Top 10 Reasons Deviation Investigation Systems Fail

Top 10 Reasons Deviation Investigation Systems Fail

September 28th, 2018 // 1:13 pm @


For many drug companies, we find that manufacturing is a bit of a crapshoot. There is not a great deal of basis for confidence that the proper equipment, components, materials, people and records are going to be in the proper place to start manufacturing. And once that manufacturing starts, you might need a crystal ball to figure out if that product batch is going to be on schedule.

FDA warning letters are full of examples that show major problems with many deviation investigation systems, and the ability to really solve the problem. Here are some of the top reasons we have seen that the deviation investigation/CAPA system will fail:

  1. R&D gives ill-thought out processes to the operations department, saying they did what they needed to do to file the submission to FDA before the competition does. Now, it’s time for the operations department to take part in the continuous improvement process!
  2. The deviation happens and is opened in the deviation system, but there are delays in the reporting of essential information. Not till the product is going to be released do the deviations start to surface and impede progress. No one has proper information to put together facts for a proper investigation either.
  3. Products that are affected by the deviation are not evaluated using scientific data. The perimeter of the investigation is not wide enough to deal with anything other than the one batch, and not to anything that is going to be released to the market.
  4. The actual root cause is not figured out using a disciplined method and is not properly documented. The root cause will read more like the statement of a problem, or the problem’s symptoms. The real problem is never resolved, and the solution will not be reached especially if the real cause touches on a topic that is politically sensitive at the company.
  5. Major deviations can’t be told from all the minor problems in the system. When all documentation errors are put into the system with all of the accompanying CAPA and investigation, it is not a surprise that there is a big back log and many meaningless activities going on.
  6. Deviations often are seen as single events, not as just another example of an issue that was already ID’d in the system as a deviation. There is no looking back to see if this new event is already being handled by a current work effort, or as possible evidence of a poorly handled CAPA.
  7. There often is inappropriate ownership of deviations. The people and areas that are to handle the deviations do not have any incentive to deal with the problem and fix it. They know QA knows how to write things up to get the lot out the door.
  8. Performance metrics are not shown to the management to review in an environment where assignments are handed out and are then followed up during reviews, and people are then held accountable by name for results.
  9. TrackWise gives visibility to problems and is a good tracking tool, but junk gets in there because of visibility and tracking. Much of what is in there may not be a deviation or a CAPA. All events going into a data management system need to be a deviation.
  10. No tolerance at the company for repetitive problems.

How many of these are your company guilty of?


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