Counting down the no-nos during audits: Number 7: Lunch
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 7: Lunch
Cultural differences are a very real thing that we, as auditors, need to take into account. So this audit was not so much a no-no but more or less a lesson in what you can expect in another country.
As auditors we conducted a lot of audits in the US. Given the expectations of FDA inspectors, compared to e.g. their European counterparts, we should have been prepared for a bit of a different treatment then what we were used to.
This little story is about one of the most important parts of the audit: lunch! (just kidding).
As auditors we are used to have lunches being offered to us. Normally, we just accept these invitations. We never have to concern ourselves with that.
While doing one particular audit in the US, it was getting towards lunch time and we were getting a bit hungry. When the door opened, we already smelled some of the food that was being prepared in the adjacent coffee corner area, and it did not smell bad. When we finished reviewing a certain topic, we proposed to break for lunch. Our hosts agreed and suggested to pause for 45 minutes as that should be ample time. Straight afterwards, they left the meeting room. We expected them to return with lunch……. man, were we disappointed.
After about 5 minutes we left the meeting room to see what was happening with our lunch. When we found our hosts, they indicated that we were expected to bring our own lunch as FDA inspectors should never accept company provided lunches either.
Thankfully, they were kind enough to give us directions to restaurants close to the facility.
It was surprising though, we did over 30 audits in the US in the last few years, and have never been asked to provide our own lunches. See, we keep on learning.
On a side note: In another country we were provided with Kentucky Fried Chicken, which was procured about an hour before lunch time. Let us say that eating KFC at room temperature changes the experience.
Another lunch related no-no: during an audit in Italy, we were taken out for lunch in a restaurant close by, since the auditee did not have any facilities. “Close by” turned out to be a 30-minute drive, and a quick lunch was a 3-course meal that lasted 2 hours. They must have thought that an eating auditor is not making any observations. To credit the auditee, they did not mind continuing the audit until 8PM to make up for lost time during lunch.
Next will be number 6: Do not mind that liquid spill, that is probably harmless
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?