RISK MANAGEMENT: REGULATORY EXPECTATION, RISK PERCEPTION, AND ORGANIZATIONAL INTEGRATION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 58

Risk
assessment 1

Risk
assessment 2

Risk
assessment 3

Risk
assessment n

High risk
items

Low risk
items

Risk register

Summary of all
high risk
items for site

Figure 3.1 Risk register. ( See insert for color representation of the figure .)

• The first will be a review of the QRM policy that defines what the QRM
program entails for the specific organization.
• The second area will be a review of specific procedures, which will dive
deeper into the “how” of risk management.
• The third target area for QRM audit will be the evaluation of the actual risk
assessments themselves.

The time that is actually spent on QRM during an audit will be dependent
on the risk of the product and the processes being used, the maturity and clarity
of the QRM program and procedures, effectiveness of the risk review and com-
munication processes, and the thoroughness of the individual risk assessments
reviewed.

3.3 PROBLEMS OF SUBJECTIVITY AND UNCERTAINTY DURING
QRM EXERCISES

It is said that all politics are local. In a sense, risks are as well; they are personal
and relative. ‡ We bring our individual life story to each and every risk assessment
engagement, all the while being bombarded by external stimuli.

‡ You know the story that all risks are relative—the risk depends on which one of your relatives is
taking the medicine (your wonderful loving grandmother or your crazy uncle Al)!