**8. Conclusions**

Society requires medicines possessing the purported quality, and this is only possible if we design, manufacture, monitor, and control them adequately. These undertakings, however, involve appropriately devised, built, and qualified premises and facilities, which are the outcome of a project. A pharmaceutical project is a very complex subject because it involves at least two parts, with different visions and experience, and because it implies scores of suppositions and projections into the future. The risk of straying away from the expected roadmap is quite real. Thus, risk management becomes necessary. In a project, the amount of information is limited and thus, while using risk analysis tools, it is essential to bear in mind that what really matters is to understand which problems are at stake and to get a clear picture of their respective relevance. Once this is achieved, it is easier to provide adequate solutions. Risk is controllable, if we know and understand it!

A frequent problem, when trying to evaluate risk, is that information is so varied and multiform that it becomes difficult to ascertain, which are the hazards and distinguish them from, say, causes and effects, let alone the logical organization of the information. To overcome these difficulties, we propose two tiers of solutions: on one side, to use simple risk analysis tools focusing more on hazard and control measures than on risk quantification and on the other, to use defined simple quality hazards as the point of departure for the analysis.

#### **Conflict of interest**

None.
