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

WCQI Day 4

Last day of the conference and for the first session I present on “Knowledge Enables Change.”

Similar to my BOSCON talk, which was the beta so I think I covered things better in this one.

Expand Your Impact on the Culture of Quality by Kathy Lyall

Solid focus on both external and internal signifiers of quality culture. A little basic but very worth reinforcing.

And then I left, skipping the last keynote to get to the airport.

Good conference this year. Overall I felt that many of my choices for sessions ended up being more basic than I thought, but there is a lot of value in that. I will hopefully make the time to turn my thoughts into better blog posts.

Risk Management is about reducing uncertainty

Risk Management is all about eliminating surprise. So to truly start to understand our risks, we need to understand uncertainty, we need to understand the unknowns. Borrowing from Andreas Schamanek’s Taxonomies of the unknown, let’s explore a few of the various taxonomies of what is not known.

Ignorance Map

I’m pretty sure Ann Kerwin first gave us the “known unknowns” and the “unknown knowns” that people still find a source of amusement about former defense secretary Rumsfield.

KnownUnknown
KnownKnown knowns Known unknowns (conscious ignorance)
Unknown Unknown knowns (tacit knowledge) Unknown unknowns (meta-ignorance)

Understanding uncertainty involves knowledge management, this is why a rigorous knowledge management program is a prerequisite for an effective quality management system.

Risk management is then a way of teasing out the unknowns and allowing us to take action:

  1. Risk assessments mostly easily focus on the ignorance that we are aware of, the ‘known unknowns’.
  2. Risk assessments can also serve as a tool of teasing out the ‘unknown knowns’. This is why participation of subject matter experts is so critical. Through the formal methodology of the risk assessment we expose and explore tacit knowledge.
  3. The third kind of ignorance is what we do now know we do not know, the ‘unknown unknowns’. We generally become aware of unknown unknowns in two ways: hindsight (deviations) and by purposefully expanding our horizons. This expansion includes diversity and also good experimentation. It is the hardest, but perhaps, most valuable part of risk management.

Taxonomy of Ignorance

Different Kinds of Unknowns, Source: Smithson (1989, p. 9); also in Bammer et al. (2008, p. 294).

Smithson distinguishes between passive and active ignorance. Passive ignorance involves areas that we are ignorant of, whereas active ignorance refers to areas we ignore. He uses the term ‘error’ for the unknowns encompassed by passive ignorance and ‘irrelevance’ for active ignorance.

Taboo is fascinating because it gets to the heart of our cultural blindness, those parts of our organization that are closed to scrutiny.

Smithson can help us understand why risk assessments are both a qualitative and a quantitative endeavor. While dealing with the unknown is the bread and butter of statistics, only a small part of the terrain of uncertainty is covered. Under Smithson’s typology, statistics primarily operates in the area of incompleteness, across probability and some kinds of vagueness. In terms of its considerations of sampling bias, statistics also has some overlap with inaccuracy. But, as the typology shows, there is much more to unknowns than the areas statistics deals with. This is another reason that subject matter experts, and different ways of thinking is a must.

Ensuring wide and appropriate expert participation gives additional perspectives on unknowns. There is also synergies by finding unrecognized similarities between disciplines and stakeholders in the unknowns they deal with and there may be great benefit from combining forces. It is important to use these concerns to enrich thinking about unknowns, rather than ruling them out as irrelevant.

Sources of Surprise

Risk management is all about managing surprise. It helps to break surprise down to three types: risk, uncertainty and ignorance.

  • Risk: The condition in which the event, process, or outcomes and the probability that each will occur is known.
    • Issue: In reality, complete knowledge of probabilities and range of potential outcomes or consequences is not usually known and is sometimes unknowable.
  • Uncertainty: The condition in which the event, process, or outcome is known (factually or hypothetically) but the probabilities that it will occur are not known.
    • Issue: The probabilities assigned, if any, are subjective, and ways to establish reliability for different subjective probability estimates are debatable.
  • Ignorance: The condition in which the event, process, or outcome is not known or expected.
    • Issue: How can we anticipate the unknown, improve the chances of anticipating, and, therefore, improve the chances of reducing vulnerability?

Effective use of the methodology moves ideally from ignorance to eventually risk.


Ignorance

DescriptionMethods of Mitigation
Closed Ignorance
Information is available but SMEs are unwilling or unable to consider that some outcomes are unknown to them.

Self-audit process, regular third-party audits, and open and transparent system with global participation
Open Ignorance
Information is available and SMEs are willing to recognize and consider that some outcomes are unknown.
Personal
Surprise occurs because an individual SME lacks knowledge or awareness of the available information.

effective teams xxplore multiple perspectives by including a diverse set of individuals and data sources for data gathering and analysis.

Transparency in process.
Communal
Surprise occurs because a group of SMEs has only similar viewpoints represented or may be less willing to consider views outside the community.
Diversity of viewpoints and sue of tools to overcome group-think and “tribal” knowledge
Novelty
Surprise occurs because the SMEs are unable to anticipate and prepare for external shocks or internal changes in preferences, technologies, and institutions.

Simulating impacts and gaming alternative outcomes of various potentials under different conditions
(Blue Team/Read Team exercises)
Complexity
Surprise occurs when inadequate forecasting tools are used to analyze the available data, resulting in inter-relationships, hidden dependencies, feedback loops, and other negative factors that lead to inadequate or incomplete understanding of the data.
System Thinking


Track changes and interrelationships of various systems to discover potential macro-effect force changes
12-Levers


Risk Management is all about understanding surprise and working to reduce uncertainty and ignorance in order to reduce, eliminate and sometimes accept. As a methodology it is effective at avoiding surrender and denial. With innovation we can even contemplate exploitation. As organizations mature, it is important to understand these concepts and utilize them.

References

  • Gigerenzer, Gerd and Garcia-Retamero, Rocio. Cassandra’s Regret: The Psychology of Not Wanting to Know (March 2017), Psychological Review, 2017, Vol. 124, No. 2, 179–196.
  • House, Robert J., Paul J. Hanges, Mansour Javidan, Peter Dorfman, and Vipin Gupta, eds. 2004. Culture, Leadership, and Organizations: The GLOBE Study of 62 Societies. Thousand Oaks, Calif.: Sage Publications.
  • Kerwin, A. (1993). None Too Solid: Medical Ignorance. Knowledge, 15(2), 166–185.
  • Smithson, M. (1989) Ignorance and Uncertainty: Emerging Paradigms, New York: Springer-Verlag.
  • Smithson, M. (1993) “Ignorance and Science”, Knowledge: Creation, Diffusion, Utilization, 15(2) December: 133-156.

Making Learning a Part of Everyday Work

Cultivating expertise, in short learning, is critical to building a quality culture. Yet, the urgency of work easily trumps learning. It can be difficult to carve out time for learning in the inexorable flow of daily tasks. We are all experienced with the way learning ends up being in the lowest box on the 2×2 Eisenhower matrix, or however you like to prioritize your tasks.

For learning to really happen, it must fit around and align itself to our working days. We need to build our systems so that learning is an inevitable result of doing work. There are also things we as individuals can practice to make learning happen.

What we as individuals can do

Practice mindfulness. As you go about your daily job be present and aware, using it as an opportunity to ability to learn and develop. Don’t just sit in on that audit; notice and learn the auditor’s tactics and techniques as you engage with her. Ask product managers about product features; ask experts about industry trends; ask peers for feedback on your presentation skills. These kinds of inquiries are learning experiences and most peers love to tell you what they know.

Keep a to-learn list. Keep a list of concepts, thoughts, practices, and vocabulary you want to explore and then later later explore them when you have a few moments to reflect. Try to work a few off the list, maybe during your commute or at other times when you have space to reflect.

Build learning into your calendar. Many of us schedule email time, time for project updates, time to do administrative work. Make sure you dedicate time for learning.

Share meaningfully. Share with others, but just don’t spread links. Discuss why you are sharing it, what you learned and why you think it is important. This blog is a good example of that.

What we can build into our systems

Make sure our learning and knowledge management systems are built into everything we do. Make them easy to use. Ensure content is shared internally and leads to continuous improvement.

Ensure learning is valued.

Plan for short-term wins. There is no nirvana, no perfect state. Ensure you have lots of little victories and shareable moments. Plan for this as part of your schedules and cycles.

Learning is a very effective lever for system improvement. At the very least it gives us the power to “add, change, evolve or self-organize system structure” (lever 4) and can also start giving us ways to change the paradigm (lever 2) and eventually even transcend paradigms (lever 1).

Industry specific knowledge

How do regions acquire the knowledge they need to diversify their economic activities? How does the migration of workers among firms and industries contribute to the diffusion of that knowledge? Here we measure the industry-, occupation-, and location-specific knowledge carried by workers from one establishment to the next, using a dataset summarizing the individual work history for an entire country. We study pioneer firms—firms operating in an industry that was not present in a region—because the success of pioneers is the basic unit of regional economic diversification. We find that the growth and survival of pioneers increase significantly when their first hires are workers with experience in a related industry and with work experience in the same location, but not with past experience in a related occupation. We compare these results with new firms that are not pioneers and find that industry-specific knowledge is significantly more important for pioneer than for nonpioneer firms. To address endogeneity we use Bartik instruments, which leverage national fluctuations in the demand for an activity as shocks for local labor supply. The instrumental variable estimates support the finding that industry-specific knowledge is a predictor of the survival and growth of pioneer firms. These findings expand our understanding of the micromechanisms underlying regional economic diversification.

C. Jara-Figueroa, Bogang Jun, Edward L. Glaeser, and Cesar A. Hidalgo. “The role of industry-specific, occupation-specific, and location-specific knowledge in the growth and survival of new firms” PNAS December 11, 2018 115 (50) 12646-12653; published ahead of print December 10, 2018 https://doi.org/10.1073/pnas.1800475115

Interesting academic paper on industry domain knowledge that has ramifications on the pharmaceutical industry, including the quality domain.