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.


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.


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.


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.


  • 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

Environment, Health and Safety and the compliance domain

Benefits of Written Rules:
Capture important learnings and assumptions
Establish a standardized, organized and reproducible, method of conducting work safely
Ensure effective transfer of knowledge to new members of the group
Require disciplined thinking to formally document thus reducing errors in processes
Create a framework for delegation of decision-making
Demonstrate the organizations commitment to safety

Chet Brandon “Tried and True: Written Procedures are a Foundation of EHS Success

I don’t think there is a quality person who would read that list and not nod knowingly. Reading the excellent article quoted above reminded me that we all probably do EHS, Quality and compliance in general all wrong.

Yes, Health & Safety is about the employee; Quality is about the product (and legal is about following the law and finance does something about money) but what when you look at the tools we pretty much have a common tool-box. Root cause analysis, procedures, risk management, system thinking.

What is truly different is the question we ask:

  • Quality asks about the customer
  • Health and Safety asks about the employee
  • Environment asks about, well, the environment

I find it fascinating that it became environment, health and safety and most companies, as again, the question asked is rather different. In companies where care of the environment is separate (such as the energy industry) you will definitely see it as a separate entity.

I have only been at one company that was on the path of looking at quality, environment, health and safety were all similar disciplines and united them under a chief compliance officer (who was also head of legal). My current company is still struggling along the path of uniting standards and tools.

There is definitely a lot of different domain knowledge between the three, the same way quality is different between industries. However the commonalities that unite us are many and ones we should spend more time exploring.