TS 16949 Audits - Manufacturing Process (8.2.2.2) - Product (8.2.2.3)

[paulnguyen]

Hi,

Regarding the Manufacturing Process Audit (8.2.2.2):

I thought that the internal audit must include each single manufacturing process (ie. receiving, stamping, welding, packaging, shipping, ect.)

Regarding the Product Audit (8.2.2.3):

I thought that the internal audit must include each single product (ie. each part number) at each production stage.

If this is true then my internal audit will take weeks (or months) since I have around 200 different part numbers, each has at least 3 to 4 production stages!

Anyone can help?


Paul N.

 

[Roger Eastin]

8.2.2.2 to me just reinforces the TS emphasis on the manufacturing process. It is one sentence and doesn't really add anything, but is just a reminder to audit the manufacturing process. 8.2.2.3, IMO, is very similar to the QS9K dock audit. If you have done those before, I think this is the same thing. You don't need to be concerned with 200+ products and detailed spec audits on them. It is a sampling type requirement.

 

[paulnguyen]

Thanks, Roger.

Couple of people that I've spoken with, said the same thing.

Paul N.

 

[Sam]

- Each manufacturing process has to be audited.

- in-process inspection, final inspection coupled with the "dock audit" should satisfy this requirtement.

 

[paulnguyen]

Thanks, Sam.

The standard says "The organization shall audit products at appropriate stages ..."

Is it acceptable to use sampling plan? Or is it the case of rounding up is better than rounding down?

Since the word is "appropriate", I guess I can skip less critical steps of manufacturing process, such as blanking (prior to forming).

Regards.

Paul N.

 

[Roger Eastin]

You are left to define "appropriate" for your organization. Also, I would think that a sampling plan would work for your organization. I think you just have to justify how you came up with the sampling plan.

 

[Sam]

A sampling plan is fine, however , at some point I would expect that you would have audited all products and processes for compliance to the customer requireemnts.

 

[wisanu]

I think 8.2.2.2&8.2.2.3 are not just doing in-process and final inspection like the QS9000 (element 4.10)

Please note that 8.2.2.2&8.2.2.3 are under the "8.2.2 Internal audit". Internal audit needs audit plans, auditor qualification, impartiality and audit reports/CARs follow up.

For in-process and inspection (you may perform them against Control plans with defined sampling plans), it should be done under 8.2.3.1 "monitoring and measurement of manufacturing processes" and 8.2.4 monitoring and measurement of product" requirements.


For example, "8.2.2.2 manufacturing process audit",
In-process or Final inspection is an process of manufacturing processes. They may be audited to verify its effectiveness, e.g. are inspectors follow instruction and/or control plan?, are inspectors qualified?, etc.

"8.2.2.3 product audit"
Agree, it is similar to "dock audit" in QS9000. And I think it is a reducdant requirement to "8.2.4 monitoring and measurement of product". Exception, if the product characteristics are inspecting by production inspectors (not by QC/QA inspectors) - you may need additional product "internal audit" by another auditor who independent from the operation being inspected.

Please comment.

 

[Cheryl]

I discussed this with my reg auditor this week as well. We run approx. 1200 different part numbers through an average of 6 different process MONTHLY. I have been advised that so long as I audit through all process and while there audit the part numbers that are running through, this would be acceptable. I will need to conduct both my process and product audits at the same time however my auditors will need to use separate check/question sheets to show evidence for both.