QMS Audit, Process Audit, Product Audit - Can these be audited together?



QMS audit, process audit, product audit

In the element 8, the requirements asked for the QMS audit, manufacturing process audit and product audit.
Can all these audit be done together ?

What are the main differences between all of these audits, in term of approach, in term of area to look for, sampling , etc ?



I have taken this approach:
- QMS - I use the 50 page checklist that my CB uses. Similar to the one published by AIAG. I will do this audit once per year.

- Manufacturing Process Audits- I will use the approach described in the IAAG supplier auditor course; inputs, activities,support processes, interfaces, outputs. Process auditing is the key to a successful audit.
This audit includes all areas effecting Mfg.,i.e., scheduling, industrial engineering, maintenance.
I wil initially conduct these audits monthly for the first year and then move to quarterly.

- Product audit - I see this as a random sampling of completed product from a cell or partially completed product prior to moving to the next cell. I will conduct these audits once pr day per product type.


My thinking on this would be that a process audit would/could be a control plan audit.

And a product audit would be coverd by a dock audit (an audit of finished goods).

Do you think that this would cover the requirements?


IMO, to do only Dock Audit may be not enough for Product audit since the standard require to perform product audit every appropriate production stages.
What I am thinking is to combine process and product audit in the same time by using process control plan as a guide, then randomly check product with specification.
Is this make sense?



In our process there are only really four stages. Mold, trim, punch, and package. All of these can easily be checked in a dock audit. Our dock audits are performed on a different part each week. The frequency is raised if we have a problem part.

I still think that this should work. We just submitted our package to Entela, so I guess we will soon find out. :eek:


IMO, either way will work, As long as your process is defined and results documented.


I sure hope so! Hey we need a symbol with crossed fingers. :bonk:

Where in Oklahoma are you from Sam? I was born in OKC.


As we ramp up for TS 16949 .....planned for Nov. 03. Our approach has been to select a part and "walk the control plan" to ensure that we are meeting requirements to the control plan. We have expanded the audit to include the review of: documentation (doc. control), calibration (both process and product), qualification of assigned employees, tracking and staging of product etc. This has proved to be beneficial primarily because it gives us a vertical slice of our processes and in doing so a better feel as to our compliance in all of our QMS areas. Right or wrong this is our story and for now we are sticking to it LOL. :rolleyes:
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