Having been an auditee and an auditor, I have seen how difficult we can make it for the auditee. My top 2 words of advice would be to BE KIND. As an AUDITEE, we know that there are gaps in our processes and sometimes we are just not given the time or resource to have these resolved. My advic…

The below process flow shows how anyone (Subject Matter Expert), that is trained on the change control process, can raise a change within the organisation. The change management process to be followed can essentially be paper based or electronic however, both can follow the process illustrated b…

The Q in Quality stands for Questioning. As a good auditor, not only should you be asking the appropriate questions, you need to also have the right technique in asking questions. These are my 10 tips below…. Be clear why you are asking the question; what is it you are hoping to achi…

How can airlines keep the required temperature range in the cargo hold during flight? An increasing number of temperature-controlled pharmaceuticals, of different temperature ranges, are being flown all over the globe. For airlines, it is quite a challenge to keep the temperature between t…

Change is always hard to accept. However, experiencing the EU MDR transition from MDD (Medical Device Directive) in The Supplier Quality department, was not so challenging after all. At the time of starting the transition it did appear to be a daunting task. However, by separating all new clause…