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:
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
Lifelong learning Personal initiative Innovativeness Independent work Sense of responsibility Readiness for change
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.
Investigative report on FDA enforcement under Trump from Science’snews 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?
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.
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
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.
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.