Question

Explain the complete HAZOP procedure as followed in the industry. See summary below.

Explain all the main parts of HAZOP study in details given in the Pdf file including:

1. Overview (including definitions and usage)

2. Hazop methodology (including phases like definition, preparation, examination, documentation and follow-up). Give examples also

3. Risk review

4. Risk communication

Guidance: Study the procedure carefully and then write the answers in your own words.

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 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.

1.1 Definitions: When describing the HAZOP methodology, the following definitions1 are useful: Hazard - Potential source of harm. Deviations from design or operational intent may constitute or produce a hazard. Hazards are the focus of HAZOP studies, and it should be noted that a single hazard could potentially lead to multiple forms of harm. Harm - Physical injury or damage to the health of people or damage to property or the environment. Harm is the consequence of a hazard occurring and may take many forms: patient or user safety, employee safety, business risks, regulatory risks, environmental risks, etc. Risk - Combination of probability of occurrence of harm and the severity of that harm. In a strict sense, “risk” is not always explicitly identified in HAZOP studies since the core methodology does not require identification (also referred to as rating) of the probability or severity of harm. However, risk assessment teams may choose to rate these factors in order to further quantify and prioritize risks if needed.

1.2 Usage: HAZOP is best suited for assessing hazards in facilities, equipment, and processes and is capable of assessing systems from multiple perspectives: Design o Assessing system design capability to meet user specifications and safety standards o Identifying weaknesses in systems. Physical and operational environments o Assessing environment to ensure system is appropriately situated, supported, serviced, contained, etc. Operational and procedural controls o Assessing engineered controls (ex: automation), sequences of operations, procedural controls (ex: human interactions) etc. o Assessing different operational modes – start-up, standby, normal operation, steady & unsteady states, normal shutdown, emergency shutdown, etc.

2.1 Definition Phase: The Definition Phase typically begins with preliminary identification of risk assessment team members. HAZOP is intended to be a cross-functional team effort, and relies on specialists (SMEs) from various disciplines with appropriate skills and experience who display intuition and good judgment. SMEs should be carefully chosen to include those with a broad and current knowledge of system deviations. HAZOP should always be carried out in a climate of positive thinking and frank discussion. During the Definition Phase, the risk assessment team must identify the assessment scope carefully in order to focus effort. This includes defining study boundaries and key interfaces as well as key assumptions that the assessment will be performed under.

2.2 Preparation Phase: The Preparation Phase typically includes the following activities: Identifying and locating supporting data and information. Identification of the audience and users of the study outputs. Project management preparations (ex: scheduling meetings, transcribing proceedings, etc.). Consensus on template format for recording study outputs. Consensus on HAZOP guide words to be used during the study HAZOP guide words are key supporting elements in the execution of a HAZOP analysis. According to IEC Standard 61882: The identification of deviations from the design intent is achieved by a questioning process using predetermined “guide words”. The role of the guide word is to stimulate imaginative thinking, to focus the study and elicit ideas and discussion. Risk assessment teams are responsible for identifying the guide words that will best suit the scope and problem statement for their analysis. Some common HAZOP guide words include: No or not, other than, more, earlier, less, later, as well as, before, part of, after.

2.3 Examination Phase: The Examination Phase begins with identification of all elements (parts or steps) of the system or process to be examined. For example: Physical systems may be broken down into smaller parts as necessary.Processes may be broken down into discrete steps or phases. Similar parts or steps may be grouped together to facilitate assessment. The HAZOP guide words are then applied to each of the elements. In this fashion a thorough search for deviations is carried out in a systematic manner. It must be noted that not all combinations of guide words and elements are expected to yield sensible or credible deviation possibilities. As a general rule, all reasonable use and misuse conditions which are expected by the user should be identified and subsequently challenged to determine if they are “credible” and whether they should be assessed any further. There is no need to explicitly document the instances when combinations of elements and guide words do not yield any credible deviations.

2.4 Documentation & Follow-up Phase: The documentation of HAZOP analyses is often facilitated by utilizing a template recording form as detailed in IEC Standard 61882. Risk assessment teams may modify the template as necessary based on factors such as: Regulatory requirements. Need for more explicit risk rating or prioritization (ex: rating deviation probabilities, severities, and/or detection). Company documentation policies. Needs for traceability or audit readiness.Other factors: A typical HAZOP recording template is shown on the following page, including example entries that correspond to the cleaning process analysis example from section 2.2.

Hazard & Operability Analysis (HAZOP) Once the HAZOP analysis is complete, the study outputs and conclusions should be documented commensurate with the nature of risks assessed in the study and per individual company documentation policies. As part of closure for the HAZOP analysis, it should be verified that a process exists to ensure that assigned actions are closed in a satisfactory manner.

3   Risk Review: On a long-term basis, operational feedback should confirm that the assessment and control steps are adequately addressing the risk question. If this is not the case, it may be necessary to review all assumptions. Feedback should correspond to ensuring that assumptions made about the level of residual risks are still valid. Residual risks are risks that are expected to remain after risk control strategies have been exercised. It is also important to note that new risks may arise from risk control practices. Sometimes risks that were not originally identified or may have been filtered out during the initial risk assessment can become aggravating factors due to the implementation of risk control measures.

4   Risk Communication: HAZOP is a powerful communication tool. The output of the tool should always be presented at a level of detail appropriate for the various stakeholders. This is important not just for presenting results, but also for obtaining early buy-in on the approach. In cases where HAZOP is used as the basis for a “GxP” decision or some other regulated authorization, the approach should be documented in a Standard Operating Procedure. It may not be necessary to include detailed scoring steps or algorithms in the procedure, but they should be documented in a controlled report. Updates to the portfolio should also be controlled.

Answer 1

HAZOP GOES THROUGH THE FOLLOWING PHASES: DEFINITION, PREPARATION, EXAMINATION, DOCUMENTATION, RISK REVIEW AND RISK COMMUNICATION. IN THE DEFINITION PHASE, THE RISK IS IDENTIFIED PRIMARILY BY THE TEAM MEMBERS WHO ARE SPECIALISTS. THEY IDENTIFY THE BOUNDARIES OF THE STUDY, THE KEY INTERFACES AND THE KEY ASSUMPTIONS UNDER WHICH THE ASSESSMENT WILL BE DONE. NEXT, IS THE PREPARATORY PHASE, UNDER WHICH SUPPORTING INFORMATION AND DATA ARE IDENTIFIED, THE USERS AND AUDIENCE OF THE STUDY IS ALSO RECOGNIZED AND PREPARATIONS ARE MADE FOR PROJECT MANAGEMENT WHICH GENERALLY INCLUDE ACTIVITIES LIKE MEETING'S SCHEDULE ETC. HAZOP GUIDE WORDS LIKE OTHER THAN, NO,MORE ETC ARE IDENTIFIED WHICH ARE THE KEY ELEMENTS IN THE ANALYSIS. THIRD, IN THE EXAMINATION PHASE, THE ELEMENTS OF SYSTEMS THAT RE TO BE EXAMINED ARE IDENTIFIED AND HAZOP GUIDE WORDS ARE APPLIED TO THEM. THEIR CREDIBILITY IS TESTED BY IDENTIFYING THEIR REASONABLE USE. DECISION IS MADE WHETHER THESE SHOULD BE FURTHER ASSESSED. THEREAFTER DOCUMENTATION PHASE BEGINS IN WHICH A TEMPLATE IS USED TO RECORD THE ANALYSIS WHICH IS GIVEN IN IEC STANDARD 61882. THE DOCUMENTATION IS REQUIRED FOR TRACEABILITY. WHEN HAZOP ANALYSIS IS COMPLETED, THEN THE OUTCOMES ARE TO BE DOCUMENTED ALONG WITH THE RISKS ASSESSED. ALSO, THE HAZOP ANALYSIS SHOULD BE CLOSED IN A SATISFACTORY MANNER AS PER ASSIGNED ACTIONS. AFTER DOCUMENTATION, RISKS ARE REVIEWED THROUGH OPERATIONAL FEEDBACKS. IF THE FEEDBACKS DOESN'T CONFIRM THE VALIDITY OF RISK QUESTIONS THEN, ALL THE ASSUMPTIONS ARE TO BE REVIEWED. FEEDBACKS SHOULD ENSURE THAT THE ASSUMPTIONS ABOUT THE RESIDUAL RISKS ARE VALID. LASTLY, HAZOP GOES THROUGH THE RISK COMMUNICATION PHASE. THE OUTCOMES SHOULD BE COMMUNICATED TO ALL THE STAKEHOLDERS IN DETAIL. IT HELPS IN EARLY BUY-IN APPROACH. HAZOP SHOULD BE DOCUMENTED IN THE STANDARD OPERATING PROCEDURE WHEN IT IS USED TO MAKE "GxP" DECISIONS. ON THE WHOLE, HAZOP IS A POWERFUL TOOL OF COMMUNICATION.