What is a risk-based approach to TMF management?

Risk-based approach…a buzzword which doesn’t seem to be going anywhere and which has many people nodding in acknowledgement yet perhaps aren’t fully aware of what this term entails.  

This short blog post aims to provide a brief and simple explanation of what this means in relation to data management.  

Breaking it down  

When you have 100s, 1000s or tens of thousands of documents to check, checking these individually would be nearly impossible unless you had a lot of human resource you could assign to this task.  

In cases such as these, rather than looking at every single applicable document, a subset of them is taken as a representative portion and assessed.  

For example, you may take 10% of your total documents as sample to see if they are ok.  

If all of these pass your inspection then you can take the view that all – or most – of your documents are fine.  

However, if only half of these suffice then you know you probably have a problem with a larger number of them.   

Therefore, if you’re opting for this route, it’s essential you include your most important documents (i.e. those which are most likely to be audited) and ensure these are included within the sample selection.  

A simple way to identify these is to ask yourself: 

• Which documents have the highest level of risk? 
• Which documents are most vital in being correct?   

What are the benefits in adopting a risk-based approach? 

 By thinking ahead and identifying the risk level of your documents, you can identify: 

• What gaps exist in your current approach  
• Identify the risks and level of severity in the gaps identified  

• Boost and expand the wider organisation’s knowledge and understanding of risk and regulatory outcomes  
• Allows for change and improvements to be made in the event of an inspection 

In closing… 

Ultimately, it’s down to you and your organisation’s needs and resources to understand if this approach is right for you.  

It may even be that it serves you as a great starting point to check and understand your data management processes and subsequent requirements. Whether you choose to trial this method or not, I hope you’ve found this blog helpful.  

If you have any other questions, please don’t hesitate to reach out to us.