Tag: quality domain

Aging in the Workforce – or Why All Those Years Matter

Source: https://flowingdata.com/2024/06/18/older-or-younger-than-the-population/

Wow, I’m older than a lot of people. When did that happen? (Shout out to my small cohort of fellow Gen-Xers!) So, in a bit of reflection, I want to discuss why I think aging in the quality profession is so critical.

The quality profession is an experience-heavy field. While formal education can provide some necessary theoretical knowledge, the practical skills required for the quality profession can only be mastered through extensive hands-on experience, practical application of skills, and the ability to adapt to real-world challenges.

Key characteristics

  1. Direct Experience: Students participate in activities that require them to apply what they have learned in a practical setting. An old adage is that you must do a job for three years before understanding it. However, you must keep going through the iterations since quality comprises multiple jobs. For example, my progress from deviation reviewer to eQMS implementation, to computer systems quality, to risk champion, to quality engineering, to change management process owner, to computer system implementor, to technology implementor, to validation quality, to operational excellence, to quality systems leader, to validation leader (and I am leaving a lot out). Layering and layering real experience again and again.
  2. Reflection: Reflection is a critical component of experiential learning. Most people don’t do that enough. The quality profession requires us to think about our experiences, analyze what we have learned, and consider how it applies to our work. Audits and inspections are interesting tools that can drive reflection when approached correctly.
  3. Active Participation: Quality professionals must be active agents in their learning process. They take initiative, make decisions, and are responsible for the outcomes of their actions. This active engagement helps to deepen their learning and develop critical thinking skills.
  4. Community Engagement: I joke about being able to tell what company some spent their formative years in. And that is not a good thing. Quality professionals need to seek out collaboration with the wider community members, often through professional organizations.
  5. Integration of Knowledge and Practice: Experiential fields bridge the gap between theoretical knowledge and practical application. Quality professionals must integrate what they have studied with real-world experiences, enhancing their understanding and retention of the material. And then do it again.

The quality profession is a dynamic and interactive learning environment emphasizing learning by doing, reflecting, and applying knowledge in real-world contexts.

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.

Conceptual Framework

David Gray discusses conceptual frameworks in the MIT Sloan Management Review article “What Makes Successful Frameworks Rise Above the Rest.” In this article he provides 7 criteria to evaluate a conceptual framework that are very useful for consider the frameworks we develop and use.

Having an analytical framework to evaluate the strength of our tools and methodologies can be very valuable, and this is something I’ll be coming back to.

Situational Awareness and Expertise

One of the key aspects of being an expert is the capacity to apply situational awareness: the perception of relevant information, comprehension of their meaning and the projection to future events.

Developing this situational awareness is a critical part of problem-solving and we can map the 4Cs of trouble-shooting onto these three elements.

Perception

The ability to perceive important information is a critical first step to being able to problem-solve, and one that takes time to develop especially in the highly complex and demanding environments most of us operate in. Knowing which information is important and have an understanding of the many subtle cues to evaluate is one of the hallmarks of an expert. But even for experts it can be difficult, which is why building perceptual cues in our checklists, procedures and such is important.

Comprehension

From perception we can draw meaning and significance, allowing the expert to combine, interpret, store and retain information. Integrating multiple pieces of information to arrive at a determination of relevance.

Projection

Experts are able to project from current events to anticipate future events and their implications.

Model of situation awareness in dynamic decision making (Endsley, 1995)

Further Reading

What is this quality profession all about?

A theme of this year for me has been focusing more and more on the difference between the product integrity focused approach to quality that folks in my profession normally focus in on and a more excellence focused approach. The two are not in opposition, but I can’t help feeling that the product integrity exclusiveness of many pharmaceutical quality professionals is holding us back.

This is especially on my mind coming back from ASQ WCQI and thinking about just how few of my pharma colleagues identify with that organization There are a whole host of reasons (including the fact that many people don’t associate with ANY professional association) but I can’t help but contemplate how do we make the excellence side of quality more relevant to not just pharmaceuticals but to wider questions of just what is quality anyway?

I’ve discussed the need to realize that we have different types of domain knowledges, but just what is this domain we call quality and is it truly its own discipline?

Disciplines can be modeled as a system comprising an “activity scope” that is enabled by a “knowledge base” but conditioned by a “guidance framework”.

From Rousseau, et al “A Typology for the Systems Field”
  • The 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. You can see this in the various flavors of continuous improvement or better yet, the presence of a sustainability push within the society.
  • The knowledge base is the data, theories and methodologies that drive the discipline
  • The activity scope describes the range of activities in a disciple, including the professional practice.

We’re probably truly multi-disciplinarian, in that the we draw from multiple other disciplines, a short list includes: Engineering, Computing, Control Theory, Mathematics, Information Theory, Operations research, system theory, Management sciences, a whole range of social sciences and more than I can think.

What does this mean?

I am more thinking aloud than anything at this point, but I think it’s important to work on developing the QBOK along a guidance framework, knowledge base and activity scope methodology. Then as we develop sub-body of knowledges we drill down from there, either in a very knowledge base way (such as the CMQ/OE) or in an activity scope (like the CPGP). I often feel that the way we develop these are more hit-and-miss and could do with some coherence – the biomedical auditor and hazop auditor are great examples of wanting to meet a very narrow need and thus being very very specific to a small set of the knowledge base.

I guess I’m striving towards applying theory to our practice a little more deliberately.

Some of the technical forums (Human Development and Leadership comes to mind) seem especially designed to pull information from one or two different originating disciplines and adapt it to the knowledge base. I think this process would be added by a coherent understanding of our guidance framework and just what the activity scope we are trying to address as discipline.

In short I am just thinking that a little more coherence, strategy and transparency would aid us as a profession. As I heard in many a conversation last week, we should probably as an organization be better at what we preach.

Sources

  • Bourke, J (2014). On Process Excellence vs. Operational Excellence vs. Business Excellence. BEX Institute.
  • Rousseau, D., Wilby, J., Billingham, J., & Blachfellner, S. (2016). A Typology for the Systems Field. Systema 4(1), 15-47
  • Wageeh, N. A. (2016). The Role of Organizational Agility in Enhancing Organizational Excellence: A Study on Telecommunications Sector in Egypt. International Journal of Business and Management, 11(4), 121