Spoiler Alert: This article isn’t going to tell you how many SOPs to create.
Instead, I want to provide a framework for thinking about SOPs and other documents, and what the benefits are to different approaches. Each company will handle this question differently, depending on the specific tools and shortcomings of that company. However, it’s best to take a conscious approach to this question.
What do I mean by SOPs?
In the Quality world, people love to use different terms and acronyms for the same things. What I mean by SOP is: Standard Operating Procedure, Quality Procedure, Procedure, Top Level Procedure, etc. Wherever you document your training process is what I mean as an SOP.
However, the same approach can be applied to Work Instructions (WI, work guides, work standards, you get the point). All of the documents ultimately fit into this same framework.
What do you need to document?
When a company decides to embark on the mission to meet a QMS standard (such as ISO 13485), they are presented with a list of processes that it must create and document. These processes will eventually be documented in SOPs.
If the company wants to meet the standard, they don’t have a choice for which processes to implement. Everything in the standard must be documented in some way (outside of exclusions and non-applicable sections).
That said, no one is telling you the number of SOPs you need to contain all of these processes.
If you are an absolute lunatic, you could put every SOP for your company in one giant Quality Manual (believe it or not, you could pull this off and still have a shorter Quality Manual than some companies).
On the other hand, if maintaining documents is your passion, you can create an SOP for every aspect of design control or each line of your document control process (review of documents, approval of documents, availability of documents). I’m not stopping you (your boss probably will).
For a more realistic example, look at our recent articles on Supplier Management, Purchasing, and Verification of Purchased Products. An organization can combine all these processes into the same SOP or break them out into individual SOPs. Or, it can put Supplier Management and Purchasing in one SOP, and add Verification of Purchased Product in to an SOP on inspection. Or any other combination that makes sense!
How do they choose?
What this comes down to is: do you want a larger number of SOPs that are more concise or fewer SOPs that are longer?
Greater Number of SOPs
I’m going to talk about having more SOPs that are concise first because that is my bias. But, I won’t judge you for taking a different approach; it’s your QMS and organization.
The benefits of this approach are:
- The more precise an SOP is, the easier it is to find the relevant information in the document.
- It’s easier to train people on a particular process. Maybe your Purchasing personnel need to train on both the Supplier Management process and Purchasing process, while Quality personnel only need to train on Supplier Management. If both of these processes are in one SOP, you can’t differentiate the training.
- Speaking of training, I believe this approach is better for having people actually read documents. If you hand them a 25-page procedure, it’s going to be a slog to get through. If you hand them five 5-page procedures, they can get through each one of them with a cup of coffee.
- Changes:
- If the process is specific, you might need fewer people to review and approve changes to an SOP.
- If you need to make a change to an SOP, you can do so without affecting broad procedures.
The issues with this approach:
- You have more documents to maintain and review.
- While I believe this is a better approach to training, it is certainly harder to maintain training documentation.
- It can be harder to find the particular document you need.
- In an audit scenario, you will need to flip between more documents.
- This approach will necessarily lead to a greater number of changes. If the change control process is complicated, this will be a challenge.
- If you require a lot of preliminary information in your procedures (responsibilities, definitions, etc.), you may end up with a bunch of documents that are one page of intro and half a page of the actual procedure.
Looking at these, it’s easy to imagine why this needs to be an organization-specific decision. If you don’t have a good system for handling documents, it will be difficult as there are more documents to maintain. If the company’s change control process is a slog, you might want to make fewer changes.
This is why it’s best to understand how everything functions within a system at your organization.
Fewer SOPs
In the other corner, let’s look at having fewer SOPs that are longer. Overall, you can take the above pros and cons, and flip them for this approach. So, to keep things interesting I will try to add some new information on the specifics.
Some benefits of having fewer SOPs are:
- This approach could be better if your SOPs are focused on a very high-level view of the process with separate Work Instructions to build out the specifics.
- It can make your SOPs seem more important. Looking at the typical document pyramid, you have policies at the top, followed by SOPs. If you have only 10 SOPs, they may feel more significant than 30 SOPs. It’s all about perception, after all.
- All of the documents will be easier to maintain. You do not need to review as many procedures or have as many documents in training files, it will reduce your records and more.
- You can combine similar processes. If you want everything related to one subject in the same area, this is the way to go.
Additional risks and issues with this approach:
- Making a change or editing the document could feel like a monumental task. Do you really want to change a 30-page SOP to fix a couple of minor issues? Or, you can add them up as drafts over time and leave yourself with a massive undertaking when it is time for change control.
- It could be harder to match each process required by ISO to the correct SOP.
- Training will be more difficult. People will have to read longer documents, or, if you are doing in-person training, employees will have to take in a lot of information that does not apply to their job.
- If the company decides to implement a completely new process, say, human factors, where are they going to put it? Will it be the only shorter SOP? Will it be added to the design control process, making it even longer?
Once again, you will have to do what is best for your organization. There is no set number or limit of required SOPs, and each approach should be based on the unique situation.
Put things where they make sense
Finally, when you are deciding on how many SOPs you need at your company, remember to put things where they make sense. Keep it simple.
While I prefer having more SOPs that are shorter, this doesn’t mean I break things up as much as possible. For example, when I created a document control procedure at my company, I included a section on records.
Could I break them up if I really wanted to? Sure, but it would not add the same benefits that I discussed.
For example, the documents and records live in the same place within our QMS. If there were two SOPs, I would have to discuss the system twice. Also, everyone who is going to be trained on document control is going to be trained on records.
However, if this is different with your organization or your document control procedure is becoming too lengthy, it’s totally fine to break them up.
Another example is with Corrective and Preventive Actions. Are these the same processes? Technically no, and they are in two different sections of ISO 13485. But do they use the same system? Are they similar enough to combine? This is why most organizations choose to have one CAPA SOP.
Put each process in the SOP that makes the most sense for your organization while keeping SOPs lean enough to get the benefits discussed above.
Didn’t you mention something about Work Instructions?
Yes, much of what we talked about for SOPs can also be applied to Work Instructions.
Say you are assembling a wheelchair.
If one person is assembling the wheelchair from assorted parts, it could make sense to have a single WI titled Assembling the XXXX Wheelchair WI.
However, imagine there’s a welding step involved. You can ask yourself: “Is the welding process performed only for this one model, or is it used on many different wheelchairs”?
If the company has a welding step for multiple unique models of wheelchairs, you could break out welding into its own WI, and reference it in the assembly WI. If the welding is only for one model but is performed by a separate individual or functional group, it could also make sense to break up the WI.
That said, it’s not a great idea to take this to the extreme. Maybe all of the wheelchairs involve a step to screw in the wheel. This doesn’t mean you want an entire WI dedicated to screwing in the wheels that is one step long and is referenced from all of your assembly WIs.
The goal is to find a balance between having someone jump between 20 different documents and having massive, cumbersome WIs that include long, repeated sections and involve five different functional groups.
Wrapping Up
Hopefully, this article was able to bring you some clarity on how you want to document SOPs and WI for your QMS. If you liked the article, be sure to check out the rest of the website which is focused on making better Quality Management Systems, and sign up for our newsletter below.