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How do you do "Validation of Process" of production?

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Howard Atkins

Howard Atkins

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Staff member
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#12
#12
H.Singer said:
I am very confused by 7.5.2 and 7.5.2.1
Do we have to apply it to all the processes in production or not?
For example, we have one process only where the product itself is not measurable (or we'd have to break it). I understand we have to validate that process. But what about other processes where we can measure and monitor the output?
If we validate one process, do all the others have to be validated too??
:confused:
Click to expand...
In TS 7.5.2.1 gives no lea way.
In ISO 9001 you are free to choose what you want as long as you can justify it
 
R

Rajeeva

Quality Manager, CMQ/OE, CQA
#13
#13
ALFINSA said:
please I need help
I am very confused
how do you do "Validation of process" of production?
Click to expand...
Hi,

I think what you are asking is how the requirements of clause 7.5.2 are to be addressed.

Mr. Jason has addressed your concerns very well. In the earlier version, it was addressed under "special processes".

In construction industry, we apply this requirement for concrete works, welding works and painting works. We validate these processes in two stages.

1 stage of validation - Prepare the procedure, identify the equipments/ skilled manpower required, carryout trials and test them to ensure the desired results.

2 stage of validation - comes after the completion of warranty period (after 6 months/ one year as agreed with the Customer)

Regards,

Rajeev
 
S

senthilkumar

#14
#14
All the production process needs to be validated irrespective of whether it can be tested / verified or not.

Why because, Even processes where output can be measured, We may or maynot check all the parts (100%) during production. Also by the time you held up with a nonfoncormity the process is over. So it is only a detection control.

So, by process validation we can assure that our process will yield correct output and it is a prevention type of control.

How to validate a process:

Example : Welding Process

Define & Establish the following:
Criteria for review: Welding strength, Welding bead thickness etc.
Criteria for approval: Write the specification to be achieved, Ex: 30Nm
Approval of equipment: Calibration, Machine capability, OEE required for m/c
Qualification of personnel: Define the per.qualification required for the welding process
Specific method / Procedure: Establish SOP / Control plan for welding, DOE etc.
Records: Applicable records as an outcome of the above
Revalidation: Define the situations when we'll revalidate the process.

By this we are validating our process inputs in order to get consistent ouput irrespective of whether the output can be checked or not.

I hope this will add some more clarity.

Senthil:agree:
 
K

kalyhan

#15
#15
Not to beat a dead horse, but I've read all the TS 7.5.2 stuff (at least, I caught several different postings here) and some parts of 7.5.2 are still a little fuzzy. Someone was kind enough to post a msg stating that this clause is the most interpreted clause of TS and I could not agree more.

We recently passed out TS 16949 Stage 2. Just as soon as our corporate office fixes their NCR's, we will receive our certificate (Yeah!).

My question is in regards to our external auditor. He mentioned during the stage 2 "You may want to take a look at 7.5.2.". How vague can you be? :frust:

We are an OEM supplier for the truck plants. We have our control plans, instructions, procedures, PPAPs, etc. They have existed for years and we continually update them. We have weld criteria and certified welders. We validate/test & inspect the 1st part, last part off and in-process inspections per an AQL chart (for every process but wash!). I've racked my brain all morning trying to think of anything that we do not test or inspect and I'm drawing a blank.

Any suggestions as to what our auditor may have been referring to? I've known our auditor for a couple of years. Anytime I hear the "You may want to look at..", usually means he sees something out of whack and he gives us the opportunity to fix it before he writes it up next time.

Suggestions? Ideas?

:thanx:

Karen
 
M

mirrorcrax

#16
#16
I think it would be reasonable and straight to the point if you asked the auditor straight off what he meant, especially if he's been around for a while, than have us try to guess what he meant
 
M

mjoakin

Involved In Discussions
#17
#17
senthilkumar said:
How to validate a process:

Example : Welding Process

Define & Establish the following:
Criteria for review: Welding strength, Welding bead thickness etc.
Criteria for approval: Write the specification to be achieved, Ex: 30Nm
Approval of equipment: Calibration, Machine capability, OEE required for m/c
Qualification of personnel: Define the per.qualification required for the welding process
Specific method / Procedure: Establish SOP / Control plan for welding, DOE etc.
Records: Applicable records as an outcome of the above
Revalidation: Define the situations when we'll revalidate the process.

By this we are validating our process inputs in order to get consistent ouput irrespective of whether the output can be checked or not.

I hope this will add some more clarity.

Senthil:agree:
Click to expand...
I was looking for this ... but have a question ... do we need to make this validations at planned intervals? e.g: every two months, or is this something we need to verify on a daily basis? We sew seat covers for GM. We have a procedure where the operator is asked to verify the first, middle and last piece, the operator knows the specs to be verified and they have the the equipment to do the measurements. I thought this was a way to validate the process, because I'm making sure that the sewings are correct, no loose thread tension or wide seams ... because sometimes until the cover is built you can detect these kind of defects. So, what do I need to meet this requirement? or do I need to convince my Auditor that I'm already validating the sewing process???
 
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