RT Journal Article
SR Electronic
T1 What Does It Really Look Like to Properly Address a “Human Error Problem” in Biopharma? The Human Performance Blue-Sky Description That Will Help Improve Industry Performance
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 391
OP 400
DO 10.5731/pdajpst.2018.009621
VO 73
IS 4
A1 Clifford Berry
A1 Brian Chviruk
A1 Danny Hernandez
A1 Matt Beaugard
A1 Kelly B. Stevens
A1 Joe Polizzotto
A1 Lene Bjerregaard
A1 Daan Purbrick
YR 2019
UL http://journal.pda.org/content/73/4/391.abstract
AB A clear picture of what Human Performance success looks like is now available from BioPhorum, where members of the Human Performance workstream have defined a blue-sky for the industry. This blue-sky document is both a guide and an assessment tool, which includes warning flags that help to identify significant obstacles in the way of effective human performance integration with operations that must be addressed. The effort to improve reliable operations within biopharma using elements of human performance borrowed from other industries have experienced uneven results and slow progress across the last seven years and has been bogged down for multiple significant reasons. These include a mental model that persists within the industry where workers are assumed to be the problem that needs fixing, the mistaken belief that Lean/Operational Excellence is a cure-all and nearly equivalent to human performance, neglecting the need to fundamentally rethink why and how investigations are performed, and truly underestimating the time, effort, strength of sponsor support, and strategy needed to change how work is designed, executed, and then later learned from.LAY ABSTRACT: Human Performance is an integrated risk management approach to improving systems, that includes human factors and systems safety, that leads to higher reliability and enhanced operational resilience. A clear picture of what Human Performance looks like in biopharma is available from the BioPhorum, where members of the Human Performance workstream have defined a blue-sky for the industry. This blue-sky document is both a guide and an assessment tool that will help to identify the steps to effective human performance integration with operations. The effort to improve reliable operations within biopharma using elements of human performance borrowed from other industries has experienced uneven results and slow progress across the last seven years and has been bogged down for multiple significant reasons. These include a mental model that persists within the industry where workers are assumed to be the problem that needs fixing, the mistaken belief that Lean practices (intended to improve productivity & efficiency) is a cure-all and nearly equivalent to human performance, neglecting the need to fundamentally rethink why and how investigations are performed, and truly underestimating the time, effort, strength of sponsor support needed to change how work is designed, executed, and then later learned from.