**2. Knowledge is the base of everything**

QRM is a powerful machine but to move has to be filled with a kind of fuel called "knowledge". If we don't know anything about our product or process, we cannot manage risk. Risk, by definition, is the combination of the probability and severity of a hazard. And if we don't know the hazards, not to say their likelihood and importance, there is no way for QRM.

**Figure 1.** Hazard – Risk - Harm

This explains why knowledge management is put beside QRM as an enabler. Experience shows that more often than not information on the products and on the processes is "lost", either because it is not duly registered and disappears or because it is just kept away by a given person and never diffused within the company. The result is that in many cases there is or there was information but it is not available when needed by the persons of the company who have to take a decision.

And the fact is that if we cannot gather information on the product or process, either in house or outside it (other sites, publications, courses, etc.) it is very unlikely that we might follow a QRM approach. In other words, both enablers are linked and thus, the amount and characteristics of the knowledge at our disposal will be one of the main factors which will dictate how to perform our QRM.

**Figure 2.** Quality risk management steps

QRM is the result of a certain number of operations or steps, which can be summarized in different ways differing only slightly one from the other. The first part of QRM is evidently devoted to the quality risk analysis (QRA), that is, to *the estimation of the risk associated with the identified hazards*, whereas the second one concerns, properly speaking, the administration of this risk. Any QRM process has to start by defining its goal (what is intended) and by gathering information. All other steps are shaped by this first one.

But, speaking in practical terms, what kind of knowledge we need? Let us try to respond to this question by considering three different cases.
