Counting down the no-nos during audits: BONUS – a yes-yes -: The CAPA we really like to see again!
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.
To start the new year on a positive note: BONUS – a yes-yes -: The CAPA we really like to see again!
There is one thing I would not want to keep from you as it has become my ‘golden standard’ for taking actions when receiving an observation. And this was not even an observation.
Situation:
We were performing an audit in beautiful Japan for one of our clients. This particular pharmaceutical company had several production buildings, a large warehouse and a QC laboratory where approx. 150 people worked. During the audit, the company showed that it was excellent, really excellent. When we walked into the QC laboratory, we noticed it was completely empty, however. The staff was probably instructed to leave the laboratory as soon as the auditor entered. Not something we are unfamiliar with.
What happened:
When we walked through the lab, we encountered a bottle of HPLC grade Acetonitrile. The bottle had been opened as it was clearly no longer filled up to the top. The technician probably opened the bottle right before we came in. In their rush to leave, they forgot to apply a label indicating the day of opening, a new expiry date and the name of the person who opened the bottle, a standard practice in our industry. When we passed by, we casually mentioned the missing label, and indicated it should be there.
The next morning, as we were eager to start the second day of the audit, the site manager asked if we would allow him to provide documented evidence of the CAPA he had taken on the observation the day before. When asking which observation, he mentioned the Acetonitrile bottle.
We were surprised as we had not decided yet whether it was something we would create an observation for. Nonetheless, he had gathered the entire staff of the QC lab (over 150 people), before their normal working hours (so unpaid), to sit through a 30-minute training on the importance of labeling bottles of solvents when opening them. He showed over 30 slides (in Japanese, so I have to trust them on the content 😉 ) and the attendance sheets of over 150 people.
Then he asked whether we were satisfied with his actions, or whether we thought he should do more………..
From that day on, whenever someone asks what an appropriate CAPA approach is, we tell them this story and add………’but a little less is also OK’.
We hope you enjoyed this series and look forward to good and positive audits. Let us hope we can countdown the yes-yes’s during audits at the end of 2019
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
Number 5: Oops, the cleanroom is flooded
Number 4: Doing the audit at all cost
Number 3: The audit as a black tie event
Number 2: Power outage on the site
Number 1: Bribing the auditor