8 Tips For Documenting SOPs (Standard Operating Procedures)

documenting SOPs (Standard Operating Procedures)There are many reasons why an organisation might need to document their SOPs. From training staff and identifying critical dependencies, to meeting regulatory demands and sharing organisational knowledge. Here are 7 tips to ensure your SOPs are as effective as possible.

1. What does the SOP need to achieve?

Are you documenting an existing procedure so it can be replicated exactly as it is? Or is the objective to understand and then optimise that procedure? Do you need to ensure some specific GxP or ISO requirements are incorporated in the structure of the task? Who are the people who are going to consult and use the document - and in what conditions are they likely to be doing so?

Creating Standard Operating Procedures is never about creating documentation for ‘its own sake’. Keep your business objectives and audience in mind whilst you are working on SOPs to avoid scope creep and ensure clarity in the final document.

2. A typical Standard Operating Procedure document should capture the following

  • The purpose and intent of the SOP document - i.e. why it was created
  • Its scope - Who and what should be governed by the SOP (note that the purpose and scope should remain distinct)
  • Who does what – List all the different job roles and subtasks required to complete the process defined in the SOPs
  • Create a step by step description of the task - Ask yourself, can it be understood by its target audience or followed by someone who has never done the task before?
  • Important references – List and link to all documents related to the SOP as clearly as possible - in a way that supports the intention of the document. This might include providing links to appropriate standards and regulations, approved versions of other SOPs and third party documentation (such as instruction manuals)
  • Assumptions – List any assumptions made in the drafting or execution of the procedures as well as any caveats or warnings that might be necessary for understanding how and when a task should be tackled
  • Materials & Equipment - List materials the user will need to satisfactorily complete the procedure as well as the equipment they will need to do so

3. Ensure your SOP is kept at a manageable size

SOPs that are excessively long can be confusing and impractical for use as a teaching and learning tool. Think of it from a training point of view. If a SOP incorporates a long trail of subtasks that involve only a portion of the people who you are training to fulfill the whole task, then this might be an indication that it should broken down into separate SOPs.

4. Engage with your team members

The most effective way to decide what steps should be included in a SOP and to ensure it reflects what needs to be done, is to consult the people who are actually carrying out the work on a day to day basis. Get a flip chart and a pen and map it out together using flow diagrams. Let them describe to you how the task works, what are the moments where things can go wrong or choices have to be made. Together you can create the process maps that can become the SOP documents that will be most meaningful and helpful to the those who need to use them. If your objective is to optimise the way your business performs the tasks you are documenting - working together in this way is crucial to gain insight and collectively agree on the ‘way you do things’ before you commit to a final version.

5. Mind your language

When writing SOPs be careful to keep descriptions of tasks concise and unambiguous. You need to strike a balance between giving required details and becoming so prescriptive that following them becomes burdensome. Be precise, not pedantic. Aim to keep the attention and enthusiasm of your audience as they use your documentation to master the SOPs and understand what their required outcomes are.

6. Test them out

When you’ve completed your documentation perform a dry run of the activity using your SOP as your guide. If you can, use an individual from a different team who has never performed this task before and see whether they can reproduce the steps based on your documentation. This will show up any gaps in your SOPs and will allow you to correct any mistakes - or make updates to optimise their utility. Validate the process and its outcomes against what was required and intended by the SOP.

7. Use diagrams and flowcharts (and photos and videos)

The use of flow charts, diagrams, pictures and even videos, in your SOPs can make the difference between SOPs that merely tick compliance boxes and those that are actually helpful and practical for their intended audience.

Business Management System

Graphical representations of the flow of tasks are a great way to remove ambiguities, demonstrate dependencies and flag up points where errors can happen or choices need to be made.

We would argue that the ability to capture processes graphically and for them to be accessible to the business as a whole, should be a key feature of any digital business or quality management system you choose. A Graphical Business Management System, for example, can help you visualise the entire structure of a business diagrammatically, letting you drill down into the structure of individual departments and their SOPs as required. This helps workers contextualise operations, while giving them the detail they require to do their jobs more effectively.

8. Maintain the Documentation

Your work isn’t finished once the standard operating procedure is written. In order for it to remain relevant and useful, it’s got to be updated to reflect:

  • any changes in the way you do things,
  • the advent of new equipment
  • new regulatory requirements.

Storing and maintaining SOPs in a version-controlled document management system will help you keep a historical record of the evolution of your business practice, which will be helpful both for trouble shooting and auditing purposes. The right Quality Management tools will even be able to notify key stakeholders at regular intervals to review the SOPs for accuracy and relevance.

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The last word

SOPs should be more than just box ticking for compliance, they should be an essential resource for your entire company to understand and optimise critical business activities. To help this happen we would advise the following. Always keep the needs of your intended audience in mind when you’re documenting your SOPs. And see that the documentation remains accessible, up-to-date and relevant. If you manage that, there’s a greater chance your documents will prove useful, and be used across your organisation...

Cognidox manage business graphically

Tags: ISO 9001:2015, quality management system, New Product Development

Joe Byrne

Written by Joe Byrne

Joe Byrne is the CEO of Cognidox. With a career spanning medical device start-ups and fortune 500 companies, Joe has over 25 years of experience in the medical device and high-tech product development industries. With extensive experience in scaling businesses, process improvement, quality, medical devices and product development, Joe is a regular contributor to the Cognidox DMS Insights blog where he shares expertise on scaling and streamlining the entire product development cycle, empowering enterprises to achieve governance, compliance, and rigour.

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