Month: April 2021

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.

Who-What Matrix

Effective organizations assign people to particular roles, such as Process Owners, to solve problems better and make choices faster. Yet, it is frighteningly easy it is to exclude the right people in problem-solving. Who plays what role is not always clear in organizations. In organizations where specialized knowledge and expertise are distributed widely the different parts of an organization can see different problems in the same situation. Ensuring that the right people are at the whiteboard to solve the problem.

The Who-What Matrix is a great tool to ensure the right people are involved.

By including a wider set of people, the Who-What Matrix assists in creating trust, commitment, and a sense of procedural justice, and thus, enhance the likelihood of success. The matrix can also integrate people across functions, hierarchy, business units, locations, and partner organizations.

Once the need to problem-solve is identified, the matrix can be used to determine what people and organizations should be involved in which roles in problem-solving and whose interests should betaken into account in the deliberations. Players may provide input (information, ideas, resources); be part of the solving process(formulating problem, gathering data, doing analyses, generating solution options, supporting the work), be among those making choices or executing them. Considering the interests of all players during problem-solving can lead to better choices and outcomes.

The aim is to use the framework’s categories to think broadly but be selective in deciding which players play what role. A lengthy collection of players can be so overwhelming as to lead to neglect. The same player can play more than one role, and roles played can change over time. Players can come and go as problem-solving proceeds and circumstances change.

By deliberately bringing people into problem-solving, we are showing how to give people a meaningful role in the learning culture.

Who-What Matrix

The roles breakdown as:

  • Input: Provide input, provide data gathering, data sources
  • Recommend: Evaluate problem, recommend solutions and path forward
  • Decide: Make the final decision and commit the organization to action
  • Perform: Be accountable for making the decision happen once made
  • Agree: Formally approve a decision, implies veto power
  • Outcome: Accountable for the outcome of problem solving, results over time