Standard Operating Procedures (SOPs) – a quick guide
Mar 10, 2013 in Research, Study Management
So what is an SOP? A standard Operating Procedure (SOP) is a document that contains accurate and detailed instructions to perform a process or procedure to ensure that the procedure is performed the same way each time and the same way by each person.
Without relevant SOPs in place, whilst everyone may want to do the right thing, often everyone’s version of that right thing is likely to be slightly different. So how things are done are likely to vary according to who is doing that thing. If the expectation is that everyone is to follow the rules, then everyone needs to know what those rules are. That means that the rules need to be written down. The larger the organisation, and the greater the staff turnover, the greater the likelihood that there will be a lack of detailed consistency if there are no SOPs being followed.
A good SOP isn’t arduous to read and it allows anyone to get on with the task at hand with confidence. SOPs are most effective when they are not too wordy, long winded, or vague – as vagueness often increases the likelihood of errors or inconsistency. A good SOP is clear and brief, making it easy to follow. It emphasizes the critical steps and warns about safety issues.
Most organisations will have their own SOP template. If you don’t have one, the main sections of a usual template are SOP number, title, purpose, list of equipment or material used in the procedure, roles and responsibilities, scope, procedure steps, summary and change history.
It is important when starting to write an SOP that you define the procedure about which it will be written. This allows you to start gathering the necessary information to meet the requirements for the procedure. It is also good at this point to define the critical and non-critical steps of your SOP then list the steps in sequence to be executed.
Try to keep the reader in mind while you write the content. Identify who will be reading it, and think about their experience and background. Using active voice makes an SOP more direct which can also be helpful to the reader. Draw attention to any safety issues, and caution readers about any steps that carry risk, before you describe how they are to perform that specific step. Try to be accurate and consistent with your terminology / nomenclature. Avoid words like ‘all, never, maximise, minimise’ and try to stay to facts, avoid opinions or preferences.
Use of tables and flowcharts can be very useful and can give readers a “visual” – both for the steps they will undertake to perform, and the procedure according to the SOP.
Once written, SOPs should be reviewed by appropriate individuals for your specific SOP. Reviewers could include colleagues who will be using the SOP, Quality Assurance (“QA”) managers, research facilitators, lab manager(s) or governance managers. They should review an SOP for accuracy; are steps clearly written in the correct order? are they based on facts not opinions? is the wording accurate and is there any repetition? The SOP should also be reviewed for quality to determine the degree to which it meets the planned objectives.
Reviewers are exactly that: reviewers. They submit their comments to the author of the SOP, who is responsible for incorporating comments into a revised version.
A reviewed and revised SOP is then submitted for approval by the SOP author. Some organisations have SOP committees who approve SOPs. Sometimes it is the responsibility of one person e.g. the QA Manager or Lead Nurse.
Approved SOPs are ready for distribution and implementation. Your organisation should have an established process of how this is done. Often there is an SOP explaining this process. It is important to think about how the necessary individuals are made aware of new SOPs and how you ensure they have understood and are capable of carrying out the SOP. This may involve training, creating an SOP signature log which is kept either as a hard copy or on an electronic database. Some organisations have an online system which lists and logs SOPs, SOP users and alerts when SOPs are due to be reviewed etc. Systems vary, but it is important to think about how you communicate SOPs to the relevant individuals. Also think about how these individuals will communicate back to you, e.g. as to how well the SOPs are functioning and when changes may need to be made to update the SOPs as requirements change.
Don’t forget to set a date for SOP review, e.g. in maybe 12, 18 or 24 months down the line from approval. If you are audited or inspected, it will be important that you can show a system for monitoring and controlling your SOPs.
SOPs can seem a little daunting when you are first asked to produce one! But once you start, you begin to learn to art and science of producing a document that is clear and brief and allows the reader to carry out a task or process with confidence and ease. Writing SOPs is like riding a bicycle, once you learn how, you never forget and you might even find you actually enjoy it!
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