Product Audit Process Requirements - Clause 8.2.2.3

[Sebastian]

Briefly - during process audit I am focused on operations (I do not care if product is OK or NOK), but if everything is done according to our QMS procedures and work instructions. During product audit I am interested in status "product versus specifications" (I do not care how it was done).
Schedules for both these audit types is based on a control plan, where are defined requirements related to process and product. E.g. during process audit of curing operation, I audit process parameters against work instruction and during product audit for cured part I audit product characteristics against inspection checksheets.
I simply pick up few samples of in-process parts and I ask inspector for testing them, resulting in damage of parts. In case of final product I check them only visually or measure using gauge for final inspection, because I am not able to refill missing quantity in warehouse.

 

[chaosweary]

Gee the last time I did a product audit was when I was a QA inspector 14yrs ago. The 16949 standard doesn't state that internal auditors have to do product audits, they just have to be done by someone that is not part of the same group makin the darn thing. QA has always and still does product audits in our company throughout the line at an operator level. They also do an out of box sample, all which will always meet the intent of the standard just fine. Your process appears to be fine Raffy...I agree with Ralph.

 

[Raffy]

We have our Desk audit yesterday, we clarify with our auditor that product audit performed by Internal Audit is different from the product audit performed by our Inspector because he said that Product Audit performed by our Inspector is already part of the process. However Product Audit performed by Internal Auditor is an add value to the system. Is it really right? I’m confused.
Thanks in advance.
Please advise.
Best regards,
Raffy

 

[Quality Ian]

I merged process and product together audits together.
Start from Goods Inwards or despatch doesnt really matter depends on your prediliction.
Follow the process through and grab a series of parts during the manufacturing process and watch the manufacturers inspect record the results.

Our Certification auditor was killing us with his 'heavy demands' i decided that walking the areas twice and generating two lots of paperwork was ludicrous.
So i merged the 2 and use the manufacturers (with my studious supervision - to ensure that it is being inspected right) was the best approach.
As for the certification auditor i stood my ground and proved requirements were being met. Now we focus on the audit not the auditors interperetations you can see the difference.

As for the product verification he accepts this as part of the audit.

 

[Icy Mountain]

Smoke signal to Chief Icy Mountain -
Always a good idea to ask your customer authorized representative .

Customer representative says that the product needs to be retested by "Quality", pointing out that "the purpose of Product Audits is an independent examination of the product to determine whether or not it meets the requirements of the established product specification. This would include actually testing the product." This was coupled with a direct quote from the (non-auditable) guidance on Sections 8.2.2.1 through 8.2.2.3: "There are many approaches to analyze quality management system, product quality and process performance. In the context of the internal audit clause, internal audit for the organization should be independent of those having direct responsibility for the work performed. Personnel should not audit their own work."

Therefore, as before, I will combine the product and process audits but I am going to time the production portion of the process audit so that I am able to re-test a unit myself, right after it has been production tested. This may seem like a waste of time. However, coupled with the process audit, it allows me to get a hands-on audit of the test equipment condition, process instruction accuracy, agreement between my measurements and the technician's, etc. I can also make my other audit measurements at this time, thus saving me from actually removing the unit from the box in shipping (only checking contents and labeling).:truce:

 

[Hoeyster]

I merged process and product together audits together.
Start from Goods Inwards or despatch doesnt really matter depends on your prediliction.
Follow the process through and grab a series of parts during the manufacturing process and watch the manufacturers inspect record the results.

Our Certification auditor was killing us with his 'heavy demands' i decided that walking the areas twice and generating two lots of paperwork was ludicrous.
So i merged the 2 and use the manufacturers (with my studious supervision - to ensure that it is being inspected right) was the best approach.
As for the certification auditor i stood my ground and proved requirements were being met. Now we focus on the audit not the auditors interperetations you can see the difference.

As for the product verification he accepts this as part of the audit.

Good for you Quality Ian, I did the same thing. The company I am at go so overboard on everything it's ridiculous. We have Process Audits, Product Audits & Doc Audits. Out inspectors perform product and doc audits everyday but they are never documented as any kind of audit at all. It took me a week to convince my supervisor that the combination of the product & doc audits into the inspectors daily duties will satisfy the standard and then some. We are doing more that we really need to but since the inspectors are already out on the floor may as well have them document what they do.

 

[vanputten]

In my opinion, checking inspection records is not a product audit per TS 16949. Checking inspection records is a process audit of the inspection process.

A product audit should directly verify if the product conforms to all requirements- an independent verification from the normal process.

 

[delorfra]

In my company we manufacture metal stamped & assembled products.

Our operators (level 1) and Quality inspectors (level 2) check visual & dimensional specifications on a regular basis following the control plan.

Now, some others dimensions are not covered at these levels of inspection. Neither are raw material, heat treatment & functional specifications (annual complete functional tests are sometimes paid by the customers eg. : fatigue tests).

So our product audits include those other specifications (which don't need to be checked as often) and are carried out by our internal laboratory staff (level 3).
They also include a dock audit to check the packaging & label condition.
This way we make sure that 100% of the specifications are checked on the whole.

By the way, German manufacturers impose their own product audit standard (VDA 6.5) so there is less room for interpetation when we follow it.



Note : for our type of products, the 8.2.2.3 and 8.2.4.1 requirements are almost the same.

8.2.4.1 Layout inspection and functional testing
A layout inspection and a functional verification to applicable customer engineering material and performance
standards shall be performed for each product as specified in the control plans. Results shall be available for
customer review.

Note : Layout inspection is the complete measurement of all product dimensions shown on the design records

Hope this helps.

Francois

 

[Hoeyster]

In my opinion, checking inspection records is not a product audit per TS 16949. Checking inspection records is a process audit of the inspection process.

A product audit should directly verify if the product conforms to all requirements- an independent verification from the normal process.

I don't believe I stated anywhere that my inspectors were checking just inspection records. Along with verifying all the paperwork at a work station my inspectors inspect the product. It is an independent audit over and above the normal process. The inspectors perform this inspection every couple of hours or however long it takes them to make a round of the production floor. Once the product in inspected the inspectors then perform the Doc Audit.

 

[vanputten]

Hello Hoeyster:

I think you are assuming that my comment is directed at you since my posting follows yours. Someone on the thread stated that their Product Audit consisted of a review of the inspection records. Of course, now I can't find that posting.