Quality Profession Needs to Stand for Quality in Public Practices

The Quality profession either stays true to its’ principles and ideals, or it is useless. We either support transparency and driving out fear or we don’t. Then we become the shallow, and dangerous crutch of demagogues and tyrants. One of the reasons Six Sigma has immense problems it still has not successfully grappled stems from how it is centered on the tyranny of Jack Welch.

The ASQ’s Government Division has taken a great step recently by endorsing the adoption of ISO/TS 54001:2019 “Quality management systems — Particular requirements for the application of ISO 9001:2015 for electoral organizations at all levels of government”.

We should be demanding elections built on the foundations of good quality. This should be part of electoral reform requirements at the Federal level. We need to oppose attempts to restrict voting. We need to drive fear out of our electoral system.

The United States is a signatory of international standards of policing. And yet no state follows those standards. Federal law needs to respect our treaty obligations and impose these standards, and we need to hold states and localities accountable.

As a quality professional I spend the day figuring out how to truthfully measure results. Yet an entire party has gleefully adopted lies and disinformation. I strive to democratize leadership, to build a culture of psychological safety. And yet all around us we see demagoguery.

Our workplace cultures are influenced greatly by external factors. We cannot hope to drive lies and fraud out of our systems, to create cultures of safety, to build excellence when all around us is a disregard for those standards. For this reason the quality profession must be political. It must standard for truth, for fair standards applied equitably. For driving out fear.

Site Training Needs

Institute training on the job.

Principle 6, W. Edwards Deming

(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.

US FDA 21CFR 210.25

All parts of the Pharmaceutical Quality system should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities.

EU EMA/INS/GMP/735037/201 2.1

The organization shall determine and provide the resources needed for the establishment,
implementation, maintenance and continual improvement of the quality management system. The organization shall consider:

a) the capabilities of, and constraints on, existing internal resources;
b) what needs to be obtained from external providers.

ISO 9001:2015 requirement 7.1.1

It is critical to have enough people with the appropriate level of training to execute their tasks.

It is fairly easy to define the individual training plan, stemming from the job description and the process training requirements. In the aggregate we get the ability to track overdue training, and a forward look at what training is coming due. Quite frankly, lagging indicators that show success at completing assigned training but give no insight to the central question – do we have enough qualified individuals to do the work?

To get this proactive, we start with the resource plan. What operations need to happen in a time frame and what are the resources needed. We then compare that to the training requirements for those operations.

We can then evaluate current training status and retention levels and determine how many instructors we will need to ensure adequate training.

We perform a gap assessment to determine what new training needs exist

We then take a forward look at what new improvements are planned and ensure appropriate training is forecasted.

Now we have a good picture of what an “adequate number” is. We can now set a leading KPI to ensure that training is truly proactive.

Teams Need Vision Too

Teams exist to execute to organization objectives. In order to meet these objectives, a team needs a vision of itself. There are eight major elements to a team’s vision:

  1. Consistency with organizational objectives: The team vision should be aligned with and derive from the organization’s overall purpose and strategy. Teams are sub-elements in a wider organization structure and their success will be judged on the extent to which they make valuable contributions to the overall purpose of the organization. In some circumstances a team may decide that it is important for its own values, purposes and orientations to act as a minority group which aims to bring about change in organization objectives – perhaps like a red team.
  2. Receiver needs: Teams focus on providing excellence in service to its customers, whether internal or external.
  3. Quality of work: A major emphasis within organizations is the quality of work. The relationship between quality and other functions like efficiency is important.
  4. Value to the wider organization: Understanding the importance of the team just not for the wider organization but beyond, leads to team cohesion and greater team effectiveness. Team members need a clear perception of the purposes of their work.
  5. Team-climate relationships: Team climate refers to aspects such as the warmth, humor, amount of conflict, mutual support, sharing, backbiting, emphasis on status, participation, information sharing, level of criticism of each other’s work and support for new ideas.
  6. Growth and well-being of team members: Growth, skill development and challenge are central elements of work life and teams can be a major source of support. Teams provide opportunities for skill sharing and support for new training. Teams need to be concerned for the well-being of its members, including things like burnout.
  7. Relationships with other teams and departments in the organization: Teams rarely operate in isolation. They interact with other team and departments within the organization. Teams must be committed to working effectively and supporting other teams. Avoid silo thinking.
Criteria for Team Vision

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 #49 – Supply Chain and Risk Management The W. Edwards Deming Institute® Podcast

In our 49th 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. Deming.org article on supply chain: https://deming.org/how-people-are-using-demings-management-ideas-to-respond-to-covid-19-conditions/ Show Notes [00:00:14] Deming Lens – Episode 49 – Supply Chain ad Risk Management [00:04:50] Deming is More Than Toyota [00:06:20] Forgotten Lessons and No Learning [00:08:04] Reducing Variation [00:13:20] The Deming Legacy     Transcript [00:00:14] In Episode 49 of The Deming Lens, I'll discuss supply chain and risk management through the system of profound knowledge. Hi, I'm Tripp Babbitt, host of the Deming Institute podcast, and in this Deming lens, I was looking for something around current events that are happening around the world.   [00:00:42] And I did come across John Hunter's article at Demnig titled How People Are Using Deming's Management Ideas to Respond to covid-19 Conditions. And obviously Supply-Chain issues have come to the forefront since this pandemic started, with manufacturers having to close and there's a shortage now. Pretty much everyone's aware in semiconductors. And John's article hits upon, you know, some of the things that are happening with the supply chain disruptions and can be looked at or targeted back to just in time types of manufacturing, which is where materials come in to a manufacturer just as they need need it so that they can produce whatever final product might be, raw materials. That could be some other product from a supplier. That's part of some broader thing, like a car. And so just in time, reduced a lot of the waste in inventory. And as John pointed out, that these problems or that just in time basically has components of making problems visible, reducing waste, reducing inventory costs and being able to adjust to market conditions. And especially if there's explosive amounts of change in the supply chain. The adjustments to the market conditions are kind of what's up in the air, at least in my mind.   [00:02:34] So the market conditions, obviously, or the conditions out there is you still have a demand for these products, yet you don't have all the resources available or suppliers are shut down. And therefore you have these supply chain disruptions, as I mentioned, with the semiconductors. So, John, link to a Reuters article on Toyota and business continuity. And basically it points out the article itself, the Fukushima disaster kind of got. Companies thinking a little bit about risk management in their organization and that Toyota in particular saw risk and started to have their suppliers store two to six months worth of semiconductors or the components for it. And there are a few things here that I'm going to make a comment on, which is to me, John mentions Lean quite a bit in the article. From my viewpoint, lean is an outcome of the application of Deming's thinking, and I posted on this many times in LinkedIn and other articles that I write, and Dr. Deming helped Japan get back on its feet by teaching them statistical quality control and some of the thinking associated with that developed in Japan during the 1950s, 60s and and on. And so for me, because lean is more of an outcome, it misses, I think, some things when you go back to Dr. Deming's original philosophy, and that is that his system of profound knowledge and before that, his 14 points, the system of profound knowledge made up of primarily systems thinking, theory of knowledge, knowledge of variation and psychology is kind of what he left us.   [00:04:50] Prior to his death in 1993, so to me, if you go back to kind of those basics, I do believe organizations would find new solutions other than trying to copy Toyota or do things associated with that. And I know I bump heads every once in a while with people from the lean community over that. So it is what it is. That's just my belief is that if you go back to Dr., a system of profound knowledge is that that's you could come up with something maybe better. So, you know, John makes a comment in here and I'll just read from the article. I'll post a link to it, which is Toyota learns from results and maintains that knowledge for decades often adapt organizations adapt in the short term and over time lapse into the same systemic recognizes that cause them problems. So a few years later, they fail in a way that would have been prevented if they just learned and kept the improvements from that hard learned lesson. Now, that's a statement packed with a lot of great information, because this is what I see in most organizations as there's no learning, there's reaction for the short term and maybe adjustments to inventories because, oh, that happened.   [00:06:20] But as time goes by, it's kind of like, well, you know, I it's there's no learning. Therefore, an incident may be like it, but not exactly the same thing creates a situation where organizations are not prepared because they forgot the lesson they learned before. And I think it's shocking to me how many organizations are not prepared for some of the risks that that may exist in their environment. And I think some of that needs to come from not leaving, but from, you know, the ability to look at your system, the broader systems that are out there, as Toyota did, and see that there's, you know, some risk associated with what's happening and that just in time may not be the best thing. Now, there's a lot of solutions for that. We talk about that in a minute. But before I do that, I do want to point out that point four of Dr. Deming's 14 points talks in terms of a single supplier. And the reason for this, I originally out of college, I worked for an industrial distributor. And, you know, we had 20 different vendors for, let's say, a drill drill bit. And, you know, there's a whole series things, things associated even with electronic inventory or things put into a computer system where you can easily have 20 vendors available there.   [00:08:04] But the problem is, is there were a lot of minimums for these companies. So let's say was a 50 dollar minimum. Well, a lot different than in the 1980s. And today it might be more you had a minimum to place and somebody place a 20 dollar order. You were unable to order that drill bit or set of drill bits until they met the minimum. And having those on record are problematic because it just sits there and the customer never gets there their item. But there's a whole series of things associated with a single supplier. But most of it has to do with reduction of variation. And, you know, now I'm seeing from conversations with some executives that, you know, oh, well, we're having these supply chain disruption. Therefore, the solution should be that I carry multiple suppliers. And I think as we get into some of the solutions associated with this, that we still need to keep in mind that we're trying to reduce the amount of variation that we're getting into our products and that vendors may not necessarily be the answer. I think there may be more things associated with solutions around geographic location of where things are. And, you know, we saw with PPE the difficulties in the United States at least getting things from China during that time period because they had a need. And so if you're manufacturing something in China and they have a need for the same PPE products that they're going to keep.   [00:09:49] Them and maybe not honor the requests that are coming from the United States or the increased demand associated with it. So all these things, I think, are going to get looked at and hopefully not. And then just a knee jerk reaction type of thing, because there are a lot of risks out there. You know, I read a few things down here. You know, we've had geographically, we've had a chip block, the Suez Canal. We've had, you know, the government imposing tariffs on Canadian lumber, therefore increasing, helping to increase the cost of lumber here, here, at least in the United States. And so all these things have unintended consequences. The political ramifications of doing things are going to affect other things that that people didn't anticipate. And, you know, as our government, as governments get more centralized in order to control things, the free market goes away. And then the more of these unintended consequences tend to show themselves up because nothing can be completely planned from that particular standpoint. So but there are other risks that that are our potential, there are the ones that come very regularly like hurricanes and tornadoes, where we've seen power grid disruptions, we're starting to see some in the United States and as well as other countries where these things are maybe more common.   [00:11:28] You know, civil unrest. We've had this pandemic. You've got war. You've got civil war, I mean, and varies by country. And I would say that even the most democratic or the republics that are out there do face additional types of risks these days. For me, it's associated with what our financial institutions have done with regards to inflation. And that's a whole nother conversation, too, in this particular podcast. But we also have the risk of things that maybe are less likely but have happened before. And like the geomagnetic type of storm, like happened in 1859 that burned out all of the telegraph wires. And today, if we had all of our wires burned out, it would be a whole different type of risk associated with with bringing things to a standstill. So I think it's you know, as I look forward to maybe some of the solutions that are out there, I do hear a lot of the same old solutions that are what I would probably classify as unwise, because most of the people that are making decisions are very analytical thinkers. They they think in terms of compartments and are not synthetic thinkers or systems thinkers enough in their environment to look more broadly at the risks associated with their company. Now, one thing that has happened is covid has exposed us, you know, as humanity, and there will be other challenges in the future.   [00:13:20] And I think we're going to have to go back to some of Dr. Deming's original thinking that he left us with his system of profound knowledge. And again, for those that aren't familiar with Dr. Deming system, profound knowledge, it's systems thinking, it's theory of knowledge. How do we learn? And these are some of the things that Dr. Deming implemented in Japan very early and not just a Toyota, you know, almost all the manufacturing that's out there and that we have to have knowledge of variation and knowledge of psychology and some of the things that, like neuroscience, that have gained knowledge about how our psychology works, is affected by how our brain works. So as we look forward to the future, I think it'd be better for folks to go back to Dr. Deming's original system, profound knowledge to look for what the new solutions are. It's not a road map, John points out. Dr. Deming's philosophy is not prescriptive. I have a tendency to believe that Leane is more prescriptive in nature and because of it being an outcome of some of Dr. Deming's original thinking, and that Dr. Deming was wise to leave us a philosophy as opposed to a connect the dots type of environment.
  1. Deming Len's Episode #49 – Supply Chain and Risk Management
  2. Deming Len's Episode #48 – Management (Still) Doesn't Know What Its Job Is
  3. Deming Len's Episode #47 – SoPK: The Interaction of the Parts
  4. Deming Lens #46 – The Art of Tampering
  5. Deming Lens #45 – Thank You, Ron Moen

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

Structured What-If Technique as a Risk Assessment Tool

The structured what-if technique, SWIFT, is a high-level and less formal risk identification technique that can be used independently, or as part of a staged approach to make bottom-up methods such as FMEA more efficient. SWIFT uses structured brainstorming in a facilitated workshop where a predetermined set of guidewords (timing, amount, etc.) are combined with prompts elicited from participants that often begin with phrases such as “what if?” or “how could?”.

At the heart of a SWIFT is a list of guidewords to enable a comprehensive review of risks or sources of risk. At the start of the workshop the context, scope and purpose of the SWIFT is discussed and criteria for success articulated. Using the guidewords and “what if?” prompts, the facilitator asks the participants to raise and discuss issues such as:

  • known risks
  • risk sources and drivers
  • previous experience, successes and incidents
  • known and existing controls
  • regulatory requirements and constraints

The list of guidewords is utilized by the facilitator to monitor the discussion and to suggest additional issues and scenarios for the team to discuss. The team considers whether controls are adequate and if not considers potential treatments. During this discussion, further “what if?” questions are posed.

Often the list of risks generated can be used to fuel a qualitative or semi-quantitative risk assessment method, such as an FMEA is.

A SWIFT Analysis allows participants to look at the system response to problems rather than just examining the consequences of component failure. As such, it can be used to identify opportunities for improvement of processes and systems and generally can be used to identify actions that lead to and enhance their probabilities of success.

What-If Analysis

What–If Analysis is a structured brainstorming method of determining what things can go wrong and judging the likelihood and consequences of those situations occurring.  The answers to these questions form the basis for making judgments regarding the acceptability of those risks and determining a recommended course of action for those risks judged to be unacceptable.  An experienced review team can effectively and productively discern major issues concerning a process or system.  Lead by an energetic and focused facilitator, each member of the review team participates in assessing what can go wrong based on their past experiences and knowledge of similar situations.

What If?AnswerLikelihoodSeverityRecommendations
What could go wrong?What would happen if it did?How likely?ConsequencesWhat will we do about them Again – prevent and monitor
What-If Analysis

Steps in a SWIFT Analysis

SWIFT Risk Assessment
  1. Prepare the guide words: The facilitator should select a set of guide words to be used in the SWIFT.
  2. Assemble the team: Select participants for the SWIFT workshop based on their knowledge of the system/process being assessed and the degree to which they represent the full range of stakeholder groups.
  3. Background: Describe the trigger for the SWIFT (e.g., a regulatory change, an adverse event, etc.).
  4. Articulate the purpose: Clearly explain the purpose to be served by the SWIFT (e.g., to improve effectiveness of the process).
  5. Define the requirements: Articulate the criteria for success
  6. Describe the system: Provide appropriate-level textual and graphical descriptions of the system or process to be risk assessed. A clear understanding is necessary and can be is established through interviews, gathering a multifunctional team and through the study of documents, plans and other records. Normally the
  7. Identify the risks/hazards: This is where the structured what-if technique is applied. Use the guide words/headings with each system, high-level subsystem, or process step in turn. Participants should use prompts starting with the phrases like “What if…” or “How could…” to elicit potential risks/hazards associated with the guide word. For instance, if the process is “Receipt of samples,” and the guide word is “time, timing or speed,” prompts might include: “What if the sample is delivered at a shift change” (wrong time) or “How could the sample be left waiting too long in ambient conditions?” (wrong timing).
  8. Assess the risks: With the use of either a generic approach or a supporting risk analysis technique, estimate the risk associated with the identified hazards. In light of existing controls, assess the likelihood that they could lead to harm and the severity of harm they might cause. Evaluate the acceptability of these risk levels, and identify any aspects of the system that may require more detailed risk identification and analysis.
  9. Propose actions: Propose risk control action plans to reduce the identified risks to an acceptable level.
  10. Review the process: Determine whether the SWIFT met its objectives, or whether a more detailed risk assessment is required for some parts of the system.
  11. Document: Produce an overview document to communicate the results of the SWIFT.
  12. Additional risk assessment: Conduct additional risk assessments using more detailed or quantitative techniques, if required. The SWIFT Analysis is really effective as a filtering mechanism to focus effort on the most valuable areas.

Guideword Examples

The facilitator and process owner can choose any guide words that seem appropriate. Guidewords usually stem around:

  • Wrong: Person or people
  • Wrong: Place, location, site, or environment
  • Wrong: Thing or things
  • Wrong: Idea, information, or understanding
  • Wrong: Time, timing, or speed
  • Wrong: Process
  • Wrong: Amount
  • Failure: Control or Detection
  • Failure: Equipment

If your organization has invested time to create root cause categories and sub-categories, the guidewords can easily start there.