NCM (Non-Conforming Materials) Procedure questions

C

cab886

#1
I new to quality (formally metrology) and I have been tasked with bringing our start-up into ISO 9001:2008 certification from scratch. Right now I am struggling with the Control of nonconforming product procedure (8.3).

My company creates 1x1mm optical filters and we get 1000 parts per run and ship about 20,000 parts a month. Most of our runs we have under a 5% NCM rate. We track each of the different failure modes and issue CAR's on any single failure mode over 5%.

Right now we tag and segregate the NCM, but all of the parts are filed away (as NCM) with the justification that it could work for another customer in the future. My issue is that we were just blasted by successive Customer Audits because we keep all of our NCM parts. One customer issued a Corrective Action because the NCM were in drawers (not "secured"), and the other because NCM was "overloaded". But with

I have a few questions:
  • Can we keep parts in NCM (theoretically) forever?
  • Do we need to issue a CAR on every failed piece? or is our 5% rule sufficient?
  • Does our NCM area need to be locked? or is segregation and labeling enough?

Thank you for your help.
 
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John Broomfield

Leader
Super Moderator
#2
I new to quality (formally metrology) and I have been tasked with bringing our start-up into ISO 9001:2008 certification from scratch. Right now I am struggling with the Control of nonconforming product procedure (8.3).

My company creates 1x1mm optical filters and we get 1000 parts per run and ship about 20,000 parts a month. Most of our runs we have under a 5% NCM rate. We track each of the different failure modes and issue CAR's on any single failure mode over 5%.

Right now we tag and segregate the NCM, but all of the parts are filed away (as NCM) with the justification that it could work for another customer in the future. My issue is that we were just blasted by successive Customer Audits because we keep all of our NCM parts. One customer issued a Corrective Action because the NCM were in drawers (not "secured"), and the other because NCM was "overloaded". But with

I have a few questions:
  • Can we keep parts in NCM (theoretically) forever?
  • Do we need to issue a CAR on every failed piece? or is our 5% rule sufficient?
  • Does our NCM area need to be locked? or is segregation and labeling enough?

Thank you for your help.
cab,

Your customer is worried that they may receive some of those nonconforming filters and your segregation arrangements did not inspire confidence.

Do customers exist for the nonconforming filters? What types of nonconformity are they prepared to accept? Do the filters in the nonconforming batches each share exactly the same type of nonconformity?

And what about conformity to your own standards to build and protect your reputation?

In short, it seems to me, your retained stock of batches of nonconforming filters represents a sloppy attitude to quality.

And it seems to me that your 5% rule would allow the release of nonconforming filters. How much does this cost your organization?

As you draft your quality policy I doubt it will sanction anything less than delivering filters known to conform to your standards or your customer's requirements; whichever is highest.

John
 

Chennaiite

Never-say-die
Trusted Information Resource
#3
I new to quality (formally metrology) and I have been tasked with bringing our start-up into ISO 9001:2008 certification from scratch. Right now I am struggling with the Control of nonconforming product procedure (8.3).

My company creates 1x1mm optical filters and we get 1000 parts per run and ship about 20,000 parts a month. Most of our runs we have under a 5% NCM rate. We track each of the different failure modes and issue CAR's on any single failure mode over 5%.

Right now we tag and segregate the NCM, but all of the parts are filed away (as NCM) with the justification that it could work for another customer in the future. My issue is that we were just blasted by successive Customer Audits because we keep all of our NCM parts. One customer issued a Corrective Action because the NCM were in drawers (not "secured"), and the other because NCM was "overloaded". But with

I have a few questions:
  • Can we keep parts in NCM (theoretically) forever?
  • Do we need to issue a CAR on every failed piece? or is our 5% rule sufficient?
  • Does our NCM area need to be locked? or is segregation and labeling enough?

Thank you for your help.
None of your question perhaps has a straight forward answer. They only have Decisions that is bound by one of the so-called principles of ISO 9001 - Factual approach to Decision Making. Does keeping parts forever has implication on achieving your Business targets? And so is the case with 5% failed pieces and NCM area without lock? The answers to your original questions lie there in analyzing data to answer the follow-up questions.
 
S

sitapaty

#4
The 5%NCW should move into a non moving store or enclosure.If the NCW is not used for too long,some business sense should be applied to dispose off the same.
 
M

MichelleMcR

#5
Right now we tag and segregate the NCM, but all of the parts are filed away (as NCM) with the justification that it could work for another customer in the future.
Are your NCMs only due to a measurement that falls outside of the acceptable window?

If so, I would record it as an NCM for the specific manufacturing set-up, and follow all of your NCM procedures. If you then think it could be used in the future for another customer, you could write a process that would allow the NCM to be absorbed into stock as long as accurate measurements are recorded and there is some indicator of the fact that the part was not originally intended to measure its current size.

You may also need to ensure that the customer is aware of the original status of the filter and formulate an acceptance process in order to satisfy 8.3.b, but others may have more experience with such a requirement/procedure.
 
#6
The 5%NCW should move into a non moving store or enclosure.If the NCW is not used for too long,some business sense should be applied to dispose off the same.
It's not required to lock stuff up! What should happen is Non-conforming product should be dispositioned promptly so it doesn't require storage in anything but the usual place (if it's going to be "use as is". This idea of keeping it around until someone finds a home for it (under lock and key) is an old fashioned practice.
 
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