Procedures account for more than 40% of human error events in manufacturing. The majority of regulatory citations are also related to procedures. Procedures are essential for both execution and audits. These should be written for users without missing relevant information for regulators. Usually, procedures have weaknesses that harm productivity, quality, and regulatory standing. We will discuss from content development to formats designed for human error reduction due to procedures.

Areas Covered in the Session:
•  SOP writing outline
•  Content development
•  The rationale for procedure use
•  Regulatory compliance background
•  Universal purpose of procedures
•  The Human Perspective
•  Human Error as a root cause
•  The thinking and reading process
•  Common mistakes and causes
•  How to create and maintain a procedure
•  Goals of a procedure
•  Good Procedure Writing practices (Terminology, Formats, layouts, mixed cases, steps content, familiar words, references, branching, conditional steps, the use of “Precautions”, “Warnings” and “Cautions,”
•  Procedure styles
•  Use of electronic information networks for procedure access.