Put it right in writing!

2021-01-01

The audit has finished. Now is time to put it right in writing. And for some reason, although this step is the most important -in most cases-, auditors fail to do it right. The top mistakes detected:

a) The vocabulary is too technical, not clear or the abbreviations used are excessive. Example: “The observation is from a small scope of the NDA’s taken for the due diligence carried out by Compliance for ML” What? No wonder why people can’t understand what you are doing… and the worst: by writing like this you are limiting the value the Internal Audit area has.


The language used must be bulletproof: anyone in the company should understand you. It is of no use that you have detected important risks if no one understands how this could affect them and the company.


b) The report does not give value. Example:


OBSERVATION: The legal area is not complying with the data protection law.

RECOMMENDATION: That the legal area complies with the data protection law.


Really? I mean what kind of recommendation is that? It would be better to know why they have not complied with it. Do they know the reason? Do you as an auditor know the reason? By asking why, you can get to know the real cause, give value, and not give an obvious recommendation.


c) The report is too long…when you hear that “the report should speak by itself”, it means that every observation must have support documentation, not that it has so much detail that the reader is lost. The better it is concise and clear, the more the reader is going to understand it.


The importance of an audit report is… that it’s the only thing others will see about your work. So, put it right in writing!

 


Do you want to seize more about Auditing? Join us at the Auditing Major Project Online Masterclass on 11th & 12th May, 2022.

 

Also check our Agile Audit & Assurance In-house Training for train your employees to gain more knowledge about auditing.





Get a feel for our events

Signal and Risk Management in Pharmacovigilance US MasterClass

Signal and Risk Management in Pharmacovigilance US MasterClass

23 - 26 May, 2022

The focus of this two days pharma online masterclass will be on providing an update of ongoing activities regarding medicines’ risk and signal management.

CRO Oversight MasterClass

CRO Oversight MasterClass

26 & 27 May, 2022

CRO Oversight online masterclass provides an overview of the key concepts and best practices for CRO management in a global clinical trial setting.

Viral Clearance MasterClass

Viral Clearance MasterClass

30 & 31 May, 2022

Viral Clearance online masterclass will give an overview of the sources and impacts of viral contaminations of biotherapeutics.

check all pharma events