ASQ to quality professionals – change is hard!

The ASQ has announced​ the theme for the 2019 World Conference On Quality And Improvement: “Leading Change”.

Change has always been constant, but in today’s digital landscape the pace of change is accelerating at a faster and faster rate. Within this dynamic is the opportunity for quality professionals to lead their organizations through the changes that each is destined to go through.

The focus areas are:

  • The Future of Quality
  • Managing Change
  • Building and Sustaining a Culture of Quality
  • Quality Basics
  • Advanced Content Master’s Series

For those interested, you can submit your proposal at https://asq.org/conferences/wcqi.

Looking back at the last few years:

  • The 2018 theme, was the “Innovation of You,” with focus areas of​ “Building and Sustaining a Culture of Quality”, “Master’s Series”, “Quality 4.0: The Future of Quality Starts Here”, “Quality Fundamentals in the Digital Age” and “Risk and Change.”
  • The 2017 theme was “Grow Your Influence: In the Profession, Through the Organization and Around the World” with focus areas of “Focus on the Customer
    Operational Excellence”, “Quality as a Competitive Advantage”, “Quality Fundamentals” and “Risk and Change.”

From this I draw the following opinion:

  1. Change is perceived as hard
  2. The future is murky
  3. Culture of Quality is definitely something important (we might not be sure exactly what it is, but it is important!)

All of which are true. It also iterates what I fundamentally believe is a core function of quality. We drive change, we build a culture of excellence, we help navigate the future.

I enjoyed the 2018 ASQ WCQI in Seattle and will certainly plan on going whether as a speaker again or a participant. While I wish the ASQ would be the perfect organization of my dreams, I do deeply believe that an approach defined in the 2019 focus areas is one that brings a lot of value to any organization.

I have begun recommending co-workers submit this year, and I have a few ideas I am toying with myself. Proposals are due Aug. 17. I encourage you to be contemplating the best practices in your organization and be considering how you can share them with the wider quality world.

Seven Skills for success

Adam J. Gustein and John Sviokla explore a topic that is probably on many people’s minds in the Harvard Business Review in the article “7 Skills That Aren’t About to Be Automated.”

In this article seven skills are set out seven skills that make you employable no matter what: communication, content, context, emotional competence, teaching, connections, and an ethical compass.

It is a good, broad, skill set and also demonstrates exactly what every quality professional should have. And points out a great direction for growth.

I am a big fan of the seven basic quality tools, but the day is quickly coming when four of them will be fully automated (Control charts, Histogram, Pareto chart, and Scatter diagram). Most big companies already have pilots in place as part of their big digital transformations.

A fun example of just why this skill set matters can be seen from playing with a semantic network like ConceptNet. Look a look at the word quality, and you see pretty easy why several of the above skills make a difference and will continue to do so.

Quality professionals are well placed on many of these skills. As automation continues the life of a quality professional will change. This change brings us a great many opportunities, and isn’t that one of quality’s core competencies?

Open Spaces

Jason Kottke is spot on “Open offices result in less collaboration among employees

In the past few weeks I’ve had more and more upset conversations with co-workers who have moved to open office work locations. And the Royal Society study that Jason references is a good read for anyone contemplating open spaces.

Being here in Boston, and having done my share of hanging out at MIT, I’ve seen some good open space concepts. But what the best ones actually do is create modular areas of privacy and areas for scalable interactions. And this is what the application of open offices I’m seeing in the corporate world are missing.

I’m hoping to ride this trend out. Or at least until the open office concept has been improved to a more scalable modularized office. I know it is currently one of my criteria for considering moving jobs and I’ve turned down an offer because of the location’s open office.

How folks work contributes to the culture. We should be driving interaction, collaboration (another problematic concept according to some studies) and problem-solving. Folks sitting with headsets on as they wait to get a Skype call does none of that. As the research shows, and anecdotal evidence supports, open spaces drive down productivity and make folks more likely to tune out and move on to a new job.

Deep expertise, quality culture and the long road

Dr. Zeynep Tufekci, a professor who writes about the social impact of technology, wrote and excellent Op-Ed in the New York Times this past weekend titled “What Elon Musk Should Learn From the Thailand Cave Rescue.” In this she takes to task silicon valley, stresses the importance of hard-earned expertise and the “safety culture” model. A topic near-and-dear to my heart as a quality professional, as she stresses the importance of deep expertise, lengthy training and the ability to learn from experience (and to incorporate the lessons of those experiences into future practices) as a valuable form of ingenuity.

Safety culture = quality culture. It has been said many times that the only real difference is that of the question asked (patient safety vs employee safety), but lets all agree that the tools used are pretty equivalent.

What this article really reminds me of is an article from A Lean Journey back in February titled “Lean Culture: Do You Want Firemen or Farmers in Your Organization.”

I see this a lot in Lean, especially early in the transformation process. An idea that any expert is equivalent, that quick, fast wins are the best. Which is sometimes relevant, often not good for the long run. Its interesting that we are, what, 30-40 years into Lean as a management methodology in this country (my entire adult life I have been involved in Lean projects of one sort or another) and it still feels new in most places.

I think that the trends Dr Tufekci and Mr McMahon are discussing are very similar. Stem from similar causes, and probably lead to why a lot of long-term transformations don’t get the benefits we intend.

Quality, the Pharmaceutical Industry, and Public Trust

By-and-large the last few decades have been solid ones for the pharmaceutical industry. The public has largely trusted that what we make is safe, efficacious and in general a quality product. That is, after all, what the regulations are designed to do. And we, as quality professionals, together with our peers, have demonstrated a real passion for the patient.

But as the recent St Louis verdict against Johnson & Johnson shows, the industry has a growing issue with the public’s perception that pharmaceutical corporations need to stop placing profits over safety.

As the New York Times says:

Johnson & Johnson and its peers were once lauded as a collective of hero-innovators and credited with bringing an avalanche of lifesaving, world-changing technology from lab bench to patient bedside. Today they are more readily associated with rampant price gouging, the worst drug overdose epidemic in modern history and a steady beat of cases similar to the talc-cancer one, in which profitable products caused real harm.

We also have the FDA catering to industry, the revolving door between the FDA and industry, and a growth of scary pseudo-science that continues to erode trust (vaccine deniers are fairly highly placed in the current government).

As quality professionals, it is our responsibility to “Hold paramount the safety, health, and welfare of individuals, the public, and the environment.” Whether it’s in our companies, our professional associations, or our connections with the community we need to be striving to be the voice of science, of quality and of integrity.

International Council of Harmonization Q7-Q14

The Pharmaceutical GMP Professional certification from the ASQ body of knowledge has, as its first area, Regulatory Agency governance, as it should, as a solid understanding of not only what the regulations and guidances say is important, it is pretty important to understand the why, and how they work together.

The subsection Regulations and Guidances states: “Interpret frequently used regulations and guidelines/guidances, including those published or administered by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S), Health Canada, the World Health Organization (WHO), the International Conference on Harmonization (ICH), the European Medicines Agency (EMA), the Food & Drug Administration (FDA), the USDA 9CFR, the International Pharmaceutical Excipients Council (IPEC), and Controlled Substance Act (CSA) 21 CFR 1300. (Understand)”

The ICH is on my mind this week as I’ve had a few different conversations with folks as part of development conversations and other places about understanding regulations, and this post is my jotting down a few thoughts for future development and thought.

I am focusing on Q7 to Q14 (Q7-Q11 are published, Q12 in draft, Q13 and Q14 just recently announced). There are other Qs and there are certainly other aspects of the ICH, those just are not what I am interested in here.

Q7-Q14, in many ways, involves the development of a philosophy between the ICH member nations and the various observers. Like any harmonization and guidance process, it has a few difficulties, but the developing philosophy has been developed to establish a more proactive and risk-based approach to the industry. As such, being well versed in the principles is good for a pharmaceutical quality practitioner.

Quality trio ICH

Q7

ICHQ7 “Good Manufacturing Practice Guide for Active Pharmaceutical” was a fairly late product of the ICH. Founded in 1990 it was not until 1998 that it was determined that a GMP document was needed. It took another 2 years to complete and then another year or two for adoption by the member nations of the time. Which for the ICH is rocket speed.

Q7 is basically a solid list of what makes a functioning pharmaceutical quality system. Its the great big giant check-box of stuff to make sure you have. Personnel Qualification! Check! Production Controls? Check! Cleaning Validation? Check (well….)

Q7 covers API and has a great table on page 3 that covers applicability for types of API and the increasing GMPs. That said, Q7 is pretty much a great stopping place for anyone evaluating their quality system in a GMP environment. Most of the principles are universal, for example stating about master production records “These records should be numbered with a unique batch or identification number, dated and signed when issued. In continuous production, the product code together with the date and time can serve as the unique identifier until the final number is allocated.”

The Q&A released for Q7 in 2015 is telling. It is either all narrow specifies (including a definition of terms) or it is “Can I use risk management with X”, such as “To what extent can quality risk management be used in establishing appropriate containment measures to prevent cross-contamination?” To which the answer is basically “That is why we wrote Q9”

A good document to have around when setting standards.

Q8

ICHQ8 “Pharmaceutical Development” is the place where quality by design really starts coming into its own a solid concept. Finalized in 2005, it started being adopted in 2009/2010 (with Canada adopting it in 2016).

Q8 is all about setting forth a systematic, knowledge-driven, proactive, science and risk-based approach to pharmaceutical development. And at its heart, this is the philosophy that these ICH guidances rest on.

Q9

ICHQ9 “Quality Risk Management” was finalized in 2005 and quickly adopted in 2006 (except in Canada). This guidance pretty much recognizes that nothing the ICH was going to do would work without a risk-based approach, and it is arguable that the pharma industry might not have been all on the ball yet about risk. Risk management is without a doubt the glue that holds together the whole endeavor.

Q10

Q10

ICHQ10 “Pharmaceutical Quality System” was finalized in 2008 and adopted from 2008-2010 (except Canada). Q10 lays out a quality system approach that, based on a science and risk-based approach, establishes 4 pillars: Process Performance and Product Quality Monitoring; CAPA; Change Control; and, Management Review. Your welcome pharmaceutical industry, the ICH has now told you how to do your job and after Q10 we are getting serious about figuring out how to get ready for new technologies and be nimble and stuff.

The Pharmaceutical lifecycle is set out in 4 phases: Pharmaceutical Development, Technology Transfer, Commercial Manufacturing and  Product Discontinuation; with the requirements of each pillar being explained at a high level for each phase.

Knowledge management gets poked at as a key enabler.

Q9 and Q10 together basically set out to demonstrate just how to do the things that are a requirement in order to have quality by design (Q8) but also show how to move from Q7 to a proactive, risk-based approach to running your pharmaceutical lifecycle. We are moving from a set of discrete compliance requirements (which Q7 is sort of a bow-tie around) to a comprehensive quality systems approach over the lifetime of the product to establish and maintain a state of control and facilitate continual improvement. Breaking down silos this approach united product development with manufacturing, with distribution. I feel almost like I am having a mystic experience when I contemplate what this path we are on can do. Because frankly, we are still on the path.

Q11

ICHQ11 “Development and Manufacture of Drug Substances” was finalized in 2012 and adopted in the next 4 years. This is a bow guidance as it shows how to implement Q8, with the support of Q9 and Q10. This is based on six principles that stem from the three previous guidances: Drug-substance quality linked to drug product; Process-development tools; Approaches to development; Drug-substance CQAs; Linking material attributes and process parameters to drug substance CQAs; and, Design space.

Q11 is our blueprint, drug substance manufacturers. Others can learn a lot of how to implement Q8-10 through reading, understanding and internalizing this document.

Q12

In November of 2017 the long-anticipated draft of ICHQ12 “Technical and Quality Considerations for Pharmaceutical Product Lifecycle management” was published. Q12 provides a framework to manage CMC changes across the lifecycle of the product. In short, it utilizes Q8, Q9, and Q10 and says if you do those things then here are how post-marketing changes will work and the expected regulatory benefits. Which means getting changes to market faster. Knowledge management is expanded upon as a concept.

Q12 enshrines established conditions, which is a term that wraps a few QbD concepts and provides a regulatory framework. Still, in draft, there is a fair share of controversy (for example, the EMA can’t adopt it as is it appears) and I am certainly curious to see what the final result is.

At this point we have: Q7 – summary of GMPs; Q8 – QbD; Q9- risk management; Q10 – quality systems; Q11 – a roadmap for drug substances; and in draft, Q12 – lifecycle management.

The ICH primary exists as a way for regulatory bodies to align and work out the thorny issues facing the industry. The process is not perfect, but it’s much better to be involved then to ignore.

Q13 and Q14

This last June the ICH met and, amongst other things, announced the roadmap for what is next:

  • Analytical Procedure Development and Revision of Q2(R1) AnalyticalValidation (Q2(R2)/Q14)
  • Continuous manufacturing (Q13)

Q2 is desperately in need of revision. It was finalized back in 1996 and does not take advantage of all the thought process expressed in Q8-Q11. Apply QbD, risk management, and quality systems will hopefully improve this guidance greatly.

Q13 appears to be another in the line of how to apply the Q8-Q10 concepts, this time to everyone’s favorite topics – continuous manufacturing. Both the FDA and EMA have been taking stabs at this concept, and I look forward to seeing the alignment and development through this process.

I look forward to seeing formal concept papers on both.