In the manufacture of any form of product it is inevitable that, from time to time, things will not go to plan.  Problems and deviations from normal practice are a fact of life, and in GMP this is permitted, as long as they are controlled and dealt with correctly.
Recent updates to EU GMP Chapters 1 and 8, on the Pharmaceutical Quality System and Complaints, Quality Defects and Product Recalls both have similar statements with regard to being careful about blaming the operator when a problem occurs:

In Chapter 8 it states:

“Where human error is suspected or identified as the cause of a quality defect, this should be formally justified and care should be exercised so as to ensure that process, procedural or system-based errors or problems are not overlooked, if present” (8.17)

shutterstock_396735082In other words – be careful of putting “human error” as the cause of a problem, without considering what caused the human to make the error in the first place.  I do work with some pharmaceutical companies that have banned the use of putting “human error” as the reason for a problem.  I think that this is a bit excessive, as we can all make mistakes, but here are a list of things that you might want to consider before we blame the human.

  • Was their training sufficient?
  • When where they last trained?
  • Was their training evaluated?
  • Has the job changed?
  • Has the environment changes?
  • Have procedures changed?
  • Are the procedures clear to the user?
  • What other tasks were they doing?
  • Were they tired?
  • What pressure were they under?
  • Were there any distractions?
  • Did they deliberately do it wrong?
  • Did they understand the ramifications of doing it wrong?

It will be worth thinking about these things in any problem solving and deviation investigation that you do.  If you would like further help with Problem Solving training then please have a look at this course.

1 Comment

  1. Roger Langford

    Interesting here that the emphasis is on training. In the work I have done in pharmaceutical companies they “do” lots of training (if you regard reading a course on a Learner Management System to be actual learning), what they fail to do at almost all stages of the learning process is to validate the learning and to ensure it has been put to good practice in the actual work flow and has achieved the change it set out to address. That is why I advocate that training is part of the capability development process and should also sit within an actual Competence Management System- which is not something done on a computer..


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