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

Authors

  • Kerstin Bodmann Lonza AG, Lonzastrasse, CH-3930 Visp, Switzerland
  • Constanze Reinhard Lonza AG, Lonzastrasse, CH-3930 Visp, Switzerland
  • Michael Mödler Lonza AG, Lonzastrasse, CH-3930 Visp, Switzerland;, Email: michael.moedler@lonza.com
  • Kevin Tinson Lonza Biologics plc, 640 Ajax Avenue SL1 4DH Slough, UK
  • Mark Johnson BioPhorum Operations Group (BPOG) Westbrook Court, Sharrow Vale Road Sheffield, S11 8YZ UK

DOI:

https://doi.org/10.2533/chimia.2016.610

Keywords:

Error prevention, Gmp, Human performance, Procedures, Training for competence

Abstract

Errors are a part of life. With human errors accounting for approximately 50% of quality incidents and related problems within the pharmaceutical industry, the need to improve human performance in manufacturing operations is obvious. The purpose of this article is to describe error-proofing ways of structuring and writing knowledge documents, procedures, batch records, as well as practices for structuring, conducting, and documenting training to assure competence. These practices are recommended for adoption to shift the current 'training for compliance' paradigm to a 'training for competence' paradigm. It will also be demonstrated that a training for competence focus achieves GMP compliance. Results at Lonza have been encouraging, with human error-related quality deviations and non-conformities reduced by more than 40% across 13 sites globally within the first two years of the implementation of its Error Prevention System.

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Published

2016-09-14

How to Cite

[1]
K. Bodmann, C. Reinhard, M. Mödler, K. Tinson, M. Johnson, Chimia 2016, 70, 610, DOI: 10.2533/chimia.2016.610.