Competencies in Quality

Competence is the set of demonstrable characteristics and skills that enable, and improve the efficiency of, performance of a job. There are a ton of different models out there, but I like to think in terms of three or four different kinds of competences: professional and methodological skills; social competence; and self-competence which includes personal and activity- and implementation-oriented skills. Another great way to look at these are competencies for inter-personal (maps to social competence), intrapersonal (maps to self-competence), and cognitive (maps to professional and methodological skills).

The ongoing digital transformation (Industry 4.0) leads to changing competence requirements which means new ways of life-long teaching and learning are necessary in order to keep up.

We can look at the 4 competencies across three different categories: Human, Organization and Technology:

Human is those skills we need as individuals
Organization is the framework of the organization, the culture
Technology covers what we need to put in place

	Human	Organization	Technology
Professional & methodological expertise (Cognitive)	System thinking Process thinking Results oriented work Complexity management Business thinking Problem solving Sensitization ergonomics Structured, analytical thinking Change management	Qualification/further education Agile methods/tools Lean Enterprise Client orientation Workplace design	Soft/hardware understanding Cyber-physical system understanding Usability Human-machine interfaces
Social Competence (Inter-personal)	Inter-disciplinary thinking Managerial competence Ability to work as a team Conflict management Communication Empathy	Employee satisfaction Human centering	Social networking
Self-Competence (Intrapersonal)	Lifelong learning Personal initiative Innovativeness Independent work Sense of responsibility Readiness for change	Process orientation

When it comes to the professional competencies there is a large spread depending on what our industries requires. As a pharmaceutical quality professional I have different professional expertise than a colleague in the construction industry. What we do have in common is the methodological expertise I listed above.

Understanding competencies is important, it allows us to determine what skills are critical, to mentor and develop our people. It also helps when you are thinking in terms of body of knowledge, and just want communities of practice should be focusing on.

FDA enforcement actions decline

Investigative report on FDA enforcement under Trump from Science’s news department shows a steep decline in enforcement actions.

I’ve noticed this, but it is good to see actual data behind it.

I’ll be frank, it would take a lot of data that does not exist to make me feel the companies under the FDA’s oversight have gotten better as a whole. Anecdotally, well there are a lot of less than sterling players out there.

I have mostly questions:

Have we seen this trend in previous Republican administrations, and is it more pronounced here?
Is there any evidence that the increase under Obama was a reaction to the previous Republican administration? Are we in a cycle of lax and then tougher enforcement that maybe evens out? That sort of variance is not healthy.
What, if any data, will we be able to see about impact? There are certainly concerns that the FDA has not done enough. Will this be exacerbated?
What will it take for this to start affecting the mutual recognition agreements with the EU and other major bodies?

Product Drift

As we continue to have multiple biosimilar and potential interchangeable approvals for the same reference product, it is important to consider how product drift will impact biosimilar products approved at different times, as well as the characteristics of the biosimilar product itself.
Ha Kung Wong (2019). Will product drift cause a rift? PharmaManufacturing

Excellent article on biosimilars and product drift. The rush for biosimilars needs to always remember how biologics are extremely sensitive to changes in the manufacturing process. Biosimilars require the most robust of quality systems and I worry that companies attracted to them for their price savings might cut corners.

A great primer on the topic is: Ramanan, S. & Grampp, G. Drift, Evolution, and Divergence in Biologics and Biosimilars Manufacturing. BioDrugs (2014) 28: 363.

Let’s make sure that we don’t get another Thalidomide, we don’t need other examples for our GxP classes and new employee orientations.

Burnout Needs a Systematic fix

It is more like being involved in a complicated love affair. One minute it’s thrilling, passionate, engaging. The next, it’s exhausting and overwhelming, and I feel like I need a break.
— Read on hbr.org/2019/07/when-passion-leads-to-burnout
Jennifer Moss, When Passion Leads to Burnout. HBR

It is the responsibility of leaders “to keep an eye on the well-being of their staff.” Organizations whose staff feel unmotivated due to stress and burnout cannot aspire to achieve a culture of excellence. Our systems need to be designed to eliminate the root cause for stress and burnout.

Five mechanisms can be leveraged to improve organizational system design: 1) Eliminate organizational issues related to roles, responsibilities and authorities of employees, 2) establish a policy of transparency and effective “bottom-up” internal communication channel to permit employee contribution and recognition, 3) establish criteria for resource distribution, 4) establish a commitment to identify needed training and provide resources for the purpose and 5) establish a systemic feedback loop for analysis and improvement of employee motivation based on periodic measurement of employee motivational levels.

If employees know exactly what their tasks are, without sustained overload, with necessary resources and competence, and recognition for the task well performed, there will be no major system-induced reason for demotivation.

This gets to the heart of Deming’s use of psychology in his System of Profound Knowledge. Lean calls it Respect-for-People. This is all about ensuring our organizations are healthy places to work and thrive.

Self Awareness and Problem Solving

We often try to solve problems as if we are outside them. When people describe a problem you will see them pointing away from themselves – you hear the word “them” a lot. “They” are seen as the problem. However, truly hard problems are system problems, and if you are part of the system (hint – you are) then you are part of the problem.

Being inside the problem means we have to understand bias and our blind spots – both as individuals, as teams and as organizations.

Understanding our blind spots

An easy tool to start thinking about this is the Johari window, a technique that helps people better understand their relationship with themselves and others. There are two axis, others and self. This forms four quadrants:

Arena – What is known by both self and others. It is also often referred to as the Public Area.
Blind spot – This region deals with knowledge unknown to self but visible to others, such as shortcomings or annoying habits.
Façade – This includes the features and knowledge of the individual which are not known to others. I prefer when this is called the Hidden. It was originally called facade because it can include stuff that is untrue but for the individual’s claim.
Unknown – The characteristics of the person that are unknown to both self and others.

The original Johari Window (based on Luft, 1969)

An example of a basic Johari Window (my own) can be found here.

Users are advised to reduce the area of ‘blind spot’ and ‘unknown’, while expand the ‘arena’. The premise is that the lesser the hidden personality, the better the person becomes in relating with other people.

The use of Johari Window is popular among business coaches as a cognitive tool to understand intrapersonal and interpersonal relationships. There isn’t much value of this tool as an empirical framework and it hasn’t held up to academic rigor. Still, like many such things it can bring to light the central point that we need to understand our hidden biases.

Another good tool to start understanding biases is a personal audit.

Using the Johari Window for Teams

Teams and organizations have blind spots, think of them as negative input factors or as procedural negatives.

The Johari Window can also be applied to knowledge transparency, and it fits nicely to the concepts of tacit and explicit knowledge bringing to light knowledge-seeking and knowledge-sharing behavior. For example, the ‘arena’ can simply become the ‘unknown’ if there is no demand or offer pertaining to the knowledge to be occupied by the recipient or to be shared by the owner, respectively.

The Johari Window transforms with the the four quadrants changing to:

Arena – What the organization knows it knows. Contains knowledge available to the team as well as related organizations. Realizing such improvements is usually demanded by network partners and should be priority for implementation.
Façade – What the organization does know it knows. Knowledge that is only available to parts of the focal organization. Derived improvements are unexpected, but beneficial for the organization and its collaborations.
Blind Spot – What the organization knows it does not know. Knowledge only available to other organizations – internal and external. This area should be investigated with highest priority, to benefit from insights and to maintain effectiveness.
Unknown – What the organization does not know it does not know, and what the organization believes it knows but does not actually know. Knowledge about opportunities for improvement that is not available to anyone. Its identification leads to the Façade sector.

We are firmly in the land of uncertainty, ignorance and surprise, and we are starting to perform a risk based approach to our organization blind spots. At the heart, knowledge management, problem solving and risk management are all very closely intertwined.