Procedure—Noun
An established or official way of doing something.
SOPs—Noun
Standard Operating Procedures
Practice—Noun
Actual performance; application of knowledge
Why is it important to review your facilities procedures (SOPs) against the actual laboratory execution practices? Per the definitions above, SOPs typically reflect the execution instructions derived from a validation or qualification protocol. Generally, the SOPs are written by Management or Senior Technical staff. While laboratory procedures are most often transmitted verbally between employees or found in notes “on the wall.” Laboratory practices tend to simplify workflow or use of equipment that the personnel have learned/picked up over their time performing the procedures.
Standard operating procedures (SOPs) are step-by-step instructions that function as guidelines for employee work processes. These are step by step instructions that are written to ensure the product that is produced is consistent and predictable over time.
As the laboratory business grows, the complexity of the work being performed increases, staffing increases, and training workload increases. Simultaneously, there is an increase in the number and types of analytical equipment used, SOPs, and Test Methods. During fast growth, it is stressful for laboratory staff, and it is easy for the executed tasks to start to diverge from the SOP.
Examples include:
OA Test Method was written while the lab was new and had a limited number of analytical equipment. The method describes a bioassay where the process has not changed, but specifically defines the plate reader to be used. At the time it was written, there was only one plate reader. Due to growth, now there are multiple plate readers available. There is now a deviation from the Test Method. Since this error probably will not influence the product (sample result), it can mistakenly be let go.
A second common error is when the process changes due to optimization at the bench. An example is a test method that has been validated and has hundreds of samples to analyze over a long period of time. The laboratory personnel started to optimize or streamline the procedure. For example, how long you leave a sample on a vortex mixer or only use a particular piece of equipment. These types of errors occur when the laboratory workers have been performing the assay for so long that they are able to optimize the method. Unfortunately, if the method is not properly updated, this is also a deviation that will need to be investigated.
A third scenario that can occur is when analysts train new analysts “by memory” and/or incorporate the “optimizations” into the training of the new person. This can perpetuate the gap between what is supposed to happen and what actually happens.
It is these perceived small and “unimportant” changes that build up over time until practice has diverged significantly from procedure.
Process Alliance has decades of experience in laboratory design, setup, SOP generation, process vs procedure audits, and management. We strive to provide high value and quick project turnaround to support our clients' goals of competitive excellence.
Written by Rick Delhaye, Senior Science Consultant at Process Alliance. Rick has a 25+ year career in the lab, specializing in good lab procedure, implementation and design.