NAFEMS NAFEMS Quality Assurance Procedures for Engineering Analyses

Due to the evolving nature of the engineering analysis and simulation market this publication no longer represents current best practice and has been archived. The document may be of historical interest and is therefore still available for purchase.

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.

i	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
1.1	Quality Policy	10
1.1.1	Scope	10
1.1.2	Responsibilities	10
1.1.3	Procedure for documenting the Quality Policy (4.1.1)	10
1.1.4	Quality records	10
1.2	Organisation	11
1.2.1	Scope	11
1.2.2	Responsibilities	11
1.2.3	Procedure for recording responsibility and authority in the supplier's organisation (4.1.2)	11
1.2.4	Quality records	11
1.3	Quality system review	12
1.3.1	Scope	12
1.3.2	Responsibilities	12
1.3.3	Procedure for review of non-conformances and corrective actions (4.13)	12
1.3.4	Procedure for review of the quality system (4.1.3)	12
1.3.5	Quality records	13
1.4	Internal quality audits	14
1.4.1	Scope	14
1.4.2	Responsibilities	14
1.4.3	Internal audit procedure (4.17)	14
1.4.4	Procedure for recording the internal audit (4.16)	16
1.4.5	Procedure for control of non-conformances and corrective actions (4.13, 4.14)	16
1.4.6	Third party surveillance	16
1.4.7	Quality records	16
1.4.8	Documents	16
2	SUPPORT ENVIRONMENT	17
2.1	Training	17
2.1.1	Scope	17
2.1.2	Responsibilities	17
2.1.3	Procedure for training review (4.18)	17
2.1.4	Procedure for control of training non-conformances (4.13, 4.14)	18
2.1.5	Quality records	18
2.2	Analysis resources	19
2.2.1	Scope	19
2.2.2	Responsibilities	19
2.2.3	Procedure for purchasing (4.6)	19
2.2.4	Procedure for vendor approval (4.6)	20
2.2.5	Procedure for inspection and testing of software and hardware (4.6.4, 4.10)	20
2.2.6	Procedure for inspection and testing of sub-contracted services (4.6.4, 4.10)	21
2.2.7	Procedure for resource approval and issue (4.5.2)	21
2.2.8	Procedure for resource identification and traceability (4.8)	21
2.2.9	Procedure for control of non-conforming resources (4.13, 4.14)	21
2.2.10	Quality records	22
2.3	Documentation and records	23
2.3.1	Scope	23
2.3.2	Responsibilities	23
2.3.3	Procedure for control of quality documentation (4.5)	23
2.3.4	Procedure for control of quality records (4.16)	24
2.3.5	Procedure for dealing with customer supplied product (4.7)	24
2.3.6	Procedure for control of non-conforming documentation and records (4.13, 4.14)	25
2.3.7	Quality records	25
3	ENGINEERING ANALYSIS	26
3.1	Analysis input	26
3.1.1	Scope	26
3.1.2	Responsibilities	26
3.1.3	Procedure for analysis planning (4.4.2)	26
3.1.4	Procedure for Contract Review (4.3)	28
3.1.5	Procedure for contract amendments (4.5.3)	29
3.1.6	Procedure for input data review (4.10)	30
3.1.7	Procedure for control of non-conforming analysis input (4.13, 4.14)	30
3.1.8	Quality records	30
3.1.9	Documents	30
3.2	Analysis process	31
3.2.1	Scope	31
3.2.2	Responsibilities	31
3.2.3	Procedure for analysis process and change control (4.4.9)	31
3.2.4	Procedure for control of non-conforming analysis process (4.13, 4.14)	31
3.3	Analysis output	32
3.3.1	Scope	32
3.3.2	Responsibilities	32
3.3.3	Procedure for model validation	32
3.3.4	Procedure for compiling the analysis report	33
3.3.5	Procedure for inspection and testing of analysis (4.10)	34
3.3.6	Procedure for analysis approval and issue (4.5.2)	34
3.3.7	Procedure for identification and traceability of analysis data (4.8)	34
3.3.8	Procedure for handling, storage, packaging, preservation and delivery of analysis (4.15)	34
3.3.9	Procedure for control of non-conforming analysis output (4.13, 4.14)	35
3.3.10	Quality records	35
3.3.11	Documents	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	41
2	Responsibility and authority	42
3	Organisational chart	43
4	Quality system Review	44
5	Audit and quality system review meeting forward programme	45
6	Audit schedule - system executive and support environment	46
7	Audit schedule - engineering analysis	47
8	Non-conformances, observations and corrective actions	48
9	Non-conformance status log	49
10	Personnel training	50
11	Approved personnel list	51
12	Resource purchase details	52
13	Resource item review	53
14	Approved vendor list	54
15	Quality manual revision status and distribution	55
16	Procedure qualification	56
17	Contracts Log	57
18	Analysis plan - overview	58
19	Analysis plan - idealisation summary	59
20	Model validation plan	60
21	Contract amendments	61
22	Transmittals	62
23	Model validation	63
24	Analysis records	64
25	Analysis report release	65
26	Despatch note	66
27	Archive record	67

Document Details

Reference	R0064
Author	Smith. J
Language	English
Audiences	Analyst Manager
Type	Publication
Date	1st January 1999
Region	Global

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NAFEMS Quality Assurance Procedures for Engineering Analyses

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