I presented on change management and then I spent the afternoon focusing more on ASQ member leader stuff. So not much to report on sessions.
My session, Lessons on Change Management went well. I probably should have cut the slides way back instead of re-purposing slides from a longer presentation, but I think I hit a lot of key points and hopefully it was valuable for folks.
I ended up working the FDC Division table after that, so I skipped the final session of the day. Probably best, after presenting its always hard for me to focus for a little while.
Tomorrow is a full day, and I present on data integrity.
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.
Theresa Mullin, FDA’s Associate Director for Strategic Initiatives for the Center for Drug Evaluation and Research recently gave a presentation “Update from FDA CDER” at GMP by the Sea (I need to go to that that some-year).
Optimized set-up and cleaning procedures are documented as best practice process and rolled out throughout the whole plant.
A large percentage of equipment on the shop floor is currently under statistical process control.
For root cause analysis, the firm has standardized tools to get a deeper understanding of the influencing factors for problems.
Goals and objectives of the manufacturing unit are closely linked and consistent with corporate objectives and the site has a clear focus.
Manufacturers have joint improvement programs with suppliers to increase performance.
All potential bottleneck machines are identified and supplied with additional spare parts.
For product and process transfers between different units or sites,standardized procedures exist that ensure a fast, stable and compliant knowledge transfer.
Charts showing the current performance status such as current scrap rates and current up times are posted on the shop floor and visible for everyone.
The firm regularly surveys customers’ requirements.
The firm ranks its suppliers and conducts supplier qualifications and audits.
This are some pretty low hanging fruit. They are also the pretty necessary in any organization, not just pharmaceuticals.
There was also a little discussion on the use of Q10 that really makes me wish I had been there to hear exactly what was said. I hope it was “Just freaking implement it already.”
In general, useful slides, I recommend going and checking them out.
Last November, officials from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) met with industry representatives in London to discuss the various quality challenges that arise when the development of investigational products is accelerated .
The report was recently published, and can be found here.
The workshop discussed process validation, control strategies, good manufacturing practice (GMP) compliance, comparability, stability and regulatory tools of early access approaches. Throughout they discussed two elements:
Scientific which includes technologies and scientific concepts or principles for development, manufacture and quality risk management, which may or not be present or implied in existing guidelines. Examples include concurrent validation, new modelling methodologies, new analytical techniques, etc.
Regulatory/procedural tools are described in the legal, regulatory framework and can be specific to PRIME (or Breakthrough Therapies) (e.g. kick-off meetings) or generally applicable [e.g. Post-approval change management protocols (PACMPs), recommendations, scientific advice (SA)].
I strongly recommend reading the report in it’s entirety.
The guidances that health authorities adopt for themselves can tell us much about what they think is important. WHO recently revised the Guidance on QMS for National Inspectorates to align with international standards and the latest quality management system (QMS) principles and to expand the document’s scope. This guidance is pretty much saying “Get with the times.”
Nothing here is that unfamiliar to folks who are familiar with IS 9001 or most other standards. There are sections on management, management system planning, resources, personnel, infrastructure and documentation. There is a section on a section on operational planning and performance evaluation. WHO states inspections, should be planned in advance and risk management principles should be established for prioritizing inspection.
The document is in it’s comment period through September.
Investigations of a Dog 