I think it is no secret that I inherently view Quality as a progressive endeavor, and do not see eye-to-eye with colleagues who are conservative. How anyone can take our anti-Taylorist endeavor and not get to stands like the importance of human rights and the need to center those whose rights are challenged – like women – is beyond me. How can we stand for autonomy and not fight for the autonomy of all.
The silence of quality organizations is deafening.
What I want to write about now is how the roll-back of Roe in Dobbs should be a real clarion call to the life science industry, which needs to stop funding conservative politicians because those politicians do not have our best interests at heart.
The fight over Mifepristone and Misoprostol has already begun. The religious conservatives will go after it, and this reactionary court will need to gut the FD&C and the rest of the regulatory regime behind drugs in this country to let that happen. This will be really bad. It will cause life science companies to pull research, clinical trials, and manufacturing from this country as we will no longer be the gold standard in the life sciences. We will be a joke.
I push decision-making to the right people as appropriate.
To make this work, it is critical to teach decision-making. A popular method is RAPID, an acronym of 5 words that refer to the group of people involved in the steps of decision-making -Recommend, Agree, Perform, Input, Decision. This was a framework developed by Bain & Company as a systemized framework to design an action plan regarding a problem.
With the base of how a decision is made, the next step is to decide what sort of decisions exist in the organization, and how they get made. I recommend two axis:
The Scale of the Decision: What is the risk level of the decision
The Level of Process Controls: How well defined is the process around the area of the decision
W. Edwards Deming’s substantive influence upon management thinking and practice is evidenced by the number of organizations that have worked to implement his key points, the abundance of books and papers related to his ideas, and the impact of his ideas on the practice of business today. While I’m not a fan of the term Quality Guru, it is hard to miss his impact.
Deming’s main concepts can be summarized as:
Visionary Leadership: The ability of management to establish, practice, and lead a long-term vision for the organization, driven by changing customer requirements, as opposed to an internal management control role.
Internal and External Cooperation: The propensity of the organization to engage in non-competitive activities internally among employees and externally with respect to suppliers.
Learning: The organizational capability to recognize and nurture the development of its skills, abilities, and knowledge base.
Process Management: The set of methodological and behavioral practices emphasizing the management of process, or means of actions, rather than results.
Continuous Improvement: The propensity of the organization to pursue incremental and innovative improvements to processes, products, and services.
Employee Involvement: The degree to which employees of an organization feel that the organization continually satisfies their needs.
Customer Satisfaction: The degree to which an organization’s customers continually perceive that their needs are being met by the organization’s products and services.
Summarizing the System of Profound Knowledge
Almost thirty years after the publication of The New Economics for Industry, Government, Education and we are still striving to realize these. They are still as aspirational and, for many organizations, out of reach today as they were in the eighties. We can argue that a lot of the concepts that swirl around Quality 4.0 is just trying out new technologies to see if we meet those objectives.
We can, and should, discuss the particulars of the System of Profound Knowledge. For me, it makes an excellent departure point for what we should be striving for. By looking to the past we can discover…
We are all familiar with the traditional feedback loop: you receive feedback, reflect on it, make a plan, and then take action. This means feedback is given after a series of actions have taken place. Feedback addresses a few key observations for future improvements. In a situation when actions and sequences are quite complicated and interdependent, feedback can fail to provide useful insights to improve performance. Micro-feedback potentially canbe leveraged to prevent critical mistakes and mitigate risks, which makes it a great way to build culture and drive performance.
Micro-feedback is a specific and just-in-time dose of information or insights that can reduce gaps between the desired behavioral goals and reality. Think of it as a microscope used to evaluate an individuals comprehension and behavior and prescribe micro-interventions to adjust performance and prevent mistakes.
Microfeedback, provided during the activity observed, is a fundamental aspect of the Gemba walk. These small tweaks can be adapted, and utilized to provide timely insights and easy-to-accomplish learning objectives, to drive deep clarity and stay motivated to modify their performance.
Where and when the microfeedback happens is key:
1. Task–based microfeedback focuses corrective or suggestive insights on the content of a task. To provide higher impact focus micro-feedback on the correct actions rather than incorrect performance. For example “Report this issue as an incident…”
2. Process-based micro-feedback focuses on the learning processes and works best to foster critical thinking in a complex environment. For example, “This issue can be further processed based on the decision tree strategies we talked about earlier.”
3. Self-regulation-based micro-feedback focuses on giving suggestive or directive insights helping individuals to better manage and regulate their own learning. For example, “Pause once you have completed the task and ask yourself a set of questions following the 5W2H formula.”
For microfeedback to be truly successful it needs to be in the context of a training program, where clear behavorial goals has been set. This training program should include a specific track for managers that allows them to provide microfeedback to close the gap between where the learner is and where the learner aims to be. This training will provide specific cues or reinforcement toward a well-understood task and focus on levels of task, process, or self-regulation.
During change management, provide positive micro-feedback on correct, rather than incorrect, performance. This can be very valuable as you think about sustainability of the change.
Leveraged sucessful, but well trained observers and peers, microfeedback will provide incremental and timely adjustments to drive behavior.
I think many of us are considering what work looks like, grappling with a return to offices, hybrid situations, and being fully remote. I think the media focuses rather extensively on companies like Apple, where a good chunk of the workforce seems to be up-in-arms about a mandatory return to the office.
In the pharma world, things are a little more complicated, especially as it applies to the quality profession.
At the heart sits the question, what sort of labs and manufacturing facilities do you have on site? This physical presence requires that certain employees be on-site. Which in most pharmas makes a bundle of those who must be on-site, and those who do not need to be on-site.
I understand the desire for those who can work remotely to want to work remotely. There are a lot of good reasons for working remotely, and I personally chose a company that was purely remote for a chunk of those.
But, and this is a big but, what does equity look like?
Take for example an average quality department. It is broken down into those who support labs, manufacturing, clinical trials and post-marketing surveillance (for simplicity). You thus have in the same department individuals who must be always on-site; who need to show up a few days a week; and those who can do their job perfectly well remotely. To complicate matters you might even have a big chunk of your partners (all those clinical trial, medical affairs, pharmacovigilance folks) that have no attention of coming back to the office.
So, what does equity look like? How do you treat these three camps? How to you compensate those who come into the office, that have commutes on top of their days that co-workers do not? How do you ensure everyone has equal opportunity to be seen, heard and participate? What does this organization look like?
I thnk this is one of the major challenges for quality organizations moving forward. I do not think there is one size fits all, and there is no easy answer.