ComplianceOnline

Course Description:

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behaviour CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges it is really important to understand human behaviour and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. This course offers practical approaches to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.



Learning Objectives:

  • Understand human error: factors and causes.
  • Understand the importance: regulatory and business.
  • Define the process to manage Human Error deviations.
  • Identify Root Causes associated to human error deviations.
  • Identify what I can do to support human reliability.

Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar



Areas Covered:

  • Background on Human Error Phenomena
  • Importance of Human Error Prevention/reduction
  • Training and human error
  • Facts about human error
  • Human Error as the Root Cause
  • What is Human Error?
  • How is Human Error controlled?
  • Common mistakes: Memory failures, Overconfidence, We believe we are above average, Visual Detection, Vigilance Effectiveness.
  • Types of error
  • Human error rates and measurement
  • Trending and tracking
  • Prediction
  • CAPA effectiveness


Who will Benefit:

  • Training managers and coordinators
  • Operations
  • Manufacturing
  • Plant engineering
  • QA/QC staff
  • Process excellence/improvement professionals
  • Industrial/process engineers
  • Compliance officers
  • Regulatory/legislative affairs professionals
  • General/corporate counsel
  • Executive management




Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:00 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

9:00 a.m. – 10:00 a.m. How to write error free procedures.

  • Introduction.
  • Human error basics.
  • Background and best practices in other industries.
  • Human error vision, error types and initial classification.
  • Human error taxonomy, framework and methodology.
  • Human error cause categories.
  • Performance shaping factors associated to procedures

10:00 a.m. – 10:15 a.m. BREAK

10:15 a.m. – 12:00 p.m.
Procedures and regulations- The importance for human error prevention, training and other uses.

  • The purpose of procedures and the importance for human error prevention.
  • Regulatory compliance background and agencies’ expectations for procedures. Importance of procedures.
  • Universal purpose of procedures: training, execution, and troubleshooting.
  • The Human perspective and instructions writing: how do we understand written instructions?
  • Procedures as a root cause: when, how and why do we categorize procedures as a root cause? Why resistance to procedures?
  • Documentation hierarchy: from policies to record documents, documentation levels and level of detail.

12:00 p.m. – 1:00 p.m. LUNCH

1:00 p.m. – 2:30 p.m. The Human perspective

  • The thinking and reading process.
  • The human brain and errors of interpretation.
  • Cognitive process and impact in manufacturing execution.
  • Perception and understanding.
  • Brain function and instructions development.
  • Human thinking model: how we react to stimuli and process information.
  • Rule based behavior and skill based behavior: impact on execution.
  • Common mistakes and causes found in the industry.

2:30 p.m. – 4:30 p.m. How to create and maintain procedures.

  • Facts about effective procedures.
  • How to accomplish procedures main goal?
  • Six step process:
    • plan,
    • investigate,
    • organize,
    • draft,
    • draft revision,
    • validation (field test),
    • Maintenance


8:30 a.m. – 10:00 a.m. Human Engineering Procedures

  • Discussion of insights from Day 1
  • Writing rules and content development.
  • Writing steps, sub-steps, and conditional statements.
  • Page format: Font size, spacing, use of white space, title structure, control features, and other requirements.

Practice writing steps, sub-steps and conditional statements.

10:00 a.m. – 10:15 a.m. BREAK

10:15 a.m. – 12:00 p.m. Human Engineering Procedures (cont.)

  • Procedure styles
  • Format styles: when to use which?
  • Making sure procedures are complete: what-if analysis and FMEA.
  • Electronic vs. Paper based procedures: advantages and disadvantages.
  • Validation and field testing steps.
  • Procedure maintenance and change management.
  • Document configuration and control system

Practice: evaluate your procedure and suggest changes. Group discussion.

12:00 p.m. – 1:00 p.m. LUNCH

1:00 p.m. – 2:30 p.m. Human error deviations related to procedures.

  • Root cause analysis.
  • Procedure related near root causes and root causes.
  • CA-PA and procedures: be very careful.
  • Process vs. procedure assessment.
  • When to perform a process vs. procedure analysis and why it is so important to do so before establishing procedure revision as a CAPA for human error.
  • How to avoid deviations related to procedures.

2:30 p.m. – 2:45 p.m. BREAK

2:45 p.m. – 3:45 p.m Writing recommendations and final thought on metrics.

  • High end and low end recommendations.
  • KPI’s
  • Human error rate
  • 1st time pass rate
  • Trending
  • Tracking

3:45 p.m. – 4:00 p.m. Review and Key Insights Materials






Meet Your Instructor

Ginette M Collazo
Industrial/Organizational Psychologist at Ginette M. Collazo

GINETTE COLLAZO, PH.D is a human error and human behavior expert. She has spent more than 15 years in technical training, organizational development and human reliability areas. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth, and has been a consultant with major firms like Abbott, Johnson & Johnson, Perrigo, among many others. Also has implemented human error reduction programs and technology in many more small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.





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