Month: March 2014

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/TS 16949 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
http://www.DevosAssociates.com

For more on this topic, please visit ASQ’s website.

Lead Auditor Qualification

Audit, audit by exception

Question

My manager and I have a question about internal lead auditor and auditor qualification. As stated in section 8.2.2 of ISO 9001:2008, “the organization shall conduct internal audits at planned intervals to determine whether the quality management system…”

Our question is do internal lead auditors and auditors have to be certified by an organization or trained by a certified lead auditor? May a person read ISO 19011:2011 and with his/her experiences in his/her field then perform audit tasks as stated in section 8.2.2 of ISO 9001:2008? If yes, would an ISO registrar consider it to be a non-conformance finding?

Thank you in advance for taking time to answer our question.

Response

Thanks for contacting ASQ’s Ask the Experts program.  With regard to your question, it is important to know that ISO 9001:2008 does not prescribe any specific requirements for the qualifications of persons conducting QMS audits.  ISO 19011:2011, provides guidance not mandatory requirements for determining Auditor qualifications.  As you are aware, an internal audit is one of the most valuable tools that an organization has to determine the effectiveness of its quality management system as well as to identify opportunities for improvement.

For this reason, it is essential that the personnel or consultants used to conduct audit activities, have the qualifications and experienced needed to provide these services.  As a minimum, I would suggest that your internal audit personnel  attend Auditor classroom training accredited by ASQ, RABQSA or IRCA.  This training should be supported by arranging for their participation in future audits as an audit team member.  This audit should preferably be conducted by an individual who has a current certification as an ASQ CQA or an RABQSA or IRCA Lead Auditor.

Another consideration is to ensure that the Lead Auditor can provide an audit log as evidence of his/her past audit experience.  The Lead Auditor should also provide evidence of their continued training to maintain their competency as an Auditor.  Another key point, is to ensure that the Lead Auditor has a working knowledge of your organization’s product line, processes or services.  The importance of using trained and experienced Auditors can’t be overstated.

I hope this helps.

Best regards,
Bill Aston
ASQ Senior Member
Managing Director of Aston Technical Consulting Services
Kingwood, TX
www.astontechconsult.com

For more about this topic, please visit ASQ’s website.