EMC Laboratory Quality Manual - flexautomotive.net · reference: 200093 laboratory management...

LABORATORY MANAGEMENT SYSTEM MANUAL

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REFERENCE: 200093 LABORATORY MANAGEMENT SYSTEM MANUAL

FRONT PAGE

ISO/IEC 17025:2005

Laboratory Management System Manual

200093

Site/Location EMC Laboratory Technical & Marketing Facility Address 213 Harry Walker Parkway South

Newmarket, Ontario, L3Y 8T3 26525 American Drive Southfield, Michigan, 48034

Telephone (905) 952-1000 (248) 263-8700

MASTER COPY

http://intranet.invotronics.com/


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FRONT PAGE 1

INTRODUCTION 6

1.0 SCOPE 8

2.0 REFERENCES & CERTIFICATES OF REGISTRATION 8

3.0 TERMS AND DEFINITIONS 8

4.0 MANAGEMENT REQUIREMENTS 10

4.1 ORGANIZATION AND MANAGEMENT 10

4.1.1 LEGAL RESPONSIBILITY 10 4.1.2 LABORATORY RESPONSIBILITY 10 4.1.3 LABORATORY FACILITY 10 4.1.4 CONFLICT OF INTEREST POLICY 10 4.1.5 RESOURCES 10

4.1.5.1 Responsibility, authority and interrelationships 10 4.1.5.2 Laboratory Quality Manager 11 4.1.5.3 Laboratory Technical Manager 11 4.1.5.4 Personnel aware of the relevance and importance of their activities 12 4.1.5.5 Effectiveness of communication process within EMC lab 12

4.2 EMC LABORATORY QUALITY SYSTEM (ISOISO/IEC 17025 & TS16949) 12

4.2.1 DOCUMENTATION OF THE SYSTEM 12 4.2.2 EMC LABORATORY ISO/IEC 17025 QUALITY MANUAL 13 4.2.3 ISO/IEC 17025 QUALITY SYSTEM PROCEDURES 13 4.2.4 ISO-ISO/IEC 17025 QUALITY POLICY AND LABORATORY OBJECTIVES 13 4.2.5 MEETING CUSTOMER, STATUTORY, AND REGULATORY REQUIREMENTS 13

4.3 DOCUMENT CONTROL 15

4.3.1 GENERAL 15 4.3.2 DOCUMENT APPROVAL AND ISSUE 15

4.3.2.1 Maintaining and generating quality documents 15 4.3.2.2 Documents review, distribution, and retention 16 4.3.2.3 Documents uniquely identified 16

4.3.3 DOCUMENT CHANGES 16 4.3.3.1 Document revision change 16 4.3.3.2 Documents change/release approval 17 4.3.3.3 Amendment of documents by hand 17 4.3.3.4 Changes in computerized systems 17

4.4 REVIEW OF REQUESTS, TENDERS, AND CONTRACTS 17

4.4.1 CONTRACT - ORDER REVIEW 17 4.4.2 RECORDS OF REVIEWS 18 4.4.3 SUBCONTRACTED WORK REVIEW 18 4.4.4 DEVIATION FROM THE CONTRACT 18 4.4.5 CONTRACT AMENDMENTS 18

4.5 SUBCONTRACTING OF TESTS 18

4.5.1 SUBCONTRACTOR COMPETENCY 18

4.5.2 SUBCONTRACTED WORK ARRANGEMENT 18 4.5.3 SUBCONTRACTED WORK RESPONSIBILITY 18 4.5.4 APPROVED SUBCONTRACTORS LIST 18


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4.6 PURCHASING SERVICES AND SUPPLIES 19

4.6.1 PURCHASING OF SERVICES AND SUPPLIES PROCEDURE 19 4.6.2 SERVICES AND SUPPLIES COMPLIANCE RECORDS 19 4.6.3 PURCHASING DOCUMENTS 19 4.6.4 SUPPLIERS EVALUATION 19

4.7 SERVICE TO THE CLIENT 19

4.8 COMPLAINTS 20

4.9 CONTROL OF NONCONFORMING TESTING WORK 20

4.9.1 NONCONFORMING WORK INVESTIGATION 20 4.9.2 NONCONFORMING WORK CONCESSION 21 4.9.3 NONCONFORMING WORK IDENTIFICATION 21 4.9.4 NONCONFORMING WORK ROOT CAUSE 21

4.9.4.1 Corrective Action for Equipment 21 4.9.4.2 Corrective Action for test software applications 22

4.9.5 REPORT OF NONCONFORMITY 22

4.10 IMPROVEMENT 22

4.10.1 GENERAL 22

4.11 CORRECTIVE ACTION 22

4.11.1 GENERAL 22 4.11.2 CAUSE ANALYSIS 23 4.11.3 SELECTION AND IMPLEMENTATION OF CORRECTIVE ACTIONS 23 4.11.4 MONITORING OF CORRECTIVE ACTIONS 23 4.11.5 ADDITIONAL AUDITS 23

4.12 PREVENTIVE ACTION 23

4.12.1 Sources of non-conformances 23 4.12.2 Preventive Actions Procedures 23

4.13 CONTROL OF RECORDS 24

4.13.1 GENERAL 24 4.13.1.1 Quality records procedures 24 4.13.1.2 Records retention 24 4.13.1.3 Records security 24 4.13.1.4 Records back-up 24

4.13.2 TECHNICAL RECORDS 24

4.13.2.1 History records 24 4.13.2.2 Records per task 24 4.13.2.3 Records change history 24

4.14 INTERNAL AUDITS 25

4.14.2 CORRECTIVE ACTIONS DRIVEN BY INTERNAL AUDITS 25 4.14.3 INTERNAL AUDIT RECORDS 26

4.15 MANAGEMENT REVIEW 26

4.15.1 LABORATORY'S QUALITY SYSTEM REVIEW 26

5.0 TECHNICAL REQUIREMENTS 27


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5.1 TECHNICAL REQUIREMENTS - GENERAL 27

5.1.1 CORRECTNESS AND RELIABILITY OF THE TESTS FACTORS 27 5.1.2 DEVELOPING TEST METHODS AND PROCEDURES BASED ON RELIABILITY FACTORS 27

5.2 PERSONNEL 27

5.2.1 COMPETENCY 27 5.2.2 TRAINING 27 5.2.3 CONTRACTORS 28 5.2.4 JOB DESCRIPTIONS 28 5.2.5 PERSONNEL RECORDS 28

5.3 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS 28

5.3.1 LABORATORY FACILITIES FOR TESTING 28 5.3.2 ENVIRONMENTAL CONDITIONS 28 5.3.3 LABORATORY LAYOUT 29 5.3.4 TEST AREA ACCESS CONTROL 29 5.3.5 HOUSEKEEPING 29

5.4 TEST METHODS AND METHOD VALIDATION 30

5.4.1 GENERAL 30 5.4.2 SELECTION OF METHODS 30 5.4.3 LABORATORY-DEVELOPED METHODS 30 5.4.4 NON-STANDARD METHODS 31 5.4.5 VALIDATION OF METHODS 31

5.4.5.1 Correlation of test methods 31 5.4.5.2 Test method records 31

5.4.6 UNCERTAINTY OF RESULTS 31 5.4.6.1 Uncertainty of calibration 31 5.4.6.2 Uncertainty of measurement 31 5.4.6.3 Uncertainty components 32

5.4.7 CONTROL OF DATA 33 5.4.7.1 Data verification 33 5.4.7.2 Data transmission and storage 33

5.5 EQUIPMENT 34

5.5.1 EQUIPMENT INVENTORY 34 5.5.2 EQUIPMENT SELECTION 34 5.5.3 EQUIPMENT OPERATORS 34 5.5.4 EQUIPMENT ITEM UNIQUELY IDENTIFIED 34 5.5.5 EQUIPMENT RECORDS 34 5.5.6 EQUIPMENT SAFE HANDLING, TRANSPORT AND STORAGE 34 5.5.7 OUT OF SERVICE EQUIPMENT 35 5.5.8 EQUIPMENT LABELING 35 5.5.9 RETURNED EQUIPMENT VERIFICATION 35 5.5.10 INTERMEDIATE EQUIPMENT CHECK-UP 35 5.5.11 TEST SOFTWARE UPDATES 35 5.5.12 HW/SW SAFEGUARD 35

5.6 MEASUREMENT TRACEABILITY 35

5.6.1 GENERAL 35 5.6.2 SPECIFIC REQUIREMENTS 36

5.6.2.1.1 External calibration services 36 5.6.2.1.2 External calibration certificates 36


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5.6.2.2 Testing 36 5.6.2.2.1 Uncertainty of measurement evaluation 36 5.6.2.2.2 Traceability of measurements 36

5.6.3 REFERENCE STANDARDS AND REFERENCE MATERIALS 36 5.6.3.1 Reference standards 36 5.6.3.2 Reference materials 36 5.6.3.3 Intermediate checks 36 5.6.3.4 Transport and storage 37

5.7 SAMPLING 37

5.7.1 THE NUMBER OF SAMPLES TO BE TESTED 37 5.7.2 SAMPLING DEVIATIONS 37 5.7.3 SAMPLING RECORDS 37

5.8 HANDLING OF TEST ITEMS 38

5.8.1 TRANSPORTATION, RECEIPT, HANDLING, PROTECTION, STORAGE, RETENTION PROCEDURES 38 5.8.2 DUT LABELING 38 5.8.3 DUT AND EXERCISER HW/SW VERIFICATION 38 5.8.4 TEST ITEMS STORAGE AND HANDLING 38

5.9 ASSURING THE QUALITY OF TEST RESULTS 39

5.9.1 MONITORING AND REVIEWING TEST RESULTS 39 5.9.2 QUALITY CONTROL DATA ANALYSIS 39

5.10 REPORTING THE RESULTS 39

5.10.1 GENERAL 39 5.10.2 EMC TEST REPORTS 40 5.10.3 TEST REPORTS DATA 41

5.10.3.1 Test reports resolution 41 5.10.3.2 Test samples info 41

5.10.4 CALIBRATION CERTIFICATES 41 5.10.4.1 Test equipment calibration certificates data 41 5.10.4.2 Test equipment calibration statement of compliance 42 5.10.4.3 Equipment repaired during calibration process 42 5.10.4.4 Test equipment calibration time interval 42

5.10.5 TEST RESULT OPINIONS AND INTERPRETATIONS 42 5.10.6 TESTING OBTAINED FROM SUBCONTRACTORS 42 5.10.7 ELECTRONIC TRANSMISSION OF RESULTS 42 5.10.8 FORMAT OF REPORTS 42 5.10.9 AMENDMENTS TO TEST REPORTS 42

6.0 A2LA ADVERTISING POLICY 43

7.0 A2LA TRACEABILITY POLICY 43

8.0 A2LA PROFICIENCY TESTING REQUIREMENTS 43

9.0 ABBREVIATIONS TABLE 44

ANNEX A - EMC LABORATORY MANAGEMENT WITHIN PARENT ORGANIZATION STRUCTURE 45

ANNEX B - LABORATORY QUALITY MANAGEMENT SYSTEM POLICY 46

ANNEX C - REFERENCED DOCUMENTS 47

QUALITY MANUAL REVISION HISTORY: 49


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INTRODUCTION

Corporate History Invotronics Manufacturing was established in 1988 as a result of the consolidation of Invotronics Research and Development, Modu-tronics and Invotek, Anatron. Invotronics Manufacturing was previously owned 100% by Atoma a division of Magna International. Invotronics Manufacturing moved to its present location in 1989. Invotronics Manufacturing was acquired by C-MAC Industries on September 5, 2000. The company then changed its name to C-MAC Invotronics. On December 5, 2001 C-MAC Invotronics was acquired by Solectron and changed its name to C-MAC Invotronics dba Solectron Invotronics. Solectron was a supplier of electronic and electro-mechanical products to the OEM automotive industry, and the consumer electronics industry. Starting with October 2007 the entire Solectron organization was acquired by Flextronics and our laboratory name changed to Flex Automotive EMC Laboratory. In July 2010 Flextronics Automotive Inc was re-located from Scarborough to Newmarket Ontario. Flextronics Automotive Inc recognizes its responsibility as provider of quality services. To this end, Flextronics Automotive Inc has developed and documented a quality management system to better satisfy the needs of its customers and to improve management of all departments, including the EMC Laboratory. The quality system complies with the international standards.


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***

EMC LABORATORY

DOCUMENT STRUCTURE

QUALITY TECHNICAL

EMC LAB DATABASE JOB#

CAPABILITY 705304

DC 1DC-11225

DC-111224 LP-388C-XX

GM

GMW31003

GMW3097

GMW3172

FORD ES-XW7T-1A278-AC

CISPR-25

ISO-10605

ISO-1145 (1,2,3,4)

ISO-6100-4-2

ISO-7637 (1,2,3)

SAE-J1113/22 MIL-STDE-416E

INTERNAL

INTERNATIONAL

OEM

ISO-17025

TS-16949

EQUIPMENT

DUT SPECS

TEST

PLAN

Policy Statement

Internal Audits

Document Control

Records

Nonconformance

LP-388C-XX

REPORTS

Organizational Chart

Management Reviews

Corrective Action

Preventive Action

Training

Procedures

Purchase Order

Appraisals

MAINTENANCE

TEST#

APPROVAL

RESULTS LOG

SCHEDULER

EXERCISER

OEM SETUP

CALIBRATION

STORAGE

BACKUP

ADM011

ADM114

Continual Improvement

Professional Practice

ISO/TS16949 Compliant

ISO/IEC 17025 Certified

QMS050

QLT735

QMS090

ADM035

ADM035

ADM906/ ADM140

ADM105

Customer Focus

MAT007

ADM160

LMS002 Test Request

LMS001 C.O.I.

LMS004 Test Plan

LMS005 Test Setup

LMS006 Handling

LMS007 Equipment

LMS008 SW Control

201709 Competency

721178 Supplies

900712 Labels

http://intranet.invotronics.com/e-ecn/emclab/portal/oem/gm/specs/GMW3103.pdf



http://intranet.invotronics.com/e-ecn/emclab/portal/oem/fd/specs/ES-XW7T-1A278-AC.pdf


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1.0 Scope

This Laboratory Management Manual describes the quality assurance program used to perform activities within laboratory's scope of accreditation per ISO/IEC 17025 as well as complying with Flextronics Automotive Inc ISO/TS16949 Quality System. Flextronics Automotive Inc recognizes its responsibility as provider of quality services. To this end, Flex Automotive has developed and documented a quality management system to better satisfy the needs of its customers and to improve management of the company. EMC Test Laboratory ISO/IEC 17025 Quality Manual, together with a set of quality related procedures, creates the documentary base for the effective lab activity. This manual assures laboratory's compliance to ISO/IEC 17025 and establishes the duties and responsibilities of the personnel. In addition, this manual is utilized for the purpose of informing our customers of the laboratory's scope, and what specific controls are implemented to assure service quality. 2.0 References & Certificates of Registration

ISO/IEC 17025, ISO/TS16949. See also Abbreviations.

3.0 Terms and Definitions

Laboratory Quality Management System: The operations or processes of the laboratory which define its policies and objectives and the manner in which they are implemented to ensure that the objectives are met.


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Quality: The ability of the qualitative analytic identification and quantitative (accuracy, precision) data to satisfy the requirements of their purpose. QA Management: The part of the laboratory management system that focuses on the quality of the data generated by the laboratory. Quality Assurance: Documented procedures in place within an EMC laboratory that define how the laboratory’s work is to be conducted so as to be confident that the obtained data are of the required quality. QA consists of quality control and quality assessment activities:

Quality Control: The practices and procedures that lead to the achievement of quality analytical data (suitable facilities, staff competence and training, good laboratory practices, standard operating and reporting procedures). Quality Assessment: The practices and the data generated by them that illustrate that the QC activities have been effectuated and that the data generated are of the quality required (inter-laboratory comparisons, control charts, auditing, and statistical analyses).

Internal Client: in this manual refers to testing performed for Flextronics products/projects. External Client: in this manual refers to testing contracted by third party companies for their products/projects. OEM: in this manual refers to original automotive car makers. Item: an all-inclusive term used in place of any of the following: assembly, component, equipment, material, module, part, structure, system, unit, software or results. Uncertainty: is a measure of the precision of an instrument or test method. As a good rule of thumb, the uncertainty of a measuring device is 20% of the least count. Whenever reported, the uncertainty of the measurement should be given with the actual measurement, for example, 41.64 ± 0.02 dBuV." FlexAutomotive EMC Laboratory does not report the measurements uncertainty for compliance to OEM test methods and/or international standards. Flextronics maintains records of equipment calibration from accredited laboratories that reports the uncertainty of their data as contributors to a test method uncertainty budget.


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4.0 Management Requirements

4.1 Organization and Management

4.1.1 Legal responsibility

Flextronics Automotive Inc as part of Flextronics Corporation holds legal responsibility for its FlexAutomotive EMC and Electrical Test Laboratory operation. The laboratory is organized to operate in a permanent facility in accordance with the requirements of ISO/IEC 17025, and to satisfy the needs of automotive electronics OEMs, the regulatory authorities, or organizations providing recognition (A2LA, AEMCLRP).

4.1.2 Laboratory responsibility

The EMC laboratory carries out its testing activities to meet the requirements of ISO/IEC 17025 and to satisfy the needs of the client, the regulatory authorities or organizations providing recognition.

4.1.3 Laboratory facility

EMC laboratory is part of Flextronics Automotive Inc, a supplier of products to the OEM automotive electronics industry. The FlexAutomotive EMC Laboratory Management System is designed to cover work carried out in the laboratory's permanent facility. 4.1.4 Conflict of interest policy

Our services provider policy ensures that no potential conflict of interest (LMS001) amongst EMC lab personnel will affect their work quality.

LMS001 EMC LAB, CONFLICT OF INTERESTS POLICY

For deputies key managerial personnel see Annex-A in this manual.

4.1.5 Resources

EMC lab personnel is free from any undue internal and external commercial, financial and other pressures and influences that may adversely affect the quality of their work. 4.1.5.1 Responsibility, authority and interrelationships Laboratory's policies and procedures ensure the protection of its clients' confidential information and proprietary rights, including procedures for protecting the electronic storage and transmission of results. Customer proprietary documentation (manuals, schematics, test results) is subject to the confidentiality restrictions prohibiting unauthorized copying and disclosure to other parties as outlined in confidentiality agreement 201497 between Flextronics and internal/external clients. 201497 CONFIDENTIALITY AGREEMENT The management avoids lab personnel involvement in any activities that would diminish confidence in its competence and minimize chances of success before starting achieving a task. All decisions are made based on impartiality, fairness, correct judgment, and operational integrity. The EMC LAB ORGANIZATION CHART (see Annex A) shows its place in Flextronics parent organization, and the relationships between quality management, technical operations and support services.


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All employees must complete and obtain the certificate for the annual ethics training made available online by Flextronics University. All employees must acknowledge Flextronics Code of Conduct corporate document made available by document control over the intranet website. MAT010 SOURCING OF SUPPLIERS, CONTRACTORS OR SUB-CONTRACTORS PROCEDURE 4.1.5.2 Laboratory Quality Manager The quality manager responsibility:

Establish, review and improve the documented system of the Lab.

Effectively implement Quality Management System and ISOISO/IEC 17025 compliance.

Determine resource needs and obtain sanction for effective Management of the Lab Operation.

Identify opportunities for continual improvement and take effective corrective and preventive action.

Maintain operational integrity of lab operations to assure confidence in test results and report to top Management regarding performance of Lab Quality Management system.

Participates in meetings to assure a strong customer relationship: o test requisition process o contract review o internal client test requisition o external client test requisition o services proposal for external clients o complaints - examines all documents and records associated with complaints, coordinates root-

cause analysis, corrective actions, and customer follow up

Assure the quality of testing through: o Establishment and implementation of Quality Policy, Quality objectives and QMS. o Continuous professional development of self and subordinates, formulating goals with respect to

the education, training and skills of the lab's personnel. o Analyses data and records for identifying nonconforming work. o Initiate internal audits and investigates adverse audit findings. o Encourage participating in inter-laboratory comparison for proficiency testing to enhance

competencies of the lab's operation. o Participate in Management Reviews and report to top management about the effectiveness of the

Quality Management system of the Lab. o Providing adequate support in ordering required lab equipment. o Monitoring the performance of subordinates and proactively supports them in meeting the quality

objectives. o Maintaining the Quality Manual

QMS090 MANAGEMENT REVIEW PROCEDURE ADM160 PERFORMANCE APPRAISALS PROCEDURE ADM910 BUILDING AND INFORMATION SECURITY 201696 TEST PROPOSAL 201692 CUSTOMER COMPLAINT FORM 4.1.5.3 Laboratory Technical Manager The technical manager responsibility:

Controls technical operations and the provision of the resources needed to ensure the required quality of laboratory operations, being involved in hiring and staffing, managing and measuring work

Follows the evolution of OEM and international standards for automotive electronic compliance testing


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Establishes and maintains a cooperative working relationship with customers and associated company staff solving test issues and failures

Uses leadership, integrity, responsibility in promoting team work environment

Performs data analysis, reviews, technical reports following the testing

Coordinates the EMC lab relationship with internal engineering teams

Customer focused, action oriented, and evaluates priorities

Prepares budget requests and manages approved budget

Participates in planning, scheduling, preparing and presenting staff safety and technical training

Prepares requests for proposals and specifications for purchases of major items

Approves contractors work for EMC lab maintenance services

Participates in meetings to assure a strong customer relationship: o test requisition process o contract review o internal client test requisition o external client test requisition o services proposal for external clients o complaints (customer feedback) o investigates root causes of the problems and originates corrective actions reports

4.1.5.4 Personnel aware of the relevance and importance of their activities The entire lab personnel (deputy managers and technicians) are aware about their particular place and function within the EMC lab and how they can contribute to the achievement of the objectives of the management system. Their activity is directly tied to the effectiveness of communications through laboratory management, performance evaluations of laboratory personnel and management reviews shown in this manual. 4.1.5.5 Effectiveness of communication process within EMC lab Effective communication within EMC lab occurs through the use of written memos, telephone, Outlook email messages or oral discussions. The results of periodic management reviews are communicated to laboratory personnel to prevent system breakdowns resulting from a lack of effective communication amongst laboratory personnel (see section 4.15). 4.2 EMC Laboratory Quality System (ISO/IEC 17025 & ISO/TS 16949)

4.2.1 Documentation of the System

EMC laboratory ISO/IEC 17025 quality system is fully integrated into company's ISO/TS16949 quality management system where possible. In order to avoid overlapping many of the requirements in ISO/IEC 17025 are referring procedures, forms and work instructions, which are part of ISO/TS16949 process. The additional requirements for ISO/IEC 17025 have been documented where needed. The relationship to the TS16949 system is illustrated on the "EMC Laboratory Document Structure" visual map. This visual map is posted for Lab personnel in order for them to understand the entire system. The visual map will be controlled with this ISO/IEC 17025 Quality Manual. The specific ISO/IEC 17025 (and ISO/TS 16949) documents (policy - manual, procedures, flowcharts, work instruction) are controlled via the Document Control procedure (a master list can be filtered for ISO/IEC 17025). Specific documents will be referenced in the appropriate sections of this manual. The EMC lab quality management is responsible for providing a documented ISO/IEC 17025 quality system and ensuring that all staff familiarize themselves and comply with the policies and procedures established in the manual and associated documentation.


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QMS070 QUALITY MANAGEMENT SYSTEM PROCEDURE 4.2.2 EMC Laboratory ISO/IEC 17025 Quality Manual

The EMC lab ISO/IEC 17025 Quality Manual is a statement of individual policies that defines the quality system, and together with associated documents (including procedures) and records serve as the quality plan for the laboratory. The EMC lab quality manager approves modifications, or updates, and reviews annually the manual prior to the accreditation cycle. The overall EMC lab objectives are established and reviewed during management review. QMS090 MANAGEMENT REVIEW PROCEDURE All laboratory employees involved in testing are expected to read, understand and abide by the spirit of this quality manual in completing their job responsibilities. They are expected to read, understand, and abide by the spirit of customer specific test requirements. 4.2.3 ISO/IEC 17025 Quality System Procedures

ISO/IEC 17025 Quality System Procedures are documented to establish and maintain continuity of each activity or function affecting quality. Quality procedures are available to personnel for reference and implementation via Document Control Department (see section 4.3). The quality document structure contains this Quality Manual, Quality Procedures, Work Instructions, and Quality Records.

QMS070 QUALITY MANAGEMENT SYSTEM PROCEDURE 721111 HOW TO WRITE A DOCUMENT (PROCEDURE, WORK INSTRUCTION OR FORM)

Flextronics top management provides evidence of commitment to the development and implementation of the management system and continually improving its effectiveness.

QMS090 MANAGEMENT REVIEW PROCEDURE 4.2.4 ISO/IEC 17025 Quality Policy and Laboratory Objectives

The overall Flextronics Quality Policy is defined in Annex B - Laboratory Quality Management System Policy The EMC Laboratory objectives follow the principles of the policy. The objectives are established, monitored, and improved using Flextronics Corporate Performance Appraisals, Goals Settings. 4.2.5 Meeting customer, statutory, and regulatory requirements

The lab management maintains the overall integrity of the management system when major changes are made to the organizational structure, reporting structure or management staff of a laboratory. All changes and updates are documented through the TS document control system. They ensures that changes made to one laboratory policy or protocol, have corresponding changes been made to other areas of the document control system that are affected such that contradictions and conflicts do not exist within the system. The laboratory personnel are appropriately informed of changes that affect them. The management laboratory seeks, maintains records, and analyzes feedback from lab's clients. This feedback is solicited in a general way, related to the general performance of the laboratory, and is not restricted to report content/presentation or other narrow/limited areas of focus. The customer feedback is periodically on management's reviews agenda.


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The importance of meeting customer as well as all applicable statutory and regulatory requirements for both product and services is communicated to the organization by Flextronics Automotive Inc top management. QMS080 RESPONSIBILITY, AUTHORITY AND COMMUNICATION PROCEDURE


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4.3 Document Control

4.3.1 General

EMC Laboratory quality and technical documentation is released, maintained, approved, and integrated in Flextronics Automotive Inc QMS using: QMS010 CONTROL OF DOCUMENTED PROCEDURE ADM105 ESTABLISHING & REVISING PROCEDURES LMS007 EQUIPMENT CONTROL PROCEDURE 4.3.2 Document approval and issue

4.3.2.1 Maintaining and generating quality documents The EMC Laboratory controls, maintains, and generates specific procedures and forms part of its quality system via company's Document Control Department. Any document release or revision change has to be approved through an electronic ECN (Engineering Change Notice) procedure.

QMS010 CONTROL OF DOCUMENTED PROCEDURE FlexAutomotive Document Control Department maintains:

Regulations

Standards

other normative documents

OEM o test methods o specifications o manuals o requirements

internal o drawings o software o instructions o manuals o work Instructions o master lists

Supplier o quality manuals o software o instructions

In order to avoid using invalid and/or obsolete documents, a company-wide procedures master list (199001) identifying the current revision status and distribution of documents in the quality system is available via Document Control Website. ADM114 DOCUMENT CONTROL PROCEDURE 199001 PROCEDURES MASTER LIST 199016 EQUIPMENT MANUALS HARD COPY FORMAT MASTER LIST

http://intranet.invotronics.com/


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4.3.2.2 Documents review, distribution, and retention EMC laboratory follows ADM114 for review, distribution, and retention of documents. Authorized editions of appropriate quality and technical documents are available at all locations where operations essential to the effective functioning of the laboratory are performed. Prior to each testing session, the EMC lab personnel always checks for the latest quality related documents at FlexAutomotive Document Control Intranet Website. The latest OEM EMC documents can be obtained from Document Control. Other technical documents like equipment manuals, software manuals, A2LA documents can be located through EMC Lab Data Base Index. A summary of EMC documents and records is listed in 201757. EMC lab technical documentation list is included in 199001 PROCEDURES MASTER LIST. The EMC Lab Quality Manager will set up a cadenced meeting with lab personnel to review all documentation, and where necessary revise, to ensure continuing suitability and compliance with applicable requirements. Minutes of the meeting will contain a list of documents reviewed, the date and status pertaining to obsolescence. Technical documentation is under EMC lab personnel review whenever necessary following OEM, IEEE, SAE meetings and EMC specs distributors email notifications.

LMS012 EMC LAB, TECHNICAL TRAINING PROCEDURE LMS012 lists the methods used to make aware the EMC lab personnel of new developments in this area. EMC Lab personnel will ensure that all obsolete hard copy technical documents in the testing area are suitably marked with an obsolete stamp. Binders holding obsolete documents are marked as obsolete using the obsolete label per 900712 EMC LAB LABELS. Soft copies of obsolete technical documents will be renamed by document control to “OBS_original_spec_name” and wherever possible have a watermark placed on the document; they will be stored in folders named obsolete in a read only status. EMC lab personnel back-ups old revisions of EMC specifications as per ADM011. ADM011 ARCHIVING AND RECORD RETENTION 4.3.2.3 Documents uniquely identified All FlexAutomotive quality documents must be released via Document Control Department and they are indexed by document number, revision, release date, and the ECN number used for approval.

ADM114 DOCUMENT CONTROL PROCEDURE 4.3.3 Document changes

4.3.3.1 Document revision change

The EMC lab personnel are authorized to create new documents or request existent documents revision change via ECN process. After creating/modifying the document, the originator creates in the database a new ECN type IV and fills-in all required background info into ECN application. This ECN# is reviewed and approved by the upper management. The role of Document Control Department is to issue, to monitor, and upon ECN# approval to release the new/modified document.

ADM105 ESTABLISHING & REVISING PROCEDURES


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4.3.3.2 Documents change/release approval

Records with document's text subject to changes in a next revision must be clearly documented in Engineering Change Notice (ECN) database before release approval. The actual document highlights the changes whenever is possible. Previous revisions of the same document are kept safe as soft copy for history reference.

EMC lab specific test plans for R&D or customer returns are created and stored in EMC lab database.

Technical EMC/Electrical test plans for internal/external DV/PV testing jobs are released using OEM provided soft-copy templates. No amendments made by hand are allowed to such EMC/Electrical test plans. Discrepancies found by the EMC lab personnel while testing OEM approved EMC test plans must be immediately communicated to the test plan author to whether temporarily stop or continue testing. Corrections to OEM approved EMC/Electrical test plans are done in a new version forwarded electronically to OEM for approval.

For equipment manuals, customer test procedures, or international standards only amendments distributed by their author as addendum to the original document are valid. If discrepancies are found the OEM or organization releasing the document must be informed for further clarification.

4.3.3.3 Amendment of documents by hand

Amendments by hand to controlled documents are not allowed in the EMC laboratory. Changes must be documented using the Engineering change Notification process.

4.3.3.4 Changes in computerized systems FlexAutomotive Laboratory Management System Documents are maintained using computerized systems as shown in 4.3.3.1. & 4.3.3.2. IT department has scheduled nightly backups for all files servers in Flextronics network system. EMC lab local critical files on data acquisition systems are saved daily on shared network and weekly on CDs. ADM925 NETWORK DATA PROTECTION 4.4 Review of Requests, Tenders, and Contracts

Reviewing contracts and orders is an integral part of FlexAutomotive Quality System. 4.4.1 Contract - order review

All EMC test contracts/orders are reviewed and accepted only if the requirements are clear and understood, and the lab has the capability and capacity to assure full customer expectations.

The personnel will verify if laboratory has the capability and resources to meet the requirements.

The EMC lab personnel analyze and clarify deviations from methods approved by OEM specs. Such deviations requested in the customer's quote will be accepted only if they are approved in the EMC Test Plan by OEM.

The originator of EMC test plan will use whenever applicable the latest version of OEM's templates per our lab capability.

The EMC test plan includes tests requested in DUT's technical spec correlated with the latest OEM EMC approved methods applicable per DUT category.

Test methods requested in an approved EMC test plan and listed in older OEM EMC specs are acceptable.

Any differences between the request or tender and the contract must be resolved before any testing commences.

Each contract should be acceptable both to the laboratory and the client.

FlexAutomotive forwards to the client a proposal with an estimated funding necessary for OEM spec EMC testing. The proposal includes all resources that must be provided by customer prior to starting the test.


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LMS002 EMC LAB, TEST REQUEST PROCEDURE 201695 EXTERNAL TEST REQUEST FORM 201696 INTERNAL TEST REQUEST FORM 4.4.2 Records of reviews

EMC lab personnel maintain and track all review changes related to each internal/external-contracted work (job#). Communications are maintained with the internal/external client from request/quote through commencement of work. 4.4.3 Subcontracted work review

The subcontracted testing that affects EMC laboratory activity must meet all the OEM (scope of accreditation) and be ISO/IEC 17025 accredited. 4.4.4 Deviation from the contract

The Quality Manager informs the client of any deviation from the initial contract. Equipment technical problems might result in testing end-date delays. If an alternate OEM approved method is available for a particular test the customer is informed about this option. The time/cost initially estimated for a certain test may be insufficient due to extra-time spent to threshold errors in long DUT activation cycles. The client is allowed to change/cancel the initial scheduled starting date without being charged if the notice is provided 2 weeks in advance. 4.4.5 Contract amendments

If a contract needs to be amended after testing has commenced, the same contract review process will be repeated and any amendments communicated to all affected personnel. LMS002 EMC LAB, TEST REQUEST PROCEDURE 4.5 Subcontracting of tests

4.5.1 Subcontractor competency

In situations where FlexAutomotive EMC lab workload or temporary capacity may affect the contracted testing time frame, the management informs and gets client's approval for using a competent subcontractor. A competent subcontractor is a laboratory that is approved via AEMCLAP for the OEM EMC testing in question. 4.5.2 Subcontracted work arrangement

The EMC laboratory management informs the client of subcontracted work arrangements concerning its test request and waits for client's approval. 4.5.3 Subcontracted work responsibility

Flextronics Automotive Inc EMC Laboratory is responsible to the client for the subcontractor's work, except in the case where the client or a regulatory authority specifies which subcontractor is to be used.

4.5.4 Approved subcontractors list

Flextronics Automotive Inc EMC Laboratory maintains a register of all subcontractors that it uses for tests or calibrations and a record of the evidence of compliance with ISO/IEC 17025 for the work in question.


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201706 EMC LAB APPROVED SUBCONTRACTORS LIST

4.6 Purchasing services and supplies

The subcontractors, which conduct test or calibration services, must meet all the OEM (scope of accreditation) and be ISO/IEC 17025 accredited. 201706 EMC LAB APPROVED SUBCONTRACTORS LIST 4.6.1 Purchasing of services and supplies procedure

The technician uses QMS procedures to purchase services and supplies affecting the quality of testing:

MAT007 PURCHASE ORDER PROCEDURE MAT010 SOURCING OF SUPPLIERS, CONTRACTORS OR SUB-CONTRACTORS

PROCEDURE

EMC related consumables are verified and labeled before being placed in EMC storage area (900712).

4.6.2 Services and supplies compliance records

The laboratory personnel ensure that purchased supplies and consumable materials (automotive fuses, batteries, banana plugs and jacks, cables, connectors, electrical tape, copper tape, noise suppressors, relays, EMC chamber cleaners, and exerciser build related materials) affecting the quality of tests are not used until they have been inspected or otherwise verified as complying with standard specifications or requirements defined in the OEM methods for the tests. The EMC lab personnel keep copies of purchase orders, supplies manufacturer technical data sheets, and supplier package sleeps in EMC lab dedicated storage areas.

721178 EMC LAB SUPPLIES AND CONSUMABLE COMPLIANCE RECORDS

The purchase of calibration services is controlled by Calibration Section.

4.6.3 Purchasing documents

EMC lab personnel obtain quality and technical documentation via Document Control Department, which handles the purchasing of all recordable documentation. These purchased documents are reviewed by EMC lab specialists and approved by technical management for technical content prior to release.

4.6.4 Suppliers evaluation

The laboratory personnel evaluate, and maintain records and lists of approved suppliers:

See approved subcontractors/suppliers list

Records - calibration reports/certificates

Supplies and services which affect the quality of testing and calibration,

All EMC & Electrical test equipment supplier is selected based on EMC OEM specs compliance requirements.

201724 CALIBRATION SUPPLIER EVALUATION FORM 201728 EMC LAB, APPROVED CALIBRATION SUPPLIERS LIST 721179 EMC LAB TEST REPORTS DATABASE

4.7 Service to the client

As necessary, the EMC laboratory works with the client to clarify test requests, DUT operation and test results. The client is provided controlled access to the laboratory to observe the testing process of the DUT.


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To ensure confidentiality, information and devices under the test of other clients are not visible during a client visit to the laboratory.

The laboratory communicates with the client at any time prior to, during and after the EMC testing as needed to address any questions, changes and test results.

The laboratory forwards to the client the test report (summary, details, and conclusions for each test) no latter than 4 days after finishing the last item called in the test plan.

The laboratory conducts client survey (201693) to obtain feedback for its overall service. As appropriate, client feedback will be reviewed by the quality manager and used to improve the quality system through corrective and preventive actions.

201693 CUSTOMER SATISFACTION SURVEY

4.8 Complaints

The handling of all complaints received follows the overall company established complaint and corrective action procedures. Any form of customer complaint, internal complaint, or EMC lab employee complaint is logged into EMC lab issue tracker, together with investigations and corrective actions taken, by the laboratory to close the issue.

ADM035 CORRECTIVE ACTION IMPLEMENTATION ADM039 CONFORMANCE TO CUSTOMER'S COMPLAINT RESOLUTION 201692 CUSTOMER COMPLAINT FORM 4.9 Control of Nonconforming Testing Work

Flextronics Automotive Inc EMC lab has established and maintains a policy and procedures that are implemented when any aspect of testing process do not conform to its own procedures, OEM specs, or the agreed requirements of the client. 719241 NONCONFORMING WORK FLOWCHART 201697 NONCONFORMING WORK REPORT 4.9.1 Nonconforming work investigation

The nonconformance of the work may be due to shipping damage, operator error, equipment malfunction or any other parameter that jeopardizes the integrity of the test result. It may also be due to any previously undiscovered change in the measurement facility, system or method. In a scenario where nonconforming work (719241) is not detected until after forwarding the test report, the customer will be notified by the Technical Manager or Quality Manager about laboratory specific nonconformities. The laboratory representative and the customer will determine an appropriate action to take regarding the delivered test report. The decision will be documented on the Report of Nonconformity. All reports of nonconformity are tracked with a Nonconforming Work Log. The Log will track Report of Nonconformity identification numbers, assignment due dates, outcomes and close-out dates.

Nonconforming Laboratory Work Disposition:

Use As Is – The customer’s approval must be obtained to use nonconforming laboratory work.

Rework – The Report of Nonconformity is used to record the re-inspection of rework.

Scrap – The Report of Nonconformity is marked “scrap”

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Delays to the initial scheduled reporting date for a test method or entire validation are logged as “nonconforming work” except the following scenarios:

The customer asks extensive testing for a certain test method beyond the initial agreement.

The excessive number of DUT’s “deviations” lead to an extended test time well above the initial estimation of time required per test method.

The DUT’s exerciser SW/HW fails to perform as expected

The customer is informed periodically about the status of the testing and whenever assistance is required to clarify the pass/fail criteria for DUT functions evaluation. The customer is informed in advance if EMC laboratory’s dependant delays in providing its services are expected. 4.9.2 Nonconforming work concession

Nonconforming work is isolated and identified with a Report of Nonconformity generated by Quality Manager or designee for laboratory specific nonconformities. EMC lab personnel ensure that nonconforming work is identified and managed, to prevent unintended use of test results. Non-conforming problems are corrected, where applicable, and subject to verification after correction to demonstrate conformity. In the case of determination that the nonconformity does not adversely affect quality, nonconforming laboratory work may be released under concession. Where required by the contract, the proposed rectification of non-conforming work is reported for concession to the customer. These concessions must be documented on the Report of Nonconformity. 4.9.3 Nonconforming work identification

Identification of nonconforming work or problems with the quality system or with testing activities can occur at various points within the quality system, and technical operations such as:

customer complaints

quality control

instrument calibration

checking of consumable materials

staff observations or supervision

test report and calibration certificate checking

management reviews

internal or external audits

4.9.4 Nonconforming work root cause

Where the testing process evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of EMC lab operations with its own policies and procedures, the corrective actions listed below shall be followed to identify the root cause(s) of the problem and to eliminate this (these) cause(s). Root cause is the assignable source of variation that affects all the individual values of the process output/phenomenon being studied. Root cause is the reason for the primary nonconformance, which has induced other failures and for which effective permanent corrective action can be implemented. 4.9.4.1 Corrective Action for Equipment

Assess the problem

Attempt to correct the problem in-house following manufacturer’s trouble shooting guide

If in-house trouble shooting cannot correct the problem, call the equipment vendor or contracted maintenance vendor for service

Service as per vendor instruction or wait for service personnel

Label equipment as “out-of-service”

Sign purchase/invoice order form if needed


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Call client if needed

When service is completed, validate the equipment by quality control and calibration

Return the equipment for use

Log action in ECN database or equipment log register 4.9.4.2 Corrective Action for test software applications

Assess the problem

Attempt to correct the problem

Call the vendor or contracted maintenance vendor for service

Call client if needed

Up-date and validate software

LMS008 EMC LAB SOFTWARE CONTROL PROCESS

4.9.5 Report of Nonconformity

Each time nonconforming laboratory work is detected, the following information will be included on the Report of Nonconformity:

Name of the area where the nonconforming testing was detected

Purchase order number, job number, report number, DUT number

Name of the person generating the Report of Nonconformity

Date the Report of Nonconformity is generated

Description of the Nonconforming testing

Reason for the rejection of test result / report

Corrective action taken, by whom and by what date

Corrective Action Report number, if applicable 4.10 Improvement

The overall effectiveness of the ISO/IEC 17025 management system (EMC lab) is continually improved using the:

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive action Via the Management Review procedure, see 4.15. 4.10.1 General

The EMC laboratory personnel initiate corrective action when nonconforming work or departures from the policies and procedures in the quality system or technical operations have been identified. The technical and/or lab quality manager will be involved in this process as indicated in procedure ADM035. 4.11 Corrective Action

4.11.1 General

EMC Laboratory follows Flex Automotive QMS process to implement corrective actions.


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4.11.2 Cause analysis

The procedure for corrective action starts with an investigation to determine the root cause of the problem.

4.11.3 Selection and implementation of corrective actions

ADM035 CORRECTIVE ACTION IMPLEMENTATION The corrective action is initiated using company’s on-line Corrective Action tool (web application “e-CAR”) or using 201333 for internal or external audit corrective actions (see 4.14.2). After the root cause is determined appropriate corrective action(s) are taken to eliminate the problem and to prevent recurrence. The type of corrective action(s) implemented is appropriate to the magnitude and risk of the problem. All the results, and changes, are documented using the forms with the specified procedures above. 4.11.4 Monitoring of corrective actions

The laboratory quality manager monitors the implementation and the outcome of corrective actions to evaluate and report their efficiency. 4.11.5 Additional audits

The Corrective Action Implementation Procedure will require corrective action verification (audit the area). However it may be necessary to increase the internal audit frequency as indicated in the audit procedure, see 4.14 below. 4.12 Preventive action

4.12.1 Sources of non-conformances The EMC lab Technical Manager monitors all potential nonconformities related to:

OEM test method

OEM acceptance criteria

EMC laboratory test reports

Internal/external audit reports

preventive actions

documented quality management system Action plans are developed, implemented and monitored for assuring control on labs operation. Preventive action is part of corrective action process (a continuation or separate action). ADM035 CORRECTIVE ACTION IMPLEMENTATION 4.12.2 Preventive Actions Procedures

Some examples of ongoing preventive actions include:

The preventive action process is described in ADM035 Corrective Action Implementation. Company’s Corrective Action on-line tool includes provisions for Preventive Action.

The EMC lab testing process scheduler is synchronized with the equipment due date calibration time to avoid resources shortage.

EMC chambers are periodically inspected for performance and their maintenance is carried as per plan.

Preventive action is also identified on analysis of data of testing, trends of test results, and proficiency testing results.


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4.13 Control of records

4.13.1 General

4.13.1.1 Quality records procedures

EMC laboratory follows TS & Document Control Department rules for creating/changing quality records:

ADM011 ARCHIVING AND RECORD RETENTION 201757 LMS RECORDS MATRIX FORM 4.13.1.2 Records retention

Quality System Records retention period follows Document Control Department instructions or as specified in the document, example of such records include; EMC test results (database), Equipment Calibration, Subcontractor and Suppliers packing slip, and Proficiency Test Results.

4.13.1.3 Records security

Controlled copies of quality and technical documents are held secure and in confidence by Document Control Department. Key strategic proprietary documentation and records are available based on management approval for distribution via an intranet document request application.

4.13.1.4 Records back-up

The EMC laboratory database is backed up daily. Data acquisition files generated by TILE, EMTEST, EMSCAN, and other EMC test specific applications are saved on Network.

The files and database test reports stored on company's network shared folders is accessible only for EMC lab employees and whenever applicable saved with limited user rights and password protected.

ADM925 NETWORK DATA PROTECTION

Test information stored on work-stations used for equipment control configurations, raw data acquisition, plots, or any test related proprietary files format are transferred to Network drive via USB drives as new data is collected by lab personnel.

201757 LMS RECORDS MATRIX FORM

4.13.2 Technical records

4.13.2.1 History records

Data stored in EMC database application is currently available from validations performed since 1998 with full details about each performed test. The application can search, filter, and report history data via various queries and report formats to track the operator, test results, specifications, and equipment used per test number.

See 4.13.1.4 Records back-up

4.13.2.2 Records per task

EMC test observations hand notes made by technicians, and additional data calculations not retained automatically by the monitoring software in its dedicated log files, are recorded daily in EMC database application under the Job# and Test# Test Procedure and Test Result sections. A reference to the EMC test plan# section# are added for a better context definition. Files created by EMC test data acquisition and monitoring software are stored on both local and shared network drives in an OEM test method title folder, job# subfolder, test# subfolder, section# subfolder. All test plan results identifies the technician who completed all testing and the sampling.

4.13.2.3 Records change history FlexAutomotive Laboratory Management System Documents are maintained using computerized systems as shown in 4.3.3.1. EMC Laboratory test related records are maintained via EMC database core application. Each

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test method is report is indexed under a unique “test-id” with write protection set after resolution. Modifications to already reported statements to a test method report must be done in a copy of that record under a new test-id, the reason for change being stated in comments section. When mistakes are detected in EMC lab hard-copies of documented records, each mistake is crossed out, not erased, made illegible, and the correct value entered alongside. All such alterations to records must be signed or initialed by the person making the correction. In a similar manner, changes to records stored electronically must be done by the use of strikethrough fonts and must be signed-off. An additional revision change tables summarize these document modifications where possible / or needed. Changes to approved EMC test plans must be validated by the OEM specialist. Changes to an external client test plan must be controlled by their EMC product engineer. By design the EMC database will save and synchronize every 15 minutes the shared file(s) in 2 workstations and a network file server to minimize loosing stored data and to make possible an immediate data recovery. The IT department performs a daily tape backup as shown in ADM925. 4.14 Internal audits

4.14.1 The EMC laboratory shall adhere to the QMS Manual internal quality audit program and its associated procedure(s) for laboratory management system audits. The term LMS will be substituted for QMS in applicable procedures. LMS internal audits are to be carried out in planned intervals in order to: a) Determine whether or not the laboratory management system:

1) Conforms to the planned arrangements for laboratory management including the requirements of the ISO/IEC 17025 standard; all technical specifications / requirements based on the accreditation scope and any additional customer requirements.

2) Has been properly implemented and maintained; and 3) Is effective in meeting laboratory management system policy and objectives;

b) Review the results of previous audits and applicable corrective actions; c) Provide audit results to management for review; and d) Identify opportunities for continual improvement as applicable. The EMC laboratory audit program, including any schedule, shall be based on the results of risk assessments of the organization’s activities, the results of previous audits or through management request. The laboratory Quality Manager shall have responsibility for planning and organizing internal audits. Whenever possible, audits shall be conducted by internal personnel independent of those having direct responsibility for the activity being examined.

QMS110 Internal Audit Procedure 201703 LMS Internal Audit Schedule Form

4.14.2 Corrective actions driven by internal audits

Internal audit findings that lead to non-conformances (discrepancies) with the laboratory management system requirements shall be subject to timely corrective action using form 201333. Should the non-conformance cast doubt on or bring into question the validity of any testing results the LMS Control of Non-Conforming Test Work (Section 4.9 of this manual) process shall be initiated.

201333 Corrective Action Request (CAR) Non-conformance (NC) Report Form


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4.14.3 Internal audit records

Results of internal audit findings and any corrective actions generated by them shall be documented and reported to appropriate management as required by the QMS Manual. Records of audits and applicable audit non-conformance corrective actions shall be maintained for a period of at least three (3) years. Records shall be maintained by the QMS Audit Manager and the laboratory Quality and Technical Managers.

4.15 Management review

4.15.1 Laboratory's quality system review

In conjunction with the QMS Management Review process laboratory management shall schedule and conduct a review of the Laboratory Management System with the Management Review Team. The LMS management review shall be conducted on a minimum annual basis. Additional LMS reviews may be conducted separately based upon changing circumstances and/ or business needs. The comprehensive review shall take account of the following:

the suitability of policies and procedures

reports from laboratory management and supervision

the outcome of recent internal audits

corrective and preventive actions

assessment by external bodies

the result of inter-laboratory comparisons and or proficiency testing requirements

changes in the volumes and types of the work

client/ customer feedback

internal or external complaints

recommendations for and or status of planned improvements

other relevant factors such as quality control activities, resource and employees training, budgets to verify adequate resources

status / establishment of laboratory objectives and targets.

Synopsis of changing circumstances including: o Changes in legislation and or customer requirements o New activities, products or services and their aspects o New information about strategies such as new scientific/ technological process or data.

Results of management review are captured in an actionable form and serve as inputs into the laboratory’s planning system and include appropriate action plans. Findings from management review and the actions that arise from them shall be carried out within an agreed upon time frame. Records of management reviews shall be circulated to the Management Review Team. Records of management review shall be maintained for a minimum of 3 years. QMS090 QMS MANAGEMENT REVIEW PROCEDURE


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5.0 Technical Requirements

5.1 Technical Requirements - General

5.1.1 Correctness and reliability of the tests factors

EMC lab management monitors and controls factors that can determine the correctness and reliability of the EMC testing:

human factors (5.2)

accommodation and environmental conditions (5.3)

test methods and method validation (5.4)

equipment (5.5, link not correct, go to 5.4)

measurement traceability (5.6)

sampling (5.7)

handling of test and calibration items (5.8)

5.1.2 Developing test methods and procedures based on reliability factors

The extent to which the factors contribute to the total uncertainty of measurement differs considerably between types of tests. The EMC lab takes into account these factors in developing test methods and procedures, in the training and qualification of personnel, and in the selection and calibration of the equipment it uses (See 5.4.6).

5.2 Personnel

Laboratory personnel are selected for employment based on professional qualifications, including education, training, skills, and relevant experience. Staffing is sufficient to maintain the timely processing of the client workload, laboratory internal monitoring and quality control. 5.2.1 Competency

FlexAutomotive management ensures the competency of all who operate specific equipment, perform tests, evaluate results, and sign test reports. The testing jobs assignment is done based on the "EMC COMPETENCY MATRIX" (includes test method and equipment competency cross referring). The lab personnel job descriptions

201705 EMC LAB COMPETENCY MATRIX 201721 LAB PERSONNEL JOB DESCRIPTIONS

The EMC lab Technical Manager or its deputy maintains the EMC LAB COMPETENCY MATRIX applicable for technical personnel including the date of competency confirmation. The matrix is readily available being reviewed and up-dated as required. This authorizes the personnel to perform particular types of tests, to issue test reports, to give opinions and interpretations and to operate particular types of equipment.

5.2.2 Training

To maintain or improve the quality of the work to the present and anticipated tasks of the laboratory, it is essential that EMC lab personnel follow training or refresher courses from time to time. These may concern technical, quality system, and any new safety regulations. Such training can be given within FlexAutomotive or abroad, by outside specialists (equipment suppliers, accreditation organizations), or corporate conducted courses. The management evaluates and records the effectiveness of training action (form 201358) to determine the effectiveness of individual training actions that are taken for laboratory personnel in relation to the goals set during annual employee evaluation established for them. In addition, the EMC lab maintain records of evaluation of proficiency testing results, internal audits and external assessments, and actual performance evaluations of personnel relating to their defined responsibilities and as approved by the evaluator as means of attesting to the effectiveness of the training.


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201358 TRAINING EVALUATION FORM LMS012 EMC LAB, TECHNICAL TRAINING QMS100 RESOURCE MANAGEMENT PROCEDURE ADM140 ORIENTATION PROCEDURE ADM148 RECRUITMENT PROCEDURE ADM160 PERFORMANCE APPRAISALS ADM906 TRAINING ADMINISTRATION PROCEDURE 5.2.3 Contractors

The EMC laboratory senior personnel are in charge to train new employees working under contract. The management ensures that such personnel are supervised and competent and that they work in accordance with the laboratory's ISO/IEC 17025 quality system. 201591 CONTRACTOR SERVICE REQUEST FORM 5.2.4 Job descriptions

The lab maintains current job descriptions for all personal ranging from management to entry level technicians. 201721 LAB PERSONNEL JOB DESCRIPTIONS 5.2.5 Personnel records

EMC laboratory full time or contractors personnel educational, professional qualifications, training records, skills and experience are held by Human Resources Department.

5.3 Accommodation and environmental conditions

QLT842 ESD PROCEDURE ADM910 BUILDING AND INFORMATION SECURITY 5.3.1 Laboratory facilities for testing

The technical requirements for accommodation and environmental conditions at Flextronics Automotive Inc EMC lab site are following the OEM instructions for temperature and humidity for EMC & Electrical testing. The OEM requirements are translated to the “EMC test plans” (see 5.4.1).

LMS004 EMC LAB, TEST PLAN DEVELOPMENT

Work undertaken at sites other than our permanent laboratory facility is not part of our current scope of testing. If a customer suggests external testing (with a specification), the entire ISO/IEC 17025 quality management system will be reviewed and an application for test scope additions will be made.

The energy sources, lighting, heating and air conditioning system are controlled by Flextronics Maintenance Department.

5.3.2 Environmental conditions

The EMC laboratory personnel monitor, control and record environmental conditions (24/7 recorded temperature & humidity charts) as required by automotive electronics OEM specifications. The testing area must be free of unacceptable electromagnetic disturbances, radiation, temperature, sound, humidity, and vibration levels that might alter the result of testing process. Testing must be stopped when the environmental conditions jeopardize the results of the tests. Furthermore, the nature of ECM testing requires an initial ambient noise per frequency verification to be conducted for proceeding with a specific set of tests. The environmental conditions (temperature


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and humidity) that can affect the results of EMC testing are documented in each test report. Temperature and humidity charts data is stored per 201757 LMS Master Records Matrix.

5.3.3 Laboratory layout

The EMC lab is placed in a building's section with its own entrance and temperature control system, which is divided in the following work areas:

EMC chambers area (temperature control)

ESD & Transients Test room (humidity and temperature control)

Electrical tests room

Storage area

5.3.4 Test Area Access Control

The visitor access (customer or non EMC lab employee) is controlled by electronic security card access. Whenever it is possible, the EMC Test Technician and Technical Manager will be informed of a visitor prior to their arrival. Activities not related to the testing process are not allowed in this lab.

5.3.5 Housekeeping

EMC lab applies 5S program (Sorting - Systematic Organization - Shine - Standardize - Sustain). The 5S good housekeeping program is one of the lab’s quality objectives (see sections 4.2.1 and 4.14.1 above). Therefore the lab technicians are required to maintain all areas clean and tidy. Sufficient space and lighting will be provided for the test activities. The lab personnel are responsible to maintain healthy working conditions, to monitor the safety of the working area, and to implement any required corrective action. Internal audits will monitor status for:

pathways are unobstructed to the exit

first aid kit

fire extinguisher

fire alarm pull station

eye wash station

emergency equipment in view and accessible

lab benches and hoods as uncluttered as possible

overloading of shelves with infrequently used equipment and extra lab supplies

recycle paper and cardboard station

waste disposal

unused or spare equipment stored in a designated storage room QLT735 QMS INTERNAL AUDITS 201562 5S WORKPLACE AUDIT CHECKLIST


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5.4 Test methods and method validation

5.4.1 General

The OEM test methods listed in our A2LA accreditation scope are owned and validated by the OEM and only correlated via artifacts testing with OEM's EMC laboratories. Our laboratory performs OEM EMC testing in order to validate OEM end-user products. A design or product validation EMC test plan is created by the DUT supplier using an OEM's owned test plan template, test selection grid, and specifications. The EMC test plan creation process is done by DUT's supplier through a person knowledgeable of both OEM EMC/EMI specifications and product's HW/SW functions.

The EMC test plans indicate all the necessary requirements and criteria pertaining to; OEM (customer) requirements, standards to be using, preparation, set-up, environmental conditions, sampling, equipment used, tolerances (uncertainty), connections, handling (if required), and recording methods.

The operation, verification and handling of relevant EMC test equipment are done following the procedures documented by their manufacturer. All equipment related instructions and manuals are available as hard copy or soft copy in EMC lab's library via Document Control network shared folders.

LMS007 EMC LAB EQUIPMENT CONTROL PROCEDURE

Deviations from standard EMC OEM test methods listed in our EMC LAB CAPABILITY (705304) are not accepted to prove product compliance unless they are documented in the EMC test plan and approved by an OEM specialist

LMS004 EMC TEST PLAN DEVELOPMENT

The EMC test plans, OEM test specifications, and national or international standards are controlled as outlined in section 4.4 of this manual.

5.4.2 Selection of methods

The selection of test methods (EMC test plan) is based on the OEM specifications, which call out proven national or internal standard test methods. The test plan must follow within the ISO/IEC 17025 scope of test (accreditation). If the lab has the capability to run an alternate method accepted by OEM instead of the method called in the test plan, the client is informed about this option.

All EMC and Electrical test methods for GMOEM customers are described in EMC LAB CAPABILITY (705304). The same on-line document points the user to all required specifications (latest available revisions). A printable PDF version of the document is also available.

Upon client's request, the laboratory's specialists can provide EMC test plan assistance for a correct test method selection based on OEM specs per category of product.

The laboratory informs the client when a method proposed by the client in a draft test plan is considered to be inappropriate or out of date.

705304 EMC LAB CAPABILITY

5.4.3 Laboratory-developed methods

EMC laboratory-developed methods (used only for equipment verification) are documented and verified for consistency before being applied. An example would be the method used to measure correction factors for power meter in immunity testing, which is required yearly for directional couplers returned from calibration. Such tasks are recorded into EMC lab logbook over intranet website.

LMS005 EMC LAB TEST SETUP VERIFICATION PROGRAM

http://intranet.invotronics.com/e-ecn/emclab/portal/invotronics/scheduler


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The planning and monitoring of activities that pertain to internal verification test methods is done via EMC Laboratory database.

721179 EMC LAB DATABASE

5.4.4 Non-standard methods

For internal/external requests to use non-standard methods following an agreement between EMC lab and the client, a clear specification of the client's requirements, and the purpose of the test, the method developed must be validated appropriately before use. The Technical Manager will approve such methods and the test result report title reflects clearly "R&D" or "Engineering Development" objective of the test method (not accredited to ISO/IEC 17025 or A2LA AEMCLRP).

5.4.5 Validation of methods

5.4.5.1 Correlation of test methods

The EMC test methods used in FlexAutomotive are correlated with methods validated by OEM at their sites. The correlation process is based on testing artifacts provided by OEM end evaluating the results as outlined in AEMCLRP and ISO/IEC 17025 requirements.

5.4.5.2 Test method records

The EMC laboratory provides testing services for non-standard methods developed by the customer as long as all the details are clearly documented in the test request or the test plan. The results from non-standard test methods validation are recorded together with the procedure utilized and any other relevant information. The record states whether the method or procedure is fit for the intended use.

5.4.6 Uncertainty of Results

5.4.6.1 Uncertainty of calibration Flextronics Automotive Inc EMC lab only engages in testing service (no calibration). Equipment is calibrated through a process controlled by FlexAutomotive Calibration Department. The certified calibration lab includes in equipment's certificate the uncertainty of calibration results, calculated and documented in accordance with the requirements of ISO/IEC 17025. FlexAutomotive EMC lab engages only in “verifications” of test equipment (e.g. EMTEST transient-generator, HP transient limiter used for CE). Such “verifications” are done by EMC lab technicians following manufacturer’s product manual as procedure. A “calibration” sticker is applied on the equipment for reference after performing this “equipment verification”. 200031 CALIBRATION LABORATORY SCOPE

TEN205 CALIBRATION PROCEDURE 5.4.6.2 Uncertainty of measurement

Measurement uncertainty is defined by the OEM requirements (specifies limits to the values of the major sources of uncertainty of measurement) and referenced international approved standards. Therefore, measurement uncertainty analysis is simple are review of the specific equipment (via the OEM / recognized standard) to the equipment used by the lab (stated uncertainty on the external calibration ISO/IEC 17025 certificate).

Other uncertainty validations are based on knowledge of the performance of the method and on the measurement scope, and makes use of previous experience and validation data (see section 5.9).

http://www.a2la.net/documents/webindex.cfm


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Our EMC lab uses certified labs for equipment calibration and the uncertainty of measurement is attached to the certificate. Test equipment HW/SW measurement uncertainty is calculated by their manufacturer and verified by external accredited labs. Our lab does not use any form of reference materials. 5.4.6.3 Uncertainty components The result of a measurement only approximates to the true value of the measurand and is only complete when it carries a statement of the uncertainty of that approximation:

the test method usually includes set-up factors that affect the measurement

the test equipment is itself complex and includes several separate but interconnected components

the quantities involved may be electromagnetic fields, varying in space, and may be transient or continuous

Each test method approved by OEM or an international standard (ISO, CISPR) has its own uncertainty components table.

Conducted Emissions Radiated Emissions

Receiver reading Receiver reading

LISN-receiver attenuation Cable loss

LISN voltage division factor Receiver sinewave accuracy

Receiver sinewave accuracy Receiver pulse amplitude

Receiver pulse amplitude Receiver pulse repetition rate

Receiver pulse repetition rate Noise floor proximity

Noise floor proximity Antenna factor calibration

Frequency step error Antenna directivity

LISN impedance Antenna factor height dependence

Mismatch Antenna phase centre variation

Measurement system repeatability Antenna factor freq interpolation

Combined standard uncertainty Cross polarization and balance

Measurement distance variation

Site imperfections

Frequency step error


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Mismatch

Measurement system repeatability

Combined standard uncertainty

5.4.7 Control of data

5.4.7.1 Data verification

Formal Test reports (example PV/DV full validation) are verified and signed-off by the Laboratory Manager for customer release.

5.4.7.2 Data transmission and storage

Most of test methods performed in the EMC lab involve computers and automated equipment for acquisition, process, record, report, and store or retrieve test data (tables and plots).

LMS008 EMC LAB SOFTWARE CONTROL PROCESS

EMC lab develops only software for DUT exercisers and test reporting software. The EMC LAB TEST REPORTS DATABASE (721179) covers the following areas:

test data entry & storage with automated backup

test reports (summary & detailed) per job# in PDF format

test plan template

equipment list

equipment per test

equipment calibration

test scheduler

specifications per test

electronic approval process

The application is shared over the restricted password-protected network to maintain customer confidentiality. The user instructions are available via help file and online tips.

The test reports are released to the customer as PDF files. A test report includes a summary per group of tests (job#), detailed reports per test#, data plots, data tables, and pictures showing the test setup per method.

The Laboratory Manager authorizes each formal test report-id included in the full report before data is released to the customer.

The exchange of data (reports and plots) between customer and Flex Automotive EMC Laboratory is done via:

Password protected downloadable FTP folders

CD/DVD

Email

Hard copy binders

The preferred file type used for electronic data submissions (reports and plots) is PDF. If requested by customer, the file format and/or the type of protection used (password/encryption) shall be used.


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5.5 Equipment 5.5.1 Equipment inventory

The use of rented equipment is allowed only to avoid test time frame disruptions while the required equipment is sent out for calibration. The rental of test equipment for EMC & Electrical testing is allowed only from companies that provides ISO/IEC 17025 calibration compliance and is controlled by Calibration Section. TEN205 CALIBRATION PROCEDURE 5.5.2 Equipment Selection

The selection of EMC & Electrical test equipment and software is based on OEM’s approved equipment type listed for each test method. Before placing equipment into service the technician must verify the calibration labels. Prior to the actual EMC test, the equipment is always verified following the OEM procedures (for example, spectrum analyzer and power meter for RI reverberation mode tuning, injection probe for BCI, EMI receiver/spectrum analyzer for CE and RE, and chamber noise ambient). 5.5.3 Equipment Operators

Key EMC test equipment is operated by authorized technicians as shown in the equipment training matrix. The EMC lab maintains and updates a library of manufacturer manuals, calibration and maintenance instructions. Software & firmware updates are applied whenever they made available by manufacturer and do not conflict with OEM specific requirements. 201709 EMC LAB TEST EQUIPMENT COMPETENCY MATRIX 5.5.4 Equipment item uniquely identified

Each item of test equipment part of a test setup used for EMC testing is uniquely identified by labels showing their Flex Automotive inventory number and if applicable their last calibration date. The monitoring, data acquisition, and support software installation and update packages are stored on CDs labeled by their manufacturer and maintained by the EMC lab personnel. LMS007 EMC LAB, EQUIPMENT CONTROL TEN205 CALIBRATION PROCEDURE MAT007 PURCHASE ORDER PROCEDURE 5.5.5 Equipment records

The EMC lab database application records each item of equipment and support software used per test type together with their calibrations interval, last calibration date and next calibration date. The calibration information in this application is correlated with the Calibration Section scheduler in order to avoid scheduling tests part of a job# that requires temporary unavailable equipment. Additional equipment records are kept in laboratory's library and covers equipment software manuals, manufacturer instructions, copies of reports and certificates of all calibrations, adjustments, acceptance criteria, maintenance plan, and any damage, malfunction, modification or repair to the equipment. 5.5.6 Equipment safe handling, transport and storage

The EMC lab follows the equipment manufacturer for handling, transport, storage, and periodic maintenance; additional procedures for effective implementation include:

LMS007 EMC LAB, EQUIPMENT CONTROL


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TEN205 CALIBRATION PROCEDURE 5.5.7 Out of service equipment

Equipment that has been subjected to overloading or mishandling, gives suspect results, or has been shown to be defective or outside specified limits, will be taken out of service, deposited in a storage area, and labeled accordingly to prevent its use. Such equipment will be isolated until it has been repaired and shown by calibration or test to perform correctly. The EMC laboratory technician logs this event in EMC lab issue tracker database providing comments if this equipment used in previous testing might affect the validity of the test result and institutes a control of non-conforming work procedure (see 4.9)

5.5.8 Equipment labeling

The Calibration Section maintains an inventory database with all test equipment in the company. All test equipment in EMC lab area carries an inventory label and a calibration status label (last & next calibration date).

5.5.9 Returned equipment verification

When, for whatever reason, equipment goes outside the direct control of the laboratory, the laboratory technician ensure that the function and calibration status of the equipment are checked and shown to be satisfactory before the equipment is returned to EMC testing service. Equipment verification is required before starting any EMC testing to tune-up the whole test setup.

5.5.10 Intermediate equipment check-up

Intermediate check-ups of the equipment calibration status are carried out as part of the test setup verification.

LMS005 EMCLAB TEST SETUP VERIFICATION PROGRAM 5.5.11 Test software updates

EMC lab personnel is enrolled in programs offered by EMC test software makers to obtain upgrades packages. Upgrades to a new software revision level are applied to EMC lab test equipment based on proven compliance with the OEM specs. Old application software revision levels and their configuration folders are saved for further comparison and traceability of the testing performed. Whenever applicable, parameters of the equipment returned from calibration are updated into test software. Upgrades to existent software revision level or new software package installs are logged into EMC Laboratory Database.

LMS008 EMC LAB SOFTWARE CONTROL PROCEDURE LMS005 EMCLAB TEST SETUP VERIFICATION PROGRAM

5.5.12 HW/SW safeguard

EMC lab test equipment, including both hardware and software, are protected against unintentional configuration changes which would invalidate the test results. The access to the desktops and laptops is password protected and all test setup configurations are subjected to minimum daily back-up. Labels and warnings signs placed on EMC test equipment is meant also to protect visitors from reaching areas and devices that might affect their safety. 5.6 Measurement traceability

5.6.1 General

Equipment used for EMC tests (including equipment for measuring environmental conditions) that significantly can affect the measurement integrity of tests conducted by the EMC laboratory is monitored for their calibration status as part of the measurement control program. The equipment is verified before use to ensure the recall or removal from service of any equipment that are unreliable or that have exceeded the calibration interval if established.


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The personnel performs and records equipment or test setup verification before running the test as specified in OEM specs (chamber ambient, monitoring equipment sensitivity, output powers) The laboratory performs on site chambers maintenance and performance assessments using internal & external certified personnel. 5.6.2 Specific requirements

5.6.2.1.1 External calibration services FlexAutomotive EMC does not provide calibration services. The EMC test equipment is calibrated at accredited laboratories selected by Calibration Department, which maintains a calibration database scheduler for all Flextronics test equipment inventory. The external calibration laboratory selection is based on demonstrated competence, measurement capability and traceability. 5.6.2.1.2 External calibration certificates Whenever applicable, the calibration certificates issued by these laboratories contain the measurement results, including the measurement uncertainty and/or a statement of compliance with an identified international specification. These certificates are stored by Calibration Department and are made available upon request. The calibration certificate for a certain equipment item is traceable based on its Flextronics inventory# and calibration# (last/next date) label. 5.6.2.2 Testing 5.6.2.2.1 Uncertainty of measurement evaluation The EMC laboratory ensures that the equipment used can provide the uncertainty of measurement requirements mentioned in OEM EMC specifications and international standards. 5.6.2.2.2 Traceability of measurements Where traceability of measurements to SI units is not possible and/or not relevant, the EMC lab consider requirements for traceability like certified reference materials, agreed methods and/or consensus standards. 5.6.3 Reference standards and reference materials

5.6.3.1 Reference standards No references standards are handled by Flex Automotive EMC lab personnel and laboratory scope does not include calibration. 5.6.3.2 Reference materials No references materials are handled by FlexAutomotive EMC lab personnel. 5.6.3.3 Intermediate checks No reference materials are used in our EMC laboratory.


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5.6.3.4 Transport and storage No reference standards and reference materials are handled in Flextronics Automotive Inc EMC Laboratory. 5.7 Sampling

5.7.1 The Number of samples to be tested

FlexAutomotive EMC lab does not decide or follows internal procedures in determining the number of samples. The sampling required for a test method is decided by OEM as the owner of the test method. The minimum number of samples depends on the nature of testing (EMC or Electrical) and the type of validation (Design or Production). The EMC Test plan defines the minimum number of DUTs, the dwell time used to activate the DUT’s functions, and DUT’s operating modes per test method. Other sampling related info is provided by OEM (e.g. steps per frequency band, sweep time per step, RF power) as part of the test method process to properly classify DUT’s EMI/EMC and Electrical compliance with specifications. The company/person using FlexAutomotive EMC lab services will have to supply the sampling plan and the required samples, which can be more than the minimum required by OEM, as agreed upon. The client verifies OEM specs to determine and specify in the test plan (721180):

the minimum number of samples per DUT activation mode and EMC test method

allowance to use groups of samples per groups of tests for simultaneously testing

the order of the testing The rules of the thumb are:

it takes one sample to fail a test and all samples to have a pass

It takes a deviation in one sample to classify the module's response or status. The statistical control is a condition describing a process from which special causes of variation have been eliminated. In order to monitor and control the consistency in test results the OEM EMC department maintains a sampling plan procedure based on appropriate statistical methods and automotive electronics requirements. The sampling process addresses the factors to be controlled to ensure the validity of the test and calibration results. Based on the results of testing, proficiency testing feedback and analysis of tests results the sampling plan is modified if need arises. 5.7.2 Sampling deviations

The following scenarios are promptly recorded in EMC database, communicated to the appropriate customer's contact person, and mentioned in the final EMC test report:

changes to order of the tests

changes to the required number of samples per DUT activation mode and EMC test method

damaged samples and whenever applicable their replacement identifier

5.7.3 Sampling records

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uncertainty. The test artifact is the constant, featuring a repeatable output which should be measured within a narrow range of values by the EMC lab. The AEMCLRP is an example of such verification based on artifacts. The number of test samples is clearly defined in the EMC test plan, which typically follows in the requirements defined by OEM manuals. 5.8 Handling of test items

5.8.1 Transportation, receipt, handling, protection, storage, retention procedures

The EMC laboratory follows client's EMC Test Plan instructions and QMS procedures for the transportation, receipt, handling, protection, storage, retention, and disposal of test items, in order to protect the integrity of the test item, and to protect the interests of the laboratory and the client. LMS006 EMC LAB, HANDLING OF TEST ITEMS FLOWCHART QLT842 ELECTROSTATIC DISCHARGE (ESD) 5.8.2 DUT labeling

The DUT related information required before starting a validation is clearly stated in the proposal forwarded to client. Once the samples are received in EMC lab are labeled by EMC technicians as follows:

Test Job# (for external clients is practically the accepted proposal#)

Date (delivery date in EMC lab)

Customer (part supplier)

Customer P/N (preferable the OEM P/N)

Part Name (preferable the OEM version of part name)

Revision HW/SW

Return to customer (Y/N) (returned together with the resources received from part supplier)

Retention time (years) (applicable for internal projects; for external clients only upon request)

Sample Index (can be defined by client or EMC lab to identity each DUT# tested in a Job#) 900712 EMC LAB, LABELS 5.8.3 DUT and Exerciser HW/SW verification

Upon receipt of the test samples, exerciser, documentation, and support equipment required for a Job#, the EMC test technician in charge verifies and records abnormalities or departures from normal or specified conditions. When there is doubt as to the suitability of an item for test, or when an item does not conform to the description provided, or the exerciser's operation is not documented in sufficient detail, the technician consults the client's representative for further instructions. The exchange of information is recorded in Job# log file and the actual testing is not started before clarifying all the doubts. 5.8.4 Test items storage and handling

Each Job# has a dedicated "storage area#" for the period of time the validation takes place. All items are handled with care to avoid deterioration, loss or damage and the storage area has environmental controlled conditions. The EMC lab storage building is secured and the access to the storage area is controlled to protect client's confidentiality and integrity of its test items. If applicable, device under the test specific handling instructions shall be provided in the EMC test request. 201695 EMC LAB EXTERNAL TEST REQUEST 201696 EMC LAB INTERNAL TEST REQUEST


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5.9 Assuring the quality of test results

5.9.1 Monitoring and Reviewing Test Results

The EMC laboratory uses ISO/IEC 17025 and FlexAutomotive quality control procedures to monitor and maintain the OEM test compliance. The EMC test results data is recorded in such a way that trends are detectable and, where practicable, statistical data is applied for reviewing the equipment performance that can affect the test result.

self assessment and proficiency-testing for direct correlation with OEM labs following OEM proposed scheduler or artifacts testing

regular use of OEM or international standards, certified reference materials (SI units of measurement), and internal quality control using secondary reference materials

yearly replication of tests using the same or alternate methods on samples with known test results

yearly validations retesting current production items (retest new samples using the same test method)

yearly verifications retesting retained items after a period of time (retest the same samples using the same test method)

correlation of test results for different characteristics of an item (test sample) during each validation LMS005 EMC LAB, TEST SETUP VERIFICATION PROGRAM 721186 EMC LAB, TRENDS AND STATISTICS 721187 WORK INSTRUCTION EMC LAB, QUALITY CONTROL DATA

721179 EMC LAB, TEST REPORTS DATABASE The quality of the data presented in each report per test method including the attached plots is analyzed for compliance to OEM specifications criteria before submittal to the customer. Incorrect or incomplete statements or raw data are logged into 721179 issue manager and a planned action is taken to correct the problem. 5.9.2 Quality Control Data Analysis

The objective evidence required to demonstrate ISO/IEC 17025 5.9.2 clause is accomplished through quality control data analysis based on pre-defined criteria followed by planned action in case of out-of-control data. The pre-defined criteria and each criteria’s pre-defined parameters for laboratory quality control data analysis is outlined in Annex-A of 721187. Whenever the control charts, diagrams, or visual analysis indicate out-of-control data that has associated planned action, the laboratory will initiate any correction applicable for non-conforming work per 4.9 of this manual using 719241 Nonconforming Work Flowchart. Subsequently the laboratory will initiate a corrective action ADM035 per section 4.11.1 of this manual. Quality control data analysis is also part of laboratory’s preventive action plan (see 4.12 this manual), used to avoid out-of-control data non-compliance to a pre-defined parameter specified and documented within laboratory’s management system.

721187 WORK INSTRUCTION EMC LAB, QUALITY CONTROL DATA 719241 NONCONFORMING WORK FLOWCHART ADM035 CORRECTIVE ACTION IMPLEMENTATION

5.10 Reporting the Results

5.10.1 General

The results of each test, or series of tests under a job# carried out by the EMC laboratory are reported accurately, clearly, unambiguously, and objectively, and in accordance with:


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a) General EMC / Electrical OEM test specifications requirements.

b) Customer Technical Specifications (CTS), specific to each product tested.

The results reported include all information required by the OEM test method and client's specific requirements detailed in its EMC test plan (721180).

If applicable, the report includes also deviation from the test method requested by the customer. Deviations from standard test methods are accepted by EMC lab based on prior recorded agreement with the OEM and product supplier or if is stated in an approved EMC test plan.

All data containing the test results will be stored and secured in EMC Laboratory Database.

The data will be readily accessible and available for customers in a secured manner for maintaining confidentiality. The data can be submitted via e-mail as a “PDF” file or / and upon request as printed or CD copy.

5.10.2 EMC Test reports

Each technician will use the EMC database application to:

store daily test notes per Job# and Test#

create templates for summary and detailed PDF or printable test reports

create EMC test plans whenever the OEM template is not applicable

maintain the EMC equipment list and calibration due date All other test data sheets, plots, and pictures under test job# is clearly identified and saved as PDF file. Each Job# test report includes the following information requested by OEM:

Title, product name and reason for testing

Test# (index created automatically by application)

EMC laboratory name and address

Job # printed on each page

Name and address of the client

Reference project#

Supplier (client) Product Part Number

OEM Part Number

Product Revision (hardware / software)

OEM test title for standard tests or client's test title for non-standard tests

OEM test type for standard tests

OEM EMC spec, or Customer Technical Specification per product

DUT# (sample index to be tested under job#)

Test start/end date

Environmental conditions (Temperature, Humidity)

Reason for testing per job# (validation type)

Objective per test# (pass/fail OEM criteria)

Equipment List (required equipment to be used per test# )

OEM procedure description per test# and DUT activation per test plan

Test results with detailed DUT behavior during the test

Test resolution pass/fail/deviation

Bus interface

Microprocessor type

Number of operating modes

Number of DUTs tested


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Number of scenario used

Number of sweeps

Sweep time

Test setup time

Setup verification time

Number of test points

Calculated overall time per test#

References and operator comments

Job# requested by

Technician/operator

full report author

release approved by

Print date 5.10.3 Test reports data

5.10.3.1 Test reports resolution

The EMC lab test report may produce provisions for test interpretation based on DUT's performance and response when tested for emissions and immunity. The interpretation purpose is to classify the DUT overall performance or DUT's individual functions against OEM EMC specifications. Such provisions for interpretations may include additional information:

deviations from, additions to, or exclusions from the test method

information on specific test conditions, such as environmental conditions

where relevant, a statement of compliance/non-compliance with requirements and/or specifications

where applicable, a statement on the estimated uncertainty of measurement The test resolution is clearly stated in the test report:

pass (the DUT performance meets or is above the OEM spec requirements)

deviations (that places the DUT overall performance or certain DUT's functions in a class or level below the expected one)

fails (the DUT is damaged or its performance is away below the expected requirements)

5.10.3.2 Test samples info

The sampling required for a test method is decided by OEM as the owner of the test method (see 5.7.1).The EMC test report states clearly the scheduled and actual date when the test# was performed. In instances where the test last more than one day, the DUT# test# date is mentioned clearly in report's “test results” section. The “test results” section must reflect the order in which the DUTs were tested. The environmental conditions during the test are mentioned “temperature” and “humidity” sections of the test report.

5.10.4 Calibration certificates

Calibration is not part of the FlexAutomotive EMC lab scope. All equipment calibrations are handled by Calibration Department and are performed at ISO/IEC 17025 accredited labs.

5.10.4.1 Test equipment calibration certificates data

Test equipment calibration certificates are stored by Calibration Section and they include:

Environmental conditions under which the calibrations were made and any other condition that have an influence on the measurement results

the uncertainty of measurement and/or a statement of compliance with an identified metrological specification or clauses


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measurements traceability records

Upon client's or OEM request, these detailed test equipment calibrations records can be included in the final test report. Automatically the report mentions in the equipment list section of a test# the last calibration date for each item. 5.10.4.2 Test equipment calibration statement of compliance The test equipment returned from calibration is verified for performance before being used for EMC current testing. The technician investigates any compliance statement in the calibration certificate to identify which clauses of the specification are met or not met. When statements of compliance are made, the uncertainty of measurement will be taken into account before the data provided in equipment calibration tables is introduced in lab's EMC monitoring and data acquisition software. 5.10.4.3 Equipment repaired during calibration process When EMC test equipment has been adjusted or repaired by calibrator, the EMC lab technician compares calibration results before and after adjustment or repair, if available, and logs the findings in a file for future reference. 5.10.4.4 Test equipment calibration time interval

The EMC test technician verifies that a calibration certificate (or calibration label) does not contain any recommendation on the calibration interval made by calibrator except where this has been agreed with our lab. The correct calibration interval is mentioned by the manufacturer of that equipment and the next calibration date is written on the label by FlexAutomotive Calibration Section department.

5.10.5 Test result opinions and interpretations

Whenever is appropriate the EMC test report comments section may include opinions and interpretations on how to use the test result and/or guidance to be used for improvements.

Statements about compliance are mentioned in “resolution” section of the EMC Test report.

5.10.6 Testing obtained from subcontractors

When the EMC lab work load determines the management to use subcontractors, their test reports are clearly identified, verified, and approved before being attached to the final test job# report.

5.10.7 Electronic transmission of results

The EMC test reports and additional documents can be forwarded to the client via secured e-mails.

5.10.8 Format of reports

The format of EMC test report is outlined in a straight forward manner to minimize the possibility of misunderstanding or misuse.

5.10.9 Amendments to test reports

Amendments to test reports released to the customer must be clearly identified before being evaluated and approved by the laboratory manager. These amendments to test reports meet the requirements of ISO/IEC 17025. When necessary to issue a complete new report this is uniquely identified and contain in its title a reference to the original that it replaces.


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6.0 A2LA advertising policy

LMS009 EMC LAB, A2LA ADVERTISING POLICY 7.0 A2LA traceability policy

LMS010 EMC LAB, MEASUREMENTS TREACEABILITY POLICY 8.0 A2LA proficiency testing requirements

LMS011 EMC LAB, PROFICIENCY TESTING PROGRAM


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9.0 Abbreviations table

AEMCLRP Automotive EMC Laboratory Recognition Program

EMC Electromagnetic Compatibility

ISO International Organization for Standardization

ISO/TS16949 QMS Automotive Quality Management System that ISO/TS16949 specifies, in conjunction with ISO 9001, the quality system requirements for the design, development, production and, when relevant, installation and servicing of automotive-related products. In addition, it also specifies development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. This technical specification is applicable to production and service part organization sites where customer specified parts are manufactured, and can be applied throughout the automotive supply chain. Section 7.6.3.1 of TS-16949 states that "Accreditation to ISO/IEC 17025 may be used to demonstrate the organization's in-house laboratory conformity to this requirement but is not mandatory." OEM EMC correlation is possible only via AEMCLRP, which asks for ISO/IEC 17025 accreditation.

QM Quality Manual

QMS Quality Management System


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Annex A - EMC Laboratory management within parent organization structure


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Annex B - Laboratory Quality Management System Policy In accordance with the Flextronics Philosophy, Flextronics Automotive is committed to an operating philosophy based on fairness and concern for employees, customers, and the community in which it operates. The following principles are essential to the FlexAutomotive Laboratory Quality Management System Policy:

The Laboratory Quality Management System is appropriate to the nature, scale, and customer, regulatory and legal requirements of its activities.

The management system will establish, document, implement, maintain, and continuously improve a

quality system as a means of ensuring that testing performed in Flextronics Laboratories conforms to customer needs and A2LA accreditation requirements.

FlexAutomotive shall comply with and exceed where possible, all applicable customer oriented

processes, requirements and specifications; business operating goals and objectives, in its operations.

The Laboratory Quality Management System includes the implementation and review of appropriate objectives and goals (targets) to support/improve ‘Design Centre Toronto’ activity.

FlexAutomotive shall document, implement and regularly maintain, audit and review our Laboratory

Quality Management System.

Flextronics Automotive EMC Laboratory Management is committed to: 1. Good professional practice and to the quality of its testing in servicing its customers. 2. Comply with international standard ISO/IEC 17025 3. Continual improvement of QMS effectiveness

All employees shall be made aware of our objectives and principles and shall be required to incorporate

and abide by the spirit of these objectives and principles in carrying out their responsibilities. We shall ensure that the Laboratory Quality Policy is available to all employees and customers.

Flextronics is committed to providing the necessary support to ensure that these objectives and principles

are fully achieved. We shall ensure on a regular basis that all reports on Laboratory Quality Management System issues relating to FlexAutomotive are presented and reviewed by the Management Team.


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Annex C - Referenced documents

ISO/IEC 17025

ISO/TS16949

AEMCLRP

LMS001 EMC LAB, CONFLICT OF INTEREST POLICY

LMS002 EMC LAB, TEST REQUEST PROCEDURE

LMS004 EMC LAB, TEST PLAN DEVELOPMENT

LMS005 EMC LAB, TEST SETUP VERIFICATION PROGRAM

LMS006 EMC LAB, HANDLING OF TEST ITEMS FLOWCHART

LMS007 EMC LAB EQUIPMENT CONTROL

LMS008 EMC LAB, SOFTWARE CONTROL PROCESS

LMS009 EMC LAB, A2LA ADVERTISING POLICY

LMS010 EMC LAB, MEASUREMENTS TREACEABILITY POLICY

LMS011 EMC LAB, PROFICIENCY TESTING PROGRAM

LMS012 EMC LAB, TECHNICAL TRAINING PROCEDURE

QMS010 CONTROL OF DOCUMENTED PROCEDURE

QMS070 QUALITY MANAGEMENT SYSTEM PROCEDURE

QMS080 RESPONSIBILITY, AUTHORITY AND COMMUNICATION PROCEDURE

QMS090 MANAGEMENT REVIEW PROCEDURE

ADM160 PERFORMANCE APPRAISALS PROCEDURE

ADM910 BUILDING AND INFORMATION SECURITY

ADM520 KRA's

ADM105 ESTABLISHING & REVISING PROCEDURES

ADM011 ARCHIVING AND RECORD RETENTION

ADM114 DOCUMENT CONTROL PROCEDURE

ADM925 NETWORK DATA PROTECTION

ADM039 CONFORMANCE TO CUSTOMER'S COMPLAINT RESOLUTION

ADM035 CORRECTIVE ACTION IMPLEMENTATION

ADM140 ORIENTATION PROCEDURE

ADM148 RECRUITMENT PROCEDURE

ADM906 TRAINING ADMINISTRATION PROCEDURE

QLT735 QMS INTERNAL AUDITS

QLT842 ESD PROCEDURE

MAT010 SOURCING OF SUPPLIERS, CONTRACTORS OR SUB-CONTRACTORS PROCEDURE

TEN205 CALIBRATION PROCEDURE

705304 EMC LAB CAPABILITY

719252 EMC LAB, NEW EMPLOYEE TRAINING FLOWCHART

721111 HOW TO WRITE A DOCUMENT (PROCEDURE, WORK INSTRUCTION OR FORM)

721178 EMC LAB SUPPLIES AND CONSUMABLE COMPLIANCE RECORDS

721179 EMC LAB, TEST REPORTS DATABASE

719241 EMC NONCONFORMING WORK FLOWCHART

721186 EMC LAB, TRENDS AND STATISTICS

721187 EMC LAB, QUALITY CONTROL DATA

200031 CALIBRATION LABORATORY SCOPE

201358 TRAINING EVALUATION FORM

201562 5S WORKPLACE AUDIT CHECKLIST

201589 FlexAutomotive Management Review of the Quality Management System

201591 CONTRACTOR SERVICE REQUEST FORM

201692 CUSTOMER COMPLAINT FORM

201693 CUSTOMER SATISFACTION SURVEY


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201694 EMC EXTERNAL TEST PROPOSAL (Ref. LMS002)

201695 EXTERNAL TEST REQUEST FORM

201696 INTERNAL TEST REQUEST FORM

201697 NONCONFORMING WORK REPORT

201703 INTERNAL AUDIT SCHEDULE, ISOISO/IEC 17025 LABORATORY MANAGEMENT SYSTEM

201705 EMC LAB COMPETENCY MATRIX

201706 EMC LAB APPROVED SUBCONTRACTORS LIST

201707 EMC LAB, APPROVED EQUIPMENT SUPPLIERS LIST

201709 EMC LAB TEST EQUIPMENT COMPETENCY MATRIX

201721 EMC LAB PERSONNEL JOB DESCRIPTIONS

201724 CALIBRATION SUPPLIER EVALUATION FORM

201728 EMC LAB, APPROVED CALIBRATION SUPPLIERS LIST

201757 LMS Master Records Matrix

201497 CONFIDENTIALITY AGREEMENT

201780 EMC LAB SUPPLIES & CONSUMABLES VERIFICATION RECORDS

199001 PROCEDURES MASTER LIST

ISO/IEC 17025

199016 EMC LAB EQUIPMENT MANUALS HARD COPY MASTER LIST

199017 EMC LAB SUPPLIES AND CONSUMABLES VENDORS LIST

199018 EMC LAB SUPPLIES AND CONSUMABLES ITEMS LIST

900712 EMC LAB, LABELS


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Quality Manual Revision History: Rev Description of Change Date ECN# Originator

A Initial Release Jan 18, 2006 E06015 Christian Rosu

B Changes per MC: 127926, ASSMNT ID: 11653 CARs May 04, 2006 E06139 Christian Rosu C Added 5.9.2 Jun 06, 2006 E06201 Christian Rosu

D Reviewed links and Annex-A Jan 22, 2008 1138E2008 Christian Rosu

E Reviewed and modified to close deficiencies

Jun 11, 2008 1223E2008 Christian Rosu

F Multiple changes to reflect Newmarket location Apr 08, 2010 1584E2010 Peter Demski

G

Added Laboratory Management’s commitment to comply with ISO/IEC 17025 in Annex B.

May 10, 2010

1606E2010

Peter Demski Revised 4.3.3.3 to state that no amendments by hand to controlled documents is allowed.

Referenced LMS007 (Equipment Control Procedure) for controlling equipment manuals in hard copy and/or soft copy format.: 4.3 (Document Control) 5.4 (Test methods and method validation) Christian Rosu Revised 4.3.3.3 Technical EMC/Electrical test plans

Updated Annex –C Added reference to 199016 EMC LAB EQUIPMENT MANUALS HARD COPY MASTER LIST.

H Removed signature requirement in Annex B Add reference to form 201133 in 4.11.3 and 4.14.2 for use in internal and external audit CAR deficiencies Revise 5.4.7 to state that only formal 17025 accredited reports need to be signed by Technical Manager

February 16, 2011

1689E2011 Peter Demski

J 4.1.5, 5.5.1, AnnexC Remove reference to 201704 and 201710 4.13.1.4 Remove data file to CD backup requirement 5.10.9, 5.4.7.1 test report sign-off and amendments - Laboratory manager replaces technical manager 4.1.5.3 Remove report sign-off requirement and job appraisals in responsibility for technical manager

June 20, 2011 1751E2011 Dave Clutchey

K Changes to Annex A - EMC Laboratory management within parent organization structure

Feb 8, 2012 1879E2012 Christian Rosu

L Add reference to MAT010 SOURCING OF SUPPLIERS, CONTRACTORS OR SUB-CONTRACTORS PROCEDURE

Apr 18, 2012 1923E2012 Peter Demski

EMC Laboratory Quality Manual - flexautomotive.net · reference: 200093 laboratory management...

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