Control Plan

#1
I found different interpretation of rules and contain of Control Plan.
In the last time to different auditors say that Work instruction must be added in Control Plan and for this point the give nonconformity in audit.
I read and reread the APQP (base of Control Plan) and others example from different sources and I have not found this topic as “Work instruction must / have to added in Control Plan” (in text or in example).
In my opinion Work instruction is a document result behind Control Plan (request of product or process characteristic).
There are various opinions that WI should be added at “Specification / Tolerance’ or at “Control Method”...what is true, how it should be?

Thank you!
 
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#2
In my opinion, a Control Plan is a Risk Management tool. It provides value if it helps you identify and plan for risk and react appropriately when bad things happen. The people who benefit from Risk Management are your organization and your customer(s). There are different approaches what to include in a Control Plan and how much detail needs to be included. If the Control Plan provides value to your organization and your customer(s) (value being risk mitigation in all it many forms), then I conclude you are doing the Control Plan correctly. If someone has a suggestion, and that suggestion adds value to your Control Plan, then certainly consider that. If an idea adds no value, then I think the idea is only an opinion.

If an auditor has an opinion which is different from yours, they are bound by an auditor's code of conduct to listen to your explanation and consider whether your opinion has validity. If a difference of opinion cannot be resolved between you and an auditor, you are allowed to speak to the audit authority.
 

malasuerte

Involved In Discussions
#3
I found different interpretation of rules and contain of Control Plan.
In the last time to different auditors say that Work instruction must be added in Control Plan and for this point the give nonconformity in audit.
I read and reread the APQP (base of Control Plan) and others example from different sources and I have not found this topic as “Work instruction must / have to added in Control Plan” (in text or in example).
In my opinion Work instruction is a document result behind Control Plan (request of product or process characteristic).
There are various opinions that WI should be added at “Specification / Tolerance’ or at “Control Method”...what is true, how it should be?

Thank you!
Hi Cristi

That is a bad NC written.

A Control Plan is for "CONTROL" :)

The Control Plan should be a document for your org that describes the actions (measurements, inspections, quality checks or monitoring of process parameters) required at each phase of a process with a final piece of how to react/respond if the control goes bad.
 

Zero_yield

No cost too great...for Quality
#4
From my limited interaction with Control Plans, usually there's a basic sense of "If A happens, do B. If C happens, do D." Does your Control Plan contain or reference instructions on what to do in case of a few event-based items?
 

malasuerte

Involved In Discussions
#5
Hi Cristi

That is a bad NC written.

A Control Plan is for "CONTROL" :)

The Control Plan should be a document for your org that describes the actions (measurements, inspections, quality checks or monitoring of process parameters) required at each phase of a process with a final piece of how to react/respond if the control goes bad.
@Cristi Cobrac
In re-reading, I do want to clarify, since verbiage can be a concern here: The OCAP/Reaction Plan must be captured in the Control Plan.

A "Reaction Plan" is a "Work Instruction". A "Work Instruction" could also be a for maintenance, processing, metrology, etc.

So to make sure: You have the Reaction Plan in your Control Plan? If it is missing, then the NC could be correct.

But there is not a requirement to put the WI that tells someone how to process or do the work at the step.
 
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