In Reply to Parent Post by senna
Yes, I would like some more detailed info on SPC and control charting in relation to corrective action. Also, can you expand on how Paretos can be used to set threshold limits. I am assuming their use would be at a high level (say, managemnt review) to see where the majority of your CAPAs are coming from. But could they be used "in the trenches" of performing an individual CAPA? If so, how?
Thanks in advance.
I think the problem here might be that you're expecting the data to make decisions for you. People have to be able to evaluate the available data and then make decisions based on the circumstances. Al suggested Pareto analysis, which is simply a way of prioritizing. Take action on the problems that are likely to cause the most trouble, whether in terms of safety or money spent, or some combination of the two.
The help that you get here will be of a general nature, because no one here knows your particular situation and what's most important to your company. You should never set triggers or thresholds; action should be taken based on relative
importance and significance. If CAPA emanates from upper-level management review, it's probably too late. Upper management should be reviewing to insure that the system is working as designed, which would include making sure that problems are being solved at the lowest possible level.