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Hazard and operability study
View on WikipediaA hazard and operability study (HAZOP) is a structured and systematic examination of a complex system, usually a process facility, in order to identify hazards to personnel, equipment or the environment, as well as operability problems that could affect operations efficiency. It is the foremost hazard identification tool in the domain of process safety. The intention of performing a HAZOP is to review the design to pick up design and engineering issues that may otherwise not have been found. The technique is based on breaking the overall complex design of the process into a number of simpler sections called nodes which are then individually reviewed. It is carried out by a suitably experienced multi-disciplinary team during a series of meetings. The HAZOP technique is qualitative and aims to stimulate the imagination of participants to identify potential hazards and operability problems. Structure and direction are given to the review process by applying standardized guideword prompts to the review of each node. A relevant IEC standard[1] calls for team members to display 'intuition and good judgement' and for the meetings to be held in "an atmosphere of critical thinking in a frank and open atmosphere [sic]."
The HAZOP technique was initially developed for systems involving the treatment of a fluid medium or other material flow in the process industries, where it is now a major element of process safety management. It was later expanded to the analysis of batch reactions and process plant operational procedures. Recently, it has been used in domains other than or only loosely related to the process industries, namely: software applications including programmable electronic systems; software and code development; systems involving the movement of people by transport modes such as road, rail, and air; assessing administrative procedures in different industries; assessing medical devices; etc.[1] This article focuses on the technique as it is used in the process industries.
History
[edit]The technique is generally considered to have originated in the Heavy Organic Chemicals Division of Imperial Chemical Industries (ICI), which was then a major British and international chemical company.
Its origins have been described by Trevor Kletz,[2][3] who was the company's safety advisor from 1968 to 1982. In 1963 a team of three people met for three days a week for four months to study the design of a new phenol plant. They started with a technique called critical examination which asked for alternatives but changed this to look for deviations. The method was further refined within the company, under the name operability studies, and became the third stage of its hazard analysis procedure (the first two being done at the conceptual and specification stages) when the first detailed design was produced.
In 1974 a one-week safety course including this procedure was offered by the Institution of Chemical Engineers (IChemE) at Teesside Polytechnic. Coming shortly after the Flixborough disaster, the course was fully booked, as were ones in the next few years. In the same year the first paper in the open literature was also published.[4] In 1977 the Chemical Industries Association published a guide.[5] Up to this time the term 'HAZOP' had not been used in formal publications. The first to do this was Kletz in 1983, with what were essentially the course notes (revised and updated) from the IChemE courses.[2] By this time, hazard and operability studies had become an expected part of chemical engineering degree courses in the UK.[2]
Nowadays, regulators and the process industry at large (including operators and contractors) consider HAZOP a strictly necessary step of project development, at the very least during the detailed design phase.
Method
[edit]The method is applied to complex processes, for which sufficient design information is available and not likely to change significantly. This range of data should be explicitly identified and taken as the "design intent" basis for the HAZOP study. For example, a prudent designer will have allowed for foreseeable variations within the process, creating a larger design envelope than just the basic requirements, and the HAZOP will be looking at ways in which this might not be sufficient.
A common use of the HAZOP is relatively early through the detailed design of a plant or process. However, it can also be applied at other stages, including later operational life of existing plants, in which case it is usefully applied as a revalidation tool to ensure that unduly managed changes have not crept in since first plant start-up. Where design information is not fully available, such as during front-end loading, a coarse HAZOP can be conducted; however, where a design is required to have a HAZOP performed to meet legislative or regulatory requirements, such an early exercise cannot be considered sufficient and a later, detailed design HAZOP also becomes necessary.
For process plants, identifiable sections (nodes) are chosen so that for each a meaningful design intent can be specified [citation needed]. They are commonly indicated on piping and instrumentation diagrams (P&IDs) and process flow diagrams (PFDs). P&IDs in particular are the foremost reference document for conducting a HAZOP. The extent of each node should be appropriate to the complexity of the system and the magnitude of the hazards it might pose. However, it will also need to balance between "too large and complex" (fewer nodes, but the team members may not be able to consider issues within the whole node at once) and "too small and simple" (many trivial and repetitive nodes, each of which has to be reviewed independently and documented).
For each node, in turn, the HAZOP team uses a list of standardized guidewords and process parameters to identify potential deviations from the design intent. For each deviation, the team identifies feasible causes and likely consequences then decides (with confirmation by risk analysis where necessary, e.g., by way of an agreed upon risk matrix) whether the existing safeguards are sufficient, or whether an action or recommendation to install additional safeguards or put in place administrative controls is necessary to reduce the risks to an acceptable level.
The degree of preparation for the HAZOP is critical to the overall success of the review. "Frozen" design information provided to the team members with time for them to familiarize themselves with the process, an adequate schedule allowed for the performance of the HAZOP, provision of the best team members for their role. Those scheduling a HAZOP should take into account the review scope, the number of nodes to be reviewed, the provision of completed design drawings and documentation and the need to maintain team performance over an extended time-frame. The team members may also need to perform some of their normal tasks during this period and the HAZOP team members can tend to lose focus unless adequate time is allowed for them to refresh their mental capabilities.
The team meetings should be managed by an independent, trained HAZOP facilitator (also referred to as HAZOP leader or chairperson), who is responsible for the overall quality of the review, partnered with a dedicated scribe to minute the meetings. As the IEC standard puts it:[1]
The success of the study strongly depends on the alertness and concentration of the team members and it is therefore important that the sessions are not too long and that there are appropriate intervals between sessions. How these requirements are achieved is ultimately the responsibility of the study leader.
For a medium-sized chemical plant, where the total number of items to be considered is around 1200 pieces of equipment and piping, about 40 such meetings would be needed.[6] Various software programs are now available to assist in the management and scribing of the workshop.
Guidewords and parameters
[edit]Source:[7]
In order to identify deviations, the team applies (systematically i.e. in a given order[a]) a set of guidewords to each node in the process. To prompt discussion, or to ensure completeness, appropriate process parameters are considered in turn, which apply to the design intent. Typical parameters are flow (or flowrate), temperature, pressure, level, composition, etc. The IEC standard notes guidewords should be chosen that are appropriate to the study, neither too specific (limiting ideas and discussion) nor too general (allowing loss of focus). A fairly standard set of guidewords (given as an example the standard) is as follows:
| Guideword | Meaning |
|---|---|
| No (not, none) | None of the design intent is achieved |
| More (more of, higher) | Quantitative increase in a parameter |
| Less (less of, lower) | Quantitative decrease in a parameter |
| As well as (more than) | An additional activity occurs |
| Part of | Only some of the design intention is achieved |
| Reverse | Logical opposite of the design intent occurs |
| Other than (other) | Complete substitution (another activity takes place or an unusual activity occurs or uncommon condition exists) |
Where a guide word is meaningfully applicable to a parameter (e.g., "no flow", "more temperature"), their combination should be recorded as a credible potential deviation from the design intent that requires review.
The following table gives an overview of commonly used guideword-parameter pairs (deviations) and common interpretations of them.
| Parameter / Guide Word | No | More | Less | As well as | Part of | Reverse | Other than |
|---|---|---|---|---|---|---|---|
| Flow | no flow | high flow | low flow | deviating concentration | reverse flow | ||
| Pressure | vacuum | high pressure | low pressure | ||||
| Temperature | high temperature | low temperature | |||||
| Level | no level | high level | low level | ||||
| Time | sequence step skipped | too long / too late | too short / too soon | extra actions | missing actions | backwards | wrong time |
| Agitation | no mixing | fast mixing | slow mixing | ||||
| Reaction | no reaction | fast reaction / runaway | slow reaction | ||||
| Start-up / Shut-down | too fast | too slow | actions missed | wrong recipe | |||
| Draining / Venting | none | too long | too short | deviating pressure | wrong timing | ||
| Inerting | none | high pressure | low pressure | contamination | wrong material | ||
| Utility failure (e.g., instrument air, power) | failure | ||||||
| DCS failure[b] | failure | ||||||
| Maintenance | none |
Once the causes and effects of any potential hazards have been established, the system being studied can then be modified to improve its safety. The modified design should then be subject to a formal HAZOP close-out, to ensure that no new problems have been added.
HAZOP team
[edit]A HAZOP study is a team effort. The team should be as small as practicable and having relevant skills and experience. Where a system has been designed by a contractor, the HAZOP team should contain personnel from both the contractor and the client company. A minimum team size of five[8] is recommended. In a large process there will be many HAZOP meetings and the individuals within the team may change, as different specialists and deputies will be required for the various roles. As many as 20 individuals may be involved.[2] Each team member should have a definite role as follows:[1]
| Name | Role |
|---|---|
| Study leader / Chairman / Facilitator | Someone experienced in leading HAZOPs, who is familiar with this type of process but is independent of the design team. Responsible for progressing through the series of nodes, moderating the team discussions, maintaining the accuracy of the record, ensuring the clarity of the recommended actions and identifying appropriate actionees. |
| Recorder / secretary / scribe | To document the causes, consequences, safeguards and actions identified for each deviation, to record the conclusions and recommendations of the team discussions (accurately but comprehensibly). |
| Design engineer | To explain the design and its representation, to explains how a defined deviation can occur and the corresponding system or organizational response. |
| Operator / user | Explains the operational context within which the system will operate, the operational consequences of a deviation and the extent to which deviations might lead to unacceptable consequences. |
| Specialists | Provide expertise relevant to the system, the study, the hazards and their consequences. They could be called upon for limited participation. |
| Maintainer | Someone who will maintain the system going forward. |
In earlier publications it was suggested that the study leader could also be the recorder[2] but separate roles are now generally recommended.
The use of computers and projector screens enhances the recording of meeting minutes (the team can see what is minuted and ensure that it is accurate), the display of P&IDs for the team to review, the provision of supplemental documented information to the team and the logging of non-HAZOP issues that may arise during the review, e.g., drawing/document corrections and clarifications. Specialist software is now available from several suppliers to support the recording of meeting minutes and tracking the completion of recommended actions.
See also
[edit]Notes
[edit]- ^ If an individual team member spots a problem before the appropriate guideword is reached it may be possible to maintain rigid adherence to order; if most of the team wants to take the discussion out of order no great harm is done if they do, provided the study leader ensures that the secretary is not becoming too confused, and that all guidewords are (eventually) adequately considered
- ^ This relates to the Distributed Control System (DCS) hardware only. Software (unless specially carefully written) must be assumed to be capable of attempting incorrect or inopportune operation of anything under its control
References
[edit]- ^ a b c d IEC (2016). Hazard and Operability Studies (HAZOP studies) – Application Guide. International Standard IEC 61882 (2.0 ed.). Genève: International Electrotechnical Commission. ISBN 978-2-8322-3208-8.
- ^ a b c d e Kletz, Trevor A. (1983). HAZOP & HAZAN. Notes on the Identification and Assessment of Hazards (2nd ed.). Rugby: IChemE.
- ^ Kletz, Trevor (2000). By Accident... A Life Preventing Them in Industry. PFV Publications. ISBN 0-9538440-0-5
- ^ Lawley, H.G. (1974). "Operability Studies and Hazard Analysis". Chemical Engineering Progress. 70(4): 105-116.
- ^ Chemical Industry Safety and Health Council (1977). A Guide to Hazard and Operability Studies. London: Chemical Industries Association
- ^ Swann, C. D.; Preston, M. L. (1995). "Twenty-five Years of HAZOPs". Journal of Loss Prevention in the Process Industries. 8(6): 349-353
- ^ Crawley, Frank; Tyler, Brian (2015). HAZOP: Guide to Best Practice (3rd ed.). Amsterdam, etc.: Elsevier. ISBN 978-0-323-39460-4.
- ^ Nolan, Dennis P. (1994) Application of HAZOP and What-If Safety Reviews to the Petroleum, Petrochemical and Chemical Industries. Park Ridge, N.J.: Noyes Publications. ISBN 0-8155-1353-4.
Further reading
[edit]- Gould, John (2005). Review of Hazard Identification Techniques (PDF). HSL/2005/58. Buxton: Health and Safety Laboratory.
- Kletz, Trevor (1999). Hazop and Hazan. Identifying and Assessing Process Industry Hazards (4th ed.). Rugby: IChemE. ISBN 978-0-85295-506-2.
- Explanation by a software supplier:
- Lihou, Mike. "Hazard & Operability Studies (1 of 2)". LihouTech. Archived from the original on 2008-06-10.
- Lihou, Mike. "Hazard & Operability Studies (2 of 2)". LihouTech. Archived from the original on 2008-05-12.
- New South Wales Department of Planning (2011). HAZOP Guidelines (PDF). Hazardous Industry Planning Advisory Paper (HIPAP) No. 8. Sydney, N.S.W.: New South Wales Department of Planning. ISBN 978-0-73475-872-9.
- PrimaTech. "HAZOP". PrimaTech. Retrieved 2023-07-08.
- PrimaTech (2018). "HAZOP Fundamentals - Design Intent, Parameters, Guidewords, and Deviations" (PDF). PrimaTech. PrimaTech White Paper. Retrieved 2023-07-08.
- Whitty, Steve; Foord, Tony (2009). "Is HAZOP Worth All the Effort It Takes?". Wilde. Archived from the original on 2015-04-02. Retrieved 2015-03-05.
Hazard and operability study
View on GrokipediaBackground
Definition and Purpose
A Hazard and Operability Study (HAZOP) is a structured and systematic qualitative technique used for identifying hazards and operability issues in complex planned or existing processes, particularly within chemical, petrochemical, and process engineering industries. It involves a multidisciplinary team examining the design and operation of a system to uncover potential deviations that could lead to safety risks, environmental impacts, or operational inefficiencies.[6] This method is standardized internationally through guidelines such as IEC 61882, which emphasizes its application in high-risk facilities to ensure robust risk management. The primary purpose of HAZOP is to detect deviations from the intended design and operating conditions early in the project lifecycle, thereby enhancing overall safety, reliability, and operability before full implementation or modification.[7] By systematically probing "what could go wrong," it helps prevent accidents, reduces downtime, and optimizes process efficiency, making it a cornerstone of proactive risk assessment in industries handling hazardous materials.[8] Ultimately, HAZOP aims to mitigate consequences from process upsets, such as leaks, explosions, or equipment failures, by identifying safeguards and design improvements.[9] At its core, HAZOP relies on detailed process representations like Process Flow Diagrams (PFDs) or Piping and Instrumentation Diagrams (P&IDs) as the foundational basis for analysis, dividing the system into nodes for node-by-node examination.[6] Unlike other hazard analysis techniques, such as Failure Mode and Effects Analysis (FMEA), which focuses on individual component failure modes and their effects, HAZOP specifically targets deviations in key process variables (e.g., flow, temperature, pressure) caused by interactions within the system.[9] This deviation-centric approach, often prompted by standardized guidewords applied to parameters, distinguishes HAZOP as a holistic process-oriented method rather than a component breakdown.[7]Historical Development
The Hazard and Operability (HAZOP) study originated in the early 1960s within the Imperial Chemical Industries (ICI) in the United Kingdom, evolving from earlier techniques such as "critical examination" used for scrutinizing management decisions in chemical processes.[10] Developed by a team in ICI's Heavy Organic Chemicals Division, including contributions from safety advisor Trevor Kletz who joined in 1968, the method was initially applied internally to identify potential hazards and operability issues in complex process plants.[11] The technique gained formal recognition with its first published description in 1974, when H.G. Lawley of ICI presented "Operability Studies and Hazard Analysis" at the AIChE Loss Prevention Symposium, marking the initial external documentation of the structured approach using guide words to examine deviations.[10] The adoption of HAZOP accelerated following major industrial incidents, particularly the 1974 Flixborough disaster in the UK, where an explosion at the Nypro chemical plant killed 28 people and highlighted deficiencies in hazard identification for process modifications.[12] This event prompted widespread implementation of HAZOP as a standard risk assessment tool in the UK chemical industry, extending its use to sectors like oil and gas and nuclear power.[13] The 1984 Bhopal disaster in India, involving a Union Carbide plant and resulting in thousands of deaths, further drove global adoption, influencing the development of process safety regulations such as the US Occupational Safety and Health Administration's Process Safety Management standard in 1992, which mandated techniques like HAZOP for hazard analysis.[14] In the pharmaceutical sector, HAZOP was increasingly applied post-Bhopal to address risks in batch processes and high-containment facilities.[15] Key milestones in HAZOP's evolution include the 1977 publication of "A Guide to Hazard and Operability Studies" by ICI and the Chemical Industries Association (CIA), which standardized the procedure and popularized the acronym HAZOP.[16] During the 1990s, HAZOP integrated with complementary methods like Layer of Protection Analysis (LOPA), a semi-quantitative risk assessment tool developed concurrently to evaluate independent protection layers identified in HAZOP studies, enhancing decision-making for safety instrumented systems.[17] Formal internationalization occurred with the release of IEC 61882 in 2001, providing a global application guide for HAZOP studies, which was revised in 2016 to broaden its scope for diverse systems including non-chemical processes and to incorporate advancements in risk communication.Methodology
Core Process Steps
The Hazard and Operability (HAZOP) study follows a structured, sequential methodology to systematically identify potential hazards and operability issues in process systems, as outlined in the international standard IEC 61882. This workflow ensures comprehensive coverage of the process design by breaking it down into manageable parts and examining deviations from intended operation. The process is typically conducted in team meetings and emphasizes brainstorming to uncover unforeseen risks, with documentation serving as a key output for risk management integration. In the preparation phase, the study begins with defining the scope and boundaries of the analysis, often focusing on specific process sections or nodes, such as equipment units like reactors or pipelines. Process and instrumentation diagrams (P&IDs) are gathered, along with other relevant documentation like operating procedures and safety data sheets, to provide a clear basis for examination. The design intent for each node is explicitly stated, describing the expected normal operation, including parameters like flow rates, temperatures, and pressures under defined conditions. This phase also involves selecting appropriate nodes to ensure the study remains focused and feasible, avoiding overly broad or narrow divisions that could miss critical interactions.[6] Preparation concludes with logistical planning, such as scheduling sessions and preparing worksheets, to facilitate efficient team discussions.[8] Deviation generation forms the core analytical step, where predetermined guidewords are systematically applied to key process parameters within each node to generate potential deviations, such as scenarios questioning "what if" conditions arise. For instance, guidewords might probe changes in flow or pressure to identify abnormal situations that could lead to hazards. Only credible deviations—those with plausible causes—are pursued further, ensuring the study remains practical and targeted. This structured prompting encourages the team to explore beyond obvious issues, revealing subtle operability problems that might otherwise be overlooked. The process proceeds node by node, maintaining a logical progression through the system to cover all elements without redundancy.[6] Following deviation identification, consequence analysis evaluates each selected deviation by determining its root causes, potential effects on safety, environment, or operations, and the adequacy of existing safeguards. Causes are traced to possible failures, such as equipment malfunctions or human errors, while consequences are assessed in terms of severity, like releases of hazardous materials or process shutdowns. Safeguards, including alarms, interlocks, or relief systems, are reviewed to gauge their effectiveness in preventing or mitigating impacts. If gaps are found, specific recommendations for design modifications, procedural changes, or additional controls are proposed, often with assigned responsibilities and timelines. This step prioritizes risks based on likelihood and impact to guide actionable outcomes.[8][6] The wrap-up phase involves compiling all findings into standardized worksheets that capture deviations, causes, consequences, safeguards, and recommendations for traceability and future reference. Actions are prioritized, typically using qualitative risk matrices, and integrated into broader risk management frameworks, such as layer of protection analysis. A final report summarizes key issues and resolutions, with follow-up mechanisms to verify implementation. Due to its iterative nature, the HAZOP process may be revisited after design changes or during revalidation to address evolving risks, ensuring ongoing applicability.[8]Guidewords and Parameters
In the HAZOP methodology, guidewords are systematically combined with process parameters to generate deviations from the design intent, enabling the identification of potential hazards and operability issues. The standard guidewords, outlined in the international standard IEC 61882:2016, consist of seven primary terms: No/None, More, Less, As Well As, Part Of, Reverse, and Other Than. These guidewords are designed to provoke creative questioning by the study team, focusing on quantitative changes (More, Less), qualitative modifications (As Well As, Part Of), negations or opposites (No/None, Reverse), and substitutions (Other Than). Each guideword has a specific meaning and application. "No/None" represents the total absence or negation of the intended parameter, such as no flow in a pipeline, which could result from a blockage or equipment failure. "More" indicates a quantitative increase beyond the design, like higher pressure in a vessel, potentially leading to rupture. "Less" signifies a quantitative decrease, for instance, reduced temperature in a reactor affecting reaction rates. "As Well As" denotes an additional or qualitative increase, such as the unintended presence of an impurity in a stream. "Part Of" implies a partial or qualitative reduction, like incomplete mixing in a blending operation. "Reverse" refers to the logical opposite, exemplified by reverse flow due to a faulty valve. "Other Than" covers substitutions or completely different behaviors, such as using the wrong material in a process line. These guidewords are applied sequentially to ensure comprehensive coverage without overlap. Process parameters are selected based on the nature of the system node under review, typically including Flow, Pressure, Temperature, Level, Composition, Reaction, and others relevant to the context, such as pH or viscosity for chemical processes. The choice of parameters depends on the design intent and the type of node—piping and instrumentation diagrams (P&IDs) for continuous processes or procedures for batch operations—ensuring deviations are meaningful and targeted. For instance, in a pump node analysis, the parameter "Flow" paired with the guideword "More" generates the deviation "More Flow," which may cause cavitation if the pump operates beyond its capacity, leading to vapor bubble formation, vibration, and mechanical damage due to low inlet pressure.[8] To illustrate the application of standard guidewords, the following table provides their meanings alongside representative examples in a chemical process context:| Guideword | Meaning | Example Deviation (Parameter: Flow) |
|---|---|---|
| No/None | Complete absence | No flow: Blockage prevents material transfer, risking upstream overpressure. |
| More | Quantitative increase | More flow: Overspeed pump causes cavitation and erosion.[8] |
| Less | Quantitative decrease | Less flow: Valve partially closed reduces throughput, delaying production. |
| As Well As | Qualitative addition | As well as flow: Unintended leak introduces contaminants. |
| Part Of | Qualitative reduction | Part of flow: Partial blockage causes uneven distribution. |
| Reverse | Logical opposite | Reverse flow: Backflow contaminates upstream sections. |
| Other Than | Substitution or different state | Other than flow: Pulsating flow disrupts steady-state operation. |
Implementation
Team Composition and Roles
A Hazard and Operability (HAZOP) study typically involves a multidisciplinary team of 4 to 8 members to balance comprehensive analysis with efficient decision-making.[5] This size allows for diverse input without overwhelming the process, as larger teams can slow progress and dilute focus.[20] The team is led by a facilitator, who coordinates the effort, while core members provide specialized perspectives essential for identifying hazards and operability issues. Core roles in a HAZOP team include the process engineer, who serves as the technical lead by offering detailed knowledge of the design and process parameters; the operations representative, who contributes practical insights into day-to-day functioning and potential real-world deviations; the safety expert, responsible for evaluating hazards and recommending safeguards; and the scribe, who documents discussions, findings, and recommendations in real time.[5] Optional specialists, such as an instrumentation engineer, may join for specific nodes requiring expertise in control systems or equipment.[21] The facilitator plays a pivotal role by guiding discussions, ensuring systematic coverage of all process nodes using guidewords and parameters, and maintaining neutrality to foster open dialogue without influencing outcomes.[22] This leadership prevents oversight of critical deviations and keeps the team aligned with the study's objectives.[5] Diversity in team composition is crucial, drawing from cross-functional expertise across engineering, operations, and safety disciplines to avoid bias and uncover blind spots that a homogeneous group might miss.[5] Such interdisciplinary collaboration enhances the quality of hazard identification by integrating varied viewpoints.[22] Team members, particularly the facilitator and scribe, require training in HAZOP methodology, often through certification programs to ensure proficiency in the technique and effective application.[5] This preparation equips participants to contribute meaningfully and adhere to standardized procedures.[21]Study Execution and Documentation
The execution of a Hazard and Operability (HAZOP) study involves structured team meetings focused on real-time brainstorming of potential deviations within defined process nodes. These sessions are typically scheduled for 4 to 6 hours per day, with analysis progressing node by node to maintain focus and prevent fatigue, often allocating 2 to 4 hours per node based on its complexity. Led by a facilitator who guides discussions and a scribe who records inputs, the team systematically examines each node, prompting for causes, consequences, and safeguards through interactive dialogue. To optimize productivity, sessions are limited to 3 or 4 days per week, allowing time for preparation and reflection between meetings.[23][24] Documentation during execution relies on standardized worksheets to capture findings in a traceable format, ensuring all discussions are systematically recorded for later review. A typical worksheet includes columns for key elements, as outlined in the table below, which facilitates organized analysis and action tracking:| Column | Description |
|---|---|
| Node/Line No. | Identification of the specific process section under review. |
| Guide Word/Parameter | The applied guide word and process parameter prompting the deviation. |
| Deviation | The identified abnormal condition arising from the guide word application. |
| Causes | Potential reasons leading to the deviation. |
| Consequences | Possible outcomes or impacts of the deviation. |
| Safeguards/Controls | Existing measures to prevent or mitigate the deviation. |
| Recommendations/Actions | Proposed improvements or further actions needed. |
| Action Assigned To | Responsible party and due date for implementation. |
| Risk Ranking | Optional qualitative assessment of severity and likelihood (e.g., high/medium/low). |
| Comments | Additional notes, assumptions, or rationale. |