Process Validation and the Problem of Induction:


From “The Simpsons”

Marge: I smell beer. Did you go to Moe’s?

Homer: Every time I have beer on my breath, you assume I’ve been drinking.[1]

In today’s post, I will be looking at process validation and the problem of induction.  I have looked at process validation through another philosophical angle by using the lesson of the Ship of Theseus [4] in an earlier post.

US FDA defines process validation [2] as;

“The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”

My emphases on FDA’s definition are the two words – “capability” and “consistency”. One of the misconceptions about process validation is that once the process is validated, then it achieves almost an immaculate status. One of the horror stories I have heard from my friends in the Medical Devices field is that the manufacturer stopped inspecting the product since the process was validated. The problem with validation is the problem of induction. Induction is a process in philosophy – a means to obtain knowledge by looking for patterns from observations and coming to a conclusion. For example, the swans that I have seen so far are white, thus I conclude that ALL swans are white. This is a famous example to show the problem of induction because black swans do exist. However, the data I collected showed that all of the swans in my sample were white. My process of collection and evaluation of the data appears capable and the output consistent.

The misconception that the manufacturer had in the example above was the assumption that the process is going to remain the same and thus the output also will remain the same. This is the assumption that the future and present are going to resemble the past. This type of thinking is termed the assumption of “uniformity of nature” in philosophy. This problem of induction was first thoroughly questioned and looked at by the great Scottish philosopher David Hume (1711-1776). He was an empiricist who believed that knowledge should be based on one’s sense based experience.

One way of looking at process validation is to view the validation as a means to develop a process where it is optimized such that it can withstand the variations of the inputs. Validation is strictly based on the inputs at the time of validation. The 6 inputs – man, machine, method, materials, inspection process and the environment, all can suffer variation as time goes on. These variations reveal the problem of induction – the results are not going to stay the same. There is no uniformity of nature. The uniformities observed in the past are not going to hold for the present and future as well.

In general, when we are doing induction, we should try to meet five conditions;

  1. Use a large sample size that is statistically valid
  2. Make observations under different and extreme circumstances
  3. Ensure that none of the observations/data points contradict
  4. Try to make predictions based on your model
  5. Look for ways and test your model to fail

The use of statistics is considered as a must for process validation. The use of a statistically valid sample size ensures that we make meaningful inferences from the data. The use of different and extreme circumstances is the gist of operational qualification or OQ. OQ is the second qualification phase of process validation. Above all, we should understand how the model works. This helps us to predict how the process works and thus any contradicting data point must be evaluated. This helps us to listen to the process when it is talking. We should keep looking for ways to see where it fails in order to understand the boundary conditions. Ultimately, the more you try to make your model to fail, the better and more refined it becomes.

The FDA’s guidance on process validation [2] and the GHTF (Global Harmonized Task Force) [3] guidance on process validation both try to address the problem of induction through “Continued Process Verification” and “Maintaining a State of Validation”. We should continue monitoring the process to ensure that it remains in a state of validation. Anytime any of the inputs are changed, or if the outputs show a trend of decline, we should evaluate the possibility of revalidation as a remedy for the problem of induction. This brings into mind the quote “Trust but verify”. It is said that Ronald Reagan got this quote from Suzanne Massie, a Russian writer. The original quote is “Doveryai, no proveryai”.

I will finish off with a story from the great Indian epic Mahabharata, which points to the lack of uniformity in nature.

Once a beggar asked for some help from Yudhishthir, the eldest of the Pandavas. Yudhishthir told him to come on the next day. The beggar went away. At the time of this conversation, Yudhishthir’s younger brother Bhima was present. He took one big drum and started walking towards the city, beating the drum furiously. Yudhishthir was surprised.

He asked the reason for this. Bhima told him:
“I want to declare that our revered Yudhishthir has won the battle against time (Kaala). You told that beggar to come the next day. How do you know that you will be there tomorrow? How do you know that beggar would still be alive tomorrow? Even if you both are alive, you might not be in a position to give anything. Or, the beggar might not even need anything tomorrow. How did you know that you both can even meet tomorrow? You are the first person in this world who has won the time. I want to tell the people of Indraprastha about this.”

Yudhishthir got the message behind this talk and called that beggar right away to give the necessary help.

Always keep on learning…

In case you missed it, my last post was If a Lion Could Talk:

[1] The Simpsons – Season 27; Episode 575; Every Man’s Dream




[5] Non-uniformity of Nature Clock drawing by Annie Jose

In-the-Customer’s-Shoes Quality:


I had a conversation recently with a Quality professional from another organization. The topic somehow drifted to the strict Quality standards in Japan. The person talked about how the product gets rejected by his Japanese counterparts for small blemishes, debris etc. The “defects” met the corporate standards, yet the product gets rejected at their Japanese warehouse. This conversation led me to write this post. My response was that the Japanese were looking at the product from the eyes of the customer. The small blemishes and debris impact the perception of quality, and can bring distaste as the product is being used.

In Japanese, the term for quality is Hinshitsu (hin = goods, and shitsu = quality). With the advent of TQM (Total Quality Movement), the idea of two “Qualities” was made more visible by Professor Noriaki Kano. He termed these;

  1. Miryokuteki Hinshitsu, or Attractive Quality
  2. Atarimae Hinshitsu, Must-Be Quality

These concepts were not exactly new, but Prof. Kano was able to put more focus on this. The “Attractive Quality” refers to something that fascinates or excites the customer and the “Must-Be Quality” refers to everything that is expected from the item by the customer. For example, a new phone in the market is expected to function out of the box. It should be able to make calls, connect to the internet, take pictures, play games etc. But if the phone came with the case or if the phone came with the name of the owner etched on the back, then that particular attribute is exciting for the customer. It was not something that he was expecting, and thus it brings “joy” to the customer. The interesting thing about the Attractive Quality is that today’s Attractive Quality becomes tomorrow’s Must-Be Quality. Would you purchase a phone today without the ability to browse the internet or take pictures? These features were added as Attractive Quality features in the past, and they have become Must-Be Quality features today.

The Japanese Quality guru Kaoru Ishikawa called these “Forward-looking qualities” and “Backward-looking qualities”. He called the special features like “easy to use”, “feels good to use” etc. as forward looking qualities. In contrast, “absence of defects” was called as backward looking. The father of Statistical Quality Control, Walter Shewhart called these as Objective and Subjective qualities.

Sometimes the Miryokuteki Hinshitsu also refers to the “Aesthetic Quality” of the product. Apple products are famous for this. There is a lot of attention paid by the Apple Designers for the Aesthetic Quality of their products. The IPhone should feel and look good. Even the package it comes in should say that it contains a “quality product”. In the Japanese culture, the concept of Aesthetics is rooted in “Shibui” and “Mononoaware”. Shibui can be defined as a quality associated with physical beauty “that has a tranquil effect on the viewer”. It brings to attention the naturalness, simplicity and subdued tone. Mononoaware on the other hand refers to the merging of one’s identity with that of an object. (Source: The Global Business by Ronnie Lessem, 1987).

The Total Quality Movement (Or Total Quality Control Movement as it is often referred to in the Japanese books) was taken quite seriously by the Japanese manufacturers. The following concepts were identified as essential;

  1. Customer orientation
  2. The “Quality first” approach
  3. Quality is everyone’s responsibility – from top management down
  4. Continual improvement of Quality
  5. Quality assurance is the responsibility of the producer, not of the purchaser or the inspection department
  6. Quality should be extended from the hardware (i.e., the product) to the software (i.e., services, work, personnel, departments, management, corporations, groups, society and the environment)

Source: Kaoru Ishikawa

Rather than relying on inspection, the Japanese manufacturers, including Toyota and Nissan, believed in building in quality throughout the entire process. The awareness of quality was seen as essential by the operator involved in making the product. It became a matter of owning the process and taking pride in what the operator did. Kenichi Yamamoto, the previous chairman of Mazda, is quoted to have said by BusinessWeek – “any manufacturer can produce according to statistics.”Yamamoto’s remark is about not focusing simply on quantities. Even when we are focusing on quality we should focus on both the objective and subjective quality. This reflects how our company culture views the ownership of quality.

Final Words:

I have always wondered why the windows in an airplane are not aligned with the airplane’s seats. It appears that the plane’s body is built based on a standard, and the seats are later added based on what the plane carriers want. There is not always a focus on what the customer wants, which explains why the seats are not aligned with the windows. I refer to the idea of the quality of a product as “in-the-customer’s-shoes quality”. If you were the customer, how would you like the product?

I will finish off with a story I heard from one of the episodes of the delightful TV show, “Japanology Plus”. This story perfectly and literally captures the concept of in-the-customer’s-shoes quality.

The episode was interviewing a “Japanophile” who was living in Japan for quite a long time. He talked about one incident that truly changed his view on Japan. He went to a small tea house in Japan. He was requested to remove his shoes before entering the room. After the tea, when he came out he was pleasantly surprised to see that his shoes were now moved to face away from the room. This way, he did not have to turn around and fumble to put his shoes on. He can simply put the shoes on his way out without turning around. He was taken aback by the thoughtfulness of the host.

Always keep on learning…

In case you missed it, my last post was “Four Approaches to Problem Solving”.

Four Approaches to Problem Solving:


As a Quality professional, I am always interested in learning about problem solving. In today’s post I will be looking at the four approaches to Problem Solving as taught by the late great Systems Thinker, Russell Ackoff. He called these “Problem Treatments” – the ways one deals with problems. They are;

  1. Absolution – This is a common reaction to a problem. This means to ignore a problem with the hope that it will solve by itself or it will go away of its own accord.
  2. Resolution – This means to do something that yields an outcome that is “good enough”, in other words, that “satisfices”. This involves a clinical approach to problems that relies heavily on past experience, trial and error, qualitative judgment, and so-called common sense.
  3. Solution – This means to do something that yields the best outcome that “optimizes”. This involves a research approach to problems, one that often relies on experimentation, quantitative analysis, and uncommon sense. This is the realm of effective counterintuitive solutions.
  4. Dissolution – This means to redesign either the entity that has the problem or its environment in such a way as to eliminate the problem and enable the entity involved to do better in the future that the best it can do today – in a word, to “idealize”.

I see it also as the progression of our reaction to a big problem. At first, we try to ignore it. Then we try to put band aids on it. Then we try to make the process better, and finally we change a portion of the process so that the problem cannot exist in the new process. Ackoff gave a story in his book, “The Democratic Corporation”, to further explain these ideas. Ackoff was called in by a consultant to help with a problem in a large city in Europe. The city used double-decker buses for public transportation that had a bus driver and a conductor in it. The driver got paid extra based on how efficiently he could keep up with the schedule, and the conductor got paid extra based on how efficiently he could collect fares and keeps track of receipts. The conductor was also in charge of letting the driver know when the bus was ready to move by signaling to them from the rear entrance to the bus. During peak hours, problems arose. To meet the high volume of passengers, conductors started to let passengers in without collecting fares with the thought that they could be collected between stops. The conductors could not always get back to the entrance to signal to the driver that they were ready to move. The drivers started to determine themselves when they could move by trying to see that no one was getting off or on to the bus. All this caused delays that were costly to the driver. This resulted in great hostility between the drivers and the conductors. The drivers were trying to do what was best for them, and the conductors were trying to do what was best for them.

The management at first tried to “absolve” by pretending that the problem would go away on its own. When things got worse, the management tried to “resolve” by proposing to retract the incentives. This was not met well by both the drivers and conductors, and the management was not willing to increase their wages to offset the incentives. Next the management tried to “solve” the problem by proposing that the driver and the conductor share the total sum of incentives. This also was not met well by the drivers and the conductors because of lack of trust and unwillingness to increase their interdependence.

Finally, Ackoff proposed a modification to the process. He proposed that during the peak hours the conductors should be taken off the bus and placed at the stops. This way he can collect the fares from the people already at the stop, and he can verify the receipts of the people getting off the bus. He also can easily signal the bus driver. The problem was “dissolved” by this modification to the process.

Final Words:

One of the best teachings from Ackoff for Management is that to manage a system effectively, you must focus on the interactions of the parts rather than their behaviors (actions) taken separately. The next time you are facing a problem, think and understand if you are trying to absolve, resolve, solve or dissolve the problem. I will finish with a great story from Osho about the butcher who never had to sharpen his knife.

There was a great butcher in Japan and he was said to be a Zen master. After hearing about him, the emperor came to see him at his work. The emperor asked only one thing, about the knife that he used to kill the animals. The knife looked so shiny, as if it had just been sharpened.

The emperor asked, “Do you sharpen your knife every day?”

He said, “No, this is the knife my father used, and his father used, and it has never been sharpened. But we know exactly the points where it has to cut the animal so there is a minimum of pain possible — through the joints where two bones meet. The knife has to go through the joint, and those two bones that meet there go on sharpening the knife. And that is the point where the animal is going to feel the minimum pain. I am aware of the interactions.”

“For three generations we have not sharpened the knife. A butcher sharpening a knife simply means he does not know his art.”

Always keep on learning…

In case you missed it, my last post was Respect for People in light of Systems Thinking.

The Pursuit of Quality – A Lesser Known Lesson from Ohno:


In today’s post, I will be looking at a lesser known lesson from Taiichi Ohno regarding the pursuit of Quality.

“The pursuit of quantity cultivates waste while the pursuit of quality yields value.”

Ohno was talking about using andons and the importance of resisting mass production thinking. Andon means “lantern” in Japanese, and is a form of visual control on the floor. Toyota requires and requests the operators to pull the andon cord to stop the line if a defect is found and to alert the lead about the issue. Ohno said the following about andons;

“Correcting defects is necessary to reach our goal of totally eliminating waste.”

Prior to the oil crisis, in the early 1970’s in Japan, all the other companies were buying high-volume machines to increase output. They reasoned that they could store the surplus in the warehouse and sell them when the time was right. Toyota, on the other hand, resisted this and built only what was needed. According to Ohno, the companies following mass-production thinking got a rude awakening in the wake of the oil crisis since they could not dispose off their high inventory. Meanwhile Toyota thrived and their profits increased. The other companies started taking notice of the Toyota Production System.

Ohno’s lesson of the pursuit of quality to yield value struck a chord with me. This concept is similar to Dr. Deming’s chain reaction model. Dr. Deming taught us that improvement of quality begets the natural and inevitable improvement of productivity. His entire model is shown below (from his book “Out of the Crisis”).

Deming Chain reaction

Dr. Deming taught the Japanese workers that the defects and faults that get into the hands of the customer lose the market and cost him his job. Dr. Deming taught the Japanese management that everyone should work towards a common aim – quality.

Steve Jobs Story:

I will finish with a story I heard from Tony Fadell who worked as a consultant for Apple and helped with the creation of the IPod. Tony said that Steve Jobs did not like the “Charge Before Use” sticker on all of the electronic gadgets that were available at that time. Jobs argued that the customer had paid money anticipating using the gadget immediately, and that the delay from charging takes away from the customer satisfaction. The normal burn-in period used to be 30 minutes for the IPod. The burn-in is part of the Quality/Reliability inspection where the electronic equipment runs certain cycles for a period of time with the intent of stressing the components to weed out any defective or “weak” parts. Jobs changed the burn-in time to two hours so that when the customer got the IPod, it was fully charged for him to use right away. This was a 300% increase in the inspection time and would have impacted the lead time. Traditional thinking would argue that this was not a good decision. However, this counterintuitive approach was welcomed by the customers and nowadays it is the norm that electronic devices come charged so that the end user can start using it immediately.

Always keep on learning…

In case you missed it, my last post was Challenge and Kaizen.

Eight Lessons from Programming – At the Gemba:

At the gemba - coding

In today’s post, I will be writing about the eight lessons I learned from Programming. I enjoy programming, and developing customer centric programs. I have not pursued a formal education in programming, although I did learn FORTRAN and BASIC as part of my Engineering curriculum. Whatever I have learned, I learned with an attitude of “let’s wing it and see”.

  • Be Very Dissatisfied with Repetitive Activities:

Our everyday life is riddled with repetition. This is the operative model of a business. Design a product, and then make them again and again. This repetitive way of doing things can be sometimes very inefficient. The programmer should have a keen eye to recognize the repetitive non-value adding activities that can be easily automated. If you have to generate a report every week, let’s automate it so that it is generated every week with minimal effort from you.

  • There is Always a Better Way of Doing Things:

Along the same lines as the first lesson, you must realize that there is always a better way of doing things. The best is not here yet, nor will it ever be. This is the spirit of kaizen. Even when a process has been automated, there is still big room left for improvement. The biggest room certainly is the room for improvement.

  • Never Forget Making Models:

When a Lean Practitioner is looking at a system, creating a model is the first step. This model could be a mental model, a mathematical model or even a small scale physical model. This model can even be a basic flowchart. This is part of the Plan phase of PDCA. How do the components work with each other? How does the system interact with the environment? What happens when step A is followed by Step B? A good programmer should understand the system first before proceeding with creating programs. A good programmer is also a good Systems Thinker.

  • Keep Memory in Mind:

A good programmer knows that using up a lot of memory and not freeing up memory can cause the program to hang and sometimes crash. Memory Management is an important lesson. This is very much akin to the concept of Muri in Lean. Overburdening the resources has an adverse impact on productivity and quality, and it is not a sustainable model in the long run.

  • Walk in Their Shoes:

A good programmer should look at the program from the end user’s viewpoint. Put yourself in their shoes, and see if your program is easy to use or not. Programmers are sometimes very focused on adding as many features as possible, when the end user is requiring only a few features. There is some similarity with the use of lean or six sigma tools at the Gemba. If it is not easy to use, the end users will try to find a way around it. This brings us to the next lesson.

  • Listen to the Gemba:

One of the lessons I learned early in my career is that I am not the owner of the program I write. The person using the program is the owner. If I do not listen to the end user then my program is not going to be used. I do not make the program for me; I make it for the end user. Less can be more and more can be less. The probability of a program being successful is inversely proportional to the distance of gemba from the source of program creation.

  • Documentation:

I wrote at the beginning that I learned programming from a “winging it” attitude. However, I soon learned the importance of documentation. A good programmer relies on good documentation. The documentation should explain the logic of the program, the flow of the program, how it will be tested and qualified, how the program changes will be documented and how the bugs will be tracked. The simplest tool for documentation can be a checklist. My favorite view on using checklists is – not using a checklist for a project is like shopping without a shopping list. You buy several things that are not needed, and do not buy the things that you actually need.

  • Keep a Bugs List – Learn from Mistakes:

Bugs to a programmer are like problems on a factory floor to a lean practitioner- it depends on how you view them. For a lean practitioner, problems are like gold mine. They are all opportunities to improve. In this same line of thinking, bugs are also a programmer’s friends. You learn the most from making mistakes. No program is 100% bug free. Each bug is unique and provides a great lesson. The goal is to learn from them so that you do not repeat them.

Another important lesson is – ensure that fixing a problem does not cause new problems. A programmer is prone to the law of unintended consequences. Any change to a program should be tested from a system standpoint.

Final Words:

I will finish off with my favorite anecdote about programming:

When Apple introduced the IPod, they were very proud of its “shuffle” feature. There is no accurate way of truly randomizing songs. However, there are several algorithms that can generate a pretty good random order. Apple utilized such an algorithm. It was so good that the users started complaining because sometimes the same song was repeated, or the same artist was played repeatedly. That is not how random should be – the end users argued. Steve Jobs then asked his programmers to change the algorithm so that it is less random.

The Digital Music Service company, Spotify faced the same problem. As they explained on their blog;

“If you just heard a song from a particular artist, that doesn’t mean that the next song will be more likely from a different artist in a perfectly random order. However, the old saying says that the user is always right, so we decided to look into ways of changing our shuffling algorithm so that the users are happier. We learned that they don’t like perfect randomness.”

The perception of random for the end user meant that the songs are equally spaced from one another based on how similar they are. The end user did not want randomness in a theoretical sense. They wanted random from a human practical sense.

Spotify changed their algorithm in 2014. “Last year, we updated it with a new algorithm that is intended to feel more random to a human.”

Always keep on learning…

In case you missed it, my last post was Be Like Coal At the Gemba.

Dharma, Karma and Quality:


In today’s post I will be looking at the statement – quality is everyone’s responsibility. This is an interesting preachy statement. There are two questions that can be answered by this statement;

  1. Who is responsible for quality?
  2. What is everyone responsible for?

The first question (who is) is a wrong question to ask because it leads to blaming and never results in an improvement of current state. The second question is just too broad to answer. Everyone is surely responsible for more than just quality.

Dharma and Karma:

The best way to explain responsibility is by looking at “dharma”. “Dharma” is an ancient Sanskrit term, and goes back to about 1500 BC. The word was first explained in the ancient Indian script Rig Veda. This was explained as a means to achieve a sense of order in the world. The term loosely can be translated as “responsibility”, or “something that needs to be done from a sense of duty”. The main purpose of dharma is to preserve or uphold the order in a system. For example, the dharma of a plant is to bloom.

This brings me to the next word – “karma”. “Karma” is more commonly used in the English language, and everybody has some understanding of this word. The term actually means “action” in Sanskrit. The action can be in the past, present or in the future. However, every one of your actions has a consequence. This attaches the “cause and effect” meaning to the word “karma”.  There are three types of karma identified in the Sanskrit texts;

  1. Karma = action
  2. Vikarma = wrong action
  3. Akarma = no action (doing nothing is a form of action, and sometimes this is the right thing to do)

If everybody performs karma according to their dharma, then the system is sustained successfully.

Top Management – 85% or 100% Responsible?

The answer to the question, “who is responsible for quality” is sometimes answered as “Top Management”. Dr. Deming taught that “85% of all quality problems are management problems”. He is also supposed to have stated “85% of TQC’s (Total Quality Control program) success depends on the president.” This can be depicted as the chart below.


I have viewed this as – patient zero is in the board room.

Taiichi Ohno’s, the father of Toyota Production System, view on this was as follows;

“In reality, TQC’s success depends on the president’s resolution to assume 100% responsibility. The president should imagine him or herself taken hostage by TQC and become devoted to human quality control.”

Dr. Deming has also said that – Quality is made in the board room. However, he goes on to clarify this. Quality is everyone’s responsibility, but top management has the most leverage of all to make a meaningful impact with their decisions.

In this light, the answer to the question – “what is your responsibility?” is “You are responsible for what you can control.”

Top management’s dharma is to lay down the framework for the entire organization to grow. This involves strong vision, big and drastic improvements (innovation) and growth. Middle Management’s dharma is to enforce and reinforce the framework through maintaining the status quo while encouraging small improvements (kaizen) and developing people. The operator’s dharma is to aid middle management to maintain status quo while looking for opportunities for improvements. The push for maintaining status quo is to provide a temporary structure for the process so that it can be studied for improvements. The main goal is destruction of the status quo so that a new standard can be achieved. If the karma aligns with the dharma, then the organization will sustain itself, grow and be successful.

Final Words:

I have recently rediscovered Dr. Deming’s definition of quality – Quality is the pride of workmanship. I will use Dr. Deming to succinctly summarize this post.

“In a well organized system all the components work together to support each other. In a system that is well led and managed, everybody wins. This is what I taught Japanese top management and engineers beginning in 1950.”

I will finish off with a Zen monk story;

A monk was driving his car when a dog from nowhere crossed the road. Although the monk tried stopping his car, he ran over the dog, killing it. The monk stopped his car and parked it. He looked around and saw a temple across from the road. He went to the temple and knocked at the door. Another monk opened the door.

The first monk bowed his head and said “I am so sorry.”

He pointed to where the accident happened and continued; “My karma ran over your dogma over dharma”. (My car ran over your dog over there.)

Always keep on learning…

In case you missed it, my last post was To Be or Not To Be.

To Be or Not To Be:


In today’s post, I will be looking at the process of decision making and the use of a modified Pugh Chart to quantitatively conduct decision making.

The general process for decision making looks like something below;

  1. What do I have to decide? What is it about?
  2. What are my choices?
  3. What are the pros and cons for each?
  4. Act upon the decision and see if any further action is needed.

Decision Making is an Emotional Process:

As you go deeper into the decision making process, you can see that it gets more and more interesting. The neuroscientist, Antonio Damasio made the striking discovery that decision making is emotional in nature, and is rarely logical. He studied several patients who suffered injuries to their brains which impaired their emotions. Their reasoning capabilities were not impacted. They all had difficulty making decisions. The patients were all cognitively normal except that they had lost their ability to experience emotions, and this significantly impacted their ability to make decisions.

So at the point of decision, emotions are very important for choosing. In fact even with what we believe are logical decisions, the very point of choice is arguably always based on emotion.   

Complexity in Decision Making:

As a leader in your organization, you are required to make decisions on a daily basis. The types of decisions can be broken down into three classes;

  1. Surface – Simple situations requiring routine decisions
  2. Shallow – Complicated situations requiring supervisorial or managerial level decisions
  3. Deep – Complex situations requiring Upper management level decision making

This approach is adopted from Bennet and Bennet. The surface decisions are made on a daily basis, and do not have a high risk associated with them. The shallow decisions are more infrequent and have a medium level of risk associated with them. Finally, deep decisions are rare and have high risk associated with them.


Jeff Bezos, founder of, talks about a similar approach. He argues that there is no one-size-fits-all approach for decision making. In his opinion, there are two levels of decisions to be made. “Type 1 decisions” are those decisions that have critical consequences and are irreversible or nearly irreversible. He calls them “one-way doors”. He advises making Type 1 decisions carefully, slowly and with great thought and deliberation. The other kind is the “Type 2 decisions”. These are simple and easily reversible decisions. These decisions should be made much faster and frequently. A wise man knows the difference between the two.

To Include or to Exclude:

When you think about it, decision making is a process of deciding whether to include or exclude something. I came across a great article on this involving the custom of arranged marriages in India. The decision making process in an arranged marriage uses the approach of inclusion or exclusion. The two types of thinking are;

  • Inclusion – After careful thought, out of the 100 applicants choose the few that you think are most suitable for your child.
  • Exclusion – After careful thought, out of the 100 applicants eliminate the applicants that you think are not suitable for your child.

The counterintuitive outcome is that if you utilize the inclusion approach, you will select much fewer candidates. If you use the exclusion approach, you will retain a higher number of candidates, even though you are using eliminating criteria. Additionally, when the exclusion approach is used, you are highly likely to choose an “average” candidate. On the other hand, when the inclusion approach is used, you are highly likely to choose a candidate who is very strong in certain categories.

Quantitative Pugh Matrix Method:

My favorite tool for decision making is a version of the Pugh Matrix method. The steps for the Pugh Matrix are as follows;

  1. Decide upon the categories that are most important for making the decision
  2. Assign a weighted scale for each category
  3. Choose a scale for each category. This can be 1 – 5, where 1 = worst and 5 = best
  4. Score each category for the different options
  5. Find the final weighted score for each option. The option with the highest weighted score wins.

As an example, let’s look at the highly complicated decision of where to go for dinner. The following categories maybe suitable for this example – food taste, service, pricing, dessert quality and drinks. The next step is to assign the weighted scale. The sum of all the weighted scales should add up to 1 (100%). I have shown this below.


The next step is to assign the scores (1 to 5) for each category for the different options (Restaurant A, Restaurant B, and Restaurant C). This is shown below.


The final step is to multiply each score with its associated weighted scale, and sum it all up. This is shown below.


This shows that Restaurant A is the best choice for me based on the initial categories I chose. This tool is applicable for all kinds of scenarios. I have attached the excel spreadsheet I used for the example here. Even in the Pugh matrix, some values carry an emotional component.

I will part with a teaching from the great Zen master Shunryu Suzuki.

In the beginner’s mind there are many possibilities, but in the expert’s there are few.”

Always keep on learning…

In case you missed it, my last post was Talking Trash.

Take Pride in Your Work – Ji Kotei Kanketsu:


As a Quality professional, I am always interested in how “Quality” is handled in the Toyota Production System. A “Quality model” that Toyota uses is “Ji Kotei Kanketsu” or JKK. “Ji” in Japanese means “self”, “kotei” means “process” and “kanketsu” means “completion”. Putting all the words together, JKK means “Completion of your own work”. JKK has also been translated as “taking pride in what you are doing”, “not passing defects along to the next process”, or “next process is your customer”. The idea that the next process is your customer was something that Kaoru Ishikawa, the Japanese Quality Master, talked about a lot as part of the Total Quality Control movement.

Customer First:

JKK was initiated by Toyota as a means to increase employee awareness about quality. Every process after your process depends on your level of quality. They are all your customers. The concept of JKK is present in all facets of Toyota. JKK starts with the Engineering group through the product design and specifications – the best possible design. This is followed by Purchasing – ensuring quality components from suppliers. This is then followed by Production – maintaining and controlling the standardized work. Finally, Sales and Marketing – early detection and resolution of any potential problems. The model below is taken from the Toyota website.


Toyota describes the EDER (Early Detection, Early Resolution) program as follows;

EDER is a communication system for quickly detecting quality issues, immediately resolving issues, and swiftly providing results of rectification and kaizen feedback to customers.

Toyota teaches JKK as part of kaizen, continuous improvement. By focusing on your process and looking at the weak points in the process, you are identifying areas for improvement. JKK is practiced by the following four steps;

  1. First, clarify target and objective of task
  2. Clarify detailed procedure of task
  3. Clarify Ryohin jyoken (quality points)
  4. Immediately contact your supervisor, if a problem and/or delay may occur (pull Andon) and repeat Kaizen.

The Big Picture:

There is a counterintuitive aspect to JKK. By focusing on your own operation, you are required to focus on the next process – to ensure that the next process is successful. Thus, JKK is instilling a big picture mindset – a system approach in the employees.

Final Words:

The concept of Jidoka, is embedded in JKK. The ability to stop the line to fix the problem is the basis of building in quality. JKK is ensuring Quality Assurance in everybody’s work. Quality is defined as meeting customer’s requirements. Thus, customer satisfaction is the outcome of quality. In this regard, every Quality professional can be viewed as a customer service personnel.

I will finish off with an anecdote from the late founder of Matsushita Electric Industries, Konosuke Matsushita.

Matsushita was having a conversation with a western executive, and the discussion led to customers and treating customers like kings.

“No, that is wrong”, Matsushita said. “The customer is a god. Because, a king is a human, and thus capable of making mistakes. But a god does not make mistakes!”

Source: The Shift to JIT, Ichiro Majima.

Always keep on learning…

In case you missed it, my last post was Giving Time for Kaizen to Work.

PDCA and the Roads to Rome:

Different roads to take, decision to make

In today’s post, I will be trying to look at the concept of equifinality in relationship to the scientific method PDCA. In Systems Theory, the concept of equifinality is defined as reaching the same end, no matter what the starting point was. This is applicable only in an open system. An open system is a system that interacts with its environment (external). This could be in the form of information, material or energy.

I wanted to look at the repeatability of the PDCA process. PDCA stands for the Plan-Do-Check-Act cycle, and is the framework for the scientific method. If three different people, with different ways of thinking, are facing the same problem, can all three reach the same end goal using the PDCA process? This would imply that equifinality is possible. This concept is shown below. Point A is the initial condition, and point B is the final desired condition. The three different colored lines depicts the three different thinking styles (the different thinking styles indicates the different starting points).


Iterative Nature of PDCA:

The most important point about PDCA is the iterative nature of the cycle. Each cycle of PDCA leads to a new cycle that is more refined. The practitioner learns from each step of the PDCA cycle. The practitioner observes the effect of each step on the problem. Every action is an opportunity to observe the system more. The results of his experiments lead to more experiments, and yield a better understanding of multiple cause-effect chains in the system.

If the scientific method is followed properly, it is highly likely that the three different practitioners can ultimately reach the same destination. The number of iterations would vary from person to person due to different thinking styles. However, the iterative nature of the scientific method ensures that the each step corrects itself based on the feedback. This type of steering mechanism based on feedback loops is the basis of the PDCA process. This idea of multiple ways or methods to have the same final performance result is equifinality. This is akin to the saying “all roads lead to Rome”. This idea of “steering” is a fundamental concept of Cybernetics. I will be writing about this fascinating field in the future.

Final Words:

This post was inspired by the following thought – can a lean purist and a six sigma purist reach the same final answer to a problem if they pursued the iterative nature of the scientific method? There has been a lot of discussion about which method is better. The solution, in my opinion, is in being open and learning from the feedback loops from the problem at hand.

I will finish this post with a neat mathematical card trick that explains the idea of equifinality further. This trick is based on a principle called Kruskal Count.

The Effect:

The spectator is asked to shuffle the deck of cards to his heart’s content. Once the spectator is convinced that the deck is thoroughly shuffled, the magician explains the rules. The Ace is counted as 1, and all the face cards (Jack, Queen and King) are counted as 5. The number cards have the same values as the number on the card.

The spectator is asked to think of any number from 1 to 10. He is then directed to hold the cards face down, and then deal cards face up in a pile. He should deal the amount of cards equal to the number he chose in his mind. The spectator takes a note of the value of the final card dealt. The spectator is directed to deal those many cards face up on the already dealt cards.

deck_discardThis is repeated until the spectator has reached a card at which point there are not enough cards to deal. For example, the card was 8 of Hearts, and there are only six cards remaining. This card is his selected card. He then puts the face up cards on the table on top of the cards he has on his hand. They do all of this while you have your back turned. You easily find their selected card.

The Secret:

All roads lead to Rome. This trick has an over 80% success rate.

The secret is to repeat exactly what the spectator did. You also choose a random number between 1 and 10, and start dealing as described above. Just like the concept of equifinality, no matter which number you chose as your starting position, as you go through the process, you will choose the same set of cards at the end resulting in the same selected card! Try it for yourself. Here is a link to a good paper on this.

Always keep on learning…

In case you missed it, my last post was If the Learner Has Not Learned, Point at the Moon.

Qualities of a Lean Leader:


In today’s post I will look at the qualities of a lean leader. I have been using the term “lean leader” in my posts. This is not an official title, and this does not mean “supervisor” or “manager”. A lean leader is someone who takes initiative in improving one’s process and in developing those around them.

I have wondered which qualities a lean leader needs. I believe that the best source for this is Michael J Gelb’s 1998 book, “How to Think Like Leonardo Da Vinci.”Michael researched Leonardo’s life and identified seven attributes to help one think like Leonardo Da Vinci. Michael listed them as Italian words to pay homage to the master. These are as follows;

  • Curiosità – An insatiable quest for knowledge and continuous improvement
  • Dimostrazione – Learning from experience
  • Sensazione – Sharpening the senses
  • Sfumato – Managing ambiguity and change
  • Arte/Scienza – Whole-brain thinking
  • Corporalità – Body-mind fitness
  • Connessione – Systems thinking

1) Curiosita:


Being curious is an essential attribute a lean leader should have. Being curious forces you to ask questions. Asking questions allows the other party to be involved. This leads to continuous improvement and discoveries. Michael defined this as “an insatiably curious approach to life and an unrelenting quest for continuous learning.”

2) Dimostrazione:

Soichiro Honda

This can be described as a willingness to fail in  order to learn from mistakes. Michael described this as “a commitment to test knowledge through experience, persistence, and a willingness to learn from mistakes.”The example I have here is of Soichiro Honda. Soichiro did not have any formal education, and he went on to build Honda Motor Co.

3) Sensazione:


Taiichi Ohno would be proud of this attribute. Michael described this as “the continual refinement of the senses, especially sight, as the means to enliven experience.” As the lean learners know, Ohno was famous for his “Ohno circle”. Ohno used to teach supervisors, managers and engineers alike to learn to observe the wastes by making them stand inside a hand drawn chalk circle. They had to stay inside there until they start seeing the wastes like Ohno did.

4) Sfumato:

less is more
Sfumato refers to the style of painting Leonardo used. Sfumato is the technique of allowing tones and colors to shade gradually into one another, producing softened outlines or hazy forms. Michael described this as “a willingness to embrace ambiguity, paradox and uncertainty.” Toyota Production System has many paradoxes and counter-intuitive principles. Most of this is because of the trial and error methods that Ohno utilized. All of the manufacturing norms were challenged and broken.

5) Arte/Scienza:


This attribute represents the synergy between art and science; logic and intuition. The classic TV show Star Trek played around this theme since the two main characters Spock and Kirk represented logic and intuition respectively. A lean leader needs both logic and intuition in order to develop oneself. Michael described this as “the development of balance between science and art, logic and imagination”.

6) Corporalità:


In the Book of Five Rings, Miyamoto Musashi talked about fluidity. “Really skilful people never get out of time, and are always deliberate, and never appear busy.”To me, this is the essence of Corporalita. Michael described this as “the cultivation of grace, ambidexterity, fitness and poise.” The quality of Corporalita is achieved only through constant practice as one strives towards their ideal state.

7) Connessione:


Dr. Deming and Eliyahu Glodratt would be proud to see this attribute on the list. This attribute is about “systems thinking”. Michael described this as “a recognition and appreciation for the interconnections of all things and phenomena.” A lean leader should be able to see everything from a big picture as well as a small picture view points. My favorite meme about Systems Thinking is the Never Miss A Leg Day meme. Local optimization of the just exercising the upper body leads to poor system optimization (muscular upper body and disproportionate skinny legs).

Leonardo, the Writer:

Leonardo da Vinci was also a writer. In his notebooks, he wrote numerous “jests” and fables. I will finish this post with a jest and a fable from the great mind of Leonardo Da Vinci:

A Jest:

It was asked of a painter why, since he made such beautiful figures, his children were so ugly; to which the painter replied that he made his pictures by day, and his children by night.

 The Tree & the Pole, A Fable:

 A tree which grew luxuriantly, lifting to heaven its plume of green leaves, objected to the presence of a straight, dry old pole beside it.

“Pole, you are too close to me. Can you not move further away?”

The pole pretended not to hear and made no reply.

Then the tree turned to the thorn hedge surrounding it.

“Hedge, can you not go somewhere else? You irritate me.”

The hedge pretended not to hear, and made no reply.

“Beautiful tree,” said a lizard, raising his wise little head to look up at the tree, “do you not see that the pole is holding you up straight? Do you not realize that the hedge is protecting you from bad company?

Always keep on learning…

In case you missed it, my last post was Dorothy’s Red Shoes and Toyota.