Risk-Based Validation: Decreasing Documentation?
Recently, one of my colleagues here at Tanis and I, along with a customer, were discussing whether we had seen a decrease in the amount of documentation generated since the industry more formally adopted a "risk-based" approach to validation.
Our customer was surprised that their work effort had not seemed to decrease since adopting a risk-based approach. What we determined was that the same work effort is being expended, but the effort is earlier in the life cycle of the project. This is a direct result of performing a Risk Assessment during the early stage of the project, when positive changes to the system can still be made, as opposed to the previous unfortunate method of finding problems during commissioning or validation testing.
At our customer's plant, it seems that the overall amount of documentation is remaining steady, but it's frontend-loaded as opposed to backend-loaded. For Tanis' part, we have always operated under a "risk-based" approach, though we didn't have a term for it at the time: we've just always been loathe to spend a lot of time writing and executing protocols in areas where there didn't seem to be much call for overly agressive testing. Still, we have seen a decrease in the length of protocols we are producing lately, mainly because QA and Validation departments are buying-in to the risk-based approach, and are therefore willing to decrease testing emphasis on low-risk areas.
This is a welcome change to our industry: expending effort earlier in the project where we can make a significant quality difference, as opposed to at the end of the project when changes are more problematic.
