Lonza Error Prevention System (EPS) - Changing Human Performance in Pharmaceutical Operations.

Area of Science:

• Pharmaceutical Manufacturing
• Quality Management Systems
• Human Factors Engineering

Background:

• Human errors contribute to approximately 50% of quality incidents in the pharmaceutical industry.
• Improving human performance in manufacturing is critical for quality and compliance.
• Current training often focuses on compliance rather than genuine competence.

Purpose of the Study:

• To present error-proofing strategies for knowledge documents, procedures, and batch records.
• To outline best practices for structuring, conducting, and documenting training to ensure competence.
• To advocate for a paradigm shift from 'training for compliance' to 'training for competence'.

Main Methods:

• Implementing structured error-prevention systems in documentation and training.
• Developing and applying error-proofing techniques in knowledge management.
• Focusing on competence assurance through structured training programs.

Main Results:

• A significant reduction in human error-related quality deviations and non-conformities.
• Over 40% decrease in quality incidents across 13 global sites within two years.
• Demonstrated achievement of Good Manufacturing Practice (GMP) compliance through a competence-focused approach.

Conclusions:

• Error-proofing documentation and training effectively minimizes human errors in pharmaceutical manufacturing.
• A 'training for competence' model enhances GMP compliance and operational quality.
• The Error Prevention System yields substantial, measurable improvements in quality and reduces deviations.