SOPs - Run for Cover?

Originally published in 2014

Someone recently asked me for a clear definition of a Standard Operating Procedure (SOP). Hmmm, good question. Everyone knows what an SOP is, right? It is that bunch of documents they made us read when we started here. SOPs define how we do things.

According to the Merriam-Webster dictionary, here is one definition for a Standard Operating Procedure:

“: established or prescribed methods to be followed routinely for the performance of designated operations or in designated situations — called also standing operating procedure.”

In regulated industries such as pharma, we need SOPs. The FDA and Health Canada and everybody else likely to come and inspect us expect us to have SOPs. Actually, they expect us to have a documented consistent approach to performing a process and for people to be trained on it.

Here is the kicker though…SOPs are often complex and convoluted and rarely written by the people who need to use them. So, do we read them or run for cover?

I once saw an SOP that was 50 pages long, it had a 5 page section called “generalities” at the beginning and it had 6 appendices, each two pages. So count them…yes, that means the SOP was actually 62 pages. Really? This was an SOP on regulatory inspections readiness. Do you think anyone felt ready for an inspection after reading this SOP? Not particularly. They just wanted to crawl into a hole and stay there until the inspector left the building. Bad idea.

Tip: Write the SOP as a process flow

So, what did our team do? Insert drum roll here!

• We brought together an operations and a quality assurance team.
• We went through the SOP and drew a flow-chart with the following steps: notification, preparation, execution, closing and report/action. That took a whole page.
• Then, we filled in the boxes with action words and wrote the procedure. A couple more pages.
• We removed the generalities since these were not needed (we couldn’t figure out if these were guidelines, obligations or just information that had been transferred from one version to the next).
• The appendices became instructions for specific types of tasks. Note: Although and instruction still requires proper approval, it can be changed more easily than an SOP as long as it does not affect the SOP content.

Voilà! A total of 11 pages to read:  One SOP 5 pages long, 6 one page clear and concise instructions, and a partridge in a pear tree! Oops, holiday cheer creeping in!

Skillpad help clients in Pharmaceuticals, Biotechnology & other regulated industries to reduce costs, increase profitability and improve efficiencies. 

Nathalie Bourgouin, PMP – Vice-President Compliance, Skillpad Canada Inc. is a leader in project management and a subject matter expert with an extensive background in risk-based quality assurance processes and training in manufacturing and clinical trials areas.