A Titanic Mix-Up — What’s HuP?

We’ve all seen by now the latest NYT reporting about Emergent and the mix-up that cost between 13 and 15 million doses of the J&J Covid-19 vaccine. As a human performance practitioner, my hair lit on fire when reading this statement: “An investigation is now underway, but federal and former company officials suspect the lot […]

A Titanic Mix-Up — What’s HuP?

My friend and colleague Dakota Stad writes on what recent reporting tells us about Emergent’s culture. Dakota’s points are spot-on – these issues start with senior leadership and are not on indicative of any sort of “rogue actors”.

It would be an easy narrative to blame the workers, but as always we should stay focused on building a just culture.

Three year retrospective

This blog is three years old and my experiences as a practitioner of quality and as a leader has been driven during this time by narrative writing. Writing gives the space and time to look back, re-live and re-experience, and ultimately reflect upon our work. Writing these blog posts is an effective way of digesting experience on the job. Through
writing this blog I have attempted to understand situations from various viewpoints and perspectives.

I get asked a lot why I do this, and how I make time for writing. Let’s be honest, there are long periods of time where I do not. But when I do make the time it is for these reasons.

Writing as a catalyst for reflective thought

In an era where lifelong professional learning is continuously promoted, professionals need to continuously learn and take the role of practitioner-researcher. The narrative writing I engage in on this blog plays an important role that aids this ongoing development. Through writing I enhance my reflective awareness.

Writing helps reduce the imbalance I feel between theory and practice. Too often we need to make immediate decisions and it is difficult to balance what-must-happen with what-should-happen. Writing this blog allows me to think critically about my past actions and how these together with theory can inform future practice.

Writing this blog is a way of thinking that helps me in understanding myself; my own actions; my thoughts; my emotions; my experiences. Apart from self-understanding, self-reflective narrative also assists professional learning because it aids professional thinking. In short, writing helps me think, reflect, and develop. I write, therefore I think.

First-order narratives: promoting self-understanding

The narratives in this blog are first-order narratives where I write about my own experiences, as opposed to second-order narratives where the author writes about the experiences of others. Everything I write starts as a challenge or an experience I am processing. This blog rarely engages in journalistic reporting, and when it does report on the news it is always part of reflection.

Through writing about my experiences as a quality professional, and reflecting on them, I strive to construct meanings, interpretations, new knowledge and understandings.

By engaging in systematic reflection I am promoting questioning, and questioning encourages me to think of new possibilities. This is where ideas come from, and this drives my professional quality practice forward.

Conversing with oneself

Conversing with someone else offers the possibility of feedback and exposure to different viewpoints. This is why I look to professional societies as one way to enhance my work. I’ll be honest though that is not as easy as I would like it to be.

Unfortunately, I often feel isolated. People are busy and it is difficult to carve out the time for reflection and discussion. It can often feel that collaboration and sharing about non-project deliverables are limited to non-existent at worst. By blogging I am conversing with myself in public. It would be great to engage in dialogue with people, but I feel this public dialogue is a way to engage with the larger body of knowledge.

I think this is one of the reasons I blogged less after starting my current job. All my time was going into collaborative narratives as I strove to determine what came next in this new role.

Looking deeper into issues

Sitting down and writing a blog post offers time for reflective thought. Sure, I talk about these issues all day, but writing journal entries, because I tend to think about it a lot more, allows me to explore additional dimensions of the issue. Narrative writing affords me the space for focused reflective thinking. This blog is my medium for reflection, questioning, critical analysis, thinking, reasoning, and the building of arguments.

Often I write in preparation for some task or project. Or to analyze how it is progressing and to solve problems.

Creating causal links

A narrative should have an evaluative function; offering valuable information about how the author interprets and connects meanings to lived situations and experiences. A narrative must add up to something; it is more than the sum
of its parts. Through writing this blog I am connecting the various parts of quality that are important to me in a wider whole. And by crafting that whole, develop new learnings to apply.

Blogging is tiring but valuable

I have experienced periods of tiredness, frustration, and a lessened motivation to blog, and this resonates with the argument that practitioners are usually so busy that they have little time for their own writing. This has especially been true during the last year of this pandemic.

However, I strongly view this blog as a core part of my learning, and that learning benefits from the longitudinal process of blogging. Writing about my experiences as a quality professional has promoted detailed observations of my work, analysis of that work, imagined solutions, implementation of such imagined solutions, and re-analysis of alterations to practice. Writing this blog has been an ideal way of showing experiential learning and my own development.

What comes next?

I set myself a goal of writing at least one post a day in March, and I found that amazingly rewarding. Not sure if I can keep that pace up but I am committed to continuing to use this blog space for reflection and development. I hope folks find some use out of that, and I look forward to the various communities this space engenders.

Photo by Andrea Piacquadio on Pexels.com

ASQ change control change management collaboration communication complexity conference cultural excellence data integrity decision making document control Ethics expertise facilitation fda ICH knowledge management leadership Lean learning culture living risk assessments metrics presentation Problem solving process project management psychological safety quality culture quality intelligence quality systems regulatory regulatory inspections risk assessment risk management speaking system design system thinking team Team excellence team performance tools training uncertainty warning letter WCQI

Leveraging some graphic resources

Let’s be honest – slides and presentations from quality professionals tend to be text heavy and graphic poor. I’m no expert here, but I have settled on a few subscriptions that help me produce fair to middling presentations and graphics.

  • SlideModel, SlideGeeks, SlideTeam – You probably don’t want all three (or one of the other competitors) but have a subscription to just one of these have saved my sanity more times than I can count.
  • NounProject – Oh how I love the icons this organization makes available. I use them everywhere! Presentations, procedures, technical systems. Great price structure, decent licensing. Now with a decent photo library too. Someday I will organize one of their Iconathons for developing a good set of icons around quality principles and tools.
  • Photolibrary – So many free and low priced ones out there. I don’t use photos nearly enough but I keep up a low level shutterstock subscription and use my monthly quota.

My goal this year is to use more graphics in my blog. Well actually my goal is to post more this year, 2020 was kind of a wash.

2019 State of the Blog

ASQ change control change management collaboration communication complexity conference cultural excellence data integrity decision making document control Ethics expertise facilitation fda ICH knowledge management leadership Lean learning culture living risk assessments metrics presentation Problem solving process project management psychological safety quality culture quality intelligence quality systems regulatory regulatory inspections risk assessment risk management speaking system design system thinking team Team excellence team performance tools training uncertainty warning letter WCQI

I started this blog as an exercise in deliberate practice, as well as reflective. In order to grow it is important to engage in critical reflection, which requires a process of mutual learning, a consciously organised process of deliberative and distributed reflection. Which is what I strive to do in my blog posts.

At the end of last year, I evaluated my blog goals through an ACORN exercise, as well as updating a SWOT. These stand up pretty well, even in a year of changes where I took on member leader responsibilities as the chair of the ASQ’s Team and Workplace Excellence Forum and took a new job.

I met my posting goal, which was 1.5 posts a week, with 81 posts and 33.5k words.

The top 5 posts of 2019 are:

  1. FDA signals – no such thing as a planned deviation: Written in 2018 this post directs a lot of traffic to the blog from search engines, and has the largest geographic spread. Key message here continues to be all temporary changes, all planned departures, need to go through a change control system of appropriate rigor based on the risk involved.
  2. Risk Based Data Integrity Assessment: Data Integrity and Risk Management are two of my favorite topics and in this post I combine the two and provide a fairly usable tool. I wrote this post while at the ASQ’s Audit Conference, where I presented on data integrity.
  3. Lessons Learned as a Developing Leader: I am very gratified that this piece of introspection was viewed as many times as it was. Three months into my current job and this post, and the followup, are a good roadmap.
  4. Decision Quality: How we make decisions, deal with subjectivity and uncertainty and problem-solve are all big concerns for our organizations. This post serves as a good anchor for my thought and practice, as well as the direction of future endeavors.
  5. Driving for Mature Quality Organizations – FDA recent perspective: Building a quality culture, driving maturity in our organizations are critical. The FDA is spot-on, and companies really need to be coming to grips and dealing with this systematically.

Looking ahead to 2020 for the blog, I am going to take a bit of direction from Luigi Sille who set the following goals for himself:

  1. Build up my expertise
  2. Grow my network
  3. Continuously improve every single day

For building expertise, I want to continue to focus on building tools and methods to: deal with subjectivity and uncertainty around decision making and risk management; proactively build a culture of quality and excellence, especially dealing with aspects of data integrity; and, find connections between the larger organizational/leadership/operational bodies of work and adapt them to the quality profession.

This blog is a large part of growing my network and I want to get to 2 blog posts a week consistently. I’ll continue to work with the ASQ as chair of the Team and Workplace Excellence Forum, including holding at least 2 events (including an unconference!). I am also trying to pull together a group of speakers to bring data integrity and quality culture as a stream to ASQ BosCon. I’ll speak at least 2 ASQ Conferences. I’ll also deepen some ties with the PDA, including speaking at one conference.

As I continuously work to improve, I will bring the topics I’m learning and implementing back to this blog.

Top 5 Posts by Views in 2019 (first half)

With June almost over a look at the five top views for 2019. Not all of these were written in 2019, but I find it interesting what folks keep ending up at my blog to read.

  1. FDA signals – no such thing as a planned deviation: Since I wrote this has been a constant source of hits, mostly driven by search engines. I always feel like I should do a follow-up, but not sure what to say beyond – don’t do planned deviations, temporary changes belong in the change control system.
  2. Empathy and Feedback as part of Quality Culture: The continued popularity of this post since I wrote it in March has driven a lot of the things I am writing lately.
  3. Effective Change Management: Change management and change control are part of my core skill set and I’m gratified that this post gets a lot of hits. I wonder if I should build it into some sort of expanded master class, but I keep feeling I already have.
  4. Review of Audit Trails: Data Integrity is so critical these days. I should write more on the subject.
  5. Risk Management is about reducing uncertainty: This post really captures a lot of the stuff I am thinking about and driving action on at work.

Thinking back to my SWOT, and the ACORN test I did at the end of 2018, I feel fairly good about the first six months. I certainly wish I found time to blog more often, but that seems doable. And like most bloggers, I still am looking for ways to increase engagement with my posts and to spark conversations.