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

[Paul Simpson]

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

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).

 

[krishkaar]

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

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??

 

[Paul Simpson]

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

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.

 

[Valeri]

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

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.

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.

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

I'm done now.

 

[vanputten]

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

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

 

[potdar]

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

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.

 

[krishkaar]

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

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

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

 

[potdar]

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

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.

 

[vanputten]

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

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

 

[potdar]

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

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).