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How to Write Procedures to Avoid Human Errors

Thursday, 12 October 2017  11:30 AM PDT, 02:30 PM EDT

Training Duration = 90 Min                    Sponsored by Online Compliance Panel

Click Here to register $250.00

Click Here to register and receive CD recording $500.00

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.

Learning Objectives:

  • Understand the importance of procedures
  • Learn why people refuse to use procedures
  • Learn 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

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 never 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 instructions weaknesses are, so procedures can be human engineered, improved and/or fixed.

Topics

  • SOP writing outline
  • Content development
  • The rational 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

Instructor

Dr. Ginette M. Collazo obtained her PhD in Industrial/Organizational Psychology from the Interamerican University of Puerto Rico. Ginette has over 15 years of experience in the pharmaceutical industry with the Technical Training, Organizational Development and Human Reliability fields.

Her work experience is from Bristol Myers Squibb, Johnson & Johnson, Schering Plough and Wyeth, holds specialized studies in Human Reliability, and has authored various publications on this topic. Her most recent publication is "Error Humano: C4c06 Modelo de Determinacion de Raiz Causa", a book that describes success factors that reduce human errors. Having implemented Human Reliability programs in various industries, she understands firsthand what works and what doesn't when trying to change a culture from an error tolerant environment to an error free learning organization.

Currently she is the president of Ginette M. Collazo, Inc. a firm that works with organizations to improve productivity by helping them identify and implement innovative strategies that will warrant that business objectives and results are met and exceeded. GMC, Inc. specializes, also, in Human Error reduction allowing organizations to achieve savings and reduce/avoid unnecessary costs associated with people's mistakes.

Ginette's clients all over the world including Germany, Argentina, USA, Trinidad Tobago, Dominican Republic, Singapore, Europe, and more. She has been a guest speaker about these topics in several professional conferences including American Institute for Chemical Engineers Global conference, Center for Chemical and Process Safety, American Society for Quality, California State Lands Commission Prevention First 2010 conference, Interphex PR and NY, FDAnews, among others.