Thoughts from the pre-day at ASQ World Conference of Quality Improvement. May become a more meaty post.
Food, Drug and Cosmetic Division (FDC)
What separates this division for the biomedical division? The commonalities between food, drug, cosmetics and medical devices are more pronounced in the US with the common regulatory responsibilities. But I have trouble seeing the cosmetics industry more closely aligned to me than a medical device.
I think there is more commonality between cosmetics and type 1 and drugs and type 3 than there is often between drug and cosmetics. Though the drug to cosmetic or drug to food is a slippery slope.
The type of conferences the FDC division attends tend to be more focused on nutrients and OTC then cutting edge bio it feels like.
I’d love to see a SWOT, force-field analysis and definitely an X-matrix as they discuss strategic plan.
Yep, ASQ is not getting technology. Oh dear, I feel what they really want is a stack exchange (ASQ should totally have licensed stack exchange instead of whatever is powering my.ASQ)
Love to understand the decrease in CPGP. I think there is a a value statement the ASQ has failed to make.
Would like to learn more about the new CHA BoK. Will it recognize the greater value of the tool outside of food industry? Can it do that without weakening the BoK’s value for the food industry?
Still no training for the CPGP. Still volunteering and hoping to get called on. Part of forming that value statement will need to be good training.
Maybe I should be glad my attempts to volunteer this year never went anywhere. Lots of talk on expense reports and I am super bad at expense reports.
Pins. Between badges and ribbons and pins I feel like I am back in the boy scouts.
Still not feeling the commitment to transparency that should be at the heart of a quality organization
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.
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.
Risk management is then a way of teasing out the unknowns and allowing us to take action:
Risk assessments mostly easily focus on the ignorance that we are aware of, the ‘known unknowns’.
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.
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
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.
Methods of Mitigation
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
Information is available and SMEs are willing to recognize and consider that some outcomes are unknown.
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.
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
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)
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.
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.
House, Robert J., Paul J. Hanges, Mansour Javidan, Peter Dorfman, and Vipin Gupta, eds. 2004. Culture, Leadership, andOrganizations: The GLOBE Study of 62 Societies. Thousand Oaks, Calif.: Sage Publications.