PPM

Question 1

You mentioned QRM and PPM – can you describe how you would use QRM in a PPM Programme

Answer 1

Criticality of Equipment
Frequency of Use
Lists of Critical Spares

Question 2

Can you describe how you would use QRM in a PPM programme

Answer 2

FMEA to capture all risks associated with the equipment / facility. I would then look at what actions could be completed to mitigate the risks. I would initially start by addressing the risks with the highest scores until the risk score is reduced to an acceptable level. As per chapter 1 the level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk. Anything that cannot be mitigated - could it be designed out/ replaced? These risks would be captured on the quality risk register

Question 3

During a Self Inspection one of your colleagues notices that the contract with the third party who performs calibration has been cancelled. The records of calibration can’t be found, the contractor doesn’t have a copy and the individual who did the calibration has been dismissed. What are your concerns?

Answer 3

We have a period where we do not know we were in calibration - could impact batches on market. Need to review trends of calibration and understand what we may have. Get them calibrated ASAP to understand what the issues are. What are you going to do between now and being able to calibrate again?… Deviation, Risk Assess, ensure that production understand that any continued use of equipment (especially critical equipment), carries the risk of batches not being releasable once the calibration is performed. What are you going to do about the product you have out there in the market at that time?…. Not recalling yet as we don’t know what the issues are. What if it was a flow meter on an Anderson impactor? As this determines whether the test is operating correctly we don’t know whether it would pass and whether a patient would receive correct quantity of medicine (potentially patient risk). So we would risk assess the results of previous calibration (how much previous drift), establish which batches and when produced, Quarantine what we have left in stock. Establish when we can get calibrated equipment and alert DMRC that we are working through the issue and that we may have a recall situation if it is found these batches are out of spec.