Analytical test methods – to err is human. Practical application of risk management to analytical testing

So called “human error” almost invariably translates into human’s causing the error.  The first is a denial of responsibility, whereas the latter can be prevented. For example, what training do we provide to people who write analytical methods?  Few people are born with technical writing skills and “mix until a clear solution is obtained” or just “mix” is open to six different interpretations at first consideration.  Likewise “thaw the sample.”  What about instructions such as “use reagent x…or equivalent.”  How robust is the method validation itself and is it a lifecycle event i.e. do you subsequently use control charts to check that different analysts, equipment and reagents over time (especially the “or equivalent” kind) are performing in a reproducible manner?  This presentation will look at prevention of error in analytical methods by:

• Investing in education and improving the technical writing skills of analytical R&D personnel responsible for writing methods (risk communication, risk mitigation)
• Performing robust methods validation after formal risk assessment
• Risk monitoring of method performance using control charts and continued methods (process) verification (CPV)
• CAPA, auditing, oversight and feedback as risk communication
• Management review for risk review and updating of risk assessment