Could somebody tell me
The question is based in this direction:
If we are saying that we have Current Process Controls and we put in this column our inspections like part of our Controls.

Should I consider all inspections that we have like a processes
This means that analyze them like another process operation
If it is true
Why ?

Smile is good for your health!


:bigwave: :bigwave:

The question is "Are all inspections a process control", right?

I would think so. I'm trying to think of an example where an inspection would not be a form of process control.

That said, every process control is not an inspection.

Sounds to me like the question is 'is inspection a process', as such do we need measure, analyse and improve this process ?

I would say that inspection is a process, but i would concentrate my measurement, analysis and improvement on my product realisation processes.

I also feel that inspection is a "Process Step". Now my question is "Can the inspection step have Failure Modes?" While my experience makes me answer a resounding "YES", that may not be so in all cases. If the answer is, in fact, yes I feel it should be analyzed via the PFMEA and "controlled" via the Control Plan.

In summary, should we include the inspection is the FMEA as a process operations ?

For example Incoming inspection ?

Please advise

:bigwave:

Concerning "Incoming Inspection", I can only tell you that I treat it as a "process step". I address it in the PFMEA "Cause" column as "Supplier sent out of spec. material". I then address controlling the Failure Mode in the Control Plan "Reaction Plan" column.

Hope this helps you out somewhat.

Thanks Bill.

In the last QS9000 Audit, my Auditor mentioned something about the Inspections,,, According with him, all the inspections should be in the FMEA, (actually we don't include it), he said this is part of the 3rd edition changes,,,,

Did somebody have a summary of these changes ?

what about "electrical test" to my wire harness (inspection operation) , this normally is part of my control to the assembly operations ?

Thanks

:bonk:

Refer to page 49 of the FMEA manual. It's broken down into prevention and detection controls. Other then that there doesn't appear to be much difference.