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 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:

  1. Have we seen this trend in previous Republican administrations, and is it more pronounced here?
  2. 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.
  3. 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?
  4. 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.