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 Conformance for a Non Value Add Company

Automotive inspection, TS 16949, IATF 16949

Question
We’re a fabless semiconductor company, Tier 2, who is in the process of designing and developing an automotive product to deliver through our TS 16949 certified subcontractor, Tier 3, to an auto supplier Tier 1, for an OEM.

We know and understand that we cannot get TS 16949 certified, but we are still working at bringing up our ISO 9001 processes certified for 14 years to withstand a TS 16949 audit.
As we do our internal process audits in preparation for our ISO 9001/14001 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 TS 16949 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 TS 16949 certified company that we would pass a TS 16949 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 semiconductor companies designing to deliver for auto, or it’s already been done.  If it has, then what is this type audit of called and do you know anyone who has done it?

Thanks for any input you may provide.

Answer
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 Standards Exclusions

Checklist, Conformity, Go/No Go

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.

Answer

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

Measurement System Analysis

ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories

Question:

Is there ever an exception to the rule about needing full Measurement System Analysis for any instrument placed in the Evaluation / Measurement Technique column on the Control Plan?  If an instrument is listed on the control plan, does it HAVE to have GRRs done, in addition to having to prove stability?  Please base off of ISO 9001 and TS 16949 requirements, and if there is a difference between them for this requirement.   

Answer:

Thank you for this interesting question. Clause 7.6 of ISO 9001-2008 makes most of this fairly clear. Any monitoring and measuring equipment used to verify conformity of product must “be calibrated or verified, or both, at specified intervals, or prior to use. . .” Notice I made ‘at specified intervals’ bold. This is just to bring to light the importance of calibration cycles. You/your organization can determine what those cycles will be based on the stability of the measuring tool, frequency of use, working conditions, etc. For example, if you were using a micrometer to check close tolerance parts and, you found it a good process to measure the parts frequently, this would be a contributing factor to the decision process. Then, if the working conditions included a lot of cutting fluids or perhaps a good deal of metal dust, another factor is added to the decision process. What I am driving at is this; once you have determined that the product conformity which you are checking is good and/or consistent and that your sample frequency is satisfactory, you would have no definite requirement for GRR’s on the measuring equipment. The calibrations and or verifications you do must be with equipment which is traceable to international or national measurement standards. If you use working standards as gages to check measuring equipment throughout production and those standards are traceable, then you are doing fine. The processes you use to verify the tools and any in-process measuring practices should be documented in Work Instructions or even with the use of photographs or flow charts.

In the second part of your question, you ask if there is a difference between 9001 and TS 16949. I reference section 7.6.1 of TS 16949. Here it is put straight forward:

7.6.1  Measurement System Analysis 

Conduct statistical studies to analyze variation present in the results of each type of MMD that is referenced in the Control Plan.

Use analytical methods & acceptance criteria that: 

Conform to methods and criteria in customer reference (MSA) manuals Or use other methods, if approved by the customer 

This is an automotive sector specific QMS standard. Herein it is necessary to consider safety and liability in everything you do. So, Gage R&R’s are a common practice. Nonetheless, the necessity for these is dictated by individual processes. Some may need them, some may not.

So, if an instrument is listed on YOUR control plan, GRR’s will become a requirement based on all the criteria I’ve noted above. A gage which has proven stability is most often safe from that requirement under 9001 but TS16949 has more extensive requirements.

Bud Salsbury, CQT, CQI

Applicability of TS 16949 to Non-Manufacturing Organizations

Automotive inspection, TS 16949, IATF 16949

Q: My conpany is certified to ISO 9001:2008 Quality management systems–Requirements. We provide integrated circuit chip design and outsource the manufacturing of the IC chips to our approved subcontractors. Recently, we won a contract to design and supply chips to one of our customers who, in turn, supplies to the automotive industry (the first automotive customer for my company).

One of the key deliverables of this project is to get ourselves certified to TS16949:2009 Quality management systems — Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations in the next 6 to 9 months.

We would like to know:

1. Is TS16949 applicable to a company, like mine, that does no manufacturing?

2. In general, what does it take to be at least compliant to the TS16949 requirements?

3. Since TS16949 is based on ISO 9001 with addtional requirements, does that mean that once a company is certified to TS16949 it is not necessary to recertify to ISO 9001?

A: Thank you for your questions.

The answer to your first question is that a company like yours is not eligible to become registered to TS16949 because it is not a manufacturer.  Clause 1.1 General of TS16949 states this very clear:

“This Technical Specification is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured.”

Furthermore, clause 3.1.11 from Terms and Definitions defines a “site” as:

“Location at which value-added maufacturing processes occur.”

Your second question is about how to attain TS16949 compliance.  Simply, you would need to purchase a copy of TS16949 and ensure that your ISO 9001 quality management system meets all of the TS16949 requirements.  The biggest difference between ISO 9001 and TS16949 are the requirements associated with advanced product quality planning (APQP) and production part approval process (PPAP).

The answer to your third question is yes, registration to TS16949 includes full compliance with all the requirements in ISO 9001.  A separate registration is not necessary.

If you have further questions, please don’t hesitate to ask.

Denis J. Devos, P.Eng
A Fellow of the American Society for Quality
Devos Associates Inc.
London Ontario
www.DevosAssociates.com

TS 16949 Calibration Management

Automotive inspection, TS 16949, IATF 16949

Q: Under the standard ISO/TS 16949:2009 Quality management systems – Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations — is it acceptable to allow an instrument user to request a calibration extension under certain circumstances?

Here are just a couple of examples:

The user is in the middle of a test that they don’t want to disrupt until completed.
Equipment is installed on a test vehicle that is at a remote location and is not readily available.

I should note we are an automotive supplier engineering facility doing advanced product development.

A: Here is my usual advice about calibrations:

1. The calibration frequency is both a matter of use and criticality of measures. Instrument companies err on the side of frequent recalibrations.

2. As with most standards based on ISO 9001:2008, the calibration frequency is an internal company decision as the requirement is:

•    Process for calibration management
— Records need to show (7.6.2):
> Equipment identification, including the measurement standard against which the equipment is calibrated
> Revisions following engineering changes
> Any out-of-specification readings as received for calibration/verification
> An assessment of the impact of out-of-specification condition
> Statements of conformance to specification after calibration/verification
>  Notification to the customer if suspect product or material has   been shipped

Therefore, it is the supplier who determines the frequency of the calibration, as well as the standard to which they are using. If the supplier sets a frequency schedule they should follow it unless they get a concession from their customer.

I have done a large calibration study where an engine plant did the statistical analysis, which saved them millions of dollars to set optimal gauging schedules for an engine plant. I recommend that such a study be conducted by this company as soon as possible.

Ron Berglund
Voting member of the U.S. TAG to ISO/TC 176
ASQ Fellow
Canton, MI