Prior to the adoption of Q12 in Singapore at the end of 2019 there was a lot of rumbling from regulatory agencies on how Q12 would be more aspirational in many ways. In the last few weeks we’ve started to see just what that will mean.
FDA to release a guidance
The FDA’s Mahesh Ramanadham, from the Office of Pharmaceutical Quality in the FDA’s Center for Drug Evaluation and Research, provided an update on the agency’s implementation of ICH Q12 in the US on 25 February at the annual IFPAC meeting in North Bethesda, Md. He started that the FDA will soon be issuing guidance implementing the International Council on Harmonization’s Q12 guideline in the US that will, among other things, translate ICH post-approval change classification categories to FDA supplement categories, and address how to file established conditions (ECs).
This Q12 guidance will replace the agency’s 2015 draft guidance for industry on established conditions and reportable chemistry, manufacturing and controls changes to approved drug and biological products. It is expected to be issued in May 2020. The guidance will also discuss the relationship between FDA comparability protocols and the post-approval change management protocol (PACMP) established by the ICH Q12 guideline.
EU says not so fast in their adoption
However, additional scientific risk-based approaches to defining Established Conditions and associated reporting categories, as described in Chapter 3.2.3, and the Product Lifecycle Management (PLCM) Document, as described in Chapter 5, are not considered compatible with the existing EU legal framework on variations.
It is important to note that the legal framework always takes precedence over technical and scientific guidelines. More specifically this means that the definition of Established Conditions and their reporting categories must follow the requirements laid down in the current EU Variations Regulation and associated EU Variations Guidelines. With respect to the Product Lifecycle Management (PLCM) document, in case such a document is submitted, it cannot be currently recognised in the EU due to the fact that it is not referred to in the EU legal framework.
In an explanatory note accompanying the adoption of ICH Q12 and related annexes, the European Commission and the European Medicines Agency point out that there are “some conceptual differences” between the ICH guideline and the EU legal framework on managing post-approval changes, ie, the variations regulation (Regulation (EC) No 1234/2008).
The EU authorities offer no clarity on when and how ICH Q12 would be fully implemented in the EU. The note merely states that the new “tools and concepts in the ICH Q12 guideline that are not foreseen in the EU legal framework will be considered when this framework will be reviewed.” The EU regulators said they would continue to work on the implementation of the ICH Q12 within the existing EU legal framework. The explanatory note also points out that despite some conceptual differences between ICH Q12 and the EU framework, there is also considerable common ground. In fact, some tools and concepts in ICH Q12 tools can already be applied by industry by following the current EU variations framework.
Next Steps
Companies should be ensuring that their knowledge management and risk management processes and understanding continue to grow. ICH Q12 will be a rocky road and I’m not sure we’ll see some of the potential streamlining of regulatory processes for a long time.
I ran into Stuart MacDonald, the magician from yesterday in several sessions today. I love when keynotes at a conference show their passion by learning from fellow practitioners. I bought his book, so it also worked on that level.
Morning Keynote of “Achieving Operational Excellence with Passion and Creativity” by Kaplan Mobray
As a facilitator I always approve of walking into a session with a name tag, file cards, paper, and crayons. It warms my heart.
Career coaches and motivational speakers are a tough one for me as I rarely connect with them as a conference speaker. Mr. Mobray had a high energy level, but what I really enjoyed was him using various facilitation techniques (graphic drawing) as a way to focus on his simple points, such as “pass it on” or “evolve” or “progress over persecution.”
“Steering Towards Zero Issues” by Franco Seravalli
Starts with the dilemma of poor quality and a high level overview of the case study at an automobile parts supplier in Costa Rica.
Though his case study covered their path root cause analysis and gap analysis and then went to improvement strategy.
People – Trust our people
Containment
Correction/Prevention
People was the most important.
Step by step process to create a quality culture and sell change.
Steps for strengthening people
Focus on people and talked about human error and human performance.
Awareness – create a sense of pride and empathy with the customer. Transparency and candor and making the quality issues public
Commitment – Public displays of support. Talk and listen. Management walking-the-walk
Empowerment – Trust your people, decision-making authority
Accountability – interesting point about cultural differences (for example Spanish and Portuguese do not have this word)
Recognition
Credit where credit is due
Containment – focused on stop the bleeding and close the circle. Containment is fairly high level and felt very industry specific in his details.
Corrective Actions – laid out the typical deviation to CAPA to effectiveness review path. Covered 8D, talking about need to add risk analysis/management and the place of effectiveness reviews.
Covers risk and PFMEAs.
Again, not an intermediate discussion. We need better criteria for ranking a session. I would have gone to this even if it was marked basic as the speaker is a member of the Team and Workplace Excellence Forum, but I worry for other participants.
“See One, Do One, Go Do One” by Karissa Craig
Karissa laid out a journey to develop, trial, implement, evaluate, and refine their approach through a case study.
Brings a good qualification approach to Lean with “See One” and “Do One” are classroom learning and the “Go Do One” is application.
Talked about the resistance and the need for accountability for application. A “want to” and not a “have to”
Demonstrated the A3 as rubric for the “Go Do One”. Offered some good discussion of how firefighter cultures (which healthcare) and how you need to build the right culture to do problem and root cause and not jump to solutions.
Gave a nice 8-week (with added 1-week pre, 1-week post) schedule for training and doing.
For training focused on basic problem solving, talked about avoiding perfectionism and set reasonable expectations. Karissa described a great sounding training program. This three hour class seemed very well put together.
Had an interesting share on how training led people to realize that problem solving was harder than they used to think and impacted employee engagement. This led to a sponsor training so sponsors understood how to support teams.
“Run with scissors” about how transformation involves risk and the ways to deal with it.
Rest of the Day
I spent the afternoon networking and connecting and conducting some ASQ Team and Workplace Excellence Forum business and didn’t attend any of the afternoon sessions. I was ambivalent about the afternoon keynote speaker/piano player.
Back again this year in sunny Phoenix for the ASQ Lean and Six Sigma Conference
These are all my rough, first draft impressions. So it will be mostly stream of conscience.
The Six Sigma Forum Award for the Advancement of Six Sigma is a mouth full. Dr Jamison Kovach. Awards are one part of the professional society experience that I do not really understand why we do them, but Dr Kovach has contributed to the field and is certainly deserving. I’m glad to see her get all the recognition that we can give her for her continued contributions.
Greg is a distant past president of the ASQ, and I think it is important to stress distant as that perspective informs much of his speaking. Whenever I hear Greg I always feel like I’m back in the late 1990s and then I have an urge to check on y2k projects.
But as a consultant, he had to get on board with the tsunami that is industrial transformation. And to be fair, I’m impressed by the approach he is taking.
He references an article from Richard Young from 2001 and then draws a path to “thinking systems.” He makes a good point that quality is never settled, and we need to use the past to set the future and asks the question of “can we simplify our way of pursuing quality in a digital world.” Going back to profound knowledge he talks about organizational excellence and how we need architects that blend science, mathematics and engineering with artistic thinking to create a functional system that weathers its potential environment and is attractive to customers.
That is good. And then he went back to the 60s and I might have taken a nap. Don’t get me wrong, I love history and it’s important to understand it, but there might be a problem with understanding of quality 4.0 if we need to reference early days to make points.
Offers a definition of quality as “Quality is the relentless pursuit of goodness coupled tightly with the persistent avoidance of badness.” Break down to a product quality definition, service quality definition, process quality definition.
Product quality: Fit for use by the customer in the intended application and the actual environment.
Service quality: Consistent delivery of the desired service level over an extended period of time and across all locations.
Process quality: Maximizing the level of productivity relative to the customer demand with minimal waste, cost, inefficiency or loss
To get to quality 4.0 we must become trusted advisors and coaches to the executive team. Quality as lifeblood of the organization. Question we need to ask is how do I become that type of person
Organization Excellence three types of improvement:
Continual Improvement – Process focus, work changes
Breakthrough Projects – technology
Transformation projects – game changers in redirecting the purpose of organizational strategic intent
Hits on an issue I know many quality people grind their teeth on, especially in pharma
Managing organizational gemba the nature and structure of each Gemba changes in focus and content and must be improved in different ways
Quality characteristic
Gemba #1
Gemba 2
Gemba 3
Customer focus
Workers
Customers
Owners
Work objectives
Work productivity
Work priority
Work Profitability
Dominant function
Perform/operate
Supervise/Manage
Command/Control
Performance focus
Flow efficiency
Productivity
Resource efficiency
Performance approach
Quality/efficiency
Productivity growth
Financial growth
Quality mindset
Right the first time
Service the Customer
Get business results
Team approach
Work group/circle
Program/Project
Committee/Council
Gemba 1 is continual improvement
Gemba 2 Breakthrough
Gemba 3 is transformation
Goes back to profound knowledge as delivering a systemic view of how work is carried out so that future performance may be predicted with a string degree of probability.
Systemic perspective
Managing the knowledge domain
Predictive analytics
Human understanding
System thinking and how hoshin kanri defines the strategic front-end that identifies, manages and enables critical change projects to achieve desired organization goals.
Knowledge of variation is a way that establishes change targets and sets priorities in a way that does not use unreasonable stretch targets the demotivate workers or spread fear.
Building worker competence and agility will enable people-intensive processes to run as an effective support system for the digital tools employed in deploying quality 4.0.
Profound knowledge enables insights necessary to design systems of fture and provide checks and balances to assure managerial oversight of
How to manage change
Operationalize profound knowledge across aly management system
Facilitate business improvement change
Balance resources
I’m really mixed by this presentation. There were some good points, but I really feel they get buried underneath the continued hearkening back to the 1980s and 1990s. Our history is important, but it shouldn’t bury us.
“Lean Transformation Lessons for Practitioners and Students” by Nicole Radziwill and Rebecca Simmons.
Rebecca is an assistant professor at James Madison University and a member of the Team and Workplace Excellence Forum and Nicole is one of the better thinkers on the impact of industrial transformation (IX) and Quality 4.0. Nicole wasn’t able to make the conference but is online. This means the presentation was a little different than expected but handled well.
Defined lean transformation as “installing the habits and practices that will enable yur organization to deliver a continuous flow of value to customers”
This cannot happen without cultural shift and stresses the importance of learning-by-doing. Old-habits to break, learning is easier than unlearning. Change requires cognitive energy and people are selective about where they spend that energy.
Identify the Need
Is Lean the right approach? Some traditional questions but focused on very good question:
Employee turnover is high
Always short staffed
Cross functional conflict
Frequent pivoting
Power of observation, indicators of culture
Are people first? – this is a good thing to develop a tool on what and how to observe interactions to see this?
Who has accountability & ownership?
How are mistakes handled?
Examine the system, follow the question
Assess Readiness
Once need and lean is right approach, is organization ready.
Can the organization absorb any additional change efforts? Capacity is finite and what else is going on? Is there a reasonable chance of success for this specific change? Time out – is no the right time?
Is there a reasonable chance of success for this specific effort?
Leadership engagement – questions about time resources and actual commitement as self-discipline. Sustained hard work over time. Commitement is not enough
Process definition – enough to start but not enough that this is not value added. Who gets blamed when there is a problem?
Process stability – may need to triage first
Covered the visual triange. Information is power and sharing information with everyone in the facility means giving up control and power and this is very telling of true level of commitement.
Covers the sources of resistance and has a table based on 1993 study
Talks about importance of power balance and how shifts in power balance can create resistance.
Shared some good case studies. Love the fact they used the Baldridge as the rubric for the assessment.
Key Findings
Assess process maturity upfront
Build an organizational backbone – include standard work for leaders and “tech follows behavior” are good things emphasized here.
Create a sole source of truth which drives effective decision making
Design Strategic Quick Wins – the hardest project is not the first on to tackle. Leadership to recognize
“The Importance of PLAN in PDC/SA and DMAIC” by Grace Duffy
We need to make sure that our working level is comfortable with what they are doing. The above metric captures a balanced approach that Grace covered.
Ensured her audience was grounded on the idea of a perpetual system of improvement discussing how lean and six sigma fit together, with her concept of modular kaizen, linking back to benefits against an ideal cost of quality model. Coming back to a theory of constraints where resources and bottlenecks, finding the weak link in time.
Talks about the disruption loops as part of the PDCA loops of the modular kaizen approach. Discussed how we need to get people to think in terms of gap assessments. This is an interesting observation, and fits into a thread I’ve ben working on around situational awareness.
Building off on this Grace then covers a systems view of continuous operation.
Covering the seven step project sequence for modular kaizen improvement activities. I like her bringing QFD in here.
Overall assessment – I will go on the record again that I am a huge fan of Grace’s thoughts. She is an influential thinker in quality. I’ve also attended maybe 7 talks by Grace in the last two years and it has been interesting as she continues to refine and push ahead her system-based approach to continuous improvement.
“Practice Doesn’t Make Perfect, It Makes Habit” by Ryan Burge and Shrey Tarpara
Starting with a resistance of change, covering it at an extremely high level, hitting a little on individuals fear of changes.
The habit discussed is to build a habit of consideration around change. Briefly touched on risk management as part of analysis of change need.
Laid out a framework for dealing with resistance and fears around change.
Stuart MacDonald Keynote
Entertaining. I was really happy with this. I’m linking to his TED talk, which is a super abbreviated version of his talk.
Throughout the day I had great conversations with awesome people. My favorite part of a conference.
Today I spoke at the ASQ Lean and Six Sigma Conference on sustaining change. Great crowd (though I felt bad for the folks sitting on the floor) and the session has spawned a bunch of great conversations that I hope continues in the future.
Conference attendance is both an important way to make connections and to grow as a quality leader. I’m here in Phoenix for the ASQ Lean and Six Sigma Conference, and in waiting for the event to begin I have a few thoughts on planning for conferences as part of development.
Plan your conference attendance 6-12 months out, and treat it as a rolling calendar.
Go and do some research on the conferences that make sense to you. It is easy to start with those of your professional organization, like the ASQ. Whenever you come across a conference and it seems to be in your wheel house, add it to the list. You want to pay attention to three key dates: When the conference is, when the registration deadlines tend to be, and when the call- for-speaker periods end. This last one is important because…
Speak at the Conference!
The best way to get value for a conference is to speak at it. Conferences compensate attendance, and that means your organization is much more willing to let you go (and pay for travel). Speaking allows you to talk about the work you, your team and your organization have done. This draws in people who are interested in the problems you are solving, which helps with networking. It serves as advertising, can help recruiting, and can build reputation.
Yes, you can speak at a conference. If you are new to it, speak at a local regional conference first. You get better by doing these, and I’m serious, the opportunity to discuss the issues important to you will be plentiful. Your team has solved problems. You have learned things. This is gold to others! There is nothing more popular than a good case study talk.
The people you meet at the conference will be more valuable then the talks you attend. Talks are usually fairly high level and are targeting a wide audience (yes, even mine). But they do help you identify people with problems similar to yours. And you will learn a lot. A few key tactics:
Introduce yourself to each and every speaker you attend. Ask questions, follow-up, share. As a speaker I treasure these conversations
Never sit by yourself. Sit by someone, introduce yourself and talk. Even we introverts can do this, and you will be amazed by what you learn this way.
Engage in the hallway track – those impromptu conversations in the hall can often become the main event (well other than your presentation of course)
Make sure to take notes and share them. With your team back home, with the world. I will always take 3-4 key things I learned and do a lunch-and-learn or coffe klatch at work. I also like to do blog posts and share with the world. This will help solidify your key take aways and continue those excellent conversations.
Remember that conference attendance is part of your development. Do a retrospective and determine what went well, what was valuable, was it as valuable as missing those days of work would have been? Use that learning for the next conference. Take an iterative approach and plan for the next engagement.
