Repeat Non -Conformity

[Bev D]

So….without more exact specifics of the original NC, cause and corrective action as well as the exact new NC we cannot provide better advice than what has already been given - investigate this one and implement an effective corrective action prior to your next external audit and you should be fine. This is what monitoring and Corrective action are about - so if you do this you will be perfectly compliant.

Even effective corrective actions can ‘disappear’ later and then a recurrence of the original Problem with the same cause can happen. Well meaning people can unknowingly undo an effective corrective action. In this case I advise you to also look at how the CA was undone and not caught. (For example, ineffective change control review and approval)

Focus on the investigation cause and corrective actions and not on whether or not you might get a minor or major NC in yoru next external audit. This is exactly analogous to focusing on makign good parts rather on ho to inspect for bad parts.

 

[Jen Kirley]

What Bev said. It seems to me that your process is working. Sometimes corrective actions do not work. Maybe there was more than one recognized cause to address, or a person decided to revert to the old ways. It is not possible to know this detail from here. You are quite right, however to re-open the internal NC. Self identifying an issue helps - it would be far worse for your process to have missed this.

The CB auditor might still open a repeat because of rules they are expected to follow, but matters will be improved by your taking this on. You can review it together.

 

[Randy]

Reverse the process flow to find possible cause. I experienced a client who had multiple computer chips fail after installation from dust contamination and resulting customer complaints and corrective action with limited success (numbers decreased but didn't disappear and a p-pot full of $ was involved). As part of my audit assignment was the corrective action process. Turned out as we retraced the cause analysis in reverse process flow the quality guy I was with observed some very small dust particles in the light during a transfer step to packaging (coming out an almost microscopic brake in a drywall corner of the window). To maintain integrity of the process there was a minor issued which they corrected and did extended detailed examinations throughout mfg and packaging for similar problems (seems like it all worked out in the end).

Crap happens. Many times it can be the least obvious thing that cause the greatest heartburn. Try backtracking.

 

[Bev D]

Backtracking (aka progressive elimination from problem to cause) is the most effective framework.

 

[Ed Panek]

I agree with everyone else. Just treat how your QMS directs you to. Any auditor that harps on it as a repeat. Well. That’s the whole world too. Show you follow your QMS and you take it seriously. Customer focus.

A QMS and cert don’t actually mean your product has great performance. It will be consistent and you know the levers. The industry could still think your product stinks. There are QMS and certified companies that provide the cheapest product on the market. That’s what they’re known for. Customer buy it because it’s super cheap. <Shrug>

 

[Golfman25]

While I agree with a bunch of what has been said re RC and CA, this isn't a product issue as much as it's a compliance issue to the clause in the standard regarding inventory turns. Root cause is likely a tracking/compliance issue. More detail from the OP would help with advice. But dealing with FIFO inventory at my own place is quite the challenge.

Example: Employee has two boxes of parts to choose from. One is a partial box of 380 pcs. from a month or two before. One is complete box of 500, made this week. Customer order is for 500 pcs. Much easier for the guy to pull the complete box, than to make up two partial boxes. Really doesn't matter in our case. OP's case may be different. Technically we would violate the standard if FIFO was "required."