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‘”

Are You Learning or Just Staying Busy? In Their Own Words

If you've led an organization or a team for more than a few years, you've probably watched the same problems resurface again and again. Different initiatives. Different people. Same underlying issues.   In this episode, John Dues joins Andrew Stotz to dig into a puzzle Dr. Deming pointed to decades ago: "Experience without theory teaches nothing." John unpacks what Deming meant: experience doesn't come with its own explanation. It can answer a question, but only if you're asking one in the first place. Without a theory of why something works, all that hard-won experience just repeats itself. This episode is a great listen for anyone who has ever wondered why years of effort don't always add up to real improvement. TRANSCRIPT 0:00:02.2 Andrew Stotz: My name is Andrew Stotz, and I'll be your host as we dive deeper into the teachings of Dr. W. Edwards Deming. Today, I'm continuing my discussion with John Dues, who is part of the new generation of educators striving to apply Dr. Deming's principles to unleash student joy in learning. The topic for today is why experience isn't enough, and it leads to a pretty interesting puzzle. If experience is such a great teacher, shouldn't businesses and schools and school districts just keep getting better over time? John, take it away.   0:00:42.7 John Dues: Yeah, thanks for having me back, Andrew. Yeah, I think that's exactly the question that got me thinking about this. When I think about my own experience as a school leader and people I've worked with over the years, once you've been, let's say, a principal for 10 or 15 years or a teacher or superintendent, you're a school leader or a teacher leader, you've probably observed hundreds or maybe even thousands of lessons. You've dealt with all kinds of issues, discipline problems, staffing challenges, parent concerns. You've seen curriculum come and go, state assessments change, new initiatives, budget decisions, all kinds of unexpected problems. And yet, I think organizations, complex organizations like schools, you can spend years wrestling with essentially the same challenges year after year, even as the initiatives change and people sometimes change and terminology changes, but a lot of times the underlying problems can remain really, really consistent. And so I started thinking, if experience naturally produces learning, why doesn't all of this experience that gets accumulated reliably produce better organizations? And then I was thinking about something that I read from Deming, who more than 30 years ago said… Probably more than 40 years ago said now, "Experience without theory teaches nothing."   0:02:24.0 Andrew Stotz: This one… That statement always kind of got me when I first heard it. Sometimes I listen to that, "Experience without theory teaches nothing." and think to myself, I know what that means. And sometimes I listen and I think, I don't really know what that means. And so it is kind of a provocative statement because I'm thinking about, well, how did I learn? Did I learn in my past? Are we talking about individual learning or are we talking about learning within an organization? And also, isn't experience the best teacher? So what do you think Dr. Deming meant?   0:03:02.2 John Dues: Yeah, it's like a lot of things I think that he talked about, you sort of have to stop and think. And even after you've thought about it once or twice, you can come back to it and kind of question yourself, "Did I really understand that?" You might have to go talk to somebody. But when I first read it, truth be told, as I was learning this stuff, I thought he had to be exaggerating. I thought the same thing: how could experience teach us nothing? I mean, obviously, like you were saying, we learn things from experience. But I think my interpretation is that Deming's point is subtler than that. I don't think he's saying, or he wasn't saying, that experience has no value. I think what he was saying is that experience doesn't come with its own explanation. Something happens in our classroom or our school and we observe it, but what does that experience mean? What should we conclude from it? What should we do differently next time? I don't think that experience can answer those questions by itself. And in 'Out of the Crisis', Deming wrote, "Experience will answer a question, and a question comes from theory." And I think that's really the key. I think experience becomes useful when we're using it to answer a question about how we think the world works. Again, in our classroom, our school, our school district, that type of thing.   0:04:27.7 Andrew Stotz: Imagine that you're a kid walking down the street and a pit bull comes running at you and bites you on the arm. It's not too serious. The owner manages to get them off you. There's an experience. And it's experience tied with an emotion, which means it's memorable. You'll never forget that. What could you learn from that? Can you learn from that? Does what you learn from that apply to other dogs? It just, it opens up a Pandora's box that I like to think about in that particular case.   0:05:11.8 John Dues: Well, and I think in a case like that, you go through an experience like that, you're definitely gonna have a theory the next time you run into a dog, what you're gonna do, right? Especially if it looks like a…   0:05:23.4 Andrew Stotz: Yeah.   0:05:23.5 John Dues: Yeah. For sure.   0:05:24.4 Andrew Stotz: And this word theory, most of the time we don't really use that in our daily life, but we have words like theory, hypothesis, guess, hunch. So what exactly do you think he's talking about when he says theory?   0:05:45.9 John Dues: Yeah, I think that that can be, for if you're not in academia, I think that that can maybe be one of the biggest barriers to understanding this idea. I think, kind of like what you're saying, when people hear the word theory, you often are imagining something academic or something abstract. But if you think about it, we're using theories constantly, no matter what our work is. And when I'm saying theory, I'm just talking about an explanation for how and why something works. So, really every decision I'm making as a leader rests on some theory. I'm thinking about, if I'm a principal and I decide that something like weekly classroom observations will improve instruction, there's a theory behind that decision. I'm saying really, by putting weekly classroom observations into my practice, I'm saying if we increase the frequency of classroom observations and feedback, then teaching will improve. Right? That's my theory. If a superintendent who's leading his district and they have some issues with reading and they purchase a new reading curriculum, there's a theory, if teachers use this curriculum, student reading outcomes will improve. And this could apply to any number of things. The leadership team of a school district changes the schedule, they restructure what staffing looks like across their schools. You add an intervention period to your school building, the state changes the teacher evaluation system, or the state launches an attendance initiative in response to this chronic absenteeism problem we've been seeing. Every one of these decisions reflects a theory about cause and effect, basically.   0:07:46.5 Andrew Stotz: And there's two things about theory that I like to do when I'm teaching. I like to ask a question that we could prove what the answer is. And let's just say, how many companies in the world have a strong level of profitability and growth relative to peers sustained over a five-year period? That's a very specific question and I have very clear definitions of all of that. And out of… Then I ask the audience, my students, out of 8,500 companies in the sample that I have, how many companies do you think have sustained this outperformance over five years? And then they make guesses as to what they think the answer is, and then I walk them through, here's how I tried to prove it. Now, you could argue that my… You'd define something differently or you'd do the test differently over three years or seven years. One student said, "Why not 10 years?" All of that. But in the end, I say, "Okay, my answer to that question is 400."   0:08:59.9 John Dues: Interesting.   0:09:01.0 Andrew Stotz: And so then that leads me to another step in the process. And what I'm trying to teach my students in Valuation Masterclass Bootcamp is the idea of how do you think like an analyst? An analyst says they come up with a theory or an idea, like, "I think some stock, stock ABC, is gonna double in the next six months." Okay, that's a theory, and you're gonna put money down on that theory. You may try… You need to try to support it with evidence and all that, and then in six months, if you didn't write it down, you'll probably forget it or you'll misremember it.   0:09:37.7 John Dues: Yep.   0:09:38.3 Andrew Stotz: So the question isn't really whether leaders have theories. I think we all have theories, and we're acting on these theories. So where do we go from there?   0:09:49.9 John Dues: Yeah, I think what you just said is exactly right. The question is, I think, whether those theories are explicit enough to examine. So you talked about writing it down, that's a common misstep. We don't write our theories down. I think most of our theories are implicit. We don't say, "Here's my theory about how this system works. Here's my theory about how this classroom works. Here's my theory about why weekly classroom observation will work to improve instruction." We just sort of act, and then something happens. Sometimes the results improve, sometimes they get worse, sometimes nothing really changes. Probably a lot of the time it's that. And then typically what we do is tell ourselves a story about why that outcome happened, whichever one it is, right? And that's, I think, where experience becomes particularly dangerous, because two people can observe exactly the same event and draw completely different lessons from that.   0:10:52.2 Andrew Stotz: And my lesson is the correct one. So give me an example of when you've seen that?   0:11:01.9 John Dues: Yeah, I mean, I think, imagine a school that introduces a new instructional strategy and then test scores rise the following year. It'd be very easy for that principal to say, "The strategy worked. Now let's expand it." Another might say, "Well, wait a second. The tea… Or sorry, the students were simply a stronger cohort that particular year." Someone else might say, "Well, remember, we also changed how we staffed that particular school last year." Another might say, "Now, I just noticed that the state test that we were looking at actually was easier this year than in previous years." Everybody has access to that same, the same instructional change and then the same exact outcome, but they're interpreting that experience through different theories about what caused the results. So, in an example like that, experience doesn't settle the question. Theory determines what questions we ask of the experience.   0:12:16.1 Andrew Stotz: So once you start looking at organizations this way, you say you began seeing theory everywhere? So what do you mean by that?   0:12:25.5 John Dues: Yeah, I mean, I think once you start to think in this way or see in this way, you almost can't unsee it. It's like a lot of things with the Deming philosophy. For example, a strategic plan. We talked about that last time. A strategic plan, the whole plan in and of itself is a theory. It basically says, "We believe these priorities and these actions will move us toward this aim or outcome." A budget is a theory. In that case, we're saying, "We believe putting resources here rather than there will produce greater value." Our approach to professional development, it's a theory about how adults learn and how changes in adult knowledge will affect student outcomes. Another example would be teacher evaluation systems contain theories about motivation and improvement. Accountability systems contain theories about how performance changes. Hiring systems contain theories about what predicts effectiveness. The point here isn't that any particular theory is necessarily right or wrong. The important thing is that these theories already exist. They're guiding our behavior whether we've made them visible or not. And I think the main point here is that if the theory is invisible, then it's very, very difficult to improve it.   0:13:48.2 Andrew Stotz: And you connect this idea to your own experience with strategic planning, which we've talked about a lot at United Schools. So how did your theory change?   0:13:59.7 John Dues: Yeah, I think I kind of mentioned this in the last episode, but several years ago, my thinking about strategic planning really started to evolve and change quite a bit. We had written strategic plans a number of times before. We've often done it with an outside consultant. And we had done that about a decade ago, and it wasn't a bad plan. It had good priorities, useful ideas, and those types of things. But once it was kind of finalized, increasingly as we got away from the point where it was a new plan, it just kind of really quickly became disconnected from the way we actually manage the organization. But I think fundamentally the problem wasn't the plan itself. Our plan reflected our theory at the time about what strategic planning was supposed to do. And our basic theory was something like, you go through a planning process, you identify your priorities, you create the plan, and then you implement it. And basically over time, I've stopped believing that that's an effective approach basically.   0:15:10.1 Andrew Stotz: Yeah. I mean, one of the things that goes on in my head is the, what's the difference between strategy and planning? And now after doing a lot of work on strategy, strategy is some element that we think is something that could really… It's a pivotal point of what in our business we can change to be able to affect a significant outcome. The plan is kind of how we implement that. And that's where you see a lot of plans are very weak because they're just priorities and plans, but the clear vision of where you're going and the unique way that you're gonna break this down and implement it is something that I think a lot about. So you've talked about how your idea has changed over time. Tell me what's changed?   0:16:05.4 John Dues: I think what I eventually realized was that we didn't just need this document that we put a bunch of time and effort into. And it did describe where we wanted to go, but really what we needed to do was we needed the plan to make our thinking visible. We needed it connected to the way we actually manage the organization. And we needed it to be capable of changing as we learned. So that's a delicate balance there, right? And basically we were changing how we thought about what happened after the plan was implemented. We really needed a management system. It affected how we ran our leadership team meetings, it affected how we reviewed performance, it affected how we connected our long-term strategy to annual goals and smaller quarterly priorities and then down to the daily work. So the important learning wasn't that we finally figured out how to write a better strategic plan. It wasn't that. The deeper learning was we changed our theory about what strategic planning was for. And I think that's really the distinction that's most important here.   0:17:19.1 Andrew Stotz: So you're connecting planning with PDSA. So talk to me a little bit about that, because I think this may be the most important part of what you're talking about.   0:17:34.0 John Dues: Yeah, I think they're closely connected. So if organizations like a school system are gonna learn from experience, they need a disciplined way to do sort of three things. First, what we've already talked about, we got to make the theories explicit. The big theories or the main theories that are gonna guide our work, we got to write them down, make them explicit, let everybody in our organization know that they're there. And then second, we have to have a way to test those theories against reality. And then third, we have to revise the theories based on what they learn. And I think that's really where planning, something like the plan within the strategic plan and something like the Plan-Do-Study-Act cycle, really fit together. In either case, planning exists to make theory explicit. But when we create a plan, what we're really doing is putting our current thinking on the table. We're saying, "Here's our aim, here's what we believe matters, here's what we're gonna do, and here's what we expect will happen." And I think a good plan makes all of those assumptions visible to the entire team.   0:18:42.4 Andrew Stotz: So to the listeners out there, the viewers, ask yourself, "Am I making my theory explicit?" You know, that's one of the things I… We're in the process of testing a new strategic move for my coffee business. And we've pulled together a team of the best qualified people to start to test it. And we've definitely written out a lot, but now, just listening to you, I realize that I think we need to do more to make our theory very explicit so that we don't drift also into just doing the work, that we really are trying to make a strategic move that's gonna make an impact. So when we think about plan and making theories explicit, so tell me about how PDSA will test that?   0:19:38.8 John Dues: Yeah, I think that's how I'm kind of thinking about this. Your strategic plan has your priorities, your goals, and maybe even your quarterly actions. But then where your PDSA comes in, the PDSA cycle, it's basically there to then test and improve that theory. So you know PDSAs well, and probably a lot of the Deming community does as well. You make a prediction, we test a change, we observe what actually happens, and then we compare the prediction with the result. And the difference between those things is really where all the value lies, because that's where the learning occurs. So the goal of PDSA isn't merely to answer, did it work? That's often too simplistic. The better question is, what did this test teach us about our theory? Maybe the result matched the prediction, maybe it didn't, but either way, it generated new knowledge for us to then influence the next prediction, the next test, and eventually the plan itself.   0:20:40.7 Andrew Stotz: So what you're saying is that planning and PDSA are really parts of the same system. And what I'm thinking about myself is that I'm working with my accounting team on PDSAs. And you can say it's a very small and narrow part of our business that they're working on because they don't have the influence across the whole business. And they say that to me, and I understand that. So we focus in on what they can change and what testing out what that would mean. And then… But at the corporate level, at the senior level, it is this strategic planning. So maybe you can explain a little bit more.   0:21:17.6 John Dues: Yeah, the way I have started to think about it is that planning, strategic planning, and PDSA are really parts of the same system. So planning makes our current theory explicit, and then PDSA is what we do to improve that theory over time. So sort of put together, they form the learning system within an organization. So again, the plan sort of represents our best current understanding of how we're gonna achieve our aim. And then we actually meet reality. We start to act. We make predictions, we test the changes, we study what happens, we revise our understanding, and eventually that revised understanding gets reflected back in the plan. So you get into this sort of continual cycle, aim, current theory, action, PDSA, learning, revised theory, updated plan, and then that cycle just sort of continues on and on forever, right? And that's a very different conception of leadership from simply creating plans and implementing. Leadership becomes the work of continually improving the organization's understanding of how its system works, basically.   0:22:33.7 Andrew Stotz: Yeah, so I wanna repeat two things that you said. Planning makes our current theory explicit and PDSA improves that theory. That, those are the keys. And one of the things to think about is organizations accumulate activity, I believe is what you're saying, much faster than they accumulate knowledge. And that could be your explanation why they're not improving or improving at the pace that they could be.   0:23:04.2 John Dues: Yeah, I think this is probably true in the vast, vast majority of organizations. This idea of organizations accumulating activity much faster than they accumulate knowledge. And just think about the organization that you've been a part of or observed in. Think about everything that's going on day-to-day, the meetings, the initiatives, the training and professional development, assessments, planning sessions, data reviews, consultants, new programs, new technology, new policies. There is no shortage of activity. I know that's for sure true. This would resonate with 100% of educators, I am sure of that. But the thing is that activity and learning are definitely not… They're not the same thing, so… And that brings us sort of the point back to the intro. You can run the same process year after year without getting any better at it. You can hold hundreds of data meetings without improving your theory about what produces better outcomes. You can implement initiative after initiative, and this is what school systems do without learning very much about the underlying system. So I think the question for leaders isn't just "What did we do?", it's "What did we learn that changes what we believe about how the system works?" And if you can't answer that question, I think what you've done is accumulated experience without accumulating much knowledge. And again, I think this is probably the sort of typical way most school systems operate.   0:24:35.7 Andrew Stotz: Congratulations. You've run the same process year after year without substantially improving it in any way. So how does this change the way you think about what's the leader's job? Because everybody's doing all these things.   [overlapping conversation]   0:24:51.2 John Dues: Exactly. And I'm… Over time… Yeah, I mean, at different times, I've been just as guilty of this as the next leader. But it does completely sort of change how I think about the leader's job. Earlier in my career, I thought what leadership was was largely about knowing exactly what to do. You gain experience, you develop expertise, you get better at recognizing patterns, and then eventually you're in the leadership chair and you're the person who has all the answers. And I think a lot differently now. I think experience matters. Expertise matters, clearly. But I think the leader's job isn't simply to accumulate answers. The leader's responsibility is to build an organization capable of learning. And that, again, goes back to making those theories explicit. I think a big part of this is making predictions a part of how you operate every day. Testing and experimenting should be how you operate every day, studying the variation in your system, making it safe to discover that our assumptions were wrong, and then we sort of model revising our thinking. So the goal isn't to prove that leadership was right, which is sometimes what's happening in places. The goal is to continually improve the theory that's guiding the organization.   0:26:19.8 Andrew Stotz: That's quite a challenge. If someone listening remembers just one thing from this conversation, what would you say?   0:26:28.1 John Dues: Yeah, I mean, I think one, turning back to that original quote from Deming, "Experience without theory teaches nothing." And I'm sure people that have studied Deming will recognize that's the first part of a longer sort of section that goes on about this particular idea. But again, most organizations already have an enormous amount of experience. What they often lack is that disciplined system for turning that experience into knowledge. I think every important leadership decision rests on some theory about how the system works. So you have theories. You just do. That's just a fact. The question is whether you can make those theories visible enough to test them. And that's why I've come to believe that organizations don't improve simply by accumulating experience. They improve when they systematically improve the theories that guide their actions. And I think planning can help make the theories explicit and then PDSA can help us test and improve them. And so together, I think that that's the way organizations will then be able to continually learn towards… Learn their way towards their ultimate aim, their purpose.   0:27:42.8 Andrew Stotz: Yep, that's a great wrap-up. And I think if I had to say one thing, I've taken a lot of notes here and I would say what I like is that planning makes our current theory explicit and PDSA improves that theory. And that just, that loop to me is a big takeaway. So I appreciate that.   0:28:10.3 John Dues: Yeah, it was a great discussion.   0:28:12.3 Andrew Stotz: Yeah. So on behalf of everyone, of course, at The Deming Institute, I wanna thank you again for the discussion. And for listeners, remember to go to deming.org and jump into DemingNEXT to continue your journey. You can find John's book, 'Win-Win: W. Edwards Deming, the System of Profound Knowledge, and the Science of Improving Schools' on amazon.com. This is your host, Andrew Stotz, and I'll leave you with one of my favorite quotes from Dr. Deming, and that is, "People are entitled to joy in work."
  1. Are You Learning or Just Staying Busy?
  2. A New Lens with Balaji Reddie (Part 7)
  3. From Teacher to The Deming Institute Leader: Jake Rodgers' Story
  4. Why Strategic Plans Fail (And What Actually Works Instead)
  5. A New Lens with Balaji Reddie (Part 6)

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.

Whataboutism

Whataboutism is the common term for a version of the tu quoque fallacy, a diversionary tactic to shift the focus off of an issue and avoid having to directly address it by twisting criticism back onto the critic and in doing so revealing the original critic’s hypocrisy.

Whataboutism often results in a comparison of issues as pure deflection. We see it when individuals are always focused on why others get ahead and they don’t, looking for comparisons and reasons they are being treated unfairly instead of focusing on their own opportunities for improvement. It is so easy to use when we are faced with criticism, “Well, what about … ?”

We also see whataboutism in our cultures. Maybe it is a tendency to excuse your own team’s shortcomings because obviously the sins of another team is so much worse. This is a result of, and strengthens, silo-thinking.

Building the feedback process to reduce and eventually eliminate whataboutism is critical.