Standardisation of Procedures in Safety Critical Organisations

Standard Operating Procedures or SOPs are used widely across safety critical organisations to capture safe practices and to guide operatives.  SCT’s Mario Pierobon reports on SOP development and usage best practice.

A Standard Operating Procedure (SOP) is a written instruction or document that details a series of steps to achieve a desired outcome in a predictable and repeatable way. SOPs are an essential tool for planning and implementing operational activities in a safety critical organisation, and the adoption of SOPs to guide the execution of the work can make a significant contribution to improved safety performance. Developing SOPs in a consistent way for an organisation can be a lengthy exercise, but with advanced planning to coordinate the SOP development, endeavours can make SOP developers more engaged in the procedural development work and focus the overall safety effort.

Development of SOPs and their Safety and Efficiency Benefits

The World Health Organization (WHO)’si “Guidance for developing SOPs” emphasises that the development and use of SOPs is beneficial to clarifying job requirements and expectations in a format readily applied on the job, to minimise errors due to misinterpretation or miscommunication, to ensure consistency in performing tasks, to implement regulatory requirements, to facilitate training, and the evaluation of operational performance.

According to the Biosafety Manual defining the biological safety policies and procedures pertaining to research operations at Boston University (BU)ii, one of the main reasons why SOPs are developed is to provide individuals performing operations with all the safety, health, environmental, and operational information required to perform a task properly. SOPs also serve to ensure that operations are done consistently to maintain quality control of processes and products or services. “SOPs ensure that processes continue and are completed on a prescribed schedule and that no failures occur in manufacturing and other processes that would harm employees or anyone in the surrounding community”, the manual says. “Approved procedures are followed in compliance with company and government regulations and serve as a training document for teaching users about a process. SOPs serve as a historical record of the how, why, and when of steps in a process for use when modifications are made to that process and when a SOP must be revised”.

How can we increase safety reporting in this industry? Find out in  Safety Reporting in Safety Critical Industries.

SOPs serve as an account of steps in a flow that can be reassessed in event investigations that aim to improve safety practices and operating conditions. “The SOP should include identifying information (e.g., title and/or number) and all the procedure’s steps, including associated hazards and precautions”, the BU’s Biosafety Manual says. “Precautions for the employee’s overall health and safety must be addressed, especially in terms of training and personal protective equipment and what to do in emergencies. The SOP also must address the precautions needed to prevent any impacts to the environment, whether it is the immediate workplace environment, the waste disposal system, or the surrounding community”.

Action Planning and SOP Development

The WHO’s implementation toolbox points out that an action plan to develop SOPs should be issued based on the results of the assessed needs. “All SOPs do not have to be produced at the same time, a realistic schedule is needed to ensure that SOPs will be developed, released and implemented at a pace compatible with the available resources. The action plan should present the list of existing SOPs, the list of SOPs to be deleted, created or modified and the rationale for doing so and the process to be followed in order to delete, create, or modify an SOP”, says the WHO’s implementation toolbox.

The development or update of an SOP should be a collaborative effort occurring through a series of consultations with different actors involved with the SOP. “A core group of 5-7 people with different backgrounds and competencies should be assigned to the task of planning and coordinating the development of the SOPs. Involving different actors in the development of SOPs is a good opportunity to foster teamwork among different types of staff and ensures that the SOPs are more complete, useful, and better accepted”, says the WHO’s implementation toolbox.

According to BU’s Biosafety Manual, an SOP is best developed by a group that includes the operatives, their supervisors and a safety or health professional. It is important to identify one person to draft the SOP, people who already perform the process described in the SOP and people with expertise in the subject of the procedure, says the manual.

It is also important to track the history of the SOP and record all the revisions. This expectation should be integral part of all SOP development and maintenance processes. The SOP should be reviewed by the team that created it when there is a change in regulatory requirements, operating procedures have changed significantly, forms used or the record management system has changed, or when there is the introduction of new facilities, equipment, risks, hazards, or processes, says BU’ Biosafety Manual.

According to the WHO’s implementation toolbox, a step-by-step approach to develop SOPs includes the following activities:

1. Define the purpose and scope.
2. Gather information.
3. Identify the actors to be involved in developing the SOP.
4. Draft the SOP: if the process has already been carried out, a detailed list of steps by observing someone performing the process in its current state has to be made.
5. Review the SOP: Ask people who already perform the process to review the first draft and provide comments and modifications (internal review), ask people with expertise in the subject to review the first draft and provide comments and modifications (external review), and revise the SOP based on the internal and external reviews.
6. Test the SOP: ask someone unfamiliar with the process to follow the draft SOP. Watch and modify any step of the procedure that causes confusion or hesitation. Then return to step 5 to review the new version.
7. Validate the SOP: ask the competent authorities to validate the SOP.

SOP Forms

The standardisation of procedures can take different forms. According to a paper by David Grusenmeyer, Sr. Extension Associate PRO-DAIRY, Cornell University (available online)iii, one form consists of a set of simple steps or a checklist. “These are easy to write and follow and work well for short, simple, straightforward tasks”, he says.

Another form of SOP development includes elements of hierarchical analysis. It is an extension of the simple steps format and works better for tasks that require additional detail or sub-steps within each primary step, highlights Grusenmeyer.

There is also the linear flow chart which is a graphic version of the two previous formats. “It works well for tasks where activities must be done in a specific order and where an easy to-follow reminder at the job site is useful”, says Grusenmeyer.  The annotated pictures form works best in those circumstances where there may be a language barrier. “Since pictures can dramatically reduce the need for written explanations, this format helps to shorten complex and detailed SOPs. For some employees, SOP pictures can make excellent work site reminders. For example, a photo illustrating how a work site should be set up or arranged, or the proper locations of shields, levers, switches and handles on a piece of equipment”, says Grusenmeyer.  An additional form is that of the branching flowchart. “This format makes complex SOPs, especially those with a number of decisions that affect subsequent steps, easier to follow. Boxes within the flow chart can also be expanded to include checklists or sub steps”, according to Grusenmeyer.

The WHO’s implementation toolbox points out that an SOP should be kept simple and short and written in a concise, step-by-step, easy-to-read format with several short sentences instead of long sentences. “The information presented should be unambiguous and not overly complicated. The active voice and present verb tense should be used. The term ‘you’ should not be used, but implied. Acronyms and abbreviations, if any, should be used sparingly”, the implementation toolbox says. “Procedures should not replace training and should include only steps that are essential and should be performed in the same way by all users. A long list of steps should be avoided. If there are more than 10 steps, it is better to divide the SOP into logical sections of about 10 steps per section”.

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Content of the SOPs

As far as the actual content of the SOP is concerned, it is important to define for each SOP the person who is overall responsible of the execution. When a given procedure requires that different individuals participate in the execution of the task, then the roles and responsibilities of each one involved should be thoroughly annotated.

The WHO’s implementation toolbox recommends that a standardised format be used for all the SOPs to facilitate their use and that the items which should usually be included in any SOP be the following ones:

SOP Review

According to Grusenmeyer, any SOP may have several different uses. “Depending on the intended use at the time, the SOP may be written or presented differently to be more effective. A SOP that is part of a reference manual may contain large amounts of explanatory detail and even supporting background information, so employees understand the biology and importance behind certain SOP steps”, he says.  To capitalise on the effort committed to SOP development, it is important to focus and think about the ways the SOP will be used after it is developed (e.g. employee orientation and training, refresher training, advanced training, work site reminders, cross training, performance appraisal, employee safety and accident prevention etc.).

Three Steps

Once the development is complete, three important steps should be conducted. The first is to educate employees about the new SOP. The second is to control ‘procedural drift’ by ensuring that the SOP is followed consistently over time. The third step is to establish an evaluation and review system to be certain that over time all the steps of an SOP are still correct and appropriate for the production system, says Grusenmeyer.

Summing up

As a last remark it should be noted that the use of an SOP in the line environment should not be overly narrow. Ideally system designers and SOP developers would want to foresee every possible instance operatives are faced with in the line environment, yet uncertainty remains a defining feature of operations in safety critical industries. It is important that buffers be built in the operational set-up to allow for the needed performance adaptation of operatives to cope with uncertainty and for them to contribute to the usefulness of the SOP, including by reporting on its effectiveness. It is in this context the SOPs will yield the safety benefits for which they are developed in the first place.

[i] Implementation Toolbox Tool 18. Guidance for Developing SOPs. World Health Organization, 2018, www.who.int/ihr/publications/Tool18_guidance_SOPs_Final_2018_09_07.pdf.

[ii] “Institutional Biosafety Manual.” Boston University Medical Campus, Boston University / Boston Medical Center, June 2010, www.bumc.bu.edu/bergethonlab/files/2011/09/Revised-BU-Biosafety-Manual-JUNE-2010.pdf.

[iii] Grusenmeyer, David. “Developing Effective Standard Operating Procedures.” Cornell University Library, Cornell University, 1 Feb. 2003, ecommons.cornell.edu/handle/1813/36910.