Standard Operating Procedures (SOPs): How to Write Them to Be Effective Tools
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Standard Operating Procedures (SOPs): How to Write Them to Be Effective Tools
Janet Gough, MA Consultant. Tallahassee,
Florida
Michael Hamrell, PhD MORIAH Consultants. Yorba Linda, California
Key Words SOP; Compliance; Procedure
Janet Gough (email: [email protected]).
This is the third of three articles on standard operating procedures or SOPS. It addresses how to write SOPs in clear, concise language so that processes and activities occur as they are supposed to. The first article addressed the need for SOPs and their value to the business unit. The second article addressed what SOPs an organization needs to think about and how to determine what SOPs to put in place. SOPs
INTRODUCTION During a training session on document management, a participant testily took issue with the concept that standard operating procedures (SOPs) are binding for a company, and that a procedure in place means the company must follow it. Such a perception can only cause grief for a company, for it points to a fundamental misunderstanding of the role of SOPs. Companies are more closely bound by their procedures than they are by the actual regulations. They can depart from the regulations provided they have a sound reason for doing so and they have documented it. They must, however, abide by their own procedures, and the Food and Drug Administration (FDA) and other regulatory bodies hold them accountable for this compliance (1). The regulations do tell what companies must do, but they do not say how. That is the role of the procedural documents a company puts in place, whether they are standard operating procedures, work instructions, methods, manuals, plans, or another type of process document. These documents are the foundation for all product-related activities such as supply chain management, data gathering and analysis, planning, reporting, summarizing, and qualification and validation. In sum, they tell how a company functions (2). As such, they must be clear, complete, and easy to follow. Often they are not. Common citations in 483s and warning let-
are the first line of defense in any inspection, whether it be by a regulatory body, a partner or potentialpartner, a client, or afirm conducting due diligence for a possible purchase. It does not matter what a company calls them; any document that is a how-tofalls into the category of procedures. SOPS,in fact, define expected practices in all businesses where quality standards exist.
ters consistently cite problems with SOPs that are threefold. Companies fail to establish them; they fail to maintain them; and they fail to follow them. Examples of the citations can be found on FDA's website in the posted warning letters (3).They typically read as follows: "Failure to establish and maintain procedures for
implementingcorrective and preventive action." "Failure to establish and maintain procedures for identifying product during all stages of receipt, production, distribution and installation to prevent mix-up." "You failed to establish adequate written procedures describi
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