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.
At ASQ BOSCON 2019 I spoke on “Knowledge management & effective change management.” From my proposal:
An effective change management system includes active knowledge management, leveraging existing process and product knowledge; capturing new knowledge gained during implementation of the change; and, transferring that knowledge in appropriate ways to all stakeholders. This session will focus on three key areas of knowledge management as it enables change. It will provide an understanding of the principles of knowledge management, including: transforming data into information; the acquisition and creation of knowledge; and the some shared best practices for dissemination and using information and knowledge for the purpose of change management and building a quality culture.
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.
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).
Many of us have had, or given, a talk about how we can learn from children in how to communicate, whether it is being thoughtful in our relationships or learning to adapt and be resilient, or some other point.
What we are really talking about how communicating empathetically is essential, including to building a quality culture and it is a key part of change management. People need to feel respected and have a sense of self-worth in order to be motivated, confident, innovative, and committed to their work and to appropriately engage in quality culture.
I am not going to pretend to be an expert on empathy. I think it is fair to say that is still (always) one of my key development areas. That said, I think a core skill of any quality leader is that of giving feedback.
need to feel respected and have a sense of self-worth in order to be motivated,
confident, innovative, and committed to their work.
provide good feedback focus on doing the following:
Focus on facts.
Respect and support others. Even when people aren’t performing their best, they need to feel your support and to know that they’re valued.
Clarify motives. Don’t jump to conclusions. Keep others’ self-esteem in mind, and you’ll be more likely to ask, “What can you tell me about this error?” instead of, “Don’t you care about quality?”
someone has done a good job, succeeded at a task, or made a contribution, you
want to enhance that person’s self-esteem. Some ways to do that are to:
Acknowledge good thinking and ideas. Demonstrations of appreciation encourage people to think and contribute, and they support innovation and intellectual risk taking.
Recognize accomplishments. People need to hear specifically what they’ve done to contribute to the team’s or organization’s success. This encourages them to sustain or exceed expectations.
Express and show confidence. Voicing your trust and then calling on people to show what they can do boosts their confidence and their feelings of self-worth.
Be specific and sincere. When you describe in detail what people do well and why it’s effective, they know exactly what you’re recognizing.
can deflate people’s confidence faster than telling them they’re responsible
for something, and then doing it yourself. Conversely, when you provide support
without removing responsibility, you build people’s sense of ownership of the
task or assignment as well as the confidence that they can accomplish it. When
you use this Key Principle, remember to:
Help others think and do. Provide your support in two ways: Help others think of ideas, alternatives, and solutions, then support them so that they can execute the plan.
Be realistic about what you can do and keep your commitments. Remember that you don’t have to do it all, but be sure to do whatever you agree to.
Resist the temptation to take over—keep responsibility where it belongs.
quality individuals tend to be action oriented and task driven, so keeping
responsibility where it belongs can take resolve, even courage. You might have
to overcome the protests of a team member who is reluctant to stretch into new
areas or even brave objections from a key manager about your decision to
support others rather than take over.
Feedback Conversation Structure
In the OPEN
step you ensure that the discussion has a clear purpose and that everyone understands
the importance of accomplishing it.
Always state purpose and importance clearly in the discussion opening.
If you initiate the discussion, explain what you would like to accomplish and why.
If someone else is leading the discussion, ask questions if necessary to pinpoint the purpose and importance.
Cite how accomplishing the purpose would benefit others in the discussion.
Ask if there are any related topics to discuss.
There are two
types of information to seek and share in this step: facts and figures and
issues and concerns. Both are essential to building a complete picture of the
Facts and figures are the basic data and background information that people need to understand the situation and make informed decisions.
Exploring issues and concerns provides insight into potential barriers to achieving your purpose. It also helps reveal people’s feelings about the situation, which is valid, important information to gather.
developing ideas, it’s important to ask questions and include others in the
process. Most likely, you’ll have ideas about what to do, and you should share
them. However, you should put equal emphasis on seeking others’ ideas.
Involving people in thinking about alternative approaches can:
Spark their creative energy.
Result in more and better ideas than you alone could generate.
Build commitment to turning ideas into action.
It’s important that you and the people involved agree on a plan for
following through on the ideas that were developed and for supporting those who
will take action. During this step:
what will be done, who will do it, and by when.
on any follow-up actions needed to track progress in carrying out the plan.
sure to agree on needed resources or support.
This is the final chance to make sure that everyone is clear on
agreements and next steps and committed to following through. Closing
discussions involves a summary of actions and agreements as well as a check on
the person’s or team’s commitment to carrying them out.