Although SOPs vary from company to company—and sometimes from facility to facility within the same company—they should all
have a consistent format that reflects applicable regulatory compliance requirements and includes "how-to" information specific
to the job task (Figure 1).
Figure 1. An example of a standard operating procedure
Because the purpose of an SOP is to ensure consistent, compliant performance of employees and processes, it goes without saying
that SOPs should be understandable to users. Unfortunately, many SOPs are not. The FDA requires that authors of SOPs be qualified
individuals with necessary technical and compliance experience and expertise in the particular subject matter addressed by
the SOP. Yet, those qualified authors, despite their experience and expertise, may lack the necessary writing, instructional
design, and technical skills to effectively communicate with workers with different learning needs. In addition to varying
literacy levels, companies increasingly face the challenge of presenting SOP information in multiple languages, or in conformance
with different cultural norms. That challenge is unlikely to shrink. Even as life sciences companies continue their global
expansion, they are likely to be held to the same SOP requirements, either imposed by FDA or by comparable regulatory authorities
in other countries.
Fortunately, technology now offers alternatives to the infamous SOP manual that afflicted generations of employees with incomprehensible
material. Internet-based technologies can produce SOPs that cut through the fog created by pages of written explanations.
Graphics, animation, sound, and simulation can be employed to illustrate proper procedures and processes, rather than merely
explain them. Skillful use of these instructional techniques can engage employees and enhance comprehension, ensuring that
the SOP's intent is achieved. Optimally, SOPs are developed by teams of professionals, equally proficient in the subject matter
as in technology, the learning psychology of adults, and interpersonal communications.
SOP distribution may appear simple and easy. It is neither. Hundreds or thousands of SOPs that change regularly with any shift
in regulation, corporate policy, or production process can easily affect hundreds or thousands of employees. It is not unusual
for employees to experience, within a relatively short period of time, SOP versions one, two, and three for the same job task.
The FDA requires that SOPs be distributed in a timely manner and that each employee validate the receipt and understanding
of it. The volume of material that must be distributed, validated, and stored virtually requires a technology-enabled system,
such as an Electronic Data Management System (EDMS). Dozens of vendors offer SOP or document management systems, but not all
systems are equal. An optimal system must comply with all Part 11 regulatory requirements, provide secure access for program
monitoring and management, and store data in an audit-ready format that is quickly available for FDA examination during an
inspection or investigation.
The days of simply distributing information to fulfill regulatory requirements are long gone. Today, the standard of SOP compliance
requires that SOPs be applied. "Failure to follow written procedures" occurs frequently in FDA's 483s and Warning Letters,
suggesting that employees neither understood nor applied the necessary knowledge to properly fulfill their job responsibilities.
Interestingly, many of these violations occur in companies compliant with basic SOP requirements related to written procedures,
and distribution and validation of employee receipt and understanding of the SOP. Yet, those same companies often lack a mechanism
to confirm comprehension.
All SOP programs should incorporate testing or evaluation features that clearly establish an employee's level of comprehension
for any individual SOP. Online-based testing gives managers immediate access to this information, promoting timely responses
to identified knowledge gaps. Just as important, testing documentation assures regulators of a company's commitment to effective
employee education rather than simple document distribution.