Description

This webinar would provide tools that can be implemented and used after this event. These include practical tools and recommendations. It presents an overview of the five pillars of 5S: Organization (Sort), Orderliness (Set in Order), Cleanliness (Shine), Standardization (Standardize), and Discipline (Sustain). The contents of this course are based on Hiroyuki Hirano’s, 5 Pillars of the Visual Workplace.

Human error is known to be 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. One method to improve productivity and reduce human error is the “5S Method”. This webinar is intended to provide you with practical knowledge on how to keep your workplace cleaner, safer, simpler, and organized, helping you to achieve the intended goals and successfully execute assigned activities.

Areas Will Be Covered

• Understanding Human Error
• Types of Errors and the Psychology of Mistakes
• Benefits of 5S for me as an operators
• Benefits for the Organization
• 5 Pillars in detail
• Sort
• Set in Order
• Shine
• Standardize
• Sustain
• How to support implementation
• Conclusions

Description

Join this session, where expert speaker Ginette Collazo, Ph.D., will discuss the practical approaches for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues. Ginette will discuss why supervision is important in reducing and preventing human error. The session will discuss supervision approaches, near root causes and root causes for supervision related errors, and will address the 5 main elements of assuring an error free environment.

Areas Covered in the Session

• Background on Human Error Phenomena
• What is Human Error
• Importance of Human Error Prevention/reduction
• Supervision and human error
• Facts about human error caused by supervisors and how to avoid it
• When operator error is the Root Cause?
• How is Human Error controlled by supervision?
• Common mistakes: Memory failures, Overconfidence, Visual Detection, and Vigilance Effectiveness and how supervision can help improve these
• Types of error
• Human error rates and measurement
• Trending and tracking
• Prediction
• CAPA Effectiveness

Description

The CFR - Code of Federal Regulations Title 21 Subpart B Organization and Personnel Sec. 211.22 talks about the “Responsibilities of quality control unit.” and it states that “There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.” That being said Human Error is NOT a root cause. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be controlled reducing the likelihood of these occurrences.

Areas Covered in the Session

• Understand the psychology of error
• Regulatory requirements in GMP environments for managing human performance deviations
• Root Cause Analysis and Investigation
• Root Cause Determination Tool
• Establish the Human Error Rate at your site
• Implementing the program
• Metrics and KPI’s

Description

Even though the training is considered the “vaccine for mistakes,” training is not responsible for most human error deviations. To ensure training programs are effective and can be ruled out as a root cause for human error deviations, we will discuss the elements necessary when implementing/improving a training program. We will discuss elements of the training programs like curricula, training management systems, training effectiveness, and other important elements of a compliant training program.

Areas Covered in the Session

• GMP regulations on the training topic
• Agencies expectations of the training program
• Training general aspects
• Responsibilities of the training program
• Requirements for New employees
• Transferred Employees
• External Service Providers
• Training Events
• Skills Qualification Program (OJT)
• Training Assessment
• Retraining
• Training Outline/Contents
• GMP
• Technical Training
• On the Job
• Training Frequency and Topics
• Instructor’s Qualifications
• Training Curricula
• Training Documentation
• Review of Training System Effectiveness
• Deviations related to performance