Change Strategies for Accelerating Changes

The five change strategies that leaders can utilize:

Directive strategy – the manager uses his authority and imposes change with little or no involvement of other people.
Expert strategy – usually involves expertise to manage and solve technical problems that result from the change.
Negotiating strategy – manager shows willingness to negotiate and bargain in order to effect change with timely adjustments and concessions.
Educative strategy – when the manager plans to change peoples’ values and beliefs.
Participative strategy – when the manager stresses the full involvement of all of those involved and affected by the anticipated changes.

These are not mutually exclusive. It is not uncommon to use 2 or 3 or even all five on larger, more complicated changes.

Critical ATMP Deficiencies

ERC The Netherlands B.V. received thirteen deficiencies from a recent inspection, one of which was classified as a critical deficiency.

These were mainly related to five main components:

Quality and safety of starting materials. Inspection of chemicals and consumables is insufficient.
The quality and safety of the final product is not guaranteed. The product is not sufficiently defined and characterized.
The effectiveness of a gama irradiation step, and therefore the safety of the product, is not guaranteed.
The change for the transition from Contractor 1 to Contractor 2 for gamma irradiation of cells has not been carried out as referred to in the GMP for ATMPs.
Prevention of (cross) contamination is not sufficiently guaranteed.
The environmental monitoring program and personnel monitoring are inadequate.

Reviewing this together with Emergent’s 483 (and resulting actions) starts to define a set of concerns in the ATMP world.

Lilly in the news

“rewrites factual data provided by subject matter experts to formulate responses she feels are more beneficial.”
“Lilly hit by staff accusations, FDA scrutiny at COVID drug factories“

Yesterday Reuters published a piece based on a purported recent internal complaint at Lilly on a Quality leader purportedly falsifying data.

This comes on top of a March report that “Insider alleges Eli Lilly blocked her efforts to sound alarms about U.S. drug factory.”

Lilly has had several decades of “promising to address GMP issues.” Are these signs of not addressing cultural issues? Of the balkanization of fixes? Of the infamous pendulum swing? I have no insight, but as an individual who was involved in the work of consent decree remediation at another company, I certainly have lots of questions about what is up at Lilly.

Conceptual Framework

David Gray discusses conceptual frameworks in the MIT Sloan Management Review article “What Makes Successful Frameworks Rise Above the Rest.” In this article he provides 7 criteria to evaluate a conceptual framework that are very useful for consider the frameworks we develop and use.

Having an analytical framework to evaluate the strength of our tools and methodologies can be very valuable, and this is something I’ll be coming back to.

Transparency

Transparency in organizations generally falls into one of two categories: proactive and demand-driven.

Proactive dissemination refers to information that the organization’s leadership makes known about its activities and performance. Practical expressions can range from strategic and tactical goals, third-party evaluations, and organizational risks.
Demand-driven access refers to an organizational commitment to respond to employee requests for specific kinds of information or documents which otherwise would not be accessible.

The idea of transparency can also be unpacked in terms of its directionality. Disclosure cuts both ways, channeling information upwards as well as downwards in the organization. Leadership sharing insight into decisions is an example of downwards, where idea management processes are upwards.

The type of transparency also matters:

Opaque or fuzzy transparency involves the dissemination of information that does not reveal how organizations actually behave in practice, whether in terms of how they make decisions, or the results of their actions. The term also refers to information that is divulged only nominally, or which is revealed but turns out to be unreliable.
Clear transparency sheds light on organizational behavior, which permits interested employees to pursue strategies of constructive change.

This distinction between clear and opaque is grounded on the premise that if transparency practices are going to meet their goals of transforming organizational behavior, then they must be explicit in terms of who does what, and who gets what.

Transparency requires not only a willingness, but processes to drive it.