SOPs: What You Need to Know

Mark Crawford

According to the FDA, the problem cited in 60 percent of all warning letters is SOP—standard operating procedures.

That’s actually a good thing because it is relatively straightforward (but not always easy) to fix SOPs. Identifying them is one thing—they also need to be concise, clearly written, well-communicated, monitored, and enforced. Taking the time to meet or exceed FDA SOP expectations will not only bring you into compliance but also improve operations and productivity in every department—leading to higher quality, improved profits, lower costs, faster delivery to market, and improved customer satisfaction.

Although you may have staff that can handle the review and overhaul of SOPs in all your departments, chances are they don’t have the time. In addition to being available, experienced SOP consultants in the medical device industry have the advantage of accrued experience from working with multiple companies across the industry. They also know what the FDA wants.

Edwin Wallbusser is an experienced medical device consultant in the greater Philadelphia area and founder of Medical Device SOP Advisors (, which—you guessed it—specializes in SOP procedures. He offers the following suggestions regarding SOPs:

What is the biggest problem medical device manufacturers (MDMs) have with SOPs?
Wallbusser: The biggest problem is level of detail. If the SOP is too short there may be several interpretations of the procedure. If it is too long and detailed it runs the risk of not being referred to because it is difficult to understand.
When it is the top complaint by the FDA regarding SOPs?

Companies are trying to game the system by quickly restating the regulation in a SOP format. The result is obvious—it is not a system that can be followed to achieve a result.

What is the solution?

The MDM must take the time and the expense to first develop a system that meets the regulations and works (test it!). Then, when everybody involved buys in, document it.

Can you audit SOPs internally?

Definitely. Organizations and procedures evolve and should be changed through a change control process. You do not want the FDA to find that people are following their own version of a procedure and maybe using hidden sticky notes as reminders
What is the advantage of getting a consultant involved?

An experienced consultant knows what to do and how to do it—this saves time and achieves better results. In the long run it saves money by avoiding FDA problems. It is even more cost-efficient to start with proven, generically written SOPs, such as those found at, and customize as needed. A good consultant customizing generic SOP templates will spend typically 1-2 hours per SOP. SOPs should be audited in detail as part of the companies internal audit process.

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