Things you should never say during a regulatory inspection

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Sometimes we learn best by seeing what NOT to do. I have accumulated a few of the comments I have heard during my 35+ years in healthcare industries. Some of these were actually said during a regulatory inspection (not by my choice, believe me!), but many others were voiced during mock regulatory inspections or audits. Each instance was an opportunity for coaching outside the context of the inspection/audit. Despite our best efforts to train our teams on how to respond to regulatory questions, it is common for an individual (not all inexperienced either) to make an off-beat comment in the heat of the inspection that they know was wrong.

So, for your entertainment and, hopefully, use in your own regulatory inspection training, here are the comments:

  1.  “We had to release that lot, it was the only one we had and we needed to keep production running.”
  2. “Our micro lab is across the street.  Would you like us to take you over there right now?”
  3. “We are still amazed at how sharp last year’s inspector was.”
  4. “If you think this is bad, you should see how our sister plant down the street does it.”
  5. “We have no idea how that happened!”
  6. “The only guy that knew how to do that retired last year.  We’ll give him a call during the lunch break.”
  7. “We’ll show that area to you later after we finished cleaning it up.”
  8. “This OOS was unusual because almost all our problems are due to unclean glassware.”
  9. “Give me just a minute.  I think they keep that password here in the bottom drawer.”
  10. “Really, what’s the big deal.  All we’re talking about is a few complaints!”
  11. “We keep all the SOPs in the supervisor’s office.  If we kept them here in the production area, they would be a mess.”
  12. “If we had known you were coming, we would have cleaned the place up.”
  13. “That’s not so bad, we’ve done a whole lot of things worse.”
  14. “I don’t know for sure, but I assume…..”
  15. “I’m sure you won’t understand this, but let me try to make it simple for you.”
  16. “I’m not sure, but let me take a guess….”
  17. “Before you leave, can we show you a new system that we’ve been implementing?  We’re very proud of it.”
  18. “Actually, we’re pretty lucky that it wasn’t any worse than that.”
  19. “I know you only asked for this, but I brought along several related documents that you might find helpful.”
  20. “We had to make a number of changes during our process validation study, but we eventually got it to work.”
  21. “That test method is so complex that only one or two of our analysts can get the right numbers.”
  22. “We had results all over the place, but we’re sure that the result that met our specifications was right.”
  23. “We have quality personnel in production only during first shift because we don’t have a second shift crew.”
  24. “We think our interpretation of that statute is probably more current than yours.”
  25. “You know what they say, ‘The end justifies the means.’”

Just a few take-aways from these comments:

  • Be sure you continually re-enforce that individuals should just answer the questions asked and offer only information specifically requested (unless approved by the inspection manager)
  • Never hide requested information from the investigator – however, you are under no obligation to expose issues not requested, either
  • When in doubt, the less said, the better – don’t be afraid of silence
  • Never offer to show an area, system, document, data, or anything else not specifically requested, no matter how proud of it you might be – the only exception is if this might help you make a point raised by other questions asked
  • When a cGMP violation has been identified, don’t make it worse by trying to justify your actions or by revealing other related issues – take your medicine and correct other issues internally
  • Always respect the investigator, no matter what happens or how you feel – they are just trying to do their job to protect our ultimate consumers

Good luck on your next inspection! Have a great day!

 

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