Where is the shall?

Howard Atkins

Forum Administrator
Staff member
Admin
#1
This is in fact a question to the auditors amongst us, but not exclusively of course;
From ISO/TS 16949
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. (my emphasis)

Is there in fact any obligation to add the layout to the control plan?
Where does it say that it must be there?
I have seen auditors saying it must be there but must it?
CSR's obviously must be adhered to but if there are none.
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Hi Howard,

My take is yes.

When a clause says we shall do XYZ "as specified in the control plans" it infers the control plans do talk about the thing and we are doing it the way we describe. Now the question about being required to do it each and every time is another discussion point; the control plans would define the activity.

Having results available for customer review doesn't mean we are sending them; having them available upon request would seem okay to me. In my view, it follows there would be a time frame for keeping them somewhere or at least a description somewhere about where such results are located for sending to the customers as requested.
 

Howard Atkins

Forum Administrator
Staff member
Admin
#3
Jennifer Kirley said:
Hi Howard,

My take is yes.

When a clause says we shall do XYZ "as specified in the control plans" it infers the control plans do talk about the thing and we are doing it the way we describe. Now the question about being required to do it each and every time is another discussion point; the control plans would define the activity.

Having results available for customer review doesn't mean we are sending them; having them available upon request would seem okay to me. In my view, it follows there would be a time frame for keeping them somewhere or at least a description somewhere about where such results are located for sending to the customers as requested.
Jennifer,
the records are obvious and as you say.
But is "infer" enough?
It does not say "A layout inspection and a functional verification to applicable customer engineering material and performance standards shall be specified in the control plans, and performed accordingly" rather performed as in the CP. If I do not put it in the CP then I will never perform it which is OK as this is the
"frequency" defined in the CP
Can I get a NC because the CP does not include the layout?
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Could be an argument point similar to the phrase "all process shall be audited...all shifts shall be audited." I know of a QA Mgr who successfully argued the standard does not clearly say all processes on all shifts...

Similarly this clause might be interpreted different ways.

The more liberal interpretation would mean the control plan lays out when inspection and functional verification is to occur--not promising it will always occur.

To put it in another way, we could think of it as a "weasel word" like "as appropriate" and "as needed:" "...as specified in the control plans."

I bet others in this forum would agree with the more liberal interpretation. What say you all? Calling all responders...
 
T

tyker

#5
What a very good question.

I suspect the answer is going to be found in the customer specific requirements, some of which specify a frequency for layout inspection and Annex A to TS states that the production control plan documents all tests that occur in mass production.

My customers do not specify a frequency for layout inspection and I do not include it in the control plan. I do, however, want layout inspections to happen so I have a process map which specifies the responsibilities, frequency, follow up actions etc and this has always been accepted by our registrar.

I'm keen to read other opinions.
 

Caster

An Early Cover
Trusted Information Resource
#7
Let's go the other way. Forget the shall.

Decide what makes sense for your business. Do that.

A good auditor will have no problem with whatever you decide to do.

If you get an audit finding (and you may go for years before you do), then and only then do you have to deal with it.

Our system has a lot of poorly implemented "shalls". I always amazed at what an auditor misses....and what they pick to get "all het up" about.

The big things seem to get overlooked (perhaps because that involves dealing with management?) while the trivial things seem to get hammered (the infamous cal sticker missing).
 

Howard Atkins

Forum Administrator
Staff member
Admin
#8
Caster said:
Let's go the other way. Forget the shall.

Decide what makes sense for your business. Do that.

A good auditor will have no problem with whatever you decide to do.

If you get an audit finding (and you may go for years before you do), then and only then do you have to deal with it.

Our system has a lot of poorly implemented "shalls". I always amazed at what an auditor misses....and what they pick to get "all het up" about.

The big things seem to get overlooked (perhaps because that involves dealing with management?) while the trivial things seem to get hammered (the infamous cal sticker missing).
The trouble is not the good auditor rather the creature that we have all meet occasionally. In this specific issue lots of companies without specific CSR's do not perform layouts.
To add layout to all Cp's with frequency - never is a waste of effort but is this the only manner.
What works for me is unfortunately not getting involved in stupid arguments with "stupid" auditors!
Do I really need to add layout to all CP's
 

Helmut Jilling

Auditor / Consultant
#10
Howard Atkins said:
This is in fact a question to the auditors amongst us, but not exclusively of course;
From ISO/TS 16949
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. (my emphasis)

Is there in fact any obligation to add the layout to the control plan?
Where does it say that it must be there?
I have seen auditors saying it must be there but must it?
CSR's obviously must be adhered to but if there are none.
This is not 100% clear. I think it says it has to be in the control plan, right in the very passage you sited. However, it does not specify the frequency. A few customers do, DCX for one, as annual, and that is what needs to be stated in the control plans. Prior to TS, I used to feel it did not need to be IN the CP, but agree it is the best place for it.
 
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