Validation of processes - 7.5.2 - Are Ppk's for process capability to be done also?

[cleverfox]

Okay, I have until July 9, 2003 before our phase 1 audit and there is so much to do!!! Has anyony got some input for me about what works for validation of processes?

7.5.2 - Validation shall demonstrate the ability of these processes, including a, b, c, d and e?

I know this is only for validation as it applies to production, but the company I am working has never done anything to validate its processes. They do not even submit a sample inspection sheet for new product samples (which I intend on changing).

I propose that this should be a process sign-off of sorts. Maybe a modified checklist based on Chrysler's PSW checklist. But are Ppk's for process capability to be done also?

Input needed badly.

 

[howste]

You posted this in the ISO 9001:2000 forum, but you mentioned Chrysler, so I'm confused. Do you need to live up to the increased automotive requirements in TS 16949?

If it's just ISO 9001:2000, then this only applies to processes that you can't verify the results of afterward by monitoring or measurement. I agree that this is basically a process sign-off - you're validating that you can trust the results of the process without significant ongoing monitoring. I would also think that statistical studies should be done if they can be. This often involves destructive testing. As an example, I've done capability studies on case hardness, tensile strength, plating thickness, etc.

It would probably help if you would let us know what processes you need to validate. Depending on your processes, some testing that might be included is:
• Durability
• Salt spray
• Function
• Hardness
• Tensile strength
• Plating thickness

 

[db]

Good reply, howste.

This is the old "Special Clause" in 9K 1994. Normally these processes require "desctructive testing". TS adds that it applies to all processes. That is where howste is coming from (I believe).

Exactly how you validate the process is up to you. All you must do is to show that the process has the ability to achieve planned results. In a realistic world, all of your processes will be validated, so the TS requirement will be met through normal means. It still should be nothing new.

 

[cleverfox]

Thanks for responding. I believe you are right. I was interpreting it differently, but in light of what you have said I think that is better.

So, I do not have to address this because we do not have any such processes.

Thanks for turning me around.

 

[Graeme]

Actually, becasue it is in the standard you do have to "address" it. If it does not apply to your current production processes, it would probably be better to say something such as:

(The organization) does not have any processes at this time where the output cannot be verified by later monitoring or measurement. If any such processes are required in the future, appropriate validation will be planned and implemented.

Naturally, this is also something that should be reviewed whenever a process is added or modified.

 

[cleverfox]

Graeme, thanks, I realize that what ever is in the standard needs to be addressed. I will take the exemption and explain it away....

 

[db]

Actually, becasue it is in the standard you do have to "address" it. If it does not apply to your current production processes, it would probably be better to say something such as:

(The organization) does not have any processes at this time where the output cannot be verified by later monitoring or measurement. If any such processes are required in the future, appropriate validation will be planned and implemented.

Naturally, this is also something that should be reviewed whenever a process is added or modified.

You must define your processes as required by 4.1. Now would be an ideal time to look at how each process will be validated. Also, you can develop an audit checklist for the process while you are at it.

 

[florin pirvulescu]

same subject - different question

I have a question on the same subject, that's why I didn't open a new thread. I hope someone to see it.
Assembling computers. We purchase components that we put together in a box called computer. Incoming inspection means for us visual examination, as an incoming functional examination it is not practical and economical (for instance the HDDs, or CPUs). We figure out about the component functionality in the assembling moment (in production or final tests let's say). In that phase everything could be OK, but sometimes bad feedback happen after delivery in use. I could say these are results that we have not under control in the incoming inspection.
Is that a case of "special process"?
If "yes" how can we validate the process of inspection or what process should validate?
Thanks in advance
Florin P.

 

[p_tww]

I have a question on the same subject, that's why I didn't open a new thread. I hope someone to see it.
Assembling computers. We purchase components that we put together in a box called computer. Incoming inspection means for us visual examination, as an incoming functional examination it is not practical and economical (for instance the HDDs, or CPUs). We figure out about the component functionality in the assembling moment (in production or final tests let's say). In that phase everything could be OK, but sometimes bad feedback happen after delivery in use. I could say these are results that we have not under control in the incoming inspection.
Is that a case of "special process"?
If "yes" how can we validate the process of inspection or what process should validate?
Thanks in advance
Florin P.

Hi, Florin,
If field failure is related to welding problem, it would be considered as special process. you should test your product performance at defied process specification limitation and related person's competence and environment condition, material,equipment etc.
If all your process is just assembly all purchased parts, without any welding/riverting etc. it would not be special process.

 

[howste]

I agree. Incoming inspection is not a "special process." Special processes are value-added processes where the results cannot be verified later.