External Nonconformance Not Corrected - Audited same area and found same problem

[jmp4429]

Okay, I really need help here. Last year during our surveillance audit, we received a nonconformance for people not filling out their line side forms correctly. We were lucky it was a minor, because it had happened in several places.

I was not here at the time, but I understand we instituted corrective action (retraining – Yuk) and the registrar Okayed it and closed out the nonconformance.

We just audited the same area and found the same darn problem (caused by the same darn people) all over again.

Our surveillance audit is rapidly approaching. Do we:

1. Issue a major against ourselves and develop a new corrective action plan.
2. Issue a minor against our corrective action system.
3. Something else I can’t come up with right now.

I lean toward issuing a major against the actual problem with new corrective action. But then that opens us up to getting a nonconformance against our corrective action system.

It’s been a long day, and I can’t think straight. Can anyone tell me from an auditors point of view how to handle this?

 

[howste]

I'd call it a nonconformity against the corrective action system. Along with the corrective action corrective action (that is, the action taken to eliminate the cause of the problem with the corrective action system), previous corrective actions should be reviewed to determine any that haven't been effective.

One of the most common problems I see when I audit a QMS is that so called "corrective actions" are frequently really corrections or containment activities. Also, the required records (records of the results) are missing. In other words, there is frequently a record of what actions were taken, but no record of verification that the actions taken were effective.

A "major" nonconformity to me is a systemic problem. If this problem is found in other areas as well, then maybe it is a major nonconformity - you make the call.

 

[Helmut Jilling]

Okay, I really need help here. Last year during our surveillance audit, we received a nonconformance for people not filling out their line side forms correctly. We were lucky it was a minor, because it had happened in several places.

I was not here at the time, but I understand we instituted corrective action (retraining – Yuk) and the registrar Okayed it and closed out the nonconformance.

We just audited the same area and found the same darn problem (caused by the same darn people) all over again.

Our surveillance audit is rapidly approaching. Do we:

1. Issue a major against ourselves and develop a new corrective action plan.
2. Issue a minor against our corrective action system.
3. Something else I can’t come up with right now.

I lean toward issuing a major against the actual problem with new corrective action. But then that opens us up to getting a nonconformance against our corrective action system.

It’s been a long day, and I can’t think straight. Can anyone tell me from an auditors point of view how to handle this?

In registrar and automotive auditor training, this type of situation is generally regarded as a major nonconformity because the corrective action process is not effective. The first corrective action did not take, and the verification did not adequately verify/detect that it had come apart. And that is consistent with Big 3 automotive rules (QS and TS).

Fortunately, I think, auditors have a little bit of judgement when to apply this, and your failure may be such an example. Limited violation, apparently limited risk.

However, the greater failure is your corrective action process was not effective. The first corrective action limited itself to "training," as if the folks didn't already know how to fill out the form. The verification apparently was brief and inadequate. This is what constitutes a major, in my judgement.

If I were your auditor, and you had already flagged it, and were doing appropriate root cause and comprehensive corrective, I would note it in the report and monitor the effectiveness of your internal corrective action. For that reason, an internal major would be more important, in my opinion.

 

[bpritts]

Generally I will second the comments by howste and hjilling- the third party registrar (under QS and/or TS - you didn't say whether this was your standard) would be expected to write a major when a recurrence of a previously-written n/c was detected on the next audit. Since you found it, good for you; that's the first step.

Two possibilities you might consider:

-- re-assess the original corrective action in detail. You have already noted that it may have been weak (re-training!). Call a spade a spade, declare that
past CAR inadequate, and step up with a stronger C/A.

-- While re-assessing, take a hard look at the root cause. Consider the possibility that there may be different root causes at work-- e.g. lack of training; lack of literacy; lack of a systematic follow-up on the reports... then
make sure your new C/A tackles the additional root causes.

By the way, it may be useful to do a more focused internal audit of this particular aspect of your system. If this is a shop floor tracking report, go and audit a bigger sample of them. (E.G. if your original audit found 2 or 3 wrong, go audit 25 and see how they fall out.) Maybe you will find that 24 of 25 are good; if so, then it's believable that the original CA was effective (for a time). On the other hand, if you find them 50% wrong, then come up with a CA with a lot more teeth and get to work.

Either way, it will be better for you (IMHO) if you find the problem and start the C/A; don't wait for the third party.

Best of luck

Brad

 

[Cari Spears]

...people not filling out their line side forms correctly. ...it had happened in several places.

Good advice all around - I would reconsider the importance of the form if everyone can consistently fill them out wrong and no one cares.

 

[D.Scott]

Good advice all around - I would reconsider the importance of the form if everyone can consistently fill them out wrong and no one cares.

And that, my friends, is about the best advice I have seen today.

I wish I could put up a clapping hands avatar but that feature isn't working on my browser.

Dave

 

[Don Palmer]

Good advice all around - I would reconsider the importance of the form if everyone can consistently fill them out wrong and no one cares.

This is great advice!

 

[ISOPete]

Definitely a major. Issue 8D and ensure the 8D is actually whole heartedly done this time. As part of the 8D I personnally feel that whomever was responsible for the half hearted retraining should be reprimanded in some form.

Pete

 

[jmp4429]

Thanks for the input, everyone. My boss was concerned about writing an NCR about the forms, because that would open the external auditor to write an NCR against our corrective action system. We also didn’t want to write an NCR against our corrective action system, because we believe the system is really pretty solid. After sleeping on it, I think I may have come up with a decent solution.

Our quality manual and procedures say that we reserve the right to re-open a nonconformance report if the corrective action is deemed ineffective at any time in the future. They also say that we go back and check for effectiveness of a corrective action after 3-6 months and in every subsequent audit of that process. During all of our verifications and re-verifications, the corrective action appeared to have worked – all forms were filled out flawlessly. So we allowed it to remain closed.

During yesterday’s audit, we found a lot of forms not completely filled out. (I suspect I know the root cause and appropriate corrective action – and it ain’t training). My personal opinion is that the problem started popping up again after nearly a year because the original corrective action has started “wearing off” (nobody’s checked up on my forms in a while, and nobody’s dragged me into any training in a while, so I can probably stop doing them and get away with it).

Could I write up in my audit report that we attempted to re-verify the effectiveness of said corrective action and found that in the long term, it was not effective? Then we could re-open the NCR and force a more in-depth look at root cause.

It seems to me that this would show that our corrective action system was working properly, and cover our butts when the auditor finds those forms that aren’t filled out all the way. What do you experts think?

Edited to add: Cari, I would agree with you that if nobody notices a form isn't being filled out, the form probably doesn't need to exist. I should clarify, though, to say that these are the forms the operators use to ensure their machine is running properly and at the correct settings. In past places I have worked, this just took the form of a work instruction, but here we have a form and require them to sign off on each item to show they checked it. The signing-off may not be that important, but these forms indicate they haven’t been checking their machine before running it.

Worse still, the portions not being filled out aren’t the simple operator’s checks, but the checks performed by the Technical Staff (setup guys). These are the settings that could really conceivably cause bad product to be built and not detected further down the line. I have no idea how we'll handle corrective action, but I'll say that I think some companies take Deming too literally when they say "drive fear out of the organization."

A healthy fear that "If I choose not to do my job, I'll get fired" is a good thing...

 

[Justin]

Our quality manual and procedures say that we reserve the right to re-open a nonconformance report if the corrective action is deemed ineffective at any time in the future. They also say that we go back and check for effectiveness of a corrective action after 3-6 months and in every subsequent audit of that process. During all of our verifications and re-verifications, the corrective action appeared to have worked – all forms were filled out flawlessly. So we allowed it to remain closed.

I do believe you answered your own question friend. Sounds like your procedure had it covered all along .

I do believe that you will have no problem handling the situation in this manner. More importantly, you found it before the auditor, so now they cannot ding you for it.

good work