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The Myth of the Generic SOP

Copyright (c) 2009-2019

How many times has this happened to you? You have been assigned the task of writing a Standard Operational Procedure (SOP). When you grimace and explain that you don't have an extra eight hours to spend on it, your boss says "Why can't we just download a generic one off the internet?" He says this with such naivete that you realize that more discussion is pointless. You decide to give in and go along. Big mistake.

Before we find out why let's review what an SOP is supposed to do. An SOP is a set of instructions for employees that allows them to perform complicated tasks correctly. It also defines a single way that tasks are done in your company. Even though many different employees may be performing the task, an SOP insures that they all do it the same way.

So here you are with your fresh generic sop. All you have to do is substitute in your company's terminology, train the employees, and get it approved, right? Let's see what happens.

The first thing you need to do is find out how your company performs the task. Easier said than done. Usually there's no one person in the company that knows. Let's assume you gather the knowledgeable people together. Now you're ready to begin substituting your company's terminology into the new SOP.

The problem with substitution is that it doesn't work one-to-one. Where your company has one department, the generic SOP mentions two. Where your company has two forms that need to be filled in, the generic SOP has nothing. Your new generic SOP covers parts of the task that are described in other SOPs that you already have. It leaves other parts of the task uncovered and you have to write that part of the SOP yourself.

This generic SOP also doesn't allow you to take advantage of modularization. That's when you break up a complicated task into subparts, each with its own SOP. In every place in one SOP that mentions a particular subpart simply refer to the SOP for that subpart in your new SOP. This allows you to keep SOPs down to a handy size. And you can easily modify a subpart of a task without having to update a large SOP.

So simple substitution turns out to be more difficult than advertised.

Well, after spending half a day twisting and cutting the generic SOP to fit your terminology you're ready to train the workers. But now it gets worse. No two companies have the same procedures at the detail level; and that's the level that an SOP needs to be written at in order to be useful. As you attempt to train the employees they point out all the embarrassing gaps in the new SOP. It's so vague that it doesn't help them to know the details that they need to follow if they are going to do their job right. Their respect for you is now non-existent.

The new SOP is actually worse than useless because there is an appearance of control that doesn't really exist. Employees don't have a single way to perform the task. The new SOP does not fully define the task. So the company now has as many ways of performing the task as there are employees do it.

At the end of the day you can go back to your boss and get his approval for the new SOP. Maybe he'll be happy to see you, but probably not. He'll want to know what you've been doing all day long. After all, it should only have taken you an hour to download that generic SOP and train the employees. So you've had the rest of the day to get real work done.

Would it have been better to give him the bad news up front? Probably so. It would have taken you the same amount of time to write a good SOP from scratch. But you would now have an SOP that is actually useful. You would have a single defined process for your employees to follow. And you would still have their respect.


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Norm Howe, Senior Partner at Validation and Compliance Institute, consultants for the pharmaceutical and medical device industries. He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA. He has held many management positions in FDA regulated industries, most at BASF. http://www.vcillc.com

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Last Distribution Date:
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