TS16949 Certification Requirements

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
http://www.DevosAssociates.com

Posted in TS16949 - Automobiles | Leave a comment

Lead Auditor Qualification

Question

My manager and I have a question about internal lead auditor and auditor qualification. As stated in section 8.2.2 of ISO9001:2008, “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 ISO9001:2008? 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

Posted in Auditing, ISO 19011 - Auditing, ISO 9001 - Quality Management Systems | 1 Comment

ISO 9001:2008 Quality Manager Titles

Question:

Is it a requirement that a person in an ISO 9001 registered organization who is responsible for fulfilling the duties and requirements of the management representative hold the title of Management Representative, i.e., is it a noncompliance that such person holds a different title, e.g., specifically, Quality Representative?

Response:

I have seen this question come up at other times.  Basically, I refer to how we need to understand the word “shall”.  “Shall”, when used in the ISO standards,  indicates a requirement.

Therefore, when clause 5.5.2 in ISO 9001:2008 says, “Top management shall appoint a member of the organization’s management . . . .”, then it is a requirement. There are good reasons for this. For one, the Management Representative must have the authority to perform those duties necessary for the successful implementation and continuation of a quality management system. Generally, a person in management knows the company’s business and has a working relationship with all the departments.
It is sometimes a practice to give a person a management title but limit their authority to that which is related to the QMS.

I hope this is helpful to you and thank you for sending your question.

Bud Salsbury
ASQ Senior Member, CQT, CQI
Takco Manufacturing
Phillips, WI
http://www.takcomfg.com

Follow Up Question:

Hello,

I appreciate and fully understand your answer, however, I probably did not pose my question adequately. The responsibilities of the MR is clearly assigned to a member of management, and, in fact is the QM, but does not use the title “Management Representative”, but instead uses “Quality Representative”.  So, in affect, there is no “MR” in the company.  Is this an issue?

Thanks.

Response:

If you wanted to add verbiage to your Quality Manual or one of your documented procedures (i.e. Management Responsibility) which clarifies this you could. However, you do not have to.

The standard says your MR shall be a member of management. The standard does not direct you to make this an official “title”.  It just needs to be clear that someone from management fulfills all the responsibilities of the MR. Those responsibilities can be in addition to that individual’s primary function.

It sounds like you are doing OK.

Bud Salsbury
ASQ Senior Member, CQT, CQI
Takco Manufacturing
Phillips, WI
http://www.takcomfg.com

Posted in ISO 9001 - Quality Management Systems | Tagged , | Leave a comment

Recommended AQLs for Packaging Material in the Pharmaceutical Industry

Question:

Are there recommended AQLs (critical, major and minor defects) for packaging material (primary and secondary) for the Pharmaceutical Industry?
Thank you

Response:

Though there are no recommended AQLs (or LTPD) for packaging materials, some industry standards have begun to surface. The following table is a guideline that I have seen used successfully for a risk based approach to sampling. Based on the severity and criticality of the packaging materials, these guidelines can be adjusted up to down per your risk management process.  Utilizing a c=0 sampling plan based on the binomial distribution, the sample size can be calculated using the following formula.

 

Primary

Secondary

Confidence (%)

Reliability (%)

Sample Size

Confidence      (%)

Reliability (%)

Sample Size

Critical

99.5

99

527

99

97

151

Major

99

97

151

97

95

68

Minor

97

95

68

95

90

28

I hope this assists you.

Steven Walfish
Secretary, U.S. TAG to ISO/TC 69
ASQ, CQE
Principal Statistician, BD

http://statisticaloutsourcingservices.com

Posted in Sampling | Tagged , , | Leave a comment

ISO 9001:2008

QUESTION
ISO 9001:2008 states in 8.2.4 Monitoring and measurement of product:  “Evidence of conformity with the acceptance criteria shall be maintained.”

When our plan identifies periodic inspections, variable or attribute, are performed, how can we show evidence without recording the specific results obtained during the inspection?

REPLY:
Thanks for contacting ASQ’s Ask the Experts Program.  With regard to your question, please note that the primary intent of ISO 9001:2008, clause 8.2.4 is to ensure that the organization has established acceptance criteria and that a record is maintained to verify that product requirements have been met.  This verification can be performed by documenting the results of actual measurements taken onto a spreadsheet, shop router, traveler, quality plan or other suitable means.

Another approach could be the use of a “Go” “No Go” gauge and a checklist to record inspection measurement results as pass or fail.  There are many different ways of maintaining a record of inspection results.  However, regardless of how measurements are taken, their results must be documented to provide evidence of conformance.  Unless a record is maintained, there is no evidence that the inspection ever happened or that the product meets defined requirements.

I hope this helps.

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

Posted in ISO 9001 - Quality Management Systems | Tagged , | Leave a comment

Statistical Methods/Control Charts

Question:
My question is regarding a threading process.  There is 100% inspection for go/no go check and about 5% rejection/rework.  The batch size is 5,000 nos and is completed in 3 days of production. Two such batches are produced in a month.

What type of control chart should be used to monitor the process? How should the process capability be calculated in this case?

Response:
The type of control chart first depends on what type of data you are measuring.  If you are doing go/no go then you are limited to a “P” chart or a “C” chart.  A “P” chart looks at % good (or bad).  A “C” chart looks at the number of defects found.

If you are measuring thickness or strength, (something that can be measured), then you can use a X-bar/R chart or an X-bar/S chart depending on many samples are taken.

That is the simple answer; part of this depends on how you are taking samples and how often.  If samples are taken at the start and the finish, then I would probably recommend the “P” chart.

If you can measure throughout the manufacturing process, and you look at the type of defects, then I recommend a “C” chart.

Ideally, if you can get measurement data, you are better off with the X-bar/R or the X-bar/S charts.  These tend to be better predictors and it is easier to calculate capability.

With the capability for the go/no go data, you can get % defective, (or % good) and multiply that by 1,000,000 to get your capability estimate in defects per million.

Jim Bossert
SVP Process Design Manger, Process Optimization
Bank of America
ASQ Fellow, CQE, CQA, CMQ/OE, CSSBB, CSSMBB
Fort Worth, TX


Additional ASQ resources:

ASQ Learn About Quality- Control Charts

The Shewhart p Chart for Comparisons
by Marilyn K. Hart and Robert F. Hart

 

Posted in Other, Statistics | Tagged ,

Internal Lead Auditor/Auditor Qualifcations

Question:

Dear ASQ Associate,

My manager and I have a question about internal lead auditor and auditor qualification. As stated in section 8.2.2 of ISO9001:2008, “the organization shall conduct internal audits at planned intervals to determine whether the quality management system ….”

Our question is this; does the internal lead auditor and auditor have to be certified by an organization, or trained by a certified lead auditor? May a person read ISO19011:2011 and with his/her experiences in his/her field then perform audit tasks as stated in section 8.2.2 of ISO9001:2008? 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.

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

For more on this topic, check out these ASQ Resources.

Books:

How to Audit the Process-Based QMS, Second Edition, by Dennis R. Arter, Charles A. Cianfrani, and John E. “Jack” West

The ASQ Auditing Handbook, Fourth Edition, edited by J.P. Russell

The Internal Auditing Pocket Guide, by J.P. Russell

Articles:

Pointed in the Right Direction, by Thea Dunmire

Improving the Internal Audit Experience, by Theresa Wasche

Posted in Auditing | Tagged , ,