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.

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?

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

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???

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

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:

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

Process validation is easily covered by, for example by following the APQP phases and producing records that satisfy PPAP.

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.

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.

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.

Excuse my frustration but I am amazed at how there can be such different understanding of these processes that have been around now for 13 years. :frust:

APQP, yes. Process validation and PPAP both form a small but integral part of APQP, which is an umbrella activity.In no way is process validation a "small" part of APQP.

It is fundamental to being able to demonstrate (validate) that the process is capable of producing good parts at the rate and capability the customer expects. It includes capability studies for both short and long runs. APQP generates records throughout the process and these are used to generate a package of information that the supplier holds to show there product and processes are capable.

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. Control plans at each of the phases are required pre PPAP - they form part of the deliverables of the APQP process. The control plan documents the checks that are required throughout the production processes - they may be an output of the process validation activities.

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. It is an automotive supply chain maze that I presume (as this is an ISO TS thread) the OP wants to be part of.

APQP list a whole range of activities that the OP has to do if they want to provide product to anyone in the supply chain that uses APQP / PPAP. Their customer may require all of the activities listed and will require at least some of them.

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

In your opinion. You are welcome to share it. I prefer to start at the beginning and work forward.

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. I repeat myself .... it is a significant part.

If you have a look at the PPAP document listing they are pretty much all oututs from product / process verification validation activities.

If you have a look at APQP activities the phase on process validation talks about:
Production trial run
Preliminary process capability study
Production part approval
Packaging evaluation
Production control plan
Planning sign off


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. How can you separate customer requirements for product / process validation from the clause of ISO TS? :confused:

If the customer requires APQP / PPAP then that defines what the supplier has to design their system to achieve to satisfy clause 7.5.2.1. All this particular clause says is that you have to apply 7.5.2 to all production and service provision processes.

Now maybe the customer doesn't call up APQP / PPAP but it will be something similar.

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.

Paul, I am deliberately starting with the OP's original query. few things are very clear:

The OP is talking about automotive supply chain. (Of course 7.5.2.1 does not exist in ISO 9001).

He simply wants to know what is so different in this clause than 7.5.2 and what exactly is he supposed to do.

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

I have just tried to put on the trainer's shoes and tried to give him a practical guideline. In my experience as a trainer, such queries come mainly from parties who already have established parts being supplied and are trying to upgrade from ISO to TS. In their case, APQP was never done for the existing parts and if at all, the vintage records are missing. Most stages in APQP are not relevant in these cases as there is no 'advance' planning to be done. The parts are already proven.

That done, if we engage in a debate over issues like whether the chicken comes first or the egg, semantics like small and big parts I think we are diverting from the issue.

Just to put my points briefly again, both APQP and PPAP relate to parts, not processes. Of course processes form a portion of these activities (you may choose to call them small or big).

Control plans at each of the phases are required pre PPAP - they form part of the deliverables of the APQP process. The control plan documents the checks that are required throughout the production processes - they may be an output of the process validation activities.

They are an output of process validation activity

If you have a look at the PPAP document listing they are pretty much all outputs from product / process verification validation activities.

If you have a look at APQP activities the phase on process validation talks about:
Production trial run
Preliminary process capability study
Production part approval
Packaging evaluation
Production control plan
Planning sign off

You may notice that CP is formalised post PPA (refer PPAP manual). Please note that all these are activities internal to the organisation. PPAP is an activity external to the organisation in which records produced as an output of APQP are simply submitted for approval (here the customer is bothered mainly about the finished part; not the intermediate stages). Once again, pre PPAP or post PPA (the mother of PPAP)?

As you rightly say, it is a maze. We can continue to dissect it to no end. But why mix it up with a simple answer to a simple question?

As per the guidelines of APQP, whatever process parameters are listed in the control plan are supposed to be listed only after they are validated. Activity sequence:

Production validation testing
Packaging evaluation (nothing to with the query)
Production control plan

Just ensure that you have records on hand for the validation testing done for whatever you have stated in your control plan.

Looks like we're getting closer to agreement - the only substantive difference is you are saying PPAP is for customers and control plans are the key to process validation - I will deal with these.
He simply wants to know what is so different in this clause than 7.5.2 and what exactly is he supposed to do.

So when I said:

If the customer requires APQP / PPAP then that defines what the supplier has to design their system to achieve to satisfy clause 7.5.2.1. All this particular clause says is that you have to apply 7.5.2 to all production and service provision processes.
That should have answered the question? Or perhaps s / he wanted information as to how it should be done - hence my directing the OP to the APQP process that has a whole section on process validation and what is used in automotive.


I have just tried to put on the trainer's shoes and tried to give him a practical guideline. In my experience as a trainer, such queries come mainly from parties who already have established parts being supplied and are trying to upgrade from ISO to TS. In their case, APQP was never done for the existing parts and if at all, the vintage records are missing. Most stages in APQP are not relevant in these cases as there is no 'advance' planning to be done. The parts are already proven. It doesn't state that in the OP. If s / he has established parts then 7.5.2.1 does not apply (except for re-validation).

That done, if we engage in a debate over issues like whether the chicken comes first or the egg, semantics like small and big parts I think we are diverting from the issue. This is one that has recently been resolved. :D It has to be the egg because that is the first time all the DNA can come together from two "near chicken" parents.

On a serious point if you post something that says: 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.
Then I have to reply to say that APQP describes a range of activities that cover validation of processes.

It may be semantics to you. It is basic principles to me. If the industry can't agree on what the requirements are then what hope is there for new people into the field? :mg:


Just to put my points briefly again, both APQP and PPAP relate to parts, not processes. Of course processes form a portion of these activities (you may choose to call them small or big).

Again a big NO!

APQP describes a phased process for new product introduction (as in my earlier post). The phases it covers are:

Plan and Define (for the project)
Product Design & Development
Process Design & Development
Product and Process Validation
Feedback assessment & Corrective action


The OP should look at APQP and find the processes and activities their customer wants them to use.

They are an output of process validation activity. They are in their final form - they are also developed for all the product stages:

Prototype Control Plan
PreLaunch Control plan-
Production Control plan




You may notice that CP is formalised post PPA (refer PPAP manual). Please note that all these are activities internal to the organisation. PPAP is an activity external to the organisation in which records produced as an output of APQP are simply submitted for approval (here the customer is bothered mainly about the finished part; not the intermediate stages). Once again, pre PPAP or post PPA (the mother of PPAP)?

You have chosen to ignore my earlier point about PPAP being about having a range of documents available internally to demonstrate that you have followed APQP.


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.

Your customer may require you submit some of them for their review / records.
As you rightly say, it is a maze. We can continue to dissect it to no end. But why mix it up with a simple answer to a simple question? Again if we start off without understanding the principles then we end up with a a right mess - no way out of the maze.

As per the guidelines of APQP, whatever process parameters are listed in the control plan are supposed to be listed only after they are validated. Activity sequence:

Production validation testing
Packaging evaluation (nothing to with the query)
Production control plan
[/QUOTE]
The finalized control plan summarizes controls to be operated on the process after it has been validated. It is not, however, a record of process validation or a validation method itself.

Just ensure that you have records on hand for the validation testing done for whatever you have stated in your control plan. Agreed. Your PPAP file.

I'm happy that we seem to be agreeing to a limited extent. I think it is time for the original poster to come in and comment. Has his query ben satisfied?

Just something to munch on for you Paul. APQP is Advanced Product Quality Planning. PPAP is Production Part Approval Process. Both are focussed on something other than Process.

If the industry can't agree on what the requirements are then what hope is there for new people into the field?

Ideally the industry should have agreed on what they want. The unfortunate fact is they dont. Thats why we dont have a standard on our hands. All we have is a specification.

APQP and PPAP are both not a part of TS 16949. They are supporting documents. There are subscribers to TS (know some people around who practice VDA?) who are not really impressed with these documents. Some of these will tolerate your documentation in these formats. Some (Benz) will insist that their own guidance / formats be used.

Whoever be your customer, whatever guidance documents you use, 7.5.2.1 has to be satisfied. Why limit the discussion to the supply chain of the QS triad?

Wonderful deliberations.

I am thankful to the many opinions expressed on this interesting topic.

Is my understanding correct:

"the Process validation referenced in APQP manual and the Validation of Processes for production and service provision-supplemental per 7.5.2.1 of ISO/TS 16949:2002"

ARE THEY ONE AND SAME??

Something is not convincing me, if one looks at the basic definition of a Process. (ISO 9000:2005) and the many places where this term is used in the same standard????

krishkaar,

I am attaching my audit checklist for the 5 phases of the APQP process. As indicated, the inputs & outputs are already identified. Hopefully, this will help your understanding. Be advised, this is the requirements for any customer requiring the use of the AIAG APQP requirements. Customer specific requirements may be different.

Just something to munch on for you Paul. APQP is Advanced Product Quality Planning. PPAP is Production Part Approval Process. Both are focussed on something other than Process.After the calm comes the storm! ;) Thank you for highlighting the words - I can read.

How do you think parts are produced? They don't materialize in finished form but require processes to deliver them. APQP concentrates on all the processes needed to deliver conforming product to the customer in the quantities they need. Specifically the production processes that require validation as per TS.

Ideally the industry should have agreed on what they want. The unfortunate fact is they dont.

The industry I was talking about is ours - the "quality" profession. You and I have looked at the same documents (following the OP) and seem to have completely different opinions as to what they mean.

BTW yes, it would be ideal for the automotive industry to agree on a NPI process for suppliers - it just ain't going to happen.

Thats why we dont have a standard on our hands. All we have is a specification.

TS is a specification because it takes a standard (ISO 9001.2000) and adds automotive industry specific requirements (developed by the IATF).

It has not been developed by the technical committee with responsibility for the standard (TC / 176) but is acceptable to a majority of them for publication as a normative document. It may be published as a standard in the future if:

The automotive industry falls in with the ISO committee structure
The (new?) committee can agree on requirements
The automotive industry is prepared to hand accreditation of certification bodies back to the accreditation industry
He11 freezes over (Sorry, I don't know where that last one came from)



APQP and PPAP are both not a part of TS 16949. They are supporting documents. There are subscribers to TS (know some people around who practice VDA?) who are not really impressed with these documents. Some of these will tolerate your documentation in these formats. Some (Benz) will insist that their own guidance / formats be used.

Fine. My example of APQP and PPAP was to direct the OP to a document that covers process validation.

Whoever be your customer, whatever guidance documents you use, 7.5.2.1 has to be satisfied. Why limit the discussion to the supply chain of the QS triad?

Not the case. As above I gave an example about how an automotive supplier (this is the TS thread isn't it?) might find examples of how you validate processes (as required by 7.5.2 in ISO 9001 - as mandated in 7.5.2.1 in TS). I am quite happy to discuss other ways if you want to suggest them ......

Thanks for the immeditae response.

My basic question is still not answered--

Are we talking about only a manufacturing process OR is it any process??

The confusion sets in becuase of the language::

7.5.2.1 validation of Processes
7.3.6 -design and development validation (read with NOTE-1 and NOTE-2)

Wonderful deliberations.You think so? I am a bit disappointed the discussion is going on as long as it is.

"the Process validation referenced in APQP manual and the Validation of Processes for production and service provision-supplemental per 7.5.2.1 of ISO/TS 16949:2002"

ARE THEY ONE AND SAME??Yes. 7.5.2.1 refers to 7.5.2 of ISO 9001 which talks about: " The organization shall validate any processes for production and service provision ..."

and the scope is clarifed in TS to say "all processes for production and service provision"

Something is not convincing me, if one looks at the basic definition of a Process. (ISO 9000:2005) and the many places where this term is used in the same standard????

You can have many processes within the organization including sales, marketing, purchasing, etc., etc. This clause (7.5.2.1) only relates to processes for production and service provision - i.e. those within clause 7.5.

Thanks for the immeditae response.

My basic question is still not answered--

Are we talking about only a manufacturing process OR is it any process??
This clause (7.5.2.1) only relates to processes for production and service provision - i.e. those within clause 7.5.

The confusion sets in becuase of the language::

7.5.2.1 validation of Processes
7.3.6 -design and development validation (read with NOTE-1 and NOTE-2)
I see where the confusion could come about. The two requirements are not contradictory.
In order:
7.3.6 Note 2 says validation applies to manufacturing processes.
7.5.2.1 says that validation applies to all processes for production and service provision (anything in 7.5).

Yes sir. The provision of clause 7.5.2.1 applies to "processes for production and service provision"

Lets see
clause 7.5 tilted production and service provision,
7.5.1 - Control of production and service provision

This is followed by sub-sections 7.5.1.1 to 7.5.1.8.

Now ishould we apply validation of processes to all sections and sub-sections, taking as a whole.???

The requirements of ISO 9001:2000, clause 7.5.2 was very clear (.... where the resulting output cannot be verified.....).

Is it lack of clarity in ISO/TS OR is it my lack of understanding??

Yes sir. The provision of clause 7.5.2.1 applies to "processes for production and service provision"

Lets see
clause 7.5 tilted production and service provision,
7.5.1 - Control of production and service provision

This is followed by sub-sections 7.5.1.1 to 7.5.1.8.
There are many other clauses up to 7.5.5.1.

I think you have totally missed the point .....

Now ishould we apply validation of processes to all sections and sub-sections, taking as a whole.???Yup, you've missed the point.

You don't validate against the clauses of ISO TS. You validate the manufacturing processes, like:

Machining
Fabrication
Plating
Assembly


The requirements of ISO 9001:2000, clause 7.5.2 was very clear (.... where the resulting output cannot be verified.....). This is because the intent behind this clause was very specific.

TS extended the requirement for validation to all manufacturing processes (Those under 7.5 of ISO).

Is it lack of clarity in ISO/TS OR is it my lack of understanding?? I fear it is the latter.

Unless the level of discussion moves up a couple of notches I shall be off todo something useful ... like paint my toenails.

I'm going to make one more stab at what I THOUGHT was a simple question that Jennifer's first post answered with regards to clauses 7.5.2 and 7.5.2.1.:confused:

Within TS16949 specification, anything in a box is the ISO9001:2000 requirement; anything outside the box are additional automotive specific requirements which override or add to the ISO standard.

:2cents:If you are looking for a flow chart/process for "validation of all processes", this happens throughout the APQP process.

I'm done now.

I hope that APQP and PPAP type activities are process centric. If not, the main intent of those pre-planning philosphies has been lost. The "Process Approach" may be replaced by the "Product Approach" based on some of the discussion in this thread.

Regards,

Dirk

Yes sir. The provision of clause 7.5.2.1 applies to "processes for production and service provision"

Lets see
clause 7.5 tilted production and service provision,
7.5.1 - Control of production and service provision

This is followed by sub-sections 7.5.1.1 to 7.5.1.8.

Now ishould we apply validation of processes to all sections and sub-sections, taking as a whole.???

The requirements of ISO 9001:2000, clause 7.5.2 was very clear (.... where the resulting output cannot be verified.....).

Is it lack of clarity in ISO/TS OR is it my lack of understanding??

It applies to 7.5.1 as a whole. The sub clauses aid you in understanding the requirements of 7.5.2

7.5.1.1 Control Plan - guideline reg what to validate. Refer annex A. Prove that you get b when you follow c and d.

7.5.1.2 Work Intructions - may not be present for all processes. The processes for which these are made shall be validated.

7.5.1.3 Verification of job set-ups - routine practice. Normally an indicator of jig changes requiring revalidation(7.5.2 e)

7.5.1.4 - 1.8 affects revalidation frequency.

For revalidation requirements refer 7.3.6.3 or your internal specifications. Useful guideline - PPAP manual.

This covers the WHAT and WHEN of validation / revalidation. From the discussion so far, I take it that you are comfortable on the HOW part.

Many thanks to everyone who have enlightened me on the topic.

Let me comeback after attempting a few (validation) trials.

I hope that APQP and PPAP type activities are process centric. If not, the main intent of those pre-planning philosphies has been lost. The "Process Approach" may be replaced by the "Product Approach" based on some of the discussion in this thread.

Regards,

Dirk

The APQP manual was last issued in 1994. PPAP was of a similar vintage till recently (2006).

So, your guess is as good as mine.:notme:

Hello Potdar:

What does the date of issue have to do with the philosphies upon which the advanced quality planning and production part approval concepts are based?

Thank you,

Dirk

Hello Potdar:

What does the date of issue have to do with the philosphies upon which the advanced quality planning and production part approval concepts are based?

Thank you,

Dirk

To my knowledge 'process centric approach' came to be officially recognised in 2000 with ISO 9001 and in 2002 with TS 16949. The QMS before that were not 'process centric'.

That is not to say that the word 'process' did not exist in the jargon. It did, and it was understood to mean different things in different concepts. Indeed PPAP itself is a process, and then there is SPC. APQP claims to be a method (see intro pp 3). In previous editions of PPAP (see glossary), process is defined differently (but close enough) than what we take it to be today.

These are basically support documents of QS. My understanding of QS was that APQP suggests a method of ensuring smooth NPI. PPAP is the process of getting these new parts approved by the customer. APQP to a large extent is mouldable inhouse to suit my QMS. PPAP to a large extent is dictated by the customer.

Really speaking defining PPAP as a process is more important when sourcing from my subcontractors. Unfortunately, the manual does not give much guidance on that angle, say on what submission level I should ask for in what situation (normative).

Potdar:

The concept of putting most resources into planning and understanding the processes before going to production (instead of putting resources into reacting to process problems after going to market) started decades ago if not long before that.

Deming's efforts were based in system thinking - understanding how processes inter-related to create a system. Deming supported efforts to understand processes and emphase planning as early as 1950.

The philopsophies of advanced quality planning, process and system thinking have been around for much longer than any management system standard.

ISO 9001:1987 was intended to be process centric, as was ISO 9001:1994, by the way.

I am talking about the important concepts and philosophies that are included in documents like APQP, MSA, PPAP, etc.

Without question, PAQP and PPAP are process centric. The process creates the output. Planning is where an organization generally gets its biggest bang for the buck.

Regards,

Dirk