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 Lens #51 – Pay for Performance The W. Edwards Deming Institute® Podcast

In our 51st 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. Show Notes [00:00:14] Deming Lens – Episode 51: Pay for Performance [00:02:19] A Journey with Pay for Performance [00:03:28] The New Harmony Project [00:04:33] The Result of Collectivism [00:06:35] Analytical vs Synthetic Thinking [00:10:19] Dr. Deming and Pay for Performance [00:12:22] Pay for Performance, Collectivism and Dr. Deming     Transcript [00:00:14] In the 51st episode of the Demning lens, we'll talk about. Pay for performance. Hi, I'm Tripp Babbitt, host of the Deming Institute podcast, and this is the fifty first episode of the Deming Lens. And as I was going back and searching through some of the old episodes I've done, I noticed I hadn't done one on pay for performance. And it kind of came to the forefront of my mind when I was going through some Tic Tacs. And there's a couple of people out there that are big advocates of pay for performance as ways to keep people in their organizations, which is becoming a problem now. You know, people aren't going back to work for variety reasons. The stimming check certainly plays a role in that, working from home, people being called back to work when they had got used to being at home. There's this thing that goes around on LinkedIn about you only live once and you might as well do something that that makes you happy. And organizations these days don't seem to be making people very happy. And so these are some of the topics that I think I want to talk about with regards to pay for performance. And I actually put a whole YouTube video together on my personal YouTube channel responding to Tessa White, who goes by the name Job Doc Tessa. And she used to get some pretty good advice. But one of the pieces of advice was if you're going to keep people that you got to pay for performance.   [00:02:19] So let's talk about that, because it's been an interesting journey with regards to pay for performance and at least in my own personal journey, doing public and private seminars where we would talk about pay for performance, which was something that Dr Deming obviously advocated against. And I'd often get a lot of pushback on this. You know, when you're talking about getting rid of incentives or paying for performance at almost every public or private seminar that I did, I get some pushback either allowed during the course of the seminar or privately afterwards that asking if Dr Deming was a socialist or a communist. And I've done other episodes on this particular subject, but I'm from Indiana and in Indiana. Back in the early 1980s.   [00:03:28] There was a project called and New Harmony, Indiana, that basically advocated for collectivism, which was put together as a utopian society by a gentleman, by the British industrialists, by the name of Robert Owen from 1825 to 1827. So let's have a look, maybe a little bit over a year. And then it was dissolved in 1827 because this whole concept of social education and equality did not work well for a lot of different reasons. But the idea of a utopian society in New Harmony, Indiana, was to eliminate crime and poverty and increase health, decrease misery and increase your intelligence and happiness. And this was what this community of equality was supposed to achieve in Indiana.   [00:04:33] And but what happened over time is that people discovered that the equality that this society was advocating, that there were certain rare and very hard working people, you know, putting together the agriculture that was needed for the society or building houses or whatever, is that the hard working realize that they were earning the same as the laziest of the people in the group and that caused conflict. And then people stopped working. So food wasn't being grown and houses weren't. Their houses and buildings were being built because there was kind of a pointing fingers and blame and things of that sort. So this whole utopian society based on collectivism was didn't work out. It collapsed very quickly and. You know, when you when I'm talking about pay for performance in public and private seminars. You know, the thing I'm communicating to people is that the individual cannot be separated from the system that you work in. And what I discovered over the years is there's there's something called Dunbar's number, which is 150. When an organization grows to about 150, you you become it becomes more and more bureaucratic. And the larger it grows, the more bureaucratic that it becomes. And managing that becomes very difficult. So the larger your system is, the harder it is to separate the performance of an individual from the system that that you're working in. Now, I've seen it get really bad, anywhere from 75 to 150 employees and working with some smaller organizations.   [00:06:35] And but it's borne the pay for performance. The mindset is borne from what I referenced is analytical versus synthetic thinking. And that is that, you know, we break down the pieces in analytic and analytical thinking and we break them down all the way to the individual and say, OK, here's your goals. If you just meet your goals and everybody meets their goals, the company's going to do well. And I think if you go back to the interview I did with Paula Marshall, you'll discover that you can't separate the individual from that system and that the system is greater than the sum of its parts. So the whole concept of synthetic thinking or systems thinking gives you a different view of how your organization works. And it's not something that you can just break apart all the way down to the individual and add it up. It's exponential. And managing the interconnections in a system is where you get your largest gains. So, you know, it's been interesting from my standpoint that we have gone from this concept of Dr. Deming's ideas around pay for performance, where people were, in essence, questioning whether he was a socialist or a communist or whatever. To today we seem to have this pendulum swinging, swinging where, you know, everybody should be getting the same pay. And I you know, the things that Dr. Deming worked on from my studies and my using his system of profound knowledge are getting clarity of purpose.   [00:08:29] You know, if you if you understand your system and you understand your connection to the customer, that raises your level as a worker, understanding kind of what you do as opposed to just being kind of this cog in the system that just does its thing. And there's no benefit to doing that, but that people are paid differently based on the skills that they get. And developing those skills becomes something that the organization would want to do for its own benefit, as well as the benefit of the individual. One other thing Dr. Deming advocated is innovation and that people are participating and coming up with ideas and more and more. I've seen this huge conflict in organizations between the executives micromanaging things. And, you know, you do your work and you do it in this way, as opposed to giving more responsibility that the worker has even greater knowledge because they're actually doing the work to make their own decisions about their own work. And that management's job is to remove the barriers that create problems for the workers. And they're facilitating things, moving, moving forward. And the best organizations that I've worked with either working towards that or they're getting the knowledge to work towards that. And this is what will keep people there. Never will there be this collectivism type of mentality on the one and one side of things where, you know, everybody gets the same pay.   [00:10:19] And on the other end, where there's this pay for performance, there's Dr. Deming is proposing something very different than those two concepts to be able to make the organization better and have individuals want to be a part of that and not go to things like wanting to be an entrepreneur. Fighting, though, the work from home, you know, going to a smaller company or just staying waiting till the clock runs out on their stimming checks, these are all things that are preventing us from moving forward. Now, one thing I am getting more and more concerned about is, you know, we need these large organizations to achieve big things. You know, an individual entrepreneur has to be very fortunate. You know, there's very few Jeff Bezos of the world that start from scratch and then grow a particular company into a behemoth like Amazon. And so we need these large organizations and we need them to run well because they can achieve big things, whether it's making cars or homes or whatever it is. These are very large systems and people get lost in the shuffle in the way that things are happening today. And so they're dissatisfied. We have a whole generation of people that are really caught up and trying to do something for the greater good. But I think it gets a little bit misguided. And I believe that some of the organizations that we have today with the mindset of micromanaging people and control and incentives and pay for performance are all things that are making their systems worse.   [00:12:22] And, you know. We don't need pay for performance and we don't need collectivism, but what we do need are good systems that people want to work in on a daily basis. And so that's that's the message I wanted to communicate this month in the Deming lens is this concept of pay for performance where you can separate an individual from the system, which you can't. And the larger the system is, the harder that becomes. If you're an entrepreneur, then, yeah, pay for performance. And that's that's exactly what you get when you're an entrepreneur, you know, a company of one. But as it grows, there needs to be a better an organization built on a clarity of purpose, their connection to the customer, and that the person, no matter where they are in your organization, can understand that what the customer is looking for. And I use what's called a customer lens to be able to achieve that and innovation, the ability to share ideas that they have about the work and the way that it should be done and the ownership of that by the worker as opposed to management and executives and people of that sort. So that was it for this week. I'll talk to you again next month for the latest videos, blogs, events and information from the Dummying Institute. Be sure to go to Deming dot org.
  1. Deming Lens #51 – Pay for Performance
  2. Deming Len's Episode #49 – Supply Chain and Risk Management
  3. Deming Len's Episode #48 – Management (Still) Doesn't Know What Its Job Is
  4. Deming Len's Episode #47 – SoPK: The Interaction of the Parts
  5. Deming Lens #46 – The Art of Tampering

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 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.