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NAFEMS Quality Assurance Procedures for Engineering Analysis

MEMBERS PRICE:                      £50

NON-MEMBERS PRICE:           £500







Details:

J. Smith

First Published - January 1999
Softback, 67 Pages

The objective of this document is to assist suppliers of engineering analysis services to approach quality certification to Quality System BS EN ISO 9001 1 and NAFEMS Quality System Supplement to BS EN ISO 9001 2. The procedures have been reviewed and deemed compliant against the requirements of the above-mentioned controlling standards by an ISO 9001 Lead Assessor. It was intended that the procedures should be as simple as possible, while satisfying the requirements of the controlling standards.

Overview of the procedures

This document is an example of a quality manual comprising a quality system for engineering analysis. The procedures describe the process of engineering analysis in compliance with the requirements of the controlling standards. Rudimentary sample forms upon which quality records can be created are included in Appendix D.

The procedures are arranged in three main sections:

(a) Quality system executive - relating to management of the quality system

(b) Support environment - relating to management of the analysis resources and records

(c) Engineering analysis - relating to management of the analysis process.

Organisations intending to implement this quality system will need carry out some customisation prior to implementation, e.g. quality policy, description of the analysis supplier's organisation, specification of individual responsibility and authority, etc.). An understanding of BS EN ISO 9001 and NAFEMS Quality System Supplement is assumed.

Contents

Introduction 7

  • ii A quality system for engineering analysis 7
  • iii International quality standards 7
  • iv Quality procedures 8
  • v Quality control 9
  • vi Quality system implementation 9

 

1 QUALITY SYSTEM EXECUTIVE Revision Page

1.1 Quality Policy 10

  • 1.1.1 Scope 0 10
  • 1.1.2 Responsibilities 0 10
  • 1.1.3 Procedure for documenting the Quality Policy (4.1.1) 0 10
  • 1.1.4 Quality records 0 10

1.2 Organisation 11

  • 1.2.1 Scope 0 11
  • 1.2.2 Responsibilities 0 11
  • 1.2.3 Procedure for recording responsibility and authority in the supplier's organisation (4.1.2) 0 11
  • 1.2.4 Quality records 0 11

1.3 Quality system review 12

  • 1.3.1 Scope 0 12
  • 1.3.2 Responsibilities 0 12
  • 1.3.3 Procedure for review of non-conformances and corrective actions (4.13) 0 12
  • 1.3.4 Procedure for review of the quality system (4.1.3) 0 12
  • 1.3.5 Quality records 0 13

1.4 Internal quality audits 14

  • 1.4.1 Scope 0 14
  • 1.4.2 Responsibilities 0 14
  • 1.4.3 Internal audit procedure (4.17) 0 14
  • 1.4.4 Procedure for recording the internal audit (4.16) 0 16
  • 1.4.5 Procedure for control of non-conformances and corrective actions (4.13, 4.14) 0 16
  • 1.4.6 Third party surveillance 0 16
  • 1.4.7 Quality records 0 16
  • 1.4.8 Documents 0 16

2 SUPPORT ENVIRONMENT 17

2.1 Training 17

  • 2.1.1 Scope 0 17
  • 2.1.2 Responsibilities 0 17
  • 2.1.3 Procedure for training review (4.18) 0 17
  • 2.1.4 Procedure for control of training non-conformances (4.13, 4.14) 0 18
  • 2.1.5 Quality records 0 18

2.2 Analysis resources 19

  • 2.2.1 Scope 0 19
  • 2.2.2 Responsibilities 0 19
  • 2.2.3 Procedure for purchasing (4.6) 0 19
  • 2.2.4 Procedure for vendor approval (4.6) 0 20
  • 2.2.5 Procedure for inspection and testing of software and hardware (4.6.4, 4.10) 0 20
  • 2.2.6 Procedure for inspection and testing of sub-contracted services (4.6.4, 4.10) 0 21
  • 2.2.7 Procedure for resource approval and issue (4.5.2) 0 21
  • 2.2.8 Procedure for resource identification and traceability (4.8) 0 21
  • 2.2.9 Procedure for control of non-conforming resources (4.13, 4.14) 0 21
  • 2.2.10 Quality records 0 22

2.3 Documentation and records 23

  • 2.3.1 Scope 0 23
  • 2.3.2 Responsibilities 0 23
  • 2.3.3 Procedure for control of quality documentation (4.5) 0 23
  • 2.3.4 Procedure for control of quality records (4.16) 0 24
  • 2.3.5 Procedure for dealing with customer supplied product (4.7) 0 24
  • 2.3.6 Procedure for control of non-conforming documentation and records (4.13, 4.14) 0 25
  • 2.3.7 Quality records 0 25

3 ENGINEERING ANALYSIS 26

3.1 Analysis input 26

  • 3.1.1 Scope 0 26
  • 3.1.2 Responsibilities 0 26
  • 3.1.3 Procedure for analysis planning (4.4.2) 0 26
  • 3.1.4 Procedure for Contract Review (4.3) 0 28
  • 3.1.5 Procedure for contract amendments (4.5.3) 0 29
  • 3.1.6 Procedure for input data review (4.10) 0 30
  • 3.1.7 Procedure for control of non-conforming analysis input (4.13, 4.14) 0 30
  • 3.1.8 Quality records 0 30
  • 3.1.9 Documents 0 30

3.2 Analysis process 31

  • 3.2.1 Scope 0 31
  • 3.2.2 Responsibilities 0 31
  • 3.2.3 Procedure for analysis process and change control (4.4.9) 0 31
  • 3.2.4 Procedure for control of non-conforming analysis process (4.13, 4.14) 0 31

3.3 Analysis output 32

  • 3.3.1 Scope 0 32
  • 3.3.2 Responsibilities 0 32
  • 3.3.3 Procedure for model validation 0 32
  • 3.3.4 Procedure for compiling the analysis report 0 33
  • 3.3.5 Procedure for inspection and testing of analysis (4.10) 0 34
  • 3.3.6 Procedure for analysis approval and issue (4.5.2) 0 34
  • 3.3.7 Procedure for identification and traceability of analysis data (4.8) 0 34
  • 3.3.8 Procedure for handling, storage, packaging, preservation and delivery of analysis (4.15) 0 34
  • 3.3.9 Procedure for control of non-conforming analysis output (4.13, 4.14) 0 35
  • 3.3.10 Quality records 0 35
  • 3.3.11 Documents 0 35

References 36

Bibliography 36

Appendix A Cross-reference between the procedures and BS EN ISO 9001 37

Appendix B Third party certification 38

Appendix C Glossary of terms 39

Appendix D Sample forms 40

  • 1 Quality policy statement 0 41
  • 2 Responsibility and authority 0 42
  • 3 Organisational chart 0 43
  • 4 Quality system Review 0 44
  • 5 Audit and quality system review meeting forward programme 0 45
  • 6 Audit schedule - system executive and support environment 0 46
  • 7 Audit schedule - engineering analysis 0 47
  • 8 Non-conformances, observations and corrective actions 0 48
  • 9 Non-conformance status log 0 49
  • 10 Personnel training 0 50
  • 11 Approved personnel list 0 51
  • 12 Resource purchase details 0 52
  • 13 Resource item review 0 53
  • 14 Approved vendor list 0 54
  • 15 Quality manual revision status and distribution 0 55
  • 16 Procedure qualification 0 56
  • 17 Contracts Log 0 57
  • 18 Analysis plan - overview 0 58
  • 19 Analysis plan - idealisation summary 0 59
  • 20 Model validation plan 0 60
  • 21 Contract amendments 0 61
  • 22 Transmittals 0 62
  • 23 Model validation 0 63
  • 24 Analysis records 0 64
  • 25 Analysis report release 0 65
  • 26 Despatch note 0 66
  • 27 Archive record 0 67

Purchasing Details

Members Price: £50 | $77 | €60
Non-Members Price: £500 | $762 | €592
Order Ref: R0064
Date: January 1, 1999

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