This article describes 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 also demonstrates that a training for competence focus achieves GMP compliance.
The approach uses learnings facilitated by BioPhorum. 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.