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Huh?
OBSOLETE as of 4/1998
Note: because these interpretations are now a binding extension of the
QS-9000 Chrysler/Ford/General Motors Quality System Requirements,
February 1995, Second Edition, they should be a part of every QS-9000
supplier's Contract Review documentation, and every QS-9000 registrar's
audit information file.Their FAX mail box for submission of interpretation requests is:
CONTACT: Peter B. Lake - Chairman, IAAR Auto Sector Committee Contact for the International Automotive Sector Group, IASG, at the (*NEW*) IASG FAX MAIL BOX: (412) 940-1004.
I know of no other way to get in touch with these folks. These have been 5 releases (as of right now):
- 8/25/95
- 11/9/95
- 2/15/96 (Hastily Withdrawn...)
- 3/22/96
- 10/18/96 (Contained Herein)
I know of no others that exist (other than the February 1996 release which was withdrawn due to all the errors and disagreement within the Fax Committee...). You will definitely want these as well as each of the referenced AIAG Manuals... If YOU know of any other interpretation sources, please leave me e-mail! These are considered to be external documents which must be controlled!
One of the major problems of QS 9000 is illustrated by the existance of this 'service' - the document was released with serious ambiguities and flaws. This will cost companies and registrars alike money and time, not to mention frustration.
Note: Red type (like this, although not always BOLD type...) is NOT part of the interpretations. They are my COMMENTS and thoughts...
Blue type is ORIGINAL text - my emphasis.
October 18, 1996 To be used by Chrysler/Ford/General Motors Recognized Accreditation Bodies
QS-9000 Qualified Registrars, Suppliers and Interested PartiesTable of Contents
I. INTRODUCTION
A. IASG Membership
B. How to CommunicateII. QS-9000 INTERPRETATIONS
A. General - Structure
B. Table of Contents - Interpretations
C. Interpretations
D. QS-9000 InformationIII. APPENDICES
A. IASG Protocol
B. Registrar Training Schedule
C. Accreditation Bodies Recognized by Chrysler, Ford, GM To Qualify Registrars For QS-9000
D. IASG List of QS-9000 RegistrarsCopyright © October 18, 1996. All rights retained by Chrysler, Ford and General Motors, with permission given to members of the IASG, Chrysler/ Ford/General Motors recognized accreditation bodies, accredited ISO 9000 registrars, automotive OEM customers and suppliers, and industry media, to reproduce this document for the purposes of improving the understanding and communication of QS-9000 interpretations. This copyright must be displayed.
OK - It's displayed
CONTACT: Peter B. Lake (*NEW*IASG FAX MAIL BOX: 412/940-1004)
Chairman, IAAR Auto Sector CommitteeContact for the International Automotive Sector Group, IASGI. INTRODUCTION
A. IASG MEMBERSHIP
The International Automotive Sector Group (IASG) is an international ad hoc working group consisting of representatives from:
1. Big Three Recognized Accreditation Bodies (Four)
2. QS-9000 Qualified Registrars (currently five from the Independent Association of Accredited Registrars, IAAR, and one each from the IIOC and EQNET.
3. Representatives of the Chrysler/Ford/General Motors Supplier Requirements Task Force (Three)
4. Tier 1 Automotive Suppliers (Two from North America)
The group meets periodically to discuss and resolve interpretation issues relative to the QS-9000 criteria and third party registration of auto suppliers to QS-9000. The attached "agreed" upon interpretations are sanctioned and recognized by the Chrysler, Ford, General Motors Supplier Quality Requirements Task Force, the participating ISO 9000 accreditation bodies and QS-9000 qualified registrars. The IASG intends to provide periodic releases of new and revised/updated QS-9000 interpretations for all interested parties.
The current participating members of the IASG are:
* Big Three Recognized Accreditation Bodies: Paul Fortlage, RAB; Peter Tempelman, RvA; Thomas Facklam, TGA; Steve Keeling, PAC.
* Chrysler/Ford/General Motors Supplier Quality Requirements Task Force: Warren Norrid, Chrysler; R. Dan Reid, General Motors; Steve Walsh, Ford.
* QS-9000 Qualified Registrars: From IAAR: Peter Lake (IASG Contact), Bob Levine, Malcolm Phipps, Michael Hochschwender, Royce Hoggard, From IIOC: Peter Herrmann, From EQNET: Mike Catling.
* Automotive Suppliers: Brenda Dusek; Tom Turnbull
This release was sanctioned, and its interpretations considered binding, by the Chrysler/ Ford/ General Motors Supplier Quality Requirements Task Force and the IASG, effective January 1, 1997, unless otherwise noted herein.
B. HOW TO COMMUNICATE
To submit questions or issues to the IASG for consideration, Fax inquiries, in English, to the (*New*) IASG Fax Voice Mail Box (412/940-1004). To obtain a copy of the latest IASG Sanctioned QS-9000 Interpretations, or an updated list of QS-9000 qualified registrars, or QS-9000 registered suppliers, call the American Society of Quality Control at 1/800/248-1946 or 414/272-8575, or obtain a copy from the ASQC QS-9000 Web Site at http://www.asqc.org/9000. In Europe, contact Carwin Continuous, Ltd. at Telephone No.: 01-708-861333 or Fax No.: 01-708-867941.
II. QS-9000 INTERPRETATIONS
A. GENERAL
Structure
A question and current IASG answer is labeled by a sequential reference number and a letter referring to the category in which it is found. Subsequent changes in an interpretation question and answer will show the same category/sequential number, but a new "Revision" date is so noted in the Table of Contents. Answers are valid as of the date they were agreed upon. All references are to QS-9000:1995, February, Second Edition, unless otherwise stated.
Responses to which the IASG have agreed, are grouped by the following categories:
A = Applicability
B = Appendix B: Code of Practice
C = Criteria: Subdivided by the 23 QS-9000 Elements within Sections I, II, III
D = Database
O = Other
L = Laboratory issues
P = Process
R = Registration/Accreditation
T = Training
This may help simplify things somewhat.
Interpretations were edited for simplification and are now dated October 18, 1996. Only Item R13 shows an underline for changes from the March 22, 1996 release. Any questions for the IASG should be directed to the (*New*) IASG Fax Mail Box at: 412/940-1004, for consideration in the first of two planned 1997 releases.
Summary - Key Changes or Additions for October 17, 1996 Release:
All interpretations have been reviewed and subjected to simplification, some deleted, some combined with others.
New additions include:
- a new cross-referenced index should help locating the appropriate interpretation;
- changes to the Appendix H , R13 interpretation, include more flexibility in scheduling surveillances; and
- clarification for companies not supplying the "Big 3" who want to become QS-9000 registered.
Readers should review again all pertinent interpretations, especially Section II.1 on PPAP.
Note: because these interpretations are a binding extension of the QS-9000 Chrysler/Ford/General Motors Quality System Requirements, February 1995, Second Edition, they should be a part of every QS-9000 supplier's Contract Review documentation, and every QS-9000 registrar's audit information file.
B. TABLE OF CONTENTS OF SANCTIONED QS-9000 INTERPRETATIONS
1. Interpretations
A. Applicability
B. Appendix B: Code of Practice
C. Criteria: Subdivided by the 23 QS-9000 Elements within Sections I, II, III
D. Database
O. Other
L. Laboratory Issues
P. Process
R. Registration/Accreditation
T. Training2. Information
A. Applicability
B. Appendix B: Code of Practice
C. Criteria: Subdivided by the 23 QS-9000 Elements within Sections I, II, III
D. Database
O. Other
L. Laboratory Issues
P. Process
R. Registration/Accreditation
T. Training
Agreed Upon Interpretations of October 18, 1996
INDEX Status Key:
A - Simplified does not mean that the interpretation has been "revised."
Only those revised in ACTIVE content will show a revision date.
D - DeletedType Key:
1. - Interpretation
2. - Information
Interpretation Number
Description of Interpretation
Status
Type
Revision Date
Page Number
Applicability
A01
D
A02
Eligibility for Registration
A
1.
13
A03
QS-9000 Certificate
A
1.
10/18/96
13
A04
QS-9000 Registration Requirements
A
2.
51
A05
D
A06
QS-9000 in Europe
A
2.
51
A07
D
A08
Witness Audit Must Be a Tier I Supplier
A
1.
13
A09
QS-9000 for Software Supplier
A
1.
13
A10
TE Registration not Permitted
A
2.
51
A11
Design Responsibility
A
1.
10/18/96
14
A12
D
A13
Section III. Compliance
A
1.
14
A14
D
A15
D
A16
Semiconductor QS-9000 Supplement
A
2.
52
A17
D
A18
Tier 2 (Subcontractors)
A
1.
14
A19
"Product" vs. "Material"
A
1.
14
A20
European GM Requirements
A
2.
52
A21
D
A22
Packager's Eligibility for Registration
A
1.
10/18/96
14
A23
D
A24
Combined with A22
D
A25
D
A26
Product includes Auto and Non-Auto
A
1.
14-15
A27
D
A28
Eligibility for Registration
A
2.
52
A29
Delco Electronics
A
2.
52
A30
D
A31
Truck Aftermarket Supplier
A
1.
10/18/96
15
Code of Practice
B01Registrar Affiliate Consulting
A
1.
10/18/96
15
B02
D
B03
Combined with B01
D
B04
Audit Team Requirements
A
1.
15
B05
Unlisted Registrars and QS-9000
A
1.
15
B06
D
B07
D
B08
"TickIT" Software Scheme
A
1.
16
B09
D
B10
Registrar Issuance of Certificates
A
1.
10/18/96
16
B11
Registrar Training - Eligibility to Attend
A
2.
52-53
B12
Monitoring Registrars
A
2.
53
B13
D
B14
Covered in B01
D
B15
Consulting
A
1.
10/18/96
16
B16
Handling Confidential Material
A
2.
53
B17
Audit Frequency - Design
A
1.
10/18/96
16
B18
Registrar Reporting Format
A
2.
53
Criteria
C01(QS-9000 Section Reference)
D
C02
PPAP Requests (Section II.1)
A
1.
10/18/96 2
8
C03
Documents at Supplier (Section II.1)
A
1.
28
C04
D
C05
Verbal Documentation (4.13)
A
1.
25
C06
Obsolete Specifications (4.5)
A
1.
19
C07
D
C08
Working Environment (4.9)
A
1.
21
C09
Control Plan Customer Signature (4.9)
A
1.
10/18/96
22
C10
Cost / Price Elements (Section II.2)
A
1.
33
C11
Business Plans are Controlled Documents (4.1)
A
1.
17
C12
Product Status Identification (4.12)
A
1.
25
C13
D
C14
D
C15
D
C16
PPAP Waiver (4.9)
A
1.
10/18/96
22
C17
Final Inspection - Responsibility (4.10)
A
1.
24
C18
D
C19
D
C20
Flow Charts (4.2)
A
1.
17
C21
Approved Subcontractor List (4.6)
A
1.
20
C22
Quality Manual Responsibility (4.2)
A
1.
17
C23
Approved Materials (4.6)
A
1.
20
C24
D
C25
Disposal - Quality Records (4.16)
A
1.
10/18/96
26
C26
Glossary of Terms (4.2)
A
1.
10/18/96
17
C27
Internal Audit (4.17)
A
1.
27
C28
After-Sales Servicing (4.19)
A
1.
27
C29
Special Characteristics Designation (4.5)
A
1.
10/18/96
19
C30
D
C31
D
C32
Prototype Control Plans (4.2)
A
1.
17
C33
Training Effectiveness (4.18)
A
1.
27
C34
Perishable Tools (4.9)
A
1.
22
C35
Waivers - CAD and ASN (4.4)
A
1.
10/18/96
18
C36
Appendix C and Special Characteristics (4.9)
A
1.
22
C37
Submissions / Waivers (Section II.1)
A
1.
28
C38
Purchase Orders (4.16)
A
1.
26
C39
Procedures / Job Instructions (4.9)
A
1.
10/18/96
22
C40
Subcontractor PPAP (Section II.1)
A
1.
29
C41
Subcontractor Development (4.6)
A
1.
20
C42
Process Changes (Section II.1)
A
1.
29
C43
Subcontractor Development (4.6)
A
1.
20
C44
D
C45
D
C46
D
C47
Product Changes - Lower Tiers (4.13)
A
1.
25
C48
Oil / Grease Suppliers (Section II.1)
A
1.
29
C49
D
C50
Combined with C11
D
C51
D
C52
Employee Owned Gages (4.11)
A
1.
24
C53
D
C54
Combined into C09
D
C55
Combined into C09
D
C56
Quality Manual Definition (4.2)
A
1.
17
C57
Combined into C09
D
C58
Quality Manual Organization (4.2)
A
1.
18
C59
Cross Functional Teams (4.1, Information Items)
A
2.
53
C60
Document Approval (4.5)
A
1.
19
C61
Subcontractor PPAP (Section III)
A
1.
10/18/96
34-35
C62
Restricted Substances (4.6)
A
1.
10/18/96
20
C63
Restricted Substances (4.6)
A
1.
20-21
C64
Distributors (4.6)
A
1.
21
C65
PPAP - Changes (4.9)
A
1.
10/18/96
23
C66
Documentation for Job Set-ups (4.9)
A
1.
23
C67
Continuous Improvement Plans (4.9)
A
1.
23
C68
D
C69
Calibration vs. Verification (4.11)
A
1.
24
C70
D
C71
Production Scheduling vs. Forecasts (4.15)
A
1.
10/18/96
26
C72
Active Parts - Service (4.16)
A
1.
27
C73
Emergency Runs (Section II.1)
A
1.
29
C74
D
C75
Master Sample Waiver (Section II.1)
A
1.
30
C76
Design Centers (Section II.1)
A
1.
30
C77
Tool Definition (Section II.3)
A
1.
33-34
C78
Ownership and Identification (Section II.3)
A
1.
34
C79
D
C80
CI Methodologies (Section II.3)
A
1.
34
C81
Evaluating Effectiveness (Section II.3)
A
1.
34
C82
Section III. Auditing (Section III)
A
1.
35
C83
D
C84
Document Identification (4.5)
A
1.
19
C85
D
C86
D
C87
D
C88
Equipment Affecting Product Quality (4.11)
A
1.
24
C89
D
C90
Customer-Owned Tools (Section III)
A
1.
35
C91
Supplier Lead Time (4.15)
A
1.
10/18/96
26
C92
Superseded Parts (Section II.1)
A
1.
10/18/96
30
C93
Waiver; Appearance (Section II.1)
A
1.
10/18/96
30
C94
Customer Notification (Section II.1)
A
1.
30-31
C95
D
C96
D
C97
PPAP Retroactivity (Section II.1)
A
1.
31
C98
Die Combination Changes (Section II.1)
A
1.
31
C99
PPAP Package - Location (Section II.1)
A
1.
31
C100
D
C101
Proprietary Process (4.9)
A
1.
23
C102
Changes by Subscription (4.4)
A
1.
18-19
C103
Waivers (Section II.1)
A
1.
32
C104
Continuous Improvement Changes (Section II.2)
A
1.
33
C105
CI Scope (Section II.2)
A
1.
33
C106
Acknowledging Purchase Orders (4.3)
A
1.
18
C107
QS-9000 Registration For Companies Not Supplying "Big 3" (4.2)
A
1.
10/18/96
18
C108
Work Instruction Accessibility (4.9)
A
1.
10/18/96
23
C109
Ford's DCP Control Plan (4.2)
A
1.
10/18/96
18
C110
PPAP Warrant (Section II.1)
A
1.
10/18/96
32
C111
Rework Procedures (4.13)
A
1.
10/18/96
25
C112
Service Concerns (4.19)
A
1.
10/18/96
27
C113
Steel Processors as Subcontractors (Section II.1)
A.
1.
10/18/96
32
C114
Tracking Premium or Excess Freight (4.6)
A.
1.
10/18/96
21
C115
Use of Unapproved Suppliers (4.6)
A.
1.
10/18/96
21
C116
Calibration - Test Equipment (4.11)
A.
1.
10/18/96
24-25
C117
Written PPAP Approval prior to Shipment (Section II.1)
A.
1.
10/18/96
32
Database
D01Responses to Sanctioned Interpretations
A
2.
54
D02
D
D03
QS-9000 Database
A
2.
54
D04
Questions to IASG
A
2.
54
D05
ASQC Notification
A
1.
10/18/96
35-36
D06
D
D07
D
D08
QSA Software
A
2.
54
D09
D
D10
D
D11
IASG Subscriptions
A
2.
10/18/96
54
Other
O01Tooling & Equipment Supplement
A
1.
36
O02
D
O03
IASG Requests Confidential
A
2.
55
O04
IASG Registrar Requests
A
1.
36
O05
D
O06
Revision Status of 7 Pack
A
2.
55
Laboratory Issues
L01GM GP-10 Requirements
A
1.
37
L02
ISO Guide 25 Conformance
A
1.
37
L03
Subcontractor Laboratories
A
1.
37
L04
Auditor Qualifications
A
2.
37
L05
ISO Guide 25
A
1.
38
L06
D
Process
P01Supplier Audit Confirmation Route
A
2.
55-56
P02
Opportunities for Improvement
A
1.
38
P03
Customer Performance Requirements
A
1.
38
P04
Section III. Auditing
A
1.
10/18/96
38
P05
Use of QSA Checklist
A
2.
56
P06
D
P07
Auditing of In-house Lab Facilities
A
2.
56
P08
Compliance Regulations Auditing
A
2.
56
P09
Minimum Man-days - Surveillances
A
1.
38
P10
"Should" Requirements
A
1.
39
P11
D
P12
Pre-assessment Audit
A
1.
39
P13
Business Plan
A
1.
39
P14
Audit Scope
A
2.
56
P15
Remote Locations, e.g. Design Centers
A
1.
39
P16
Waiver Documentation
A
2.
56
P17
QSA for Second Party Audit
A
1.
10/18/96
39
Registration/
Accreditation
R01Multi-site Registration - Remote Locations, e.g. Design Center
A
1.
40
R02
Multi-site Registration Certificates
A
1.
40
R03
Nonconformity Definitions
A
1.
40
R04
QS-9000 Certificate Requirements
A
1.
10/18/96
40-41
R05
Witness Audit
A
1.
41
R06
No Registrar Endorsement
A
2.
57
R07
Combined with A08
D
R08
Local Operation
A
1.
41
R09
D
R10
Surveillance - Non-conformities
A
1.
41
R11
D
R12
Automotive Experience
A
1.
41
R13
QS-9000 Appendix H - Chart Revision
A
1.
10/18/96
41-45
R14
Registering Other Companies
A
2.
57
R15
D
R16
D
R17
IASG Role
A
2.
57
R18
D
R19
VDA Certification
A
1.
45
R20
D
R21
D
R22
D
R23
Changed to C107
D
R24
D
R25
D
R26
D
R27
D
R28
Recognition of Certificates - Registrars
A
1.
45
R29
QS-9000 Audit Team Requirements
A
1.
45-46
R30
Site Scope Clarification
A
1.
46
R31
Multi-Site Registration
A
1.
46
R32
D
R33
ISO 9000 Upgrades
A
1.
47
R34
Two Step QS-9000 Registration Process
A
1.
10/18/96
47
R35
Two Step Registration - Limitations
A
1.
47-48
R36
Remote Locations
A
1.
48
R37
Multiple Registrars - Same Company
A
1.
48
R38
D
R39
Multiple Products - Same Location
A
1.
49
R40
Remote Location Sampling
A
1.
49
R41
Use of Auditor Resources
A
1.
49
R42
D
R43
Authority for Certificate Issuance
A
1.
49
R44
Design Responsibility Requires QS-9000 / ISO 9001
A
1.
10/18/96
49
R45
Two-Step Registration Process
A
1.
10/18/96
50
Training
T01
D
T02
QS-9000 Training
A
2.
57
T03
Registrar Training
A
1.
50
T04
Copyright Permission for Training
A
2.
58
T05
D
T06
D
T07
D
T08
D
T09
Internal Auditor Qualifications
A
1.
50
Whew! A 13 page table!
APPLICABILITY (A)
A02 Eligibility for Registration
Can anyone be certified by a QS-9000 qualified third party registrar to QS-9000?
Only those suppliers meeting the "Applicability" definition are required to achieve compliance/registration. Any supplier or subcontractor "site" may elect to pursue third party registration; however, to obtain QS-9000 registration, all elements of QS-9000 must be assessed and complied with. Only "Servicing" (and "Design Control" for ISO 9002) may be determined as not applicable by the registrar.
"Site" is defined as locations at which production processes occur. Definition of "site" includes warehouses and distributors of production or service parts/materials except those that only stage material and ship. The definition does not include indirect suppliers or vehicle assembly plants. Providers of bulk or raw materials should contact the procuring division buyer to determine if their material is considered to be production material. Contact your customer if in doubt.
Remote locations, e.g. Engineering, Purchasing, must be audited by registrar as they support a "site", but they can not be a QS-9000 registered location.
The registrar must assure the Code of Practice, Appendix B, requirements are met.
A03 QS-9000 Certificates
Can a QS-9000 (ISO 9000) certificate be issued by anyone other than a "QS-9000 qualified" third party registrar?
No. The term QS-9000 is a protected copyright as property of the Big Three. Only those third party registrars accredited for QS-9000 by a Big Three recognized accreditation body are permitted to issue a registration certificate with the term QS-9000.
A08 Witness Audit Must Be a Tier 1 Supplier
Can the assessment of a Tier 1 supplier to a truck manufacturer listed in QS-9000 Section III be an acceptable witness audit for registrar qualification? If not, what is required for an acceptable witness audit candidate?
No. An acceptable witness audit for registrar qualification must include a supplier which meets all applicability requirements at the ISO 9001 level, and is a Tier 1 supplier of production or service parts to Chrysler, Ford, or GM.
Examples of suppliers which would not qualify for the witness audit are: Heat treaters, Platers, Painters, Strip or Slitting operations, Assembly-only operations. Those that qualify for witness audit are those that design and manufacture production parts (QS-9000/ISO 9001).
A09 QS-9000 for Software Supplier
Does QS-9000 apply to organizations developing only software to the Big Three?
No.
A11 Design Responsibility
We are a Tier 1 supplier to the automotive OEMs. How do we determine if we have "design responsibility"?
If the supplier has the authority to establish a new product specification, or change an existing product specification, for any product a supplier ships to an OEM customer, then they are design-responsible. Design responsible suppliers still must obtain customer approval prior to implementing any changes. Customer approval of a design-responsible supplier's product does NOT waive the supplier's design responsible status. Consult your procuring division buyer for further clarification if needed.
A13 Section III. Compliance
Our plants are being individually registered and certificated. If a specific plant supplies only to Ford and GM, is the plant also required to have Chrysler and other QS-9000 signatory requirements covered and registered?
A supplier can only be held accountable to the Section III requirements of its current customers. However, the supplier would be expected to have a documented policy and procedures stating that future order acceptance from additional OEMs would include their meeting of the additional Section III requirements, as appropriate. This must be monitored by the registrar in surveillances to determine if compliance with other customer requirements is appropriate, e.g. Element 4.3.
A18 Tier 2 (Subcontractors)
If I am a Tier 2 supplier (subcontractor), how do I treat my subcontractors?
QS-9000 does not address Tier 3 suppliers and those lower in the supply chain. It is recommended that you deploy compliance to ISO 9000 or QS-9000 elements through the supply chain as appropriate.
Watch out! As Appropriate is a catch all. you had best be able to explain what is and isn't appropriate...
A19 "Product" vs. "Material"
Can you define the difference between "product" and "material"?
In general, "product" is what you sell, "material" is, in part, what you use to produce the product you sell. Consult ISO 8402 for further guidance.
A22 Packager's Eligibility for Registration
We're a Tier 1 supplier that produces metal straps or off-the-shelf packaging material (e.g. cartons) for GM. We were requested by our customer to prepare for QS-9000 registration. Is the request correct?
Packaging material is generally considered an indirect material. Customers, on a case-by-case basis, have the right to require QS-9000 registration, reference A02. If you have concerns regarding the request, you should discuss them with your customer.
A26 Product Includes Auto and Non-Auto
We've been told that the ISO portion of QS-9000 applies to all products that we manufacture and sell... also that the automotive additions in QS-9000, written in the normal or bold print, only apply to product that is manufactured and sold to the automotive companies subscribing to the QS-9000 document. Is this correct?
The intent of QS-9000 was that all automotive customer quality system requirements be met with a single quality system, reference Appendix B, #3. Suppliers could (my BOLDing) apply this same quality system to non-automotive customers as appropriate.
A31 Truck Aftermarket Supplier
We design and manufacturer a product for the aftermarket. Do the requirements of QS-9000 apply in this situation?
No; aftermarket material is not included in the QS-9000 applicability statement. QS-9000 does apply, however, to suppliers of service parts and/or materials manufactured to original OEM specifications for customers requiring QS-9000.
APPENDIX B: CODE OF PRACTICE (B)
B01 Registrar Affiliate Consulting
A registrar's subsidiary provided on-site training and consulting on QS-9000 to Company Q. Will this prevent the registrar from doing QS-9000 registration later?
Registration is NOT allowed if the registrar or affiliate has provided quality system consulting to the same client in the last two years. On-site training is considered to be consulting.
B04 Audit Team Requirements
I understood that an audit team comprising a QS-9000 trained assessor plus an automotive industry expert would satisfy the requirements covering the audit team.
Does this same requirement apply to surveillance visits; this appears very restrictive and not necessary?
Can we cover these requirements by using a team with "combined" qualifications, covering all areas but not necessarily all trained assessors, QS-9000 trained, etc. We would be accompanied by technical experts if necessary?
In addition, can our surveillance visits include an automotive expert only when necessary, possibly every other visit.
All audit team members on all QS-9000 audits and surveillances must be QS-9000 qualified: Reference Appendix G, QS-9000:1995, Second Edition. At least one team member must have relevant "automotive industry experience."
B05 Unlisted Registrars and QS-9000
We plan to use (X) registrar as our QS-9000 registrar, however, (X) is not on the current list of accredited registrars.
They must be on the list; if not, they are not permitted to issue a QS-9000 registration certificate. However, registrars having achieved Step A.2 of Appendix G, QS-9000:1995, Second Edition, are permitted to complete no more than four assessments for QS-9000, one of which must be witnessed by the accrediting body.
B08 "TickIt" Software Scheme
I am writing to ask for clarification on the requirements, when embedded software is contained in the product and the software is developed and maintained by the manufacturer. The UK has a specific scheme for software (TickIT) including embedded software, where we have to use a competent auditor (TickIT registered). What are the requirements for these auditors? Will they need to have passed the QS-9000 course, even if they only audit the software activity?
TickIT and QS-9000 are separate schemes. All members of a QS-9000 audit team must be QS-9000-qualified (QS-9000:February, 1995, Appendix G, A.12).
B10 Registrar Issuance of Certificates
Depending on the structure of the registrar, could a witnessed assessment of a registrar's local operation allow the issuance of certificates by another affiliated office in a different country?
No. Any registrar office with a certification function (e.g. issuing of ISO 9000 certificates) must comply with Appendix G requirements. If a local operation wants to issue its own certificates, and thereby appear on the ASQC's official list of accredited certification bodies, then this local operation must fulfill EN 45012 in total; i.e. independently from the mother organization, but could of course make use of services of the mother organization, and must meet all Appendix G Requirements.
If this local operation is not fully independent, it will not be included on the ASQC's list. If the local operation is a part of the mother organization, then the focal operation's certificate issuance responsibilities are with the mother-organization. (See R43)
B15 Consulting
Many times the IASG suggests that the supplier go to his registrar to obtain clarification information. Is this considered to be consulting and therefore in conflict with Appendix B, Number 6?
No. Registrars must meet the requirements of EN45012, their accreditation body(ies) and QS-9000. Registrars may not give specific advice, or have any ownership in what you do to meet the QS-9000. But, they may answer questions on clarifying or interpreting ISO 9000 and QS-9000.
When communicating with a registrar I try to only present a 'proposed' system and ask if it's acceptable to preclude the appearance of 'consulting'. On the other hand, during a recent QS9 pre-audit one of the registrar's auditors said "we'll give you some pointers on how to make things work as we go through this" and they sure did. It was not, I assure you, UL...
B17 Audit Frequency - Design
Re: Appendix B, Number 7. A company has several sites, however, there is one corporate location that performs sales, design and purchasing for all of the other sites. Does this corporate site have to be assessed every six months?
No, the remote location, e.g. design center does not have to be visited every six months. Design centers and all "sites" should be audited at least once in each consecutive 12 month period for ISO 9001 with QS-9000 registrations. See P15 and R13 (Man-day Adjustment for "Corporate" Audit Scheme)
CRITERIA (C)
Section 1. ISO 9000-Based Requirements
4.1 Management Responsibility
C11 Business Plans are Controlled Documents
Is the business plan a controlled document or can it be treated as a quality record?
Business plans are not quality records by definition, however, they must be a controlled document.
Note here that a 'business plan' does NOT have to be in one document at one location, as I understand it (and I passed a QS9 audit this way). We showed several 'elements' existed and that when requisite meetings took place, each holder of a piece brought their piece and the 'whole' was discussed at that time.
4.2 Quality System
C20 Flow Charts
Does QS- 9000 require that flow charts be included in the policy and/or procedures manuals?
No. They are welcomed by most auditors however. Flow Charts are required for PPAP.
If you're not using flow charts heavily, you're missing the boat.
C22 Quality Manual Responsibility
When documenting our Quality Policy Manual for QS-9000, is it required to include a responsible department/individual?
Yes. See ISO 10013 and QS-9000, clause 4.2.1, and QS-9000 Glossary under "Quality Manual." This manual should also include cross-references to general procedures and subordinate procedures and should include responsibilities and authorities for each element of the quality system.
OK - so is it MUST or SHOULD?
C26 Glossary of Terms
There are some definitions in all of the QS-9000 manuals which seem at variance with definitions in ISO 8402. Will a glossary of terms with a single, standard definition be forthcoming?
Where there is inconsistent terminology between QS-9000 and ISO 8402 (or other similar documents, e.g., ISO A-3), QS-9000 takes precedence for QS-9000 registration.
Can this lead to a violation of an ISO 9001 requirement? Ummm, can you say INCONSISTENCY?
C32 Prototype Control Plans
Customers have not requested prototype control plans. Are we expected to have them?
Suppliers are required to have a prototype control plan if they are supplying prototype materials, regardless of whether the customer requests it to be submitted for review.
C56 Quality Manual Definition
On page 98 in the glossary of the February, 1995 Edition of QS-9000 is a definition for quality manual. "Quality manuals shall include responsibilities and authorities for each element of the quality system." Must the manual be written this way?
See ISO 10013 for discussion of the quality manual requirements. The quality manual includes not only policy, but also includes or cross-references to general procedures and subordinate procedures. Hence, each cross-referenced procedure is part of the quality manual, and must include responsibilities and authorities for each element of the quality system. The Glossary is meant to aid interpretation in order to answer the question completely.
Folks - this is in large part about assigning responsibilities and authority... Where else to define them?
C58 Quality Manual Organization
Is there a required structure for a Quality Manual, such as it be organized to correspond to the organization of topics in QS-9000 elements?
No.(My BOLDing) Auditors often prefer to see a quality manual organized corresponding to the elements (for improved audit efficiency), however, there are acceptable alternative methods such as use of a cross-referenced matrix that ties the QS-9000 elements to supplier documents. See ISO 10013.
Best bet is to paraphrase QS 9000 and then tailor it. I have seen too many auditors go whackko when they find an 'obscure' or 'assumed' specific was not specifically addressed. Especially in elements 4.1 and 4.2.
C107 QS-9000 Registration for Companies not Supplying "Big 3"
How do companies, not previously doing business with automotive, become registered to the QS-9000 requirement? For a third party audit, records must be available as objective evidence that a system is effective. With no previous automotive business, records would be unavailable for items such as PPAP.
Demonstrated capability, (e.g., Procedures, work instructions, FMEA, Control plans, etc.) must be in place to address all QS-9000 requirements. Evidence will be evaluated at a future surveillance audit. This assumes that they have no customer utilizing QS-9000 or PPAP.
This is simply another mattrer of addressing everything. If you don't do it now you still have to have a system in place. Used to be (with ISO) you could simply state you will develop a system when and if the need arose. For QS9 you have to have the system defined and ready.
C109 Ford's DCP Control Plan
We are a Ford supplier. Do we have to comply with Ford's DCP version of the control plan as listed in the APQP Manual?
Suppliers to Ford Powertrain Operations must comply with the DCP Control Plan. If in doubt, contact your customer's responsible quality activity.
So we assume this is acceptable.
4.3 Contract Review
C106 Acknowledging Purchase Orders
Are suppliers required to return signed acknowledgment copies of purchase orders and amendments in order to comply with QS-9000?
No.
4.4 Design Control
C35 Waivers - CAD and ASN
How are requirements for computer-aided design (Element 4.4.4) and computerized system for ASN's (Element 4.15.6) regarding waiver to be interpreted by registrars?
Sub-elements 4.4.4 and 4.15.6 can be "waived by the customer" per QS-9000. Objective evidence of a waiver must be available to show the auditor.
C102 Changes by Subscription
Element 4.4 requires design control, and Element 4.5 requires that we provide for timely ...implementation of all customer engineering standards/specifications and changes... In reality, we constantly receive updated engineering specifications from all of the Big 3 via subscription service. Is it understood that we are to implement and make PPAP changes mandated by these revised specifications, even though we have received no end-part drawing change or contract modification from the customer?
The quote is from 4.5.2 which refers to the Big 3 customer Engineering standards. These are distributed by subscription. The intent is to get these reviewed, distributed and implemented in several business days, rather than weeks. A change in these customer specifications will not automatically generate a revised PPAP process. PPAP would be affected only if these changed specifications were referenced on a design record or if they affect PPAP documents, e.g. Control Plan, FMEAs.
4.5 Document and Data Control
C06 Obsolete Specifications
Regarding 4.5.2, how should the Tier 1 supplier handle a Big Three purchaser who continues to use outdated specs on old preexisting parts or specifications (but uses the new replacement specs on new parts)?
Whatever specs are being used by the customer should be used and retained by a supplier; i.e., keep all old specs in an active mode until they are no longer in use by the customer. Contract review by a registrar should take this into account if the Tier 1 supplier can show an active PO or requirement to use the outdated specification... i.e., it is not really outdated yet!
My old rule of thumb was, from my military manufacturing experience, you use the spec the contract calls out. If you're making a part for 4 years to a specific spec as called out on the drawing, only a drawing change which specifically called out a spec change (in light of a contract change) would cause a different spec to be addressed regardless of whether there is a newer spec or not.
C29 Special Characteristics Designation
Element 4.9 Designation of Special Characteristics (see Appendix C, also). Can suppliers deviate from this without a waiver?
The supplier can cross reference supplier designated characteristics, but not customer designated characteristics, unless the customer pre-approves it. At this time, equivalencies are not acceptable to any OEM except Chrysler. Work with the customer for interpretation and agreement on identification of characteristics identified in Appendix C.
And provide objective evidenct of the customer's and your agreeement.
C60 Document Approval
Is it permissible for the person preparing a document to also approve this same document?
Top management commitment and approval is required; who is authorized is a top management choice, but their choice must be documented. Review is traditionally (my BOLDing) expected to be by someone else in management other than the author.
So - Can we say the same person can review and approve?
C84 Document Identification
Regarding document control (Element 4.5) please clarify what is meant in the note on consolidation of documents locally? Do all shalls require a procedure?
"Consolidated locally" generally allows for locating all the customer drawings/specifications at one location in the manufacturing facility. The operator instructions/work instructions have to be available at each work site however. All "shalls" have to be covered in the quality system documentation, but they do not have to be addressed by individual procedures.
Operator instructions requirements are looser than it appears. The main thing is you have to well define (and document) and be able and ready to explain why you do what you do. Some places have 'local' cell books. Others post op instructions right in a person's face.
But this one can be slick. I was at one place where there was an assembly line running several hunderd feet with frames coming down the line. Sub-assemblies were being attached. Techs worked on both sides. Their work instructions were behind them. I heard a registrar auditor suggest they be put on opposite sides so the person could look across and see the instruction. Of course doing that would in fact make things worse because with the distance, if on the other side you would have to cross the line to read your work instruction... Those darn auditors!
4.6 Purchasing
C21 Approved Subcontractor List
Can different OEM customer approved subcontractor lists be combined into one list that all customers agree to? Can these issues be resolved at contract review and/or PPAP?
No, customer approved lists cannot be combined. However, a supplier can merge or cross-reference them for internal use.
C23 Approved Materials
Can you please clarify the reference to "(see Glossary)" in QS-9000, cl. 4.6.1, para. 3. What specifically is the Glossary defining?
Approved materials.
C41 Subcontractor Development
What is meant by "Subcontractor Development"?
Subcontractor development, as defined in QS-9000, refers to all activities designed to improve the fundamental quality system performance of the "subcontractor" (as defined in the QS-9000 glossary). The level of development is dependent upon the needs of the subcontractor relative to the requirements of QS-9000 and the importance of the product or process they supply. Deployment of QS-9000 through contracts, workshops, surveys, corrective/preventive actions and documentation requirements are all considered acceptable forms of subcontractor development.
This is a sweaty one. If the company is bad, do you have to provide training? Require training? Do you suggest? Do you use assessments? Do you recommend things? I have seen supplier development raqnge from having someone sent to a sub's plant for temporary residency to train and observe (not real cheap) to just sending out a survey each year and asking for an improvement plan. Be ready to explain what you are doing and why! This can easily be a GOTCHA!
C43 Subcontractor Development
If a subcontractor is so small as to not have adequate resources to develop a system according to QS-9000, I and II, should the supplier re-source?
No. Certain specified QS-9000 sub-elements may be waived by the supplier of his subcontractor. This provides some relief. The balance of QS-9000 contains fundamental quality system requirements which would be of value to any size of provider of production/ service parts/ materials. Note that there are many ways to implement a compliant system, so a simpler approach could be used for the smaller subcontractors.
Which 'certain specified sub-elements? I've seen only Design and Servicing exempted. I have not found where these are defined.
C62 Restricted Substances
Do we have to perform on-site assessment of our subcontractors to assure their compliance with the "Restricted Substances" clause of 4.6.3 or is it sufficient to obtain written evidence of compliance from these subcontractors?
No, you do not have to perform on-site assessments, however, objective evidence of compliance to Clause 4.6.3, as with all QS-9000 requirements, is required.
Wonder what constitutes 'written evidence?
C63 Restricted Substances
Which "manufacturing process" is referred to in 4.6.3, "Restricted Substances," that of the subcontractor or supplier?
It refers to both -- the supplier's manufacturing process, but the reference to purchased products includes subcontracted materials. (Refer to C62)
C64 Distributors
We are a Tier 1 supplier, a distributor, but since we do not manufacture the products we supply, we apparently cannot perform any process control, (4.9). Since all QS-9000 requirements must be met for certification, it does not appear we can become certified to QS-9000 until the appropriate waivers are allowed for situations such as ours.
Incorrect. Process control relates to the product or service you provide the customer. If distribution, handling, storage, packaging, delivery, bar coding, acceptance, release, loading/unloading, etc. of someone else's products is your business, then process control relates to how you control your processes in those areas of your business, for example, "pick & pack" operations.
C114 Tracking Premium or Excess Freight
Under 4.6.2, does the requirement to track premium or excess freight apply in contracts where the subcontractor carries the freight costs (i.e., FIS) as well as where the supplier carries that cost (i.e., FOB), or only in the latter?
Yes, it must be tracked regardless of who pays for it. It is an opportunity for continuous improvement and reduction of waste in the supply chain.
Remember that part of the goal is to get suppliers to run their business in a manner the big three see fit. This includes premium freight as a measure of problems. If you're using premium freight, you're experiencing problems and running up costs. The big three believe if you cut yor costs you will lower prices to them. They have their own idea of efficiency and cost effectiveness.
C115 Use of Unapproved Suppliers
Is QS-9000 retroactive, i.e., does it apply to requirements already in existence prior to certification? This particularly relates to 4.6.1 Approved Materials, where we have product in production which contain material purchased from subcontractors not on the customer lists -- once we are certified, will we have to change these pre-existing products to comply with the requirement to purchase from subcontractors on the customer's list? What do we have to do to comply given this?
Take appropriate actions to correct the noncompliance in order to proceed, e.g. use an approved subcontractor, get the unapproved subcontractor added or get a customer waiver. The supplier would also have to notify the customer that the product is "suspect" material per Element 4.13.1 until it can be dispositioned.
Oh boy.
4.7 Control of Customer Supplied Product
4.8 Product Identification and Traceability
4.9 Process Control
C08 Working Environment
Define environment (as used in 4.9(b), suitable working environment).
Environment will vary for each site, but generally includes: housekeeping (my BOLDing), lighting, noise, HVAC, ESD controls, safety hazards relating to housekeeping. Environment is defined in the Glossary.
C09 Control Plan Customer Signature
Must all control plans be signed by the customer? The form information in the APQP book shows (if required); where is "if required" defined or found?
GM does not provide waivers to suppliers for control plan sign-off because GM signatures on the control plan are not required.
Chrysler representative signature is not required on the control plan.
Ford requires that all control plans must be approved by the responsible Ford quality activity prior to the production part submission date. Note: Signatory approval is only required on control plans for inverted delta products and those designated by Product Engineering (e.g. with an ES specifically requiring this approval). Design responsible suppliers must also prepare a design FMEA which is subject to the same review and approval requirements. If in doubt, contact your customer responsible quality activity.
C16 PPAP - Waiver
Clause 4.9.6, PPAP, page 2, Waiver: Will the customer accept a letter from the supplier which states "unless noted otherwise it is understood you (the customer) accept this change and a waiver is granted."
No. Waivers are only issued by the customer to the supplier as appropriate.
C34 Perishable Tools
A potential QS-9000 supplier has a question regarding perishable tools. They do not employ any statistical techniques relating to predictive maintenance of perishable tools. They do, however, perform last piece inspection as a means for monitoring tool wear. Is the intent of this practice acceptable to meet the requirements of QS-9000 4.9 (specifically, page 28 relating to preventative maintenance)?
This practice, as stated, is not acceptable and does not meet QS-9000 4.9.
C36 Appendix C. Special Characteristics
Are all of the characteristic classifications listed in the left-hand column of Appendix C meant to be classified as "Special Characteristics"?
The Appendix C chart defines various types of characteristics. The definitions are left open given the mutual responsibility for identifying and finalizing these characteristics. Work with your customer.
C39 Procedure/Job Instructions
Does 4.9.1 (QS-9000 requirement) requires "documented process monitoring and operator instructions for all employees." This appears to negate 4.9 a) (ISO 9001 requirement) with regard to controlled conditions which require such documented instructions only "where the absence of such procedures could adversely affect quality?" Please clarify.
No. Clause 4.9. a) refers to Level Two Procedures (see the documentation graphic), while the intent of 4.9.1 is to refer to Level Three Job Instructions. 4.9.1 requires instructions to be in place for "all employees having responsibilities for operation of processes." Clause 4.9.1 is more specific and requires broader coverage than 4.9 a).
Again - what is your system? Can you EXPLAIN it and why you do it that way?
C65 PPAP - Changes
"Who determines whether production part approval is required if there is a change in manufacturing "location" and/or production process environment (Element 4.9.6)?"
All anticipated changes require pre-notification from supplier to the customer to determine if PPAP submission is required. For guidance when PPAP is required, see PPAP Manual.
C66 Documentation - Job Set-Ups
Concerning 4.9.5 Verification of Job Set-ups: Job set-ups shall be verified as producing parts that meet all requirements. Documentation shall be available for setup personnel. Does the term documentation refer to: a) documentation to record the verification of the set-up, or b) documentation describing how to perform the set-up?
Both are required (my BOLDing). One is the documentation that is required, and the other is the record that proves the process was followed and records the results.
C67 Continuous Improvement Plans
QS-9000, Element 4.9.3, last paragraph states: "Regardless of the capability requirement or the demonstrated process capability, continuous improvement is required, with the highest priority on special characteristics." Must all SPC characteristics, even those above a CpK of 1.33, have continuous improvement plans and results?
The intent of the 4.9.3 requirement above was that continuous improvement plans must consider all characteristics, with the highest priority placed upon special characteristics. A characteristic with a CpK above 1.33 still may not meet customer requirements, therefore the overall significance must be evaluated, documented and prioritized. The documented continuous improvement plans (at a "part" level or "characteristic" level) must be adequate for the auditor to feel confident that real progress is being made.
So - no matter what - You have to have a plan!
C101 Proprietary Process
Our manufacturing Divisions use a proprietary process which is not documented in the process flow chart, FMEA, Control Plan, or in any written work instructions, for reasons of strict company confidentiality. This proprietary process does not affect the form, fit, or function of the product, and is only required to obtain practical levels of tool life.
Is it acceptable under the QS-9000 Quality System Requirements to exclude a proprietary process from the controlled process documentation? If not, what alternative methods will meet the standard, but still allow us to keep this portion of our process confidential from our customers (and even from our registrar), as required by our company policy?
Each process has to be described in the quality system documentation. The description can be a general one for confidential processes. It is not necessary to explain the details of confidential processes to assessors, but the supplier has to prove that the documentation is in place and working effectively.
And how to do this!
C108 Work Instruction Accessibility
QS-9000 requires job instructions to be accessible at the work station. Define "accessible."
It refers to "accessibility" at the work station. The job instructions have to be available at the time they are needed without disruption to the job being performed by the operator.
This is a sticky and somewhat open issue. See my earlier comments about op instructions. What is disruption, for example? The failure modes I see in this are are at the 'explain your system and why it works' level. They generally can't.
4.10 Inspection and Testing
C17 Final Inspection - Responsibility
When a subcontractor performs a final operation, such as painting, what is required of the supplier to meet the intent of 4.10.4? Is this requirement altered if the subcontractor is on an approved list?
The supplier shall assure all quality system requirements stated in the quality plan (control plan) and/or documented procedures for final inspection and testing are met by the supplier and their subcontractor. The requirements of 4.10.4 are not altered if a subcontractor is on the suppliers approved list of subcontractors.
What is required is documented criteria of acceptability based, as a minimum, on the control plan-PFMEA-PFlow requirements at that level and/or other customer and/or internal requirements.
4.11 Control of Inspection, Measuring, Test Equipment
C52 Employee-Owned Gages
Referencing Section 4.11, Control of Inspection, Measuring and Test Equipment, what is the significance of including employee owned gages within the control system, but not addressing employee owned measuring and test equipment?
The phrase "employee owned gages" includes employee owned measuring and test equipment.
C69 Calibration vs. Verification
Referencing 4.11.3 Inspection, Measuring and Test Equipment Records:
A. Please define the words calibration and verification as found in the first sentence of this element.
Calibration involves adjusting a measuring device to a known standard. Verification involves comparison of a (non-adjustable) device to a known standard.
See my calibration item on my main WWW page. In short, you set up a verification schedule, NOT a calibration schedule. The expectation is that when a gage or other M&TE is recalled, it is recalled for verification that it is STILL in calibration. It is EXPECTED to still be in calibration. Note that it may be in calibration but out of alignment (think % accuracy) and just need adjustment. If it is found to be OUT of Calibration (which its self brings forth a host of possibilities including containment of product), how is that used? Do you (you should be) shorten your cal cycle for the instrument? More here than meets the eye! For example is adjustment trended?
B. Does calibration/verification include adjustments made to a gage, for example, on the shop floor due to environmental conditions?
No, this appears to be a gage adjustment pertaining to process control (4.9) rather than a calibration issue.
C88 Equipment Affecting Product Quality
Under Element 4.11.2 B, does "affect product quality" mean that measuring instruments used in the Tooling Department to maintain production tools must comply with the requirements?
Yes, for QS-9000 purposes.
C116 Calibration - Test Equipment
ISO 9000 Clause 4.11.2 (b) requires that the supplier shall identify all inspection measuring and test equipment that can affect product quality.
QS-9000 Clause 4.11.3 requires that specific records of the calibration/verification activity on all gauges, etc., including employee owned gauges be maintained.
Does the term all in 4.11.3 only include the equipment identified in 4.11.2? (Or is there a wider implication?)
Yes. 4.11.2(b) requires the supplier to identify and include all inspection equipment in a calibration system. 4.11.3 requires calibration records for all inspection, measuring and test equipment to contain specific items (e.g., gage conditions and actual readings) some of which are currently in an ISO 9001 guidance note (Note 18) referencing ISO 10012.
Remember the phrase 'affecting quality'. Don't ID steel pocket rulers used for reference.
4.12 Inspection and Test Status
C12 Product Status Identification
Clause 4.12 under Product Location states: "location of a product in the normal production flow does not constitute suitable indication of...status unless inherently obvious...."
Considering current production and inventory methods of KAN BAN, bar codes, cellular manufacture, etc., can this clause be strictly enforced to require additional tags, etc., on baskets, totes, product?
Latitude is permitted, beyond automated production transfer processes, if the test status is clearly identified, documented, and achieves the purpose (i.e., known status).
Again - Can you EXPLAIN your system - how it works and why? Is it logical?
4.13 Control of Nonconforming Product
C05 Verbal Documentation
Regarding 4.13.4 of QS-9000, does a verbal phone authorization from the customer, documented by the supplier, constitute "written" authorization?
No. Verbal temporary change authorizations must be followed by written authorization from the customer. All permanent changes must have prior written authorization.
The verbal should (must?) be recorded somewhere with the name of the person authorizing it with the date and preferably the time.
The written follow-up can be a FAX. I am not sure if a signature is required so I'm not sure if e-mail will do it. Probably would pass muster, tho.
C47 Product Changes - Lower Tiers
How far down the supply chain are process changes to be approved by the OEM?
OEM approval of process changes only needs to take place at the Tier 1 level; these are subject to the requirements and definitions found in the PPAP manual, which includes notifying the OEMs of subcontractor process changes (my BOLDing).
Tier 1 suppliers must be made aware of changes by their subcontractors, and through the subcontractors, of changes throughout the subcontractor's supply chain.
C111 Rework Procedures
In a pre-assessment visit, the auditor asked us for the customer approval for all "rework and repair procedures," based on the requirements of item 4.13.4.
Item 4.13.2 states that "where required by contract", the proposed use or repair of product which does not conform to specified requirements shall be reported for concession to the customer. Our procedure states that reworked or repaired parts shall comply with all customer specified requirements. Will it be necessary to have customer approval for our procedures?
Customer approval of your procedures is not required.
4.14 Corrective and Preventive Action
4.15 Handling, Storage, Packaging, Preservation and Delivery
C71 Production Scheduling vs. Forecasting
Sub-element 4.15.6 of QS-9000 requires that a suppliers production scheduling activity be order driven. Will production control systems based on customer provided forecasts or requirements to supply a certain number of parts per month, for example, satisfy this requirement? How about the supplier who uses a constant flow manufacturing process?
If the supplier's production was scheduled based upon a commitment from the customer, this would constitute an "order" driven process. If it was based upon a customer or supplier forecast, this would not meet the intent of the requirement. A "pull" system of inventory management (parts/replenishment based upon consumption) which utilizes an optimal level of inventory on hand, e.g. days; not weeks or months, would satisfy the intent of an order-driven system.
C91 Supplier Lead Time
In Section 4.15.6, Delivery, under Supplier Delivery Performance Monitoring, QS-9000 states "A supplier shall have a systematic approach to develop, evaluate and monitor adherence to established lead time requirements."
Does "established lead time requirements" refer to product lead time that the supplier has quoted to the customer? Sub-contractor lead time to produce components?
It refers to the supplier's lead time for producing and shipping parts for their customer, not their subcontractors. The subcontractor's lead time and compliance issue is found in 4.6.2 Scheduling Subcontractors.
4.16 Control of Quality Records
C25 Disposal - Quality Records
QS-9000 Element 4.16 specifies specific minimum retention requirement for certain records. Would it be considered a deficiency if records were maintained longer than the specified time?
Retention periods longer than those specified in QS-9000, Clause 4.16 can be specified by a supplier in their procedures, but records must eventually be disposed of in order to comply. Procedures should address retention and disposal.
You can use verbiage to by-pass this. If you want, you can specify a retention time of one month to 150 years, at the discretion of (the authority). Auto manufacturers look at definites in this area because of liability concerns. They like to see records dumped in a year or so. What happens if a court case comes up. They have pretty strict internal guidelines even on verbiage. The word Failure is not to be used, for example, in test results or reports. Anomoly or Event is preferred (or was a couple of years ago). Things look different in a court room 5 or 10 years down the road.
C38 Purchase Orders
Control of Quality Records, Element 4.16, under "Record Retention" refers to "..... purchase order and amendments shall be ......" Which purchase orders and amendments does it refer to?
Records retention reference to Purchase Orders and Amendments includes both those issued to and by the supplier.
C72 Active Parts - Service
With regard to the 4.16 requirement that certain records "be maintained for the length of time that part (or a family of parts) is active....etc," what is the definition of "active for production?" How is service requirements defined?
"Active for production" is addressed in the QS-9000 Glossary definition of an active part. Service part requirements are provided by the customer service part operations divisions. Service requirements refers to the OEM Divisions that provide original equipment replacement parts/materials. This does not include aftermarket parts which are not manufactured to original OEM specifications.
4.17 Internal Quality Audits
C27 Internal Audit
The QS-9000 portion of Element 4.17, Internal Quality Audits, uses the term "activity" as in "quality activities" and "activities to be audited." What activities are being referred to; areas or functions.
"Activity" can refer to both departments (areas) and/or processes (functions) in a company.
Consider 'farming out' internal audits. Firms like mine and InterTek will do this for about $30 to $40 bucks an hour.
4.18 Training
C33 Training Effectiveness
How can confirmation of training effectiveness be demonstrated as required by QS-9000 4.18?
Training effectiveness can be best judged by the performance of the trained individuals (my BOLDing) via audits and performance evaluations. See your registrar.
4.19 Servicing
C28 After-Sales Servicing
The supplier's component is part of a subassembly which in turn is attached to the vehicle. It is not repairable by the dealer network, only replaceable. The supplier does provide engineering design support, warranty analysis and subassembly component interface investigation (review for non-conformances at the OEM). What supplier activities mentioned above, if any, are considered covered by QS-9000, Section 19, Servicing?
None. Any after-sales product servicing provided as part of the OEM contract or Purchase Order would fall under Element 4.19.
So - warranty analysis is not considered servicing. OK. See the next interpretation.
C112 Service Concerns
Re. 4.19 Servicing: The QS-9000 added requirement refers to "service concerns." My question is: Does the word "service" refer to the service activities of the supplier or those of the Big 3?
The intent of the addition of "service concerns" to Element 4.19 is to ensure that the supplier's organization is aware of non-conformities that occur external to the supplier's own organization. This is also addressed in Element 4.14, in which suppliers are to analyze parts returned from customer's plants, engineering facilities and dealerships. This activity encompasses the reference to "final customers" in 4.1.6.
4.20 Statistical Techniques
Section II. Chrysler, Ford and General Motors Requirements
II.1 Production Part Approval Process
C02 PPAP Requests
Relative to PPAP, a QS-9000 applicant has continuously supplied products to the OEM's since 1987, having met all sample submission requirements, and having no interruptions or changes. They have not completed any PPAP's, nor have they been requested to do so. Is there anything else they must do to comply with QS-9000 requirements?
If there have been no changes in "part number, engineering change level, manufacturing location, material subcontractors or production process environment" since 1987, then no PPAP's would be expected unless specifically requested/notified by the OEM customer for that product. PPAP procedures must be in place and effective as appropriate for QS-9000 registration. (See C107)
So - no yearly resubmission is called out by QS9.
C03 Documents at Supplier
Supplier has PPAP process documented adequately, and if he is requested to submit parts for approval, the documented process will meet the requirements. The supplier provides "off-the-shelf" items they design for customers. Their only OEM customer has issued PPAP approval documents showing part is approved without requiring the supplier to do the PPAP requirements. Should the registrar accept this and recommend for registration to QS-9000?
Supplier must meet all required steps according to PPAP or the previous customer requirement in effect, even if request is waived. PPAP files must be available for registrar or customer review and show compliance to part submission requirements in effect at time of submission.
C37 Submissions/Waivers
Relative to PPAP:
A. Can a lower level submission (Level 1) be used for any of the first three PPAP requirements of page two of the PPAP manual under Section II when submission is required?
The level of submission is defined by the customer upon notification by the supplier of a change.
B. Can a waiver be issued by the customer for any of the first three PPAP requirements of page two of the PPAP manual under Section II when submission is required?
Direct this question to your customer's part approval activity.
C. What would be a clear definition or example of a Level 1 submission?
This is defined in the Table on Page 5 of the PPAP Manual. Each of these items must be completed each time the process changes, but levels of evidence required for submission are determined by the customer.
C40 Subcontractor PPAP
QS-9000 notes that "primary suppliers are responsible for subcontracted material and services." If I approve a PPAP from my supplier, (a subcontractor) do I then need to submit a PPAP to my customers (Ford, Chrysler, or GM) or am I entrusted to make final approval?
Suppliers control their subcontractor's material and part approvals. Your PPAP file must include all appropriate subcontractor warrants and material certifications, which you would obtain from their submission to you.Ý You are obliged to "notify" the OEM customer of any subcontractor changes made since the level of your last PPAP approval. The customer will determine if a new submission from a subcontractor is warranted.
C42 Process Changes
A Tier 1 supplier has used an "internal" engineering change level system and an external Big Three engineering change level system. This approach was accepted by a Big Three auditor according to our client.
Is the requirement for PPAP submission affected by whether it refers to the "internal" or the "external" change level system of the supplier?
Since the supplier covers the proprietary engineering changes with the "internal" change level system, he does not want to be subjected to PPAPs for these changes.
All changes must be covered by PPAP, as defined in the PPAP documentation; the establishment of two types or levels of change does not alter the supplier's responsibility to meet PPAP. The supplier should discuss the concern about proprietary engineering changes with their customer's responsible part approval activity.
This brings in the Black Box problem. If you make a black box bought on specs, how are changes in the proprietary 'guts' addressed?
C48 Grease/Oil Suppliers
We understand that producers o