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 Len's Episode #48 – Management (Still) Doesn't Know What Its Job Is The W. Edwards Deming Institute® Podcast

In our 47th 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 Dr. Deming's Last Interview. https://www.industryweek.com/operations/quality/article/21963885/dr-deming-management-today-does-not-know-what-its-job-is-part-1 Show Notes [00:00:14] The Deming Lens – Episode 48 [00:02:39] Management's Job [00:03:59] The Lost Art of Quality [00:06:20] The Source of Innovation [00:08:28] What's Happening in Organizations     Transcript [00:00:14] In the forty eighth episode of The Deming Lens, we'll look at Dr. Deming's last interview. Management doesn't know what its job is. For this month's Deming Lens, I was looking around for a subject, maybe something that I've talked about before, which after you've done a few podcast episodes, it's hard not to repeat yourself. But I came across an article from Industry Week and it was Dr. Deming's last interview with a gentleman from Industry Week. His name is Tim Stephens, and the article is titled Dr. Deming. Management today does not know what its job is. And it was a two part article. And I, as I started to read it, just brought back a lot of thinking and and it covered a lot of Dr. Deming's thoughts about quality, management, innovation and things of that sort. And it occurred to me that management still doesn't know what its job is. And in Dr. Deming's in this interview, the question was asked, what is management's job? And Dr. Deming responded, and I'm going to paraphrase a little bit. Here is Bob. They don't understand Mantid mean they management does not understand its responsibilities. They don't know the potential of the position. They lack knowledge or abilities, and there is no substitute for knowledge, which we've heard that phrase over and over again and. After you've studied the work of Dr. Deming for a long period of time, like I have when I went to his four day seminar in the 80s, you know, these things kind of resonate in your mind.   [00:02:39] And you reread them and read articles about them, people's comments about them. There is so much depth to even answering a question like what is what is management's job? And in a word, as Dr. Deming alludes to in this article, it's quality. And, you know, it's such a nebulous word. The word quality can mean a lot of different things to a lot of different people and even for organizations or customers. How do you define that? In this article, Dr. Deming basically said quality what we'll do a customer some good and that what was required was to study the customer, get ahead of him or her. The customer invents nothing we've heard thus, you know, over and over again, it's his famous line which is actually quoted in this article. No customer ever asked for an electric light, a VCR or a CD. And so these are some of the things that Dr. Deming would talk about in terms of quality.   [00:03:59] And I think as time has gone by and you look at quality, first of all, it's a word that's rarely used anymore. We talk about customer experience and we talk about innovation. And I think those are components of quality, but really understanding.   [00:04:17] To me, there's two areas. One is understanding customer expectations of what they're going to get and a product or service. And even their Dr. Deming would say, you know, you as the provider of a service or product, build the expectations of what the customer is going to get. Now. Over time, I've learned to be very critical of organizations because I've seen what they're what they're capable of and what they're performing, and there is a huge delta there between at least at my expectations and what they're delivering from a service standpoint. And there's the curse of W. Edwards Deming, I guess one might say. And so that's the first thing is this this whole thing about expectations, especially if you've experienced good service, then you experience bad service and you understand what the delta is between those two things. And then the second thing is the source of innovation or innovation in general. You start and talk in terms of coming up with new products and services and ideas, whether it's in an effort to reduce variation or to come up with actually new products and services. And actually, if yeah, I would say that you're going to increase your variation till you work on that particular product or service where you can deliver it on a high level to a customer. But but the source of innovation. Innovation is what really kind of caught my eye in this article, too.   [00:06:20] And what he says and I'm going to quote from the article when he was asked the question, what then is the source of innovation? And Dr. Deming responded, The source of innovation is freedom. All we have new knowledge. Invention comes from freedom. Somebody responsible only to himself has the heaviest responsibility. 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, new product, new design, new ideas. And this ability to be free is one of the things that I see kind of disappearing and some cases they never had. It is an ability to be free within your job, especially if you're a front line worker or an employee of an organization. And this is where I think management is really squelching employees, front line people who are interacting with customers on a daily basis as they're so centralized and almost choreographed to a point where micromanagement is, you know, the the flavor of the day. We seem to be going not not not just in organizations, but just as a whole, this kind of pendulum swing to centralization of things and control of things and working in these organizations. And interestingly, I was participating in a LinkedIn conversation that I commented on. And let me just go back to this particular conversation.   [00:08:28] This started with a LinkedIn news poll, their LinkedIn news, if you're familiar with or have different topics, and then they'll pull comments and things from from folks. But the question was the poll. Have you considered leaving your job or actually left a role to pursue a passion project in the last year? Twenty two percent said yes. And I'm not looking back. Forty four percent said yes, I've considered it. Thirty percent said no, not at all. And four percent said it depends. And now there were over fifteen thousand responses to this poll, what you'll get when LinkedIn is sponsoring a particular poll, but. I wrote in this as a response, I said there are serious problems with our organizations. Why is it people have to leave a company define YOLO jobs and YOLO jobs? Are you only live once types of jobs? Where why would I want to, you know, experience grief in an organization that I have when I only live once? I might as well quit my existing job. I went on to write This is something I've been working on with executives, executive teams for over a decade now. It isn't easy to create a system people want to work in, but it is worth it. One large factor contribute to the YOLO mentality is control micromanaged. Employees will either leave, undermine your mission or mail it in meaning disengage.   [00:10:17] You, engage employees with purpose, assist you with the customer innovation and greater good, leaving the details to employees to accomplish and control their work. Opportunities exist for those wanting to run their own show, and organizations need to compete against it or lose people. This requires new approaches and methods, and I think a lot of that response really comes from my study of Dr. Deming and what is management's job. And with all the centralization that we seem to have going on not only in government but also in our organizations, we're losing that freedom that that creates this need to create the atmosphere, to innovate. And so I wanted to just share I still think management doesn't know what its job is. I worked very hard coming up with methods to help define that. They're very imperfect. But that's been a huge focus of how do you get management to understand what their job is. And then when you look through the lens of the system of profound knowledge, you're going to see things. When you look at your organization as a system, when you understand variation and the power of of using control charts, when you and understand variation, the power of how to get knowledge and using scientific method and and then the psychology of it. And in fact, one of the things I wrote in my notes here as I was reading this was, you know, does your organization provide freedom? And it's so important you want to create stress in people.   [00:12:21] Neuroscience has found that, you know, if you don't control your own work, this this is something that is really going to drive people out of your organization. They have no freedom. They have no sense of freedom if it's just about training them. And you do step one step to follow the procedure type of atmosphere, that doesn't help her company because you've got to constantly be innovating today and today's world. And it's one of the advantage, at least here in the US we've had for a long period of time, is allowing that freedom and, you know, tapping into that to come up with not only new ways of doing things, but new products and services. So anyway, I thought I'd share that with you this month. Hopefully maybe you picked up something off of either the article, which I'll put a link to in the show notes or possibly my response in my linked in response to why people are leaving organizations. But share your thoughts. Either you can go to the LinkedIn article or reach me at tripp@deming.org. Hi, this is Tripp Babbitt, one way that you can help the Deming Institute and this podcast is by providing a reading on Apple podcast.  
  1. Deming Len's Episode #48 – Management (Still) Doesn't Know What Its Job Is
  2. Deming Len's Episode #47 – SoPK: The Interaction of the Parts
  3. Deming Lens #46 – The Art of Tampering
  4. Deming Lens #45 – Thank You, Ron Moen
  5. Deming Lens #44 – Deming Institute Podcast Audience Review

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.