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marked degradation in the outcome, but taken together there will be substantial detrimental impact. The final conclusion is that the sperm preparation method should be replaced by one based on the manufacturer’s instructions and established optimized methodology. Furthermore, because this change is not going to have an unknown or uncertain outcome on the process, there is no need to perform any validation studies of the “new” method.
Conclusions
The tools described in this Chapter are fundamental to all quality and risk management activities. Familiarity with their principles, and with their use, makes quality and risk management far less daunting prospects. Indeed, with these tools available to you, there is no need to be worried about any of the “scary” concepts or procedures that administrators or business managers, quality managers and risk managers bandy about, such as “Troubleshooting” (see Chapter 8), “Risk Management” (see Chapter 9) or “Benchmarking” (see Chapter 10). As scientists we already know and understand all the fundamental principles that underpin these tools, and most of them are no more than formalized applications of scientific method. Once tools like FMEA or RCA have been explained, many scientists, exclaim “but that’s just common sense!” – and so it is. The real problem lies in the number of people working in IVF (and not just in the lab) who aren’t aware of these tools, or can’t use them – or, far worse, who don’t see the value in their use.