Quality, Decision Making and Putting the Human First

Quality stands in a position, sometimes uniquely in an organization, of engaging with stakeholders to understand what objectives and unique positions the organization needs to assume, and the choices that are making in order to achieve such objectives and positions.

The effectiveness of the team in making good decisions by picking the right choices depends on their ability of analyzing a problem and generating alternatives. As I discussed in my post “Design Lifecycle within PDCA – Planning” experimentation plays a critical part of the decision making process. When designing the solution we always consider:

  • Always include a “do nothing” option: Not every decision or problem demands an action. Sometimes, the best way is to do nothing.
  • How do you know what you think you know? This should be a question everyone is comfortable asking. It allows people to check assumptions and to question claims that, while convenient, are not based on any kind of data, firsthand knowledge, or research.
  • Ask tough questions Be direct and honest. Push hard to get to the core of what the options look like.
  • Have a dissenting option. It is critical to include unpopular but reasonable options. Make sure to include opinions or choices you personally don’t like, but for which good arguments can be made. This keeps you honest and gives anyone who see the pros/cons list a chance to convince you into making a better decision than the one you might have arrived at on your own.
  • Consider hybrid choices. Sometimes it’s possible to take an attribute of one choice and add it to another. Like exploratory design, there are always interesting combinations in decision making. This can explode the number of choices, which can slow things down and create more complexity than you need. Watch for the zone of indifference (options that are not perceived as making any difference or adding any value) and don’t waste time in it.
  • Include all relevant perspectives. Consider if this decision impacts more than just the area the problem is identified in. How does it impact other processes? Systems?

A struggle every organization has is how to think through problems in a truly innovative way.  Installing new processes into an old bureaucracy will only replace one form of control with another. We need to rethink the very matter of control and what it looks like within an organization. It is not about change management, on it sown change management will just shift the patterns of the past. To truly transform we need a new way of thinking. 

One of my favorite books on just how to do this is Humanocracy: Creating Organizations as Amazing as the People Inside Them by Gary Hamel and Michele Zanini. In this book, the authors advocate that business must become more fundamentally human first.  The idea of human ability and how to cultivate and unleash it is an underlying premise of this book.

Visualized by Rose Fastus

it’s possible to capture the benefits of bureaucracy—control, consistency, and coordination—while avoiding the penalties—inflexibility, mediocrity, and apathy.

Gary Hamel and Michele Zanini, Humanocracy, p. 15

The above quote really encapsulates the heart of this book, and why I think it is such a pivotal read for my peers. This books takes the core question of a bureaurcacy is “How do we get human beings to better serve the organization?”. The issue at the heart of humanocracy becomes: “What sort of organization elicits and merits the best that human beings can give?” Seems a simple swap, but the implications are profound.

Bureaucracy versus Humanocracy. Source: Gary Hamel and Michele Zanini, Humanocracy, p. 48

I would hope you, like me, see the promise of many of the central tenets of Quality Management, not least Deming’s 8th point. The very real tendency of quality to devolve to pointless bureaucracy is something we should always be looking to combat.

Humanocracy’s central point is that by truly putting the employee first in our organizations we drive a human-centered organization that powers and thrives on innovation. Humanocracy is particularly relevant as organizations seek to be more resilient, agile, adaptive, innovative, customer centric etc. Leaders pursuing such goals seek to install systems like agile, devops, flexible teams etc.  They will fail, because people are not processes.  Resiliency, agility, efficiency, are not new programming codes for people.  These goals require more than new rules or a corporate initiative.  Agility, resilience, etc. are behaviors, attitudes, ways of thinking that can only work when you change the deep ‘systems and assumptions’ within an organization.  This book discusses those deeper changes.

Humanocracy lays out seven tips for success in experimentation. I find thet align nicely with Kotter’s 8 change accelerators.

Humanocracy’s TipKotter’s Accelerator
Keep it SimpleGenerate (and celebrate) short-term wins
Use VolunteersEnlist a volunteer army
Make it FunSustain Acceleration
Start in your own backyardForm a change vision and strategic initiatives
Run the new parallel with the oldEnable action by removing barriers
Refine and RetestSustain acceleration
Stay loyal to the problemCreate a Sense of Urgency around a
Big Opportunity
Comparison to Kotter’s Eight Accelerators for Change

Management’s Job

In episode 48 of the Deming Len’s podcast, the host refers back to Deming’s last interview, “Dr. Deming: ‘Management Today Does Not Know What Its Job Is‘”

Deming Lens #51 – Pay for Performance The W. Edwards Deming Institute® Podcast

In our 51st Deming Lens episode, host Tripp Babbitt shares his interpretation of wide-ranging aspects and implications of Dr. Deming's System of Profound Knowledge. This month he looks at supply chain and risk management. Show Notes [00:00:14] Deming Lens – Episode 51: Pay for Performance [00:02:19] A Journey with Pay for Performance [00:03:28] The New Harmony Project [00:04:33] The Result of Collectivism [00:06:35] Analytical vs Synthetic Thinking [00:10:19] Dr. Deming and Pay for Performance [00:12:22] Pay for Performance, Collectivism and Dr. Deming     Transcript [00:00:14] In the 51st episode of the Demning lens, we'll talk about. Pay for performance. Hi, I'm Tripp Babbitt, host of the Deming Institute podcast, and this is the fifty first episode of the Deming Lens. And as I was going back and searching through some of the old episodes I've done, I noticed I hadn't done one on pay for performance. And it kind of came to the forefront of my mind when I was going through some Tic Tacs. And there's a couple of people out there that are big advocates of pay for performance as ways to keep people in their organizations, which is becoming a problem now. You know, people aren't going back to work for variety reasons. The stimming check certainly plays a role in that, working from home, people being called back to work when they had got used to being at home. There's this thing that goes around on LinkedIn about you only live once and you might as well do something that that makes you happy. And organizations these days don't seem to be making people very happy. And so these are some of the topics that I think I want to talk about with regards to pay for performance. And I actually put a whole YouTube video together on my personal YouTube channel responding to Tessa White, who goes by the name Job Doc Tessa. And she used to get some pretty good advice. But one of the pieces of advice was if you're going to keep people that you got to pay for performance.   [00:02:19] So let's talk about that, because it's been an interesting journey with regards to pay for performance and at least in my own personal journey, doing public and private seminars where we would talk about pay for performance, which was something that Dr Deming obviously advocated against. And I'd often get a lot of pushback on this. You know, when you're talking about getting rid of incentives or paying for performance at almost every public or private seminar that I did, I get some pushback either allowed during the course of the seminar or privately afterwards that asking if Dr Deming was a socialist or a communist. And I've done other episodes on this particular subject, but I'm from Indiana and in Indiana. Back in the early 1980s.   [00:03:28] There was a project called and New Harmony, Indiana, that basically advocated for collectivism, which was put together as a utopian society by a gentleman, by the British industrialists, by the name of Robert Owen from 1825 to 1827. So let's have a look, maybe a little bit over a year. And then it was dissolved in 1827 because this whole concept of social education and equality did not work well for a lot of different reasons. But the idea of a utopian society in New Harmony, Indiana, was to eliminate crime and poverty and increase health, decrease misery and increase your intelligence and happiness. And this was what this community of equality was supposed to achieve in Indiana.   [00:04:33] And but what happened over time is that people discovered that the equality that this society was advocating, that there were certain rare and very hard working people, you know, putting together the agriculture that was needed for the society or building houses or whatever, is that the hard working realize that they were earning the same as the laziest of the people in the group and that caused conflict. And then people stopped working. So food wasn't being grown and houses weren't. Their houses and buildings were being built because there was kind of a pointing fingers and blame and things of that sort. So this whole utopian society based on collectivism was didn't work out. It collapsed very quickly and. You know, when you when I'm talking about pay for performance in public and private seminars. You know, the thing I'm communicating to people is that the individual cannot be separated from the system that you work in. And what I discovered over the years is there's there's something called Dunbar's number, which is 150. When an organization grows to about 150, you you become it becomes more and more bureaucratic. And the larger it grows, the more bureaucratic that it becomes. And managing that becomes very difficult. So the larger your system is, the harder it is to separate the performance of an individual from the system that that you're working in. Now, I've seen it get really bad, anywhere from 75 to 150 employees and working with some smaller organizations.   [00:06:35] And but it's borne the pay for performance. The mindset is borne from what I referenced is analytical versus synthetic thinking. And that is that, you know, we break down the pieces in analytic and analytical thinking and we break them down all the way to the individual and say, OK, here's your goals. If you just meet your goals and everybody meets their goals, the company's going to do well. And I think if you go back to the interview I did with Paula Marshall, you'll discover that you can't separate the individual from that system and that the system is greater than the sum of its parts. So the whole concept of synthetic thinking or systems thinking gives you a different view of how your organization works. And it's not something that you can just break apart all the way down to the individual and add it up. It's exponential. And managing the interconnections in a system is where you get your largest gains. So, you know, it's been interesting from my standpoint that we have gone from this concept of Dr. Deming's ideas around pay for performance, where people were, in essence, questioning whether he was a socialist or a communist or whatever. To today we seem to have this pendulum swinging, swinging where, you know, everybody should be getting the same pay. And I you know, the things that Dr. Deming worked on from my studies and my using his system of profound knowledge are getting clarity of purpose.   [00:08:29] You know, if you if you understand your system and you understand your connection to the customer, that raises your level as a worker, understanding kind of what you do as opposed to just being kind of this cog in the system that just does its thing. And there's no benefit to doing that, but that people are paid differently based on the skills that they get. And developing those skills becomes something that the organization would want to do for its own benefit, as well as the benefit of the individual. One other thing Dr. Deming advocated is innovation and that people are participating and coming up with ideas and more and more. I've seen this huge conflict in organizations between the executives micromanaging things. And, you know, you do your work and you do it in this way, as opposed to giving more responsibility that the worker has even greater knowledge because they're actually doing the work to make their own decisions about their own work. And that management's job is to remove the barriers that create problems for the workers. And they're facilitating things, moving, moving forward. And the best organizations that I've worked with either working towards that or they're getting the knowledge to work towards that. And this is what will keep people there. Never will there be this collectivism type of mentality on the one and one side of things where, you know, everybody gets the same pay.   [00:10:19] And on the other end, where there's this pay for performance, there's Dr. Deming is proposing something very different than those two concepts to be able to make the organization better and have individuals want to be a part of that and not go to things like wanting to be an entrepreneur. Fighting, though, the work from home, you know, going to a smaller company or just staying waiting till the clock runs out on their stimming checks, these are all things that are preventing us from moving forward. Now, one thing I am getting more and more concerned about is, you know, we need these large organizations to achieve big things. You know, an individual entrepreneur has to be very fortunate. You know, there's very few Jeff Bezos of the world that start from scratch and then grow a particular company into a behemoth like Amazon. And so we need these large organizations and we need them to run well because they can achieve big things, whether it's making cars or homes or whatever it is. These are very large systems and people get lost in the shuffle in the way that things are happening today. And so they're dissatisfied. We have a whole generation of people that are really caught up and trying to do something for the greater good. But I think it gets a little bit misguided. And I believe that some of the organizations that we have today with the mindset of micromanaging people and control and incentives and pay for performance are all things that are making their systems worse.   [00:12:22] And, you know. We don't need pay for performance and we don't need collectivism, but what we do need are good systems that people want to work in on a daily basis. And so that's that's the message I wanted to communicate this month in the Deming lens is this concept of pay for performance where you can separate an individual from the system, which you can't. And the larger the system is, the harder that becomes. If you're an entrepreneur, then, yeah, pay for performance. And that's that's exactly what you get when you're an entrepreneur, you know, a company of one. But as it grows, there needs to be a better an organization built on a clarity of purpose, their connection to the customer, and that the person, no matter where they are in your organization, can understand that what the customer is looking for. And I use what's called a customer lens to be able to achieve that and innovation, the ability to share ideas that they have about the work and the way that it should be done and the ownership of that by the worker as opposed to management and executives and people of that sort. So that was it for this week. I'll talk to you again next month for the latest videos, blogs, events and information from the Dummying Institute. Be sure to go to Deming dot org.
  1. Deming Lens #51 – Pay for Performance
  2. Deming Len's Episode #49 – Supply Chain and Risk Management
  3. Deming Len's Episode #48 – Management (Still) Doesn't Know What Its Job Is
  4. Deming Len's Episode #47 – SoPK: The Interaction of the Parts
  5. Deming Lens #46 – The Art of Tampering

I’ve written recently about driving fear out of the organization. Without a doubt I think this is the number one task for us. True North for the quality profession.

The source of innovation is freedom. All we have—new knowledge, invention—comes from freedom. Somebody responsible only to himself has the heaviest responsibility. “You cannot plan to make a discovery,” Irving Langmuir said. Discoveries and new knowledge come from freedom. When somebody is responsible only to himself, [has] only himself to satisfy, then you’ll have invention, new thought, now product, new design, new ideas.

Dr. W. Edwards Deming

Drive Out Fear on International Workers Day

Happy International Workers Day. Let’s celebrate by Driving Out Fear!

Thirty-five years ago Deming wrote that “no one can put in his best performance unless he feels secure.” Unfortunately, today we still live in a corporate world where fear and management by fear is ubiquitous. That fear is growing after more than a year of a global pandemic. As quality professionals we must deal with it at every opportunity.

Fear undermines quality, productivity, and innovation. The existence of fear leads to a vicious downward spiral.

Some sources of fear include:

  • Competition: Many managers use competition to instill fear. Competition is about winners and losers. Success cannot exist without failure. Managers deem the anxiety generated by competition between co-workers a good thing as they compete for scarce resources, power and status. Therefore, management encourage competition between individuals, between groups and departments and between business units.
  • “Us and Them” Culture: The “us and them” culture that predominates in so many organizations proliferated by silos. Includes barriers between staff and supervisors.
  • Blame Culture: Fear predominates in a blame culture. Blame culture can often center around enshrining the idea of human error.

We drive out fear by building a culture centered on employee well-being. This is based on seven factors.

FactorMeansObtained by
ResponsibilityWell defined responsibilities and ownershipThe opportunity an employee has to provide input into decision making in his department
An individual employees’ own readiness to set high personal standards
An individual employee’s interest in challenging work assignments
The opportunity an employee has to improve skills and capabilities
Excellent career advancement opportunities
The organization’s encouragement of problem-solving and innovative thinking
Management CompetenceManagers trained with skills that lend themselves to contributing to the work of their team ensures that they will be looked to for help. Managers need to be able to guide.Direct Supervisor/Manager Leadership Abilities Management is engaged and leads by example (Gemba walks)
Management by Facts
ConsiderationWhen managers act as if employees have no feelings and just expect them to do their work as if they are robots, it can make employees uneasy. Such behavior makes them feel detached and merely a tool to carry out an end. In such environments, many times the only times employees hear from the manager is when something goes well or really bad. In either case, the perception could be that the manager has mood swings and that also adds to the employee’s insecurity. They may feel reluctant to talk to their manager for fear he is in one of his bad moods.Senior Management’s sincere interest in employee well-being
An individual employee’s relationship with their supervisor
Open and effective communication
Trust in management and co-workers
CooperationThe feeling that every person is on their own to look out for their interest is a sad state to be in. Yet when everyone has a fear that the other workers will take advantage of them or make them look bad at the first opportunity, a selfish and insecure environment will result. Employees should be able to work together for the benefit of the company. They should focus on group goals in addition to their personal goals, recognizing that individually there will be failures, but that the whole is more important than the individual parts.Trust Well trained employees Collaboration as a process Organizational culture (psychological safety) Hire and promote the right behaviors & traits to match the culture
FeedbackInformation that is given back to the employee regarding their performance on the job.Know what is expected of them (clear job descriptions)
Effective processes for timely feedback
Recognition
Know their opinion matters
InformationTransparency is critical. When employees know nothing about how a company is doing in terms of where they should be, it is a source of uneasiness. Without that knowledge, for all they know the company could be doing very poorly and that could be a bad thing for everyone. When they have a better sense of where the company is in the scheme of their objectives set by management, it helps them feel more secure. That is not to say it is the news being good or bad that affects their security, but rather the fact that they actually have the news.Strategy and Mission — especially the freedom and autonomy to succeed and contribute to an organization’s success
Organizational Culture and Core/Shared
Values
Feel that their job is important
StabilityEmployees feel more secure when their role does not change frequently and they understand what tomorrow will mean.Job Content — the ability to do what I do best
Availability of Resources to Perform the Job Effectively
Career development – opportunities to learn and grow
Photo by fauxels on Pexels.com

Driving out Fear

Norm Howe, a colleague in the ASQ and a great guy, wrote on his company’s blog “It Doesn’t Make Any Difference How Nice the Boss Is” and I want to strongly recommend that people read it.

Norm tells an engaging story where he shares a formative experience on the value of driving out fear. He then explains that we as managers grew up in these cultures and it requires work to build a new culture.

He hits on a great note, managers are part of the cultures they grew up in. We are like trees with many rings, and it can be very difficult just to change that.

I love story-sharing like this.

Photo by cottonbro on Pexels.com

HR and Quality, joined at the hip

The interface between the Quality and Human Resources departments in pharma and medical devices can be poorly understood by many leaders in both departments. Quality tends to focus on product and process, HR on hiring, benefits, stuff like that. As a quality professional who oversees the training and personnel qualification system, I tend to sit between the two.

A quick summary of some regulations are in order. This is by no ways a comprehensive list.

RegulationRequirement
ICH E6 R2, 2.8Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
US FDA 21CFR 210.25(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee’s functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. (b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess. (c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.
Canada C.02.006Every lot or batch of a drug shall be fabricated, packaged/labelled, tested and stored under the supervision of personnel who, having regard to the duties and responsibilities involved, have had such technical, academic, and other training as the Minister considers satisfactory in the interests of the health of the consumer or purchaser.
EU EMA/INS/GMP/735037/201 2.1All parts of the Pharmaceutical Quality system should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities.
WHO Annex 3-GMP9.2 The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience. The responsibilities placed on any one individual should not be so extensive so as to present any risk to quality. 9.3 Responsible staff should have its specific duties recorded in written descriptions and adequate authority to carry out its responsibilities. Its duties may be delegated to designated deputies of a satisfactory qualification level. There should be no gaps or unexplained overlaps in the responsibilities of personnel concerned with the application of GMP. The manufacturer should have an organization chart. (also see section 9.6 and 9.7 on key personnel)
WHO Annex 5-GDP 7.2Key personnel involved in the distribution of pharmaceutical products should have the ability and experience appropriate to their responsibility for ensuring that pharmaceutical products are distributed properly
Guideline on good pharmacovigilance practices (GVP) EMA/541760/2011Achieving the required quality for the conduct of pharmacovigilance processes and their outcomes by an organisation is intrinsically linked with the availability of a sufficient number of competent and appropriately qualified and trained personnel (see I.B.6.).  All personnel involved in the performance of pharmacovigilance activities shall receive initial and continued training [IR Art 10(3), Art 14(2)]. For marketing authorisation holders, this training shall relate to the roles and responsibilities of the personnel [IR Art 10(3)].
21 CFR 58.29(a) Each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions.
(b) Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study.
(c) There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol.
21CFR 820.25(a)Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.
A few examples of regulations that ouch on personnel

This assortment of regulations provides structure for every aspect of employment from how we hire to how we manage people. We can divide this into the following major areas: Curricula Vitae, Job Description, Hiring Process, Training Records, Org Chart, External Job Identification. All informed by the rest of our quality system, especially Process (SOP) Roles and Responsibilities.

Like most things that concern us we want all of this to be consistent and accurate.

Training and Personnel Qualification within the Quality System

Looking at the 2020 FDA 483 data we can see that these regulations are a concern throughout organizations.

Citation Program AreaReference NumberShort DescriptionLong DescriptionFrequency
Bioresearch Monitoring21 CFR 58.29(a)Personnel: education, training, experienceNot all individuals engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study have education, training, and experience, or combination thereof, to enable that individual to perform assigned functions.  Specifically, ***1
Devices21 CFR 820.25(b)Training – Lack of or inadequate proceduresProcedures for training and identifying training needs have not been [adequately] established. Specifically, *** 30
Devices21 CFR 820.25(b)Training records Personnel training is not documented. Specifically, ***18
Drugs21 CFR 211.25(a)Training–operations, GMPs, written proceduresEmployees are not given training in [the particular operations they perform as part of their function] [current good manufacturing practices] [written procedures required by current good manufacturing practice regulations].  Specifically, ***18
Drugs21 CFR 211.25(a)Training , Education , Experience overallEmployees engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] required to perform their assigned functions.  Specifically, ***14
Drugs21 CFR 211.25(a)GMP Training FrequencyGMP training is not conducted [on a continuing basis] [with sufficient frequency] to assure that employees remain familiar with CGMP requirements applicable to them.  Specifically, ***7
Drugs21 CFR 211.25(b)Supervisor Training/Education/ExperienceIndividuals responsible for supervising the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.  Specifically, ***2
2020 483 citations related to Training and Personnel Qualification

Reaching beyond the regulations, we really need to ensure that a fear climate does not exist inside the organization, what is often called psychological safety. Looking to Deming, quality should extend to the performance check processes, and frankly those that introduce ranking of employees or departments are not the best for a culture of excellence.

As we end the year it is a good idea to think about this question in your organization. I’ll be expanding on the practice in the weeks ahead.