How to Write Standard Operating Procedures (SOPs) that Avoid Human Error
Speaker: Ginette Collazo, Ph. D
Speaker Designation: CEO, Human Error Solutions
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Speaker: Ginette Collazo, Ph. D
Speaker Designation: CEO, Human Error Solutions
Human error is the primary cause of quality and production losses in many industries.
Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Procedures play a vital role in human reliability. Nevertheless, it is essential to understand human behavior and the psychology of error as well as understand precisely where the instruction's weaknesses are so that procedures can be human-engineered, improved, and fixed.
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 content development to formats designed for human error reduction due to procedures.
After completing the webinar, you’ll be able to:
In modern industries like pharmaceuticals, healthcare, manufacturing, and aviation, prioritizing operational efficiency, safety, and quality is crucial. Despite advancements, human error persists as a major hurdle to upholding these standards. Customized SOPs aimed at human error prevention offer a proactive strategy for safeguarding operations, bolstering safety measures, and ensuring regulatory compliance in high-risk sectors. Through the integration of optimal procedure design, comprehensive training, and a culture of continuous improvement, organizations can successfully diminish the influence of human fallibility and maintain their dedication to excellence.
Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with more than 20 years of experience specializing in Engineering Psychology and Human Reliability. These disciplines study the interaction between human behavior and productivity. She has held positions leading Training and Human Reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.
In 2009, Dr. Collazo established Human Error Solutions (HES), a US-based boutique consulting firm. She has positioned herself as one of the few Human Error Reduction Experts worldwide. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development, and effectiveness implemented and proven amongst different industries globally. Furthermore, this scientific method has been applied in critical quality situations and workplace accidents. As a GMP expert also has a Keynote Speaker at significant events around the world.
Ginette Collazo, Ph. D., is the author of several books, “Human Error: Root Cause Determination Model” and “Mission Matters: World Leading Entrepreneurs Reveal their Top Tips to Success.” Also, she is the host of The Power of Why Podcast. A show about human behavior in the workplace and critical thinking.
FDAnews has called her a “veteran of helping drug, biologic and device firms reduce manufacturing errors,” and the Caribbean Business describes her as “ the missing link in modern business.” Today her Error Reduction System has been implemented in all types of industries worldwide.