The Cost of Generics

Production of generics has shifted overseas, where it’s harder for the Food and Drug Administration to inspect factories. Major companies have been caught faking and manipulating the data that is supposed to prove that drugs are effective and safe. Probable carcinogens have been discovered in the drug supply. During the pandemic, which caused several countries to ban the export of medical supplies, a new fear has arisen: that faraway factories might one day cut Americans off from their drugs. Dozens of lifesaving medications are made with ingredients no longer manufactured in the United States.

Stockman,FarahOur Drug Supply Is Sick. How Can We Fix It?” The New York Times, 18 September 2021

Philip Runyan pointed out this article today, and it is worth reading. It has personal connection with me, as well as professional in that my wife takes Levothyroxine. I’m a huge fan of Katherine Eban’s Bottle of Lies, and this opinion piece fits excellently into that strand of reporting. We need more reporters on this beat.

I do not think the quality of drug manufacturers worldwide are rising to the level of the US and Europe. I think onshoring is one of those trends that is going to shake the pharmaceutical world over the next decade. Civica is ahead of the curve, but not by much.

Good shoutout to Redica, one of my favorite tools for regulatory intelligence (but expensive).

Notice that Viatris (Mylan) fails at driving out fear. Layoffs are one of the largest possible sources of fear.

We will eventually see a quality rating system. Whether it looks like the FDA’s current metric initiative remains to be seen.

Engaging for Quality

When building a quality organization, we are striving to do three things: get employees (and executives) to feel the need for quality in their bones; get them to understand what quality is and why it is important; and build the process, procedure, and tools to make quality happen. Practitioners in change management often call this heart, head, and hands.

Engage the heart, head and hands to build a quality culture

In our efforts we strive to answer give major themes of questions about why building a culture of quality is critical.

ThemeQuestions
WhyWhy do we need quality? Why is it important? What are the regulatory expectations? What happens if we do nothing?
WhatWhat results are expected for our patients? Our organization? Our people? What does out destination look and feel like?
HowHow will we get there? What’s our plan and process? What new behaviors do we each need to demonstrate?
YouWhat do you need to fulfill your role in quality? What do we need from you?
MeWhat do I commit to as a leader? What will I do to make change a reality? How will I support my team?
Five Themes of Change

The great part of this is that the principles of building a quality culture are the same mindsets we want embedded in our culture. By demonstrating them, we build and strengthen the culture, and will reap the dividends.

Be Preventative: What actions can be taken to prevent undesirable/unintended consequences with employees and other stakeholders. We do this by:

  • Involving end-users in the design process
  • Conduct risk assessments and lessons learned to predict possible failures
  • Ensure the reason for change is holistic and accounts for all internal and external obligations
  • Determine metrics as soon as possible
  • Focus on how the organization is responding to ongoing change
  • Think through how roles need to change and what employees need to be accountable for

Be Proactive: What actions can be taken to successfully meet objectives?

Be Responsive: What evidence-based techniques can be used to respond to issues, including resistance?

This is all about leveraging the 8 change accelerators and effectively developing strategies for change.

Dealing with Emotional Ambivalence

Wordcloud for Ambivalence

Ambivalence, the A in VUCA, is a concept that quality professionals struggle with. We often call it “navigating the gray” or something similar. It is a skill we need to grow into, and definitely an area that should be central to your development program.

There is a great article in Harvard Business Review on “Embracing the Power of Ambivalence” that I strongly recommend folks read. This article focuses on emotional ambivalence, the feeling of being “torn” and discusses the return to the office. I’m not focusing on that topic (though like everyone I have strong opinions), instead I think the practices described there are great to think about as we develop a culture of quality.

ISPE’s cultural excellence model

The Risk Register

Every organization should ask themselves seven questions about the health of their risk management program.

  1. Do you have a risk management plan?
  2. Have you identified and captured your risks in a risk register?
  3. How have you evaluated and prioritized your risks?
  4. Have you engaged the appropriate stakeholders in the risk identification and evaluation processes?
  5. What about risk owners? Does each risk have a risk owner?
  6. Have the risk owners developed risk response plans for the highest risks?
  7. Are you facilitating a review of your risks periodically, resulting in updates to the risk register and effective risk responses?

At the heart of this program sits the Risk Register, which brings together information about risks to inform those exposed to risks and those who have responsibility for their management. A risk register is used to record and track information about individual risks and how they are being controlled. It can be used to communicate information about risks to stakeholders and highlight particularly important risks. While it can be used at any level of the organization where there are a large number of risks, controls and treatments that need to be tracked, a risk register really shines as a central component of a quality management review. The risk register includes:

  • List of risks, failure modes or hazards and expected outcomes
  • A statement about the probability of consequences occurring
  • Sources or causes of the risk
  • Priority or risk levels
  • What is currently being done to control the risk
  • Risk owner
  • Actual outcome, if and when available

Risks are generally listed individually as separate events but interdependencies should be flagged.

In recording information about risks, the distinction between risks (the potential effects of what might happen) and risk sources (how or why it might happen) and controls that might fail should be explicit. It can also be useful to indicate the early warning signs that an event might be about to occur.

Many risk registers also include some rating of the significance of a risk, an indication of whether a risk is considered to be acceptable or tolerable, or whether further treatment is needed and the reasons for this decision. Where a significance rating is applied to a risk based on consequences and their likelihood, this should take account of the possibility that controls will fail. A level of risk should not be allocated for the failure of a control as if it were an independent risk.

A risk register is used as the basis for tracking implementation of proposed treatments, so it should contain information about treatments and how they will be implemented, or make reference to other documents or data bases with this information. (Such information can include risk owners, actions, action owners, action business case summaries, budgets and timelines, etc.). This living document can usually roll (or even serve as) the Quality Plan.

Strengths of risk registers include the following.

  • Information about risks is brought together in a form where actions required can be identified and tracked.
  • Information about different risks is presented in a comparable format, which can be used to indicate priorities and is relatively easy to interrogate.
  • The construction of a risk register usually involves many people and raises general awareness of the need to manage risk.

By doing this, the risk register serves as a central underpining for the organization as it builds a risk culture, driving transparency and accountability.

Building Risk Based Thinking in the Organization requires a strong governance structure


Pay attention the the following limitations:

  • Risks captured in risk registers are typically based on events, which can make it difficult to accurately characterize some forms of risk
  • The apparent ease of use can give misplaced confidence in the information because it can be difficult to describe risks consistently and sources of risk, risks, and weaknesses in controls for risk are often confused.
  • There are many different ways to describe a risk and any priority allocated will depend on the way the risk is described and the level of disaggregation of the issue.
  • Considerable effort is required to keep a risk register up to date (for example, all proposed treatments should be listed as current controls once they are implemented, new risks should be continually added and those that no longer exist removed).
  • Risks are typically captured in risk registers individually. This can make it difficult to consolidate information to develop an overall treatment program.

Artifacts, like the risk register, both demonstrate and channel culture. Invest the time in your organization’s register, and you will reap dividends towards developing a risk friendly culture.

Quality, Decision Making and Putting the Human First

Quality stands in a position, sometimes uniquely in an organization, of engaging with stakeholders to understand what objectives and unique positions the organization needs to assume, and the choices that are making in order to achieve such objectives and positions.

The effectiveness of the team in making good decisions by picking the right choices depends on their ability of analyzing a problem and generating alternatives. As I discussed in my post “Design Lifecycle within PDCA – Planning” experimentation plays a critical part of the decision making process. When designing the solution we always consider:

  • Always include a “do nothing” option: Not every decision or problem demands an action. Sometimes, the best way is to do nothing.
  • How do you know what you think you know? This should be a question everyone is comfortable asking. It allows people to check assumptions and to question claims that, while convenient, are not based on any kind of data, firsthand knowledge, or research.
  • Ask tough questions Be direct and honest. Push hard to get to the core of what the options look like.
  • Have a dissenting option. It is critical to include unpopular but reasonable options. Make sure to include opinions or choices you personally don’t like, but for which good arguments can be made. This keeps you honest and gives anyone who see the pros/cons list a chance to convince you into making a better decision than the one you might have arrived at on your own.
  • Consider hybrid choices. Sometimes it’s possible to take an attribute of one choice and add it to another. Like exploratory design, there are always interesting combinations in decision making. This can explode the number of choices, which can slow things down and create more complexity than you need. Watch for the zone of indifference (options that are not perceived as making any difference or adding any value) and don’t waste time in it.
  • Include all relevant perspectives. Consider if this decision impacts more than just the area the problem is identified in. How does it impact other processes? Systems?

A struggle every organization has is how to think through problems in a truly innovative way.  Installing new processes into an old bureaucracy will only replace one form of control with another. We need to rethink the very matter of control and what it looks like within an organization. It is not about change management, on it sown change management will just shift the patterns of the past. To truly transform we need a new way of thinking. 

One of my favorite books on just how to do this is Humanocracy: Creating Organizations as Amazing as the People Inside Them by Gary Hamel and Michele Zanini. In this book, the authors advocate that business must become more fundamentally human first.  The idea of human ability and how to cultivate and unleash it is an underlying premise of this book.

Visualized by Rose Fastus

it’s possible to capture the benefits of bureaucracy—control, consistency, and coordination—while avoiding the penalties—inflexibility, mediocrity, and apathy.

Gary Hamel and Michele Zanini, Humanocracy, p. 15

The above quote really encapsulates the heart of this book, and why I think it is such a pivotal read for my peers. This books takes the core question of a bureaurcacy is “How do we get human beings to better serve the organization?”. The issue at the heart of humanocracy becomes: “What sort of organization elicits and merits the best that human beings can give?” Seems a simple swap, but the implications are profound.

Bureaucracy versus Humanocracy. Source: Gary Hamel and Michele Zanini, Humanocracy, p. 48

I would hope you, like me, see the promise of many of the central tenets of Quality Management, not least Deming’s 8th point. The very real tendency of quality to devolve to pointless bureaucracy is something we should always be looking to combat.

Humanocracy’s central point is that by truly putting the employee first in our organizations we drive a human-centered organization that powers and thrives on innovation. Humanocracy is particularly relevant as organizations seek to be more resilient, agile, adaptive, innovative, customer centric etc. Leaders pursuing such goals seek to install systems like agile, devops, flexible teams etc.  They will fail, because people are not processes.  Resiliency, agility, efficiency, are not new programming codes for people.  These goals require more than new rules or a corporate initiative.  Agility, resilience, etc. are behaviors, attitudes, ways of thinking that can only work when you change the deep ‘systems and assumptions’ within an organization.  This book discusses those deeper changes.

Humanocracy lays out seven tips for success in experimentation. I find they align nicely with Kotter’s 8 change accelerators.

Humanocracy’s TipKotter’s Accelerator
Keep it SimpleGenerate (and celebrate) short-term wins
Use VolunteersEnlist a volunteer army
Make it FunSustain Acceleration
Start in your own backyardForm a change vision and strategic initiatives
Run the new parallel with the oldEnable action by removing barriers
Refine and RetestSustain acceleration
Stay loyal to the problemCreate a Sense of Urgency around a
Big Opportunity
Comparison to Kotter’s Eight Accelerators for Change