Scenario: a rogue tablet is found during finished goods inspection, i.e. a tablet other than those being packed is found in a finished pack. You quarantine the batch, conduct an investigation on how the rogue tab got there. Assess the possibility that other batches produced in the same facility may contain a rogue tablet. What else would you do?
First I assume that the “rogue” tablet was a tablet manufactured in the same plant.
Second I “re-sort” the whole batch in order to ensure at 100% that the rogue tablet is isolated.
Third I have to draft the possible hypotheses for having such a tablet in another batch. The 5 “M” method is helpful in this exercise.
Fourth I test the hypotheses and I try to assess the probability that this mix-up is not unique.
According to the result only I could release the batch or trigger for a “huge” investigation into the batches that are still in the plant…
Fifth, I will ask the medical department to provide me with a therapeutical risk assessment of what could be the consequence(s) if a patient would take the “rogue” tablet insted of the expected medication.
Seventh, depending on the importance of my “discoveries” I would consider to alert both the corporate level and the competent authority.
Best regards.
JDM
Thanks JD. What’s the 5 M method?
5M is simply an investigation / conceptual method that helps you in determining logically what are the different parameters and sub-parameters that could impact the topic.
5M stands for : Materials, Machines, Methods, Men and Milieu. It is usually graphically represented with the Ishikawa fishbone.
You will certainly find a lot of examples on Internet.
Best regards
JDM
Many thanks JD. Simplicity and logic, I love it!