ABSTRACT
Hazard and operability (HAZOP) analysis is a structured and systematic technique for system examination and risk management. It is often used to identify potential hazards in a system and operability problems likely to lead to non-conforming products. HAZOP is based on a theory that assumes risk events are caused by deviations from design or operating intentions. Identification of such deviations is facilitated by using guidewords as a systematic list of deviation perspectives. This approach is a unique feature of the HAZOP methodology that helps stimulate the imaginations of team members when exploring potential deviations. As a risk assessment tool, HAZOP is often described as:
• A brainstorming technique • A qualitative risk assessment tool • An inductive risk assessment tool; a bottom-up risk identification
approach in which success relies on the ability of subject matter experts (SMEs) to predict deviations based on past experiences and their general expertise
The International Conference on Harmonisation (ICH) Q9 Guideline titled Quality Risk Management endorses the use of HAZOP as one of many alternative tools for managing pharmaceutical quality risk and is also used in marine operations and environmental studies. In addition, to its utility in quality risk management, HAZOP is also commonly used to assess industrial and environmental health and safety applications. Additional details on the HAZOP methodology may be found in IEC International Standard 61882, Hazard and Operability Studies (HAZOP) Application Guide.
