Counting down the no-nos during audits: Number 2: Power outage on the site
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 2: Power outage on the site
“Anything that can go wrong, will go wrong” (Murphy’s Law) added by “at the most inconvenient moment”
You may recognize the statement above from number 5 and, yet, we had another experience it applies to.
During this audit we visited a company which was facing a pretty difficult challenge. Early in the morning, while we were approaching the industrial site where the company was located, we noticed that the area was pretty much covered in darkness. Street lights were switched off and most companies seemed closed, or to say the least, there was not much activity. The moment we arrived at the auditee’s company , the lights switched on again. We walked in only to find out that a major power outage had occurred just before we arrived.
All manufacturing equipment had stopped functioning. The key equipment, which had to operate at an elevated temperature, had cooled down and excess product had solidified. Processes of cleaning and restarting were just beginning; it would take the company 3 days to be fully operational again.
And on top of that: They were audited.
Fortunately, there is little we have not seen yet, so we were able to conduct the audit without putting too much of a burden on the manufacturing, laboratory and warehouse staff. By means of going through paper documentation that was available, we were able to assess most of the systems we had intended to check.
Yes, there were items that we could not look at, but given the situation, we decided it would be better for the company to be up and running again, documenting the impact on the products and assessing the damages, rather than just entertaining an auditor.
Next will be number 1: Bribing the auditor
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