TRY THIS TODAY
A Roll of the Dice
The key to operational excellence is process documentation
by William A. Levinson
When it comes to documentation requirements, ISO 9001:2015 is much less prescriptive than ISO 9001:2008. According to clause 7.5.1 of the revision, an organization must maintain documented information required by the standard, and any additional documentation the organization deems necessary for the effectiveness of its quality management system (QMS).
What an organization considers necessary is key—under-documentation of key processes can put the organization’s quality and efficiency at risk.1 The organization must ask itself whether its goal is simply to become ISO 9001 certified, or whether it is to use the standard to achieve and maintain operational excellence.
How, for example, do you audit a process for which there is no documented procedure? One approach is to ask the process owner, "What is your process?" But a scene from the Broadway musical "Guys and Dolls" illustrates the possible drawbacks of this approach.
Big Jule, a gangster from Chicago, points a gun at the protagonist, Nathan Detroit, and demands a chance to win back the money he lost to Detroit playing craps. Big Jule insists on using his lucky dice, which are blank. He removed the spots for luck but assures Detroit that he remembers which sides of the dice are which. Needless to say, Big Jule soon wins back his money—and more.
Now suppose Detroit is a quality auditor and Big Jule is the process owner. The same interaction would look something like this:
Detroit: "But there isn’t a documented procedure for that process."
Big Jule: "I had the documented procedure removed for luck, but I remember what it is. Do you doubt my memory?"
Even if the process owner recalls the process to the best of his or her knowledge, not having a written procedure makes it much harder to understand or pre-audit the process for inputs, outputs and handoffs to other processes. If multiple shifts or job sites necessitate multiple process owners, each process owner may have a different—albeit legitimate—perception of the process.
Any process that influences the effectiveness of the QMS or affects the quality of the organization’s output should be documented—regardless of whether it’s explicitly required by ISO 9001:2015—because:
- Documents specify the best-known way to perform a job and prevent reverting to substandard methods.
- Documents support ISO 9001:2015’s process approach, including handoffs and interactions between processes.
- Documents are a form of organizational knowledge (clause 7.1.6) that, per Joseph M. Juran, hold the gains and prevent backsliding to inferior methods. This explicit concept predates the standard by roughly 90 years. Henry Ford wrote, "An operation in our plant at Barcelona has to be carried through exactly as in Detroit—the benefit of our experience cannot be thrown away."2
The first part of Ford’s quote makes it clear that the process definition cannot be left to the memories of individual process owners. The second part reminds us that the invention of writing is, regardless of the requirements of ISO 9001:2015, the foundation of all progress.
Don’t gamble with your process. If it has inputs from or outputs to other processes, or if it creates quality records, it almost certainly should be documented.
Note and Reference
- For more information about documented information, read "Guidance on the Requirements for Documented Information of ISO 9001:2015," International Organization for Standardization, https://tinyurl.com/y74dew3e.
- Henry Ford and Samuel Crowther, Today and Tomorrow, Doubleday, Page & Co., 1926.
William A. Levinson is the president of Levinson Productivity Systems P.C. in Wilkes-Barre, PA. He has a master’s degree in applied statistics and an MBA from Union College in Schenectady, NY, and holds ASQ certifications in quality auditing, engineering and reliability. Levinson is the author of The Annotated and Expanded My Life and Work: Henry Ford’s Universal Code for World-Class Success (Productivity Press, 2013).