Repeat Major NC - What can happen during External Audit by Registrar

C

C Emmons

#11
Why couldn't someone just reopen the original corrective action as not effective and begin again in this case. Start the process over. I would think a 3rd party writing an nc on a problem you have already identified and/or are addressing is a little redundant. Too simple?
 
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Randy

Super Moderator
#13
Yes, too simplistic. Because the issue at hand is no longer the original problem, but the fact that the effectiveness of the organization's corrective action process, including root cause analysis, is questionable.
Exactly what Sid said. We've gone past the original issue to a deeper one now.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#14
Exactly what Sid said. We've gone past the original issue to a deeper one now.
I was just building upon the point made by the distinguished gentleman from the other side of the aisle.

By the way, I sense a re-engineered Mr. Daily around us; a kinder, softer, less in-your-face-drop-and-give-me-100-push-up's, more eloquent Cover. :applause:
Hope springs eternal...
 
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A

adaline

#16
Re: Repeat Major Nonconformance - External Audit by Registrar

Hello Stijloor.
Here are a few answers
• How did Top Management respond to the first major NC? “Get it fixed –!”• Was the effectiveness of corrective action verified? Yes
• What have the internal auditors done between Major 1 and Major 2? Increased internal audit frequency on the floor, but did not audit Calibration as a process.• Have you had Management Reviews? Yes – 2. The first time we were on track and trending in a good direction. Then our Gage manager retired and we replaced him with one that didn’t know what our plan is. (was). So we lost considerable ground in the 3 months since our lastManagement Review. Actually, we discovered the issue during Management Review – as the new manager was asked for an update.• Was clause 5.6.3 considered? Yes.
 

Randy

Super Moderator
#17
How about consideration to clause 6.2.2 and the new dude. Apparently you just talked yourself into another NC there because that didn't happen. I would imagine he had some training and education and experience but not the requisite competence due to a poor process of development to meet "your" requirements.

Looking at what has now transpired I could probably justify another Major with little effort.

Remember this is a "System" and not just a bunch of individual things that have to be done. The old story "For the want of a nail" perfectly describes a system and interaction of processes. You have a cause and effect relationship across the whole thing.
 

Stijloor

Staff member
Super Moderator
#18
Re: Repeat Major Nonconformance - External Audit by Registrar

Hello Stijloor.
Here are a few answers
• How did Top Management respond to the first major NC? “Get it fixed –!”• Was the effectiveness of corrective action verified? Yes
• What have the internal auditors done between Major 1 and Major 2? Increased internal audit frequency on the floor, but did not audit Calibration as a process.• Have you had Management Reviews? Yes – 2. The first time we were on track and trending in a good direction. Then our Gage manager retired and we replaced him with one that didn’t know what our plan is. (was). So we lost considerable ground in the 3 months since our last Management Review. Actually, we discovered the issue during Management Review – as the new manager was asked for an update.• Was clause 5.6.3 considered? Yes.
Hello adaline,

How has the "defunct" (for a period of 3 months) calibration process affected the organization's ability to verify product requirements in accordance with the requirements? This appears to be a much bigger issue...i.e.: a "can of worms?"

Stijloor.
 

BradM

Staff member
Admin
#19
Re: Repeat Major Nonconformance - External Audit by Registrar

...i.e.: a "can of worms?"

Stijloor.
Exactly.

OK, Adaline, please understand all here are trying to help, and not frustrate you. Thank you for providing more details.

By your post, this is what appears to me: There was a problem. Management assumed someone in the company took care of the problem, without ever determining what the problem really was, and if it was truly corrected.

Not sure how many instruments we're talking about, but someone (oh, say, an upper manager this phase of the game) needs to take the list and make sure you have your tools/instruments under control. If your tools are under control, get them all in current calibration by sending them to a competent labs qualified for those instruments.

If you have instruments coming back failed from calibration, then you need to deal with that. If they are within tolerance, then you can have confidence in your instruments.

Then, given the superb suggestions by others, your organization needs to make the necessary process improvements and develop good communication with the auditor. (Just an aside-if you have been performing internal audits and this major problem was never addressed, that may be another area ripe for improvement.)

No one expects a system to be perfect. It is, though, supposed to improve and generate original mistakes.
 
A

adaline

#20
Hi Brad - No I'm not frustrated (yet). Some of you are responding in ways that I expected - so you are just confirming my worst fears. YIKES.
Sooo. what I probably need is a "New Process Owner Orientation"? We have in the neighborhood of 1500 gages, some are check part set up gages some are gages to inspect the final product.:bonk: Approximatly 10% of those gages are past due for calibration.
 
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