This presentation by Ginette Collazo will discuss key topics including content development and formats designed for human error reduction due to procedures. Procedures are important for both execution and audits. These should be written for users without missing important information for regulators. Usually, procedures have weaknesses that harm productivity, quality, and regulatory standing.
WHY SHOULD YOU ATTEND?
One of the major causes for incurring quality and production losses in many industries is human error. Although it is unlikely that human error can ever be totally abolished, many human performance problems could be prevented. Human errors begin at the design stage. Procedures play a vital role in human reliability. Nevertheless, it is extremely necessary to understand human behavior and the psychology of error as well as understand exactly where the instruction's weaknesses are, so procedures can be human-engineered, improved, and/or fixed.
AREA COVERED
- 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, common words, references, branching, conditional steps, the use of precautions, warnings, and Cautions)
- Procedure styles
- Use of electronic information networks for procedure access
LEARNING OBJECTIVES
- Understand the importance of procedures
- Learn why people refuse to use procedures
- Learn the best formats and content elements for SOPs
- Learn document hierarchy and different types of procedures based on their use
- Understand the common Human Errors and deviations related to the use of procedures
- Understand the reading and writing processes and how people may impact the processes
WHO WILL BENEFIT?
- QA/QC directors and managers
- Process improvement/excellence professionals
- Training directors and managers
- Plant engineering
- Compliance officers
- Regulatory professionals
- Executive management
- Manufacturing operations directors
- Human factors professionals
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