Being Small and Speciality Does not Exempt from the GMPs

Specialty Process Labs LLC is a specialty API manufacturer of natural desiccated thyroid. Which is, yes, what you might think it is. And as far I can tell, mostly ships direct to compounding pharmacies and patients. This month they got a warning letter.

The warning letter highlights:

  1. Failure to validate the process
  2. Failure to test to specification
  3. Failure to exercise sufficient controls over computerized systems

All three of these observations make me rather glad my loved-ones take levothyroxine and I am deeply aware of all the difficulties in that drug supply.

Focusing more on the computer system, it is an unsurprising list of bad access controls, change controls not controlled, and failure to validate excel spreadsheets.

The last observation really stood out to me:

Manufacturing master batch records held in electronic form on your company’s shared drive do not have restrictions on user access. Your quality unit personnel stated that there are no restrictions for any personnel with login credentials to access new and obsolete master records. Our investigator observed during the inspection multiple versions of batch records were utilized for API lot production.”

This is truly a failure in document access and record management. And it is one I see a lot of places. The core requirement here is really well stated in the PIC/S Data Integrity Guidance requirement 8.4 “Expectations for the generation, distribution and control of records.” Please read the whole section, but pay close attention to the following:

  • Documents should be stored in a manner which ensures appropriate version control.
  • Master documents should contain distinctive marking so to distinguish the master from a copy, e.g. use of coloured papers or inks so as to prevent inadvertent use.
  • Master documents (in electronic form) should be prevented from unauthorised or inadvertent changes.
  • Document issuance should be controlled by written procedures that include the following controls:
    • details of who issued the copies and when they were issued; clear means of differentiating approved copies of documents, e.g. by use of a secure stamp, or paper colour code not available in the working areas or another appropriate system;
    • ensuring that only the current approved version is available for use;
    • allocating a unique identifier to each blank document issued and recording the issue of each document in a register; – numbering every distributed copy (e.g.: copy 2 of 2) and sequential numbering of issued pages in bound books;
    • where the re-issue of additional copies of the blank template is necessary, a controlled process regarding re-issue should be followed with all distributed copies maintained and a justification and approval for the need of an extra copy recorded, e.g.: “the original template record was damaged”;
    • critical GMP/GDP blank forms (e.g.: worksheets, laboratory notebooks, batch records, control records) should be reconciled following use to ensure the accuracy and completeness of records; and
    • where copies of documents other than records, (e.g. procedures), are printed for reference only, reconciliation may not be required, providing the documents are time-stamped on generation, and their short-term validity marked on the document

There are incredibly clear guidelines for these activities that the agencies have provided. Just need to use them.

WCQI – Member Leader Day

I made it to Anaheim, I must admit I am pretty surprised, as I’ve backed out of a few other events this year for reasons of family and health, and while I did do the ISPE Aseptic Conference, being at a WCQI feels almost surreal, especially since this is a fairly small WCQI compared to pre-pandemic years.

I decided to attend the member leader workshops. I thought long and hard, as I have had a rough and rocky road as a member leader during the pandemic and I’ll need to think about what that looks like going forward. I made the decision to attend because I hope the experience will help drive action on my part. Also, in some transparency, I bought my plane ticket without realizing that I would otherwise have a free day, and Disney is not my jam.

I think member leaders have a difficult role. There is a lot of administrative work, on top of the need/desire to drive programming. The changes in ASQs financial structure has made that even harder, with the need to be more revenue-neutral driving a lot of decisions. So member leaders have to find the time to be organizers, raise funds, and make programming happen. All while keeping the day job. I always tend to think this is one of the reasons so many seem to be consultants, who can leverage the time as a way to build a reputation.

Building a reputation as a subject matter expert is a fairly traditional path for many of us. At the heart of a professional organization is the question “How do you build real expertise instead of shallow?” and I think member leaders are one part of the answer to that question.

The future of professional societies strikes me as an interesting one. What is the mix of in-person and remote events? Do you try to do hybrids (my recommendation is no). How do you maintain focus. I was hoping to hear that today, but in general, I do not think I did.

The elephant in the room is that the last few years has seen a lot of change forced on the ASQ. Change often feels like it was done to the membership instead of driven by the membership. The ASQ has really struggled to put the tools and methodologies it advocates for into action. And then, on top of everything, there was the horrible nature of the pandemic, which has slowed down and fragmented change.

For example, the change in the membership model where everyone can join every technical community (divisions) is one that has not been really absorbed beyond the major hit to the budget (again something that feels imposed upon the society).

Perhaps I am some sort of radical and think the technical communities need to be decomposed and restructured, but I think this is a real core thing for my experience. Sometimes it feels like technical communities are fighting for the same volunteers and what any technical community focuses on has more to do with the volunteer base than any rhyme or reason to the QBok.

There was a lot of obvious frustration on the part of the technical community members about their role in the organization.

My.ASQ still remains a major point of contention. I tend to think this stems from a combination of technical design and structure. The design need to push technical communities had led to some real balkanization within the structure, which makes it difficult to find content. Add to the fact the tool is not very flexible in how it manages the content and we have a painful adoption three years later.

Technical communities really exist to drive content creation. But I sometimes feel they are more content silos. Content curation is a topic from and center in a lot of member leaders’ minds.

I’m always disappointed when quality professionals get together and there is no structure, no facilitation. When we don’t use the tools our profession is based on. An over-reliance on brainstorming and discussion I think really limits the value of these events as it feels like we are swirling around the same topics.

I attended the following three breakout sessions.

Young professionals

Less than 10% of the membership is under 35, with students being around 5%. I think the central question for all professional societies is how do we change this? Let’s be honest, I am not a spring chicken at 51 and I sometimes feel young at ASQ events.

I think it’s telling on the communication issue that the NexGen section on my.ASQ, touted during this talk, has 3 posts, the last in February.

Mentorship programs are a lot of work for the mentors involved (and the mentees). How do we incentive folks to do it? What does real mentorship look like?

The Power of Collaboration

The ASQ and ASQE split (one of those things done to members, not from members) certainly are central to the question of collaboration within the ASQ. At the heart of collaboration is the central question of content creation.

I feel the ASQ is suffering from a lack of a strong model here. The connections between the QBok and the member organizations (technical and geographical) are weak in many places. There is no real definition of activity scope, guidance framework, and knowledge base.

The central question for collaboration in the ASQ is how do we bring more content that is valuable to our members, which means we need to do a better job of identifying what members need.

WhatWhat is this?My thoughts on what this means for the ASQ?
Guidance FrameworkThe guidance framework typically involves multiple worldviews. The same subject matter can be studied from different worldviews, and the theories around a given subject can be interpreted differently from different worldview perspectives.The ASQ as a whole, the principles of the profession.
Knowledge BaseThe data, theories, and methodologies that drive the disciplineThis is the Qbok and the technical communities that serve specific methodologies and approaches (Lean, Statistics, HD&L, QMD, TWEF, Six Signa, etc)
Activity Scope The range of activities in a disciple, including the professional practice.These are the industry segment specific technical communities

There is a real tension right now in that the board of the ASQ and certainly headquarters, wants to see the technical communities generating more content, more IP. But many in the technical communities are feeling tense, and a little abused by the process.

I think a central question is how do we connect folks with questions to subject matter experts who can answer those questions. my.ASQ hasn’t really solved that issue. And something like Connex is really a marketplace to sell consulting services. This leads us to the third breakout session I attended.

Subject Matter Experts of Tomorrow

Building expertise is a particular focus of mine, and I think it is really important for the ASQ to think about what areas we need subject matter experts (SME) in, and how to leverage those SMEs.

I think we really grapple with just what topics are valuable to quality. Frankly, I think we haven’t reached the promise of the core, the foundational knowledge. We need to avoid thinking sexy “whats” are the key to a profession that focuses more on the hows and whys.

Want to call out the facilitators for using a tool to facilitate the session, while still brainstorming it made a difference.

The central question to answer the question about how we can connect knowledge experts with the skills necessary to be an effective SME?

The key is deliberative practice. As an organization, we need to have a deliberative practice pathway that builds skills in speaking, presentation, and develop area expertise. While we cannot directly give most people a job opportunity to do something, we can look for other opportunities to further e

Closing Thoughts

I have many questions, many thoughts, and no good answers. I waited until after the conference to make sure I had a chance to reflect.

WCQI Day 4

Last day.

Disciplined Problem Solving Demands Disciplined Communication by Frasier Pruitt

The Minto Pyramid Principle as a tool for problem communication. I guess I shouldn’t be snarky at a tool that came out of McKinsey. I’m sure organized crime has provided many useful tools for society.

Structuring information is critical, there are lots of tools out there to help utilize storytelling, I’m a big fan of the work of Nancy Duarte, and I have praised the A3 many a time for its use as for structured narrative around problems and solutions.

The Two Elements

Mutually Exclusive, Collectively Exhaustive (MECE) is a concept that we cannot stress enough as it fundamentally gets to issues of cognitive load, and forms a great example of externalizing and constructing.

Mutually Exclusive, Collectively Exhaustive (MECE)

Great structure, which originally appeared in Quality Progress, for utilizing this with a DMAIC.

Well done structure, this was a great writing training. This could be expanded into a workshop focusing on narrative structure. One recommendation for Fraser would be using a simpler paper for the writing exercise.

The Innovation Management Principles of ISO 56000 by Peter Merrill

Innovation is one of those things that requires system and process to truly be successful. I appreciate the ideas beyond ISO 56000, and the basis of the Innovation Management System

  1. Realization of value; and benefit
  2. Future-focused leaders; curious, courageous
  3. Strategic direction; will change
  4. Culture; creativity and execution to co-exist
  5. Exploiting insights for unmet needs
  6. Managing uncertainty through a portfolio
  7. Adaptability as context changes
  8. Systems approach; serial innovation

Love the focus on how QMS and Innovation interlink.

Closing Keynote by Jose Morey

Okay, I’ve fan-boyed Leonardo da Vinci in the past, but this did not work for me as an ending keynote. It was shallow and rather generic.

But I got my Bingo card completed.

Which is sad.

Good conference. It was great to be back in person.

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 3 (first half)

Heather McGowan

I am a huge fan of The Adaptation Advantage: Let Go, Learn Fast, and Thrive in the Future of Work by Heather E. McGowan and Chris Shipley. So I was thrilled when I heard Heather was going to speak. I could write for ever, but you are much better off listening to her yourself.

One of the things I think the quality community is bad about is forming connections with researchers who are basically researching topics at the heart of quality. Heather is a great example of this, she should see herself as a fellow traveler, but I do not think she does. Feels like another post.

Anticipating Disruption in the Supply Chain: Rethinking Business Continuity by Russell Snyder

I chose to come to this session because I was really curious about a practical application of Adam Grant’s model from Think Again.

And my bingo card quickly gets another spot marked off by the speaker extolling Steve Jobs as some sort of good role model.

The central point that in times of constraint everything is a quality issue is an important one for us all to ponder.

Does a good job discussing the rethinking cycle vs the overconfidence cycle, and other parts of Grant’s rethinking model.

The rethink approach is Model (scenarios and revenue impact); Map (all sub-tier supplier networks of key components); and, Mitigate (design your supply chain to withstand disruptive effects).

Very much aligned with a risk-based approach. The examples he discusses were pretty valuable shares relevant across many industries. I am already adapting several of his slides to an ongoing project I have.

I love seeing Grant’s work percolate into quality thinking. Applying it to supply chain disruptions was as fascinating as I was hoping it would be.

Bingo Card at Half-day

My pessimistic self is surprised I’m not complete yet. Well, one more day to go!

Design & Construction Technical Community Body of Knowledge

Based on the member leaders day on Sunday (I need to finish that post, so may thoughts) I was really curious how a body of knowledge was developed recently by a technical community.

A body of knowledge for a broad area like construction is interesting. You need to make it specific enough to be relevant to construction but broad enough to avoid niches. The speakers spoke passionately about this balancing act.

I wish this had gone deeper. I’m really fascinating to understand how we talk about commonalities likerisk based auditing or knowledge management differently in this body-of-knowledge. It is really that quesiton of application.

ASQ Insights on Excellence Tool

I am so excited to see this tool out in the world. I had the priviledge of providing a few ideas to it a while back, so seeing it in use, at the conference was just amazing.