The World Economic Forum (WEF) has developed a Global Skills Taxonomy that provides a framework for aligning around a universal language for skills. It synthesizes and builds on existing taxonomies by integrating definitions and categorizations of skills that are of growing relevance in a fast-changing labor market 1
According to the World Economic Forum’s Future of Jobs Report 2023, quality control is one of the top 10 core skills listed in the Global Skills Taxonomy. In the WEF taxonomy, Quality control refers to the process of verifying that a product or service meets specified standards or requirements. It appears to bundle both quality control and quality assurance into this definition.
Quality Control was not listed in the top 10 in the 2020 report. Throughout you find reference to a skill set called “Quality control and safety awareness”, so we can assume this is a refinement in the reporting. In any case, this is an interesting development that I wish the WEF’s material provided more detail on, especially as the 2021 Skills Taxonomy doesn’t include an entry for Quality Control.
You need to go to the Data Explorer for Quality Control to see valuable information. Including this nice chart on the 7 top countries emphasizing quality control.
What facinates me most here is how it is not developing countries, there are some economic power houses here.
The industry categories of importance are interesting. Some industries I consider strong on quality rank below the mean and ohers above the mean. Others, Information and technology services I am looking at you, rate well below the mean on importance and it explains a lot of what is wrong with the world.
It would be nice to see the taxonomic entry. I’m fascinated by this one on Problem-Solving, which contains the first 2 in the top 10.
Interesting read that creates a lot of questions for me. But France and Canada, feel free to hit me up since it seems you are skill building.
And to help the WEF out, here is a nice way to break down what Quality is all about.
AI and its capabilities are big in the news right now, and inevitably folks start asking “What will this mean for my profession.”
The pharmaceutical GxP world is inherently slow to adopt new technologies. How many of my CxOs are still using 1990s technology? All of them. However, AI/ML has been showing up in more and more places so it is good to examine the potential to the Quality profession
It may seem counter-intuitive but the first place AI-powered software is making a difference is in improving the speed, accuracy, and efficiency of document review. From the eTMF to lab results to all the forms still used on the manufacturing floor, AI is already reviewing at a rate much faster than humans (and more reliably). Expect to see these options grow and become more part of offerings, such as your eTMF.
Trending is another place where AI/ML software is more capable than humans. Basically, anything that involves analysis will eventually be done by AI software, and will be done by software. We’re already seeing more and more automation be built into COTS and we will continue to see this trend grow.
There’s a long way to go before AI can even do the things above. Have you asked one to write a policy on use of AI in GxP? Said policy would result in no AI ever being used in the GxPs.
Here is an example of a GxP policy for the use of AI to write SAS scripts, provided by an AI:
GxP Policy for Use of AI to Write SAS Scripts
Purpose: The purpose of this policy is to provide guidance on the use of AI to write SAS scripts in compliance with GxP regulations.
Scope: This policy applies to all AI systems and applications used to write SAS scripts for the analysis of data subject to GxP regulations.
Responsibilities: It is the responsibility of all employees to comply with this policy and to report any non-compliance to the appropriate management.
Compliance with GxP Regulations: All AI systems and applications used to write SAS scripts must be designed, developed, validated, and maintained in compliance with applicable GxP regulations.
Data Integrity: All data used by AI systems to write SAS scripts must be accurate, complete, consistent, and attributable. Data must be protected against unauthorized access or modification.
Validation: All AI systems used to write SAS scripts must be validated to ensure that they produce accurate and reliable scripts.
Change Control: Any changes to AI systems used to write SAS scripts must be documented and approved through a formal change control process.
Training: All employees involved in the use of AI systems to write SAS scripts must receive appropriate training on their use and on this policy.
Audits and Inspections: All AI systems used to write SAS scripts are subject to internal and external audits and inspections to ensure compliance with this policy and with applicable GxP regulations.
Continuous Improvement: This policy will be reviewed regularly and updated as necessary to ensure its continued effectiveness.
Awesome. I’ll circulate this beauty for approval right away.
W. Edwards Deming’s substantive influence upon management thinking and practice is evidenced by the number of organizations that have worked to implement his key points, the abundance of books and papers related to his ideas, and the impact of his ideas on the practice of business today. While I’m not a fan of the term Quality Guru, it is hard to miss his impact.
Deming’s main concepts can be summarized as:
Visionary Leadership: The ability of management to establish, practice, and lead a long-term vision for the organization, driven by changing customer requirements, as opposed to an internal management control role.
Internal and External Cooperation: The propensity of the organization to engage in non-competitive activities internally among employees and externally with respect to suppliers.
Learning: The organizational capability to recognize and nurture the development of its skills, abilities, and knowledge base.
Process Management: The set of methodological and behavioral practices emphasizing the management of process, or means of actions, rather than results.
Continuous Improvement: The propensity of the organization to pursue incremental and innovative improvements to processes, products, and services.
Employee Involvement: The degree to which employees of an organization feel that the organization continually satisfies their needs.
Customer Satisfaction: The degree to which an organization’s customers continually perceive that their needs are being met by the organization’s products and services.
Summarizing the System of Profound Knowledge
Almost thirty years after the publication of The New Economics for Industry, Government, Education and we are still striving to realize these. They are still as aspirational and, for many organizations, out of reach today as they were in the eighties. We can argue that a lot of the concepts that swirl around Quality 4.0 is just trying out new technologies to see if we meet those objectives.
We can, and should, discuss the particulars of the System of Profound Knowledge. For me, it makes an excellent departure point for what we should be striving for. By looking to the past we can discover…
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.
What
What is this?
My thoughts on what this means for the ASQ?
Guidance Framework
The 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 Base
The data, theories, and methodologies that drive the discipline
This 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.
I think a common challenge is how do we as a new quality professional joining an organization replicate the same success we have had in past roles
Quality requires a support structure, and I think it is easy to underestimate the impact of the absence, or the lack of, that structure. Just parachuting quality professionals into different organizations where they are left without the scaffolding they’ve implicitly grown to expect and depend on can lead to underperformance. Some adapt, of course, but others flounder, especially when hired with daunting short-term expectations, which can often be the case in organizations looking to remediate gaps in a fast way. I think this is only exacerbated as a result of the pandemic.
Culture can have a steep learning curve and being able to execute requires being very well-versed in the culture of an organization. You have to know how your organization works in order to get it to work diligently like a well-oiled machine to execute the higher-level quality vision.
Learning the culture doesn’t mean simply parroting the oft-repeated mantras received during orientation, but truly internalizing it to an extent where it informs every small decision and discussion. At the best of times, that’s difficult and takes time, particularly as there isn’t usually a single monolithic culture to learn, but myriad microcultures in various different parts of the organization. Doesn’t matter the size, this is a challenge.
In the worst case, where an organization has a culture diametrically opposite to that of the previous workplace, “learning the culture” also requires un-learning almost everything that led people to get to their current level in the first place. The humility to strive to turn themselves into the leader the organization truly needs, rather than the leader they’ve grown to be over the past years, is a hard one for many of us. Especially since we are usually brought on board to build and remediate and address deficiencies.
To be a successful agent of change one has to adapt to the current culture, try experiments to accelerate change, and do all the other aspects of our job.
This is hard stuff, and a part of the job I don’t think gets discussed enough.
Investigations of a Dog 