ASQ Poster Session

In 2023 I start my leadership cycle through the Food, Drug and Cosmetic division, starting as chair-elect. This means time to do some content creation! Here’s the first thing I have planned.

The Food, Drug, and Cosmetic Division will be hosting a poster share on February 28th from 3-5 pm in Boston, with a cocktail hour afterwards (5-6). The event is being sponsored by Veeva Systems and will be free (big shout out to Veeva!)

We are looking for individuals and companies to share a poster on the theme of “What are you proud of in your eQMS? What about your implementation or continued use stands out and that you want to share?”

If interested in presenting a poster, please complete this form.

We ask that all posters be completed by the 22nd of February so we can get them printed.

We will record the poster presentation and make them available through my.ASQ after the event. Poster presenters must sign a standard ASQ waiver (we will make it available before the event).

An event sign-up will come out in January.

The event is open to all. While I’m thinking the focus will be heavily focused to FD&C and medical device members, other quality professionals will get value.

So please present a poster! I am very excited about this sort of sharing of ideas. I want to keep experimenting with alternative ways to share information and network, and I think the old poster session is something that has renewed utility in this day-and-age. Sort of a speed conference. Easier to create a poster and can be a compact event.

Subject Matter Experts Role in Knowledge Management – a Competency Approach

A Subject Matter Experts (SME) is a fascinating creature, both those within an organization and those considered a SME outside their organization – for example by a professional society.

A SME is engaged in knowledge management activities, what we want is for those activities to be a explicit and systematic management of the processes of creating, gathering, validating, categorizing, archiving, disseminating, leveraging, and using knowledge – whether for improving the organization and the individuals in it or the broader profession.

The thing is, this is another skill set for most SMEs. There will be SMEs out there who can do this from practice, but we need to be more deliberate in providing the skills. To provide the skills we must understand what we need to teach, which is where a competency model is valuable.

For the purpose of this post I’ll use the same three levels the ASQ Human Development and Leadership technical community uses for their competency framework:

  • Basic: Possesses general, conceptual knowledge or awareness of this concept OR a limited ability to perform this skill. Needs reference materials to complete tasks related to this concept.
  • Intermediate: Able to apply knowledge of this concept in work OR can perform this skill consistently with minimal guidance.
  • Advanced: ¬†Provides expert advice and make sound judgments using knowledge of this concept OR provides consultation and leadership to others using this skill. Can foster greater understanding of this concept among colleagues and stakeholders.
CompetencyLevel to build towards
Knowledge of principles of knowledge management, for example conceptualizing, managing, preserving, and/or maintaining organizational knowledge.Advanced
Knowledge of methods and techniques for capturing and codifying knowledge, for example storytelling, data mining, cognitive mapping, decision trees, and/or knowledge taxonomies.Advanced
Knowledge of methods and techniques for disseminating and/or sharing knowledge across individuals, groups, and organizations.Advanced
Skill in designing and implementing knowledge management strategy.Intermediate
Skill in identifying the quality, authenticity, accuracy, impartiality, and/or relevance of information from various sources, for example databases, print and online media, speeches and presentations, and observations.Advanced
Skill in organizing and synthesizing information from multiple sources, for example databases, print and online media, speeches and presentations, and observations.Advanced
Skill in curating instructional content, tools, and resources, for example researching, evaluating, selecting, and/or assembling publicly available online courseware.Basic
Skill in identifying the type and amount of information needed to support the development of others in the topic.Advanced
Skill in developing, managing, facilitating, and/or supporting knowledge networks and communities of practice. Advanced

We need to recognize that not every SME will get to this level, or have the time to consistently apply it. This is why it is important to have knowledge management experts to support, nurture and step in where needed to assist.

WCQI – Member Leader Day

I made it to Anaheim, I must admit I am pretty surprised, as I’ve backed out of a few other events this year for reasons of family and health, and while I did do the ISPE Aseptic Conference, being at a WCQI feels almost surreal, especially since this is a fairly small WCQI compared to pre-pandemic years.

I decided to attend the member leader workshops. I thought long and hard, as I have had a rough and rocky road as a member leader during the pandemic and I’ll need to think about what that looks like going forward. I made the decision to attend because I hope the experience will help drive action on my part. Also, in some transparency, I bought my plane ticket without realizing that I would otherwise have a free day, and Disney is not my jam.

I think member leaders have a difficult role. There is a lot of administrative work, on top of the need/desire to drive programming. The changes in ASQs financial structure has made that even harder, with the need to be more revenue-neutral driving a lot of decisions. So member leaders have to find the time to be organizers, raise funds, and make programming happen. All while keeping the day job. I always tend to think this is one of the reasons so many seem to be consultants, who can leverage the time as a way to build a reputation.

Building a reputation as a subject matter expert is a fairly traditional path for many of us. At the heart of a professional organization is the question “How do you build real expertise instead of shallow?” and I think member leaders are one part of the answer to that question.

The future of professional societies strikes me as an interesting one. What is the mix of in-person and remote events? Do you try to do hybrids (my recommendation is no). How do you maintain focus. I was hoping to hear that today, but in general, I do not think I did.

The elephant in the room is that the last few years has seen a lot of change forced on the ASQ. Change often feels like it was done to the membership instead of driven by the membership. The ASQ has really struggled to put the tools and methodologies it advocates for into action. And then, on top of everything, there was the horrible nature of the pandemic, which has slowed down and fragmented change.

For example, the change in the membership model where everyone can join every technical community (divisions) is one that has not been really absorbed beyond the major hit to the budget (again something that feels imposed upon the society).

Perhaps I am some sort of radical and think the technical communities need to be decomposed and restructured, but I think this is a real core thing for my experience. Sometimes it feels like technical communities are fighting for the same volunteers and what any technical community focuses on has more to do with the volunteer base than any rhyme or reason to the QBok.

There was a lot of obvious frustration on the part of the technical community members about their role in the organization.

My.ASQ still remains a major point of contention. I tend to think this stems from a combination of technical design and structure. The design need to push technical communities had led to some real balkanization within the structure, which makes it difficult to find content. Add to the fact the tool is not very flexible in how it manages the content and we have a painful adoption three years later.

Technical communities really exist to drive content creation. But I sometimes feel they are more content silos. Content curation is a topic from and center in a lot of member leaders’ minds.

I’m always disappointed when quality professionals get together and there is no structure, no facilitation. When we don’t use the tools our profession is based on. An over-reliance on brainstorming and discussion I think really limits the value of these events as it feels like we are swirling around the same topics.

I attended the following three breakout sessions.

Young professionals

Less than 10% of the membership is under 35, with students being around 5%. I think the central question for all professional societies is how do we change this? Let’s be honest, I am not a spring chicken at 51 and I sometimes feel young at ASQ events.

I think it’s telling on the communication issue that the NexGen section on my.ASQ, touted during this talk, has 3 posts, the last in February.

Mentorship programs are a lot of work for the mentors involved (and the mentees). How do we incentive folks to do it? What does real mentorship look like?

The Power of Collaboration

The ASQ and ASQE split (one of those things done to members, not from members) certainly are central to the question of collaboration within the ASQ. At the heart of collaboration is the central question of content creation.

I feel the ASQ is suffering from a lack of a strong model here. The connections between the QBok and the member organizations (technical and geographical) are weak in many places. There is no real definition of activity scope, guidance framework, and knowledge base.

The central question for collaboration in the ASQ is how do we bring more content that is valuable to our members, which means we need to do a better job of identifying what members need.

WhatWhat is this?My thoughts on what this means for the ASQ?
Guidance FrameworkThe guidance framework typically involves multiple worldviews. The same subject matter can be studied from different worldviews, and the theories around a given subject can be interpreted differently from different worldview perspectives.The ASQ as a whole, the principles of the profession.
Knowledge BaseThe data, theories, and methodologies that drive the disciplineThis is the Qbok and the technical communities that serve specific methodologies and approaches (Lean, Statistics, HD&L, QMD, TWEF, Six Signa, etc)
Activity Scope The range of activities in a disciple, including the professional practice.These are the industry segment specific technical communities

There is a real tension right now in that the board of the ASQ and certainly headquarters, wants to see the technical communities generating more content, more IP. But many in the technical communities are feeling tense, and a little abused by the process.

I think a central question is how do we connect folks with questions to subject matter experts who can answer those questions. my.ASQ hasn’t really solved that issue. And something like Connex is really a marketplace to sell consulting services. This leads us to the third breakout session I attended.

Subject Matter Experts of Tomorrow

Building expertise is a particular focus of mine, and I think it is really important for the ASQ to think about what areas we need subject matter experts (SME) in, and how to leverage those SMEs.

I think we really grapple with just what topics are valuable to quality. Frankly, I think we haven’t reached the promise of the core, the foundational knowledge. We need to avoid thinking sexy “whats” are the key to a profession that focuses more on the hows and whys.

Want to call out the facilitators for using a tool to facilitate the session, while still brainstorming it made a difference.

The central question to answer the question about how we can connect knowledge experts with the skills necessary to be an effective SME?

The key is deliberative practice. As an organization, we need to have a deliberative practice pathway that builds skills in speaking, presentation, and develop area expertise. While we cannot directly give most people a job opportunity to do something, we can look for other opportunities to further e

Closing Thoughts

I have many questions, many thoughts, and no good answers. I waited until after the conference to make sure I had a chance to reflect.

Balancing Expertise

Quality professionals are often defined by our technical knowledge, and with that can come a genuine and intense love and interest in the work. In the pharmaceutical/med-device work, I work in this is defined by both a knowledge of the science and of the regulations (and that stuff inbetween – regulatory science).

The challenge here is that we start defining ourselves by our role as we progress as representing the highest level of expertise in this technical expertise, which means senior Quality (as in the department) jobs are defined in terms of in service to our function – patient safety and product quality (safety, efficacy, and quality). This can then lead to seeing people as the “means” to that end. This inevitably leads to prioritizing that outcome over people.

Do not get me wrong, results matter, and I am a firm proponent of product quality and patient safety. But this approach is reductionist and does not serve to drive fear out of the organization. How can people be safe if they are considered a means to produce value? We need to shift so that we realize we can only get to quality by focusing on our people.

Quality Goes Way Beyond a Few Regulations

The quality profession in the pharmaceutical industry is wider than the overseeing regulations from health authorities. The GXPs are truly a starting point, not an ending point which is why we often use that little “c” for “current.”

The GXPs (and the regulations behind them) serve an important purpose. But they are the start of excellence and not the end.

The GXPs are an outline. When we start with these requirements and then fill in the details we build a robust and beautiful engine for quality.

The 5Ps of GXPs: People, Procedure, Product, Premise, and Principles.

This is often why we talk about compliance being the start of quality, and not the end.