Before you start writing or updating your SOPs, you need to have a clear idea of what they are meant to achieve and who they are for. Define the scope and objectives of each SOP, and align them with your organizational goals, policies, and standards. This will help you avoid duplication, confusion, or contradiction among your SOPs, and ensure that they are relevant and useful for your intended audience.
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Consider this idea: instead of viewing SOPs as rigid documents with a set format, why not adopt a more flexible approach? By managing knowledge units, we can easily share them across various SOPs in a modular fashion. This approach allows us to represent knowledge in a temporary format that can be aggregated when and where needed. So why not try it out and see how it can streamline our processes and boost our efficiency?
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To ensure consistency and accuracy across multiple SOPs, establish standardized formats and templates, maintain centralized management, implement version control, include cross-referencing, conduct regular reviews, provide training and communication, perform quality assurance checks, adhere to documentation standards, align with best practices, and incorporate feedback mechanisms. Through these steps, organizations can maintain uniformity, clarity, and reliability in their SOPs, enhancing operational efficiency and compliance.
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For businesses with operations that run 24/7 or both weekdays and weekends, if the SOP is only applicable to day shift or night shift workers, OR is applicable only to weekday employees ensure this parameter is captured in the scope section. For instance, let us say that ABC Clinic operates during the week and on Saturdays. The Administrator wants to capture the registration process but recommends, since the process is drastically different during the week than on Saturdays, that the SOP owner write two different SOPs. The "scope" section of the SOP being written for the weekday staff could read, "This SOP is applicable to weekday patient registration only. For details on how to perform Saturday patient registration see SOP X."
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Establish the scope and aims of your SOP Before commencing the creation or revision of your SOPs, it is imperative to possess a distinct understanding of their intended purpose and audience. Clearly outline the range and goals of each SOP, harmonizing them with your organizational objectives, policies, and benchmarks.
One of the easiest ways to ensure consistency and accuracy across multiple SOPs is to use a common template and format for all of them. A template can help you structure your SOPs in a logical and standardized way, and include all the necessary elements, such as title, purpose, scope, roles and responsibilities, procedures, definitions, references, and approval. A format can help you use consistent fonts, headings, numbering, spacing, and colors for your SOPs, and make them easy to read and follow.
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Balance the length against the number of different Standard Operating Procedures. For complex processes, such as Sponsor's Clinical Oversight, consider writing an SOP with multiple work instructions and associated forms and templates rather than a lengthy procedure. Use visuals to make it easy to absorb. Incorporating charts and diagrams within written procedures to explain activities can help present complex information in a digestible manner and increase process adoption.
Another important step to ensure consistency and accuracy across multiple SOPs is to establish a SOP review and approval process that involves all the relevant stakeholders. A review process can help you check your SOPs for accuracy, completeness, clarity, and compliance, and identify any errors, gaps, or inconsistencies. A approval process can help you validate your SOPs and ensure that they have the authority and endorsement of your management and subject matter experts.
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In my experience when writing SOPs we use the following process: 1. process owner writes the SOP; 2. sends it to be tested by a fellow colleague; 3. sends to their supervisor for review of accuracy and to ensure it follows the company's standard; 4.on a regular cadence the company's designated "SOP Officer" conducts a QA check on at least 10% of all SOPs.
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It will be an effective approach that before publishing leaders should have subject matter experts look over SOPs to ensure they are correct and easy to understand. Management and a quality assurance group should also have a look at the document to furnish input or make any changes. The objective is not to get the document in a place where it is never published, but it is important to have diverse perspectives so the SOP can address them.
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I learnt that all the SOPs are linked to organisational missions and goals. They are governed by project governance which defines the basis of application of SOPs to projects. Moreover the business and the environment in which business operates would be never the same so to be relevant, it is important to review the SOPs periodically and update them as needed.
Once you have created and approved your SOPs, you need to implement a SOP management system that allows you to store, distribute, access, and update your SOPs easily and securely. A SOP management system can help you keep track of your SOP versions, revisions, and statuses, and ensure that everyone has the latest and correct SOPs at their disposal. A SOP management system can also help you monitor and evaluate the effectiveness and compliance of your SOPs, and trigger any necessary changes or improvements.
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SharePoint is a great tool to leverage for an SOP management system as it allows you to limit access, store previous versions, and see when the last time a document was accessed, as well as who accessed it. It is good idea to establish a naming convention when it comes to titling SOPs to further drive consistency. For instance, determine whether you want the title of the SOP to start off with "How to..." or with an actual verb, e.g., "Perform...", "Check...", "Facilitate..." Will the title be followed by the department/unit's name? Such standards should be communicated in any applicable SOP guides.
Finally, to ensure consistency and accuracy across multiple SOPs, you need to provide SOP training and feedback to your staff and stakeholders. SOP training can help you educate and inform your staff and stakeholders about the purpose, content, and expectations of your SOPs, and ensure that they understand and follow them correctly. SOP feedback can help you collect and analyze the opinions, suggestions, and issues of your staff and stakeholders regarding your SOPs, and use them to improve your SOP quality and performance.
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Individuals identified to write the SOP should be trained on how to do so and how to utilize any associated templates and/or software. Previously written SOPs are a great training tool as well.
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SOP management should be electronic. That way version controlling, traceability to who has access, training and finding overlap would be almost error proof. Whenever a procedure is being updated; a find/search option will help find all documents cross referenced and all of these documents can be identified in the change control. Secondly, whenever there is overlap; only a cross-reference to the topic should be made - eg. refer the current version of the balance operating SOP. In the references section; the SOP number can be mentioned. That way the risk of incorrect content is minimized.
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Collaboration between various functions and departments is critically important, as a change in one SOP could require an update to another Controlled Document, and you should approach the review and update of your internal Quality Management System holistically.
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