ISO/TS 16949 Manufacturing Audits - Check List Questions - 8.2.2.2

I

IEGeek - 2006

#11
Also I just looked at the PDF file you posted in the thread you referenced. That looks like a checklist to me, disguised as a process diagram.....

:)
Man, I tired to disguise that better. I will work on my document camouflage...

Just kidding... I would prefer to see a set of guidelines (questions to ponder, open ended, no multiple choice) on a audit walkthrough. For example;

"Define Top Management interaction related to this process."
"Who is responsible?"
"What are the quality objectives of this process?"
"What data is collected in this process?"
"What are some improvement objectives?"
"How does this processes output relate to the next process?"
"What are the resources available to the process?"

Things like that.

Those types of questions seem to prohibit checking a box and then moving on to the next question.

Just some thoughts....
 
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J

jmurph01

#12
Man, I tired to disguise that better. I will work on my document camouflage
:lmao:

Just kidding... I would prefer to see a set of guidelines (questions to ponder, open ended, no multiple choice) on a audit walkthrough. For example;

"Define Top Management interaction related to this process."
"Who is responsible?"
"What are the quality objectives of this process?"
"What data is collected in this process?"
"What are some improvement objectives?"
"How does this processes output relate to the next process?"
"What are the resources available to the process?"

Things like that.

Those types of questions seem to prohibit checking a box and then moving on to the next question.

Just some thoughts....
but that's similar to what my audit checklist is...I thought... :biglaugh: I think we're on the same side of the fence...we just don't know it....
 
J

jmurph01

#13
I come down somewhere between IEGeek and jmurph01, and I think it all depends not on whether checklists are used at all, but how they're used. There's nothing wrong with using a checklist as a mnemonic device--a "memory jogger"--especially when there's a lot of ground to cover. On the other hand, checklists, if allowed to, can become sort of like blinders for auditors who believe that the checklist is the audit "bible," and never stray away from it. A qualified auditor won't let the tail--the checklist--wag the dog--the audit.
I hear ya....

aren't we all just a bunch of agreable folks! :lol:
 
J

jefnik3201028

#17
Hello all,
I've been confused also on how to justify to our auditors that we perform system audit and manufacturing audit at the same time.
To make it more simple what should be the questions that need to be asked during the manufacturing audit and how do we satisfy the definition in item 8.2.2.2 which states "The organization shall audit each manufacturing process to determine its effectiveness".
I think what confused him was we showed a set of questions which seems to refer also to quality system audit type of question.
Hope you can also shed light on this.

Regards,
Freddie
 

Stijloor

Staff member
Super Moderator
#18
Hello all,
I've been confused also on how to justify to our auditors that we perform system audit and manufacturing audit at the same time.
To make it more simple what should be the questions that need to be asked during the manufacturing audit and how do we satisfy the definition in item 8.2.2.2 which states "The organization shall audit each manufacturing process to determine its effectiveness".
I think what confused him was we showed a set of questions which seems to refer also to quality system audit type of question.
Hope you can also shed light on this.

Regards,
Freddie
Effectiveness can be defined as the ability of a process to produce the expected results.

I would expect a manufacturing process to produce:
  1. Error-free product
  2. On time
  3. Right quantity
Now, what specifically would provide the evidence that this indeed happens?
  • Quality (inspection - test) data?
  • Production schedules?
  • Productivity data?
When the evidence shows that there are issues...you must dig deeper to find out what the weaknesses are in the process that contributed to its ineffectiveness.

See? No need to make this unnecessarily complex.

Stijloor.
 
Last edited:

Jim Wynne

Staff member
Admin
#19
Hello all,
I've been confused also on how to justify to our auditors that we perform system audit and manufacturing audit at the same time.
To make it more simple what should be the questions that need to be asked during the manufacturing audit and how do we satisfy the definition in item 8.2.2.2 which states "The organization shall audit each manufacturing process to determine its effectiveness".
I think what confused him was we showed a set of questions which seems to refer also to quality system audit type of question.
Hope you can also shed light on this.

Regards,
Freddie
Process Audit: verifies that a process is operated according to requirements.

Product Audit: verifies that the product meets specifications, perhaps at various stages (and across different processes).

You satisfy 8.2.2.2 by verifying that the process(es) and product satisfy design intent.
 
#20
Typically, a quality system audit is performed somewhat similarly to a CB audit. It might start with the receipt of an RFQ or order and follow the processes through to the shipment of product.

A manufacturing process audit (in the TS 16949 world) would typically focus on and follow the Product Control Plan, from receipt of materials, through manufacturing to the packaging of product.

If you have made a distinction between the two, I'd be confused about how you went about them too! They are quite different audits.
 
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