About The Audio Book

The audio book version of Do Quality Differently is FREE. It is set up similar to a podcast and we encourage you to share the episodes with others who you want to influence and help.

The audio in the episodes have been created using a service called ElevenLabs. The voice is AI generated, and as such you will notice occasionally that some words are mangled and acronyms that are sometimes spoken as a word are sometimes later spelled out with the letters— and vice versa. This is rare, and when it does happen the context makes the meaning clear. ElevenLabs is relatively inexpensive, easy to use, and the audio output compared to other similar products is exceptional.

We chose AI for the audio book because it is both a time savings and cost savings. We believe we made a good choice.

As of the writing of this post, not all the chapters have been converted to audio. Our planned schedule is to create and post two chapters every two weeks. We do not plan to convert the Appendices or the content that follows to audio. You will need to purchase the book to have access to the following appendices.

Appendix A - Lego Activity for Humble Inquiry
Appendix B - Jenga Activity for Risk-Ready Review and Post-Job Review
Appendix C - Soma Cube Activity For After Action Review
Appendix D - Behavior Engineering Model (BEM) Analysis Worksheet
Appendix E - Application of Force Field Analysis and Behavior Engineering Model Worksheet

Enjoy. Stay kind and curious.

P.S. - The audiobook is also available on Spotify.

Introduction - Do Quality Differently

This is the Introduction of Do Quality Differently. The authors describe the current state of work design and operational learning within the biopharma manufacturing industry, while inspiring the listener to think differently and lead change.

Episode Footnotes:

Blue line is a contemporary human factors and system safety term that refers to the reality of how work is actually done and acknowledges the necessity of worker adaptation in managing risk and creating success.

Chunking is when a long string of characters is broken up into smaller strings or chunks by inserting spaces or dashes as delimiters. For examples of chunking, look at the account number on one of your credit cards or the phone number in your email signature.

A 2018 study from Pennsylvania State University found that when the size of a minority committed to social change reached just one-quarter of the group, it was consistently able to establish a new norm in the larger group, a finding with implications for behavior in the workplace, online, and in our communities.

Chapter 1 - Understanding 'Human Error'

In Chapter 1 the authors provide a brief history of human performance, from when the nuclear power industry began attempts to educate their workforce and INPO’s programmatic move to operationalize the ideas. to the first attempts of the biopharma manufacturing industry to solve their ‘human error’ problem.

The chapter explains the current misunderstanding within biopharma that ‘human error’ is a cause rather than an outcome. This fallacy is given life by by regulators and senior leaders. The authors provide a definition for both ‘human error’ and human performance.

Episode Book Images

Illustration of Robustness Versus Resilience

Episode Footnotes
According to McNab et al, system thinking involves exploring the characteristics of components within a system, such as work tasks and technology, and how they interconnect to improve understanding of how outcomes emerge from these interactions.

In the biopharmaceutical industry, the term human factor(s) is often misused as a synonym for human error. The term should always be used in reference to work processes and technology being designed to fit people.

System safety is the forward-looking identification and control of hazards to acceptable levels to prevent mishaps.

Human performance, or human and organizational performance, was born of concepts that originated in cognitive system engineering from the 1970s. Cognitive system engineering then evolved over thirty to forty years into what is now known as new view, safety differently, Safety-II, and resilience engineering; all of which share common ideas, concepts, and practices. Human and organizational performance has matured as it stayed connected to the offshoots of cognitive systems engineering.

The INPO Special Review Committee on human performance was established to examine ways to create a working environment that enhanced human performance at nuclear plants.

The Three Mile Island reactor near Middletown, Pa. partially melted down on March 28th, 1979. This was the most serious accident in U.S. commercial nuclear power plant operating history, although its small radioactive releases had no detectable health effects on plant workers or the public. Its aftermath brought about sweeping changes involving emergency response planning, reactor operator training, human factors engineering, radiation protection, and many other areas of nuclear power plant operations.

Capacity factor is the measure of how often a power plant runs for a specific period of time. It’s expressed as a percentage and calculated by dividing the actual unit electricity output by the maximum possible output.

Chapter 2 - Your Blue Line

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.

Chapter 3 - A Sponsor Is Born

In Chapter 3 the authors explain what it takes to create a sponsor, the role of the sponsor, creating a strategy for change, and distilling a compelling vision for the organization.

Episode Book Images

Table comparing situational surprise to fundamental surprise, adapted from Airpower’s Response to Fundamental Surprise, a Monograph by D. Elgersma, 2018, School of Advanced Military Studies US Army Command and General Staff College Fort Leavenworth, KS.

This table of suggested vocabulary enables organizations to integrate human and organizational performance principles and practices.

Episode Footnotes

A star wheel is a wheel with notches formed on the outer periphery that engage a vial and move it along a circular path to the next station.

As defined by David Woods, a founder of resilience engineering as an approach to safety in complex systems, the performance of a brittle system rapidly falls off or collapses when events push it beyond its boundaries for handling changing disturbances and variations.

DMAIC is a continuous improvement acronym for Define, Measure, Analyze, Improve, and Control. DMAIC is a data driven improvement cycle used for improving business processes.

For example, a person can have a mindset such as quality is a priority, but when faced with a job deadline, a lack of support, confusing HMI prompts, or ostracism for slowing down work to better manage the risks, these workplace factors influence or motivate behavior that may not align with their mindset. Thus, focusing on mindset alone, which may not need to be changed, may be insufficient to influence behavior as desired.

Lingchi, or death by a thousand cuts, was a form of torture and execution practiced in China where a knife was used to remove portions of the body over an extended period of time, eventually resulting in death. The phrase in modern times has come to mean a situation where many small undesirable things are happening, none of which are significantly impactful in themselves, but which add up to a slow change in thinking or a significant outcome.

Describing human error as an attribution, a judgement of a behavior based on an outcome, can be traced back to the 1983 NATO Conference on human error. Internationally recognized specialist in the fields of resilience engineering and system safety Erik Hollnagel stated that human error characterizes the outcome of an action rather than the cause.

Chapter 4 - How To Get Started

The Amy Wilson AI-generated voice reads Chapter 4. In this chapter the authors discuss the issues of change management critical to integrating human and organizational performance into operations, as well as the importance of HOP principles.

Episode Book Images

CAPA Strength

Fluency Steps

Illustration of the five principles of human and organizational performance.

Table of Primary Cultural Embedding Mechanisms adapted from Exhibit 13.1, How Leaders Embed Their Beliefs, Values, and Assumptions, in Organizational Culture and Leadership, Third Edition, by Edgar H. Schein, published by Jossey-Bass, A Wiley Imprint, 2004.

Table of Gilbert’s Behavior Engineering Model adapted from Table 3.2, Local Factors Categories in Risk-Based Thinking, Third Edition by Tony Muschara, published by Routledge Taylor & Francis Group, 2018.

Episode Footnotes

According to Jerry Pournelle’s Iron Law of Bureaucracy, in any bureaucracy, the people devoted to the benefit of the bureaucracy itself always gain control, and those dedicated to the goals the bureaucracy is supposed to accomplish have less and less influence, and are sometimes eliminated entirely.

According to Edgar Schein, learning anxiety is the feeling that if we allow ourselves to enter a learning or change process or if we admit to ourselves and others that something is wrong or imperfect, we will lose our effectiveness, our self-esteem, and maybe even our identity.

Journey and roadmap are common terms likely used by your stakeholders. We believe the terminology suggested by Erik Hollnagel, terms such as voyage and nautical chart, are more applicable since there is no regularly travelled known road to implementing human and organizational performance. However, in this case, we use the language of stakeholders.

A project charter typically includes the project requirements, the business needs, a summary schedule, assumptions and constraints.

Sidney Dekker describes a Looking Good Index as a negative outcome of bureaucracy where metrics are manipulated to obscure poor performance.

BioPhorum is a global collaboration of biopharmaceutical industry leaders. BioPhorum’s purpose as stated on their website is “To solve pertinent pre-competitive industry challenges, improve operational best practices, and engage with key industry stakeholders.” More information can be found at https://www.biophorum.com/.

A pre-job brief is a conversation among people who will be performing a work activity. This includes a discussion about risks associated with the work, and how risks will be managed. Pre-job briefs are covered in more detail in chapter twelve.

Positive control is when all that happens is as intended, and nothing else happens.

Performance management is an ongoing process of communication between a supervisor and an employee that occurs throughout the year, in support of accomplishing the strategic objectives of the organization. The communication process includes clarifying expectations, setting objectives, identifying goals, providing feedback, and reviewing results.

Sharp-end is a way of saying that the person is ‘in touch’ and appreciates the actualities of the work. It is roughly equivalent to the British and Australian idiom “at the coalface”, which refers to the workplace of an underground mine worker where coal is being cut from the rock, and these workers being directly involved with the core of the business.

Humble Consulting is the title of a book by Edgar Schein in which he describes how consultants can be more effective and helpful by working with clients in a more personal way, with authentic openness, curiosity, and humility.

Gemba is a Japanese word for the actual place, and when used as part of Lean it refers to the place where the actual work is done.

Human beings enjoy the exercise of their realized capacities (their innate or trained abilities), and this enjoyment increases the more the capacity is realized, or the greater its complexity.

The Harm Principle originates from the book, On Liberty, written by John Stuart Mill. The subject passage reads “The only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others. His own good, either physical or moral, is not sufficient warrant.”

There are multiple adaptations of the original Behavior Engineering Model developed by Gilbert. We present an adaptation developed by Tony Muschara. Additional references include Training Ain’t Performance by Harold D. Stolovich and Carl Binder’s Six Boxes.