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.

{ 2 comments… read them below or add one }

Vanessa Jackson November 13, 2010 at 2:17 pm

I think SOP’s should be just that. A standard. It should not contain far too many intricate details.. Leave that up to your work instructions or Training manuals. For example,. the exact annual training test should not be included in your SOP. I think the SOP should simply state “a qualifying test will be utilized at each session.” If this is not done then each time you change the test… then you MUST change the SOP. Rules, regulations studies etc. change with time, and so should your training materials. Now the HACCP plan must be detailed, but overall make this a very well written standard. I once had an SOP that stated”all QA doors must remain locked at end of day”. Well, how was I going to SHOW that this was done.. another form of course perhaps….so I removed it and just place signs on the door..”only authroized EE allowed”….. NEVER had one problem with an auditor over this. What do you think?

Sandra Gauvin November 13, 2010 at 10:34 pm

I agree that many SOP’s contain too much information, much of which is non-value added and put a company at risk during an audit. The best situation is to provide the ‘how to’ details in a work instruction and training. Unfortunately, many companies use SOP’s as work instructions and either have too much information that’s difficult to maintain or the SOP’s are too vague and the training is poor…either situation can lead to issues (e.g. nonconformances, audit findings).

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