Tools & Techniques

[Dawn]

Here's a hot one:
4.2.4.5 "The supplier shall perform process studies on all new processes to verify process capability and to provide additional input for process control. The results of process studies shall be documented with specifications where applicable for means of production, measurement and test, and maintenance instructions. These documents shall include objectives for process capability, reliability, maintainability and availability, as well as acceptance criteria."
This is one h___ of a paragraph. Does it mean we shall do capability studies on every part; every dimension?
The TS Checklist states an auditor will look for related actions based on the results; defined acceptance criteria based on objectives;and if the studies include objectives for capability, reliability, maintainability, availability and the acceptance criteria.
HELP!!!!!!

[Marc]

I would think these would be limited to critical characteristics. As far as The results of process studies shall be documented with specifications where applicable for means of production, measurement and test, and maintenance instructions. the sentence sorta sucks. But I read it to say that your process studies have to drive production, measurement and test, and maintenance considerations.

...shall include objectives for process capability, reliability, maintainability and availability, as well as acceptance criteria... I would think these would be developed early on. I can only think they want to ensure these aspects documented.

Does it mean we shall do capability studies on every part; every dimension?

I don't think so. Critical characteristics.

[Dawn]

I'm not sure on this. This is not atated in QS, it is added. So I'm thinking we need to state evidence of how we determine reliability, etc. and I am clueless how to show evidence of this. (Thanks, Marc)

[Marc]

Well, it is and it isn't. Only the wording has changed. For example, where it says "...shall be documented with specifications where applicable.." - this simply means that you have to cite any specs you use. Let's say you use an ANSI spec for a characteristic - you have to cite the spec. No different than if you sample to the old mil standard. Stating the standard you use and not stating it are two different situations.

They're looking to make sure you are basing the stuff you do on something and where there's a spec you name it. Instead of saying "...We have maintenance instructions..." you have to say "...Maintenance instructions were derived from the manufacturers recommendations (or the equipment manual or where ever) and consideration to use of the equipment was considered..."

Look at "...defined acceptance criteria based on objectives..." You have an acceptance test. What is it based upon? The objective is to meet or exceed a threshold (the 'pass' point) and to reach (or improve upon) a specified (by you) capability.