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Problems happen in work and in life.  Problems also happen within any quality system.

GMP requires problems to be dealt with correctly:

any deviation  … should be avoided as far as possible.  If a deviation occurs, it should be approved in writing … (EU GMP Chapter 5 – clause 5.15).

And, to find and deal with the root-cause of the problem:

“an appropriate level of root cause analysis should be applied during the investigation of deviations, suspected product defects and other problems … In cases where the true root cause(s) of the issue cannot be determined, consideration should be given to identifying the most likely root cause(s) and to addressing those … (EU GMP Chapter 1 – clause 1.4xiv). 

So, it is important that we have an appropriate approach for dealing with problems.  Problems are often referred to as incidents, non-conformities and/ or deviations in many organisations.  What is needed is to deal with these in a way that proves that you have got to the root-cause of the problem and have taken the appropriate action to deal with this correctly.  Readers should also refer to our other article on CAPAs.

In order to prioritise dealing with problems (incidents, non-conformities and/ or deviations) target dates are often given for dealing with them. In many organisations, I have seen nominal targets of 30-days allowed to deal with all non-conformities.  Whilst fixing a date to deal with problems is a good thing, having a “one-size-fits-all” timeline often leads to more problems.  The issue is that, in order to deal with a problem correctly, you often need to gather data to prove that any actions you have taken have actually dealt with the problem for good.  If they haven’t, further actions will be needed, often taking additional time.  To ensure that you have truly fixed a problem for good often takes time, and may take more than 30-days (for example).  Adding a nominal target for dealing with all problems (such as 30 days) often results in two things.  Firstly a rush of activity on days 28, 29 and 30 trying to find a solution to the problem.  This is then often accompanied by quick fixes (corrections) rather than true corrective actions that get to the reasons why the problem occurred coupled with supporting evidence that the problem has been dealt with for good.  Whilst I agree with the need to set a target date for dealing with any problems, I believe that any dates applied should be based on a case-by-case basis considering the risks involved.

 What is your personal experience on timelines for problem resolution in GMP? Please leave a comment. 

You may also be interested in our GMP Problem Solving course.


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