Counting down the no-nos during audits: Number 5: Oops, the cleanroom is flooded.
As auditors for the pharmaceutical industry, we have the opportunity to visit the most wonderful places as well as the most interesting companies. We are lucky enough to conduct audits all over the world.
Apart from visiting some exemplary companies, we sometimes encounter things we would rather not see. In these last few weeks of 2018, we are counting down the 10 most surprising experiences of 2018 which we truly hope we will not encounter again: some funny, some awful, some just completely unacceptable. And as we are only human after all, some things that happened were through our own making.
Number 5: Oops, the cleanroom is flooded
Most of us have heard of Murphy’s law: “Anything that can go wrong, will go wrong”. We would like to add to that: “…at the most inconvenient moment”.
During an audit we were about to visit the cleanroom where our client’s product was being manufactured (class C, for anyone who wants to know). While walking up the stairs to the visitor’s airlock, the supervisor comes running down the stairs and pulls the host of the audit aside. “You cannot go to the cleanroom”, he said: ”There is 10 cm (4 inches) of water on the floor of the entire cleanroom”. One can imagine we decided to postpone the visit to the cleanroom to the following day, and were very curious to find out what had happened.
The second day we had learned that, at the day of the audit, construction works had been performed on the system that drains the rainwater from the building. Therefore, some drains were disconnected and others were closed off. Just before our visit, there was a big downpour and the water had taken the easiest route which, apparently, led to a sink in a cleaning cabinet in the grade D hallway leading to the cleanroom. There was an enormous amount of water that flooded the entire floor.
On the plus side: we witnessed at first-hand how the disaster recovery procedure was executed, how the product was secured, how the deviation handling system worked and how everything was documented. In hindsight, our impression was probably much better after the audit than it would have been without this incident for the company showed that it was very capable of handling such issues and solving problems.
Not that we would recommend flooding your cleanrooms though………..
Next will be number 4: Doing the audit at all cost
As you can see, after reading this countdown series, we have extensive auditing experience and have encountered almost all possible situations: good and bad.
Would you like to take advantage of that experience and expertise? Contact us here and see how you can benefit.
Did you like this post: You can find the series HERE
Number 10: Living Pest Control
Number 9: Threatening the auditor
Number 8: Audit, was that today?
Number 7: Lunch
Number 6: Do not mind that liquid spill, that is probably harmless