Oops You Did it Again – Revising Standard Operating Procedures

by Sandra Gauvin

I’m sure you’ve had this happen before, where an auditor (internal or external) has cited you with a finding, 483, or an observation that you quickly addressed by adding a line or two of information to a particular Standard Operating Procedure (SOP)…that was easy.

But then you go through another audit and find yourself making more changes to the same SOP.  Within a couple of years, that one SOP could have gone through several revisions as a result of audit responses…especially if it’s a global procedure.

What you may not realize is that over time, the SOP slowly becomes misaligned from a process perspective when you add or delete information without evaluating the entire SOP.  Any misalignment will make it difficult for staff to follow or even understand.  Next thing you know, the procedure is associated with several nonconformances.

Additionally, a simple change to one SOP may impact other SOP’s, so it’s important that you understand the relationship between procedures and the processes they govern.  An example would be your noncnformance (NC) and corrective and preventive action (CAPA) process.

Let’s say you made changes to your nonconformance SOP that required all investigations to have a CAPA assigned to them.  Had you read the CAPA procedure, you’d realize that only nonconformances that pose moderate to severe risk must have a CAPA.

Which requirements are people supposed to follow since the two SOP’s have conflicting information?  And what about your response to an auditor that questioned why some investigations didn’t have a CAPA assigned to them?  And lastly, how many nonconformances were a result of this oversight?

In the end, your good intentions of addressing an audit finding by quickly revising an SOP may result in more problems.  The next time you’re asked to add a line or two to an SOP, follow these guidelines, then proceed with confidence!

  1. Always access the entire SOP before making changes. This will help you identify confusing language or potential conflicts within the procedure itself…make sure the process within the SOP makes sense!
  2. Identify other SOP’s that may be impacted by the changes and revise as necessary. This can be simply done by understanding the relationships between processes.

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