This definition closely parallels Dr. Shewhart’s opening statement for his (1939) book Statistical Method from the Viewpoint of Quality Control:
“Broadly speaking there are three steps in a quality control process: the specification of what is wanted, the production of things to satisfy the specification, and the inspection of the things produced to see if they satisfy the specification.”



This idea of an operational definition, which Shewhart and Deming popularized from the work of the philosopher C. I. Lewis, provided the seed for what grew into the Shewhart or PDSA Cycle.

Plan-Do-Study-Act Cycle does form a powerful framework for any improvement effort, it has often been reduced to a checklist to be followed mechanically. This has led to a proliferation of “expanded” PDSA cycles where each of the steps on the checklist are specified in ever increasing detail.
But before we go down this path, I would like to back up and generalize a bit.

In Dr. Deming’s own conversations, when individuals would start telling him about what they or their organization were planning to do, he would invariably have one of two responses for them:
“By what method?” or “How will you know?”
Either one of these questions would generally end the conversation since the individual would have no answer. After discerning this pattern to Dr. Deming’s responses, it finally occurred to me that these two questions corresponded to the last two parts of an operational definition. This realization, in turn, resulted in a generalization of an operational definition to become:

1. What do you want to accomplish?
2. By what method will you accomplish it?
3. How will you know when you have accomplished it?

Whatever you may be doing, until you can answer all three of these questions, you do not have an operational definition but merely a basis for an argument. Shewhart understood this, and in his work he used the concept of an operational definition in the development of the “operation of statistical control.”

Orginal and full text is on SPC Press online

Statistical Process Control has been around for over 70 years.
However, there is today considerable confusion about the nature and purpose of SPC. I believe this is because many have sought to reshape SPC according to their own background and experience. Some hear the words Statistical Process Control and immediately think of classical statistical procedures.
They try to fit SPC into this framework of parameters, distributional assumptions, tests of hypotheses, and confidence levels. Of course, when this group tries to share their version of SPC they are met with that same total lack of comprehension which is the fate of classical statistics. But statisticians are accustomed to rejection, so this is nothing new.



Others hear the words Statistical Process Control and think of process control techniques. SPC is thought of as a manual process-control technique to be used to maintain the status quo for a process. It is merely a process monitoring technique, to be used after you have already gotten the process into a satisfactory state. “And, since this is what SPC is about, wouldn’t you like to know about some of the neat algorithmic process-control techniques and process modeling techniques that have been developed in the past few years?” This group would be glad to give you a course or sell you some software. But once again, there is a hurdle of truly mathematical proportions to be overcome. The faint of heart need not apply. Those without calculus should not enter in to this door.



A third group uses the word “control” to denote conformance to specifications, and so when they hear the words Statistical Process Control they think about trying to produce product within specifications. Given this perspective, they think of SPC as a complex route to a simple objective, and accordingly they try to simplify SPC. This group tends to want to bypass the computations based on the data and instead use the specifications to set action limits. While this simplicity sells well, it has the unfortunate characteristic of completely misrepresenting what SPC is all about. Those who use these simplified approaches may meet with some limited success, but because their objective falls short of what can be done, because they do not seek to get the most out of their processes, they do not reap the benefits available from SPC. The reality falls short of the promise, and the users return to sorting as a way of life—make enough stuff and some of it is likely to be good.

read full text on SPC Press Reading Room

As part of the Toyota Production System, a kamishibai board is used as a visual control for performing audits within a manufacturing process. A series of cards are placed on a board and selected at random or according to schedule by supervisors and managers of the area. This insures safety and cleanliness of the workplace is maintained and that quality checks are being performed.(From Wikipedia, the free encyclopedia)

Kamishibai System Strengthens ISO 14001 and Heightens Environmental Awareness at TMMWV (Toyota Motor Manufacturing, West Virginia, Inc.)

Although ISO 14001 certification was a milestone to be celebrated, the challenge to maintain this high level of intensity requires constant monitoring and kaizen of the Environmental Management System (EMS).



In order to integrate EMS to standard work practices, TMMWV created environmental kamishibai consistent with the Toyota Production System. The establishment of the kamishibai system began with a list of all the tasks that could be audited.
Included in these were questions and answers; document control; proper paperwork; record retention; objectives and targets; and area inspections.

These tasks were then broken down into groups and assigned to numbered cards. ISO Area representatives took on the responsibility of performing weekly assessments to ensure these items are kept up to standards. While many of the cards are completed each month, this system ensures that even those low frequency items, completed on a quarterly basis, are not missed out. With the kamishibai system of assessments, TMMWV’s momentum is never lost. TMMWV’s environmental actions are steadily being promoted.

Toyota

Toyota Motor Corporation’s vehicle production system is a way of “making things” that is sometimes referred to as a “lean manufacturing system” or a “Just-in-Time (JIT) system,” and has come to be well known and studied worldwide.
This production control system has been established based on many years of continuous improvements, with the objective of “making the vehicles ordered by customers in the quickest and most efficient way, in order to deliver the vehicles as quickly as possible.”
The Toyota Production System (TPS) was established based on two concepts: The first is called “jidoka“(which can be loosely translated as “automation with a human touch“) which means that when a problem occurs, the equipment stops immediately, preventing defective products from being produced; The second is the concept of “Just-in-Time,” in which each process produces only what is needed by the next process in a continuous flow.



Based on the basic philosophies of jidoka and Just-in-Time, the TPS can efficiently and quickly produce vehicles of sound quality, one at a time, that fully satisfy customer requirements.
Just-in-Time

“Just-in-Time” means making only “what is needed, when it is needed, and in the amount needed.” To efficiently produce a large number of products such as automobiles, which are comprised of some 30,000 parts, it is necessary to create a detailed production plan that includes parts procurement, for example.
Supplying “what is needed, when it is needed, and in the amount needed” according to this production plan can eliminate waste, inconsistencies, and unreasonable requirements, resulting in improved productivity.



Kanban System

In the TPS, a unique production control method called the “kanban system” plays an important role. The kanban system has also been called the “Supermarket method” because the idea behind it was borrowed from supermarkets. Supermarkets and mass merchandizing stores use product control cards on which product-related information, such as product name, product code, and storage location, is entered. Because Toyota employed kanban signs in place of the cards for use in production processes, the method came to be called the “kanban system.” At Toyota, when a process goes to the preceding process to retrieve parts, it uses a kanban to communicate what parts have been used.

Visit toyota.co.jp for more about Toyota production system

resilience

institutions, and revised hospital accreditation guidelines have sharpened the clinical and administrative hospital
staffs’ concern for evaluating the quality of care they provide. Evaluation is particularly important for detecting and rectifying, as early as possible, any adverse effects caused by recent cost-containment efforts.Physicians have traditionally enjoyed a great deal of autonomy in their practices,’ and the mechanisms for monitoring and assuring the quality of the care they provide in hospital have tended to be based on internal peer review.23 Time, however, has torn away much of the curtain of professional mystique. The growth of the consumer movement, governmental concerns about spi-ralling health care costs, public policy debates over health care priorities, financial restraints on health care

4Physicians and administrators now must face the challenge of establishing comprehensive and vigorous
systems of quality assurance and learn to avoid the traps that impede implementation of such systems. Much of
the insecurity and frustration that they feel can be avoided by remembering that quality assurance is a very
simple process that deals with finding problems and fixing them.

5 Implementation of a quality assurance program does not imply that some unknown authority is about to challenge physicians or administrators on how they practise their professions, and the program should not be regarded as yet another bureaucratic measure that diverts time and energy from the important business of caring for patients; quality assurance is simply the systematization, documentation and assessment of certain evaluative activities and should be seen as a
stimulus that makes these activities as rigorous and pertinent as possible. Indeed, it may be argued that a hospital’s attention to quality assurance is one indicator of the overall quality of care provided by the hospital.

making it work
Thus, a comprehensive definition of quality health care would be as follows:
6 The optimal achievable result for each patient, the avoidance of physician-induced (iatrogenic) complications, and attention to patient and family needs in a manner that is both cost effective and reasonably documented.
The success of any quality assurance program depends almost entirely on the commitment and interest of the administrators, nurses, paramedical staff and physicians. A lack of commitment is far more injurious to the program than any technical flaws in the evaluative process. Coordinators of quality assurance programs must select a strategy that inspires interest and commitment without burdening clinical and administrative staff with an activity they neither understand nor believe in.
As Affeldt and associates7 have stated: “Just as a good manager monitors the status of the budget or staffing
levels routinely to assure a cost-effective department, the quality of the care in each department and in the
hospital [as a whole] should be monitored routinely with equivalent rigour.”

Recognition and consideration of five basic issues can do much to improve hospital-based quality assurance activities.

1. The temptation to try to buy an easy way out Hospital leaders – administrators and heads of clinical divisions or departments – must invest time and effort to learn the principles and practice of quality assurance. The installation of “canned” quality assurance packages is no substitute for leaders’ becoming intimately involved in the development of quality assurance ideas and activities.
2. The needfor a “utilization-focused” approach Acquiring information is no problem, but acquiring information that will actually help to resolve a problem is the sine qua non of an effective evaluation system.

It iS essential that a quality assurance program assure the relevance and utility of the results of the evaluation – the so-called utilization-focused approach.
8To assure the program’s utility, the coordinator of a quality assurance program must expend considerable
energy in helping the key decision makers and information users, identify and sharpen relevant questions.
9 Those who are most likely to be affected by the results of an evaluation must work together to define the issues and determine how they might best be resolved.

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As a result, some experiments were entirely destroyed. One scientist had been working for 18 years on an experiment to measure the winds on Titan, and his data was supposed to be transmitted on channel A. But since somebody at NASA or the Italian space agency forgot to turn on channel A, none of that data was transmitted. And thus, 18 years of waiting was lost.

All of this reminds me of the fiasco that happened when NASA sent the rovers to Mars. When the rovers first got to Mars and started taking pictures, NASA suddenly discovered that, ‘Gee! The onboard computer memory is getting full!’ For some reason, when you actually take photos, it takes up memory. And after only a couple of days, the rovers were unresponsive because they were constantly rebooting due to the fact that their memories were full. It was as if no one had thought to actually test the rovers here on Earth before launching them into space at a cost of 800 million dollars.

So I have a question. Why do we as a nation spend literally billions of dollars to launch hardware into space when that hardware is being programmed and operated by bumbling idiots who can’t flip a switch or remember to test the hardware before launch day?

Of course, NASA always manages to put a positive spin on these events. The Mars rover missions were ultimately proclaimed a great success, but only because some sharp-minded system administrators were able to ‘hack’ the rovers from Earth with a process that reprogrammed the way the rovers store images.

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This subject area is one which, perhaps more than most, relies on the meaning, use and interpretation of words and phrases used to define concepts, and which suffers as a result from a degree of misunderstanding and confusion.

For example, there is huge difference between ‘quality’ management and ‘quality management’. Both terms rely on an understanding of the meaning of both ‘quality’ and ‘management’, which will vary depending on the context in which they are used. Similarly, quality thinking could be ‘quality’ thinking or ‘quality thinking’, ie thinking about ‘quality’ or a ‘better and more effective way of thinking’.
What is quality?

The following responses to this question show how varied our ideas can be:

* ‘a measure of excellence’
* ‘the characteristics of a product or service that bear on its ability to satisfy stated or implied needs’
* ‘better than you would, or could, have ever expected’
* ‘what the customer perceives it to be’
* ‘doing the right thing right, every time’
* ‘the degree to which an item or process meets or exceeds the customers’ requirements and expectations’
* ‘how closely a product or service meets its design specification’
* ’surpassing customer needs and expectations throughout the life of the product’
* ‘a product or service free of deficiencies’
* ‘reducing the variation around the target’
* ‘a state of mind’
* ‘the extent to which products, services, processes, and relationships are free from defects, constraints, and items which do not add value for customers’
* ‘never having to say you’re sorry’
* ‘an ever-evolving perception by the customer of the value provided by a product. It is not a static perception that never changes but a fluid process that changes as a product matures (innovation) and other alternatives (competition) are made available as a basis of comparison’
* ‘peace of mind’
* ‘never an accident’
* ‘the inherent features possessed by a product or service’
* ‘when what comes back is the client, not the product’
* ‘no surprises!’
* ‘not achieved by doing different things. It is achieved by doing things differently’
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Software development control

Quality in software development projects doesn’t happen on its own. It also doesn’t occur after a small group of heroes rides in on white horses and waves its shiny swords to vanquish the problems. Quality happens only when careful planning is done, when the entire project team maintains a quality-conscious approach every step of the way, and when problems don’t escape from the phase in which they were introduced. A quality product is a team effort. It’s planned and predictable. It’s without heroes, and it’s faster and cheaper than a low-quality effort.

How can this be? Let’s look at some sample projects. The first is a normal, low-quality, late project. We’ll call it project “Hurry Up” (HU for short).

Project HU got a bit of a late start due to the ongoing maintenance issues of its predecessor project “Just Ship It” (JSI). JSI was handled by a project manager (PM) who felt it was more important to ship on time than to ship a high-quality product. So he did. This PM was rewarded for his ability to “pull it together,” “get it out the door” and “meet the schedule.” The JSI PM was given a bonus for meeting his schedule and is now vacationing in Tahiti while the team deals with the fallout of the numerous bugs and unhappy customers.

Lesson #1: Don’t reward for shipping on schedule. Anyone can ship garbage. Base rewards on quality metrics.

During the last month of the project, the JSI developers worked 80-hour weeks. One heroic fellow was recognized for working 120 hours in one week, stopping only for brief rests. He heroically repaired multiple interfaces between applications. Those interfaces had not been properly specified (there were no design documents), no integration testing was done (no time to do it), and the QA team fought quality issues throughout system test.

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The development and implementation of process-control plans for the manufacture of threaded components is complex. Used in a wide variety of components from aerospace to automotive applications, the screw thread is one of the more difficult characteristics produced in general manufacturing operations. In many instances, the breakdown of process validation has its origin in the design phase. Incomplete product details and unrealistic tolerances are all too common.The net result increases production costs, extends delivery, and complicates the entire manufacturing process. As a manufacturer and designer of both standard and special inspection systems, our company is often required to manufacture special out-ofthe- box gaging solutions for unique requirements, when a simple design modification will permit use of standard off-theshelf gaging. Occasionally, complex designs coupled with excessively stringent dimensioning produce a part incapable of quality verification at any cost. The old adage “keep it simple” should be a design standard.



As products evolve from design to manufacture, the challenges increase. A first step in the development of a processcontrol plan is a complete understanding of the potential sources of variation. Unlike most manufacturing characteristics, the geometry defining the thread form defies easy solutions. Variation is not limited to change in the pitch diameter, but also to the interdependence of size and form variation as indicated by the functional size. Defined as the cumulative effect of profile variation, functional size includes the entire effect of thread-angle and thread-lead error on the pitch diameter size, and is related to the ability of a thread to assemble. In any control plan, it’s critical to control and minimize the difference between the functional and pitch-diameter size as a means of variability reduction.

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