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How do you manage SOP changes and revisions in a consistent and transparent way?

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Standard operating procedures (SOPs) are essential documents that guide the performance of tasks and processes in an organization. They ensure consistency, quality, safety, and compliance across different teams and departments. However, SOPs are not static; they need to be updated and revised regularly to reflect changes in regulations, technology, customer needs, or best practices. How do you manage SOP changes and revisions in a consistent and transparent way? Here are some tips to help you.

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1 Establish a revision policy

The first step is to have a clear and documented policy for how and when SOPs are revised. This policy should define the roles and responsibilities of the SOP owners, authors, reviewers, approvers, and users. It should also specify the criteria and triggers for initiating a revision, such as feedback, audits, incidents, or new requirements. The policy should also outline the steps and timelines for the revision process, such as drafting, reviewing, approving, distributing, and implementing the revised SOP.

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Christopher Sutton

Accomplished pharmaceutical quality executive with achievement in all aspects of technical operations, from initial concept to commercialized, regulated products.
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I have found the best SOPs involve transparency among; Quality, Management and the Operators. As long as everyone is on the same page, better SOPs result.

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Maria Veleva

Clinical Research Quality Expert | Consultant MD, MRQA
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The policy should also specify how much time is given for training. Typically, there is a time lag (in my experience most of the time this is about a month) between the approval and the release of an SOP to allow sufficient time for training.

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Lokesh Singh
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Managing SOP changes and revisions consistently and transparently involves establishing a structured change management process, maintaining centralized documentation with version control, documenting revisions comprehensively, involving relevant stakeholders in the review and approval process, communicating changes effectively, providing training and education on updated SOPs, soliciting feedback from employees, and continuously monitoring and improving SOPs. By following these steps, organizations ensure that SOPs are updated in a controlled and transparent manner, promoting compliance and minimizing risks.

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Carrie Leach

Director, Quality Assurance
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Change management processes, internal audits, and any CAPAs resulting from quality events should take into account procedure updates when assessing impact.

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2 Use a version control system

The second step is to use a version control system that tracks and records the changes and revisions made to the SOPs. A version control system can be a software tool, a database, or a document management system that allows you to create, edit, compare, and archive different versions of the SOPs. It can also help you assign version numbers, dates, authors, and approval statuses to the SOPs. A version control system can help you avoid confusion, duplication, and errors when revising the SOPs.

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3 Communicate and train

The third step is to communicate and train the relevant stakeholders on the revised SOPs. Communication and training are crucial for ensuring that the revised SOPs are understood, accepted, and followed by the SOP users. Communication and training can be done through various channels and methods, such as emails, newsletters, webinars, workshops, or e-learning modules. Communication and training should also include the rationale and benefits of the revisions, as well as the expected impacts and outcomes.

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Maria Veleva

Clinical Research Quality Expert | Consultant MD, MRQA
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Please don't forget to document the training, either by completing a form for a self-reported training, or a training webinar/workshop attendance log or in the Learning Management System, depending on the method of training.

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Savanna Downing

Marketing Manager | Operations | MS in Management
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Make sure to train the current staff regarding newly created SOPs or if major changes are made. Current staff can need just as much attention and education as new staff, especially when new concepts are being introduced.

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4 Monitor and evaluate

The fourth step is to monitor and evaluate the effectiveness and compliance of the revised SOPs. Monitoring and evaluation are important for assessing whether the revisions have achieved the desired goals and objectives, as well as identifying any gaps, issues, or risks that may arise. Monitoring and evaluation can be done through various measures and indicators, such as feedback, surveys, audits, inspections, or performance metrics. Monitoring and evaluation can also help you identify the need for further revisions or improvements.

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5 Document and report

The fifth step is to document and report the results and outcomes of the revision process. Documentation and reporting are essential for maintaining a record of the revision history, as well as providing evidence and accountability for the changes and revisions made to the SOPs. Documentation and reporting can be done through various formats and tools, such as logs, reports, dashboards, or charts. Documentation and reporting can also help you share and disseminate the lessons learned and best practices from the revision process.

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Savanna Downing

Marketing Manager | Operations | MS in Management
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If small changes are being consistently made to SOPs, rather than sharing every change individually you could consider a weekly or monthly recap message. Summarize all the changes made into a single message, and share the new documents so employees can adopt the changes at once, rather than overwhelming them with keeping track of multiple changes in a given period.

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6 Review and improve

The sixth step is to review and improve the revision process itself. Review and improvement are necessary for ensuring that the revision process is efficient, effective, and responsive to the changing needs and expectations of the organization and its stakeholders. Review and improvement can be done through various methods and techniques, such as feedback, surveys, audits, or benchmarking. Review and improvement can also help you identify and implement the opportunities and recommendations for enhancing the revision process.

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7 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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Carrie Leach

Director, Quality Assurance
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Sometimes processes change often and SOPs can become out of date quickly. Ensuring the appropriate reviewers and approvers are included depending on process, can help make documents more flexible. If possible, limiting the number of sign-offs, based on scope, for a SOP can help keep document review an agile process.

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How do you manage SOP changes and revisions in a consistent and transparent way?

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3

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1 Establish a revision policy

2 Use a version control system

3 Communicate and train

4 Monitor and evaluate

5 Document and report

6 Review and improve

7 Here’s what else to consider

Standard Operating Procedure (SOP)

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