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

Y

YKT

#1
#1
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 ?

Thanks
 
QMS for Medical Device Companies
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S

Sam

#2
#2
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.
 
M

MsHeeler

#3
#3
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?
 
Q

qsmso

#4
#4
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?

Regards,
QSMSO
 
M

MsHeeler

#5
#5
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:
 
M

MsHeeler

#7
#7
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.
 
A

ADVENTURE

#8
#8
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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