Are Your SOPs "Reference-Crazy"?

February 4, 2013

While Standard Operating Procedures (SOP’s) are widely and rightly used to control processes, there is sometimes a tendency within organizations to go “reference crazy”. In a well-meaning attempt to be thorough, a generous helping of references to other SOP’s are placed throughout the text. The resulting tangled-web of references may become so difficult to deal with that writers will compensate by creating less-than-optimal SOP content, further compounding the problem that will eventually have to be addressed.

Fortunately, the frequency and impact of SOP references can be minimized through a disciplined approach to content, and emphasis on the organization’s training program. Writers should keep SOP’s focused on describing (in simple, concise terms) the steps of a specific process. Under this approach, the need to reference other SOP’s might actually indicate poor process definition.  It may also become an opportunity to eliminate redundant (and possibly contradictory) documents.

Consider eliminating any SOP reference in the “References” section that is not cited in the body of the SOP, as this is a sure sign that the reference is not part of the process. The process-focused approach also helps resist the temptation to use an SOP reference to “remind” the reader about all the other important SOP’s out there. Leave that job to the training program, which should include the requirement for an employee-specific training syllabus identifying the critical SOP’s across the quality system, for which evidence of training must exist.

Please consider the opportunity to employ these techniques to realize the benefits of minimal SOP references, the next time you create, modify or review an SOP.

TAGS:

July 7, 2016

FDA Issues Quality Metrics Technical Conformance Guide

On July 28, 2015, the FDA published a draft guidance, entitled “Request for Quality Metrics.” The draft guidance “outlines FDA’s authority to require owners and operators of such establishments to...

September 11, 2013

Do Not Neglect GMP in your Serialization Project

In what for some may be a relatively chaotic run-up to meeting California’s 2015 serialization regulation, it is critical for serialization project managers to assure implementation falls within the...

Sustainable Media Program for the Pharmaceutical Industry, Part I: Simple and Straightforward Information and Tips

Would your media program pass the test? The FDA inspection test, that is. In this new blog series, ProPharma Group’s Simona Gherman breaks down the FDA regulatory requirements for a successful media...