Re: Major/minor
Originally posted by KenS
I noticed in a few posts reference to requiring "Major" NC's to be "corrected" in a shorter time frame than "Minors".
Only my 2 cents
I think you have the right idea Ken. I was going to say something similar. Our N/C's are typically just reported as pass/fail. The auditors have the authority to write them up in such a way as to quantify them i.e. they might write up the N/C saying "ten of the twelve examples" or that the problem appears to be systemic, or it appears to be isolated. We use the same time frame for all investigations. The key word here is investigations. You have one week to perform the investigation, which includes identifying the root cause. We can make adjustments to that due date if the department can show the need and it has to be outlined as to what their plan of attack is to find the root cause.
When the root cause is determined, a plan of corrective actions to be taken must be established. (dependent of course on the effects/severity/yada yada) The auditors will review those corrective actions, assist in evaluating whether or not the proposed due dates are within reason and a final implementation date for the corrective actions are set. Follow-up audits are set using the implementation date plus a reasonable amount of time to accumulate objective evidence that the actions taken were effective and satisfactory.
We get some actions that are performed even as the audit report is being distributed, and then there are some that take months. It all depends.
I realize that this is getting long, but stick with me here....It is my belief that there are a lot of people out there who confuse a the root cause analysis with corrective actions. I recently discovered that a large percentage of the technical people on our staff did not understand the difference. I asked in one of our meetings why we did not have any investigations on some customer issues (some of those things that happen in a startup that you discover and fix on the fly so actions were not appropriate anymore.) Out of the eight people in the room, five looked at me and said, "We don't have to investigate every issue, it says right in our manual that we can choose not to make changes if the problem isn't worth worrying about." Every one of the people in that room had been in this industry over 10 years. Every one of them had come from an ISO certified plant, and six out of the eight had come from a sister division.
I know that everyone in the division I came from knew the difference between root cause analysis and corrective actions. Why are so many systems lacking what should be basic knowledge of corrective and preventive actions?
OK, I'm stepping down from the soapbox. But if anyone cares to share their opinions on this, I'd sure like to hear them.