Element 4.9.1 Process Monitoring

  • Thread starter Christopher Kierans
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Christopher Kierans

My question refers to Element 4.9.1 Process Monitoring and Operator Instructions. (QS9000 3rd edition, p. 36)

"Process Monitoring and operator instructions shall include, or reference, as appropriate:

Operation name and number keyed to the process flow diagram. ..."

I would be interested in hearing from people as to how they comply with this requirement.

Our division got nailed on an corporate (internal) audit because the steps in our Process Flow were not numbered. In fact, they are saying that we should LINK our process flow, FMEAs, Control plans, and our Operator instructions with numbered steps.

I had always heard that this was a suggestion, but I was told that registrars are hitting the suppliers with majors if they do not comply. All suggestions are welcome (from manufacturers especially) Also , what is the appropriate meaning of "as appropriate"...? Does this turn the shall into a should?
 
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Sam

<<"Our division got nailed on an corporate (internal) audit because the steps in our Process Flow were not numbered. In fact, they are saying that we should LINK our process flow, FMEAs, Control plans, and our Operator instructions with numbered steps.">>

I was also nailed on this at a previous place of employment.Refer to step 15 & 18 in the APQP for directions on the control plan.
This is the statement that I was referred to for review.

<<"I had always heard that this was a suggestion, but I was told that registrars are hitting the suppliers with majors if they do not comply.">>

I don't see it fitting the catagory for a major, but then again it depends on the mood of the auditor. Even if you contest and win you have wasted a lot of tme and money.

<<"All suggestions are welcome (from manufacturers especially) Also , what is the appropriate meaning of "as appropriate"...? Does this turn the shall into a should?">>

I don't see it turning into a should or a shall, but if you reach a consensus it could turn into an "Opportunity for improvement"
 
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Christopher Kierans

Sam, thanks for your reply. I am guessing you are referring to Steps 15 & 18 in the Control Plan methodology at the back of the APQP book. I have looked at these. The problem is the Element 4.9.1 is worded such that no reference is made to Control Plans, only the linkage between PFD and the operator instructions. I realise this shouldnt be a big deal, but I would be interested in how other manufacturers addressed this issue. Chris Kierans
 
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Sam

Yes I'm referring to step #15 & #18 on page 39.
Also refer to the 2nd Para of 4.9.1 " These instructions . . .
 
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