ASQ Audit Conference – Day 1 Morning

Day 1 of the 2019 Audit Conference.

Grace Duffy is the keynote speaker. I’ve known Grace for years and consider her a mentor and I’m always happy to hear her speak. Grace has been building on a theme around her Modular Kaizen approach and the use of the OODA Loop, and this presentation built nicely on what she presented at the Lean Six Sigma Conference in Phoenix, at WCQI and in other places.

Audits as a form of sustainability is an important point to stress, and hopefully this will be a central theme throughout the conference.

The intended purpose is to build on a systems view for preparation for an effective audit and using the OODA loop to approach evolutionary and revolutionary change approaches.

John Boyd’s OODA loop

Grace starts with a brief overview of system and process and then from vision to strategy to daily, and how that forms a mobius strip of macro, meso, micro and individual. She talks a little about the difference between Deming and Juran’s approaches and does a little what-if thinking about how Lean would have devoted if Juran had gone to Japan instead of Deming.

Breaking down OODA (Observe, Orient, Decide Act) as “Where am I and where is the organization” and then feed into decision making. Stresses how Orient discusses culture and discusses understanding the culture. Her link to Lean is a little tenuous in my mind.

She then discusses Tom Pearson’s knowledge management model with: Local Action; Management Action; Exploratory Analysis; Knowledge Building; Complex Systems; Knowledge Management; Scientific Creativity. Units all this with system thinking and psychology.  “We’re going to share shamelessly because that’s how we learn.” “If we can’t have fun with this stuff it’s no good.”

Uniting the two, she describes the knowledge management model as part of Orient.

Puts revolutionary and evolutionary change in light of Juran’s Breakthrough versus Continuous Improvement. From here she covers modular kaizen, starting with incremental change versus process redesign. From there she breaks it down into a DMAIC model and goes into how much she loves the measure. She discusses how the human brain is better at connections, which is a good reinforce of the OODA model.

Breaks down a culture model of Culture/Beliefs, Visions/Goals and Activities/Plans-and-actions influenced by external events and how evolutionary improvements stem out of compatibility with those. OODA is the tool to help determine that compatibility.

Discusses briefly on how standardization fits into systems and pushes a look from a stability.

Goes back to the culture model but now adds idea generation and quality test with decisions off of it that lead to revolutionary improvements. Links back to OODA.

Then quickly covers DMAIC versus DMADV and how that is another way of thinking about these concepts.

Covers Gina Wickman’s concept of visionary and integrator from Traction.

Ties back OODA to effective auditing: focus on patterns and not just numbers, Grasp the bigger picture, be adaptive.

This is a big sprawling topic for a key note and at times it felt like a firehose.. Keynotes often benefit from a lot more laser focus. OODA alone would have been enough. My head is reeling, and I feel comfortable with this material. Grace is an amazing, passionate educator and she finds this material exciting. I hope most of the audience picked that up in this big gulp approach. This system approach, building on culture and strategy is critical.

OODA as an audit tool is relevant, and it is a tool I think we should be teaching better. Might be a good tool to do for TWEF as it ties into the team/workplace excellence approach. OODA and situational awareness are really united in my mind and that deserves a separate post.

Concurrent Sessions

After the keynote there are the breakout sessions. As always, I end up having too many options and must make some decisions. Can never complain about having too many options during a conference.

First Impressions: The Myth of the Objective & Impartial Audit

First session is “First Impressions: The Myth of the Objective & Impartial Audit” by William Taraszewski. I met Bill back at the 2018 World Conference of Quality Improvement.

Bill starts by discussing how subjectivity and first impressions and how that involves audits from the very start.

Covers the science of first impressions, point to research of bias and how negative behavior weighs more than positive and how this can be contextual. Draws from Amy Cuddy’s work and lays a good foundation of Trust and Competence and the importance in work and life in general.

Brings this back to ISO 19011:2018 “Guidelines for auditing management systems” and clause 7.2 determining auditor competence placing personal behavior over knowledge and skills.

Brings up video auditing and the impressions generated from video vs in-person are pretty similar but the magnitude of the bad impressions are greater and the magnitude of positive is lower. That was an interesting point and I will need to follow-up with that research.

Moves to discussing impartiality in context of ISO 19011:2018, pointing out the halo and horn effects.

Discusses prejudice vs experience as an auditor and covers confirmation bias and how selective exposure and selective perception fits into our psychology with the need to be careful since negative outweighs.

Moves into objective evidence and how it fits into an audit.

Provides top tips for good auditor first impressions with body language and eye contact. Most important, how to check your attitude.

This was a good fundamental on the topics that reinforces some basics and goes back to the research. Quality as a profession really needs to understand how objectivity and impartiality are virtually impossible and how we can overcome bias.

Auditing Risk Management

Barry Craner presented on :Are you ready for an audit of your risk management system?”

Starts with how risk management is here to stay and how it is in most industries. The presenter is focused on medical devices but the concepts are very general.

“As far possible” as a concept is discussed and residual risk. Covers this at a high level.

Covers at a high level the standard risk management process (risk identification, risk analysis, risk control, risk monitoring, risk reporting) asking the question is “RM system acceptable? Can you describe and defend it?”

Provides an example of a risk management file sequence that matches the concept of living risk assessments. This is a flow that goes from Preliminary Hazard analysis to Fault Tree Analysis (FTA) to FMEA. With the focus on medical devices talks about design and process for both the FTA and the FMEA. This is all from the question “Can you describe and defend your risk management program?”

In laying out the risk management program focused in on personnel qualification being pivotal. Discusses answering the question “Are these ready for audit?” When discussing the plan asks the questions “Is your risk management plan: documented and reasonable; ready to audit; and, SOP followed by your company?”

When discussing risk impact breaks it down to “Is the risk acceptable or not.” Goes on to discuss how important it is to defend the scoring rubric, asking the question”Well defined, can we defend?”

Goes back and discusses some basic concepts of hazard and harm. Asks the questions “Did you do this hazard assessment with enough thoroughness? Were the right hazards identified?” Recommends building a example of hazards table. This is good advice. From there answer the question “Do your hazard analses yield reasonable, useful information? Do you use it?”

Provides a nice example of how to build a mitigation plan out of a fault tree analysis.

Discussion on FMEAs faultered on detection, probably could have gone into controls a lot deeper here.

With both the PTA and FMEA discussed how the results needs to be defendable.

Risk management review, with the right metrics are discussed at a high level. This easily can be a session on its own.

Asks the question “Were there actionable tasks? Progress on these tasks?”

It is time to stop having such general overviews at conferences, especially at a conference which are not targeted to junior personnel.

Mindsets and Attitudes

Mindsets are lenses or frames of mind that orient individuals to particular sets of associations and expectations. Mindsets help individuals make sense of complex information by offering them simple schematics about themselves and objects in their world. For employees, mindsets provide scaffolding for understanding the broad nature of their work. Mindsets can be intentionally and adaptively changed through targeted interventions, so the goal is to build the processes to assess, monitor and shape as part of our quality systems.

Attitudes are the beliefs and feelings that drive individuals’ intentions and actions. Attitudes are the lens through which individuals make sense of their surroundings and impart consistency to guide their behavior .

Mindset influences attitudes, which influence behaviors, which influence actions, which influence results, which influence performance. And performance leas to changes in mindsets, and is a continuous improvement loop.

Since behaviors drive the actions we want to see, they are often a great pivot point. By thinking and working on mindsets and attitudes we are targeting the fourth and second leverage points.

Another way to think about this is we are developing habits. The same three factors apply:

  1. Start small: If you have ever tried to tackle multiple resolutions all at once, you know it is next to impossible. Often, the habits will lack cohesion with one another, leading to more stress and less progress. The cognitive load increases, and the brain processes things in a more scattered, less congruent manner. It’s better to focus on one new habit at a time.
  2. Enact the new habit daily: We can’t predict how long a specific habit will take to form, but all the research I’ve seen indicates that the more often people account on the new behavior, the more likely it is to become routine.
  3. Weave into existing processes: When we blend the new behavior with current activities, it’s easier to latch on to, which make sit become an unconscious action more quickly.

Habits are contagious within social contexts, but scaling positive pressure on an organization level is a big challenge.

Another way to view this is in the framework of experiences, build beliefs, which lead to actions and give us results. By building this into our systems we can make sure the appropriate processes are in place to make sure these new habits stick. Building a quality culture is a multi-year journey requiring incremental, layered and additive formation.

This formation comes through building the mindsets that lead to the behaviors we want to see. Following the ISPE’s recommendations there are four good behaviors we can target (these are not the only ones nor are they exhaustive).

  • Accountability: Employees consistently see quality and compliance as their personal responsibilities. Establishing clear individual accountability for quality and compliance is a foundational step in helping shape quality mindset and cultural excellence. Accountability should be communicated consistently through job descriptions, onboarding, current good manufacturing practice (cGMP) training, and performance goals, and be supported by coaching, capability development programs, rewards, and recognition. Leaders should hold themselves and others accountable for performing to quality and compliance standards
  • Ownership: Employees have sufficient authority to make decisions and feel trusted to do their jobs well. Individual ownership of quality and compliance is a primary driver for shaping quality mindset. When individuals are fully engaged, empowered, and taking action to improve product quality, organizations typically benefit from continuous improvement and faster decision-making.
  • Action orientation: Employees regularly identify issues and intervene to minimize potential negative effects on quality and compliance. Establishing the expectation that individuals demonstrate action orientation helps shape quality mindset and foster cultural excellence. Leaders should promote and leverage proactive efforts (e.g., risk assessments, Gemba walks, employee suggestions) to reinforce support for the desired behavior. Additionally, it is important that rewards and recognition be aligned to support proactive efforts, rather than reactive fire-fighting efforts.
  • Speak up: Employees are not afraid to speak up, identify quality issues, or challenge the status quo for improved quality; they believe management will act on their suggestions. Empowering individuals to speak up and raise quality issues help foster quality mindset. Leaders should support this by modeling the desired behavior, building trust, and creating an environment in which individuals feel comfortable raising quality issues, engaging front-line personnel in problem solving, and involving employees in continuous-improvement activities.

Creating a high level action plan of experience -> Target Belief -> Target Action ->Target Result might look like this:

ISPE, Cultural Excellence Report

Sources

  • Aguire, D., von Post, R & Alpern, M. (2013). Culture’s role in enabling organization change. PWC
  • Ajzen, I. (2005). Attitudes, personality and behavior. (2nd ed.). Berkshire, GBR: McGraw-Hill Professional Publishing
  • Ball, K., Jeffrey, R.W., Abbott, G., McNaughton, S.A. & Crawford, D (2010). Is Healthy behavior contagious: associations with social norms with physical activity and healthy eating. International Journal of Behavioural Nutrition and Physical Activity, 7 (86)
  • Fujita, K., Gollwitzer, P. M., & Oettingen, G. (2007) . Mindsets and pre-conscious open-mindedness to incidental information. Journal of Experimental Social Psychology, 43(1), 48-61.
  • Gollwitzer, P. M. (1990). Action phases and mind-sets. In E. T. Higgins & R. M. Sorrentino (Eds.), Handbook of motivation and cognition: Foundations of social behavior, Vol. 2, pp. 53-92). New York, NY, US: The Guilford Press.

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).

How we tell our story

“If it Isn’t Written Down, then it Didn’t Happen” is a guiding principle of the quality profession.

There are four major types of writing in quality: instructional, informational, persuasive and transactional. When evaluated against the three major document types instructional is a functional document, informational is a report and transactional is a record. This is not to say that all transactional business writing should be considered a record, the traditional argument against emails in quality systems for example.

It is important to understand these differences as they require differences in writing style, format and grammar. An SOP (instructional/functional) is very different that an informational/report). When building your writing competencies it is important to remember these are different (with a common foundation).

We utilize reports in our quality systems (and everywhere else) to act, to communicate information, to capture work completed, to record incidents, to finalize projects and recommendations, and to act as an archive. A well written report allows the reader to easily grasp the content and, if applicable, make informed decision. Report writing is a cornerstone of a CAPA system (from incident identification to root cause through CAPA completion and effectiveness review), validation, risk management and so much more.

In short, reports are our stories, they form the narrative. And how we tell that narrative determines how we think of an issue, and how we will continue to thing of it in the future.

We tend to mix and match two modes in our report writing — Story thought and system:

  • Story thought emphasizes subjective human experience, the primacy of individual actors, narrative and social ordering, messiness, edge cases, content, and above all meaning.
  • System thought emphasizes 3rd-person descriptions of phenomena from a neutral perspective, the interchangeability of actors and details, categorical or logical ordering, measurements, flow, form, and above all coherence.

We tend to lean more heavily on system thought in quality,the roots of the discipline and the configuration of our organizations make us predisposed to the system thought mode. This means that over time, best practices accumulate that favor system thought, and many of our our partners (regulatory agencies, standard setting bodies, etc) favor the measurable and the reducible. However, by favoring the system thought mode we are at jeopardy of missing how human beings function in our organizations and how our organizations need to deal with society. And we make mistakes. Me make bad decisions. We fail to deal with the truly complicated problems.

It is time to learn how to utilize story though more in quality.