Non Value Added Corrective Actions

[Mike_H]

... None of the "corrections" affected what we actually do. We just reworded and reworked the control plan to "fix" the offending items.

... All of the "fixes" need to be done to 100 control plans before he shows up again. Otherwise, there's something about ineffective corrective actions and major non-conformances. Seems like a complete waste of time. I would rather update them as they need a substantive change.

Any words of wisdom to tell the guy when he comes back?

Issue a QA System Deviation (or whatever you want to call it) to cover control plans which addresses the required change and commit to changing individual plans to whatever schedule is best for you. In my experience auditors want to see an agreed plan and perhaps updates from time to time to show the plan is on track, not necessarily all completed actions by the time the next visit!! The audit "finding" doesn't affect product conformity so I'd question the hell out of it.

 

[davejen21]

Ok. Let give an example. We have a step called "setup." We set the tooling,. make samples, verify the samples against the print, and make any tooling adjustments necessary. The CP form wants both process and product controls. As a tooling dominant process, we don't have a lot of process controls - i.e.; specific machine settings. Those that we do have, have been compiled in our routing/traveler structure over the years. So when we put together control plans, we used the product characteristics (the print) as opposed to process characteristics (machine settings). The net result is the same. Setup, verify, adjust.

Our "corrective action" was to simply rephrase the wording into "process characteristics" and move on. (I did file an appeal but the higher ups had no interest in listening). Absolutely provided zero value. Fine. As we make new plans (or change old ones) we make the change. No real issue there. The problem being the older plans. There is no value going back and updating.

The control plans not in use or the ones NOT updated should be removed out of the system in an obsolete folder. Then as one is required re introduce it into the system, update it not forgetting to raise the revision level.
Auditor has to accept this. (will save a lot of work)

 

[LUV-d-4UM]

How many of the 100 Control Plans did the auditor sampled and mentioned in your audit report. My own suggestion, if you decide not to appeal, is to correct the ones that he mentioned in the audit report and, for Corrective Action to conduct the periodic review of the Control Plan.

 

[Golfman25]

Seriously I want to know the root cause the client identified so that they came up with the corrective action like that.

It sounds to me that "simply rephrase the wording into "process characteristics" is a "correction" and not a systematic corrective action.

If the control plan describes product characteristics and process parameters inaccurately, if this is a fact - it indicates a systematic deficiency in control plan development process.

- If the CB accepts "simply rephrase the wording into "process characteristics" as an appropriate corrective action to close this NC, I agree that it is a totally no value added corrective action. But I doubt that they accept this?

- If it otherwise leads to a corrective action to fix why the control plan was developed in that incorrect way, it would not be a no value added corrective action.

If you have any good basis that the auditor understanding is wrong, you can argue at the closing meeting and refuse to sign the acceptance of the audit report/ NC report.

It is pretty simple actually. Unlike machining, molding, etc., we are a tooling dominant process -- there are few, if any specific machine settings. We don't have feeds and speeds. We did not consider tooling setup in a stamping press to be a process characteristic. Instead we consider the results, the samples produced, as a product characteristic. It is, in fact, a distinction without a difference. That was our root cause -- basically a different interpretation. So by moving the words "tooling setup" from product column to process column a few other tweaks, we suddenly had a "good" control plan.

 

[Golfman25]

The control plans not in use or the ones NOT updated should be removed out of the system in an obsolete folder. Then as one is required re introduce it into the system, update it not forgetting to raise the revision level.
Auditor has to accept this. (will save a lot of work)

They are all in use. So obsoleting wasn't an option.

 

[Golfman25]

How many of the 100 Control Plans did the auditor sampled and mentioned in your audit report. My own suggestion, if you decide not to appeal, is to correct the ones that he mentioned in the audit report and, for Corrective Action to conduct the periodic review of the Control Plan.

Basically 2. But they are all similar as they are all derivatives created over the years. So the "error" was compounded from day 1.

We did appeal. Won on a couple of things but most issues where sustained without any thought. The entire process was BS. Bottom line, the incident cost them a client. We punted and are going a different direction.