A Titanic Mix-Up — What’s HuP?

We’ve all seen by now the latest NYT reporting about Emergent and the mix-up that cost between 13 and 15 million doses of the J&J Covid-19 vaccine. As a human performance practitioner, my hair lit on fire when reading this statement: “An investigation is now underway, but federal and former company officials suspect the lot […]

A Titanic Mix-Up — What’s HuP?

My friend and colleague Dakota Stad writes on what recent reporting tells us about Emergent’s culture. Dakota’s points are spot-on – these issues start with senior leadership and are not on indicative of any sort of “rogue actors”.

It would be an easy narrative to blame the workers, but as always we should stay focused on building a just culture.

Indirect Accountability

The kind of accountability most of us are familiar with is direct accountability: a role is assigned a task and is directly accountable for their result. The role understands the quality, quantity, timeframe, and resource constraints of the deliverable and has the authority to implement plans to achieve it. When completing a RACI this is what we mean by accountability.

Ideally, the individual with direct accountability has the context to understand the limits in which they must work and sufficient knowledge about all of the factors that must be considered to make good decisions. However, that’s not always the case, and for this reason, organizations need to establish lateral roles of indirect accountability to ensure these factors are brought to the attention of the role with direct accountability.

Indirect roles are responsible for initiating action toward directly accountable roles. Indirect roles may be responsible for:

  • Informing: being aware of the factors surrounding the direct and initiating contact to offer advice and recommendations.
  • Persuading: persuading the direct to adjust their actions when there is a risk of undermining process control or when multiple roles fail to work together effectively.
  • Instructing: ordering the direct to stop when working outside of limits and/or take prescribed action to mitigate a catastrophic event.
  • Responding: Provide the direct service and support

Often these indirects are accountable in a supporting process.

Changes, Changes Everywhere

It is sometimes unfortunate that ICHQ10 defines Change Management as “A systematic approach to proposing, evaluating, approving, implementing and reviewing changes.” This lifecycle approach can sometimes confuse people as they are used to the definition popular elsewhere that change management is “the discipline that guides how we prepare, equip and support individuals to successfully adopt change in order to drive organizational success and outcomes.”

I tend to think this is an issue of focus and lack of coherence in the organization that stems from:

  • Not understanding that all changes are to a system that involves people, organization, technology and process
  • Balkanized change processes leads to changes being atomized or channeled though discrete processes that do not drive system thinking

Both of these can lead to a change going to a default change control process and not appropriately dealing with all aspects of the change. Teams tend to have their default (IT puts everything in as a computer change, facilities always uses a an equipment change) but those defaults are not built to deal with a change holistically.

Change is a movement out of a current state (how things are today), through a transition state, and to a future state (how things will be done). Change management needs to be about how we manage that change from the entire system – people, organization, technology and process. Only by approaching change from a full system perspective do we ensure the full benefit and avoid unintended consequences.

Change Identification

Changes come from everywhere. They are driven by other quality processes, by business needs, by innovation. To quickly address change it is important to have a good funnel system that will get the change to evaluation.

Change Evaluation

All changes should be evaluated for risk and impact. This evaluation is iterative and determines the level and form of evaluation.

Change Control

Right sized change control based on risk and impact. Some changes are one-and-done. But many are multi-faceted, and it is important to structure it appropriately.

I’ve written a lot on change management that covers this in more detail. Explore them here

Improvisation

Improvisation Takes Practice” in HBR is a great read. When I first read it, I chuckled at how it brings my gamer hobby and my quality practice together.

Employee creativity—the production of novel and useful solutions, procedures, products, and services—is critical to organizational success. I would argue, creativity drives excellence. Improvisation is a key employee behavior that drives creativity and innovation.

Improvisation is essential for navigating volatile, uncertain, and complex environments and dealing with unforeseen obstacles. Improvisation is also key to drawing distinctions, implementing new ideas, and converting knowledge and insights into action in real time. When confronted with critical and disruptive events, employees can resolve challenges by following existing protocols and procedures. In contrast, when faced with novel events, employees cannot rely on routines and conventions to respond. Rather, they will have to shift their focus to new perspectives, features, and behaviors.

The process of building expertise, when practices are assimilated, embodied, and rendered tacit, creates improvisational competence. Improvisation is an important source of action generating learning: people act to make events meaningful and situations understandable and, in the process, deepen their expertise through further learning, becoming reflective practitioners.

As part of knowledge management, today’s improvisations are absorbed and embedded into tomorrow’s routines.

Improvisation leads to better decision making, as I discussed in the post “Yes…but….and

Emergent FDA 483 from April 2020

Earlier in the week after reading the New York Times reports “U.S. Bet Big on Covid Vaccine Manufacturer Even as Problems Mounted” I commented that “This is a pretty damning report. Especially to the FDA for a failure of their inspection program if even half of it is true.”

Today John English pointed out the April 2020 FDA 483 for the Baltimore site of Emergent. And it is a doozy in six pages. Thank you FOIA.

Observation 1: Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel

This one is a real bellwether to me. The failure of the quality unit to ensure a robust computer system validation program was in place, to ensure data integrity. The fact that the three parts to the observation run the gamut from infrastructure to implementation to on-going use stands out that there are significant weaknesses in data integrity as an approach.

Observation 2: Established specifications, test procedures and laboratory control mechanisms are not followed and documented at the time of performance.

Well, forget about contemporaneous. Significant data integrity and culture failure here.

Part (b) indicates a failure to manage and track lab errors.

Also some concerns on chain of custody of samples are raised.

Observation 3: The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

This observation raises some significant questions in how they manage OOS investigations.

Observation 4: Employees are not given training in the particular operations they perform as part of their function and current good manufacturing practices

Build training plans, execute training plans, document training.

Observation 5: Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected components before disposition

It is like the FDA saw exactly what was going to happen and did nothing to stop it.

Thoughts

This 483 chilled me to the bones reading it. Major failures in quality here. The fact that this was in April of 2020 raises significant concerns in my mind about how Emergent got any contracts for vaccine delivery.

I have written to my congressional representatives demanding hearings. We need to know who made what decisions when. The trust in our regulatory regime requires full transparency and introspection.