How do you document and archive your SOP review process and outcomes?

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A standard operating procedure (SOP) is a document that describes the steps, roles, and responsibilities for a specific task or process. It helps ensure consistency, quality, and compliance in your organization. But how do you make sure your SOPs are up to date, relevant, and effective? That's where a SOP review process comes in. A SOP review process is a systematic way of evaluating, revising, and approving your SOPs on a regular basis. It involves checking for accuracy, clarity, completeness, and alignment with your goals and standards. In this article, you'll learn how to document and archive your SOP review process and outcomes, so you can keep track of your improvements, identify gaps, and avoid errors.

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1 Define your review criteria

Defining review criteria is the first step in documenting and archiving the SOP review process. These criteria refer to the standards and expectations used to assess SOPs, such as relevance, accuracy, clarity, completeness, and compliance. To ensure consistency in your reviews, you can use a checklist, a rubric, or a rating scale to document your criteria. This will help you evaluate your SOPs accurately and effectively.

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Rachael Koch

Study Director/Laboratory Supervisor at MB Research Laboratories
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SOPs should not contain personal pronouns, as they cause confusion. This article would improve by removing the personal pronouns. For example: To ensure consistency in the SOP review process, utilize checklists, rubrics, or a rating scale to ensure all review criteria are verified. This will ensure that the SOP was evaluated accurately and effectively.

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Lokesh Singh
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To document and archive the SOP review process and outcomes, I maintain a detailed log of all review activities, including meeting dates, participants, and key discussion points. I create a summary report outlining findings, recommendations, and any agreed-upon changes, which is shared with relevant stakeholders. Each SOP version and its modifications are saved with version control to track the history of changes. All documents, including review logs and summary reports, are stored in a centralized digital repository for easy access and future reference. At Cognizant, I used a shared drive with access controls to archive these documents, ensuring integrity, security, and easy retrieval.

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Saroj Pradhan
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An SOP review involves assessing its accuracy, clarity, and compliance with current regulations while identifying areas for improvement. Reviews ensure alignment with organizational goals and are typically conducted annually or biennially. The review period may vary based on industry needs, ensuring the SOP stays relevant and effective. Regular updates are crucial for maintaining its alignment with evolving processes and standards

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2 Conduct your review process

The next step is to conduct your review process according to your review criteria and schedule. To do this, you can employ various methods and tools, such as self-reviews, peer-reviews, audits, and tests. Self-reviews involve the SOP owner or yourself reviewing the SOP and noting any issues or areas for improvement. Peer-reviews involve a colleague or subject matter expert providing feedback and suggestions. Audits involve a formal inspection or verification of the SOP and its implementation, while tests measure the performance and outcomes of the SOP in a simulated or real scenario. Additionally, you should document your review process and its results using a template, form, or software, as well as recording the date, reviewer, method, feedback, and actions taken.

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3 Revise and approve your SOP

The third step is to revise and approve your SOP based on your review process and feedback. You should make the necessary changes, corrections, or enhancements to your SOP, following your organization's guidelines and procedures. You should also ensure that your SOP is clear, concise, and consistent in its format, style, and tone. You should document the changes made, the reasons for them, and the approval status of your SOP. You should also indicate the version number, the author, and the date of your revised SOP.

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4 Communicate and train your SOP

The fourth step is to communicate and train your SOP to your relevant stakeholders and users. You should inform them about the changes made, the benefits of the new SOP, and the expectations of their roles and responsibilities. To effectively use the new SOP, you can organize interactive workshops, develop online courses or modules, produce short videos, and create comprehensive manuals. Additionally, it is important to document your communication and training process with a template, form, or software. This should include the date, audience, method, feedback, and evaluation.

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Rachael Koch

Study Director/Laboratory Supervisor at MB Research Laboratories
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You cannot train your SOP. You train stakeholders and users to perform the procedures outlined in an SOP. Also, a new or updated SOP should be distributed to users prior to the date the new or updated SOP becomes effective. This allows users to obtain any necessary training or make any updates to processes based on the new SOP (e.g., generate new forms, change machinery settings, etc.). All employees need to have access to the current SOPs. All SOPs should include Management's approval.

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5 Archive your SOP

The final step is to archive your SOP and its review process and outcomes. You should store your SOP and its related documents in a secure and organized location, such as a cloud-based platform that allows you to store, share, and access your SOPs and their review records online, a document management system that enables you to manage, track, and control your SOPs and their review workflows, versions, and approvals, or a physical folder that contains printed SOPs and their review documents. It is important to archive the documents for future reference, audit, or improvement purposes. Additionally, your organization's retention and disposal policies should be followed for the SOPs and their review records.

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Rachael Koch

Study Director/Laboratory Supervisor at MB Research Laboratories
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The final step is to archive the retired SOP and the accompanying review documentation. The retired SOPs should be stored in a secured and organized location that allows access for future reference, audit, or improvement purposes. The use of a document management system is recommended to manage, track, and control retired and active SOPs. Additionally, the organization's retention and disposal policies should be followed.

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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How do you document and archive your SOP review process and outcomes?

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1 Define your review criteria

2 Conduct your review process

3 Revise and approve your SOP

4 Communicate and train your SOP

5 Archive your SOP

6 Here’s what else to consider

Standard Operating Procedure (SOP)

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