7.3.3.2 - Process approval acceptance criteria - Approval vs. Acceptance

D

dbzman

Under 7.3.3.2 one of the items listed states "process approval acceptance criteria".

I would under stand this if it had said either approval or acceptance, but not both.

What are they asking for here?

Thanks!

:frust:
 

Marc

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Leader
You may submit a Process Approval request but that does not mean the approval request will be accepted. Acceptance is by a set of 'criteria' which you either meet or do not meet.

Think of Process Approval as a noun, Acceptance as a verb and Criteria as - See, now I forgot formal English rules, but Criteria is something else....
 

Marc

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Leader
Sure - An acceptance criteria for a process could be a stated diameter of a rod with a stated tolerance. Or it could be "Has to match colour patch B-2345". Or both.

Acceptance criteria for a process is nothing more than whatever is specified as the process output. If you're making a rod and painting it blue, the above 2 criteria might be part of an overall set of acceptance criteria for two processes. But even here, you might have 2 diameter criteria - Pre-paint and painted.
 

towxg

Involved In Discussions
Marc, if what you said is right, the process approval acceptance creteria = the product (process output) acceptance creteria.
But I think the TS requirement is not saying so.

I think the process approval acceptance creteria may be something like " the Cpk of process must be > 1.33 " etc.

Am I right??? Any other ideas? :bonk:
 

Marc

Fully vaccinated are you?
Leader
If there is a critical characteristic, process capability would usually be one of the acceptance criteria.
 
D

D.Scott

towxg said:
Marc, if what you said is right, the process approval acceptance creteria = the product (process output) acceptance creteria.
But I think the TS requirement is not saying so.

I think the process approval acceptance creteria may be something like " the Cpk of process must be > 1.33 " etc.

Am I right??? Any other ideas? :bonk:

Don't read too much into the requirement. It is simply saying that you must include as part of the Process Design Output, what you will be using as your accept/reject criteria. There is no right or wrong answer as long as your criteria satisfies the process input requirements. As Marc says, if there is a Cpk requirement then maybe the approval is based on the Cpk. Obviously, you can't include every part in the analysis so how many will you use to make your Cpk determination and what value is the pass/fail value ? That would be the acceptance criteria. If the requirement is dimensional, then maybe passing a go/no-go test is the criteria. If the requirement is a non-critical color, maybe a simple visual inspection is the criteria.

What will the final inspector look for before saying "Parts are OK to ship"? This is probably different in every process. Look at the requirements then when you design the process to meet the requirements, determine what you will do as a final check to make sure you have met those requirements. Try to keep it simple and don't define something that you won't be able to maintain in your process.

Remember, most of the requirements of the process are addressed within the process so they don't necessarily have to be re-verified at the end of the process. If, for example, you had a dimensional requirement that was addressed in the process by engineering the tooling to error proof the dimension, it would make little sense to establish controls other than periodic verification for that dimension. In such a case, even though the dimension was a critical characteristic, it would be redundant to make measurement of that dimension the acceptance criteria. In theory, all the process controls you have put into the process should do what they are supposed to do and if there is a failure, it will be corrected per the control plan. Those problems shouldn't show up at the end of the process. If you had multiple tests durring the process, maybe verification of passing all the tests would be your acceptance criteria. If so, say how you will verify it.

Dave
 
S

Sam

I'm looking at this requirement from a different persective. Manufacturing Process DESIGN output. "Design" being the key word. We are approving the design output prior to making a part.
Process Approval Acceptance Criteria; I interpret this as meaning; What is the acceptance criteria required to approve this process? The first question should be; Has the other eight steps been completed? Other questions might be; do we have trained operators? Do we know the customer requirements? etc.
 
D

D.Scott

Good point Sam - the requirement is, after all, addressing the process, not the product.

I would also think that a process designed specifically for a single product could be assessed by successfully producing the product it was designed for. This could then bring in the things discussed in the other posts. I think whichever approach is taken, it should be defined, and justified, in the design output as the acceptance criteria.

Dave
 
S

Sam

I agree Dave. At that point we call it the "pilot lot" process which prepares the product for production.
 
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