BACKGROUND AND INTRODUCTION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 8

(QbD) and other ways to identify and mitigate risk may be one answer to
supplier and supply-related quality issues.
1.2 A PRACTICAL GUIDE TO RISK MANAGEMENT
It is important to have a clear concept on various terms used in risk management.
The concept of risk has two components: (i) probability of occurrence of harm
and (ii) the consequence of that harm (i.e., severity). A hazardous situation is
a circumstance in which people, property, or environment is exposed to one or
more harm(s)[16] [ISO 14971]. Risk analysis involves the estimation of risk(s)
for each hazardous situation or failure mode. Harm, in the context of this topic,
is damage to health, including the damage that can occur from loss of product
quality or availability. Severity is a measure of the possible consequences of a
hazard. Hazard is a potential source of harm (i.e., an immediate output from
the product/process/system that directly causes harm). Risk is the possibility of
suffering harm or loss. More specifically, risk is the relationship between impact
of a hazard and the probability of that hazard occurring to such an extent as to
result in harm. Risk to product quality is the combination of the severity or the
impact of an unwanted event and the likelihood that event will occur to a degree
which will adversely affect product quality. Some examples of hazards, harm,
and risk are listed here:
1. Hazards
• Product not sterile or impure
• Product subpotent or superpotent
• Product contaminated
• Product mislabeled
• Product unsealed or improperly sealed
• Product missing or unusable product
• Ineffective product
• Lack of product supply
• Noncompliance
• Product rejection
• Inefficient process
• Misuse of product
• Poor process yield
• Failure to receive product approval
2. Harm
• Injury to patient
• Disruption of product supply