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HDR Quality Manual

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145 views50 pages

HDR Quality Manual

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bubbles82
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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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 42085 AMETEK’ 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, Page 2 of 49 HDR POWER SYSTEMS AMETEK’ QUALITY POLICY Revision: H Elective Date: 12172017 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 Page of 49 AMETEK’ QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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 Page 4 of 49 AMETEK’ QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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 Page S of 49 AMETEK’ Revision: H Effective Date: 12/1/2017 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 Page 6 of 49 QUALITY POLICY oe AMETEK’ QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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. Page 7 of 49 AMETEK’ QUALITY POLICY —HPELPOWEA SYSTEMS Revision: H Effective Date: 12/1/2017 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 Page 8 of 49 AMETEK QUALITY POLICY HOR POWER SYSTEMS Revision: H_ Effective Date: 12/1/2017 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, Page 9 of 49 AMETEK’ QUALITY POLICY Revision: H Effective Date: 12/1/2017 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 Page 10 of 49 AMETEK QUALITY POLICY HDR POWER SYSTEMS Revision: H1 Effective Date: 12/1/2017 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, Page 11 of 49 AMETEK’ QUALITY POLICY Lowen systems Revision: H Effective Date: 12/1/2017 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. Page 12 of 49 AMETEK’ QUALITY POLICY HDR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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, Page 13 of 49 AMETEK QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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 Page 14 of 49 AMETEK QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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 Page 18 of 49 AMETEK’ QUALITY POLICY (HDL SYST Revision: H Effective Date: 12/1/2017 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 Page 16 of 49 AMETEK’ Revision: H Effective Date: 12/1/2017 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. Page 17 of 9 AMETEK’ QUALITY POLIC —HppPowersysrems 00 Revision: H Effective Date: 12/1/2017 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. Page 18 of 49 AMETEK’ QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 ‘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 Page 19 of 49 HOR POWER, AMETEK QUALITY POLICY Hea eowen srerepe Revision: H Effective Date: 12/1/2017 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 Page 20 of 49 AMETEK’ QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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 Page 21 of 49 AMETEK’ QUALITY POLICY I TREC Revision: H Effective Date: 12/1/2017 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, Page 22 of 49 AMETEK’ (ER SYSTEMS. JUALITY POLICY Revision: H Effective Date: 12/1/2017 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 Page 23 of 49 AMETEK’ QUALITY POLICY a nes RRS HOR POWER: Revision: H Effective Date: 12/1/2017 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. Page 24 of 49 AMETEK’ QUALITY POLICY HDR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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. Page 25 of 49 AMETEK’ QUALITY POLICY HALOS SYST Revision: H Effective Date: 12/1/2017 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 Page 26 of 49 AMETEK’ QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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; Page 27 of 49 AMETEK’ QUALITY POLI —tpnpowensyereue Revision: H Effective Date: 12/1/2017 ©) 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 Page 28 of 49 AMETEK QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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, Page 29 of 49 AMETEK’ QUALITY POLICY Re ae HOR POWER SY‘ Revision: H Effective Date: 12/1/2017 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, Page 30 of 49 AMETEK’ QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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 Page 31 of 49 AMETEK’ QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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 Page 32 of 49 AMETEK’ QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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 Page 33 of 49 AMETEK’ QUALITY POLICY HOR POWER SYSTEMS. Revision: H Effective Date: 12/1/2017 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. Page 34 of 49 AMETEK’ QUALITY POLICY HDR POWER SYSTEMS HOR POWER SYSTE Revision: H Effective Date: 12/1/2017 ‘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 Page 35 of 49 AMETEK’ QUALITY POLICY oe HOR POWER, Revision: H Effective Date: 12/1/2017 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. Page 36 of 49 JUALITY POLICY AMETEK: STEM Revision: H Effective Date: 12/1/2017 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 Page 37 of 49 AMETEK’ QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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, Page 38 of 49 AMETEK’ QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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 Page 39 of 49 AMETEK’ QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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, Page 40 of 49 AMETEK’ QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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 Page 41 of 49 AMETEK’ QUALITY POLICY HOR POWER SYSTEMS, Revision: H Effective Date; 12/1/2017 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 Page 42 of 49 AMETEK’ QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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 Page 43 of 49 AMETEK’ QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 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 Page 44 of 49 AMETEK’ QUALITY POLICY HOR POWER SYSTEMS Revision: H Effective Date: 12/1/2017 APPENDIX “B" Quality System Organization MARKETING ———- ENGINGERING & ‘unuiry system ‘Aztek Solids Controls settee « uncHASING CUALITY, Page 48 of 49 AMETEK’ QUALITY POLICY HDR POWER SYSTEMS. Revision: H Effective Date: 12/1/2017 APPENDIX “C” Quality System Structure Roguteners ota, ‘Syston Mangement rocedues | _ wma ano et tt Page 46 of 49 AMETEK’ QUALITY POLICY a Revision: H Effective Date: 12/1/2017 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. Page 47 of 49 AMETEK’ QUALITY POLICY HOR POWER SYSTEMS, Revision: H Effective Date: 12/1/2017 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, Page 48 of 49 AMETEK’ QUALITY POLICY ee a a Revision: H Effective Date: 12/1/2017 ‘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. Page 49 of 49

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