Leverage the Power of SOPs

Effective SOPs serve as a tool for 
maintaining high quality.

by Cindy Fazzi

Editor, MasterControl Insider

Most companies establish standard operating procedures for compliance purposes, but that’s just the start and it doesn’t leverage the power of SOPs, according to Lillian Erickson, MasterControl’s global quality manager, in a recently published article in Fleet Maintenance magazine.
Erickson told the magazine that SOPs are meant to standardize processes and reduce risk. “A large company without SOPs runs the risk of having ‘too many cooks in the kitchen’ and not having critical processes performed consistently,” she said. “A small organization without SOPs runs the risk of having very little oversight, and therefore, making decisions based on best guesses.”

The article, “The Effective Use of Standard Operating Procedures,” is part of a series titled “How to Drive Performance Improvement.” It was published in the April 2016 issue of Fleet Maintenance, a publication for the vehicle industry.

This article is related to the White Paper: 
Writing and Enforcing Your SOPs for GxP Compliance Success
To get the full details, please download your free white paper.

While SOPs are important, they sometimes have unexpected disadvantages. “I often run into procedures which were created with no room for flexibility at all. However, many processes have more than one good way of achieving the required end,” said Erickson, who spearheads MasterControl’s quality-related efforts, including its successful ISO 9001:2015 certification audit last year.

She has worked in the field of quality for the past eight years, starting in document management and then specializing in quality compliance. During that time, she has hosted over 200 client audits, led six ISO audits, and participated in over 10 FDA, EMEA, and other regulatory entity audits.

4 Don’ts in SOP Writing

Erickson imparted some “don’ts” when creating SOPs:
  • Avoid using overly verbose prose;
  • Avoid huge paragraph chunks; bulleted or numbered lists are better;
  • Don’t presume the reader knows the same things the writer knows;
  • Don’t gloss over the basic details and don’t assume they are already well-understood.

   If end-users can’t tell what they need to do after reading an SOP, then it has failed. “Objectives should be clearly stated. Responsibilities should be clearly defined. Deliverables should be clearly called out,” said Erickson.

Read the Fleet Maintenance article:

Cindy Fazzi is the editor of MasterControl Insider, a monthly publication for MasterControl users. She writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master’s degree in journalism from Ohio State University.