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Manufacturing Technology Committee – Risk Management Working Group Risk Management Training Guides

Hazard & Operability Analysis (HAZOP) 1 Overview
Hazard and Operability Analysis (HAZOP) is a structured and systematic technique for system examination and risk management. In particular, HAZOP is often used as a technique for identifying potential hazards in a system and identifying operability problems likely to lead to nonconforming products. HAZOP is based on a Definition: SYSTEM is the theory that assumes risk events are caused by deviations from subject of a risk design or operating intentions. Identification of such deviations is assessment and generally facilitated by using sets of “guide words” as a systematic list of includes a process, deviation perspectives. This approach is a unique feature of the HAZOP methodology that helps stimulate the imagination of team product, activity, facility members when exploring potential deviations. or logical system. As a risk assessment tool, HAZOP is often described as: A brainstorming technique A qualitative risk assessment tool An inductive risk assessment tool, meaning that it is a “bottom-up” risk identification approach, where success relies on the ability of subject matter experts (SMEs) to predict deviations based on past experiences and general subject matter expertise The ICHQ9 Guideline, Quality Risk Management endorses the use of HAZOP (amongst other allowable tools) for pharmaceutical quality risk management. In addition to its utility in Quality Risk Management, HAZOP is also commonly used in risk assessments for industrial and environmental health and safety applications. Additional details on the HAZOP methodology may be found within IEC International Standard 61882, Hazard and Operability Studies (HAZOP) Application Guide. This document presents some guiding principles in the execution of HAZOP analyses. Successful application of any risk management model requires that tools are used in concert with