Data Integrity Warning Letter

In July 2022, the U.S. FDA issued a Warning Letter to the U.S. American company “Jost Chemical Co.” after having inspected its site in January 2022. The warning letter listedfour significant areas:

  • Failure of your quality unit to ensure that quality-related complaints are investigated and resolved, and failure to extend investigations to other batches that may have been associated with a specific failure or deviation.”
  • “Failure to establish adequate written procedures for cleaning equipment and its release for use in manufacture of API.”
  • “Failure to ensure that all test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality and purity, and failure to ensure laboratory data is complete and attributable.”
  • “Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to establish and follow written procedures for the operation and maintenance of your computerized systems.”

I offer them the above clip as a good mini-training. I recently watched the show, and my wife thought I was going to have several heart attacks.

In a serious nature, please do not short your efforts in data integrity.

Boscon 2022

I am pretty excited that Boscon, the local ASQ section’s conference is back on and calling for proposals. So for local folks, a good time to share some best practices and case studies.


BOSCON is an annual quality conference hosted by ASQ Boston. BOSCON is the New England signature event where national and international quality professionals hear speakers discuss different quality topics and network with them. The conference focus for 2022 is Navigating Quality Performance in a post-Pandemic World (Risk management, Impact/risk & mitigation of pandemic on companies, Work-life balance, Resource management, Employee Safety, Virtual/ remote workspace, Customer satisfaction, Supply chain).

Tracks and possible focus

  • Technical Quality tool (CAPA, 5S, SPC, Lean 6 sigma, etc);
  • IT/Software (Cybersecurity, cloud, virtual workspace, etc);
  • Pandemic Supply Chain (Lean reconsidered, Change management);
  • Personnel/People (Work-life balance, resource management).

Not interested in presenting, but want to participate as a volunteer?
Contact Snehal Rane  Snehalrane90@gmail.com BOSCON 2022 Chair

B0SCON 2022 PRESENTATION PROPOSAL FORM

We invite you to submit your proposal(s) for BOSCON 2022 oriented towards one of the track areas above.  Please provide a concise and clear description of your session topic and the values it provides to our attendees. 50 minutes are provided for your presentation and any Q&A.

KEY DATES

  • August 15th => Please complete the form referenced below and submit to both Snehalrane90@gmail.com and dmanalan@alum.mit.edu as soon as possible, and no later than August 15th.
  • September 1st => Applicants will be notified if the submitted proposal was accepted, confirmation requires a signed speaker agreement.
  • September 15th => Sign speaker agreement and submit.
  • October 1st => Submit final set of slides by October 1st.

Fill out the form- Word version at

https://1drv.ms/w/s!Aq7kI8QOQQN5hD-FL4JLDqGKF8yc?e=USkE6y

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.