RISK MANAGEMENT: REGULATORY EXPECTATION, RISK PERCEPTION, AND ORGANIZATIONAL INTEGRATION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 67

3.4.1 Training

Training may be the most important factor in creating a successful QRM sys-
tem. All organizations must provide for training on any formal risk management
procedure, although the current training rarely goes beyond “read and under-
stand” requirements for the procedures. This type of training may meet the basic
requirements, but the effectiveness of the QRM system and thus the pharmaceu-
tical quality system may not be optimized. Using such “read and understand”
training provides for a nonstandard approach to understanding the companies'
principles on the subject.
The following are key focus areas of risk training for companies:
• risk management regulations, not just the “what” of the regulations, but the
“why” as well;
• the risk management tools the company chooses to use;
• standard risk management terminology to help reduce subjectivity and uncer-
tainty;
• risk assessment facilitation to assure the best outcomes from risk manage-
ment activities;
• effect of heuristics and biases on the risk assessment process to better under-
stand how we perceive risk and assist in minimizing subjectivity in the
organizations' risk decision making (see Table 3.10); and

TABLE 3.9 Risk Management Maturity
Risk Maturity Risk Skills and

Level Processes Attitude Behavior Knowledge

Skepticism No formal

processes

“Accidents will
happen”

Fear of blame
culture

Unconscious
incompetence

Awareness Ad hoc use of

stand-alone
processes

Suspended
belief

Reactive, “fire
fighting”

Conscious
incompetence

Understanding
and
application

Tick the box
approach

Passive
acceptance

Compliance,
reliance on
registers

Conscious
competence

Embedding and
integration

Risk
management
imbedded in
the business

Active
engagement

Risk-based
decision making

Unconscious
competence

Robust risk
management

Regular review
and
improvement

Champion Innovative,

confident, and
appropriate risk
management

Expert

Table adapted from A Guide to Supply Chain Risk Management for the Pharmaceutical and Medical
Device Industries and their Suppliers, 2010 .