ASQ 2022 WCQI Day 3 (second half)

Making a Quality Leader: From Theory to Practice

Always a pleasure to hear from the Human Development and Leadership (HDL) technical community. Their competency framework is a great tool that can help many a quality leader as they struggle to build the leadership competencies necessary to strive towards excellence.

Human Development & Leadership Body of Knowledge Model

Having done a lot of comptency frameworks I think the HDL has done a good job building theirs out as a progressive framework. I think a challenge is how do we make it easy to scale up to this more detailed HD&LBok from the QBok, and occasionally the same concept can be discussed a few different ways across different technical community boks and this lack of consistency is a detriment.

Stressing practice as the core part of a competency framework. A good conversation at my table was how often these competencies move back a little as we change roles and organizations.

No competency framework is valuable without a good development plan and the workshop did a great job at introducing how to use one.

Honor Deming’s 14 Points Through Modular Kaizen by Grace Duffy

Grace has always been a mentor who always brings thought provoking topics to the society.

Goes without saying that I’m a fan of the 14 points and the System of Profound Knowledge. I’ve written a lot about Driving out Fear. It ties in a lot of my thoughts about how much of what is happening now in organizational excellence is the evolution from these 14 points.

Looking to the past is an important part of building the future. I think Grace did a great job of respecting the past to drive innovation and new ideas within the quality practice. I loved the care for our past, and the urge to challenge the future in the audience. She really avoided the tendency in some quality circles to obsess about the past (Toyota nuts I am thinking of you) and thus trap the present and stifle the future.

Grace does an amazing job being a pillar of the quality community while still being an iconcolast. When you see her name on the conference session list I always recommend taking the time to attend.

Quality Past & Present

I found most of the videos to be a little personality driven instead of insightful pieces of history. I would hope this session would draw from our history in exciting ways, that was not realized. However the ending charge to create solutions instead of just solving problems is a pivotal one.

2022 Business Meeting

This business meeting drives home the struggle the ASQ has on figuring out what comes next.

As an organization we do not understand what a digital organization looks like. Only 2000 users of the app in the US is embarrassing. Teens can create apps with 100 times more users.

It is nice to admit that actively listening to the members is crucial. I look forward to that consistently happening. We don’t always do a good job of using the tools at the heart of the QBok.

Finances are still rocky, though the Federal Stimulus has left the ASQ in an okay place.

I was actually shocked to hear the chair of the ASQ say it is hard to have metrics for meeting strategic goals. We have entire methodologies dedicated to that.

There are a lot of challenges ahead of us.

WCQI 2022 Day 2

Ugwem Eneyo’s keynote this morning was interesting and the type of inspiring keynote about the importance of quality that I love to hear.

QMS for Data-Driven Decision-Making

Charles Cox starts up being a little by blurring the differences between a Quality Management System (QMS) and an electronic Quality Management System (eQMS), but quickly solidified his topic of how to foundational build digital data into the QMS in an iterative approach for decision data decision-marking and growth.

I appreciate a quality-function-deployment (QFD) approach, a tool-set that I feel folks take a little for granted and don’t utilize enough. Charles co-wrote a useful text on QFD back in the 90s, but I really haven’t read a lot from him in recent years, so this presentation is an excellent example of a practical application, updated for today.

The focus on thinking today about the needs of the future is one that we cannot stress enough. Future sense-making is a core competency for quality professionals and one we do not spend enough time discussing and performing deliberative practice on.

Aligning Organizational Structure with Quality 4.0 by Jane Keathley

Jane co-wrote a thought provoking book on organizational design – Structuring Your Organization For Innovation.

I’m always surprised when folks refer to open office plans in a positive light. The research is pretty definitive on the destructive aspects here.

Thinking about the various organization chart structures is key. In pharma, the regulations are pretty clear on the need to do this, I think a lot of organizations struggle on how to build their organizations for quality. Color me a bit pessimistic here, but I want to see network structures work but have not had the experience.

The four criteria or organizational structures influence on performance: formality, hierarchy, complexity, technology.

Provides three perspectives for organization design: Strategic, Operational, Tactical.

I think there could have been a whole session just on the vision matrix. Same for organizational network analysis. Both of these are tools I do not think enough quality folks are comfortable with. Would make a good workshop.

tratVision Matrix – the Strategic Perspetive

And I got a free book for being a know-it-all about holacracy, which means I now have 2. I’ll keep this copy because I’ll get it signed, and pass off the copy at home.

I should put McKinsey on my junk science bingo card. Support for a criminal enterprise seems to be pretty garbage.

Key message – push decision making and autonomy down as low as possible.

And then I spoke

Good turn out. I was happy with the volume of questions.

FDA Final Guidance on Recalls

The FDA published the final guidance for “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C” in March of 2022.

Nothing new here really, as the FDA has just finalized recommendations that companies make adequate preparations to operations in advance of when a recall may be needed (e.g., prepare and execute a recall communications plan). In addition to these preparations, the FDA recommends that companies consider preparing, maintaining, and documenting written procedures (in paper or electronic format) for initiating a recall and performing actions related to initiating a recall. Moreover, the document addresses how companies should develop a recall strategy and train personnel on executing a recall, as well as how companies should use adequate product coding.

Remote Inspections and Computer Systems

The US FDA recently changed the Investigations Operations Manual to allow Investigators direct access to a company’s databases during a BIMO inspection (See Section 5.10.2.1)

As the conduct of clinical and non-clinical trials increasingly moves toward 100% electronic data capture, to include electronic case report forms, medical records, patient-reported outcomes, informed consent systems and other electronic study records, it has become necessary for bioresearch monitoring investigators to have access to these electronic systems and databases in order to successfully perform inspections. Overseeing the firm’s personnel while they access their system is not always practical in BIMO inspections, as this can result in the firm having to dedicate an individual to this task.
FDA Investiations Operations Manual section 5.10.2.1

Obviously, if you haven’t, you should be updating your GCP Inspections SOP, especially since they have a few interesting requirements, such as “While you may complete a form needed by the firm in order to obtain read-only access, such as an account request form, you will not sign such form as per section 5.1.2.3. You may acknowledge via email that you have completed any required training necessary for access.”

I think for many in the GCP world this change is sort of a sleeper change. We have been used to giving access to EMA inspectors for years, who often know more about your TMF than you do by the time they walk in the door.

The real interesting thing is how this spells a shift in attitude at the agency that has been a long-time coming. And how it fits into recent trends in the increase in remote inspections.

Remote inspections are here to stay. Set aside the FDA’s current view that a remote event is not an inspection. And one of the big things that stand out about remote inspections is they do not work well to find data integrity issues, as we’ve seen from the decrease in observations that is not proportionate to the overall size of inspections. I think what we are seeing here is a recognition of that, and the first shift in mindset at the agency.

I’d expect to see the FDA change their approach on the GMP side as they continue to absorb the lessons learned from remote inspections. It is a trend that I would be paying attention to as you continue your digital journey. It is always important to think “how will an inspector view this data”. Usually, we think in terms of printouts. You should also be thinking about read-only access in the near future.

Catalent Belgium Form 483 and Contamination Control

The FDA recently released a Form 483 it handed to Catalent Belgium following an inspection of its 265,000 square-foot facility in Brussels in October 2021. Catalent is a pretty sizable entity, so it is very valuable to see what we can learn from their observations.

Failure to adequately assess an unexplained discrepancy or deviation

“Standard Operating Procedure STB-QA-0010, Deviation Management, v21 classifies deviations as minor, major or critical based on the calculation of a risk priority number, with a HEPA filter failure within a Grade A environment often classified as minor. Specifically, Deviation 327567 (Date of occurrence 04 March 2021) was for a HEPA filter failure on the <redacted> fill line, with a breach at the HEPA filter frame.”

This one is more common than it should be. I’ve recently written about categorization and criticality of events. I want to stress the term potential when addressing impact in the classification of events.

Control barriers exist for a reason. You breach that control barrier in any way, you have the potential to impact product or environment. It is really easy for experienced SMEs to say “But this has never had any real impact before” and then downgrade the deviation classification. Before long it becomes the norm that HEPA filter failures are minor because they never have impact. And then one does. Then there are shortages or worse.

It is important to avoid that complacency and treat each and every control barrier failure to the same level of investigation based on their potentiality to impact.

The other problem here is failure to identify trends and deal with them. I can honestly say that the last thing I ever want anyone, especially an inspector, to write about something where I have quality oversight is a failure to investigate multiple control barrier events.

“Other GMP manufacturing areas have a similar elevated level of HEPA filter failures, with the root cause of the HEPA filter failures unknown. There is no CAPA in support of correction action. Your firm failed to ensure your investigations identify appropriate root causes and you failed to implement sustainable corrective action and preventive action (CAPA).“

Contamination Control function

Observation 2 and 3 are doozies, but there is probably a lack of expertise involved here. The site is using out-of-date and inadequate methods in their validation. Hire a strong contamination control expert and leverage them. Build expertise in the organization through a robust training program. Connect this to all relevant quality systems/processes.

Corrective Maintenance and Troubleshooting

“Equipment and facilities used in the manufacture of drug product are not adequately maintained or appropriately designed to facilitate operations for their intended use.“

The asset control lifecycle matters, and corrective maintenance can not be shorted.

This is starting to feel a lot like my upcoming presentation at the 2022 ISPE Aseptic Conference where I will be speaking on “Contamination Control, Risk and the Quality Management System”

“Contamination Control is a fairly wide term used to mean “getting microbiologists out of the lab” and involved in risk management and the quality management system. This presentation will evaluate best practices in building a contamination control strategy and ensuring its use throughout the quality system. Leveraging a House of Quality approach, participants will learn how to: Create targeted/ risk based measures of contamination avoidance; Implement Key performance indicators to assess status of contamination control; and ensure a defined strategy for deviation management (investigations), CAPA and change management.”

Maybe we can talk more there!