Quality Progress’ Standard Issues IATF 16949 Column

ASQ Members: please find Quality Progress’ latest Standard Issues column here about IATF 16949 subclause 8.5.1. You must be logged in to view the column.

And at this link,  ASQ members may find additional articles published in Quality Progress about this updated standard.

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TS 16949, ISO 9001

Automotive inspection, TS 16949, IATF 16949

Question

Our company designs and manufactures commercial and automotive semiconductor products. We used to maintain dual certification (ISO9001 and TS16949) for all of our manufacturing and assembly locations, but recently dropped the ISO9001 certification.  My questions are as follows:

1) If we manufacture automotive and non automotive products in the same location “site”, without dedicated separation, does the TS certification eligibility apply to the entire site?

2) Can we include the non automotive design RSLs in the TS16949 certificate scope, or would we need a separate ISO9001 certificate to cover those activities?

Answer

Thank you for your question.   Yes, TS 16949 requirements would apply to all of your “automotive” processes whether they produce/support only automotive products or not.   This is actually the way you’d want to do it:  it would be more complicated to try to have two systems for automotive and non-automotive products.    If you have only one certification, the scope of your audits would have to be your whole product line, and not just your automotive products.

The answer to your second question is again related to the scope of your registration.   If you are not design-responsible for the automotive side of your business there is a risk that your TS 16949 audits (internal and external) do not include your design function.    If you want your design activity in scope, work with your registrar to roll it into your scope of registration.  Understand that if you do it that way, your non-automotive design would be subject to all of the additional 7.3 controls listed in TS 16949.  Although you should be able to cover it under one registration, It will be up to them if they want you to split it out into a separate ISO 9001 registration.  The impact of that difference should be minimal.

Please let us know if you have any follow-up questions related to this answer.

Denis

Denis J. Devos, P.Eng
A Fellow of the American Society for Quality
Devos Associates Inc.
(519) 476-8951
www.DevosAssociates.com

TS 16949 Layouts

Automotive inspection, TS 16949, IATF 16949

Question

On layout inspection, if the customer doesn’t specify, what will be the minimum required for TS16949? What is the frequency of this layout inspection for TS16949?

Answer

Thank you for your question.  ISO/TS 16949:2009 does not require an annual layout, but Clause 8.2.4.1 states that annual layouts will be performed in accordance with the Control Plan.    If the Customer requires an annual layout, you will flow that requirement down into your Control Plan and conduct the layouts.  If none of your customers require an annual layout, you are not required to do them (but you can if you choose to do so).

I hope you found this answer helpful.

Denis

Denis J. Devos, P.Eng
A Fellow of the American Society for Quality
Devos Associates Inc.
(519) 476-8951
www.DevosAssociates.com

“As received/As found” Condition Requirement in ISO/TS 16949?

Automotive inspection, TS 16949, IATF 16949

Question

It’s been mentioned to me by several people that TS16949 requires that the “as found” (sometimes known as the “as received”) condition is required to be documented on calibration certificates. However, I’ve read 7.6.2 several times and I can’t find where it requires that.

Can you point me to the section that is being understood to mean the “as found” must be included?

Answer

Thank you for your question.

Although recording the as-received readings over the range of calibration is a best practice, it is not required by ISO/TS 16949.  Clause 7.6.2 – Calibration/Verification Records requires only that “records……shall include, any out-of-specification readings as received for calibration/verification.” Therefore, “as found” readings are only required to be recorded if they are out of specification. If they are within specification, they are not.

Denis J. Devos, P.Eng
Fellow of the American Society for Quality
Devos Associates Inc.
Advisors to the Automotive Industry
http://www.DevosAssociates.com

TS 16949 Certification Requirements

Automotive inspection, TS 16949, IATF 16949

Question

My company is a fabless semiconductor company and we provide ASIC design and custom IP services, and manage our customers’ supply chain from foundry to assembly and test, and drop ship.

We are gearing ourselves up to supply IC chip to automotive customers and the prerequisites indicate our manufacturing partners must be ISO/TS16949 certified and our company’s QMS compliant to this standard.

There are a lot of documentations to be upgraded and revised, including supplier management specifications. I was thinking instead of repeating what ISO/TS16949 says from A to Z, I thought the best way is to add a clause in my supplier management spec is to specify “Suppliers manufacturing products for automotive customers must be certified to ISO/TS16949 (latest version) by a 3rd Party Registrar”.

Most of our manufacturing suppliers publish/broadcast their certifications in their external webpage and this is how we verify the certification status. Will this approach work from automotive customer’s perspectives?

Looking forward to your guidance and advice.

Response

Thanks very much for your question. A little bit about ISO/TS 16949; if your company doesn’t manufacture anything, then it is not eligible to be registered to ISO/TS 16949. You would, however, be required to be registered to ISO 9001. Double check that your customers are asking for your suppliers to be registered to ISO/TS 16949. That is not a default position. If it’s not in your contract, it won’t be a requirement (because your company is not ISO/TS 16949 registered).

If you are required to be compliant to ISO/TS 16949, make sure that your internal audit function conducts its audits against the ISO/TS 16949 Standard. At the practical level, the biggest impact to your company by being compliant is the requirement for you to use APQP and PPAP. PPAP will also apply to your suppliers.

Be careful about how you try to address supplier management in your QA manual. There’s much more to it than a one line statement. Your customers will expect a rigorous application of supplier selection and management (per ISO 9001) and they will expect you to manage APQP and PPAP with your suppliers. You will still have to be active in managing and being responsible for your suppliers. There will need to be more to your selection and evaluation process than looking at their websites for a certification.

The amount of risk depends on the closeness of the relationship with your “supplier partners”, and whether or not they have a high level of sophistication and experience in the automotive industry. This industry has a very sophisticated supply chain management process and very high performance expectations, with penalties to match.

I hope this answer gets you started.

Denis J. Devos, P.Eng
Fellow of the American Society for Quality
Devos Associates Inc.
Advisors to the Automotive Industry
www.DevosAssociates.com

ISO/TS Exclusions

Manufacturing, inspection, exclusions

Question:

I have a question regarding exclusions from the ISO/TS standards.

The majority of our business is the design and manufacture of enclosure hardware.  Recently though, a small portion of our business has become the sole North American Distributor for an Italian company. Their product lines are similar to ours. However, we procure their products and simply resell/distribute to their customers stateside, to Canada and Mexico. We do not have Design or Process Control for these items; they are pass-through product.

Therefore, my question is related to permissible exclusions from the ISO standard. Should we seek exclusions regarding certain clauses of Clause 7 of the standard, for this certain “supplier”, and/or for certain product groups that are sold on their behalf?

Response (Answered by Bud Salsbury):

At first, your question seemed relatively uncomplicated and I am inclined to say that you can simply sell or provide the products in question with a disclaimer or something identifying the fact that your company is not the designer/manufacturer of the product.  My company occasionally has purchased parts inserted into or added to the products made. Like bushings or threaded inserts, etc. We don’t have to add anything to our QMS for those as long as those items meet regulatory and statutory requirements.

However, I should mention, the standards make it clear that exclusions are permissible if “such exclusions do not affect the organization’s ability or responsibility to consistently provide product that meets customer and applicable statutory and regulatory requirements.”

Therefore, stepping away from the initial ‘simple’ answer, I would say that such exclusions would not be permissible. This is due to the fact that your organization is ultimately responsible for meeting customer requirements. Although you do not design or manufacture that specific product, you provide, and are responsible for what the customer requests.

You are also responsible for seeing to it that the OEM is meeting customer as well as any statutory or regulatory requirements. This would be of particular importance if these are electrical enclosures or intended for hazardous services, such as NEMA 7 (explosion proof enclosures).

Since you already design and manufacture your own products and have the Clause 7 included in your QMS, it would be counterproductive to add more documentation to exclude what you have mentioned. It would be wise to notify customers up-front, in the sales/purchase order process, that the product you are distributing is from a separate company.

Thanks much for this good question.

Bud Salsbury
ASQ Senior Member, CQT, CQI

Follow Up Questions:

• IF there were permissible exclusions allowed, WHO would need to ‘approve’ these or ‘allow’ them to be exclusions?  Would that be the registrar or someone else?

• IF there were permissible exclusions, would it be stated/depicted on the actual Certificate as such or only noted in the quality manual, for example?

• IF there were permissible exclusions, would it be an exclusion of the ISO CLAUSE?  And/or PRODUCT?  And/or  SUPPLIER?

• Currently we list “the design and manufacture…” in our scope.  Would we need to revise the scope to include ‘distribution’?

Response (Answered by Denis Devos):

Thank you very much for your question and your follow up.

In further response to your original question – if you are in the automotive industry, you will still be obligated to provide a Level 3 PPAP (as a default) to your customer for the product you are purchasing and reselling; whether you are design and process responsible or not.

Permissible exclusions are only granted for Clause 7.3 Product Design.  Per TS 16949, you cannot be excluded from the requirements of Clause 6.3 related to process design.    You can declare this exclusion yourself in your Quality Manual and your registrar will validate your claim during your registration audit.   The exclusion will appear on your registration certificate.  You can only be excluded from Clause 7.3 Product Design, (not process design).

Under TS 16949, you cannot exclude products from your registration if they are being sold to the automotive industry.   Sometimes, a registrar will permit only a portion of your business to be registered and that would be reflected in the scope on your certificate:  Check with your registrar.   You cannot be exempted from any requirements related to supplier management, such as Clause 7.4.

Yes, you will likely have to include “distribution” in the scope of your registration; check with your registrar.

I hope this sufficiently answers your follow-up questions and you find this advice helpful.  If you need anything further, please don’t hesitate to contact us.

Best Regards,

Denis J. Devos, P.Eng
ASQ Fellow
Devos Associates Inc.
London Ontario
www.DevosAssociates.com

TS 16949 Conformance for a Non Value Add Company

Automotive inspection, TS 16949, IATF 16949

Question:
We’re a fabless semiconductor company, Tier 2, who are in the process of designing and developing an automotive product to deliver through our TS16949 certified subcontractor, Tier 3, to an auto supplier Tier 1, for an OEM.
We know and understand that we cannot get TS16949 certified, but we are still working at bringing up our ISO9001 processes certified for 14 years to withstand a TS16949 audit.
As we do our internal process audits in preparation for our ISO9001/14001 Surveillance audit in June/13 we’re looking for TS gaps which we’ll document and work to close.
We’re looking for a registrar who would audit us to TS16949 and give us a report that basically states that, assuming we do, have withstood the audit and that if we were an Mfg’r qualified to be TS194949 certified company that we would pass a TS16949 audit.
Are you aware of any other companies who have done this or of any registrars who provide this type of service?
We’re either setting precedence for other fabless Semi’s designing to deliver for Auto, or it’s already been done and if it has than what is this type audit of called and do you know anyone who’s done it?
Thanks for any input you may provide.

Response:

Thank you for your question. There are two issues here. Firstly, contact your existing registrar with this question and see if they can comply with your request.

Secondly, this is about your obligation to provide a proper PPAP submission for these parts, whether they are manufactured by you or by a supplier. If you are the supplier for these parts, there are likely terms and conditions in your Purchase Order that require you to submit a level 3 PPAP. If these requirements are present, they are auditable as a customer-specific requirement whether you are registered to TS 16949 or not.

I hope this answers your question.

Denis J. Devos, P. Engineer
A Fellow of the American Society for Quality
Devos Associates Inc.
Advisors to the Automotive Industry
www.DevosAssociates.com

ISO/TS 29001:2010 Standard in Oil and Gas Production

Oil and gas industry, petroleum industry

Question:
We are an Oil & Gas production testing, frac flow back, and trucking company and while in the beginning stages of instituting ISO 9001:2008 standards, we ran across Oil & Gas industry specific standards ISO/TS 29001:2010 and we are curious as to whether or not we have to apply TS 29001:2010, ISO 9001:9008, and maybe some ISO standards for trucking to receive our ISO certification.

Response:
All of the TS should include ISO as the back bone with Industry specifics. The customers dictate which is required. For Auto Industry it is TS 16949 & for Aerospace AS9004. The technical specifications shall include ISO 9001 and the company is registered to the ISO with a TS. A little confusing but eliminates a vast set of international standards. The QMS is ISO 9001. I will always go on the side of using the industry specifics if that is the only industry that they work within as most TS requirements require the use of core tools. If you have these particular TS requirements I will review them but I very sure about this answer.

Ron Berglund
Global Quality Coach

ISO/TS Standards Exclusions

Question:

I have a question regarding exclusions from the ISO/TS standards.

The majority of our business is the design and manufacture of enclosure hardware. Recently though, a small portion of our business has become the sole North American Distributor for an Italian company. Their product lines are similar to ours. However, we procure their products and simply resell/distribute to their customers stateside, to Canada and Mexico. We do not have Design or Process Control for these items; they are pass-through product.

Therefore, my question is related to permissible exclusions from the ISO standard. Should we seek exclusions regarding certain clauses of Clause 7 of the standard, for this certain “supplier”, and/or for certain product groups that are sold on their behalf?

Any assistance you could provide would be helpful.

Response:

Hello,

At first, your question seemed relatively uncomplicated and I am inclined to say that you can simply sell or provide the products in question with a disclaimer or something identifying the fact that your company is not the designer/manufacturer of the product. My company occasionally has purchased parts inserted into or added to the products made. Like bushings or threaded inserts, etc. We don’t have to add anything to our QMS for those as long as those items meet regulatory and statutory requirements.

However, I should mention, the standards make it clear that exclusions are permissible if “such exclusions do not affect the organization’s ability or responsibility to consistently provide product that meets customer and applicable statutory and regulatory requirements.”

Therefore, stepping away from the initial ‘simple’ answer, I would say that such exclusions would not be permissible. This is due to the fact that your organization is ultimately responsible for meeting customer requirements. Although you do not design or manufacture that specific product, you provide, and are responsible for what the customer requests.

You are also responsible for seeing to it that the OEM is meeting customer as well as any statutory or regulatory requirements. This would be of particular importance if these are electrical enclosures or intended for hazardous services, such as NEMA 7 (explosion proof enclosures).

Since you already design and manufacture your own products and have the Clause 7 included in your QMS, it would be counterproductive to add more documentation to exclude what you have mentioned. It would be wise to notify customers up-front, in the sales/purchase order process, that the product you are distributing is from a separate company.

Thanks much for this good question.

Bud Salsbury
ASQ Senior Member, CQT, CQI