How do you handle SOP revisions and approvals?

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Standard operating procedures (SOPs) are essential documents that define the best practices and processes for your business or organization. They help you ensure consistency, quality, compliance, and efficiency in your operations. But creating and maintaining SOPs is not a one-time task. You need to regularly review, update, and approve your SOPs to keep them relevant, accurate, and effective. In this article, we will discuss some tips and tools for SOP creation and maintenance, and how to handle SOP revisions and approvals.

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1 Identify your SOP needs

The first step in creating and maintaining SOPs is to identify your SOP needs. You need to determine the scope, purpose, and audience of your SOPs, and the key processes and tasks that require SOPs. You can conduct a gap analysis, a stakeholder analysis, and a process mapping exercise to identify your SOP needs. You can also consult with your team members, customers, suppliers, regulators, and other relevant parties to get their input and feedback.

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Carrie Leach

Director, Quality Assurance
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Visually mapping process through tools like Miro is also a critical tool in SOP writing. Key stakeholders should participate and understand the flow of process prior to writing procedure. This practice will help identify process owners and any gaps where additional SOPs should be written if critical steps are missing.

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Lokesh Singh
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Handling SOP revisions and approvals requires a systematic approach. First, identify the need for revisions, then propose changes and gather feedback from stakeholders. After incorporating feedback, submit the revised SOP for approval by designated authorities. Communicate the changes to relevant personnel and provide training as needed. Maintain thorough documentation of the revision process for compliance purposes. This structured process ensures that SOPs remain accurate, compliant, and effective in guiding organizational procedures.

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2 Write clear and concise SOPs

The next step is to write clear and concise SOPs that follow a consistent format and style. You can use templates, guidelines, and examples to help you write your SOPs. You should also use simple and precise language, avoid jargon and acronyms, and use visual aids such as diagrams, charts, and screenshots to illustrate your SOPs. You should also include the following elements in your SOPs: title, date, author, version, approval, purpose, scope, definitions, roles and responsibilities, procedures, safety and quality measures, references, and appendices.

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Maryam Daneshpour

Biotechnologist | Business Development Expert | MBA
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When creating SOPs, it's important to ensure that the person writing it has a comprehensive understanding of the entire process, including the background, objectives, resources, essential components, references, and compatibility guidelines. Ideally, technical experts should write their own SOPs to ensure accuracy, but maintaining a consistent tone and adhering to industry policies can be challenging. This is because not everyone has strong writing skills.

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Robert Kobet

Senior Scientist at AstraZeneca
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Ensure multiple SOPs do not contain redundant information that may become disjointed when updating one procedure, and cross-reference related SOPs as appropriate. Review references to other SOPs during the revision process to ensure procedures remain harmonized.

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3 Review and test your SOPs

Before you finalize and approve your SOPs, you need to review and test them to ensure they are accurate, complete, and effective. You can use checklists, audits, and feedback forms to review your SOPs. You can also test your SOPs by performing the procedures yourself or by asking someone else to follow them and report any issues or errors. You should also check your SOPs for compliance with any relevant laws, regulations, standards, or policies.

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4 Approve and distribute your SOPs

Once you are satisfied with your SOPs, you need to approve and distribute them to the intended users and stakeholders. You can use a document management system (DMS) or a cloud-based platform to store, share, and access your SOPs. You should also communicate the purpose, benefits, and expectations of your SOPs to your team members and provide them with adequate training and support to follow them. You should also monitor and measure the performance and outcomes of your SOPs and collect feedback and suggestions for improvement.

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5 Revise and update your SOPs

The final step in maintaining your SOPs is to revise and update them as needed. You should regularly review your SOPs to identify any changes, gaps, or issues that may affect their validity, relevance, or effectiveness. You should also solicit feedback from your team members, customers, suppliers, regulators, and other relevant parties to find out if your SOPs are meeting their needs and expectations. You should also document any revisions or updates to your SOPs and communicate them to the users and stakeholders.

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James Zahn

Quality Assurance Raw Materials Manager at KBI Biopharma
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Outside of the normal periodic reviews, using new employees is a great way to check your SOPs for clarity and effectiveness. If your new trainee questions a step or gets confused that is a sign to get real-time feedback and make changes to your legacy SOPs.

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6 Use tools and software to simplify your SOP creation and maintenance

Creating and maintaining SOPs can be a complex and time-consuming task. Fortunately, there are tools and software that can help you simplify your SOP creation and maintenance. For example, you can use online platforms such as Process Street, SweetProcess, or Tallyfy to create, manage, and automate your SOPs. You can also use tools such as Google Docs, Microsoft Word, or Adobe Acrobat to edit, format, and share your SOPs. You can also use tools such as Grammarly, Hemingway, or ProWritingAid to check and improve your writing quality and readability.

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Carrie Leach

Director, Quality Assurance
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Investing in an easy to use, fit for purpose document management system will improve efficiency, stakeholder buy-in and ultimately save time and effort in maintaining SOPs. Using tools such as Google Docs or Word required a great deal of “hands-on” maintenance to ensure formatting is consistent and final versions are locked as well and manual tracking of periodic reviews.

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How do you handle SOP revisions and approvals?

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1 Identify your SOP needs

2 Write clear and concise SOPs

3 Review and test your SOPs

4 Approve and distribute your SOPs

5 Revise and update your SOPs

6 Use tools and software to simplify your SOP creation and maintenance

Standard Operating Procedure (SOP)

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