Product Audit Process Requirements - Clause 8.2.2.3

[Icy Mountain]

D&mn, Jim we agree!

The unholy trinity, run for your lives!!!
I agree again about some TS additions being "quality control" oriented. I am just trying to meet the standard while also accomplishing something that will actually improve process and product quality. Increasing the frequency of re-testing product doesn't seem to fit that bill.

 

[rjkozak]

Smoke signal to Chief Icy Mountain -

Always a good idea to ask your customer authorized representative .

When the canoe has washed ashore , the big lake has spoken.

When bad part sent to customer by mistake , forgot to measure twice.

" he who makes coffee nervous "

 

[AndyN]

The unholy trinity, run for your lives!!!

 

[Raffy]

What could be the frequency in conducting product audit for TS16949? Is there a requirement in TS16949 how many times to conduct product audit? And whose going to perform the audit? Is it the internal auditor? A QA Engineer? Please advise.
Thanks in advance.
Best regards,
Raffy

 

[ralphsulser]

Raffy,
The frequency for product audits is defined by your organization based on a confidence level you establish, unless specified by your customer. TS16949 does not specify how or frequency. No one else knows your processes, capabilities, and risks. Anyone who is competent can do product audits, better yet if they can also analyze the results.

 

[Raffy]

Hi ralphsulser
Thank you very much for the immediate reply.
To date, we don't encounter any problem with regard to the product itself, since we don't have any better yet set it at least once a year.
Thank you very much.
Best regards,
Raffy

 

[Icy Mountain]

The frequency for product audits is defined by your organization based on a confidence level you establish, unless specified by your customer. TS16949 does not specify how or frequency. No one else knows your processes, capabilities, and risks.

This is why this did not rise to a the level of a finding. My customer does not specify a frequency; they say, "That's your business." We functional test 100% of our units and record the results. Not a single one of our warranty returns would have been detected by quarterly or even monthly product audits that included a retest of the unit.

This is where the economic justification of quality activities is required. Unfortunately, the subject gets ignored by some quality professionals. The original forecast for this product was over 2000 units per year. We have shipped about 300 since November of 2005. We have only shipped about 25 in 2007. The margin at this rate is 0%. I cannot justify any activities that do not add value. Pulling an additional 3 or 5 or 11 units from boxes and completely retesting them isn't going to improve the long-term reliability of this product. I don't have an out-of-the box failure issue.

 

[Raffy]

Our customer does not specify a frequency of conducting product audit, but during our Pre-assessment audit, it was noted that Internal Audit must be performed, e.g. System Audit, Manufacturing Audit and Product Audit. That’s why in our Internal Audit, we revise our procedure and provide a frequency of once a year, but still I did not make any specific action on how am I going to do this. I conduct a product audit and so far I don’t see any problem with regard to the product itself. In our Production Area, they are conducting 100% Visual and Functional Tests and to date, they are not experiencing any Customer returns. In QA, we conduct sampling and there were no QA Buy-off reject.
My concern is Can we omit the process of Product Audit with the data that we have both in Production and QA? Can we say that Product Audit was thoroughly performed by our QA & Production Personnel. And that per se, can replaced the product audit? Please advise.
Best regards,
Raffy

 

[ralphsulser]

Raffy,
You cannot omit the requirement for product audit if you make and ship a product. However, from how you described your system, I think that your QA product audits would satisfy the product audit as required. You need to have records of evidence and credible documentation that shows the audit criteria and results.

 

[Raffy]

Hi ralphsulser
QA Buy-off is performed in all stages of the Production Line. Including Final Packing, that is checking the labels, the shipment pre-alert document and each buy-off were documented in a QA logsheet. It also has a QA Stamp and the signature of the inspector who conduct the product audit.
In view of this, I would rather update my Internal Audit Procedure that Product Audit was performed by QA Inspector, because if I would be the one auditing it once a year, it would be a redundant process on my end.
Thank you very much for enlightening me.
Best regards,
Raffy