Designing your QMS
September 4th, 2012 by Peter CalcottAt a recent webinar I presented for Tungsten Shield on the topic of Lot Disposition, I had an interesting question. It occurred when I was discussing review of investigation reports and it went like this:
What regulation calls for the Lot Disposition group in the US to review the technical content of an investigation before dispositioning a lot for the clinic or commerce?
And this question was prompted because of the following comments I made.
We all know that the QP in Europe examines all the information, he deems necessary prior to dispotioning a lot – it’s what he is obligated to do by law. That includes review of the investigation reports related to deviations. It includes a review for completeness and also a technical review to assure he agrees with the conclusions and the content. He further assures he understands and agrees with the logic behind the decision. I contend that in the US, the equivalent person responsible for lot disposition should also review the content to understand the decision to release the material or not and if the investigation is not complete or to his liking, should send it back before moving forward to release the lot. After all by signing the release, you have made a decision that the lot is acceptable. Part is to assure the investigation is complete but another part is that the decision is logical and supported by the report. It is not simply a compliance agreement but a techncial one as well. During an inspection, he would be asked why he released the lot. And an answer of “the investigation was complete and said so, does not wash”.
The questioner did not get it and responded that no regulation actually required it so why do it. I responded that when I sign something eg lot release, I am putting my name on the line and am assuring the decision is right. It is just a good business process.
I sense many people just do not buy into that concept but rather look to the regualtory bodies to tell them what to do rather than develop good business processes.
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