The Culture Club: Wrapping it up - Part 4 of 4
We are The Culture Club, a self-formed cross-CoP group of individuals who came together to discuss challenges encountered as we transition quality and validation into the digital world and identify ways to influence cultural changes needed within our industry to better enable innovation. As we are not all from the same CoP, we first needed to establish a way to connect and collaborate with all members of ISPE. This blog is the fourth in a series of four intended to explore how we can rethink the way we support and inspire one another as we reimagine quality and validation in a digital world.
So far, we have covered:
- Part 1 started with an introduction to the culture club and our desire to influence the cultural shifts needed to enable digital innovation in regulated space.
- Part 2 discussed transparency which can be interpreted as both a reason to push digital innovation but also can be viewed as a perceived risk or deterrent to innovate.
- Part 3 discussed how reskilling must be done to enable today’s workforce to perform their current jobs and that it is something that should be continuous.
And here we are now… It’s January (at the time of writing) and it’s a time of reflection. We didn’t want to end this series without providing a peek into our own personal journeys. We have asked ourselves what our role in this shift is and what our hurdles are. Our hope is that you can see that we all have resistance in us to some level but we ask you to look at how you can overcome these and seek innovation and challenge yourselves to adopt newer ways to achieve quality, control and ultimately, compliance!
Reflections
What are you working on now to drive digital adoption?
I have to admit that in my current work role I’m the naysayer trying to make sure that the allure of the new digital tools is balanced by the realities of deploying them in a compliant manner.
What have you learned from the Culture Club?
I need to invest a bit more time in the current class of cloud based tools to stay relevant in industry.
What brought you to the Culture Club?
I heard Levi give a presentation proposing that pre-approved test scripts were no longer necessary because a new software tool for managing development “sprints” contained all the evidence of ‘fit for use’ that is typically documented in qualification protocols. I went to the microphone and threw several challenges at him. Afterwards I had a lengthy and fun conversation with Levi and Brandi, and I agreed to be their curmudgeon.
What have been your pain points with Digital Adoption at Work?
Anyone can read an executed paper batch record and verify that the critical process steps were completed correctly. That is not true when those steps are embedded into an MES, yet QA is still tasked with verifying them to release the product. This makes design documents, qualification testing, and change control (arguably) more critical to compliance, and the output of these systems should meet the needs of QA and regulators. In my experience this is not always the case.
Issues with digital adoption personally?
It seems as the quantity of software tools being deployed has dramatically increased in recent years, especially those to facilitate remote teamwork. Learning to effectively leverage them takes time. I owned the very first PC computer model IBM produced. I’ve grown up with computers, programmed them, programmed PLC’s, written code and compiled it. I understand the potential impact of these new tools, but I’m loath to invest the time in them until a clear winner emerges.
What is your adoption upskilling persona?
First, I’ll try to figure it out. Within a few minutes of frustration, search the internet for help. Call someone as a last resort.
What is your favorite digital tool?
SimpleNote, a text only tool for keeping lists and notes. It embraces the KISS principle.
What brought you to the Culture Club?
My desire to help move the digital adoption needle for quality and validation professionals in the regulated space.
Issues with digital adoption personally?
The time barrier. I am referring to the time it takes to step back and think critically about how compliance can be achieved when things look different. Ever heard of, “Life begins when you step outside your comfort zone.”?
What have been your pain points with Digital Adoption at Work?
Getting the players in the regulated space to recognize the broad array of benefits of going fully digital goes beyond just being “paperless”; and that, true adoption of digital requires us to think differently and do things differently to achieve the full
benefits and higher levels of control.
What have you learned from the Culture Club?
There’s more to do. Hearing the different perspectives has allowed me to gain a better appreciation for what’s holding up change. Also, just because someone might appear to be resisting, they may not be closed off to change.
What are you working on now to drive digital adoption?
I lead Validation 4.0, an industry working group within ISPE with the main objective of defining tangible ways we can move this needle from the validation perspective. Also, working with other industry contacts to lean into and work through the challenges that come with change. This is how the Culture Club came about.
What is your adoption upskilling persona?
Time is the barrier for me, so I’ve been very focused on efficient ways of doing things but to take the time to learn the new skills has been the biggest hurdle. Changing requires effort so I’ve been a cross of the overly focused leader and a cowgirl!
What is your favorite digital tool?
Good question. Strava or Tulip!
What are you working on now to drive digital adoption?
The Culture Club, this blog. Using and promoting the use of digital tools. Improving process flexibility, scalability and actively changing the way I work.
What have you learned from the Culture Club?
The Culture Club reminded me of the value of ‘leaning in’ and the importance of using dialogue to frame/reframe problems allowing for constructive conversations.
What brought you to the Culture Club?
The culture club was an opportunity to have open dialogue with industry colleagues from differing backgrounds and view- points to gain a better understanding of how we can navigate some of our current obstacles of digital adoption and share potential ways to encourage progress.
What has been your pain points with digital innovation at work?
Key issues faced include difficulty with organizational change management, resource constraints, and inflexible processes. Pain points include limited resources/skills to successfully implement and manage digital solutions.
Issues with digital adoption personally?
Taking time to learn becomes second to other priorities. Over the past year or so I have been forcing myself to learn and use new tools to do some of my common work tasks.
What is your adoption/upskilling persona?
I feel that progress and change cannot happen unless some of us are willing to take action ourselves or support others in their journey. I best fit into the early adopter persona but consider myself more of a pioneer as I am open and willing to try something new or take a different path but do so in consideration of risk.
What is your favorite digital tool?
I don’t have a favorite but appreciate the ability to start/lock my vehicle, identify flowers, plants, etc. Applications for work - again no specific favorite but do appreciate the benefits of using insight tools.
What are you working on now to drive digital adoption?
Working with my team to redevelop our IT process to be completely digital and designed with a user-centered approach. Also, writing this blog!
What is your adoption/upskilling persona?
I would say I definitely fall into the early adopter / early majority for most things (I can be seen as a cowboy to those on the outside but I am actually pretty calculated)
What brought you to the Culture Club?
I feel like for me, the culture club was the next evolution in my collaboration within ISPE. It’s been this journey of making these relationships and then instead of just talking in meetings to each other about issues, actually putting things down for others to read and chime in on.
What has been your pain points with digital innovation at work?
The hardest thing I have faced is helping people to visualize what the future could look like and then working backwards to understand what is needed. I am still struggling with this today but have started to use mock-ups an¬¬¬¬¬d user stories as aids to show people an idea for the future and that seems to help get their mental gears moving.
Issues with digital adoption personally?
Hmm at first thought, I wanted to say “none” but after reflecting, I think I struggle to balance learning new technologies to understand what’s out there versus learning new technologies to improve my daily work. Alongside that balance issue, sometimes it’s easy to get fragmented because I am trying several similar tools (such as different note apps).
What have you learned from the culture club?
Honestly, embracing the opposition can be the best thing for continuous improvement. Taking in all the different viewpoints really helps with moving everyone forward.
What is your favorite digital tool?
Wow, that is hard to choose! I’m split between Azure DevOps (and similar tools - I have love for my Jira folks out there) and Power BI.
While working together during this journey, we found this article1 that relates the Demming principles to today’s world. It’s fascinating how most all (if not all) principles are still very relevant today. We’ve highlighted a few that resonate with the cultural shifts we are describing…
- Cease dependence on inspection to achieve quality
- Improve constantly and forever the system of production and service - continuously change driving improvement
- Drive out fear, drive out prejudice for what is now, what is what we’ve always done
Industry 4.0. Pharma 4.0. Quality 4.0. Validation 4.0. The “4” in all these terms is referring to the fourth industrial revolution that we are in that is characterized by connectedness that is achieved by all the technology that is available now. The word revolution infers big change; big change, in and of itself, can trigger confusing and scary emotions. As Madilynn Angel and Russell Waddel discuss in Behind the Ops podcast, episode 16,2 we need to get comfortable in the slightly uncomfortable. This can be done by setting realistic expectations [of yourself, your colleagues, your Quality partners] and not setting your sights on the perfect world. The road can be bumpy, but you won’t get there unless you walk down it!
Rounding out the series by ending with the beginning: Realize, Let Go, and Act. We associated personas of change with the stereotypes portrayed in the movie, The Breakfast Club. The Culture Club started as a group of 3 whose paths crossed due to our common goal of driving the cultural shifts. We soon came across a resistor, leaned into the resistance, brought him into the conversation so that we could learn from each other. As we end this series (maybe the first of many) we recognize that the concept of stereotypes are important because they give us a generalization of an overall group. Exposure to different perspectives allows us to move forward with different perspectives and a higher chance of success. So, no matter what department, what company, or what persona you relate to, you can be who you want to be. But you have to want to change. We’ve given a few examples, tips and pointers to get you started. We encourage you to run down this path. You need to take action! What is your sphere of influence? Challenge the status quo, but be equipped with the knowledge to support it. Upskill yourself, find a friend by building relationships, and offer alternative measures. Reach out to any/all of us! This is just the beginning of our next revolution.
- 1Eli Amdur, 2022, ‘Modern Application of Some Old Thoughts’, Forbes.com, December 10, 2022,
- 2Angel, M. & Waddell, R. (Hosts). (2022, December 01). Sometimes You’re Just Going to Get Wet (No. 16) [Audio podcast episode]. Behind the Ops Podcast. Tulip. https://www.behindtheops.com/16
