During a 3rd Party Reg.Audit...the question was posed as to why we did not list all our components on our control plan (evidently this lead to a non-conformance)...now making the necessary change to include all components is no big deal...mostly our parts contain the same components (just some cut and paste)...having said that, I would like to pose this arguement and hopefully you guys can provide some feedback.

Control Plans derive from (Process Flow & PFMEA)...if in FMEA 3rd Edition we are to assume all incoming parts/components/material are correct...is it not true then all we need to do in the 'Receiving Process' is to ensure the correct material is received (i.e. verify label to Bill of Lading or Purchase Order etc...) There is no need to list all components...it's a generic operation that the receiver does (making sure he/she is off-loading something that the organization is expecting)...with this argument listing the components makes no sense especially when you have over 20 per part.

With raw material...we have it listed because there are specific tests that we do so there are characteristics/tolerance, sample size and frequency, control method and the necessary reaction plan that must be followed.

Thanks.

You are correct in that the PFMEA should "write" your Control Plan. Your Control Plan should reflect the means you employ to control your process. If you don't perform any dimensional/visual type of verification for each component, I see no reason for listing each component at the receiving end of the process. "Grouping" them together should be fine if that works for you. Further downstream, you may need to address them individually regarding something like "component - missing", or something to that effect. Based on the information you've given, I would say your auditor is "out of bounds".

You are correct in that the PFMEA should "write" your Control Plan. Your Control Plan should reflect the means you employ to control your process. If you don't perform any dimensional/visual type of verification for each component, I see no reason for listing each component at the receiving end of the process. "Grouping" them together should be fine if that works for you. Further downstream, you may need to address them individually regarding something like "component - missing", or something to that effect. Based on the information you've given, I would say your auditor is "out of bounds".

I agree with Bill. Registrars' auditors have no business critiquing control plans so long as no customer-specific requirements have been violated.