What are some of the common challenges or pitfalls of writing SOPs for specific outcomes and objectives?

Writing SOPs for specific outcomes and objectives can pose challenges. These include unclear objectives, overcomplication, inadequate planning, lack of stakeholder involvement, resistance to change, insufficient training, and inconsistent enforcement. Overcoming these challenges requires careful planning, stakeholder engagement, effective communication, and regular review and revision. By addressing these challenges proactively, organizations can ensure that their SOPs effectively support the desired outcomes and objectives.

The scope of the SOP should be drafted early with input from all relevant stakeholders. Check that the scope does not overlap with existing SOPs. This check should include discussions with stakeholders/users. Keyword searches of existing SOPs may also be useful. The scope should be sufficiently focused that the SOP does not become too long. A good next step is drafting the SOP title. The title should be consistent with the scope and as concise as practical. Ask the stakeholders/users if the title makes it clear when the SOP should be used.

SOPs can be written in unclear or ambiguous ways, leading to confusion and errors. To avoid this, make sure instructions are concise, specific, and easy to understand. Use simple language, provide clear explanations, and consider using a table format to structure the SOP. Break down complex procedures into manageable steps and use visual aids when appropriate.

I work in the Pre clinical field and follow the GLPs, 21 CFR part 58. The GLPs provide the requirements of an SOP. I am writing mostly Equipment and Process SOPs. If you are writing about your process for doing a task, best to break it down to be clear on the steps.

Also, try and avoid using SOPs as a dumping ground for CAPAs, unless the intended change to an SOP (resulting from a deviation) has not been attributed to other outliers i.e. training issues, conflict of SOP application with downstream users, etc.

Write SOPs to convey a process and provide contingencies if the process cannot be followed. The SOP should have roles and responsibilities defined so the end user knows who to go to when questions arise.

Often flexibility prescribe a step-by-step path. But some outcomes don't align well with prescription. They require experimentation, adaptability, and flexibility. In those instances, it's helpful for the SOP to state explicitly that divergence is allowed. Perhaps, there could be a template where you document divergences from procedures with your rationale and applicable outcomes.

I want to add two other common mistakes: - Inadequate structure: Poorly structured SOPs make it difficult for users. To overcome this, organise the document logically, using headings, subheadings, etc. I like structuring the Procedures part of the SOP in a table format which makes it user-friendly. Ensure consistent formatting to improve readability and make it easier for users to navigate the SOPs. - Missing or outdated information: SOPs should be kept up to date to reflect any changes in processes, equipment, or regulations. Establish a process for reviewing and updating SOPs, involving subject matter experts and stakeholders. Maintain a centralised review and approval process to ensure consistency and alignment with company standards.