7.5.2.1 Process Validation - Supplemental - What does it mean?

Q

qsmso

7.5.2.1 Process validation - supplemental

When reading ISO9000:2000 for clause 7.5.2 Validation of processes for production and service provision, however, when review TS 16949 in the clause 7.5.2.1 "...shall apply to all processes for production and service provision.
What does it mean?

All processes shown in process control plan need to be validated?

How about some processes that we can verify output by subsequent monitoring or measurement, still need to be validated?

Confuse of English !!

Regards,
QSMSO
 
S

Sam

"where the resulting output cannot be verified by subsequent monitoring or measurement.

Example;
A welding process has the requirement that there will be no internal cracks after welding. If you are unable to verify this at a subsequent operation because,

1- you do not have an Xray machine, or other equipment,

your requirement is to validate the process with procedures and process controls, and,
to verify with the methods stated in a) through e).
 
Q

qsmso

Dear Sam,
Thank you for explain. However, I still wonder about this clause since the standard says that process validation shall cover ALL processes. So, what about machining process that we can measure dimension subsequently, how to validate machining process?

Regards,
QSMSO
 
A

Andrews

How about zinc plating? If the customer says that the "part should be zinc plated to 5 - 10 microns plating thickness and should withstand 72 hrs for red rust" , should the plating process be considered as a special process and validated?
 
S

Sam

qsmso,
Sorry, I didn't finish the post. What I said would cover the requirement for ISO. However, TS2 has included the word "ALL", which would require the validation of all processes.
Now, IMO, it realy gets muddy. How to put the word "ALL" with "resulting output cannot be verified by subsequent . . . ". Which you cannot do.
This is another one of those instanceswhere the writers of TS2 should have re-written the paragraph to describe what they want, instead of adding confusing verbiage in the form of another paragraph.
This also contradict 8.2.3.1 which requires "only new manufacturing processes to be validated.
In response to your question, IMO, all processes are required to be validated to " demonstrate the ability to achieve planned results."
 
B

Bill Ryan - 2007

Andrews

Are you in Zinc Plating? If so (even if you subcontract), aren't there means of measuring the plating thickness and tests to verify the "Red Rust" requirement? If that is the case, I would think 7.5.2 would not apply to the plating process.

Bill
 
S

SteelWoman

I'm struggling with this, too. We're in Steel processing, and there are some defects (such as sub-surface skin lamination) which by definition "become apparent only after the product is in use" - ie, we sell substrate to a supplier who then forms it into a part, and it's only in the forming process that the defect even shows itself. How am I supposed to "validate" this process??? Or am I only supposed to be concerned with MY part of the process, ie, I CAN validate that no skin lam was noted in the processing of the material?

Help?!:confused:
 
A

Al Dyer

qsmso said:

Dear Sam,
Thank you for explain. However, I still wonder about this clause since the standard says that process validation shall cover ALL processes. So, what about machining process that we can measure dimension subsequently, how to validate machining process?

Regards,
QSMSO


The machining process can be validated by using SPC. More frequent at first and declining until the process is stable. If is is statistically proven over a month or so that the process is stable and say a CpK is about 3.00, you have validated the process.

Al...:)
 
S

Sam

Steelware said,
" ie, we sell substrate to a supplier who then forms it into a part, and it's only in the forming process that the defect even shows itself. How am I supposed to "validate" this process???"

A few questions to ask;
Is the defect caused by variation in the material or is the defect caused by the forming process? Are there guidelines for forming the material? Is it cold-worked, heated or re-melted for forming?
Was the potential for the defect noted on your PFMEA?

Decisions to make;
What to validate in your process.
 
S

SteelWoman

In the particular example of lam, the defect isn't caused by the forming process - it's REVEALED in the forming process at our customer's. It's often hidden subsurface and the process of forming a part/drawing the material reveals it. Yup, noted on PFMEAs, but essentially one of those things we can't do anything about other than perform visual inspection to see the surface types of this defect - we'll NEVER see the subsurface ones. No way to test for it. Another good example would be underside scratches - no good way to catch it if it occurs, but something we can induce in the process. We can validate that the process of pickling or slitting steel is capable, but I just don't know what to do with that "apparent AFTER the product is in use" (presumably here at OUR customer's) issue.
 
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