Validation of Processes - How do I address TS 16949 Sec. 7.5.2.1

krishkaar

Involved In Discussions
#1
While understanding the differences between Sec 7.5.2 (ISO 9001:2000) and 7.5.2.1(Supplemental, ISO/TS 16949:2002), how does one address the ISO/TS requiremenst?
Can somebody, please help.
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: Sec. 7.5.2.1-Validation of procsses

My understanding of the supplemental is to over-ride the ISO 9000:2000 (7.5.2) phrase "where the resulting output cannot be verified by subsequent monitoring or measurement."

Anyone have a different view?
 
V

Valeri

#3
Re: Validation of Procsses - How do I address TS 16949 Sec. 7.5.2.1

I agree with Jennifer, it overrides 7.5.2 to include all processes - automotive requires us to validate all processes.
 

krishkaar

Involved In Discussions
#4
Re: Validation of Procsses - How do I address TS 16949 Sec. 7.5.2.1

The purpose o my query is to get a methodology for addressing the requirements of 7.5.2.1.
Any process map or procedures, please???
 

krishkaar

Involved In Discussions
#5
Re: Validation of Procsses - How do I address TS 16949 Sec. 7.5.2.1

Is there somebody who is listening to my request, please???
Thanks
 
P

potdar

#6
Re: Validation of Procsses - How do I address TS 16949 Sec. 7.5.2.1

The purpose o my query is to get a methodology for addressing the requirements of 7.5.2.1.
Any process map or procedures, please???
Validation of a process is a proof unto yourself (on record) that the process parameters you use to control a process end up giving you a process that is under control.

In TS implementation, you are putting all process parameters of all processes in their respective control plans. You are also confirming that the process is under control. Maintain the record. You have done it.:cool:
 
P

potdar

#8
Re: Validation of Procsses - How do I address TS 16949 Sec. 7.5.2.1

Process validation is easily covered by, for example by following the APQP phases and producing records that satisfy PPAP.
PPAP records are normaly generated only for part approval as a proof unto the customer. They are too much detail for the needs of 7.5.2.1 and include limited processes.

The clause requires validation unto yourself for all processes. PPAP is a good guideline but much less detail would do.
 

Paul Simpson

Trusted Information Resource
#9
Re: Validation of Procsses - How do I address TS 16949 Sec. 7.5.2.1

PPAP records are normaly generated only for part approval as a proof unto the customer.
Incorrect.

If you read the APQP manual and the PPAP manual (These still apply if you supply the big 3 and other subsribers) then the first is for management of the new product introduction process and the product / process design process and includes all stages of product and process design, verification and validation. The second (PPAP) requirement is that you generate all the documents as proof that you have managed the introduction or change.

Separately under PPAP it then goes on to say you must satisfy the customer's PPAP submission requirements and send them all or a selection of the documents that you have already produced as part of the APQP activity to give them confidence the new parts will satisfy their requirements.

They are too much detail for the needs of 7.5.2.1 and include limited processes.
If you want to supply the automotive industry then APQP / PPAP is (one example of) the requirements.

The clause requires validation unto yourself for all processes. PPAP is a good guideline but much less detail would do.
It would certainly not do if you are supplying the Big 3 or subscribing member.

FWIW a lot of the automotive supply chain is "standardizing" on APQP / PPAP.
 
P

potdar

#10
Re: Validation of Procsses - How do I address TS 16949 Sec. 7.5.2.1

Incorrect.

If you read the APQP manual and the PPAP manual (These still apply if you supply the big 3 and other subsribers) then the first is for management of the new product introduction process and the product / process design process and includes all stages of product and process design, verification and validation. The second (PPAP) requirement is that you generate all the documents as proof that you have managed the introduction or change.
Sorry Paul. I disagree.

APQP, yes. Process validation and PPAP both form a small but integral part of APQP, which is an umbrella activity. Indeed, the control plan which I take as the base of process parameters that need to be shown as validated is an output of APQP post PPAP. So far so good. But APQP has two big faults from what I see as the OP's viewpoint. It does not tell how to do process validation and it talks of so many other things irrelevant to 7.5.2.1. One could easily get lost in the maze.

Control Plan is a better starting point for the clause and a backward journey more easily "understood".

Separately under PPAP it then goes on to say you must satisfy the customer's PPAP submission requirements and send them all or a selection of the documents that you have already produced as part of the APQP activity to give them confidence the new parts will satisfy their requirements.
Exactly. PPAP is the customer's requirement. It is customer specific. As you say the industry is trying to "standardise" it. The name says it all - Production Part Approval (by customer) Process. Here again, process validation is only a part among so many requirements.

Conversely, 7.5.2.1 is an internal system requirement with its own limited standing. It will play its own small part while conducting APQP and PPAP exercises. Not vice versa.
 
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