Counting down the no-nos during audits: Number 9: Threatening the auditor
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 9: Threatening the auditor
During audits, we always try to maintain a relaxed, open and friendly atmosphere because we have found out that relaxed people are much more willing to share information than defensive people. Unfortunately, it is not always possible to retain such an atmosphere. A part of doing audits is to challenge decisions and actions people take, especially when these may not be compliant with regulations and/or agreements.
One audit of an excipient supplier in Germany stands out. This particular supplier had been supplying to the pharmaceutical industry for years and had always been very aware of the expectations we have towards change control. In this case, the company had added an extra reactor in order to homogenize a product suspension and, in that way, ensured less variability throughout the batches. According to the company, it was an improvement of the process, thus it was decided it was not necessary to document a change control, even though the company’s own procedure stated that it should be documented as such.
When confronting the auditee with this lack of compliance to GMP, procedures and Quality Agreement, a group of 5 people got off their chairs and started yelling in our direction. We speak and understand German, however, so the message was quite clear: they questioned my intelligence, my background, my mother’s profession, and were also wishing that I would catch all kinds of different diseases. Even worse: If I were to make an observation, they would no longer supply our mutual client with their product.
Thankfully, we are not easily startled. It helps that we are built to fit into a multiple X as far as our L-size clothing is concerned, so a physical confrontation was out of the question. The first part of the internal audit program had been pretty good and therefore we decided to defuse the situation by changing the subject and the auditees started to calm down. We finished the audit as planned but did not readdress the change control subject.
Of course, the observation about the lacking change was included in the audit report. The client was informed of what had happened and ceased doing any further business with this supplier. So maybe, they still got what they wanted……..
Next will be number 8: Audit, was that today?
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