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‘”

The Taguchi Loss Function: Deming in Education with David P. Langford (Part 9) In Their Own Words

What is the Taguchi Loss Function and how does it apply to education? In this episode, Andrew and David talk about statistician Genichi Taguchi's idea that the further you move from a measurable quality target, the more quality is lost, even if the item still "meets specifications." David shows how you can apply this to education. (For more about the Tachugi Loss Function, visit Wikipedia or Christopher Chapman's Digestible Deming blog post.)   TRANSCRIPT Stotz: 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 continuing my discussion with David P. Langford, who has devoted his life to applying Dr. Deming's philosophy to education, and he offers us his practical advice for implementation. Today's topic is, Taguchi loss function. David, take it away. Langford: Thank you, Andrew. And I liked how your eyes got really big when you said Taguchi loss function. Oh my gosh, it sounds frightening, doesn't it? Stotz: It does. It's a little bit overwhelming, it's exciting. I'm interested to learn. Langford: And in education, it's probably less known than it is in business. Usually when I'm working with a group of business leaders and I mention that I can get pretty strong – two-thirds of the audience probably knows something about the Taguchi loss function. I was at a conference with a whole roomful of school superintendents and I asked them, Anybody know what the Taguchi loss function was? And not a single hand went up. So less well known, but just as applicable. So in one of the earlier podcasts, we were talking about the concept of optimization of the system. And I just wanna refresh our memories and the memory of our listeners that it's really based on Deming's System of Profound Knowledge as well. So the four parts that Deming had was, Appreciation for a System, Understanding Variation, and especially statistical variation, Psychology and Knowledge of Theory. And I always add neuroscience to that mix as part of profound knowledge, because it's really critical to understand, especially in education, how the brain actually processes information. Langford: So when we're talking about the optimization of a system, we're actually talking about all of those factors being optimized, especially in a classroom or a school. So you can't just sort of optimize one thing, for instance. So over the last 30 years, I've known principals that are just really, really good managers, excellent at running the building. They never do anything out of the ordinary, everything is always perfect. The trash cans are always where they're supposed to be. They're just really good managers. They're the kind of people that if you're gonna take a school trip and they have to organize something complex, that's the kind of people you want. But if you're gonna do something really super innovative, change the system in some way, do something that's never been done before, that's not the kind of person that you want. Stotz: Right, it's interesting that you just mentioned that optimizing so many different factors, that's part of the reason why people don't do it because it is complex. David, I just pulled up Wikipedia and I thought maybe it would be interesting if we see what Wikipedia says about what is the Taguchi loss function. Would you like me to read a little bit of that? Langford: Yeah, so, go ahead. Stotz: According to Wikipedia, the Taguchi loss function is graphical depiction of loss developed by the Japanese business statistician, Genuichi Taguchi to describe a phenomenon affecting the value of products produced by a company. Praised by Dr. W Edwards Deming. It made clear the concept, of the quality does not suddenly plummet when, for instance, a machinist exceeds a rigid blueprint tolerance. Instead, loss in value progressively increases as variation increases from the intended condition. This was considered a breakthrough in describing quality and help fuel the continuous improvement movement. Langford: So now that we've lost about 80% of our audience… Stotz: Oops, sorry about that. Langford: No, that's… It's actually correct, and Taguchi was actually a contemporary of Deming, and Deming always referred to Taguchi as having one of the best, the greatest breakthroughs in systems. I really wanna focus on in education and applying this kind of thinking to education and what would that mean? So I think we looked at a Taguchi loss function diagram and if you could pull that up on the screen? Stotz: Yeah, let me pull that up for the video viewers and I'll walk you through and we'll walk you through for the audio listeners. Langford: And then we'll put a link in the show notes for that. Stotz: Yep. Langford: If you wanna contact it later. So basically you have to start to think about… And then, in the diagram right in the very middle of the diagram, is the target or what Deming would talk about as a system that's perfectly optimized. And in that, there's not losses on either side. And basically, without getting in into too much statistics or math or anything like that, the further you move away from that optimum state, the greater the loss. So, I wanna talk… Stotz: And maybe for the listeners, I'll just describe it. We're looking at a parabola. So we have… On the Y axis, we have the level of loss. In other words, if it goes down on the Y axis, the loss is going down. And on the X axis we have the value of the characteristics, meaning we wanna hit some target and the parabola is going up if you go too far away. So loss is rising if you go too far to the right or loss is rising if you go too far to the left. So, in fact, that's kind of interesting. Both if you're off target either way, it's still gonna bring you loss. Langford: So let me give you a very practical education example. My good friend, Dr. Doug Stilwell in Iowa, when he was a school superintendent, his problem was that, parents were complaining when… The time that they would get called when there was a snow day or a school cancellation during the winter. And so these complaints just had gone on year after year, after year for 20 years. And so finally, when I taught him about the Taguchi loss function, he did a little study with parents to find out the optimum time to be called. And so sent out surveys and said, "What would be the optimum time?" And if I recall, it ended up the perfect time was like 6:20 in the morning. So the further, the earlier you did it as you move towards say 6 o'clock or even earlier, if you went all the way to 5:30, then the losses became huge. There's these tons and tons of people did not like that. And on the other side, if 6:20 was the optimum, the closer and closer that you move towards 7 o'clock, there's already people going to work and making other plans and not being informed, etcetera. Langford: And so the losses are mounting on that side as well. And so he ended up implementing a system that in explaining parents always even new parents coming into the system that, "You will receive a notification by 6:20 every morning whether or not there's gonna be a school closure." And guess what? Complaints virtually disappeared completely. So I think it's a really good example about you can optimize… Even sometimes people say, "Oh well, that's not a big deal, and I'll just put up with the complaints." But why would you wanna do that? Why would you wanna have parents calling board members and calling the school and complaining about this and that. And it goes back to really making people happy within the system, but you're not just making them happy just for happy's sake, you're making them happy because you're doing a really good job of managing with the input of the people in the system because they're the most knowledgeable about the systems. Langford: So, so many managers will make a decision like that, it could be based on what's best for the front office. It could be that the decision is what's best for me as a manager. I don't like to get up before 6 o'clock in the morning and check the weather and have that to be the first thing I do during the day. And so I'm gonna do it at this time, but have no systems knowledge. They haven't taken the time to actually solve the problem or understand even what the problem is. And that is where I think Taguchi loss function really comes in. Same kind of an example I wanna share would be like in a classroom, if you're talking about the speed at which you're moving through material that you're teaching kids as they're learning about stuff, well, you go too fast, the losses are gonna be students who can't keep up, don't understand, get frustrated and get mad, etcetera. That's on one side. Langford: And on the other side, you go too slow, you have all the students that really do grasp things quickly and wanna move forward. So understanding that optimum zone, and often times in neuroscience, scientists will sometimes call it the learning zone. That there's a zone or speed that you can go in, but there's another way to optimize learning within the classroom too. And that is, as a teacher to stop managing the pace yourself and let each student learn to manage their own pace. And so now each student is starting to optimize learning based on their pace. Well, the reason we don't do that is if I've got 30 kids in the class and I got 30 kids at different paces, that's a lot more work for me as the teacher, right. Rather than me setting the pace and forcing everybody to work within that. So I would have to learn to manage the system much differently if I'm gonna optimize learning for every child within a classroom or think about a whole school that's optimized like that. Lots of teachers trained and in how to manage like that. Stotz: Yeah, I was thinking about… I love some of the quotes from Thomas Sowell in America. And he's a wise man and he says, "There's no solutions, only trade-offs." And in a way, I feel like the Taguchi loss function is really kind of the Taguchi trade-off function with loss on both sides. Whereas a lot of times we think about, there's a specification and that's what we're aiming for. And that's what is really interesting about the Taguchi loss function is that it makes you aware that either way you go, you're gonna have a trade-off. Let's say you could speed up a production process in a factory, but it will impact other processes or that type of thing. So everything is a trade-off. Langford: Yeah, and it's exactly the same concept, the same thing in a classroom or a learning system as well so… Stotz: And one other question about that is, you mentioned about optimizing in this case for the parents. Now, you could see that some people… Some teachers in a school might say, "I don't really care about the parents. I wanna optimize for my convenience and I leave for school at 6:00 AM, and I wanna know at 6:00 AM if we're gonna be closed or not, so I don't have to go in." So how does that work? Like you've gotta decide. Also, you talked about optimizing, you could optimize for each individual student versus optimizing for the group of students as a whole. How does someone figure that out when they're in that system? Langford: Yeah, so that comes back to the constancy of purpose. And that was Deming's number one point out of his 14 points is, "Do you have a constancy of purpose?" And so like for a school, if the constancy of purpose is so that you always have a place to park your car and… You always get out of the building by 4 o'clock in the afternoon, and whether that's individually or written or unwritten within the whole school, you are implementing a constancy of purpose. But if your constancy of purpose is to continually create learning experiences for youth in its day, in order to add value to society, that's a much different purpose. And that means everybody has to be focused on creating those learning experiences and looking at students as if they were in a company. You'd say they would be the customers, but they're the clients or they are the people receiving the service. And the schools that really get it, understand that that's why they exist. They exist only for student learning and no other purpose, and so everything becomes optimized around that purpose. Stotz: Great. So, maybe I'll just summarize some of the things that I took away from that. I think the first thing is, I kind of see now Taguchi loss function as it's kind of a trade-off, and we can see that the objective is to identify what are you trying to optimize for, and then understanding that deviating away from that on either side will bring loss, and ultimately what you wanna try to do is find the optimum point where that line, that parabola is having the least loss in relation to what is your constancy of purpose. What is the purpose of what you're doing? Anything else you would add to that? Langford: No, that's exactly right. And I'm sure that there are parents that are listening and they say, "Well, you know, my child's gifted in school and they really like to move fast, and if you sort of optimize the pace, my child is gonna start to be bored." But then there's other ways to think about that, that if you finish everything very quickly, you have a lot of options now, right? You could help somebody else and is somebody gonna bully you if you've been helping them on a daily basis, understand a concept or work through something. You could go ahead at your own speed, you could go faster if you wanna go on, or maybe you're not as good in another subject, and you need to spend that time optimizing the performance in Math or English or something else that you're not as good in. And so I used to always teach students that your job is to optimize your own system, right? And my job is to operate the system… Optimize this system and the superintendent and so on and so forth, all the way up to the whole nation optimizing performance. Stotz: I wanna just tell a quick story before we wrap up, and that is, I was teaching a finance course and I knew that my students did not understand finance and they were kind of terrified, and so what I had was… I would teach a little bit and then I would give them a practice problem, then I would teach a little bit more and I'd give a little practice problem. And what I did… Here's what I did and tell me what you think of it. So what I did is I basically told the students, I said, "Stand up when you've calculated the answer." So what happened was, after I did the first couple of questions, but first of all, I like to keep students moving just because I feel like make it a little bit more exciting. So, the students would stand up and you could clearly see that there was a group that would stand up first. Stotz: So what I then did, is I said, okay, now after assessing this a couple of times, I was able to see that there was five students in the class that were just not getting up really fast. I said, "Okay, now five students come down." It was a big class, it was at a university, and I said, "Okay, you five students come down to the front of the classroom and line up." So they lined up in a line, and then I told the other students, come down and get behind one of these students until we have, let's say, six people in each line. And so the students all came down and they got in line with the one that they know or whatever. And then once they were done, I said, "That's your groups." So the next time that I got, I did the next problem, I had to move around each other, the next time I had the problem, I said, "Okay, solve this problem, whatever team, where every member of the team has finished and you gotta make sure everybody's finished, that team stands up first." And then I tried to use the power of the knowledge of the senior people, or not senior, but the ones that really got it quickly to help the others, and they were helping the others just like what you said. Langford: Yeah, so what you did is it's the System of Profound Knowledge again, but from a neuroscience standpoint, yes, you're right. Students of any age have to be up and moving, we need that spinal fluid moving up and down their spine and moving back and forth in order to get blood flow going to the brain and everything, so that part's really good. What I probably would have adjusted would, I would have said, "Okay, as soon as you understand this, I want you to stand up and find somebody still sitting down and go explain it to that person and go over it until they understand it, and then now there's two of you that are gonna stand up and you're gonna find somebody else still sitting down. And so you sort of exponentially start everybody in the room, and then the noise level goes up, and the fun level goes up, and then everybody is actually looking for somebody still sitting. And sometimes… Stotz: And would you do that every time, every time? Let's say you have 20 quiz… Twenty test questions that you're giving them throughout a three-hour time period, let's say. Would you do that each time where you would just say, "Go help whoever's sitting down," or would you eventually allow them to get into groups or not? Langford: They're gonna get faster and faster and faster. Again, it comes back to your constancy of purpose. Do you have a constancy of purpose or a meaning about why you want them to get into groups? Are they struggling with group, being able to be in a group and communicate in a group and those kinds… Okay, if that's my purpose that's much different.   Stotz: Which it's not, because one of the unique things about Thais, when I teach them in Thailand is that they're much more comfortable in groups compared to let's say Americans, so they don't need group work. But I also see that what you're telling me, that method will accelerate, the process won't take as long, I think it would accelerate pretty quickly. So alright, well, I would say I learned something from today's lesson and I'm gonna test it out because my purpose for that class, I had 50 people in the class, many of them were very scared of finance, and I said, "I'm gonna get all of you to the level of competence that I want, that's my goal." It is… That was my goal in that class, and so that's part of why I did it that way. Langford: When you're optimizing it, what you're saying is correct, you're optimizing, 'cause you want every single person to really enjoy… And I have a joy in learning for finance, right? Stotz: Yeah. Langford: So how am I gonna get there? What's the quickest way I'm gonna get there? How I'm gonna optimize that? Stotz: Fantastic. Well, David, on behalf of everyone at Deming Institute, I wanna thank you again for our discussion. And for listeners, remember to go to deming.org to continue your journey. Stotz: 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. The Taguchi Loss Function: Deming in Education with David P. Langford (Part 9)
  2. The Problem with Standardized Tests: Deming in Education with David P. Langford (Part 8)
  3. Optimization of a System: Deming in Education with David P. Langford (Part 7)
  4. Quality is the Answer: Deming in Education with David P. Langford (Part 6)
  5. Continuous vs Continual Improvement: Deming in Education with David P. Langford (Part 5)

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.