**8. How to introduce QRM in a company?**

One might tend to think that what matters is to teach people how to use QRA tools and how to evaluate risk. Although this is something that has to be done, it is necessary to bear in mind that this is only second to the understanding of the purpose and practical utility of 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 is why the most important and basic task is to make up the mind of people.

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

404 Risk Management – Current Issues and Challenges

Risk = Low x High x High = Medium-High ----

table becomes more complicated.

**7.2. Quantitative evaluation** 

account.

QRM.

**Evaluation (two** 

**2 3** Expected between >50%

**3 5** Expected between >10%

**4) 7** Expected between >1%

and ≤80% of times

and ≤50% of times.

and ≤10% of times.

**8. How to introduce QRM in a company?** 

**5 9** Expected ≤1% of times. There is no trend and limits are

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

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

Risk = Low x Low x Low = Low Risk = Medium x Medium x Medium = Medium Risk = Low x Low x Medium = Low-Medium Risk = Medium x Medium x High = Medium-High Risk = Low x Medium x Medium = Medium-Low Risk = Medium x High x High = High-Medium

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

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

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

**options) PROBABILITY SEVERITY DIFFICULTY OF DETECTION 1st 2nd 1 1** Expected >80% of times. Batch is OOS and it is rejected. No detection.

One might tend to think that what matters is to teach people how to use QRA tools and how to evaluate risk. Although this is something that has to be done, it is necessary to bear in mind that this is only second to the understanding of the purpose and practical utility of

There are deviations and batch is investigated and rejected.

There are deviations and batch is investigated but accepted.

A trend is detected, but limits are not exceeded and the batch is not investigated.

not exceeded. Batch is not investigated.

Detection but only when the process is finished

Detection during a stage of the process, before finishing it.

Detection during the stage in process.

Instantaneous detection.

Risk = Low x Medium x High = Medium Risk = High x High x High = High

numbers (1, 2, 3) and this will facilitate calculation (e. g., 3 x 1 x 2 = 6).

To simplify matters it is generally agreed that a good practice is to prepare a detailed protocol describing how the company intends to develop and to apply QRM.
