Section 4.14.1 second paragraph states"Any corrective or preventive action taken to eliminate the causes of actual or potential nonconformities shall be to a degree appropriate to the magnitude of problems and commensurate with the risks encountered." Does this imply that the risks need to be prioritized??

Many other threads here - concerning nonconformance reporting

Do all non-coms need written corrective action - no - single -one time events that reasonably are/will not be re-occuring surley don't - However.. defining what is "major" enough to warrant an investigation & written action (prioritizing) would not be a bad way to go.

Regards
Jim

Basically if the fix costs $20,000 and there is minimal risk to the $0.05 a piece product...or it will be caught before it is shipped at a subsequent operation maybe its not cost effective it do the fix.....So the CA could be a consious and documented decision not to do it.

Well put, and thanks for that, Barb! I couldnt agree more.
I think that the corrective and preventive action subject in general is not fully understood in terms of practical and reasonable application by many people. In fact, I dont recall ever seeing a seminar or instructional course specific to such an important process. (anyone know of any??)
When I started here, my company was generating an 8D for EVERY internal nonconformance. Its what the procedure said we were doing. Its what they understood the standard to mean. That procedure got changed quickly. Many times, the disposition on a NCR is an effective corrective action
Economics play a vital part of the correction decisions and I have yet to interface with a 3rd-party auditor that disagreed.

Whenever I hear or see the word risk I think of the FMEA. It is a good tool to use to prioritize possible nonconformances. We use a prioritized list that includes a scoring methodology that takes into consideration the payback time of projects resulting from the prioritized list.

This also gives us the link we need between corrective and preventive action.

ASD...

Don't forget, when thinking of CA and PA, see http://Elsmar.com/ubb/Forum2/HTML/000036.html and http://Elsmar.com/ubb/Forum31/HTML/000023.html (as starters.....)

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