How do you balance simplicity and detail in your SOPs?

I like to keep SOP's simple and clear so that it is easy to comprehend, easy to comply, and easy to remember. That means NO work instructions, short and sweet (nmt 4-6 pages), and not complicated. I like to think of an SOP as a Strategy - What we are going to do - and work instructions are the Tactics - How we are going to do it.

SOPs should be written from the perspective of the people that are expected to follow the procedure. They are not prepared simply to tick a box - we have an SOP, or for the auditor. SOPs must allow the users / operators to follow the procedure consistently.

In crafting SOPs, it's crucial to strike a balance between simplicity and detail. Focus on capturing essential steps while using clear and concise language. Break down complex procedures into manageable segments and supplement written instructions with visual aids. Provide enough detail to guide users effectively without overwhelming them. Solicit feedback from users and adjust SOPs accordingly to ensure clarity and usability. Effective training and support further enhance user understanding and compliance, fostering efficient process execution.

I like to split detailed instructions on how systems work into hyper-linked documents (work instructions), so the SOP shows just who should be doing what in (roughly) what order and how documents and outputs interact in the process.

Main points are covered in the 1,2,3 There are many ways that modern, electronic documents can be structured to deliver a good balance of simplicity and detail that were not available 20 years ago. Integral or linked process maps provide a simple introduction for the first time reader/trainee & are very helpful for procedural branches (If x=true, then do y). Standardised sections & subsections can be indexed with hyperlinks for easy navigation & links can be included for detailed Instructions to be read at the appropriate part of an SOP. html (for the whole document, as a MS Word display format or PDF output) makes linking, navigation & format standardisation easier, enhances legibility & allows sections to be expanded/collapsed as needed.

One of the most important part of SOP writing is simple language. In my experience, using flow charts/diagram is always helpful. Using extraordinary vocabulary is never encouraged in SOPs.

Provide only the detail necessary for the users / operators to follow the procedure consistently. Avoid ambiguity or what may be done. State what must be done. For critical steps it is useful to include why it is important but don't try to explain why for each step. It can be overwhelming and distracting.

The SOP's should reflect what you are actually doing - even if it is not what you would like. Let employees write down their perspective of what they are doing and you can translate that into SOP-speak. If there are obvious GMP violations, then correct it on the spot, otherwise use the Change Control process and work in concert with employees doing the work to ensure clarity, comprehension, and compliance.

Involve the key people, doers in SOP building process. This will help you not only write a simple yet effective SOP, but also you will be aware of the main challenges on bench and can explain or notify that situations in your SOP.

It’s important for the team writing and owning the SOPs to stay updated. In the current era where technological advancements and regulatory requirements are evolving so fast, keeping yourself updated and aware is imperative. Keep a revision process frequency however your SOP should be upgraded with current changes . While changing a process seems to sound simple , but sometimes it comes with a holistic overview. If you do not look your systems affected by the change you may end up loosing the compliance . process mapping and planning is therefore necessary while you are revising SOP.

If you implement file audits, it becomes a little easier to keep SOPs updated. Our SOPs are mostly concise ASTM methods which get updated frequently. A file audit will force you to evaluate the source material, keeping your crew up to date.

It’s important for the team writing and owning the SOPs to stay updated. In the current era where technological advancements and regulatory requirements are evolving so fast, keeping yourself updated and aware is imperative. Keep a revision process frequency however your SOP should be upgraded with current changes . While changing a process seems to sound simple , but sometimes it comes with a holistic overview. If you do not look your systems affected by the change you may end up loosing the compliance . process mapping and planning is therefore necessary while you are revising SOP.

I agree that training systems should be strong to make the process or change go to the depth. You can write simple and understandable SOPs , but if your training system is weak, you will fail as a team somewhere. You can use classroom training sessions with team, in form of presentations if it is talking some process change , explain the change with the background.

Having a master training excel sheet, that is coded to flag SOPs after a certain time frame will force you to look into a workers training. If it has been awhile, or if there's updated to the method, implementing a technical method assessment gives management the tools needed to evaluate a workers competency.

Since starting in the pharma business back in '90s when writing SOPs to follow this one and only rule: KISS - keep it simple stupid. Why, because my supervisor at the time said, "you have to write procedures as if you're pulling a random person in off the street to work in your multi-million facility to make a billion dollar product and you want to make sure they can read, understand and execute the process w/o to much difficulty.

Chunk your work instructions into bite size pieces to help the end user retain the information faster. This also helps the end user better navigate to where they need to be at the time. Add visuals to accommodate the visual learners.

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