Scope and frequency of TS 16949 Internal Audits

[kalehner]

Our TS 16949 registrar insists that all requirements of the standard be audited at least annually (8.2.2.4 --- Internal audits shall cover all quality management related processes, activities and shifts, and shall be scheduled according to an annual plan).

The third party auditor expects internal auditors notes to reflect the evidence reviewed to assess each requirement of the standard. We believe that this level of detail is excessive and would prefer to focus on areas that provide more value to our organization auditing other areas less frequently than annually.

Design and Development is a good example. We design new products for our customers infrequently. It has been over a year since we designed a new product or re-engineered an existing product. Where is the value in auditing this element of the standard if there have been no changes since we last visited this clause in 2008?

Does TS 16949 require annual audits of every requirement and if so what is the rational for this requirement/interpretation?

 

[Chennaiite]

It has been over a year since we designed a new product or re-engineered an existing product. Where is the value in auditing this element of the standard if there have been no changes since we last visited this clause in 2008?

Do you mean, your Design and Development team is on the "bench" for over a year?

 

[AndyN]

Our TS 16949 registrar insists that all requirements of the standard be audited at least annually (8.2.2.4 --- Internal audits shall cover all quality management related processes, activities and shifts, and shall be scheduled according to an annual plan).

The third party auditor expects internal auditors notes to reflect the evidence reviewed to assess each requirement of the standard. We believe that this level of detail is excessive and would prefer to focus on areas that provide more value to our organization auditing other areas less frequently than annually.

Design and Development is a good example. We design new products for our customers infrequently. It has been over a year since we designed a new product or re-engineered an existing product. Where is the value in auditing this element of the standard if there have been no changes since we last visited this clause in 2008?

Does TS 16949 require annual audits of every requirement and if so what is the rational for this requirement/interpretation?

Unless your auditor (CB) has a requirement in your contract with them (which we don't) your individual auditor is making you do what they want not the standard's requirements. Take a look a this article I wrote for some guidance:

http:// www .nqa-usa.com/resources/articles_detail.php?id=48 - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

You are absolutely correct! It doesn't make sense to audit the D & D process, until you do some more work. I'd suggest that you respectfully request of your CB, they don't send that person again! IF it's in your CB contract, find a different CB!

 

[kalehner]

Pretty much. We are smaller and everybody wears several hats. Those involved in design perform other rolls such as validation in our labs that our products continue to meet the design specs for performance under extremes of environmental conditions etc...

What about the “every clause annually requirement” part of the questions?

 

[somashekar]

Do you mean, your Design and Development team is on the "bench" for over a year?

Design and Development activity need not deliver a new product or do any re-engineering to a period like year in this case. Perhaps the Design and Development activities may be on-going on one or more bigger projects which takes a longer time. The audits have to capture such activitites to the extent they have progressed. Not all D & D projects gets a product out and not all D & D projects start and finish within 12 months.

 

[AndyN]

In a previous life with an interior trim parts manufacturing company, we were TS registered and the audit schedule, didn't show a whole complete plan of all audits etc. What we did was to show a couple of milestone audits, just before the CB came in (like 15 days) to check on what they'd check on. Then we scheduled all other audits; process and system, based on a rolling 30 day window. We didn't define the scope etc, we just said we'd do an audit every 30 days at a minimum. We could then decide, based on what jobs were running, what processes we would look at, what customer issues there were etc. Then we'd add the scope, criteria at that point.

The idea of a whole schedule planned out 12 months is totally bogus and no-one has a crystal ball to know why/what you should be auditing in 6 - 9 months time anyway. Nor do you want to keep re-issuing the schedule!

It's not a requirement - except in some people's heads...

 

[Chennaiite]

Design and Development activity need not deliver a new product or do any re-engineering to a period like year in this case. Perhaps the Design and Development activities may be on-going on one or more bigger projects which takes a longer time. The audits have to capture such activitites to the extent they have progressed. Not all D & D projects gets a product out and not all D & D projects start and finish within 12 months.

If I am correct,the whole issue has come up only because there was no activities, whasoever, in some areas of this Organization like Design and Development.

 

[Coury Ferguson]

IMO: Base the frequency on importance and results of any external audits.

 

[AndyN]

IMO: Base the frequency on importance and results of any external audits.

Absolutely, Coury, but apparently, their CB auditor has never read this, doesn't know what it means (practically) or chooses to ignore it!

Whatever the situation, unless the customer can present a cogent, logical rebuttal of what 'status and importance actually means in their business - in a practical sense - then they aren't likely to ever get this resolved, especially since this has been a mantra in the CB world for many years! And you know how hard it is to give up some things!

 

[Jen Kirley]

I would ask your registrar to show you the source of this requirement. The TS standard specifies an audit schedule will be developed annually - not everything gets audited annually.

My organization bases its TS16949 audit schedule on the registrar's same three year cycle. That means everything gets audited at least once in three years.

But our audit schedule is designed to attend to criticality and be responsive to needs as they arise. That means stepping up the audit schedule in response to known problems, or to verify effectiveness of important fixes. Our manufacturing processes get audited every year, and each shift gets audited. Some things get audited every other year, while some get audited every three years. This has served us just fine, so I am very interested in your predicament.