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 they 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‘”

Growing Businesses in Kenya: Interview with Justin Macharia In Their Own Words

Andrew talks to Justin Marcharia, Round Table Training Africa's Managing Director, about his collaboration with The Deming Institute. His goal is to help new and small businesses in East Africa use the Deming philosophy to grow in sustainable ways. TRANSCRIPT 0:00:02.2 Andrew Stotz: Hello. My name is Andrew Stotz and I'll be your host as we continue our journey into the teachings of Dr. W. Edwards Deming. Today I'm here with featured guest Justin Macharia. Justin, are you ready to share your Deming journey?   0:00:17.2 Justin Macharia: Oh, yeah, I'm ready.   0:00:19.5 AS: I'm excited to learn… I mean there are so many things that I would like to ask you about your Deming journey and where your Deming journey is and all of that. But let me introduce you to the audience. Justin Macharia is the managing director of Round Table Training Africa Limited. Justin has been working with the Deming Institute over the past couple of years to enable DemingNEXT access into a number of East African countries through his organization. It's gonna be beneficial I think for all of our listeners to learn about this partnership and the impact that we think the Deming Institute can have in East Africa. And also, it's a great opportunity for you, Justin, to share why you think that Deming is important part of development in your part of the world and why you see the opportunity as kind of first time opportunity to enable businesses to learn and apply the Deming method. So maybe you can just talk a little bit about what you're doing first, and then we'll get into your Deming journey.   0:01:29.9 JM: Thank you Andrew. Yeah, so Deming Institute in Africa, basically East Africa, that's Nairobi, Kenya started off in the year 2020. And we've walked the journey with Kevin and Tim. And basically what we've… We've found that there was an opportunity to instill best practices in manufacturing, hospitality, and any other organizations that are moving from either raw production or the value chain addition. So what inspired us into getting into and partnering with Deming was basically the… We have a lots of trainings, consultants in our area, but however we found that they were lacking in terms of the depth and the philosophy and the models and tools. So what happens is, basically is we reached out to the Deming Institute and we did a presentation and asked if we could partner with them. And of course we had to give a little bit of background about ourselves.   0:02:34.9 JM: And what is basically happening in East Africa right now is… 'cause East Africa is be in in agribusiness, but agribusiness is on only probably small scale to large scale and mostly of the cash crops for export. But more and more now people are getting into value addition and processing. And that comes with a lot of systems, processes and management skills that are required for that. Apart from that, there's a lot of manufacturing going on and it's probably sometimes ad hoc and learning on the job which can… It can be very expensive and a little mistakes and system and processes or a lack of there of. So that has actually created the need and the appreciation and like probably Andrew had mentioned that, just a little bit earlier, is that everybody knows Deming, anybody who is in a management course, 'cause they always talk about Deming at some point during the introduction as the gurus of quality management. So the take up has been gradual and slow, but we're getting somewhere with it right now.   0:03:42.3 AS: And maybe for the listeners out there I'll explain about, what the Deming Institute is doing with DemingNEXT and trying to get, obviously all the video material that's available about Dr. Deming's teaching, but also providing all the resources necessary for training. So for those that are listening that think, God, I really wanna get more training into my company related to Deming. Well, the Deming Institute has made so much of that available through DemingNEXT. So I think that's an important message to everybody out there, is that it is a resource not only for your own personal development, but how you can bring some of that training into your company or any company that you're interacting with. Maybe you just tell us briefly about what your expectation is or what you expect to be doing with that material and with your own material and how are you doing that training. And maybe just tell us a little bit about that.   0:04:39.9 JM: Well, thanks Andrew. So what the DemingNEXT actually offers a lot of resources like you mentioned. There are PDFs, there are case studies. Because as much as we train a local organization, it's always good to give them a case study of basically where it has worked before, the successes because the industry and the verticals, probably is it the service industry, is it the telecommunication, we find 'cause somebody believes in the credibility of a process by basically seeing it has worked before with somebody else. And this what… The challenges they went through. So it shortens the learning curve because you don't have to go through the mistakes they did. They share with their case studies. And this improves like what Deming talks a lot about is the continuous improvement.   0:05:30.0 JM: Continuous improvement. So you progressively improve as you go on, get the feedback from the customers, feedback from the system itself. And this has really helped in terms of… The resources that are online on DemingNEXT has really helped in fortifying what the facilitators are actually telling and teaching the participants.   0:05:52.7 AS: Fantastic. So for all the listeners and viewers out there, make sure that you go to DemingNEXT to understand what resources are available and if you are in East Africa what's the website, your website that they could go to to learn more about what you guys are doing?   0:06:09.8 JM: Well, yeah, thanks. Our website is http://www.roundtabletraining.co.ke. There you'll find a wide array of programs and also the links to the Deming resources as well.   0:06:24.5 AS: Fantastic. So tell us about… You know, now it is time for some of the fun stuff where we talk about your Deming journey. And as you and I talked about before we turned on the mic, the recorder, you're early in your Deming journey. You've started recently and you're learning. And I know there's plenty of listeners that are early in their Deming journey. And I know there's some old timers also that are listening that are like, okay, so what's it like? So maybe you can tell us about the story about how you first came to understand and learn about Dr. Deming's teachings. And what was it that hooked you that made you think, I want to bring this training to other people?   0:07:02.6 JM: Thank you. Yeah, so my journey basically, my career has been spanning over 20 years, actually about 23 years. But actually within my career I have interacted with so many training institutions from ICT to management and leadership. However, there's always something lacking in them. There's always something I was feeling we're not giving them the depth and the case studies and proven models, things that have worked. So that's basically around 2020. Basically around the COVID time.   0:08:25.7 JM: I went actually searching and interacted with… I saw Deming. I saw… There is a Deming Institute in the US and we decided, okay, let's approach them because we know about Deming and Dr. Deming's philosophies. It's been trained and taught. But what really caught me and I remember and many people remember is the PDSA cycle, the PDSA that one… Everybody knows about that cycle. So when we reached out and they actually said, all right, we can give it a try. And hence we started off the journey in East Africa like that. So the PDSA and appreciation of systems and all that, those are the ones that basically caught us on teaching.   0:08:27.9 AS: And maybe we can talk a little bit about what's happening in Africa for I know a lot of listeners they may not really know all the stuff that's going on in your part of the world in East Africa. And I know Kenya is going through a lot of growth these days. Maybe you can just tell us a little bit about what's going on there in particular in relation to business and development. You mentioned the idea of being a resources exporter and trying to add more value to that. Yeah, maybe walk us through a little bit about what's happening in the economy of Kenya.   0:09:01.1 JM: So Kenya is very strategically positioned in Africa. It's basically the gateway of the East and Central Africa region which covers the DRC, Rwanda, Tanzania, Uganda, Ethiopia, Southern Sudan. So the economy is basically very robust especially in the… Recently the financial market, the mobile banking. Maybe some of you have heard of the mobile banking actually was actually birthed in Kenya with something called M-Pesa. So the service industry apart from the Agro and the traditional products that have been traditionally produced.   0:09:44.7 JM: There is hospitality, tourism. I know you've heard of the big five safaris. So tourism is really huge in East Africa. Not only Kenya, but Uganda, Tanzania as well. So with that is the traditional ways of commerce and the GDP relies heavily on that. However, the service and the technology has been growing recently. And thanks to the internet there is are a lot of resources as well. People are either going to school or they are self-teaching themselves. So a lot to offer from this point of view in terms of tourism, Agro-business, service, telecommunication and all that. So it's a great place to be.   0:10:32.8 AS: I'm curious, I've lived in Asia almost the majority of my life, let's say the last 30 years. And as I look back at America, I see a reason, one of the reasons why Deming has a hard time is that people are so individually focused. Like individual, they want individual compensation. They want individual rewards. They do not wanna be part of a system so much and all of that. And you can see that compares to let's say Japan where they really value being part of that system and society. They do not want the individual rewards the way that it's done. And you see every country is different. And I'm just curious, what are the motivations that drive, what are the things that drive people there that the way people think about business and doing business so that we can then understand what part of Deming is most appealing?   0:11:28.0 JM: Oh yeah, so yeah, actually it's a… I can say probably East Africa and Kenya has a lot to borrow from Japan 'cause people do get a lot of value by coming together and they value that. So there are these things we call Chamas, is like coming together maybe 10 people pulling resources and getting to a certain business investment. So it's really big all the way from the ground up we call it table banking. It could be from, let's say ladies coming together. So it's a big thing. So but what normally lacks in moving it… The transition to growth is what is normally the difficult part. They could get to point… From point A to point B but managing the growth, the change by instilling processes, systems that will enable them to grow and scale up now becomes a challenge.   0:12:28.0 JM: Hence that's why DemingNEXT and also the membership. The membership which we are also… Introduced to the market which we have individual membership for DemingNEXT and the corporate membership is what we actually been proposing to even these what I call the Chamas basically pull in and learn from the rest of the world how processes and they're very simple processes actually, DemingNEXT, actually has very simple way of breaking things up to people. So that kind of people come together in terms of business and investment but the growth trajectory is what that lacks and that's why DemingNEXT has come with this philosophies to push guys and help people move to the next level.   0:13:11.3 AS: Yeah moving to the next level is interesting 'cause I know when I moved to Thailand Justin I went out I taught a Just-In-Time inventory management class in 1992 and at that time the Japanese had really come to Thailand and producing cars. So I took my students out to a Toyota factory and I remember that the guy, the Japanese guy said I have to apologize that most of our managers are Japanese. In the beginning we just have a lot of training that we've been doing and over years you know it will grow where we'll have more of the Thai people in management. And then what you see now is when you visit Toyota and you realize wow that they've really done a huge amount of training. And many of the Thai staff that started at a low level have moved up into management and you know carrying on.   0:14:02.8 AS: So I can imagine that part of what you're talking about is that transition to just developing the core skills and then slowly developing into management and how to manage that business or your own businesses better and better. I guess that's kind of the transition that you're talking about. Would that be right?   0:14:21.2 JM: Oh yes yes. Because what is normally said managers normally they're not appointed. They grow into the position. So as they grow into the position there are some skills that we may lack in terms of managing the teams. And I like what Dr. Deming's philosophy of the psychology the soft skills part of it and relying on the process and not the big stick approach. So yeah it really helps especially new managers to fit into the role and get the rest to follow and emulate the good practices.   0:14:56.6 AS: Tell us something about let's say the characteristics of people there. And I'll give you an example. In Thailand, obviously in America if you raise your voice and you shout and you yell and say I want this and that, it… People, nobody likes that but they don't mind that, it's not a big deal. But in Thailand you never raise your voice and you just would never do that. Or else it would be people just wouldn't buy into that. And maybe tell us one characteristic that you see in Kenya that is part of the characteristic of the workforce or the way people feel socially like something that maybe an American as an example may come and think that they're bringing their culture but in fact they're not very sensitive to let's say some feeling or way that people do their… They live their lives and they think about things. Maybe you can give us some example.   0:15:51.8 JM: Alright yeah. So basically like sometimes it is very common with Kenya and of course it's spread a little bit across the region as well is appreciation the soft skills. It's continuous, celebrating small successes as well. So the populace, the employees would like to feel appreciated in the workplace. Otherwise if it's like over reliant on the processing and the system like okay it was part of your job you don't need a pat on your back. That kind a thing sometimes like oh a little pat would've helped. So it gives a smile to people. So it is the same with thank you did a good job. Even though it was part of the job. It's something that the populace really appreciate. So sometimes when you get maybe some probably managers from a different place and it is none of that it creates the silos and people pull out a little bit and it becomes an eight to five job. They're not enjoying it. It's like okay I'm just doing my job. But that's what I can actually think about right now.   0:17:00.5 AS: Yeah it's a great point and it obviously people around the world want intrinsic, they wanna feel that they're contributing to the value. And I think different societies have different need for that. I would say for Thais, they don't have as strong of a need for that but everybody likes to know when I'm contributing to the success of the organization and the role that I'm playing. So that's definitely and I'm guessing that people you know a lot of times when you look at Thailand's got an agricultural history, America has an agricultural history but it didn't last for very long because it turned into kind of in commercial and industrial agriculture. But when you look at countries that just have such a foundation in agriculture you have to work together or else in harvesting in planting villages work together in Thailand. Is that part of the history and part of the culture there? Or what's it like as far as teamwork versus individual work?   0:18:00.8 AS: Teamwork has actually been part of the culture. Because let's talk about the "Good old days" is when you're going to the farm you would go as a team. If you are ploughing, you'll plough as a team, harvesting you'll harvest as a team. So that's the same thing that has come down the generations. And even at work even though you are in the service sector you'll decide okay let's get together and let's do this. Let's get together and do this investment or let's do this team building. So it has carried on the generations and the only time maybe individualism comes and it's silos and like corporate politics, some groupings form within the organization. But that is… A good manager will know how to break the silos and to get people communicating again. So when Deming as well it gives… Has multiple courses that you can basically custom-make to break the silos which is a very popular one especially engagement, emotional intelligence and all that.   0:19:05.1 AS: Yeah. And in fact, what you learn is that the natural state of things is people don't want silos, they don't wanna be put up against each other like that.   0:19:14.8 JM: True, True.   0:19:16.5 AS: And so by breaking that… I'll tell you a funny story, when I was first working in an investment bank in Thailand, it was 1994 maybe at that time, and the Human Resource sent around a memo or a survey and they asked us to just tick what we thought and… The question was, "Would you like to have a company uniform that you would wear to work?"   0:19:41.8 AS: Now, as an American, I was like, "What? Why would I want that?" I'm an individual, I got my clothes, I don't need that. And so I just thought, nobody would answer yes to that, and then the next day then Human Resources said, "Well, it was unanimous, everybody wants a uniform, and we're gonna be working on getting those uniforms for everyone." And I was like, "Okay." I really didn't understand that about Thai people versus American people, and it just is a funny story about the idea that people wanna belong, and it's interesting that it's… In America, it really is like that individual and independent, which has it's value for sure. But that feeling of belonging, I think, is what I really like about the Deming content and what… The message of Dr. Deming. And it makes me think about… One of the questions that I like to ask is why Deming? Why now? And I'm curious, what would you answer to that, 'cause some people would say, "Oh, it's the old stuff and it's been around for a while, and there's new philosophies and new books and all that." but why would you say Justin, Why Deming? Why now?   0:20:56.1 JM: Yeah, Why Deming? Why now? Is really simple because we are in a transformational transitionary period for East Africans, and a lot of things have probably been done a little bit ad hoc, you're learning on the job, which is, we all know is costly, it's costly to learn on the job. So Deming philosophy brings forth a lot of tools and methodologies that you can basically move to the next level using international best practices. So basically what we know is a lot of tools of Deming also have been adopted in different ways, there are probably some software, have actually been designed and the background is basically the Deming philosophy, you know the PBC cycle, is it variations, understanding variations, all those things that help you to move to the next level. The PDA cycle again that again is known with the Toyota, everybody knows about Toyota and Japan after the World War II and how Deming, Dr. Deming really contributed to that. So it is done, proved, luckily also Deming Institute has also modernized the PDA cycle, there is the modern one now that it is now… It is in cognizant to the current challenges that we have today. So Deming… Right now it's in the right place, everybody should go back to the roots, those who deviated from the roots are finding themselves in unknown territory, they need to come back to the roots and we move forward.   0:22:31.3 AS: Fantastic, and I know for the listeners out there, whether you're in East Africa or wherever you are in the world, one of the things that I always see nowadays, it's like everybody thinks that KPIs and particular individual key performance indicators are the way to manage people, and I think one of the things that I really enjoy about the Deming material and the Deming method is that it's miles beyond just tracking someone's behavior, it goes much deeper than that, and it's about the psychology and bringing out the intrinsic motivation of people and getting them involved and when you do that, ultimately you unleash a power of the people that's fantastic. Maybe as we wrap up, one of the things I'd love for you to do is just share maybe one of your experiences in your training over the years that you… A story or something that you have felt like is a proud moment for you.   0:23:31.2 JM: Alright. There could be a couple I'm trying to see which one could it be but I can… Let's see. There's a time we actually had some group in-house trainings 'cause we offer open trainings, so that we get people from different organizations, but this particular one where we got into an in-house training, and so the facilitator basically got… Was sent to the organization and it was basically, the soft skills, so it was a three-day program, and what came out of it was not… Basically was not even the training, that was… Had been positioned to be trained the moment, the psychology of pains, and the breaking of the silos that came up, it became like a team building and that team building now changed the whole perspective of the training and in fact we had to change the course trajectory mid-way so that now, people can now… Because what we realized was that there were just silos, all over the place, and the training itself would not have earned any… Gotten any dividends, if it went on like that. So it was changed and they actually called us some time later to come and give them their training that had been planned, so that is why I remember that we had to change the course in between because the silos were just crazy inside there, so that one was memorable.   0:25:00.5 AS: It's interesting that you referred to silos many times in this discussion, it's clearly an issue that Deming can help solve, which is…   0:25:08.1 JM: Yes.   0:25:09.8 AS: It's happening all around the world, but it's great to think that you've got a solution, and for the listeners out there, again, if you're in East Africa, reach out and figure out how you can get some of this great stuff and this great training to your business. Well, Justin, on behalf of everyone at the Deming Institute, I wanna thank you again for coming on the show. And let me ask you, do you have any parting words for the audience?   0:25:36.9 JM: Alright. I'd like to… If you're in East Africa, you can go to our website at roundtabletraining.co.ke enroll into any program or contact the number that you'll find there, and we can come and have a visit and talk to you more about what and how Deming can transform your organization.   0:26:00.1 AS:  Fantastic, and that concludes another great story from the worldwide Deming community and how… We learn how Deming is making a footprint in East Africa. Remember to go to deming.org to continue your journey. This is your host, Andrew Stotz, and I'll leave you with one of my favorite quotes from Dr. Deming: People are entitled to joy in work.
  1. Growing Businesses in Kenya: Interview with Justin Macharia
  2. Applying SoPK: Deming in Schools Case Study (Part 2)
  3. From Taguchi to Deming: Awaken Your Inner Deming (Part 1)
  4. Define the System and the Aim: Role of a Manager in Education (Part 1)
  5. Confusion vs Clarity: Deming in Schools Case Study (Part 1)

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
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
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.

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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.

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 211.25(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 touch 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.

There are many transactional differences in the roles, but if quality is not at the table for key decisions on hiring and culture the organization has missed opportunities.