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THESE INTERPRETATIONS ARE FOR ARCHIVAL AND REFERENCE PURPOSES ONLY!!!
THEY ARE OBSOLETE!
IASG SANCTIONED QS-9000 INTERPRETATIONS
March 22, 1996 (from February 15, 1996 IASG meeting)
A February 15, 1996 IASG release was circulated briefly in early March, but distribution was halted because of the need to further modify several responses. The modifications are now included in this March 22, 1996 release.
E. "AGREED" ITEMS
Key: We underlined February 15, 1996 and the March 22, 1996 revisions to pre-existing interpretations.
APPLICABILITY (A)
9503-A01 Agreed - March 28, 1995
How are "Tier 1" suppliers to Chrysler, Ford, and GM defined relative to QS-9000?
Per page 2, QS-9000: February 1995, the following have been revised/added:
"Applicability: (Paragraph 1) QS-9000 applies to all internal and external suppliers of: a) production materials, b) production or service parts, or c) heat treating, painting, plating or other finishing services directly to Chrysler, Ford, General Motors or other OEM customers subscribing to this document."
"(Paragraph 3) Quality system requirements for Tooling and Equipment suppliers are currently under development."
"Implementation: (Paragraph 3) Third party registration to QS-9000 will be accepted and will be required by some customers (refer to Section II:
Customer Specific Requirements). Verification of conformance to ISO 9001 (or ISO 9002 for suppliers that are not responsible for the design of any product supplied to any customer subscribing to this document) is a necessary condition for registration to QS-9000. Registration to ISO 9001, however, may not be sufficient for the companies using QS-9000, since this document contains additional requirements for these companies. Subcontractor third party registration to QS-9000 is not required by Chrysler, Ford, or General Motors at this time."
9503-A02 Agreed - March 28, 1995
Rev. - February 15, 1996
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. Remote locations, e.g. Engineering, Purchasing, must be audited as they support a "site," but they can not be a QS-9000 registered location. If in doubt, contact the IASG. The registrar must assure the Code of Practice, Appendix B, requirements are met. (See 9503-A01.)
9503-A03 Agreed - March 28, 1995
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 protected as property of the Big Three. Only those third party registrars meeting the QS-9000 qualification requirements of at least one Big Three recognized accreditation body are permitted to issue a registration certificate with the term QS-9000.
9503-A04 Agreed - March 28, 1995
Would you please clarify each of the Big Three's positions on QS-9000 timing, third party registration, compliance requirements, etc.?
As of March 28, 1995 the positions are as follows:
Chrysler:
All Production and Service Part Suppliers to Chrysler must be Third-Party Registered to QS-9000 by July 31, 1997.
Ford:
For Ford North America suppliers, compliance with QS-9000 is expected by June, 1995. This means: -
A self-assessment has been conducted. -
Nonconformance issues have been identified. -
A work plan is in place to address these issues.
Ford does not require that you obtain an audit by a third party registrar. Ford will contact you on an individual basis if we wish to receive a copy, or conduct an on-site review of your self-assessment.
Suppliers located outside North America will receive QS-9000 instructions regarding timing requirements as the documents are issued.
General Motors:
New suppliers to General Motors North American operations by 1/1/96. All suppliers to General Motors Europe to ISO 9000 by 1/1/96. All suppliers to General Motors worldwide to QS-9000 by 12/31/97.
9503-A05 Agreed - August 1, 1995
Rev. - March 22, 1996
Who are the Big Three recognized accreditation bodies for QS-9000?
See "Section C."
9503-A06 Agreed - March 28, 1995
Rev. - September 28, 1995
What is the status of the European launch of QS-9000?
It is well underway. QS-9000 qualified accreditation bodies are established, and many registrars have either applied for, or achieved, QS-9000 qualification. European representatives , including registrars and accreditation bodies, now participate on the IASG. Registrar auditor and supplier QS-9000 training courses are being provided.
9504-A07 Agreed - May 1, 1995
Rev. - February 15, 1996
QS-9000:August 1994 states that registrars "be permitted to use a full QS-9000 or an ISO 9000 upgrade to QS-9000 as a witness assessment."
QS-9000, Appendix B, page 81, states that suppliers registered to ISO 9000 without consideration of QS-9000 "...shall update the quality system documentation..." as a part of being registered to ISO 9000 and QS-9000. This is clearly an upgrade option for currently ISO 9000 registered companies.
However, the above referenced sentence goes on to say that suppliers choosing registration shall... "identify these revisions to the registrar at the next surveillance visit." This appears to undermine or usurp the individual customer's process of implementing QS-9000 third party registration by selecting a date by which suppliers must be registered as opposed to "...at the next surveillance."
While the Chrysler/Ford/General Motors expectation is full compliance to QS-9000, a supplier is permitted to use a two step process involving ISO 9000 registration followed by a QS-9000 upgrade. If a two-step process is utilized, AND if QS-9000 qualified auditors are not used for the ISO 9000 (first step) registration, then the table values for the initial audit in 9503-R13 and the associated requirements shall be applicable to the QS-9000 (second step) registration upgrade. (See 9602-R34)
9508-A08 Agreed - August 1, 1995
Rev. - March 22, 1996
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. Effective immediately 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.
9508-A09 Agreed - August 1, 1995
Do the QS-9000 standards apply to organizations developing software to the Big Three?
No.
9508-A10 Agreed - August 25, 1995
Rev. - March 22, 1996
We are receiving requests for QS-9000 registrations from many companies, such as tooling and equipment suppliers, that do not fall under the current scope of the standard. Many of these companies would like to pursue QS-9000 in preparation for TE-9000. Are we required to refuse to provide QS-9000 registration services for those tooling companies requesting it?
Yes. The (to-be-issued) TE Supplement to QS-9000, a voluntary guideline, will not be permitted to be referenced on a third party registration certificate, at this time. The only option at present is registration to ISO 9000.
(See 9503-O01)
9508-A11 Agreed - August 25, 1995
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. The requirement for customer approval of changes does not affect this. Consult with your customer engineering activity for further clarification.
9509-A12 Agreed - September 28, 1995
If it is decided that QS-9000 has more applicability to service providers, other than specific customer defined requirements, will a guideline be available for interpretation of QS-9000 from a service company perspective?
IASG is willing to provide interpretations on existing QS-9000 requirements but prefers to avoid hypothetical situations.
9509-A13 Agreed - September 28, 1995
QS-9000 requires that the registrar examine a supplier company for compliance to Section III criteria. Our European registrar insists that this includes all eight (8) signatory requirements - EVEN IF YOU DO NOT SUPPLY TO THEM. Other registrar candidates indicate that they will register only those requirements that are linked directly to our customer base. We do supply, corporately, all signatories, but our registrations will be on a plant-by-plant basis.
If a specific plant supplies only to Ford and GM, is the plant also required to have Chrysler and other signatory requirements covered and registered?
If a supplier only supplies one of the three companies subscribing to QS 9000, they only can be held accountable to the Section III requirements of that customer. 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 surveillance to determine if compliance with other customer requirements is appropriate, e.g. Element 4.3.
9509-A14 Agreed - September 28, 1995
Reference Question 9503-A04 QS-9000 timing:
A. Some Tier I suppliers are asking their suppliers (Tier II or III) to comply with the QS-9000 timing and in fact have moved the date up to January 1, 1996. Is this allowed?
Yes.
B. If a Tier I supplier is asked to supply a new part to the (GM) division to which they have supplied parts for many years, is the supplier now obligated to have QS-9000 by (the GM deadline for new suppliers) January 1, 1996?
No, within GM, North American Operations (GM-NAO).
C. If a Tier I supplier is asked to supply a part to a new division, is the supplier now obligated to have QS-9000 by January 1, 1996 in all (GM) divisions they supply to including the new division?
No, within GM-NAO.
9509-A15 Agreed - September 28, 1995
When will QS-9000 be required for operations and suppliers in South America, Brazil in particular?
It applies to all suppliers worldwide, wherever QS-9000 has been launched.
See 9503-A04.
9509-A16 Agreed - September 28, 1995
When conducting a third-party audit for QS-9000 registration of a company that supplies electronic products to Chrysler, Delco Electronics or Ford and where QS-9000 requirements have been contractually applied, should the registrar be using the semiconductor supplement and AEC-100 (QSA) requirements in its audit criteria/checklist? Should the supplier have incorporated these requirements into its quality system? The letter introducing this QS-9000 supplement says that these documents may be used in either first-party, second-party or third-party assessments.
Restated; does the semiconductor supplement from Delco Electronics, Ford and Chrysler have to be used for a QS-9000 audit of a semiconductor supplier to the Big Three? Yes, the supplement says that QS-9000 and the supplement becomes the requirements for semiconductor suppliers. NOTE: This does not extend to other electronic products beyond semiconductors.
9511-A17 Agreed - November 9, 1995
If Lab X is part of a big division, and the division is planning to go for QS-9000, does Lab X need to do anything if they are already certified by A2LA? Does A2LA certification satisfy all the requirements of the QS-9000 for a lab.
Any lab certification alone does not satisfy all ISO 9000 or QS-9000 requirements for a lab, therefore the lab should be included in the preparation activities.
9511-A18 Agreed - November 9, 1995
From the definition in QS-9000, subcontractors are those who supply Tier 1 suppliers. 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. They are subject to their customers' requirements, e.g. companies may require QS 9000 or ISO 9000 of their suppliers, independent of the OEM requirements.
9511-A19 Agreed - November 9, 1995
Could you define the difference between "product" and "material" as used in doing Quality System Assessments. We are jointly owned by two companies; we receive steel coils from these two companies, plate zinc onto the strip surface, rewind coils, and ship to OEM blanking or stamping facilities as directed by our owners.
You appear to be a toll processor, i.e. a subcontractor, to Tier 1 supplier(s). The product and material may appear to be one and the same. In general, "product" is what you sell, "material" is, in part, what you use to produce the product you sell.
9511-A20 Agreed - November 9, 1995
Are the applicable requirements to the GM NAO suppliers also to be applied to the GM Europe suppliers? If not, please specify which specific requirements are applicable to the GME Tier 1 suppliers.
The requirements are the same with the exceptions noted in Section III on the GM-specific pages. QS-9000, and the other Task Force manuals were distributed to European suppliers in July 1995.
9511-A21 Agreed - November 9, 1995
As a small part of its business, (chemical manufacturer) supplies a chemical coating directly to GM. It is used to line sand casting molds used to cast cylinder blocks...making the sand casting surface smoother. Since the coating does not go directly onto the vehicle, but is used to manufacture parts by GM -- which Quality System Standard applies? We wish to pursue ISO 9001 registration but don't believe QS-9000 applies as directly to our business. Can you help in this?
This coating appears to be "indirect" or "non-product" material. If so, it is outside the applicability of the current QS-9000 requirements. Check with your customer purchasing activity for final determination.
9602-A22 Agreed - February 15, 1996
Rev. - March 22, 1996
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? Since we do not perform most of the activities addressed in QS-9000, we do not consider it very useful to undergo a QS-9000 audit.
Customers, on a case-by-case basis, have the right to require "site" QS 9000 registration, reference 9503-A02, (Revised February 15, 1996). If you have concerns regarding the request, you should discuss them with your customer.
9602-A23 Agreed - February 15, 1996
The applicability section of the QS-9000 Quality Systems Requirements states that QS-9000 applies to .... b) production or service parts .... Our question relates to the definition of service parts. Company A supplies pumps to an OEM for current production, for OEM service (dealer network), and for OEM aftermarket distribution. We design and manufacture current model-year pumps, off OEM tooling, and supply these pumps to both OEM production facilities and to OEM service (dealer network).
A) Will the QS-9000 requirements apply to this scenario?
We also supply OEM service with non-current model-year pumps which are manufactured off OEM tooling. We supply these pumps to OEM service for several years; we design and manufacture aftermarket pumps, off tooling, which are purchased by OEM service, which often require OEM specified components, and which are sold to aftermarket customers. The words "service parts" can take on several different meanings.
B) As a supplier to both original equipment and the automotive aftermarket, do the QS-9000 requirements apply only to current model year production supplied to OEM production, and service facilities?
QS-9000 applies to the quality systems of all of the above.
9602-A24 Agreed - February 15, 1996
Rev. - March 22, 1996
According to GM, the fact that we have a RD contract requires that we be certified to QS-9000. The remaining two of the big three use our product, but have not indicated that QS-9000 applies to our product. We supply packaging material (steel strapping) which is used in production and then discarded.
A. Is this considered production material? Please further define, clarify, or list what defines production material (and therefore QS-9000 is applicable) or tooling and equipment (not applicable).
Some registrars say QS-9000 is not applicable to our product and will not quote.
Strapping is generally considered a packaging material. As such you would not be required to obtain QS-9000 registration under the applicability definition, reference 9503-A02 and 9602-A22.
9602-A25 Agreed - February 15, 1996
Co X is a warehousing and distribution company located in several Midwestern cities. We provide Just-In-Time deliveries of steel coils to automakers from our facilities. We have received instructions from our customers, who are Tier 1 Suppliers of sheet steel, that we are to accomplish registration to QS-9000 by the end of 1996 or else! Our contribution to the supply process is the receipt, storage, and delivery of the steel coils. We provide no physical processing of the material. All control for carrier selection, disposition of non-conforming material, and material release to the end user is performed by our steel customers.
After extensive investigation, and many conversations with various registrars it appears we do not meet the Applicability definition, so we are not required to obtain compliance/registration by the Big Three. We also (apparently) have no way to comply with the manufacturing elements described in QS-9000, Section II. Without the registrars having the ability to declare as not applicable such elements, other than the two provided, compliance/registration would seem difficult. We are actively in pursuit of ISO-9002 registration, which should be accomplished by the end of 1996. What should we do?
You can be registered; your service can be certified in that the processes and systems you use to control the services provided are auditable to all elements of QS-9000.
9602-A26 Agreed - February 15, 1996
Rev. - March 22, 1996
Our company has been told that the ISO portion of QS applies to all products that we manufacture and sell. The group telling our company this also stated that the automotive additions in QS, writing in the normal or bold print, only applies to product that is manufactured and sold to the automotive companies subscribing to the QS-9000 document. The following is an example of use of this interpretation.
In element 4.15.3 Storage the QS-9000 additional requirements state: An inventory management system shall be established and documented to continuously optimize inventory turn over times, assure stock rotation and minimize inventory levels. A company following the above interpretation would only have this inventory management system for the OEM product. Is this what the writers of the QS-9000 standard wanted?
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 apply this same quality system to non-automotive customers as appropriate.
9602-A27 Agreed - February 15, 1996
Rev. - March 22, 1996
"9602-A27" - To Be Determined.
9602-A28 Agreed - February 15, 1996
Rev. - March 22, 1996
We believe that Tier Two registration to QS-9000 should not be encouraged by third party registrars, however Tier Two subcontractors may be certified but they must comply and show systems that comply. Section III will not apply for Tier Two unless one of their customers is GM, Chrysler or Ford . The bottom line is that the Big Three do not want exceptions to the QS-9000 registration process. Correct?
Correct... reference the requirements listed in 9503-A02, revised February 15, 1996.
APPENDIX B: CODE OF CONDUCT (B)
9504-B01 Agreed - May 1, 1995
Rev. - March 22, 1996
A supplier used a registrar's sister subsidiary as a consultant prior to ISO 9002 registration. Subsequently, that registrar registered the client. Can the same registrar be used to upgrade the client to QS-9000?
Yes, provided that the consulting actions pre-date the August 1994 release date of QS-9000. All consulting must have ceased by August 1994.
9504-B02 Agreed - May 1, 1995
A registrar's sister subsidiary provided on-site training on QS-9000 to Company Q. Will this prevent the registrar from doing QS-9000 registration later?
Yes, on-site QS-9000 training is considered consulting.
9508-B03 Agreed - August 1, 1995
It is our understanding from our meeting with the Big Three Task Force on November 18, 1994 that the implementation date of the requirements of Clause 9 of QS-9000 Appendix B, Code of Practice, is from the date of first issue of the QS-9000 document itself (August 1994). Does "two year rule" for defining consultancy apply?
No. Consultancy to the company by a registrar or related body is allowed two years before the registration audit. Because this is a new (8/94) requirement, consultancy before August 1994 is waived.
9508-B04 Agreed - August 1, 1995
I recently attended a QS-9000 course, where the requirements of Appendix B and G were explained as understood by the trainer. Unfortunately, our understanding is different and will present us with considerable difficulties unless we can resolve them.
The problem is as follows:
From the information available to me and following a discussion with the NACCB assessor, 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. On this basis I attended the course; I do not have automotive experience. It would now appear that we sent the wrong person on the course?
Does this same requirement apply to surveillance visits; this appears very restrictive and not necessary? Nowhere in the appendices is this specified.
I fully agree with these requirements but I do not understand why every member of the audit team needs to be QS-9000 trained and why the team member with automotive experience needs to be ISO 9000 and QS-9000 trained. We would currently 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, our surveillance visits would include an automotive expert only when necessary, possibly every other visit. It would appear counter productive to take an automotive expert or even possibly a QS 9000 assessor, if the surveillance visit was only to cover ISO 9000 elements without any specific QS-9000 additions?
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."
9508-B05 Agreed - August 1, 1995
We plan to use (X) registrar as our QS-9000 registrar, however, (X) is not on the current list of accredited registrars. Will an (X) certification assessment be sufficient for us as a Tier 1 supplier to the Big Three? Should we be concerned that they are not on the list?
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.
9508-B06 Removed - March 22, 1996
9508-B07 Agreed - August 25, 1995
At a recent QS-9000 training course held in the UK, the instructor indicated that the audit teams contain a lead auditor with: 1) a minimum of five years experience, 2) this is to have been in the employ of either the Big Three or a Tier 1 supplier to the Big Three. Can you confirm this?
No. The information presented in the class predated the current Interpretation. This is now left to the accreditation body and registrar to specify within the requirements defined in 9503-R12.
9508-B08 Agreed - August 25, 1995
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).
9509-B09 Agreed - September 28, 1995
I fully agree with these requirements but I do not understand why every member of the audit team needs to be QS-9000 trained and why the team member with automotive experience needs to be ISO 9000 and QS-9000 trained.
A) We would currently 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?
Not acceptable. See 9508-B04, 9508-B08 and QS-9000:Feb. 1995 Appendix
G, A. 12).
B) In addition, our surveillance visits would include an automotive expert only when necessary, possibly every other visit. It would appear counter productive to take an automotive expert or even possibly a QS 9000 assessor, if the surveillance visit was only to cover ISO 9000 elements without any specific QS-9000 additions?
Not acceptable. All surveillance audits must cover elements of ISO 9000 and QS-9000, therefore all audit and surveillance team members must be QS-9000 certificated: No exceptions!
9509-B10 Agreed - September 28, 1995
As RvA has reportedly indicated, depending on the structure of the registrar, a witnessed assessment of a registrar's local operation could allow the issuance of certificates by another affiliated office in a different country. What about this?
Not acceptable. Any registrar office with a certification function (issuing of ISO 9000 certificates) must comply with Appendix G requirements, e.g. be witnessed during one of the first four QS-9000 audits.
9509-B11 Agreed - September 28, 1995 Rev. - February 15, 1996
I believe the Chrysler/Ford/GM QS-9000 Auditor Certification course should be available to any experienced auditors with RAB QS-A and QS-LA certification.
A. Does the IASG support the development of QS-9000 auditing skills in RAB Certified Auditors?
B. If the C/F/GM Auditor Certification course is only open to Registrars, how do customer auditors obtain such certification?
To support the worldwide launch of QS-9000, QS-9000 auditor qualification has been restricted to only those auditors who are conducting QS-9000 audits for QS-9000-qualified nationally accredited certification bodies/registrars, or formal applicants, and who meet all the other requirements for auditors working for these registrars. QS-9000 training provides qualification to auditors already knowledgeable of ISO 9000 and auditing practice, and is not intended to represent another form of auditor certification. Auditors taking theQS-9000 auditor qualification course must meet the above requirements, be sponsored into the course by their registrar, and present appropriate identification to gain admittance into the class and take the exam. Violation of this by a registrar will imperil the registrar's QS-9000 qualification status.
Since the launch, many requests from internal auditors of suppliers and OEMs have resulted in the Chrysler/Ford/GM Supplier Quality Requirements Task Force authorizing the development of a "QS-9000 internal auditor" course. This course will have a slightly modified emphasis due to the target audience, but is intended to provide internal auditors with a QS-9000 credential essentially equivalent to those of the registrars' auditors.
There is now a time table for this course; see 9511-T03.
9509-B12 Agreed - September 28, 1995
Re: IASG sanctioned interpretation No. 9508-B03: How will this be monitored? Who will monitor it to ensure that this two year gap is maintained?
This is a requirement placed on the registrar which is monitored by the accreditation bodies. Monitoring includes, but is not limited to, the latter's surveillance visits of the registrar.
9509-B13 Agreed - September 28, 1995
A registrar has a number of customers who are currently ISO 9000 certified and belong to a big (Country) Holding Corporation. The customers are independent legal entities and operate different quality management systems. Some of these companies are suppliers to the Big Three, some do not supply any product to the automotive industry.
After the European launch of QS-9000 they all decided that this is a very good tool for companies who want to realize TQM. They therefore asked us to give them an introduction into QS-9000, presenting the additional requirements that go beyond ISO 9000. If such an introduction into QS 9000 is presented on the holding's premises is this regarded as consultancy and therefore not permitted?
Yes, this would be regarded as consultancy by the IASG, which supports the reasoning indicated below by the three accreditation bodies:
RAB considers any form of private training to be consulting. Specifically, the RAB Administrative Procedure R001 states on this subject: "Teaching activities may create or may be perceived to create the likelihood of concomitant consulting or the giving of advice when provided for a student group consisting exclusively or significantly of employees or agents of the supplier, or when provided on premises owned or arranged by the supplier, or when the supplier provides substantial funding or sponsorship." Therefore, RAB's answer to the arrangement described is consultancy. (RAB)
TGA: Training, introduction into requirements by a certification body to a specific company or holding is consultancy. (TGA)
RvA: Based on the text you have sent us, it appears that the introduction of QS-9000 is only open to sister companies of the holding company. For this reason, we consider the introduction to be in-company training and therefore is consultancy.
Although the sister companies are separate entities, they have a common economic goal...will not compete with one another.....overriding the fact that they are separate legal entities....therefore the training would be consultancy.
9509-B14 Agreed - September 28, 1995
We solicit a definitive interpretation of the guidelines provided in Appendix B of the Quality System Requirements.
This facility is currently certified by X to the ISO 9001 Standard. For a number of years prior to certification, we've employed their affiliate, XS, for contract evaluation and qualification of worldwide subcontractors and raw material suppliers. XS is also being considered to provide source inspection of equipment purchased in Europe for our new U.S. production line. This inspection is required to verify conformance to various standards, as well as our own purchase order requirements.
X informed us earlier this year that continued employment of XS would constitute a conflict of interest should X act as our future QS-9000 registrar. This decision was based on their understanding of paragraph (9) of Appendix B. We do NOT concur with this interpretation and seek clarification.
Would you please provide a determination of whether this situation does indeed constitute a conflict of interest? We will comply with the decision rendered by the IASG.
The role of XS appears to be one of contract inspection services and subcontractor evaluation, not quality system consulting. Under these conditions, based on the information provided, RAB would not consider the relationship between X and XS to be a conflict of interest under Appendix B (9).
9602-B15 Agreed - February 15, 1996
Many of the responses supplied by IASG for ISO 9000 issues suggest contacting your registrar for clarification rather than reply.
A. Is clarification given by a registrar considered interpretive consulting? This is not permitted of registrars...see your Appendix B, Note 9, Organizations that provide quality system consulting services to a particular client are not acceptable as registrars for that client, nor may they supply auditors.
No. Registrars must always meet all EN45012 and accreditation body requirements for conflict of interest. Registrars may not give specific advice, or have any ownership in what you do to meet the standard. But, they may answer questions on clarifying or interpreting the ISO 9000 and QS-9000 standard.
9602-B16 Agreed - February 15, 1996
Re: Appendix B, Instructions to Suppliers, 4th paragraph: This paragraph states, in part: The registrar's reports shall be made available to customers upon request. The certified company is not a first tier supplier, and the supplier's customer is in direct competition with the supplier. Is it expected that the supplier will be required to provide the referenced report? (This situation occurs quite often at the second and third tier level.) The concern on the part of second and third tier suppliers is that this report contains confidential information that they do not want to share with the customer and competitor.
Yes, any customer could request and receive, a copy of the ISO/QS-9000 certification report from their supplier, or the supplier may authorize the registrar to provide the report. It should not contain any proprietary information outside of the results of the QS-9000 system's audit.
CRITERIA (C)
Section I. ISO 9000-Based Requirements
4.1. Management Responsibility
9503-C04 Agreed - March 28, 1995
Must all elements of the QS-9000 standard be included in the management review process (4.1.3)?
Yes, even if the element does not specifically state that. For example, in 4.14.3 Preventive Action, it states that plans and results must fall under management review... BUT the section 4.14.2 Corrective Action does not state it specifically. Despite this inconsistency in the ISO 9000 standard, corrective action plans and results must also be part of management review.
The accreditation bodies, registrars, and OEM's all agree that the intent of the standard is to require all relevant ISO 9000 systems be included in management review; likewise all QS-9000 systems must be included in the management review process.
9503-C11 Agreed - March 28, 1995
Rev. - August 1, 1995
Should the business plan be a controlled document with rev#, date, distribution list, etc.?
Yes, business plans have to be controlled documents.
9511-C50 Agreed - November 9, 1995
In the recently issued interpretations dated August 1, 1995, it was stated in #9503-C11 that business plans MUST be treated as Controlled Documents. I would like to know if an alternative approach of treating these documents as Quality Records would also be acceptable?
The ISO 9000 definition of records does not include business plans; QS 9000 does require that Business Plans be controlled documents.
9602-C53 Agreed - February 15, 1996
Please clarify, if you will, Question 9503-C11: Originally listed as Agreed - May 1, 1995 and stated "business plans are not required to be controlled or shown to Registrar." Subsequently listed as Agreed August 1, 1995 and stated "business plan must be controlled." (9503-C11 was not listed in index as changed and was not identified on Page 16 as revised as others have been).
The IASG releases of November 9,1995 and of February 15, 1996, include that the business plan must be controlled.
4.2 Quality System
9508-C20 Agreed - August 1, 1995
Does QS-9000 require that flow charts be included in the policy and/or procedures manuals?
No, but they are welcomed by most auditors because they tend to clearly identify who, how, the interrelationship, and the sequence. However, flowcharts are a PPAP requirement.
9508-C22 Agreed - August 25, 1995
When documenting our Quality Policy Manual for QS-9000, is it required to include a responsible department/individual?
Yes. See ISO 10013 Guidelines for Developing Quality Manuals, and ask your registrar. Also refer to QS-9000, cl. 4.2.1 and the QS-9000 glossary under "quality manual."
9509-C26 Agreed - September 28, 1995
Many of the QS-9000 requirements reference requirements in other manuals, such as APQP, PPAP, MSA and FMEA. Definitions of terminology in each of these manuals sometimes do not agree with each other, or are at variance with those in the QS-9000 Requirements Manual. Also, there are some definitions in all of the QS-9000 manuals which seem at variance with definitions in ISO 8402. And some definitions, e.g. "Customer" in the QS-9000 Requirements Manual, which are so narrow in scope as to not recognize that a supplier may be engaged in business with customers other than automotive.
A. Will a consolidated glossary of terms with a single, standard definition for each term be forthcoming so as to offer clear guidance in Quality Standard interpretation?
We are not aware of any functional inconsistencies in definitions between the latest editions of Task Force Manuals, e.g. SPC, FMEA, APQP, QS-9000, therefore we are not planning to publish such a glossary. We would appreciate specific information on any perceived inconsistencies contained in the manuals that would impact a successful QS-9000 implementation. The term "customer" is correctly defined within the context of QS-9000.
B. If a supplier finds definitions unsatisfactory, either for clarity or applicability reasons, are definitions based on other sources acceptable if they are contained in the Quality system documentation?
No. The QS-9000 definitions are applicable. Additional clarification is acceptable only if it does not conflict with the QS-9000 definition. Ask your registrar about specific examples.
9509-C32 Agreed - September 28, 1995
We request clarification on the prototype control plan referred to in Section Element 4.2.3, page 13 of QS-9000 (reference note under prototype control plan): The note states that prototype control plans may not be required from all suppliers. Our customer base consists of Ford/GM/Chrysler and Truck Manufacturers. We sell "Black Box" products to the customer base. Customers have not requested prototype control plans. Are we expected to have control plans for prototype phase even if not required by the customer?
The supplier is required to have a prototype control plan if they are supplying prototype material, regardless of whether the customer requests it.
9602-C54 Agreed - February 15, 1996
Are all Ford Control Plans & FMEA's, including service parts and parts that have no inverted Delta ( ) items, required to have signatory approval (Reference 4.2.3 & page 62 of QS-9000 manual)?
All control plans must be approved by the responsible Ford quality activity prior to the production part submission date. Signatory approval is required on Control Plans for inverted ( ) products and those designated by Product Engineering (with an Engineering Specification specifically requiring this approval). Refer to 9503-C09.
9602-C55 Agreed - February 15, 1996
Based on previous experience and correspondence, it is our understanding that all Control Plans & FMEA's required Ford signatory approval. What is the minimum a supplier can provide as evidence if Ford SQA refuses to sign off?
Ford has to sign off only on inverted deltas and for products so designated by Product Engineering, per the Ford direction in QS-9000:Section 3 and the Production Part Approval Process Manual. If the customer requires signatory approval, and if customer personnel do not, or refuse to comply with their requirements, it should be appealed in writing to the customer.
9602-C56 Agreed - February 15, 1996
On page 98 of the February, 1995 Edition of QS-9000 is a definition for quality manual. This definition states a requirement: "Quality manuals shall include responsibilities and authorities for each element of the quality system."
The quality manual for my company deals with policy for each QS-9000 requirement. Responsibility and authority is defined generally, not for each element. Does the quality manual have to identify responsibility and authority for each individual element? And if this in fact is the way the manual is to be written, why was it not made a requirement in the applicable element instead of in the glossary?
See ISO 10013 for discussion of the quality manual requirements. The quality manual includes not only policy, but also includes or cross-references 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.
9602-C57 Agreed - February 15, 1996
Comments: QS-9000 Clause 4.2.3, Quality Planning, states "Suppliers shall establish cross-functional teams to develop Control Plans for approval by the appropriate customer engineering and quality personnel unless this approval requirement is waived by the customer." The only waiver identified in QS-9000 in Section lIl is, Customer Approval of Control Plans and Reaction Plans is waived for suppliers to GM Europe unless otherwise advised. The control plan form in the APQP/CP manual contains a line for customer engineering approval and customer quality approval. Yet, the quality contract at my largest customer (a division of the Big Three) states, we do not need to approve your control plans and have said they do not need to send me a waiver.
What do I do to demonstrate the compliance with the requirement?
The instructions for completion of the Control Plan provide for this by saying "if required by customer." If specified by customer, customer-specific requirements (or changes to requirements) supersede the fundamental requirements. You need to have objective evidence of your customer's modification of the fundamental requirement. The understanding and evidence, should result from contract review.
9602-C58 Agreed - February 15, 1996
We would like clarification of the sequence of the supplier's quality manual relative to QS-9000 and ISO 9000 elements. Clarification is required based on the following:
Item 1:
Q.S.A., Page 5, Point 1 refers .... "The manual must be organized to correspond with the organization of topics in QS-9000" elements.
Item 2:
Quality system requirements QS-9000, listed under general, 4.2.1. Note 6: "Guidance on Quality Manuals is given to ISO 10013" which states on Page 6, 4.2.2.: "Although there is no required structure or format for Quality Manuals, they should convey the Quality Policy, etc.
We have experienced difficulties in the past whereby some auditors have accepted manuals in any format as long as the ISO contents are covered, while others have demanded that the existing manual be reformatted in the sequence of ISO before approval is granted. We are concerned, unless a directive is issued clearly instructing both the supplier base and the auditors as to what is acceptable, the confusion will continue.
The QSA is not meant to be overly-prescriptive in the organization of QS 9000 topics. This is a case of the registrar's auditor being unnecessarily (and improperly) prescriptive. While choosing to use the QS-9000 elements as the structure for the manual may make the manual auditor friendly, a registrar (or their auditors) should not require this of a supplier. There are alternative ways to help an auditor and your personnel relate your documentation, such as a cross-reference matrix between QS-9000 elements and the supplier documents.
9602-C59 Agreed - February 15, 1996
What does "cross-functional team" approach mean? Is it mandatory that the suppliers use a cross-functional team for developing facilities, processes and equipment plans or is it acceptable to use a "multi-disciplinary team"?
For the purpose of QS-9000, cross-functional teams and multi disciplinary teams are the same thing.
4.3 Contract Review
4.4 Design Control
9509-C35 Agreed - September 28, 1995
Reference Subelements, Section I.4.4.4, requirements for computer-aided design and analysis and the I.4.15.6 requirements for computerized system for ASN's. We believe these are particularly uncommon and onerous for many of the subcontractors. How are these requirements 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, if applicable, must be available to show the auditor.
9511-C45 Agreed - November 9, 1995
Regarding Element 4.4, Design Control: "...to control and verify the design of the product.... what is meant by the word product?....what activities require design control?....etc.
For ISO 9000 questions, please ask your accredited ISO 9000/QS-9000 registrar. See Definitions in ISO 8402.
4.5 Document and Data Control
9503-C06 Agreed - March 28, 1995
Regarding 4.5.2, wherein the supplier shall establish a procedure to assure the timely review, distribution, and implementation of all customer engineering standards/specifications and changes. 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!
9509-C29 Agreed - September 28, 1995
I am requesting clarification on the Classification of Characteristics requirement in QS-9000. In Section 4.05 in the paragraph "Document Identification for Special Characteristics" it states that "the supplier's process control guidelines and similar documents shall be marked with the customer's special characteristic symbol (or the supplier's equivalent symbol or notation) to indicate those process steps that affect special characteristics, when required by the customer (see Appendix C)."
In section 4.9 "Designation of Special Characteristic" it states "Suppliers shall comply with all customer requirements for designation, documentation and control of special characteristics. Suppliers shall provide documentation showing compliance with these customer requirements as requested by any customer." This paragraph does not allow you to use an equivalent symbol, as I understand it.
Also in Section III of the standard, Chrysler's requirements for special characteristics call out the shield, diamond and the pentagon; Ford calls out the inverted delta and GM refers to the Key Characteristics Designation System (which are the current symbols in Appendix C).
My question is: what are suppliers going to be audited to? Compliance with Appendix C or be allowed to deviate based on Section 4.05? Do we need a waiver if we use our own symbols?
QS-9000 4.5 requires the supplier to use the customer characteristic symbol on their documentation where the customer has designated a characteristic as "special" AND requires the supplier to note those the supplier designates with the supplier's characteristic symbol or equivalent. This is not in conflict with clause 4.9, which requires the supplier to use the customer's characteristics. The supplier can cross reference the Big Three symbology for use with the supplier-designated characteristics, but not for the customer-designated characteristics, unless the customer pre-approves this.
At this time, equivalencies are not acceptable to any OEM except Chrysler.
9509-C36 Agreed - September 28, 1995
We request interpretation of QS-9000, Element 4.5.1 which states:
"Document Identification for Special Characteristics
-
The supplier's process control guidelines and similar documents shall be marked with the customer's special characteristic symbol (or the supplier's equivalent symbol or notation) to indicate those process steps that affect special characteristics, when required by the customer (see Appendix C)."
Appendix C as we read it defines three different groups. Namely,
* Non-Key Characteristic
* Key Characteristic (Not relating to Safety or Legal Considerations)
* Key Characteristic (With Safety or Legal Consideration)
We question if the first two groups should be designated as "Special Characteristics." We interpreted the first group as to mean any characteristic listed on the part drawing and we don't believe these should be included in Appendix C.
The second group is questionable as stated in the various definitions. Believe should be stated as those characteristics identified by the customer as special characteristics which affect function, fit, or appearance. The words under the General Motors definition "is likely to significantly affect customer satisfaction with a product" leaves that statement open to interpretation as it does not state if the customer or the supplier is supposed to determine which characteristics fall into this category.
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.
9602-C60 Agreed - February 15, 1996
At page 21 (under 4.5.2) of the Quality System Requirements - QS-9000 there is the standard ISO 9001 quoted: The document and data shall be reviewed and approved for adequacy by authorized personnel prior to issue. Can the same person who prepared a document sign for preparing, review, as well as approval of the document?
Top management commitment and approval is required; who is authorized by top management is up to them, but must be documented. Review is traditionally expected to be by someone else in management other than the author.
4.6 Purchasing
9503-C07 Agreed - March 28, 1995
Regarding 4.6.2 (QS-9000:August 1994) Scheduling Subcontractors - suppliers shall require 100% on-time delivery performance from subcontractors... This is not consistent with 4.15.6 which requires a GOAL of 100% on-time delivery. Since delivery is a performance factor, should not the requirement of subcontractors be "a goal of, and a delivery system with the capability and design to be able to, provide 100% on-time delivery"?
Yes. Following is the new QS-9000:Feb 1995 text:
"4.6.2 Scheduling Subcontractors"
"Suppliers shall require 100% on-time delivery performance from subcontractors. The supplier shall provide appropriate planning information and purchase commitments to enable subcontractors to meet this expectation."
"The supplier shall implement a system to monitor the delivery performance of subcontractors, including tracking of premium or excessive freight."
"4.15.6 Supplier Delivery Performance Monitoring"
(Paragraph 1) "The supplier shall establish systems to support 100% on time shipments to meet customer production and service requirements. If 100% on-time shipments are not maintained, the supplier shall implement corrective action to improve delivery performance, including communication of delivery problem information to the customer."
(Paragraph 2) "A supplier shall have a systematic approach to develop, evaluate and monitor adherence to established lead time requirements. The supplier shall implement a system to track performance to the customer delivery requirements."
9504-C15 Removed - March 22, 1996
9508-C21 Agreed - August 25, 1995
How does a supplier handle the specification of requiring that our subcontractors or suppliers be on our customer approved subcontractor's list? What if different customers' approved lists do not include the same supplier for raw materials? Why can't these issues be resolved during the contract review and PPAP and then removed from this section of the standard? (Ref. 4.6.1)
If these issues were addressed at the contract review and/or PPAP stage, the intent of this clause would be met, regardless of the technicalities of the list(s).
9508-C23 Agreed - August 25, 1995
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.
9511-C41 Agreed - November 9, 1995
What constitutes subcontractor development? (4.6.2) Does the level of development depend on the importance of the subcontractor in processing the final product?
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.
9511-C43 Agreed - November 9, 1995
Subcontractor Development (4.6.2) requires Tier 1 suppliers to evaluate and develop subcontractors using Sections I and II of QS-9000 as the fundamental quality system requirements. Many Tier 1 suppliers have subcontractors that provide outstanding quality and service, but are small operations which often do not include the resources or environment to reasonably comply to this requirement (4.6.2). If compliance is not realistic for these subcontractors should the Tier 1 supplier re-source products to a larger subcontractor with stated resources?
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 suppliers.
9602-C61 Agreed - February 15, 1996
We are a Tier 1 supplier in the process of drafting our QS-9000 procedures. QS-9000 requires subcontractor development using Section I and II of QS- 9000. Does this mean we should require all of our suppliers to go through PPAP submissions? Or does this mean it is an ultimate goal but not a requirement?
For applicable subcontractors, all elements of QS-9000 should be applied, including PPAP. If you should require your subcontractors to be QS-9000 registered, or should the subcontractor seek registration due to other reasons, then they must have a PPAP system established and capable to perform PPAP if not already doing so. Refer to 9504-C15 and 9511-C51.
9602-C62 Agreed - February 15, 1996
We are struggling with a requirement in Section 4.6.3, Purchasing Data, specifically what is meant under the Restricted Substances heading when it says "Suppliers shall have a process to assure that governmental and safety constraints on restricted, toxic and hazardous substances are complied with relative to purchased products and the manufacturing process. Do we need a system to insure the above or is an acknowledgment in writing, or acceptance of a P.O. with this statement contained within, acceptable? Our current people that visit with the supplier base are not familiar with governmental and safety requirements and as it reads we would need to have qualified personnel visit to assure compliance. The key words that drive that paragraph are ..a process and ... complied with. To address ... complied with it implies some type of visit or audit to me. Please comment.
A "process" is required to ensure that restricted substances, either in purchased products or the manufacturing process used in their production, comply with all governmental and safety constraints. If your process specifies on-site review for compliance then you would need to do so by whatever means appropriate to demonstrate effectiveness. Alternatively, your process might require subcontractor evidence of compliance (e.g. appropriate certificates or letters of compliance). Acceptance of a purchase order containing the "restricted substance" verbiage is inadequate since it does not assure compliance.
9602-C63 Agreed - February 15, 1996
In Section 4.6.3, Purchasing Data, there is a QS-9000 additional requirement dealing with Restricted Substances . The last sentence ends with the words ...complied with relative to purchased products and the manufacturing process. Which manufacturing process does this refer to -- that of the subcontractor or that of the supplier? If the subcontractor, is it expected that the supplier establish control to assure that the subcontractor's manufacturing process complies with all government and safety constraints?
It refers to both -- the supplier's manufacturing process, but the reference to purchased parts includes subcontracted materials. (Refer to 9602-C62)
9602-C64 Agreed - February 15, 1996
As a Tier 1 and Tier 2 supplier of Z shapes to the automotive industry, we are required under QS-9000 section 4.6.2 to have our quality system satisfy all requirements of QS-9000. However, because of the nature of our distribution business, not all of the QS-9000 requirements are performed by us. An example is the requirements for process control (section 4.9). Since we do not manufacture the products we supply, we cannot perform any process control.
And, 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, barcoding, 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.
4.7 Control of Customer Supplied Product
9503-C14 Agreed - March 28, 1995
The QS-9000 documentation indicates that customer-owned tooling and returnable packaging does NOT fall under QS-9000. Interpretation of Clause 4.7 of ISO 9001: it is clearly geared for exactly those sorts of items coming from the customer. How does the registrar or supplier interpret or resolve this inconsistency?
Customer owned tooling and returnable packaging does fall under QS-9000 4.7 (see 4.15.4 and 3.3).
9509-C31 Agreed - September 28, 1995
We supply (OEM) a valve which has two plastic rectangular plastic covers placed on both ends of the valve. (OEM's) employees, after unpacking and removing the plastic covers, collect them in a box and send them back to us to be sorted, washed, and reused if determined good.
Where would we address this issue in the QS-9000? Would this be considered OEM-owned parts (4.7)?
The element used is not so important as long as the process is controlled. Ask your registrar.
4.8 Product Identification and Traceability
9511-C46 Agreed - November 9, 1995
Regarding Section 4.8 ......We receive.... including wires, clips...Does "Where appropriate" refer to these types of items? "Where and to the extent that traceability".....Is specified requirement referring .....encompass all incoming...be mandatory ....?
Ask your accredited registrar about these ISO 9000 issues.
4.9 Process Control
9503-C08 Agreed - March 28, 1995
Define environment (as used in 4.9(b), suitable working environment).
Environment will vary for each site, but generally includes: housekeeping, lighting, noise, HVAC, ESD controls, safety hazards relating to housekeeping.
Environment is defined in the Glossary.
9503-C09 Agreed - March 28, 1995
Must all control plans be signed by the customer? It appears that Chrysler, Ford and GM do not have a uniform policy in this regard. The form information in the APQP book shows (if required); where is "if required" defined or found?
The answer is customer and division specific. Supplier shall document customer's position on control plan sign-off.
9504-C16 Agreed - August 1, 1995
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. In those cases where a waiver is granted verbally, written customer confirmation must follow. The PPAP file must identify the individual granting the waiver and the date granted.
9509-C30 Agreed - September 28, 1995
Clause 4.9.6 PPAP, page 2, Items 7 and 9. What constitutes any change in process? What constitutes change in subcontracted parts, materials or services?
The process has changed when any of the following are changed: part number, engineering change level (from the design record), manufacturing location, material/component subcontractor, or production process environment. If in doubt, notify the customer for their position. See definitions of "Process" and "Subcontractor" in PPAP manual.
9509-C34 Agreed - September 28, 1995
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.
9509-C39 Agreed - September 28, 1995
There is a potential contradiction between 4.9 a) and the first paragraph of clause 4.9.1. Does 4.9.1 (QS-9000 requirement) which requires "documented process monitoring and operator instructions for all employees" 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?"
Or, is the interpretation of "process monitoring and operator instructions" related to process set-ups/set-points or machine settings as apposed to how-to- work instructions?
In the one case, instructions are required for all employees, in the other case there are alternatives.
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).
9602-C65 Agreed - February 15, 1996
Could you please interpret the meaning of a manufacturing location and production process environment? QS-9000 Section 4.9.6 states that Production Part approval is required if these change.
A. Is location from one manufacturing site or building to another site or building; or is it from one location in your plant to another location in your plant? We move the manufacturing line itself -- the process flow is not altered in these cases...or the line is shifted 10 feet or so. I would not think that this case would require a new PPAP be submitted. Could you clarify?
Per PPAP procedures you are required to notify your customer. Contact your customer's PPAP activity for direction concerning the level of submission necessary, if any.
B. Also could you elaborate on a production process environment?
Environment is defined in the QS-9000 Glossary. See 9503-C08 and the PPAP Manual, Topic II, When Submission Is Required.
9602-C66 Agreed - February 15, 1996
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. One is the documentation that is required, and the other is the record that proves the process was followed and records the results.
9602-C67 Agreed - February 15, 1996
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."
During a recent pre-assessment audit by a third party auditor, a remark was made about our lack of documented improvement plans for characteristics with a CpK above 1.33 and the above requirement was cited.
It appears that the above requirement does not recognize that companies have allotted budgets and preparing improvement plans for characteristics with a CpK higher than 1.33 does not appear to be a high priority. We place a priority on characteristics with a CpK of less than 1.33 and do have documented improvement plans for those characteristics.
Was the Auditor's comment that we should have documented improvement plans for all SPC characteristics regardless of the CpK value really the intent of this QS-9000 requirement?
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.
4.10 Inspection and Testing
9508-C17 Agreed - August 1, 1995
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.
9602-C68 Agreed - February 15, 1996
Receiving Inspection and Testing - 4.10.2
For some approved subcontractors with a good quality index, a Tier one supplier is carrying out receiving inspection only to a delivery batch per year as the only receiving inspection method. Is this acceptable according to 4.10.2" Receiving Inspection and/or Testing" (e.g. sampling based on performance)?
If the tier one supplier's incoming quality systems use the receiving inspection method must every delivery be sampled?
It is not possible to determine without more information. QS-9000 Cl. 4.10.2 requires you to use one or more of the methods listed. If the only 4.10.2 activity taking place is receiving inspection and as described above, then it would not be effective. The frequency of the receiving inspection must be effective in the judgement of the auditor. Ask your registrar.
4.11 Control of Inspection, Measuring, Test Equipment
9508-C18 Agreed - August 1, 1995
We would like interpretation on the following scenario:
A supplier has been told by a certified ISO auditor and it has been published in an ISO reference book that, "gages must have calibration stickers," and "the operator must know the status of a gage (meaning the date it is due for re-calibration)." Other certified lead assessors have stated that neither is required by ISO. The supplier's current system includes a process of etching a serial number on each gage. A computer program is maintained with all required information for each gage and re-calibration is done based on computer printouts, prior to due dates. This system has passed both GM and Ford audits in previous years. Does this system meet the requirements of 4.11.2d.
Yes, it appears to, but it is suggested you address this with your registrar during the pre-audit visit(s).
9508-C19 Agreed - August 1, 1995
If we use fixtures or gages for (back-up) reference only, will this exempt them from the required calibration?
See ISO 9000, Section 4.11.1. Otherwise, with the limited information provided, we cannot answer the question. Please ask your registrar.
9511-C44 Removed - March 22, 1996
9511-C49 Agreed - November 9, 1995
Do all gaging tools have to have a sticker attached that contains the calibration status, or can all gages be serialized with a number referencing it to the available records containing calibration status?
Standard states, 4.11.2(d), that a suitable indicator or approved identification record to show the calibration status. A serial number alone on a gage, measuring or test equipment device does not state an approval status to any potential user or auditor. There are other ways to identify approval status on gages, etc., other than a sticker. Please see your registrar.
9511-C52 Agreed - November 9, 1995
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.
9602-C69 Agreed - February 15, 1996
4.11.3 Inspection, Measuring and Test Equipment Records
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.
Does calibration/verification include adjustments made to a gage, for example, on the shop floor due to environmental conditions?
If so, does the requirement for keeping records on gage conditions apply every time a gage is adjusted with the use of a master, set block, etc.? How about on the shop floor or just when the gage is received in inspection for its scheduled calibration?
No, this appears to be a gage adjustment pertaining to process control (4.9) rather than a calibration issue.
4.12 Inspection and Test Status
9503-C12 Agreed - March 28, 1995
Rev. - August 25, 1995
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).
4.13 Control of Nonconforming Product
9503-C05 Agreed - March 28, 1995
Regarding 4.13.4, wherein prior written customer authorization is required whenever the product or process is permanently changed from that currently approved... Does a verbal phone authorization from the customer, documented by the supplier, constitute "written" authorization?
It is acknowledged that this practice was used by many OEM's. The answer, however, is no. Temporary changes to process may be verbally authorized with follow-up documentation. All permanent changes must have prior written authorization.
9511-C47 Agreed - November 9, 1995
Please reference customer approval of process changes made by subcontractors as stated in 4.13.4. Company X, a Tier 2 supplier to OEMs, in manufacturing, uses a stainless steel strap which is purchased from a subcontractor which purchases steel coil from a steel mill etc. Company X sells the strap to a Tier 1 exhaust component manufacturer that supplies an assembly plant.
Does 4.6.2 imply that QS-9000 is to be applied by each successive tier to the next lower level, etc.? Does 4.13.4 require PPAP approval by the customer for every process down the chain? A supplier/company that meets the requirements of QS-9000 should be capable of authorizing changes in its subcontractor's processes? A clarification of the level to which OEM approval of process changes extend would be beneficial.
OEM Approval of Process Changes take place at the Tier 1 level and are subject to the requirements and definitions found in the PPAP Manual. The Tier 1 supplier must be made aware of changes by his subcontractor, and through the subcontractor, of those throughout the subcontractor's product supply chain, that would affect the supplier's ability to meet QS-9000 PPAP Requirements.
9602-C70 Agreed - February 15, 1996
Further clarify prioritized reduction plan (4.13.3).
A prioritized reduction plan is a plan for eliminating nonconforming product that is based upon customer satisfaction, risk and the significance of the issues.
4.14 Corrective and Preventive Action
4.15 Handling, Storage, Packaging, Preservation and Delivery
9602-C71 Agreed - February 15, 1996
On page 44, Para. 4.15.6 includes an automotive requirement Production Scheduling which specifically mandates that the suppliers production scheduling activity be order driven. How does this apply if the suppliers production activity is based on customer provided forecasts and contract requirements to supply a certain number of parts per month? Also, how does this apply to a supplier who uses a constant flow manufacturing process where the strategy is to sustain a planned inventory with predetermined inventory turn over rates?
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.
4.16 Control of Quality Records
9503-C13 Agreed - March 28, 1995
In QS-9000 4.16, Quality Records, the documentation states that the retention time is determined by the customer. Can the Big Three change the wording to read that the established retention times do not violate customer requirements...i.e., they may exceed them as needed for other reasons?
Shown below is the QS-9000:Feb 1995 revised (added) text for 4.16 Quality
Records wherein retention time is addressed:
"Record Retention"
(Paragraph 4) "These requirements do not supersede any governmental or customer requirements. All specified retention periods shall be considered `minimums'."
9509-C25 Agreed - September 28, 1995
The second revision attempted to better clarify record retention periods, however, the addition of the word "minimum" is confusing, e.g. can a record be kept indefinitely?
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.
9509-C38 Agreed - September 28, 1995
Control of Quality Records, Element 4.16, under "Record Retention" refers to "..... purchase order and amendments shall be ......" Can you please clarify whether the purchase order in this context refers to:
a) purchase orders and amendments placed on the supplier by the customer (i.e. the Big 3);
b) purchase orders and amendments placed upon a sub-contractor by the supplier; or
c) both of the above.
Records retention reference to Purchase Orders and Amendments includes both those issued to and by the supplier, i.e. c) both of the above.
9602-C72 Agreed - February 15, 1996
Regarding Section 4.16: The Record Retention part of 4.16 states that "purchase orders and amendments shall be maintained for the length of time that the part (or family of parts) is active for production and service requirements plus one calendar year."
What is the definition of active for production? If a new contract is awarded every model year, is one year the definition? Is this true even though the part may be the same part that was produced in previous years? How is service requirements defined? Does the customer have to inform the supplier of the required length of time?
"Active" part is defined in the QS-9000 glossary, and the definition addresses these questions. Service part requirements are provided by the customer service part operations department.
4.17 Internal Quality Audits
9509-C27 Agreed - September 28, 1995
Element 4.17, Internal Quality Audits, Page 46, states:
"Internal quality audits shall be scheduled on the basis of the status and importance of the activity to be audited..."
Our question is: In this case, what does the use of the term "activity" refer to? Is activity, for example, referring to a product or manufacture area? Or is activity referring to a function within the QS-9000 plant quality system such as MSA, PPAP, FMEA, control plans etc.?
We are interested in the IASG interpretation of activity as this has a direct effect on audit scheduling.
"Activity" can refer to both departments and processes in a company. The internal audits must include all processes and procedures implemented to address all elements of QS-9000. Internal audit results shall be included in Management Review (4.1.3) to be evaluated for continuing suitability and effectiveness.
4.18 Training
9509-C33 Agreed - September 28, 1995
How can confirmation of training effectiveness be demonstrated as required by QS-9000 4.18?" This question is directed at learning whether the automakers have a particular method in mind.
Training effectiveness can be best judged by the performance of the trained individuals via audits and performance evaluations. See your registrar. The automakers have no particular method in mind.
4.19 Servicing
9509-C28 Agreed - September 28, 1995
The supplier's component is part of a subassembly at the customer 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 nonconformances 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.
4.20 Statistical Techniques
Section II. Chrysler, Ford and General Motors Requirements
II.1 Production Part Approval Process
9503-C02 Agreed - March 28, 1995
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. The system for implementing PPAP must be in place. The registrar will expect to see evidence of PPAP implementation for all parts submitted since September 1993. Pre-PPAP part submissions must show compliance to the then existing customer requirements.
9503-C03 Agreed - March 28, 1995
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 file must be available for registrar or customer review and show compliance to part submission requirements in effect at time of submission.
9509-C37 Agreed - September 28, 1995
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.
9511-C40 Agreed - November 9, 1995
My question involves the QS-9000 note that reads;" primary suppliers are responsible for subcontracted material and services." I am uncertain of the scope; here are two possible, yet different interpretations:
A. The supplier is responsible for subcontracted material and services, so it is the responsibility of the supplier to assure that the material and services of the subcontractor is in compliance - therefore no further submission is required of the primary supplier in submitting a subsequent PPAP to their OEM customer. In this case, the primary supplier has absolute control over their sub- suppliers & subcontractors...or
B. The primary supplier is responsible for subcontracted material and services, but after approval of PPAP submissions from its subcontractors, the supplier must subsequently submit a PPAP to its customers for approval.
To simplify, if I approve a PPAP from my supplier, do I then need to submit a PPAP to my customers (Ford, Chrysler, or GM) or am I entrusted to make final approval?
Primarily A above. 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 in the above case. The supplier's PPAP submission is only required for the product shipped to the final OEM customer.
9511-C42 Agreed - November 9, 1995
Regarding PPAP (Interpretation #9503-C02): Over the last years a Tier 1 supplier has used an "internal" engineering change level system and an "external" Big Three" engineering change level system. Per the information of the supplier, this approach was accepted by a Big Three auditor.
Does the requirement for PPAP submission after an engineering change level refer 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 must not alter the supplier's responsibility to meet PPAP.
9511-C48 Agreed - November 9, 1995
We understand that producers of oil, grease, gasoline, anti-freeze and windshield cleaner were not required to obtain QS-9000 registration. HOWEVER, recently the IASG Chrysler representative answered "If it's in the vehicle when it leaves the assembly line -- and you supply it -- you must be registered." We are confused. These customers have never had to comply with PPAP etc.
A) Assuming a company supplies such product directly to the Big Three, do they need to register to QS-9000?
If these materials are considered to be "production" material by your OEM customer, then QS-9000 applies. Contact your customer's purchasing activity to obtain final determination.
B) What are the requirements if they do not supply directly, but supply Tier 1 suppliers?
Subcontractor QS-9000 registration is not required. Suppliers are expected to use QS-9000 to define the fundamental subcontractor quality system requirements. In this case, ask your customer.
9511-C51 Agreed - November 9, 1995
Must a company obtaining QS-9000 certification, require Section II.1, PPAP, of their subcontractors?
It varies. All GM "suppliers" as defined in QS-9000, who are required to be certified to QS-9000, must require PPAP of their commodity subcontractors, as indicated in "General Motors Operating Policy for PPAP" on page 32, Appendix D, of the PPAP manual. For bulk, raw, or indirect material, it is the Procuring Division's decision whether PPAP is required.
For all other organizations who are QS-9000 certified, the PPAP requirement for their subcontractors, must be treated by them as a "shall" or a "should" depending on their OEM customer requirements or directives. If not specifically required by the OEM customer, then it is a "should", where PPAP is a preferred subcontractor methodology, that can be replaced by an equal but more appropriate approach.
9602-C73 Agreed - February 15, 1996
Do the PPAP requirements apply to temporary out source, plant assists, or emergency run situations? What if you only have the job a weekend, a week, a month, or a few months?
Yes, you must notify your customer. These situations may be handled under 4.13.4, Engineering Approved Product Authorization, or by a PPAP submission, based upon the customer direction.
9602-C74 Agreed - February 15, 1996
What if the customer verbally tells you that they don't want you to do the PPAP requirements, and they sign off on a buy-off sample and only want you to produce as good as, or better than, the buy-off sample? At that time, what is the supplier required to do?
This would be acceptable if the customer waiver is properly documented (see 9504-C16). A customer can waive a PPAP submission for a given part, but the supplier must have a PPAP system in place with supporting records to be QS-9000 registered.
9602-C75 Agreed - February 15, 1996
Rev. - March 22, 1996
Can the retention of master samples at a supplier's facility, of PPAP submission, be waived by written notice from the customer? If I am processing for a Tier one supplier and my customer does not require a PPAP submission, am I required to PPAP material and keep the documentation at my location? If the answer is yes, can I request a written waiver from the customer? Must a supplier, who is pursuing QS-9000 Certification, PPAP non-Big 3 products? If the answer is yes, can the supplier receive a written waiver from the customer?
The customer can waive the requirement for keeping master samples. Refer to 9504-C16 and 9602-C74. A PPAP system, with supporting documentation, must be in place. The customer establishes the level of evidence to be submitted, reference the PPAP manual. If waived by the customer, a submission is not required on a part-by-part basis.
9602-C76 Agreed - February 15, 1996
We are a research, development and design contractor working as a Tier one supplier. We are currently being assessed to QS-9000 but the registrar has pointed out that the Production Part Approval Process is a mandatory element of QS-9000.
However, we do not (currently) manufacture any production parts. As of September 1995, IASG indicated that we must seek a waiver from each of the OEM customers. Hence, we approached Ford, GM and Chrysler and obtained letters confirming that we do not manufacture production parts and that we are exempt from (performing) PPAP. Our Register asked that these waivers be sanctioned by IASG .... would you please?
This category of supplier, e.g. Design Centers, can not be QS-9000 registered. They do not meet the applicability requirements as defined in QS-9000, or the definition of "site" from 9503-R13. This assumes there are no production processes located at this facility.
II.2 Continuous Improvement
9503-C10 Agreed - March 28, 1995
QS-9000 Section II, 2.1, first paragraph includes price as a continuous improvement factor. Registrars need guidelines of whether they can or should audit this and, if so, what criteria? This seems to equate price reduction with continuous improvement.
Auditing of specific part price information is not expected for third party quality system assessments. However, the use by a supplier of cost elements or price as one of the key indicators within a continuous improvement system is required and subject to registrar audit.
II.3 Manufacturing Capabilities
9602-C77 Agreed - February 15, 1996
II.3.3 TOOL DESIGN and FABRICATION:
A. What is classified as a tool? Is a replacement component to a manufacturing machine that does not directly come into contact with the customer's product classified as a tool?
A tool is generally that part of a machine that comes in contact with the part and produces a change to the part (e.g., drill bit, reamer, broach).
B. Specifically, is a quill holder for a precision grinder, subject to this requirement?
A quill holder is not considered a tool. It is, however, considered part of the machine or equipment and is subject to the requirements of 11.3.1.
9602-C78 Agreed - February 15, 1996
Section II.3.3 Tool Design and Fabrication states "Customer-owned tools and equipment shall be permanently marked so that the ownership of each item is visually apparent.
The supplier's procedure states that all production tools are customer supplied and that upon receipt of said tool, the manufacturing engineer identifies the tool/equipment, assigns an identification number and model type on a metal tag, affixes it to the tool and enters the number into a computer log designating the individual customer ownership. Also every employee questioned knew, for example, that Model N designated a GM product.
Does this meet the requirements or must the supplier affix another tag that says Property of GM?
Yes, as long as the customer part number and/or customer name is cross- referenced; an affixed tag specifically containing the part number and/or customer name is preferred to identify ownership.
9602-C79 Agreed - February 15, 1996
Section II of QS-9000, Manufacturing Capabilities, Paragraph 3.3, Last sentence ......"Customer owned tooling and equipment shall be permanently marked so ownership is visually apparent." Is an identification number OK if you can go to a database list that shows ownership?
Yes, as long as the supplier can produce records that comply with the supplier's procedure and the procedure provides for clear traceability back to the customer. An affixed tag specifically containing the part number and/or customer name, however, is preferred.
9602-C80 Agreed - February 15, 1996
2.3 Section II. I am requesting an interpretation as to why auditors are insisting that before our company can be registered, the company must have in place all the points listed?
In my opinion, our company should choose what points are appropriate, implement these and be audited on that aspect.
As far as we shall demonstrate knowledge, could this not be our company decision maker that determines what points would be appropriate for our company?
The measures and methodologies listed in II.2.3 are not all required. Knowledge of all is required. Use of all appropriate measures and methodologies is required. (Meeting the customer's requirements is typically an important part of getting his business; if his business is not important to you, the question of compliance to QS-9000 falls to your decision- maker.)
9602-C81 Agreed - February 15, 1996
Concerning QS-9000, Section II, Manufacturing Capabilities, 3.1 (Facilities, Equipment and Process Planning and Effectiveness).
How can a middle size mid-tech company develop methods for evaluating the effectiveness of existing operations and processes considering automation, ergonomics, value added labor content, etc.? This is a shall...what are used criteria to evaluate this broad requirement?
The auditor will look for documented evidence that the company has evaluated and/or developed methods for the measuring and monitoring of the effectiveness of existing operations, the elements listed must be included.
Section III. Customer-Specific Requirements
9503-C01 Agreed - March 28, 1995
Ford and Chrysler do not require lab accreditation (QS-9000 4.10.1 sub). Does GM still require lab accreditation if a supplier passes a third party assessment to QS-9000 by a "Qualified QS-9000 Registrar"?
GM has changed its policy for laboratory accreditation. Third party registration to QS-9000 in accordance with Appendix B will satisfy the GP-10 requirements for GM North American locations of laboratory facilities utilized by suppliers for inspection and testing of their own product for purposes of conformance to the specified requirements. Laboratories utilized for commercial laboratory services are excluded from this provision. This practice, as stated, is not acceptable and does not meet QS-9000 4.9.
9602-C82 Agreed - February 15, 1996
While in attendance at a meeting between the IASG, Big-3 representatives and registrar representatives in September 1995, there was discussion regarding Section III, Customer Specific Requirements. My records of this meeting relative to this topic state that the Big-3 do not expect registrars to perform a deep-dive into all customer specific requirements during the initial assessment. Rather, it was expected that the registrar would look at all of the customer specific requirements over the three years involving the registration audit and surveillance audits.
A. Is this correct?
Yes, the registrar will review compliance to essentially all Section III requirements over the three years, including a significant sampling at the registration audit.
B. Can a supplier receive a "major hold" in the QS-9000 audit if there are significant nonconformances in Section III?
Yes.
DATABASE (D)
9503-D01 Agreed - May 1, 1995
As a registrar conducts QS-9000 audits, issues or questions concerning interpretation will continue to arise. How can a registrar expeditiously obtain a timely, and valid response?
These QS-9000 interpretations made by the IASG should be considered fully sanctioned; new or updated interpretations will be distributed to and made available to you through your QS-9000 qualified registrar (as a minimum) or the ASQC, typically within a week after the IASG reaches consensus.
Interpretation requests to the IASG should be faxed to 614/847-8556 c/o IASG for review and consideration at a future IASG meeting. Sanctioned QS 9000 interpretations from IASG are available through the ASQC at 1-800-248 1946.
9503-D02 Agreed - August 1, 1995,
Rev. - March 22, 1996
Which registrars have been qualified to QS-9000, and how will it be disseminated?
See "Section D."
9503-D03 Agreed - May 1, 1995
Rev. - February 15, 1996
Will a database exist of QS-9000 certified companies? Can anyone use it for searches, etc.?
A database of QS-9000 certified companies has been developed. ASQC will be providing quarterly, written copies of the "QS-9000 Worldwide Registered Company Directory." Additionally the data base is accessible through the ASQC QS-9000 Web Page, http://www.asqc.org/9000. Search capability for this database exists through the Web Page and by ASQC. Call ASQC at 1 800-248-1946 (North America) or 1-414-272-8575 for more information.
9503-D04 Agreed - May 1, 1995
Will the IASG respond directly to me regarding my questions submitted to the Fax Mail Box?
No, but all questions submitted are considered by the IASG. Many are answered in the IASG "Sanctioned Interpretations," but some are not applicable, considered a repeat, or will be addressed at a later date.
Please discuss questions with your registrar and/or accreditation body before submitting a question to IASG.
9508-D05 Agreed - August 1, 1995
Rev. - February 15, 1996
How are supplier QS-9000 registrations documented, communicated, maintained and what information should a registrar provide?
The QS-9000 certificated supplier information shall now be provided to the ASQC, the sanctioned database provider, by each QS-9000 qualified registrar. The record should include:
1) Certified Company Name
2) Certified Company Address (mailing)
3) Certified Company Site Address
4) Certified Company Telephone Number
5) Certified Company Facsimile Number
6) Certified Company ISO Contact
7) ISO Standard Registered to
8) Issue Date of Initial QS-9000 Certificate
9) Registrar for Initial QS-9000 Certificate
10) Issue Date of Current QS-9000 Certificate
11) Certificate Number of Current QS-9000 Certificate
12) QS-9000 Scope
13) Commodity Code (US SIC or NACE)
14) Issuing Registrar Name
15) Issuing Registrar Office Address
16) Issuing Registrar Office Telephone
17) Accreditation Bodies Shown on Certificate
18) Supplier Code for each customer, e.g. Duns Number
This information shall be communicated in the ASQC-specified format. Each QS-9000 qualified registrar must maintain and can make public their list of QS-9000 registered companies. (See 9503-R04)
9511-D06 Agreed - November 9, 1995
Is there a listing of appropriate divisions of Chrysler, Ford, & GM so one can clearly answer to a supplier - they are a Tier 1 supplier to the Big Three Auto?
No. If in doubt, contact your customer.
9511-D07 Agreed - November 9, 1995
A) Is there a listing of interpretation documents as mentioned in the May, 1995 Actionline? B) How does one subscribe to Actionline? C) Can we also obtain the IASG monthly document? D) What information is available on QS-9000 for Service?
A) Contact ASQC at 1-800-248-1946, ask for Item Number T57,
B) Contact AIAG to inquire at (810) 358-3570,
C) ASQC will have the latest version. IASG interpretations are not currently issued on a monthly basis, but rather after the IASG meets which is not on a set schedule.
D) There is no QS-9000 for service suppliers, now or planned for the near future.
9511-D08 Agreed - November 9, 1995
Are the QSA audit forms, in the QSA booklet, available in software form?
How? Where?
Not from the IASG or Big Three at this time.
9511-D09 Agreed - November 9, 1995
How are suppliers expected to stay informed of changes to documents, i.e. PPAP? Is a subscription service available?
No subscription service is available at this time; please contact your customer's purchasing activity to verify the latest dates.
9511-D10 Agreed - November 9, 1995
Rev. - February 15, 1996
A. How can I get a list of the QS-9000 registered companies?
See 9503-D03.
B. Who collects this information? How is it collected?
This information is now collected by the sanctioned database provider, ASQC. Submission of the appropriate information to ASQC is required by all QS-9000-qualified registration, or certification bodies.
(See 9508-D05)
C. How many companies are currently registered to QS-9000?
As of February 1, 1996, there are 99 QS-9000 certificates issued.
OTHER (O)
9503-O01 Agreed - March 28, 1995
Rev. - February 15, 1996
We heard of a "TE-9000" for automotive suppliers of tooling and equipment...what is it?
A supplement to QS-9000 is being developed for auto suppliers of tooling and equipment. QS-9000:TE Supplement is the draft name of the QS-9000 based document. It will be a "voluntary" document for guidance only. The name TE Supplement is an internal Chrysler/Ford/General Motors Supplier Quality Requirements Task Force (copyrighted) term at this time.
The Big Three have indicated that third party registration to the TE
Supplement will not be permitted. The QS-9000 qualified Registrars, and the QS-9000 recognized Accreditation Bodies have agreed that they will not conduct or permit registration to the TE Supplement /QS-9000 "Voluntary Guideline" when issued.
9508-O02 Agreed - August 1, 1995
Rev. - February 15, 1996
Should suppliers of fixtures and gages wait for TE-9000? Are they required to implement QS-9000 if they supply fixtures & gages directly to the Big Three?
No company should wait for QS-9000:TE Supplement. If it makes sense, supplier management should consider pursuit of ISO 9000, (not necessarily registration), if their company is not otherwise eligible for QS-9000.
9508-O03 Agreed - August 1, 1995
I want to submit my request to the IASG but would like to know your procedure dealing with the method of handling "requests for interpretations." My concern is centered around supplier and registrar confidentiality.
All requests to the fax mailbox are maintained as confidential by the IASG Administrative Contact. All proprietary elements are eliminated prior to this being presented to the IASG. Therefore, no one can identify the party submitting the question.
9508-O04 Agreed - August 1, 1995
I am a Registrar. An accreditation body mentioned concerns regarding the direct contact of a registrar with the Big 3 to clarify interpretative issues. The accreditation body considers it the role of the Registrar's own Automotive Advisory Board/Governing Board Member to be involved in these matters. What is the input of the Big 3 representatives on this? I am also concerned about timely responses, if we must go with these questions through a Board Member; at this time, these contacts may be very time consuming for the Board Member.
The registrar should go to their accrediting body first and then to the IASG when more assistance is required. Only if an immediate response is needed, should the registrar contact the "Chrysler/Ford/General Motor Supplier's Quality Requirements Task Force." Any resulting question and answer should be submitted in writing to the IASG Fax Mailbox.
9511-O05 Agreed - November 9, 1995
Rev. - February 15, 1996
Can we obtain a draft copy of "TE 9000" that is currently being developed?
No. The QS-9000:Tooling and Equipment Supplement to QS-9000 is in draft form only. The TE-9000 term is no longer appropriate in referring to this document. The exact form is yet to be determined.
9511-O06 Agreed - November 9, 1995
Would you confirm the latest revision status of the following documents:
Quality System Requirements QS-9000
Measurement Systems Analysis
Statistical Process Control
Potential Failure Mode and Effects Analysis
Production Part Approval Process
Advanced Product Quality Planning and Control Plan
Quality System Assessment
Quality System Requirements QS-9000 - Second Edition, February 1995.
MSA - Second Edition, February 1995.
SPC - First Edition, Second Printing, March 1995.
PFMEA - Second Edition, February 1995
PPAP - Second Edition, Second Printing, July 1995.
APQP - First Edition, Second Printing, Feb. 1995.
QSA - First Edition, August 1994
All documents listed are currently available from the AIAG.
OTHER - Laboratory Issues (O)
9602-O07 Agreed - February 15, 1996
Follow-up to Question 9503-C01 concerning Lab Accreditation:
A. Are the requirements of GP-10 still in place even though formal GP-10 Accreditation is no longer required if QS-9000 certified?
Those requirements of GP-10 that pertain to good supplier !ab operation practices still apply. Procedures defining lab function must still be documented, even if not contained in a "test facility manual."
B. For example, is there still a need to complete a Test Facility Questionnaire or for a Test Facility Manual?
All Section lIl Customer Specific Requirements are subject to audit at any time. All Section lIl Customer Specific Requirements must be evaluated sometime during the contracted registration period.
9602-O08 Agreed - February 15, 1996
For commercial/independent laboratories, does QS-9000 or IS0/IEC Guide 25: General Requirements for the Competence of Calibration or Testing Laboratories, apply in judgement of technical competency?
For commercial/independent laboratories, ISO/IEC Guide 25 is the internationally recognized standard used world-wide in judging the technical competence of calibration and testing laboratories.
If a supplier is in doubt about the acceptability of an outside laboratory, it should be confirmed with the customer. Also see 9511-A17.
But, accreditation to ISO/IEC Guide 25 does not sufficiently address the customer/supplier interface, and is incomplete compared to ISO 9000/QS 9000.
However, for the supplier's in-house laboratory utilized by the supplier for inspection and testing of their own product for purposes of conformance to the specified requirements, QS-9000 registration is sufficient.
9602-O09 Agreed - February 15, 1996
Rev. - March 22, 1996
Sub-Contractors Requirements For Laboratories (4.6.2)... Must subcontractor laboratories meet Purchasing Element 4.6.2 Subcontractor Development of QS-9000 as the fundamental quality system requirement?
The supplier is responsible to comply with the basic ISO 9000:1994 element of QS-9000:4.6.2 in the evaluation and selection of test laboratories. However, QS-9000:4.6.2. Subcontractor Development, is NOT applicable to outside test laboratories because they do not meet the definition of "QS-9000 subcontractors", therefore these labs do not have to use QS-9000 for development, as required in 4.6.2., Reference 9503-A01 and 9602-O08.
9602-O10 Agreed - February 15, 1996
What qualifications should a QS-9000 auditor have in order to adequately judge a laboratory's compliance to QS-9000 requirements?
A QS-9000 auditor must meet all QS-9000 qualified auditor requirements. It is of benefit if the QS-9000 auditor is also familiar with the contents of ISO/IEC Guide 25, and even better (but not required), if the auditor has some experience in auditing to Guide 25. Auditing the quality system compliance of labs and testing facilities is but a small part of QS-9000.
An auditor with only Guide 25 experience has only part of the experience and capability required to audit to QS-9000.
PROCESS (P)
9503-P01 Agreed - March 28, 1995
Rev. - August 1, 1995
Will the Big Three accept any ISO 9000 or QS-9000 certificates based primarily on first party internal audits, as described by Hewlett-Packard/Motorola representatives, in their Supplier Audit Confirmation (SAC) Approach?
No. The Chrysler, Ford and GM Supplier Quality Requirements Task Force have issued a position paper to registrars and accreditation bodies to document the Big Three positions relative to the proposed Supplier Audit Confirmation (SAC) approach presented at the 1/19/94 IAF Conference in Geneva. In essence, the Big Three do not accept any first party declarations of conformance to QS-9000. Nor do they accept a third party assessment which does not meet the QS-9000 requirements; the latter includes the assessment of all quality system elements by a QS-9000 qualified assessor working for a QS-9000 qualified registrar.
9503-P02 Agreed - March 28, 1995
Must auditors always report "Opportunities for Improvement" for a QS 9000 assessment?
From QS-9000 App. B, Item 8. "..Third party auditors will identify opportunities for improvement (e.g., excessive scrap) as these become evident during the audit without recommending specific solutions. These opportunities shall be included in the report to the supplier.
Opportunities for improvement (see Continuous Improvement 2.2 of the standard) are expected of the auditor. If none are found, a statement to that effect must be reported.
9508-P03 Agreed - August 1, 1995
How should a QS-9000 auditor address customer performance requirements?
In QS-9000, supplier internal key indicators must be established to meet customer performance requirements, e.g. Analysis and Use of Company Level Data (4.1.5), Customer Satisfaction (4.1.6), On-Time Delivery (4.15.6) and Continuous Improvement (2.1). Effectiveness of a company's system must be measured and tracked by the use of these key indicators. Continued surveillance by an auditor of poor trends in those key indicators in terms of meeting customer performance requirements will jeopardize continued QS-9000 certification.
9508-P04 Agreed - August 1, 1995
We are going through a QS-9000 audit in mid-September. When will Section III requirements at the audit be imposed? Will Section III requirements be audited as sampled?
All sections will be audited during the registration audit. Conformance to Section III requirements will be evaluated under element 4.3 (Contract Review). The registrar must ascertain which of the Section III requirements are applicable to you based on your automotive customers; this should occur at the pre-audit visit, or sometime before the registration audit. Each ap