**7.1. Qualitative evaluation**

For instance in three levels:

402 Risk Management – Current Issues and Challenges

**6. How to determine risk?** 

direct factor like the other two.

the assessment.

**7. How to better evaluate risk?** 

it provides a false sensation of precision.

place. This gives us the classical formula:

estimate risk without having enough information for doing it.

Summarizing, although we talk about QRM it is perfectly acceptable just to determine hazard and manage it in terms of making the appearance of harm an unluckily event by applying corrective measures. It is better to limit a QRA to the hazards that trying to

Risk is determined by the combination of the two already mentioned factors, probability and severity, to which a third one, detection, can be added when a system of detection is in

Risk = Probability of occurrence of the harm x Severity of the harm x Detection of the harm. Instead of probability it is often used the term frequency, pointing out that most of times what we really know is how often it happened in a well established process. It is evident that even if we don't know how to estimate probability, if we really do know that harm

Severity is easier to understand because we are only asked to assess the importance of harm. The capacity of detection of harm is linked to the existence of a system for its detection. Thus, its assessment tends to be more objective, as it is related to the equipment. This factor, however, has a marked particularity: risk increases when the capacity of detection decreases; it is an inverse factor. This is not a problem if we bear in mind this fact, but it can be easily overcome by changing the way we express it, for instance, instead of talking about "detection of the harm" we could say "difficulty of detection of the harm", thus turning it a

All three risk factors can be evaluated either qualitatively or quantitatively. Again, a quantitative estimation of risk (e.g. of 45 over 50, say) might appear much more satisfactory than a qualitative one (e.g. middle), but this might be too, and often is, misleading, because

As it was discussed above, the main objection one can do regarding risk is that its determination is too subjective and this makes it unreliable. Although there is some amount of truth in this, we may, however, counterattack by explaining that the objective of assessing risk is not getting a faithful estimate of it, but obtaining a risk baseline to be used as an indicator for future improvement. This is why what really matters is providing a good deal

Independently from that, it is necessary to determine how many risk levels will be estimated for each hazard. The simplest case and maybe the commonest too is the utilization of three levels, a very intuitive approach, as we are talking about "a lot" (high), "medium" (middle) and "little" (low). More levels allow for a better classification, but they turn more complicate

of information on the rationale which led to the estimation of the factors of risk.

never happened in our process we can affirm that probability is very low.


**Table 12.** Example of qualitative evaluation in three levels

More than three levels:


**Table 13.** Example of qualitative evaluation in five levels

An important inconvenient of the qualitative evaluation of the factors appears when determining risk. Everybody would agree that low x medium x high = medium, but the score of low x low x high is not so evident (medium?). And this becomes even more unclear if we consider more than three levels.

This is however less important that it might seem at first sight. As we have seen above, risk estimation, and particularly the qualitative one, is likely to be more a rough approximation than a very exact value. Thus, adding some more roughness should not be considered critical. In any case, this inconvenient can be overcome by using a complementary table which would provide a homogeneous estimation.


Quality Risk Analysis: Value for Money in the Pharmaceutical Industry 405

Remember that the documentation of the QS has to take into account QRM

QRM is not just a kind of new task in a company. It is, in fact, a new way of looking at things, a new approach in analyzing the problems and in proposing solutions to them. This

To simplify matters it is generally agreed that a good practice is to prepare a detailed

Everybody can have a personal approach towards QRA, but experience shows that there are no simple ways. As said above a good knowledge of the subject is essential, then some dose

It has already been described the paramount importance of getting information on the subject and how this can be done. It has also been explained how to choose and use the more common (and practical) tools. Thus, getting an adequate QRA is just a question of work. Get a first draft, review it and improve it little by little until getting something satisfactory. There are no rules, but the approach of working by progressive "retouches" is

It is worth to mention that while working on QRA one of the most puzzling aspects is the frequent confusion that one tends to experience regarding "hazard", "cause" and "effect". This can be overcome in two complementary ways. Firstly by understanding well the meaning of these terms and applying them carefully to the elements being analyzed and secondly by reviewing the draft after a few hours of rest. Normally what is not seen clear now, it will be later.

QRA provides us with a systematic and deep knowledge of the problems faced by the process under study. In this sense QRA can help us to overcome one of the main troubles derived of the application of GMP, their being seen as a kind of "tables of the law". The consideration of GMP as the golden principles supposed to provide the answer for every problem, has often led to a passive attitude. We had a problem and then we looked up in

protocol describing how the company intends to develop and to apply QRM.

of experience is helpful and a big amount of patience is necessary.

is why the most important and basic task is to make up the mind of people.

**Figure 13.** Introduction of QRM in a company

Explain what QRM is and why is important and

Prepare a QRM procedure

Provide training

Introduce progressively QRM

**9. Is there a way to facilitate QRA?** 

certainly very appropriate.

**10. Why QRA is worthy?** 

**Table 14.** Example of table for the qualitative estimation of risk

It is evident that if the risk factors are estimated by using more than three levels, then the table becomes more complicated.

#### **7.2. Quantitative evaluation**

If it is done in three levels, then the approach might be exactly the same that shown above for the qualitative estimation, but instead of low, medium and high there will be used numbers (1, 2, 3) and this will facilitate calculation (e. g., 3 x 1 x 2 = 6).

The next table provides an example of quantitative evaluation in five levels, both following the natural series of numbers and an irregular (or "enhanced") one. Both are, of course, acceptable, but it is necessary to bear in mind that the final risk quantification will depend on the system which has been chosen and thus comparisons have to take this into account.


**Table 15.** Example of quantitative evaluation of the factors of risk in five levels
