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View Full Version : Implementing Defect Logs into my existing Non-conformance procedure


timmlaww3256
20th May 2008, 02:48 PM
Hello all,
New to the forum, so here goes with my first post...

My company has traditionally been what you'd typically consider a 'job shop', but we've picked up a few new programs which are being produced in a fashion which is closer to that of a typical 'production house'. Our current QMS system is ISO certified, but was crafted primarilly towards the needs of the 'job shop' culture. Recently, we've come up against the problem that many our non-conformances in the production house portion of the organization are of a very minor, and reworkable nature. Therefore, we have been generating far too many NCRs (non-conformance reports) that deal with these 'nuisance' defects, many of which are best dispositioned as either Scrap or Rework at the point of discovery without the need to initiate a full-blown NCR/Corrective Action process. An example of the 'defects' I'm talking about is easily reworkable paint imperfections. These are not acceptable to the Customer, and we've typically been touching-up the paint at various points in the process (takes about 2 seconds), but we've also been creating WAY too many NCRs because that's what our existing system mandates (i.e. a defect is a defect is a defect).

We have drafted a Defect Log to capture these defects and record operator disposition. This defect log has some caviats, for example: if we see too many of these imperfections during the process (based on Upper Control Limits), then we go ahead and issue an NCR & Corrective Action.
Now to the meat of the problem...I'm having a hard time with our QMS documentation because this proposed system is so dissimilar to the current system, but I need to use both. We currently require that non-conforming material be physically segregated during MRB disposition, but it's not practical to do this with these minor defects. This is but one example of the difficulty that I'm having trying to, in effect, use two systems; one needs to very rigid and restrictive for some product lines, and another that ideally is very much more flexible.

Any input? And, yes, we have talked about implementing two seperate systems, but Top Management doesn't want us to go that way for various reasons.

Thanks,
Tim

RCBeyette
20th May 2008, 03:34 PM
I'm all for keeping things in one system. What you should develop is guidelines or triggers that will indicate which approach to take depending on the nature of the nonconformity.

If it's a defect that results in a one-off scrap or rework, log it and move on. If it results in more than x defects / y frequency than it's time to do corrective action (including root cause analysis). All defects should be logged, but only once trigger points passed will CA be initiated.

I have also seen $$ used...if the defect results in x $ wasted or y minutes of downtime, then again, CA is done.

Make the system work for you...you don't work for the system!

rfisher
1st January 2009, 05:32 PM
Thanks, Roxane.
Our registrar follows the same philosopy, record all non-conformities, and after X amount of this type, then a corrective action is generated. Otherwise it dilutes the Corrective Action system when the system is overwhelmed with smaller defects.
However, all nonconformities must be logged.

Roger

Sandra Gauvin
4th January 2009, 07:36 PM
Tim,
Try incorporating a risk classification system into your Nonconformance process so that you don't have to manage two processes.

We would have 3 classifications of risk:
Class 1 nonconformance's represent low or no risk
Class 2, moderate risk
Class 3 , severe risk

Class 1 nonconformance's are documented but not investigated and require minimal approvals. Once a trend emerges with class 1's then it triggers a 'trend' investigation....this way we can show an auditor that we investigate and take action once the class 1's have reached a specified threshold.

We would use the same form for all nonconformance's regardless of the classification, but most of the fields for a Class 1 don't have to be filled out because no investigation is required. One process, one form....very simple. Just make sure your Nonconformance SOP clearly defines the different classifications and the expectations of each.

Hope this helps....Sandra

Raffy
5th January 2009, 01:35 AM
Hi Tim,
Welcome to the cove.

In my previous company, it is a manufacturing and just like your company can be considered as a 'jobshop'. Several NCR's were also issued that also deals with 'nuisance' defects. So what we did, for the NCR, we have the correction and disposition such as for sort, rework or reject.
However, after 3 NCR with the same defect, an RCPA (Request for Corrective and Preventive Action) will be issued. Correction means remedial and root cause is not addressed. This is done to prevent other batch / lot with the same problem.
Hope this helps.
best regards,
raffy