9. Mistakes to avoid

9.1 Don't consider customer risk alone

Our culture has accustomed us to viewing compliance in binary terms: compliant OR non-compliant. Don't forget that every decision concerning the conformity of an item (product, instrument, etc.) is associated with a pair of risks: customer and supplier. If we consider only the customer risk, compliance without taking uncertainty into account implicitly entails a potential risk of 50%. This option should be avoided at all costs.

Similarly, compliance announced taking into account the wider uncertainty implies a potential 2.3% risk of making a wrong decision (according to the deterministic approach). However, it would be more appropriate to proceed in the opposite direction: first define the risk, then make the decision...