RE: RE: RE: RE: RE: RE: HACCP on proces in pharmaceutical Contribution from Lorraine written on 2/2/2012 at 09:04
Original contribution: RE: RE: RE: RE: RE: HACCP on proces in pharmaceutical written by amir rezaeian on 1/29/2012 at 10:36) I would consider FMEA to be a better tool than HACCP and I agree that these methodologies are not used enough in the pharma industry. Everyone seems to follow through an investigation/deviation reporting system when something happens but a more proactive approach would be to assess the process beforehand for identification of failure modes and causes etc. I also believe that if an FMEA is carried out that it can be an invaluable trailing aid when introducing a new production operative having identified what can go wrong with the process. There are always errors/investigations around errors with new operatives where there are inadequacies in training. I think the approach of training in a lot of cases is that if you follow the procedure and the on the job training that it will be all ok but the focus doesn't seem to be on what can go wrong if you don't follow each step exactly or don't realise the impact of slight deviations or misconceptions on how tasks are to be carried out.
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