VDA
Quality Management
in the Automotive Industry
Based on DIN EN ISO 9001 and DIN EN ISO 9004, Part 1
4
rd
Revised Edition 2000
Quality Part 1
System Audit
Quality
System Audit
Based on DIN EN ISO 9001 and DIN EN ISO 9004, Part 1
Non-Obligatory VDA Standard Recommendation.
The Association of German Automotive Industry (VDA) recommends it’s members apply the following standard when introducing and maintaining quality systems.
Exclusion of Liability
This VDA volume is a recommendation which is available to everyone. Anyone applying it is responsible for ensuring that it is used correctly in each case.
This VDA volume takes into account state of the art technology, current at the time of issue. Implementation of VDA recommendations excludes no one from responsibility for their own actions. In this respect everyone acts at their own risk. The VDA and those involved in VDA recommendations shall bear no liability.
If during the use of VDA recommendations, errors or the possibility of mis-interpretation are found, it is requested that these be notified to the VDA immediately so that any possible faults can be corrected.
Referenced standards
The quotations from standards identified with their DIN number and date of publication are reproduced with the permission of the DIN Deutsches Institut für Normung e.V. The version with the latest issue date, available from the publishers Beuth Verlag GmbH, 10772 Berlin, is definitive for the use of the standard.
Copyright
This publication is protected by copyright. Any use outside the strict limits of copyright law is not permissible without the consent of the VDA and is liable to prosecution. This applies particularly to copying, translations, microfilming and the storage or processing in electronic systems.
Translations
This publication will also be issued in other languages. The current status must be requested from VDA-QMC.
ISSN 0943-9412 Copyright 2000 by
Verband der Automobilindustrie e. V. (VDA) Quality Management Center (QMC) D-60325 Frankfurt am Main, Lindenstraße 5
Foreword to the 4th Edition
Quality assurance has a new dimension today - it covers and integrates all divisions of the company in it’s vertical and horizontal structures (cross-sectional function).
Quality assurance has become an interdisciplinary key function (cooperation of all involved divisions at the right time). Quality assurance therefore has a decisive influence on the company's result.
Shorter model cycles and development times, greater international competi-tion and increasing cost pressure, new organizacompeti-tion forms (just in time), greater expectations placed on products and a stricter product liability demand highly effective quality assurance systems (quality systems) in all areas of the automotive industry among automotive manufacturers as well as their suppliers. In order to do justice to this development, a working circle of the VDA/DGQ specialist group "Quality Control in the Automotive Industry" has drawn up a questionnaire on quality system evaluation based on DIN EN ISO 9004 (Edition 5/90) which was published with the first edition in 1991.
This VDA Volume 6 very quickly received a good response both outside the industry and on an international level. Practical experience has shown that this publication is not only suitable for the preparation of internal audits, but also represents an excellent aid for preparation of a certification.
The practical experience of auditors led to the volume being revised and defined in more precise terms as a second edition (12/92). This simplified handling and a uniform assessment method was achieved.
The new edition of the standard series DIN EN ISO 9000 (Edition 8/94) made revision of the second edition necessary.
The 3rd Edition also includes requirements from the guidelines EAQF/94 (France) and QS-9000/95 (America). This allows comparison of the audit results. Furthermore, certification notes were incorporated.
In the 4th Edition further corrections and up-dates were included. Comments from the users and the auditor’s symposia were considered (see Para. 12.1). The audited organization is now referred to as „the company“ throughout the questionnaire.
The element Z1, so far only required for companies with international busi-ness activities, now has to be considered generally during audits/certifica-tion.
In order to make the decision on the issuance of a VDA 6.1 certificate supplement even more definite certain questions which are particularly important for product and process and for which noncompliance could lead to the failure of the quality system have been specially identified. These questions lead to determined consequences during the overall evaluation, see Para. 3.3.3. and 3.3.4.
DIN EN ISO 9001 (Edition 8/94) was used as the basis for the Quality system audit which describes a comprehensive system of industrial quality management with its elements. Questions were formulated from the requirements profile of this standard relating to the explanation of a quality management system, together with specific requirements from DIN EN ISO 9004 (Edition 8/94) and supplemented with the practical experience of the automotive industry. In contrast to the standard which treats the same subject matter partially in various places and varying depth the ques-tionnaire in this publication normally contains the subject matter only once in order to, as far as possible, avoid the repetitions contained in the standard. Quality and quality management problems are predominantly not of a purely technical nature, but often related to management, organization and struc-ture. The questionnaire is therefore divided up into the following two parts:
- M Company Management - P Product and Process.
This VDA Volume represents a supplement to those volumes already pub-lished and serves the evaluation of quality management systems under comparable conditions. It is intended to help identify weaknesses, to remedy them through corrective actions and thereby continually improve the com-pany's productivity.
The aim of this work is to unify the necessary audits in order to reduce the working expenditure for the auditor as well as for those to be audited. Car manufacturers and suppliers agree to mutually recognize, as far as possible, audits carried out on the basis of this uniform questionnaire and evaluation system for rationalization reasons. Recognition of the system-related audit allows concentration on more specific product- and process-related audits.
The quality standard of the German Automotive Industry contains further types of audits which are described in the following VDA Volumes.
Quality Standard of the german Automotive Industrie
VDA 6 VDA 6Part 1 Quality System Audit VDA 6Part 2 Quality System AuditServices
Basics for Quality Audits
VDA 6
Part 3 Process Audit
VDA 6 Part 4
Quality System Audit Production Means Auditing and
Certification
VDA 6
Part 5 Product Audit
VDA 6
We thank those companies involved and their employees for their work in drawing up these guidelines:
- Audi AG, Ingolstadt
- Adam Opel AG, Rüsselsheim - BMW AG, Munich
- BOGE GmbH, Eitorf
- Robert Bosch GmbH, Stuttgart - Daimler-Benz AG, Stuttgart
- DNV (Det Norske Veritas Zertifizierung GmbH, Essen
- DQS (Deutsche Gesellschaft zur Zertifizierung von Qualitätssiche-rungssystemen mbH), Frankfurt, Berlin
- Edscha Gruppe, Remscheid - FORD-Werke AG, Cologne - General Motors Europe, Zurich
- GLYCO-Metall-Werke, GLYCO B.V. & Co. KG, Wiesbaden - Happich Fahrzeug und Industrieteile GmbH, Wuppertal - Hella KG, Hueck & Co., Lippstadt
- ITT Automotive Europe GmbH, Frankfurt - Keiper Recaro GmbH & Co., Remscheid
- Lemförder AG & Co., Fahrwerktechnik Lemförde - Mahle GmbH, Stuttgart
- Mannesmann Sachs AG, Schweinfurt - Mannesmann VDO AG, Babenhausen - Pierburg AG, Neuss
- Dr. Ing. h.c. F. Porsche AG, Stuttgart - SIEMENS AG, Würzburg
- SKF GmbH, Schweinfurt - Teroson GmbH, Heidelberg
- TRW Fahrwerkssysteme GmbH & Co. KG, Düsseldorf - WABCO Standard GmbH, UB Fahrzeugbremsen, Hannover - Volkswagen AG, Wolfsburg
- YMOS AG, Obertshausen.
Contents Page 1 INTRODUCTION 13 2 QUALITY SYSTEM ACCORDING TO THE
DIN EN ISO 9000 SERIES 15 2.1 Explanations to DIN EN ISO 9004 (Edition 8/94) 15 2.2 Quality Assurance Model 16 3 QUALITY SYSTEM AUDIT 18
3.1 General 18
3.2 Selection of the Quality Elements and Relevant Questions 19 3.3 Evaluation and Rating 20 3.3.1 Individual Rating of Questions and Quality Elements 20 3.3.2 Overall Rating of Audit Result 22 3.3.3 Rating during Customer/Supplier Audits (2nd Party) 23 3.3.4 Awarding of the VDA 6.1 Certificate Supplement (3rd Party): 24 3.4 Summary of Results 25 3.5 Close out Meeting and Report 25 3.6 Corrective Actions 25 3.7 VDA 6.1 Certificate 25
4 DEFINITIONS 27
4.1 General terms according to DIN EN ISO 8402/1995 (Extract) 27
#.1.1 Unit 27 #.1.2 Process 27 #.1.3 Procedure 27 #.1.4 Product 28 #.1.5 Service 28 #.1.7 Organization 28 #.1.8 Organizational structure 28 #.1.9 Customer 29 #.1.10 Supplier 29 4.2 Quality-related Definitions according to
DIN EN ISO 8402/1995 (Extract) 29 #.2.3 Quality Requirements 29 #.2.15 Inspection and Testing 30 #.2.17 Verification 30 #.2.18 Validation 30 #.2.19 Evidence 30
4.3 Definitions for Quality Systems according to
DIN EN ISO 8402/1995 (Extract) 31 #.3.1 Quality Policy 31 #.3.6 Quality System 31 #.3.12 Quality Manual 31 4.4 Definitions for Tools and Techniques according
to DIN EN ISO 8402/1995 (Extract) 32 #.4.9 Quality Audit 32 #.4.10 Quality Audit Findings 32 #.4.14 Corrective Action 33 4.5 Additional Terms (Definitions for the present volume) 33
4.5.1 System 33
4.5.2 Method 33
4.5.3 Serial Production 33 4.5.4 Quality Procedures 34 4.5.5 Work Instructions (Inspection and Testing Instructions) 34 5 CROSS-REFERENCE LIST OF PARAGRAPH NUMBERS
FOR CORRESPONDING TOPICS 35 6 STRUCTURE AND NUMBER OF QUESTIONS
PER QUALITY ELEMENT 36 7 QUALITY SYSTEM AUDIT QUESTIONNAIRE 38 01 Management Responsibility 39 02 Quality System 47 03 Internal Quality Audits 57
04 Training 63
05 Financial Considerations to Quality Systems 71 06 Product Safety 75 Z1 Corporate Strategy 81 07 Contract Review, Quality in Marketing 87 08 Design Control, (Product Design and Development) 93 09 Process Planning (Process Development) 101 10 Document and Data Control 111
11 Purchasing 117 12 Control of Customer-Supplied Product 125 13 Product Identification and Traceability
(Process Control, Inspection and Test Status) 129 14 Process Control 137 15 Inspection and Testing (Product Verification) 147 16 Control of Inspection, Measuring and Test Equipment 153 17 Control of Nonconforming Product 159 18 Corrective and Preventive Action 163 19 Handling, Storage, Packaging, Preservation and Delivery 169 20 Control of Quality Records 175 21 Servicing, (After Sales, Post-production Activities) 181 22 Statistical Methods 187 8 FORMS FOR THE QUALITY SYSTEM AUDIT 191
9 LITERATURE 199
9.1 VDA-Series "Quality Management in the
Automotive Industry": 199 10 AGREEMENT WITH INDUSTRIAL ASSOCIATIONS 203 10.1 Introduction 203 10.2 Summary of the National Associations 203 10.3 International Agreement on Mutual Recognition 204 11 NOTES ON A CERTIFICATION ACCORDING TO VDA 6.1 206
12 APPENDIX 207
12.1 Changes of the 4th Edition compared to the 3rd Edition 207 12.2 Comparison Tables 210 12.2.1 Comparison Matrix VDA 6.1 / DIN EN ISO 900194 210
12.2.2 Comparison Matrix DIN EN ISO 900494 / VDA6.1 214
1 Introduction
Quality management* is an interdisciplinary key function. The quality of products and services is always the combined result of activities in every phase of the total business process. Effective quality management assigns priority to planning and prevention activities for identification of interrelations and interdependencies, as well as for appropriate measures to prevent non-conformities occurring - in contrast to the previous practices of identifying, analyzing and rectifying nonconformities which have already occurred. A well-functioning quality system* described in a quality manual,* is an essential requirement for every business in order to fulfil the demands for quality deliveries and services in a proactive and economic way. Quality management affects all areas of the business. It is therefore a primary function of business management.
Management must prove that due diligence has been shown in all areas of the business, from planning to design, procurement, production, sales and user information through to the observation of a product's market position. This applies especially in the event of a claim for damages.
It is not only sensible, but essential that all quality management activities be planned, implemented and combined in a quality system. Only a well planned and purposefully selected quality system gives business partners, authorities and, increasingly, insurers confidence in the business's ability to comply with quality requirements.
The original understanding of quality, mainly shaped by the product, and the associated duties of quality management have changed in recent years and include new additional content and dimensions.
The main duties of management are, therefore:
- Definition of the quality policy, agreeing and monitoring quality objectives
- Assuring cross-functional activities and interfaces during inter-disciplinary co-operation
*
- Definition and monitoring of quality-related costs - Consideration of product safety and product liability - Involving all employees in the responsibility for quality
These duties are covered in part M of the questionnaire with respect to the quality management system.
As operations and the interrelations of systems and processes become more extensive and complex, cross-functional activities gain in importance. Here, many resources are available, which have a great influence on pro-ductivity, overall economic performance and quality.
The product- and process-related elements are covered in part P of the questionnaire with respect to the quality management system.
Through the evaluation of the quality system with the help of the question-naire, the customer is given a general view of the supplier's ability to deliver products and services which meet his quality requirements.
The purpose of this volume is to define an agreed general procedure for the uniform evaluation of a defined quality system. In this way, the working expenditure required for further quality system audits, for example, by other customers, can be reduced.
The result of the evaluation shall show the audited company where his quality system meets the requirements and in which elements improve-ments are necessary.
The audit result is signed by the auditor and the audited company. The audited company confirms with it’s signature that the identified result has been discussed with him. He is free to provide his own response.
Information acquired during the performance of the audit is, other than for the use of the audit itself, to be handled confidentially.
certi-2 Quality system according to the DIN EN ISO 9000 Series
The DIN EN ISO 9000 series is applied as a standard in the European Union (EU) and EFTA. The German edition is identical in Austria, Germany and Switzerland.
When delivering in accordance with the regulations of the EU it is compul-sory to comply with the contents of the EN standard in order to guarantee free movement of goods under the same conditions. This also applies to the contents of the European Standard on quality management. Their compliance is therefore to be proven upon request.
2.1 Explanations to DIN EN ISO 9004 (Edition 8/94) Quality Management and Quality System Elements, Part 1: Guideline
This standard is an internationally agreed guideline in which the elements of a quality system (quality elements) are described. It represents a further development of formerly known national and branch-specific regulations with the express objective of showing, descriptively and clearly, which quality elements may nowadays be included in a quality system corresponding to the "State of the Art Technology".
In addition, it describes the obligations of the business with respect to quality management, in fulfillment of which the critical preconditions for achieving quality capability within the company should be created.
Users of this standard are enabled to select from the presented basis of elements according to extent, depth and overall requirements of the business in order to be able to completely fulfill the tasks of their own company-specific quality system.
The scope of application is not limited. The standard is to be viewed as a universal set of regulations for quality management to achieve the quality of products and services. It can be assumed that branch-specific quality regulations will thereby be replaced. In the meantime, this standard has gained a fundamental significance.
2.2 Quality Assurance Model
(according to the introduction to DIN EN ISO 9001)
The scope and depth of the quality system may depend on the type of pro-ducts to be supplied, the applied technology and the size of the evaluated company.
The following paragraphs are taken from the national foreword and the introduction of DIN EN ISO 9001: 1994-08. There it is appropriately stated:
Gaining confidence in the supplier’s ability to fulfill the defined minimum requirements on his quality system is nowadays be-coming more and more a precondition throughout the world for cooperation between the customer and his supplier. This con-fidence can be built up by presenting the quality system to the customer or an authorized body. All systematic and confidence-building activities planned within the scope of this are designated by DIN EN ISO 8402 as quality assurance or quality management systems (or quality systems).
The standards DIN EN ISO 9001, DIN EN ISO 9002 and DIN EN ISO 9003 each contain a quality assurance model. Only these three standards of the DIN EN ISO 9000 series are intended for demonstration purposes. They show a way to create confidence in the capability of a supplier.
It has to be emphasized that the quality system requirements specified in the International Standards ISO 9001, ISO 9002 and ISO 9003 are a supplement (not an alternative) to the established quality requirements (on products1) ).
It is intended that these International Standards are applied in their present form. However, occasionally they may need to be tailored for special contractual situations by the addition or omission of certain requirements. ISO 9000-1 provides guidance on such
The following alternative models for quality assurance described in three international standards represent three differing forms of "the functional or organizational quality capability" which are suitable for use in contracts between two partners (see Chapter 5: Cross-Reference List of Section Numbers)
ISO 9001Quality systems
-Model for quality assurance in design2), development, production, installation and servicing.
To be applied, when conformance with specified requirements is to be ensured by the supplier/contractor during design, develop-ment, production, installation and servicing.
ISO 9003 Quality systems
-Model for quality assurance in production, installation and ser-vicing.
To be applied, when conformance with specified requirements is to be ensured by the supplier/contractor during production, in-stallation and servicing.
ISO 9002 Quality systems
-Model for quality assurance at final inspection and testing.
To be applied, when conformance to specified requirements is to be ensured by the supplier/contractor only during final inspection and testing.
3 Quality System Audit
3.1 General
Evaluation of the quality system is performed with the help of a question-naire. The questions of the present VDA 6.1 volume are primarily
foreseen for the evaluation of companies which produce material (or tangible) products (For non-material or non-tangible products/services
- see VDA Volume 6, Part 2).
The evaluation of a company is performed either as an internal audit by the company itself (1st Party), through a representative of the customer (2nd Party) or through an accredited certification body (3rd Party). Auditors must be competent in the elements which they have to evaluate, as well as in the quality techniques used. They must be qualified to judge the suitability of the implemented quality measures, taking into account the production pro-cesses used, the state of technology and the required product quality. The extensive commercial and technical evaluation of a company in line with this quality system audit places great requirements on the auditor. In addition to this, the auditor must have, among other things, relevant training and industrial experience, integrity and the ability to deal with people.
Particularly the following quality elements: - management responsibility - quality system
- internal quality audits - training/personnel
- financial considerations to quality systems - product safety
- corporate strategy
If the quality system of a company, on the occasion of a system audit, has been found to be satisfactory in accordance Paragraph 3.3, then a periodic quality system audit is to be carried out at appropriately defined intervals. In the case of an unsatisfactory result during a quality system audit, corrective actions and a time schedule are to be established to improve the system. The evaluation of their effectiveness is the subject of a follow-up audit that examines the unsatisfactory areas.
3.2 Selection of the Quality Elements and Relevant Questions
The relevant elements and corresponding questions for the evaluation of the quality system of a company are to be defined. The elements 08, 12 and 21 can, under special circumstances, be completely/ partly omitted. Comments regarding this are given with the relevant elements.
During internal quality audits (1st Party) and customer audits (2nd Party) further quality elements and questions may also be added. Furthermore, elements of a quality system may be adapted, deleted (in exceptional cases) or extended to meet company or product-specific needs. Additional questions to the quality system must be communicated to the company/ organization to be audited beforehand.
During certification audits (3rd Party) additional requirements can only be added if they form part of the quality system of the company to be audited. In this case, their compliance and effectiveness are to be assessed. The point rating according to VDA 6 Part 1, Paragraph 3.3.1 is not applicable. Individual questions can only be omitted if they are unusual or not able to be evaluated for the company size or branch. In cases of doubt, clarification with the customer is sensible.
Questions that are not applicable and supplementary questions are to be identified and justified in the audit report (Identification for non-applicable i.e. questions that have not be evaluated = na).
In the following questionnaire, elements of a quality system which have a particular influence on product and process or which can lead to the failure of the quality system are identified by the relevant
questions with an *. Non compliance with these requirements has particular influence on the overall rating or awarding of a VDA 6.1 Certificate Supplement (see 3.3.3 and 3.3.4).
The „Requirements/Explanations“ to the question are always to be seen as an example and not as a complete checklist. The type of evi-dence or records listed as examples must not be supplied if they are not appropriate to the industry sector.
Some questions concerning the quality system can only be answered in conjunction with an evaluation of the product to be supplied and/or the corresponding technology or process applied. This can make a separate assessment (product / process audit) necessary.
3.3 Evaluation and Rating
3.3.1 Individual Rating of Questions and Quality Elements
The auditor evaluates the definition and effectiveness of the quality mana-gement activities in complying with the respective requirements by initially determining:
- Is the subject in question defined in writing in the quality system, in operational procedures with relationships and responsibilities? (e.g.: in the quality manual, in a documented procedure or work instruction)?
He must then further evaluate:
According to the following table, answers to the questions lead to a rating for each relevant question. This rating can result in 0, 4, 6, ,8 or 10 points per question. Thereby, the following point rating is valid for each question:
Subject in question Rating of answers
Defined completely in the
quality system yes no yes no yes/no
Proven effective in
practice yes yes mainly *) no
Point score 10 8 6 4 0
* Under "mainly" it is understood that all applicable requirements are proven effective in more than 3/4 of all relevant application cases and that no special risk exists.
Rating
10 points: completely defined in the quality system and proven to be effective
8 points: not completely defined in the quality system but proven to be effective
6 points: completely defined in the quality system and mainly proven to be effective
4 points: not completely defined in the quality system but mainly proven to be effective
0 points: not proven to be effective regardless of completeness of definition in the quality system
When compiling a summarized rating for a quality element, every question is equally weighted. Questions which are not applicable are not considered in the rating.
The element rating is expressed as a percentage which results from the total points assessed for all relevant questions related to the total points possible for all relevant questions.
If all relevant answers in an element achieve 10 points, then the level of compliance CE is 100%.
Calculation of element ratings:
total points assessed for relevant questions
CF = — — — — — — — — — — — — — — — — — — — — x 100 [%] total possible points for relevant questions
3.3.2 Overall Rating of Audit Result
For the two parts of the audit, M (management) and P (product and pro-cess), the individual levels of compliance CM and CP are calculated. They
are established by calculating the average value of the levels of compliance for the relevant evaluated quality elements
sum of levels of compliance of all relevant elements
CM resp. CP = — — — — — — — — — — — — — — — — — — — — — — — — — — — [%] no. of relevant quality elements
The two levels of compliance CM and CP are combined to give an overall
rating, whereby the management-specific section is given one third weigh-ting and the product-related and process-related section is given a two thirds weighting:
CM + 2 * CP CTOT = — — — — — — — [%].
3
The rating system may also be applied if further elements or questions are added or if elements or questions are omitted. If additional questions relate to product, services or applied process technology, it may then be neces-sary to adapt the point and rating system accordingly.
Note on the formula for CTOT*
The formula arises from the following consideration:
On condition that the 7 quality elements concerning management and the 16 quality elements concerning product and process (from Chapter 6) are equally weighted in CTOT
Then:
7 * CM + 16 * CP
CTOT = — — — — — — — — = 0,30 * CM + 0,70 * CP
23 should be calculated.
In order to retain a simple formula and also to give more weight to the Part M quality ele-ments, the committee defined the formula for CTOT as presented above (no mathematical
background). The elements of CM are therefore more heavily weighted by a factor of 0.33/
0.30 = 1,1.
Thereby the elements of management, as an essential part of quality assurance, are treated with more importance in the quality rating system.
* CTOT is referred to as EGES in the original German version
3.3.3 Rating during Customer/Supplier Audits (2nd Party)
Overall level of compliance in percent Evaluation of quality system Description of rating 90 to 100 full compliance A *)
80 to less than 90 mainly compliant AB *)
60 to less than 80 conditionally compliant B
less than 60 not compliant C
*) Notes
1. Companies audited and having received an overall level of compliance exceeding 90% (or respectively 80 %) but which have a level of compliance for one or more elements of less than 75% will have their rating dropped from A to AB (or respectively AB to B), as appropriate.
2. If a question marked with * which has particular influence on product and process or which can lead to a failure of the quality system is graded with less than 8 points then the company being audited is to be downgraded from A to AB or from AB to B.
3. If a question not marked with * is graded with 0 points, then the audited company is to be downgraded from A to AB.
4. Downgrading according to 1, 2) or 3) above may be applied only once. 5. Downgrading are to be justified in a commentary sheet.
3.3.4 Awarding of the VDA 6.1 Certificate Supplement (3rd Party):
1. A VDA 6.1 Certificate Supplement to an ISO 9001/9002 certificate is awarded at an overall level of compliance exceeding 90% (the level of compliance [%] is not shown on the VDA 6.1 Certificate Supplement).
Exception:
A VDA 6.1 Certificate Supplement will not be awarded, if
- one or more quality elements achieve a level of compliance below 75% or
- one or more questions marked with * are graded with less than 8 points or
- one question not marked with * is graded with 0 points. 2. Follow-up /Re-audit
A follow-up audit is possible within 90 days after completion of the audit under the following conditions (Status : Open):
a) a maximum of one question marked with * was graded with 0 points and/or
b) one or more questions marked with * were graded with 4 or 6 points and/or
c) one or more questions not marked with * were graded with 0 points and/or
d) no element achieved a level of compliance below 75%
A VDA 6.1 Certificate Supplement is awarded after a follow-up audit, if all questions marked with * are rated with at least 8 points and all questions not marked with * are rated with at least 4 points.
3.4 Summary of Results
The results of the quality system audit of Part M (management) and Part P (product and process) are to be presented as shown in the sample forms (Chapter 8). The results of each element will be entered on the sheet "Summary of Results".
3.5 Close out Meeting and Report
In the course of a close out meeting regarding the quality system audit, the auditor informs the audited company's management which nonconforman-ces are present and to what extent corrective actions are nenonconforman-cessary. These will be presented in an summary sheet "Nonconformances/Corrective Actions". After completion of the quality system audit, the auditor raises an audit repot and establishes a time schedule with the audited company for the corrective actions (see sample forms – Chapter 8). If necessary, a follow-up audit date is agreed.
3.6 Corrective Actions
The result of the quality system audit, presented as shown in the main paragraphs 3.4 and 3.5 above, serves the management of the audited com-pany as a basis for corrective actions. It is the duty of the audited comcom-pany to work out and implement an improvement program. This has to be communicated to the lead auditor responsible for heading the audit. The auditor decides on the basis of the presented improvement program to what extent a follow-up audit is carried out.
3.7 VDA 6.1 Certificate
A VDA 6.1 certificate can only be awarded if the overall rating achieved is A (see 3.3.3). A precondition for this is that the auditor is registered as a Lead Auditor with the VDA. The representative of the certifying body applies for the VDA 6.1 certificate from the VDA at the request of the company being audited.
The awarding of a VDA 6.1 certificate may also be carried out under consideration of existing certificates according to DIN EN ISO 9001/9002 or QS 9000 with supplementary auditing (see VDA Volume 6).
VDA
VERBAND DER AUTOMOBILINDUSTRIE E. V.VDA 6.1-URKUNDE
Unternehemen: Betriebsteil: Produktgruppe/n:Es wurde nachgewiesen, daß das Unternehmen ein
Qualitätsmanagement-System nach VDA 6, Teil 1
des Qualitätsstandards der deutschen
Automobilindustrie“
auf Grundlage DIN EN ISO 9001 / 9004-1
wirksam eingeführt hat.
Nachweis mit/ohne Produktentwicklung.
Ausgestellt am: gültig bis:
Das Audit wurde durchgeführt von: Registriert VDA Nr. ________
_________________________
Firma / Unterschrift des Bevollmächtigten Lead-Auditor(en): __________________ _________________________________
4 Definitions
For each of the individual elements definitions and explanations of terms are given within the questionnaire. Generic terms are briefly summarized in the following. (The numbering according to # corresponds to the DIN EN ISO Standard 8402/1995).
4.1 General terms according to DIN EN ISO 8402/1995 (Extract)
#.1.1 Unit
That which can be individually described and examined.
Note: A unit can be e.g.:
- an activity or a process (1.2) - a product (1.4)
- an organization (1.7), a system or a person or any combination thereof.
#.1.2 Process
A set of interactive resources and activities which transform inputs into out-puts.
Note: Resources can include personnel, finances, plants, equipment, techniques and methods.
#.1.3 Procedure
A defined manner in which an activity is carried out.
Note 1: In many cases procedures are documented (e.g. procedures of a quality system (3.6)).
Note 2: When a procedure is documented, the terms "written procedure" or a "docu-mented procedure" are often used.
Note 3: A written or documented procedure normally contains the purpose and scope of application of an activity; what needs be done and by whom; when, where and how it needs be done; which materials, equipment and documents have to be used; and how these must be controlled and recorded.
#.1.4 Product
The result of activities and processes (1.2).
Note 1: The term product may include a service (1.5), hardware, processed materials, software or combinations thereof.
Note 2: A product can be tangible (e.g. assemblies or processed materials) or intangible (e.g. knowledge or concepts) or a combination thereof.
Note 3: A product can be intended (e.g. offered product to customers (1.9)) or unintended (e.g. pollutants or unwanted effects).
#.1.5 Service
The result generated at the interface between the supplier (1.10) and the customer (1.9), as well as by internal activities of the supplier (1.10) to meet the customer needs.
Note 1: The supplier or the customer may be represented at the interface by personnel or equipment.
Note 2: Customer activities at the interface with the supplier may be essential to the service provision (1.6).
Note 3: Supply or use of tangible products (1.4) may form part of the service provision. Note 4: A service may be linked with the manufacture and supply of tangible product.
#.1.7 Organization
A company, corporation, business, enterprise or institution or part thereof, registered or non-registered, public or private, with its own functions and administration.
#.1.9 Customer
The recipient of a product (1.4) provided by the supplier (1.10).
Note 1: In a contractual situation, the "customer" may be called "purchaser" (1.11). Note 2: The customer can be, for example, the end user, user, beneficiary or
purchaser.
Note 3: The customer, in relation to the organization, may be either external or internal.
#.1.10 Supplier
The organization (1.7) which provides a product (1.4) to the customer (1.9).
Note 1: In a contractual situation, the supplier may be called the "contractor" (1.12). Note 2: A supplier may be, for example, the producer, distributor, importer, assembler
or service organization.
Note 3: The supplier can be either external or internal.
4.2 Quality-related Definitions according to DIN EN ISO 8402/1995 (Extract)
#.2.3 Quality Requirements
The formulation of needs or their conversion into a set of established quanti-tative or qualiquanti-tative requirements for the characteristics of a unit (1.1), to enable its realization and verification.
Note 1: It is essential that quality requirements fully reflect the established and given needs of the customer.
Note 2: The term "requirement" includes market-based, contractual, as well as internal requirements of a company (1.7). They may be developed, defined and updated in the various planning phases.
Note 3: Established quantitative requirements of the characteristics include e.g. nominal values, ratings, limit deviations and tolerances.
Note 4: The quality requirements should be expressed in functional conditions and be documented.
#.2.15 Inspection and Testing
Activities such as the measuring and examining of one or more characte-ristics of a unit (1.1), as well as comparing of the results with set require-ments, to establish, whether conformity (2.9) for every characteristic has been reached.
#.2.17 Verification
Confirmation based on an examination and the provision of evidence (2.19) that established requirements have been met.
Note 1: In design and development, verification concerns the process of evaluating the result of a given activity to determine the conformity (2.9) of this activity with the set requirements.
Note 2: "Verified" is used to describe the corresponding status.
#.2.18 Validation
Confirmation based on an examination and provision of evidence (2.19) that the special requirements have been fulfilled for a given application.
Note 1: In design and development, validation concerns the process (1.2) of exa-mining a product (1.4) to determine its conformity (2.9) with the needs of the user.
Note 2: Validation is normally performed on the end product under defined operating conditions. It may be necessary at an earlier stage.
Note 3: The term "validated" is used to describe the corresponding status. Note 4: Multiple validations can be carried out, if different applications are intended.
4.3 Definitions for Quality Systems according to DIN EN ISO 8402/1995 (Extract)
#.3.1 Quality Policy
Comprehensive intentions and objectives of an organization (1.7) with regard to quality (2.1), as formally defined by management.
Note: The quality policy is an element of the corporate policy and is approved by the management.
#.3.6 Quality System
The organizational structure (1.8), procedures (1.3), processes (1.2) and resources required for the realization of quality management.
Note 1: The quality system should be as comprehensive as required to meet the quali-ty objectives.
Note 2: The quality system of a company (1.7) is aimed primarily at satisfying the internal needs of the company. It is more extensive then the requirements of a single customer (1.9) who only evaluates the part of the quality system relevant (to him).
Note 3: For contractual or other obligatory purposes of quality assessment (4.6), de-monstration of the implementation of defined quality system elements may be required.
#.3.12 Quality Manual
A document stating the quality policy (3.1) and describing the quality system (3.6) of an organization (1.7).
Note 1: A quality manual may relate to the entire company activity or just parts of it. Title and purpose of the manual reflect the scope of application.
Note 2: A quality manual normally contains or refers at least to: a) he quality policy;
b) the responsibilities and authorities (jurisdiction), as well as the interrelations personnel who manage, perform, assess or evaluate quality-related vities;
c) the procedures (1.3) of the quality system (3.6) and corresponding structions;
d) a stipulation for reviewing, revision and administration of the manual. Note 3: A quality manual may differ in comprehensiveness and format in order to
refelct the needs of a company. It may consist of more then one document. Depending on the purpose of the manual, a title may be used such as „Quality assurance manual“ .
4.4 Definitions for Tools and Techniques according to DIN EN ISO 8402/1995 (Extract)
#.4.9 Quality Audit
Systematic and independent examination to determine, whether the quality-related activities and quality-related results comply with planned instructions and whether these instructions are actually implemented and are suitable to meet the objectives.
Note 1: The quality audit is typically applied, but is not limited to a quality system (3.6) or elements thereof, processes (1.2) or products (1.4) (including services (1.5)). Such quality audits are often called "System Audit", "Process Audit", "Product Audit" or "Service Audit".
Note 2: Quality audits are carried out by persons who have no direct responsibility in the area to be audited, however, preferably they should be working together with the relevant personnel.
Note 3: One purpose of a quality audit is to evaluate the need for improvement or corrective action (4.14). A quality audit should not be confused with the activities of quality monitoring (4.7) or reviewing (2.15) which are carried out for process control or material receiving.
Note 4: Quality audits may be carried out for internal or external purposes.
#.4.10 Quality Audit Findings
#.4.14 Corrective Action
An action taken to eliminate the causes of an existing nonconformity (2.10), defect (2.11) or other undesirable situation in order to prevent its recur-rence.
Note 1: Corrective actions can bring about changes in e.g. procedures (1.3) and systems to achieve quality improvement at any stage of the quality cycle (4.1). Note 2: One has to differentiate between a "correction" and a "corrective action":
- A " correction" concerns a repair (4.18), a rework (4.19) or an adjustment and refers to the treatment of an existing nonconformity;
- A " corrective action" refers to the elimination of the cause of the formity.
4.5 Additional Terms (Definitions for the present volume)
4.5.1 System
The structure of a company in which the jurisdiction (responsibilities, autho-rities) and interrelations, as well as procedures (#.1.3) and processes (#.1.2) are defined with the necessary resources for the realization of a task.
4.5.2 Method
A scheduled procedure (#.1.3) to given means and a given purpose which leads to technical proficiency in the solution of theoretical and practical tasks.
4.5.3 Serial Production
The manufacturing of products (#.1.4) of the same type and design, in recurrent orders.
4.5.4 Quality Procedures
Quality procedures are specific instructions that are required in order to fulfil given quality-related activities. They are to be put into force by signature.
4.5.5 Work Instructions (Inspection and Testing Instructions)
Detailed description of the working steps of an activity. Definition of indivi-dual activities and detailed instructions, order-neutral, as well as order-re-lated.
5 Cross-reference List of Paragraph Numbers for Correspon-ding Topics (accorCorrespon-ding to DIN EN ISO 9000-1, Appendix D, 1994-08)
Cross-reference list which gives the paragraph numbers for corresponding topics of the questionnaire of Chapter 7 to the paragraphs and subpara-graphs of the standards DIN EN ISO 9001, 9002, 9003 and 9004-1.
VDA- Ques-tionnaire N°. Paragraph Title according to 9001 / (9004-1)
Corresponding paragraph or sub-paragraph No. in the standard
DIN EN ISO
9004-1 9001 9002 9003
01 Management responsibility 4, 5 4.1 l l m
02 Quality system (quality system elements) 5 4.2 l l m
03 Internal quality audits (auditing the quality system) 5.4, 5.5 4.17 l l m
04 Training (Personnel) 18 4.18 l l m
05 Financial considerations of quality systems 6 − − − −
06 Product safety 19 − − − −
Z1 Corporate strategy − − − − −
07 Contract review (Quality in marketing) 7 4.3 l l l
08 Design control - product design (Quality in specification and design)
8 4.4 l − −
09 Process planning - process design (8) (4.4) − − −
10 Document and data control (Quality documents) 17, 17.3, 5,3 4.5 l l l
11 Purchasing (Quality in purchasing) 9 4.6 l l −
12 Control of customer-supplied product − 4.7 l l l
13 Product identification and traceability (Material control, traceability and identification)
11.2 4.8 l l m
(Process control) 11.4-11.6 4.9 l l −
Insp. and test status (control of insp. & test status) 11.7 4.12 l l l
14 Process control (quality of processes) 10 4.9 l l −
15 Inspection and testing (Product verification) 12 4.10 l l m
16 Control of inspection, measuring and test equipment 13 4.11 l l l
17 Control of nonconforming product 14 4.13 l l m
18 Corrective and preventive action 15 4.14 l l m
19 Handling, storage, packaging, preservation and delivery (post-production activities)
16.1, 16.2 10.4
4.15
l l l
20 Control of quality records (quality documents/records) 17, 17.2 4.16 l l m
21 Servicing, (post-production activities) 16.4, 16.5, 16.6, 7.3 4.19 l l − 22 Statistical techniques 20 4.20 l l m
Italic: Elements which extend beyond the scope of the standard
Key:
l
ffull requirementm
less comprehensive than ISO 9001 and 9002−
6 Structure and Number of Questions per Quality Element
Page No. of questions
M Management
01 Management Responsibility
DIN EN ISO 9001, Section 4.1 DIN EN ISO 9004-1, Section 4
39 6 02 Quality System
DIN EN ISO 9001 Section 4.2 DIN EN ISO 9004-1, Section 5
47 6 03 Internal Audits
DIN EN ISO 9001, Section 4.17 DIN EN ISO 9004-1, Section 5
57 4 04 Training, Personnel
DIN EN ISO 9001, Section 4.18 DIN EN ISO 9004-1, Section 18
63 7 05 Financial Considerations of Quality Systems
DIN EN ISO 9004-1, Section 6
71 4 06 Product Safety
DIN EN ISO 9004-1, Section 19
75 4
Z1 Company Strategy 81 5 Subtotal of questions in section M 36
Page No. of questions
P Product and Process
07 Contract Review, Quality in Marketing 9001, Section 4.3 / 9004-1, Section 7
77 5
08 Design Control (Product Design) 9001, Section 4.4 / 9004-1, Section 8
83 7
09 Process Planning (Process Design) 9001, Section 4.4 / 9004-1, Section 8
91 7
10 Document and Data Control
9001, Section 4.5 / 9004-1, Section 17.3
99 4
11 Purchasing
9001, Section 4.6 / 9004-1, Section 9
105 7
12 Control of Customer Supplied Product. 9001, Section 4.
113 4
13 Product Identification and Traceability (Process Control, Inspection and Test Status)
9001, Section 4.8 (4.9, 4.11, 4.12)/9004-1, Section11
117 7
14 Process Control
9001, Section 4.9 / 9004-1, Section 10
125 7
15 Inspection and Testing (Product Verification) 9001, Section 4.10 / 9004-1, Section 12
133 6
16 Control of Inspection Measuring and Test Equipment. 9001, Section 4.11 / 9004-1, Section 13
139 5
17 Control of Nonconforming product 9001, Section 4.13 / 9004-1, Section 14
145 4
18 Corrective and Preventive action
9001, Section 4.14 / 9004-1, Section 15
149 4
19 Handling, Storage, Packaging, Preservation and Delivery
9001, Section 4.15 / 9004-1, Section 16
155 6
20 Control of Quality Records
9001, Section 4.16 / 9004-1, Section 17.2
159 4
21 Servicing, (After Sales and Post-production Activities) 9001, Section 4.19 / 9004-1, Section 16
163 5
22 Statistical Techniques
9001, Section 4.20 / 9004-1, Section 20
167 6
Sub-total of questions in section P 89
7 Quality System Audit Questionnaire
For application in companies which manufacture tangible products
STRUCTURE
For every quality element the general requirements are described in an in-troduction, the subject in its context is briefly explained and the questions are stated..
In addition, reference is made to other applicable VDA Volumes which are to be considered during the realization of the quality system. Equal proce-dures and processes are permitted.
Questions on the quality system which have a special influence on the product or process or may lead to the failure of the quality system are mar-ked with an *.
Each question is structures as follows:
1. The Question 2. Definition
Where required, the terms used in the question are defined according to the relevant standard and the standard or an extract thereof is cited. The source is stated respectively.
Explanation of terms
Where required, the terms used in the question are explained, if no defini-tion is given, to provide a better understanding.
3. Requirements/Explanations
In the section ‘Requirements/Explanations’, requirements on the quality system are defined and supplemented by an explanations, if necessary.
Part M: Company Management
01 Management Responsibility
DIN EN ISO 9001, Section 4.1 DIN EN ISO 9004-1, Section 4, 5
The Management (e.g. Board of Management, Plant Manage-ment, Section Management) develops the quality policy for the company, defines it and commits all areas and levels to it. Hereby specific quality objectives and a quality management system (quality system) are to be agreed. Quality must be regarded as an overall management task.
"Management" describes the organizational unit within the com-pany that is responsible for profit and loss.
Reference DIN EN ISO 9001 9004-1 01.1
*
Has the quality policy been defined by mana-gement and has it been made known to all levels?
4.1.1 4.2 01.2
*
Have quality objectives been defined within the scope of corporate planning and the quality policy and are the results monitored?
4.1.1 4.3.1 01.3
*
Is a continuous improvement process part of the quality policy?
-- --01.4 Have the necessary resources been provided
by the company management?
4.1.2.2 5.2.4 01.5
*
Has a management representative been assigned and are his duties, authorities and responsibilities defined? 4.1.2.1 4.1.2.3 5.2.2 5.2.3 01.6 *
Does management regularly evaluate the effectiveness of the quality system?
01.1* Has the quality policy been defined by management and has it been made known to all levels?
Definition:
Quality Policy (according to EN ISO 8402/3.1):
The overall intentions and objectives of an organization with regard to quali-ty as formally expressed by the management.
Note: The quality policy forms one element of the corporate policy and is approved by management.
Requirements/Explanation:
The quality policy must be formulated in such a way that it can be under-stood, implemented and applied by employees at all levels The principles of the quality policy are to be described in a quality manual or an equivalent document (see Question 02.1).
The publication of the quality policy is achieved, for example, by - notices
- memoranda
- organizational guidelines and instructions
- informative presentations about the quality policy.
The quality objectives of the company are established from the quality policy (see Question 01.2) which are authoritative for the organization of the company and which incorporate the expectations of the customer(s).
Evidence is given by, for example, a declaration of commitment from management within the scope of the quality policy, according to which all quality requirements for activities, not only in production but in all organiza-tional units, are reliably fulfilled and the prevention of nonconformances has
01.2* Have quality objectives been defined within the scope of cor-porate planning and the quality policy and are the results monitored?
Explanation of terms:
"Quality objectives" are specifications for products, processes, operations and services, that are defined for all levels. These objectives are derived from customer requirements, the competitive situation, the legal environ-ment and internal requireenviron-ments, as well as adherence to the „zero defect strategy.“
Requirements/Explanation:
Objectives for quality within the scope of the quality policy might be, for example:
a) Corporate-wide objectives
• Fulfillment of the general company requirements (laws, regulations, directives)
• Improving market acceptance
• Making profit
• Ensuring the continued existence of the company
• Continuous quality improvement (see Question 01.3). b) Product-related objectives
• Scrap-/ failure rates (%)
• Supplier delivery quality (ppm)
• Improving product quality
• Improving process capability (Cpk)
• Improving reliability
• Environmental tolerance. c) Customer-related objectives
• Shortening of order processing time (inquiries, orders etc.) (difference in days)
• Improving customer satisfaction (e.g. reducing the number of customer complaints change %)
• Reduction in the reaction time when dealing with complaints (difference in days)
d) Higher objectives
• Reducing costs but not to the detriment of quality
• Advance quality planning (see Question 02.5)
• Increasing improvement suggestion activities (methods, equipment, operations etc.)
• Calculating and evaluating the costs assigned to all quality elements in order to minimize any loss of quality
• Monitoring the effectiveness of corrective actions on the basis of audit results
• Quality of the development of products and processes (time, menation, practicability, feasibility etc.)
• Quality system upgrade from ISO 9001/2 to VDA 6.1. Further ment towards TQM, EQA etc.
Note: The demonstration of achieved quality in comparison to objectives - see Question 04.7
The quality objectives to be agreed must be achievable and, if possible, measurable, as well as periodically revised and presented in a suitable format, e.g. using data processing systems. The achievement of objectives must be monitored thoroughly at all management levels (specified/actual comparison).
The objectives must be practically, clearly and comprehensively explained to the employees during informative discussions.
Without the definition of objectives, no efficient improvement in quality and increase in productivity in all company areas can be followed or achieved.
01.3* Is a continuous improvement process part of the quality policy?
Requirements/Explanation:
Improvement programs for the operating units and for the commercial and technical functional units of a company must be introduced and maintained. The methods cited elsewhere (see Questions 04.2 and 04.5) must be used here.
Items for improvement include, for example:
- Reducing non-value-adding activities (e.g. rework, repairs) - Simplification of processes/Optimization of production
methods.
- Minimization of waste
- Reducing unplanned down-time of machines - Shortening setting-up and tool change times
- Increasing service life/cycle times of products and equipment - Improving the ease of repair of products and equipment - Reducing water, air and energy expenditures
- Optimization of activity times - Improved handling in all areas
Note: Connections to Question 01.2 are possible. The working methods applied can be selected on a company-specific basis.
In the continuous improvement process, careful handling and economical use of resources must also be taken into account. This includes, for example:
- the logistical chain - the building / factory area - the equipment
- environmental protection
The strategy of continuous improvement applies to employees, all produc-tion processes, services and business operaproduc-tions of a company. It does not replace necessary innovative improvements. Improvements refer to, for example:
- Quality - Price - Service
01.4* Have the necessary resources been provided by the company management?
Requirements/Explanation:
So that the quality system can operate effectively, the company manage-ment has the task of providing the financial and personnel resources needed to fulfil the requirements in the quality elements. These include, for example:
- qualified staff with task-related capabilities for management, implementation and inspection activities (including project management)
- inspection and testing equipment for product development and manufacture
- computer support, e.g. for data analysis, graphic displays, sta-tistics, quality plans.
The effectiveness and efficiency of the quality system depends on the pro-vision of the necessary resources for the realization of the quality policy and the quality objectives.
Note: This question cannot be finally evaluated until the entire quality system has become transparent as a result of the audit and until it has been ascertained that all necessary resources are available.
01.5* Has a management representative been assigned and are his duties, authorities and responsibilities defined?
Explanation of terms:
The "Management representative" is the person who represents the inte-rests of management regarding strategic quality management at all mana-gement levels.
The representative must belong to the management team of the company, but does not have to be a member of the management. He/she always re-ports to that level of management, which is responsible for profit and loss.
Requirements/Explanation:
Responsibilities and authorities of the representative include: - Reporting on the quality situation
- Defining, realizing and maintaining the quality system in accor-dance with the requirements of this questionnaire, which inclu-des branch-specific adjustments
- Monitoring the strategic quality objectives
- Controlling and coordinating quality activities using interdiscipli-nary cooperation
- Demonstrating the effectiveness of the quality system and determining possible improvements.
Note: The representative may at the same time be responsible for the organizational functions "quality department", "quality assurance", "quality management„ etc.
01.6* Does management regularly evaluate the effectiveness of the quality system?
Definition:
Management Review (in accordance with DIN EN ISO 8402/3.9):
A formal evaluation by top management of the status and adequacy of the quality system (quality management system) with respect to the quality policy and quality objectives.
Requirements/Explanation:
Company management must periodically (at least once each year) assess and satisfy itself about the effectiveness of the established quality system. The aim of this assessment is to achieve a continuous optimization and adaptation to changed conditions (market, technology etc.). This can be done by collecting and evaluating the following information, for example:
- Reports on the quality situation - Regularly scheduled quality meetings
- Quality indices with respect to objectives (see Question 01.2) - Internal quality audit reports with derived measures (see
Ques-tion 03.2 and 03.3)
- Status of the continuous improvement process (see Question 01.3)
- Results of product and process analysis with corrective actions - Reports on customer satisfaction (see question Z1.4).
The review is carried out by comparing the findings with the objecti-ves of the quality policy and usually results in preventive and correc-tive actions.
02 Quality System
DIN EN ISO 9001, Section 4.2 DIN EN ISO 9004-1, Section 5
A quality system consists of the organizational structure, the res-ponsibilities, procedures, processes and resources for the imple-mentation of quality management.
The quality system is intended to promote continuous quality im-provement.
The quality system shall be defined and implemented by manage-ment, preferably in a quality manual and in supplementary docu-mented procedures or equivalent documentation.
Note: VDA Volume 4.3 is also applicable for this element.
Reference DIN EN ISO 9001 9004-1 02.1
*
Is the quality system described in a quality manual or an equivalent document?
4.2.1 4.2.2
5.3.2 02.2 Does the quality system encompass all areas,
levels and employees of the company?
4.1.2 5.1 5.2, 5.6 02.3
*
Are there documented procedures defining duties, responsibilities and authority levels for quality activities?
4.1.2.1 5.2.2 02.4
*
Is there a cross-functional project
management established which includes the quality planning process?
(4.4.3) 5.2.6 02.5
*
Is there a quality planning process for the necessary measures and procedures for fulfilling quality requirements?
4.2.3 5.3.3 02.6
*
Are there quality plans resulting from the quality planning process?
02.1* Is the quality system described in a quality manual or an equivalent document?
Definition:
Quality manual (according to DIN EN ISO 8402/3.12):
A document stating the quality policy and describing the quality manage-ment system of an organization. (see Paragraph 4.3 #3.12).
Requirements/Explanation:
All quality elements necessary for conducting the business of a company must be described in the quality manual with reference to applicable internal and external instructions, standards, regulations etc.
The documentation covers:
- Organizational structure
- Names of responsible individuals
- Implementation process for all activities affecting quality in the company.
The manual must display the approval of the company management, the validity date and the revision status. Responsibility for it’s updating, revision service and the distribution list must be defined. The main purpose of a quality manual is to define the structure of the quality system and, at the same time, to serve as a permanent reference for the implementation and maintenance of this system.
In addition, special processes can be separately defined in documented cedures, quality assurance plans etc. This also include instructions on pro-ject management (see Question 02.4).
02.2 Does the quality system encompass all areas, levels and employees of the company?
Definition:
Quality system/(Quality management system) (according to DIN EN ISO 8402/3.6):
The organizational structure, responsibilities, procedures, processes and re-sources needed to implement quality management.
Requirements/Explanation:
The quality system extends to all phases of the life cycle of a product (DIN EN ISO 9004-1 Paragraph 5.1) and all value-adding processes invol-ved. It’s interacting functions are a precondition for the continuous com-pliance with the requirements of customers, legislators and society.
A universal understanding of quality and quality assurance should extend as a „leading theme“ throughout the entire company. The understanding of quality management as a task of all employees can be demonstrated by, for example:
- actions including various departments
- appropriate training, presentations, publications - department-related objectives for quality improvement - responsibilities matrices.
Job descriptions and organization charts serve, among other things, to endorse employees, clarify relationships at interfaces and provide evidence of relevant duties. They make the organization transparent, simplify person-nel qualification and assignment and promote motivation and enthusiasm for decision-making.
02.3* Are there documented procedures defining duties, responsi-bilities and authority levels for quality activities?
Explanation of terms:
„Activities affecting quality“ relate both preventatively and reactively to the entire life history of a product.
"Quality documented procedures" are special stipulations which are necessary for the fulfillment of the defined quality-related activity. They come into effect when signed.
Requirements/Explanation:
Duties, responsibilities and authorities are to be unambiguously and clearly defined for those departments and employees which influence product and process quality. Thereby, coordination and interfaces between various de-partments and activities must be observed.
These definitions are best made, for example, in: - Quality documented procedures - Responsibility matrices
- Job descriptions,
which come into effect when signed. Hereby, it must be ensured that duties are clearly defined with the necessary independence to fulfill stipulated requirements. This requires a definition as to who, for example:
- can stop faulty products or processes
- is responsible for suggesting and monitoring problem solutions - monitors conformity with quality requirements, particularly after
changes
02.4* Is there a cross-functional project management established which includes the quality planning process?
Explanation of terms:
„Project management“ is defined as the management of activities across several departments within a company, aimed at the realization of a particu-lar project (e.g. introduction of a new product [see Question 08.1], a new process, start of a series [see Element 14]). This task begins as early as possible and encompasses the concept/design phase, the manufacturing process, through to product utilization and disposal. It includes, among other things, quality planning (see Question 02.5) and the quality plan (see Question 02.6).
Requirements/Explanation:
Project flow charts with the main details, among other things for the mana-gement of a project, must be raised and developed at a very early stage. Here, the joint activities include:
- raising the specification - concept / design, - development - production - utilization - disposal
which must be outlined and explained in the context of simultaneous engi-neering taking interface issues into account. Quality methods (such as QFD, DFMEA, PFMEA, DOE,...) must be applied on a project-specific basis. Depending on the task, the project team should include staff from De-velopment, Production Planning, Quality and Production departments etc. The Purchasing department and suppliers must be included when neces-sary.
The duties and responsibilities must, for example, be defined in project plans or respectively, in product and process development plans. The appointment of a project representative (project manager) is advantageous for all projects. In the case of new projects, it must be ensured that confidentiality, protection and security of data is guaranteed through appro-priate procedures for those involved in the project. Suppliers, if necessary, are also be included.
Note: The requirement for a "Configuration management" in the standard DIN EN -ISO 9004-1, Section 5.2.6 and 8.10, is interpreted as "Project management " in this questionnaire (also see DIN 69905[12.90] - Project implementation).