title: Lonza Error Prevention System (EPS) - Changing Human Performance in Pharmaceutical Operations.
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.
authors.affiliation: Lonza AG, Lonzastrasse, CH-3930 Visp, Switzerland.
authors.forename: Kerstin
authors.initials: K
authors.lastname: Bodmann
authors.affiliation: Lonza AG, Lonzastrasse, CH-3930 Visp, Switzerland.
authors.forename: Constanze
authors.initials: C
authors.lastname: Reinhard
authors.affiliation: Lonza AG, Lonzastrasse, CH-3930 Visp, Switzerland. michael.moedler@lonza.com.
authors.forename: Michael
authors.initials: M
authors.lastname: Mödler
authors.affiliation: Lonza Biologics plc, 640 Ajax Avenue SL1 4DH Slough, UK.
authors.forename: Kevin
authors.initials: K
authors.lastname: Tinson
authors.affiliation: BioPhorum Operations Group (BPOG) Westbrook Court, Sharrow Vale Road Sheffield, S11 8YZ UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Johnson
mesh_terms: D004345:Drug Industry; D006801:Humans; D007858:Learning; D004364:Pharmaceutical Preparations / Q000138:chemical synthesis / Q000378:metabolism / Q000592:standards*; D013647:Task Performance and Analysis
chemical_list: D004364:Pharmaceutical Preparations