SOP Deviation Procedures

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According to an Environmental Protection Agency (EPA) directive, “A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in the quality and integrity of a product or end result.” Following SOPs is mandatory at EPA and at other organizations. When a procedure cannot be performed, an SOP describes how the differences are to be handled.

Understand What Constitutes a Deviation

A company develops written SOPs to comply with state, federal and sometimes local regulations and with corporate policies. SOPs are designed to ensure the manufactured goods or systems the company produces are safe, effective and of consistent quality. A deviation is any departure from these procedures that could compromise product quality or consistency, affect customer or end-user safety or system integrity or jeopardize the company’s regulatory status.

Identify What Type of SOP Deviation Procedure You Want to Write

A deviation procedure must be specific regarding the process involved. Types of deviation include: • An unauthorized manufacturing change. • Use of nonconforming raw materials, components, subassemblies or packaging materials. • Errors or unapproved changes in labels or labeling. • Failure to validate testing methods or instrumentation. • Change necessitated by health, safety or environmental concerns. • Alteration in a cleaning or sterilization process. • Any departure from procedure that violates regulatory requirements or corporate standards.

Initiate the SOP Deviation Procedure-Writing Process

Refer to the fundamental SOP (the SOP that tells you how to write an SOP) to determine: • Who should prepare the deviation procedure? • What is the SOP approval process? • How and when should the SOP be implemented? • Who gets notified or trained/re-trained when the SOP is implemented, and how is this to be documented? • How can the SOP be revised?

Write the SOP Deviation Procedure

• Describe the deviation notification process in detail and list the title of the person or persons responsible for providing the notification. Include a standardized deviation report form to be completed by authorized personnel, identified by title, when the deviation is discovered. • Require notification of Quality Assurance within 24 hours. • Arrange for a product or process “hold” on the deviated material until Quality Assurance makes a disposition decision. • Consider adding an instruction for periodic review of the procedure to assure its continuing effectiveness.

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About the Author

An organic chemist with a Master of Science from Case-Western Reserve University and a Master of Business Administration from Northwestern University, Ann Louise Truschel has been a freelance medical and business writer since 1982. Her client list includes big pharma, insurers, CME firms, medical journals, trade magazines, professional medical organizations, newspapers and The Department of Defense.

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