In Chapter 2 the authors guide the listener to better understanding their blue line - how work is done, as well as what influences Work As Done. You will earn that you do not have a “human error’ problem. ‘Human error’ is a symptom that is alerting you to system problems.
The problem you have is organizational, involving complexity and technology. The goal is to adjust systems—work processes, technology, documentation, and their interrelationships so they help create operational success. When optimal, these will reduce the frequency and severity of failure—and human error.
Episode Images
My Wife and My Mother-In-Law by cartoonist William. Ely Hill, 1915.
Adapted from Figure 4.3, Pre-Accident Investigations: An Introduction to Organizational Safety by Todd Conklin, published by Taylor & Francis Group: CRC Press, 2012.
Episode Footnotes
Tier meetings are short duration meetings where daily operations are discussed, often used in organizations where Lean manufacturing principles and practices have been introduced. These meetings are organized by various levels of the organizational hierarchy, and information and requests are moved upwards from the factory floor to area management to senior management. Then information and support move downwards.
System is a generic and broad term used to describe an interconnected set of elements that is coherently organized in a way that achieves something. Systems can be large, like all of the work in an entire business unit, or systems can be small, such as the combination of equipment, documentation, automation, and people that are required to perform a unit operation.
Amy Edmondson defines psychological safety as a shared belief that the team is safe for interpersonal risk taking. Psychological safety means an absence of interpersonal fear, where people are able to speak up with work relevant content.
Varied terms are used within biopharma to refer to expectations of witnessing or verifying actions. We use the term witness specifically to refer to actions that require a person to be present and witness the step at the time of performance.
Batch records in biopharma manufacturing are the primary documentation that capture real time performance of production activities. Batch records are a key part of what is used to confirm that all expected and required actions have been completed within parameters to produce product that meets specifications.
Dazzle camouflage originated in World War I where startling stripes, swirls, and irregular abstract shapes were painted onto ships. Dazzle camouflage was intended to confuse the enemy rather than hide an object from the enemy.