At the risk of sounding like a pharmaceutical quality assurance heretic, standard operating procedures (SOPs) often don’t work as intended. In fact, they can do more harm than good by giving a false sense of security: “We must be OK; we have procedures for that.”

Having procedures is certainly important. The U.S. Food and Drug Administration (FDA) cites the absence or inadequacy of procedures as a compliance problem. Industry spends a lot of money on staff and infrastructure to put procedures in place. And ironically, more money is spent on validating a document management system than ensuring that the SOPs that flow through the system are effective.

Procedures are often more form than function. Words on a page don’t necessarily make things happen as intended. I have observed the general neglect of procedures for many years and have concluded that there are common reasons why procedures don't work.

Let me turn the problems around and list these 12 ways to improve the effectiveness of procedures.

1. State the purpose of procedures

Without a clear understanding of why we place such a high value on procedures in our industry, we can easily end up with a random collection of documents that vary in quality and content as much as the skills and viewpoints of the authors who create them.

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