingly
Itis the responsibilty of all personnel to ensure that the equipment used is suitable
and within its calibration period
11.5 Document(s) implementing this Policy
Control of Inspection, Measuring and Test Equipment Procedure No. H1-090110
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12.0 INSPECTION AND TEST STATUS
12.1 Scope
This policy defines the way in which inspection and test status is defined.
12.2 Referens
180 9001:2008, Section 75
180 9001:2015, Section 8.5.4
12.3. Policy
Procedures ensure all required testing be performed. Approved product is
identified as described in applicable procedures. When product fails testing or
inspection, the affected product is identified as nonconforming and disposition is
determined per section 13 of this manual
Inspection and test records identify the inspection authority responsible for release
(of in-process and/or finished product
12.4 Responsibilities
‘The individual performing the inspection / test is responsible for documenting
inspection / tests results.
12.5 Document(s) implementing this Policy
Inspection and Test Status Procedure No. H1-090120,
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13.0CONTROL OF NONCONFORMING PRODUCT
13.1 Scope
‘This Policy defines the manner for controlling material that does not conform to
specified requirements and industry standards.
132. Reference
1S0 9001:2008, Section 8.3
180 9001:2015, Section 8:7, 10.2
13.3. Policy
All nonconforming product are, immediately upon detection, identified,
documented, segregated (where practical), and held pending investigation and
disposition. Such arrangements apply to material received from suppliers, cient,
or from materials (product) produced at Ametek HDR Power Systems
All nonconforming products are reviewed to determine subsequent material
disposition and the possible need for correctivelpreventive action. Nonconforming
product may be reworked or repaired to meet specified requirements, accepted
with or without repair by client concession, re-graded for an alternative application,
or scrapped
Records of all nonconformances are maintained and periodically reviewed to
establish trends to determine the need for further preventive action.
‘Material that does not conform to client specification is only used or supplied with
the clients prior knowledge and writen consent. This applies equally to products
or services purchased from subcontractors.
Repaired and reworked product is re-inspected in accordance with the applicable
procedures,
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18.4 Responsibilities
Itis the responsibilty of all personnel detecting a nonconformance to ensure that
the material is properly identified, segregated (where practical) and reported.
‘The responsibilties for determining disposition of nonconforming material are
defined in the procedure that implements this policy. Those responsible for
disposition may refer the nonconformancs to the Corrective and Preventative
Action system,
13.5 Document(s) implementing this Policy
Control of Nonconforming Product Procedure No. H1-090130
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14.0 CORRECTIVE AND PREVENTIVE ACTION
14.1 Scope
‘This policy defines how Corrective and Preventive Action is identified,
implemented and reviewed for effectiveness,
142. Reference
1S0 9001:2008, Section 8.5
180 9001-2018, Section 10.0
143 Policy
Documented procedures for implementing corrective and preventive action are:
established. These procedures include the effective handling of cient complaints
and reports of praduct nonconformitias, investigation of the apparent cause,
determination of corrective action and application of controls to ensure corrective
action is taken and is effective,
‘Ametek HDR Power Systems’ corrective and preventive action system reviews
conditions adverse to quality via inputs from design reviews, quality inspectors,
process and work operation information, nonconforming product reports,
supervisors, client complaints, and client product retuens. The problems may be
organized into a Pareto chart to identify areas requiring corrective action
corresponding to the risks encountered. Disciplined problem solving methods are
Utiized. Parts returned from a cient are analyzed; records kept, and appropriate
corrective action taken to prevent recurrence.
Significant conditions adverse to qualiy are forwarded to Executive Management
hich assigns investigation responsibilities for cause and corrective action taken to
preciude recurrence. The cause of the conditions and the corrective action taken
is documented and reported to appropriate levels of management. Significant
conditions adverse to quality are those, which extend beyond a single or isolated
condition or item. A significant condition adverse to quality must be generic in
nature related to a large number of items or be a deficiency in the quality program
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Nonconformitie or potential causes of nonconformities may be detected in the
quality system. The Management Representative reviews each nonconforming
Condition and assigns responsibilty (department andor individual) for
determination of apparent root cause, development and implementation of
Corrective measures, and performance of follow-up efforts to verty effectiveness of
‘ctions taken.
Required changes in procedures are completed and documented according to the
documents implementing this policy.
Results of corrective and preventive actions (follow-up reports) are submitted to
the Executive Staff for management review.
144 Responsibilities
Pertinent managers are responsible for action item assignments, for coordinating
internal and external nonconformities or potential nonconformities and for ensuring
that implementation of the necessary corrective and preventive action takes place
‘and that the actions are effective
‘The Operations Supervisor, with input from QA as needed, is responsible for
determining the need for corrective and preventive action and assigning the
investigation to appropriate departments for completion. Resulting corrective
actions, corrective action implementation and follow-up on effectiveness are also
tracked by the Operations Supervisor.
14.5 Document(s) implementing this Policy
Corrective Action Procedure No. H1-090141
Preventative Action Procedure No. H1-090142
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15.0 HANDLING, STORAGE, PACKAGING, PRESERVATION
AND DELIVERY
15.1 Scope
‘This policy defines the contro's employed within Ametek HDR Power Systems for
hhandiing, storage, packaging, preservation and delivery of product.
16.2. Reference
1S0 9001:2008, Section 7.5.6
1S0 9001:2015, Section 8.5.4
18.3 Policy
Procedures are established for product handling, storage, packaging, preservation
and delivery to prevent any risk to product quality. An inventory management
system is established. Handling methods are prescribed to prevent damage or
deterioration.
Product awaiting use or shipment is identified and segregated (where practical) in
‘secure storage areas. Suitable measures are taken to prevent damage or
deterioration including a petiodic inspection for product condition. Where
‘appropriate, controls are established for receipt and issue from storage areas,
‘Ametek HDR Power Systems’ products are packaged in accordance with
prescribed methods and materials designed to ensure that the product quality is.
‘maintained during transit. Preservation methods, where applicable, are
documented. All materiais shipped are labeled according to client requirements,
‘The product description, destination and transit considerations will be specified on
the shipping documentation. Ametek HDR Power Systems arranges for the
protection of the quality of the product after final inspection including delivery to the
client destination, Ametek HDR Power Systems monitors delivery performance to
assure client requitements are met.
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‘Marking and labeling for packaging, storage and shipment of items is adequate to
‘identity, maintain and preserve the shipment, including any special instructions.
‘Additional marking of items is in accordance with clients’ specifications and
requirements,
184 Responsibilities
“The Operations function is responsible for ensuring that material is properly
received, identified, protected, stored, and issued in accordance with prescribed
routines
‘The Operations function is responsible for conducting regular audits of stock to
determine that material is maintained in a satisfactory condition,
‘The Operations function is responsible for ensuring that products are properly
prepared for dispatch and identified accordingly
165 Document(s) implementing this Potic
Handling, Storage, Packaging, Preservation and Delivery Procedure No. H1-
090150
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16.0 QUALITY RECORDS
16.1 Scope
This policy defines the maintenance of quality records.
16.2 Reference
10 9001:2008, Section 4.2
180 9001:2018, Section 7.5
16.3 Policy
‘Ametek HDR Power Systems has established and maintains procedures for
identification, collection, indexing, fling, storage, access, maintenance and
disposition of quality records,
Quallty records are maintained to demonstrate achievement of the required quality,
and the effective operation of the quality system. Pertinent sub-contractor quality
records are an element of these data
All quality records are logible and identifiable to the operating procedures involved
Quality records are stored and maintained in such a way that they are readily
retrievable from facilities that provide a suitable environment to minimize
deterioration or damage and to prevent loss. Retention times of quality records
have been established and recorded. Where agreed contractually, quality records
are made available for evaluation by the client or their representative for a given
period
Quality Records shall be classified as ‘Non-Permanent’. Records identifying the
*as-bult” condition may be forwarded to the client for retention under the clients
record system. HDR Power Systems Inc, shall not maintain lifetime records.
Quality records shall be classified in accordance with written procedures.
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16.4 Responsibilitios
Itis the responsibilly of each department manager to ensure that quality retated
records are compiled in a complete, leglble and accurate manner and are correctly
filed and stored in the location provided, where applicable.
465 Document(s) implementing this Policy
Contro! of Quality Records Procedure No. H1-090160
‘Systems Management Procedures and Department Procedures
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17.0 INTERNAL QUALITY AUDITS
17.1 Scope
‘This policy defines the conduct of intemal quality management system audits
17.2 Reference
1S0 9001:2008, Section 8.2.2
180 9001:2015, Section 9.2
ISO 19011, Systems Auditing
Internal Quality System Audits (Reference Text)
17.3. Policy
‘Ametek HDR Power Systems carries out a comprehensive system of planned and
documented intemal quality audits to verify whether quality activities comply with
planned arrangements and to determine the effectiveness of the quality system. A
suitable working environment is considered as part of the internal audit process.
‘Audits are scheduled on the basis ofthe status and importance of the activity and
carried out by personnel independent of those having direct responsibilty for the
activity being audited
‘Summary results ofthe audits are reviewed by the Executive Staff to ascertain that
the quality management system is effective in achieving ts objectives and
continues to reflect the company's policy
17.4 Responsibiities
The Management Representative is responsible for directing the planning,
performance and reporting activities ofthe internal audit tea. This may include
‘obtaining and directing the activities of contractors for the performance and
reporting of internal audits,
‘The Internal Audit Team (Lead auditor and Audit Team Members) is responsible
for ensuring the audit plan and follow-up activites are carried out,
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Department managers being audited are responsible for timely investigation of
nonconformances. Corrective Action Plans are agreed to among the Department
‘Supenvisors/Managers, the Management Representative and the Lead Auditor and
planned and implemented by the department.
17.5 Document(s) Implementing this Policy
Internal Quality Audits Procedure No. H1-090170
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18.0 TRAINING
18.1. Scope
‘This policy defines the provisions made within the company to ensure that all
personnel are adequately trained for the tasks that they are required to undertake.
18.2. Reference
180 9001:2008, Section 6.2.2
180 9001-2015, Section 7.2 &7.3
18.3. Policy
‘Ametek HDR Power Systems identifies training needs and provides training forall
positions that contain actives affecting the quality of our products and services,
Personnel performing specific assigned tasks are qualified on the basis of
education, training, and/or experience, as required,
Management and supervisory personnel are assigned based on previous
education, training and experience. Quality job responsibilities for these positions
are contained in this manual. On the job training is not documented for these
positions.
Training needs, and those receiving the training are documented and the company
Uses these to appraise the level of competence of personnel both before and
during engagement.
18.4 Responsibiities
Functional department heads are responsible for identifying specific training needs
and ensuring that only personnel who are sultably qualified perform tasks requiring
acquired skills,
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Functional department heads are responsible for analyzing instances of
rnonconformance for evidence of insufficient skill job knowledge or training,
‘The Executive Secretary is responsible for establishing and maintaining the
appropriate training records.
18,5 Documents Implementing this Poli
Training Procedure No. H1-090180
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19.0 SERVICING
19.1 Scope
This policy defines servicing as it related to Ametek HDR Power Systems
operations,
19.2 Reference
10 9001:2008, Section 7.5
150 9001:2015, Section 8.5
19.3 Policy
Ametek HDR Power Systems provides installation, training, maintenance and
‘support services for its clients based on contractual arrangements. Procedures for
performing, verifying, and reporting of service activities are documented.
19.4 Document(s) Implementing this Policy
‘Servicing Procedure No. H1-090190
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20.0 STATISTICAL TECHNIQUES
201 Scope
This policy defines the policy for use of statistical techniques within Ametek HOR
Power Systems
202 Reference
10 9001:2008, Section 8.2
1S0 9001:2015, Section 9.1
203 Policy
Where appropriate, Ametek HOR Power Systems has established procedures for
using statistical techniques for determining process capability and product
characteristics
Where statistical techniques are used for product verification, due regard is given
to the contractual requirements of the client.
204 Responsibilities
Itis the responsibilty ofall personnel using statistical techniques to observe the
relevant procedures.
20.5 Document(s) Implementing this Poli
Statistical Techniques Procedure No. H1-090200
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APPENDIX "A"
Quality System Respons
y
Buisness Manager: Responsible for defining the overall direction of the company in
terms of quality and is responsible for defining the company Quality Policy and ensuring
consistency in the quality of products and services provided to clients of Ametek HOR
Power Systems.
Managoment Representative: The MR, lirespective of other responsibilities, has the
authority and responsibilty to provide direction to the overall quality system effort. The
MR must ensure that a quality system is established, implemented and maintained, and
must report on the performance of the quality’ system to management during
management review and as a basis for quality system improvement, Qualification for this
position is based on education and experience, and would not require basic skis taining,
Executive Staff: The Staff, imespective of other responsibilities, must ensure that
{quality systems applicable to company and client requirements are met, and periodically
reviewed, with nonconformances identified and actions taken accordingly to ensure the
requirements of ISO 9001 are implemented and maintained. Qualification for this position
Js based on education and experience, and would not require basic skills training,
‘Management and Supervisory personnel: Managers and Supervisors, ltrespective
of other responsibities, have the authority and responsibilty for ensuring that quality
systems applicable to his/her operations are met, and periodically reviewed, with
rnonconformances identified and actions taken accordingly to ensure the requirements of
ISO 9001 and other quality system standards are implemented and maintained.
Qualification for these positions is based on education and experience, and would not
require basic skils training,
Technical and Administrative personnel: Technical and administrative personnel,
itrespective of other responsibilties, have the authority and responsiblity for ensuring that
ually systems applicable to hisMer operations are met, and periodically reviewed, with
rnonconformities identified and actions taken accordingly to ensure the requirements of
ISO 9001 and other quality system standards are implemented and maintained,
Qualification for these positions is based on education and experience, and would not
require basic skils training
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APPENDIX “B"
Quality System Organization
MARKETING ———-
ENGINGERING & ‘unuiry system
‘Aztek Solids Controls
settee « uncHASING CUALITY,
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APPENDIX “C”
Quality System Structure
Roguteners
ota,
‘Syston Mangement rocedues
| _ wma ano et tt
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APPENDIX “D”
Terminology
Capability - Capability iste total range of inherent variations ina stable process.
Controt Plans - Witton descriptions of the systems for contling pars and processes,
‘Thy are wtten to address the important chareclrsies and engireerng requremonts of
the product
Controlled Document - A document (form, procedure, manual or portion thereof) that is
current ae determined by the Document and Data Conral procedure (Procedure No. H1-
(80050) andor the Master List (Form No. H2-080080),
Corrective Action Plan A plan for correcting product or quay system problems
Cliont - Anyone who has purchased a product or service supplied by Ametek HDR Power
Systems,
Department Procedures - Procedures that apply to individual Departments or
workgroups and reference system level procedures,
Document Control - The function of implementing the system procedures that meet the
requirements of section 4.5, Document and Data Control, of ISO 9001
Environment - All ofthe process conditions surrounding or affecting the manufacture and
quality of a part or product.
Functional Verification - Testing to ensure the part conforms to all client and Ametek
HDR Power Systems engineering performance and material requirements,
Internal Requirements - Work responsibilities that are defined in specifications and
procedures for support and manufacturing departments of Ametek HDR Power Systems
Modification - Design changes made and documented by Ametek HOR Power Systems
to enhance performance andlor to facilitate repairs.
Nonconformance - Occurrence of product or material which does not conform to the
client requirements or specifications.
Nonconformity - An activity or process which does not conform to a quality system
requirement.
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Obsolete Document - Any controlled document that is not current as determined
‘Document and Data Control procedure (Procedure No. H1-090050) and/or the Master
List (Form No, H2-090050),
Procedure Manual - A collection of documented procedures that support the Quality
Policy Manual with detalied descriptions ofthe operations of support and manufacturing
departments.
Quality Audit -A systematic examination to determine whether functional activity results
comply with planned corporate objectives.
Quality Planning - A structured process for defining the methods that will be used in the
production of a specific product or family of products.
Quality Policy Manual - Documented overview of the Quality System that identifies the
philosophies and activities relevant to the support and manufacturing departments within
‘Ametek HDR Power Systems,
‘Systems Management Procedures - System level procedures that document
requirements that apply to the entire quality system and/or provide a point of reference
and structure for Department level procedures.
1SO Steering Committee Team - A cross-functional team that monitors the development
and implementation ofthe quality system and ensures that it continues to be effective.
Repair - Action taken on nonconforming product so that the product wil fulfl the intended
Usage although the product may not conform to the original requirements.
Rework - Action taken on nonconforming product so that it will meet the specified
requirements,
Sales Order (Pink Sheet) - intemal order entry and job order document used to
transiate client purchase requirements to HUK requirements for processing trom order
entry through invoicing,
‘Sub-Contractor - Depicts an approved company/supplier from which Ametek HOR
Power Systems purchases materials, parts or services for support of our manufacturing
functions,
Training - a) The process of leaming a job or operation with someone who is already
skilled or trained at that particular operation within Ametek HOR Power Systems, b)
‘Attending classes through the corporate training department, outside colleges, seminars,
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‘workshops, etc, to obtain or increase knowledge of a particular subject related to Ametek
HOR Power Systems.
Unit History Log (Discrepancy Log, “Red” Book) — A quality record that documents all
observations and actions for aach major system unit, @.9. power supplies, power
controllers, etc from the start of final assembly.
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