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How do you avoid duplication and confusion with SOPs for similar or overlapping processes?

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Standard operating procedures (SOPs) are essential tools for ensuring quality, consistency, and compliance in any organization. However, creating and maintaining SOPs can also pose some challenges, especially when there are similar or overlapping processes involved. How do you avoid duplication and confusion with SOPs for similar or overlapping processes? Here are some tips to help you.

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Tat Chan
Lokesh Singh

1 Identify the purpose and scope of each SOP

Before you write or revise an SOP, you need to clearly define its purpose and scope. What is the main goal or outcome of the process? Who is responsible for performing it? When and where does it apply? How does it relate to other processes or SOPs? Answering these questions will help you avoid unnecessary or redundant steps, as well as potential gaps or conflicts.

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Tat Chan
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Further to above, I would recommend looking into the SOP matrix to see whether the SOP being created or revised have any overlapping, or even contradiction to other existing SOPs. It is beneficial to have discussion with other stakeholders or functions on how to mitigate such overlapping before drafting the SOP.

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Lokesh Singh
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To avoid duplication and confusion with SOPs for similar or overlapping processes, organizations should streamline documentation through process mapping, standardized templates, and a centralized repository. Regular reviews and cross-functional collaboration help identify redundancies and ensure alignment, while robust version control and comprehensive training maintain clarity and compliance. These strategies promote efficiency and consistency in SOP management, reducing confusion and enhancing operational effectiveness.

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2 Use a consistent format and structure

Using a consistent format and structure for your SOPs will make them easier to read, follow, and update. You can use a template or a style guide to ensure uniformity across your SOPs. Some common elements to include in your SOPs are: title, date, author, revision history, approval, purpose, scope, definitions, roles and responsibilities, procedure steps, safety precautions, quality control, documentation, and references.

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Tat Chan
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In most QMS, it is necessary to define how SOPs are written, i.e. SOP on writing an SOP. While QMS may not cover other functions such as Regulatory Affairs, Pharmacovigilance, Supply Chain, you may promote the use of SOP on SOP to other functions in writing their SOPs, for harmonized format to better readability.

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3 Establish a naming and numbering system

A naming and numbering system will help you organize and identify your SOPs. You can use a combination of letters, numbers, keywords, and categories to create a unique and meaningful identifier for each SOP. For example, you can use a prefix to indicate the department or function, a number to indicate the sequence or version, and a keyword to indicate the topic or process. You can also use a suffix to indicate the status or format of the SOP. For example, SOP-MKT-001-Email Marketing-Draft.docx.

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Tat Chan
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The SOP naming and numbering algorithm can be defined in the 'SOP in writing an SOP'. On top on that, a matrix of SOP can be defined for an overview of existing of SOPs, their version, approval date, next review date, etc. For better maintenance and tracking purposes.

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4 Implement a review and approval process

A review and approval process will ensure that your SOPs are accurate, complete, and compliant. You should involve the relevant stakeholders, such as process owners, subject matter experts, managers, and quality assurance personnel, in the review and approval process. You should also establish a frequency and criteria for reviewing and updating your SOPs, as well as a method for communicating and implementing the changes.

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5 Store and distribute your SOPs securely and efficiently

Storing and distributing your SOPs securely and efficiently will prevent unauthorized access, modification, or duplication of your SOPs. You can use a document management system or a cloud-based platform to store and distribute your SOPs. You should also assign access rights and permissions to different users or groups, depending on their roles and responsibilities. You should also ensure that your SOPs are easily accessible and searchable for the intended users.

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Tat Chan
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The original signed SOPs should be stored in a secure storage accessible by limited personnel (e.g. QA only). To aviod reference to the wrong version of SOP, the distribution can be done via a document management system where viewing and printing of SOPs are controlled (i.e. Controlled copy). For physical SOP copies, distribution should be recorded so that recipients are tracked. Whenever a newer version of SOPs are rolled out, the old version should be collected from those recipients followed by destruction (i.e. reconciliation)

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6 Train and monitor your staff on your SOPs

Training and monitoring your staff on your SOPs will ensure that they understand and follow them correctly. You should provide regular and relevant training to your staff on your SOPs, using various methods such as manuals, videos, quizzes, or simulations. You should also monitor and evaluate your staff's performance and compliance with your SOPs, using tools such as audits, feedback, or metrics.

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Tat Chan
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It is recommended to maintaining a training matrix and training curriculum by most QMS. All training dates, attendees, training materials and knowledge checks should be documented for audit purpose.

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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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How do you avoid duplication and confusion with SOPs for similar or overlapping processes?

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1 Identify the purpose and scope of each SOP

2 Use a consistent format and structure

3 Establish a naming and numbering system

4 Implement a review and approval process

5 Store and distribute your SOPs securely and efficiently

6 Train and monitor your staff on your SOPs

7 Here’s what else to consider

Standard Operating Procedure (SOP)

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