Potential areas of uses can be used to establish the


Potential Areas of Use(s): can be used to establish the pathway to the root cause of
the failure. FTA can be used to investigate complaints or deviations. FTA is an
effective tool for evaluating how multiple factors affect a given issue. It is useful for
both risk assessment and in developing monitoring programs.

Validation Practices (cont’d)
•
Risk Management Tools (cont’d):

Hazard Analysis and Critical Control Points (HACCP) – see WHO Technical Report Series No
908, 2003 Annex 7

Systematic, proactive, and preventive tool for assuring product quality, reliability, and
safety. It is a structured approach that applies technical and scientific principles to
analyze, evaluate, prevent, and control the risk or adverse consequence(s) of hazard(s)
due to the design, development, production, and use of products. Seven steps of HACCP:
o
Conduct a hazard analysis and identify preventive measures for each step of the process
o
Determine the critical limits
o
Establish a system to monitor the critical control points
o
Establish the corrective action to be taken when monitoring indicate that the critical control
points are not in a state of control
o
Establish a system to verify that the HACCP system is working effectively
o
Establish a record-keeping system

Potential Areas of Use(s): used to identify and manage risks associated with physical,
chemical, and biological hazards (including microbiological contamination). HACCP is
most useful when product and process understanding is sufficiently comprehensive to
support identification of critical control points. The output of HACCP analysis is risk
management information that facilitates monitoring of critical points not only in the
manufacturing process but also in other life cycle phases.

Validation Practices (cont’d)
•
Risk Management Tools (cont’d):

Hazard Operability Analysis (HAZOP) – see IEC 61882

Based on theory that assumes that risk events are caused by deviations from the
design or operating intentions. It is a systematic brainstorming technique for
identifying hazards using “guidewords” (e.g., No, More, Other Than, Part of, etc.)
which are applied to relevant parameters (e.g., contamination, temperature, etc.) to
identify potential deviations from normal use or design intentions.

Potential Areas of Use(s): can be applied to manufacturing processes, including
outsourced production and formulation as well as upstream suppliers, equipment
and facilities, It is used primarily in the pharmaceutical industry for evaluating
process safety hazards/ HAZOP analysis is a list of critical operations for risk
management. This facilities regular monitoring of critical points in the
manufacturing process.

Preliminary Hazard Analysis (PHA)

Tool of analysis based on applying prior experience or knowledge of a hazard or failure to
identify future hazards, hazardous situations and events that might cause harm, as well as to
estimate their probability of occurrence for a given activity, facility, product, or system. Tool
consists of