Based on ICH Q9, Quality Risk Management, Hazards analysis (HA) tools for risk assessment can be further assessed through Hazard Operability Analysis (HAZOP) and Hazard Analysis and Critical Control Points (HACCP). The output of both HAZOP and HACCP is a list of critical operations for risk management to facilitates regular monitoring in manufacturing process. Preliminary hazard analysis (PHA) is another tool based on applying prior experience or knowledge of a hazard and failure to identify future hazards, the output of PHA is typically further assessed with other risk management tools. The HA rating matrix is shown as below:

HAZOP is based on a theory that assumes that risk events are caused by deviations from the design or operating intentions. It is a systematic technique using “guide-words” (e.g., No, More, Other than, Less, Part of, etc.), the “guide-words” are applied to relevant parameters to help identify potential deviations. It can be applied to manufacturing processes, safety hazard, suppliers, equipment and facilities.

HACCP is a systematic, proactive, and preventive tool for assuring product quality, reliability and safety. It can be used to identify and manage risks associate with physical, chemical, biological hazards, including microbiological contamination. It is most useful when product and process understanding is mature to support critical control point identification in manufacturing process and life-cycle phases. HACCP consists of the following 7 steps:

PHA applies 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. It is useful when analyzing existing systems or prioritizing hazards, and it is most commonly used early in development of a project when there is little information on design details or operating procedures. The tool consists of the following 4 steps:

Reference

1. ICH Q9: Quality Risk Management