Hazard and Operability Analysis

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
theory that assumes risk events are caused by deviations from
design or operating intentions. Identification of such deviations is
facilitated by using sets of “guide words” as a systematic list of
deviation perspectives. This approach is a unique feature of the
HAZOP methodology that helps stimulate the imagination 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, 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 the overall quality risk management process. This guide will present the principles of
HAZOP in the context of the accepted Quality Risk Management process consisting of Risk
Assessment, Risk Control, Risk Review and Communication and is intended to compliment
(not replace or repeat) the guidance available within IEC International Standard 61882