Embarrassing Photos

This photo is on the embarrassing side.

Messy Moderna binders from https://hbr.org/podcast/2020/11/remote-feedback

If I stumbled across this on a GEMBA walk there would be coaching on proper storage techniques of documents. My only hope is some corporate communications person made it this way on purpose and the poor person in the photo was muttering under their breath the entire time.

There is an opportunity here on connecting with communications team on best ways to showcase GxP activities. I recommend writing a good policy on the subject and ensuring it is appropriately bought into.

Happy Birthday to Franz Kafka

“I usually solve problems by letting them devour me.”

Franz Kafka, Letter to Max Brod

This blog is named after a great short story by Franz Kafka, a writer who should be read by every Quality professional.

Franz Kafka’s work has huge relevance for management and organization. The characteristics of bureaucracy that we find in Kafka’s fiction are widespread in the real world bureaucracies we find ourselves in, particularly the ambiguity of rules, the existence of informal networks within organizations, and systemic corruption. Reading Kafka has greatly influenced my ideas of organizational sense-making and has shaped many of my ideas on ethical issues and conflicts that arise within organizations. It is no exaggeration to say that Kafka’s name is as closely linked to the notion of bureaucracy as Weber’s, and deserves a central place in all organizational studies. Quite frankly, Quality as a practice and a profession would do well to read Kafka thoroughly.

The Value of Vulnerability

I’ve been thinking of the role vulnerability a lot in light of the current pandemic situation, and so I went back and re-read Professor Brené Brown’s Dare To Lead. In this book she lays out a framework for vulnerability, as a resource in leadership and within the workplace, which can impact the entire culture and creativity of a team.

Professor Brown defines vulnerability as uncertainty, risk and emotional exposure and lays out how vulnerability is essential to enabling collaboration. Leaders need to be transparent about their own challenges and encourage others to share their challenges with the group. Sharing vulnerability creates group cohesion.

At the same time I’m reading this book, I also started a new job and I’ve been in a lot of conversations about how we get folks comfortable with sharing their difficulties in their implementation around quality 4.0 initiatives.

Here’s the thing I want to stress, we can make vulnerability an organizational habit by instituting standard processes like after-action reviews and lessons learned. Building these processes into project lifecycle and our very culture provides a clear, designated space for sharing and vulnerability. By ensuring consistent application of lessons earned we can build this habit honesty, vulnerability, openness, and sharing of information. And through that we can help drive a culture of excellence.

Vulnerability can create space for “productive failure”, as Professor Brown terms it. A tricky thing for people to buy into but a way of thinking and working that turns failure into an opportunity to learn. When you know productive failure is a possibility you may be more inclined to be courageous and try and create something bigger and better despite the risks. When a workforce sees vulnerability named and shared by their leaders, and where they also acknowledge risks of failure but see it as an opportunity for learning they are likely to believe they can mirror some of that themselves.

There are a lot of reasons why organizations are bad at doing lessons learned, but I think at the core there is this unmovable idea that vulnerability is a weakness. It is probably for this reason that we see folks very willing to share their successes in case studies and at conferences, but not so willing to shares misses and failures. Even though we have a lot to learn from that vulnerability.

I’m curious. How is vulnerability expressed in your organization?

Virtual WCQI

The ASQ is hosting a virtual World Conference on Quality Improvement. Glad to see thisexperiment. While a lot of organizations have been holding virtual conferences, this use of technology is a stretch for a lot of ASQ Members.

James Clear – 1% Better Every Day

Clear’s 2019 book Atomic Habits was definitely one of the most talked about self-help books from last year.

1% Better Every Day

The book has some concerns, for example do a little googling on the Marshmallow Test, and Clear still starts his talk referencing the British Cycling Team, probably not the most convincing given their doping scandals. Clear has actually written about the scandal, so I’m surprised he continues to use it in talks.

That said, I really like his use of a score card and his four rules. No argument from me on the importance of systems.

The four laws for building good habits according to Atomic Habits:

  1. Make the habit obvious.  
  2. Make it attractive
  3. Make it easy
  4. Make it satisfying  

To break bad habits the inverse applies:

  1. Make the habit invisible
  2. Make it unattractive
  3. Make it difficult
  4. Make it unsatisfying

Great discussion on how design and environment shapes our choices. Fits nicely into “nudges.” How we organize our work space and homes is a critical thing that we as quality professionals need to spend more time on. The structuring of an environment, including social, fits nicely into quality culture.

It may be pop psychology goes, but it is a very well written book. And James Clear is a great speaker, even from comfort of his living room or study.

EU Annex 21 Published in Draft

On 20 March the new Annex 21 to the EU-GMP Guidelines was published as a draft. The document is entitled “Importation of medicinal Products”. The “Concept Paper” was published on 13 May 2015 (EMA/238299/2015) and the consultation phase ended in August 2015. The first draft for regulatory consultation was published in November 2016. Since then, no further activities or versions have been issued.

The Guidance is aimed at Manufacturing and Importation Authorisation holders (MIA holders) who import human or veterinary medicinal products from third countries. It does not cover products that do not have a marketing authorisation in the EU/EEA and are directly re-exported. The following points are to be regulated by the new Annex:

  • Physical transfer from the third country to the EU/EEA
  • Certification by the Qualified Person (QP) (link with the requirements of Annex 16)
  • Requirements for equipment and facilities
  • Required documentation
  • GMP requirements for manufacturers and exporters in third countries
  • Qualification and audits under the responsibility of the importing company and the Qualified Person (QP)
  • Import testing
  • Contractual regulations between all companies or persons involved in the import

Not much new here, but folks should be aware.