Controlling and Avoiding Change

As Alfred North Whitehead observed, part of the art of human progress has been to preserve order within a constantly changing world.  Preserving order can have many meanings when it comes to processes and systems, and comprises a broad set of approaches to thinking and action.

With any process or system, change is constantly going on within the system and in the environment around the system.  Sometimes this change leads to deviations in performance that must be fixed, but the old saying that an ounce of prevention is worth a pound of cure is an essential principle in radical quality.

However, the scope of activities in an organization that make up that ounce of prevention are probably far broader than most people recognize.  Radical quality extends beyond the control of the work on the production line or in serving customers, caring for patients, and other direct activities.  Deming’s 14 POINTS clearly establish that the scope of radical quality extends into procurement, management development, and many aspects of Human Resource Management, especially in the area of workforce development.(1)   Indeed, because training involves people, it is often mistakenly placed under Human Resources when it is actually primarily a Quality function. 

Communicating the Need for Control

While some quality practitioners have noted that Philip Crosby did not actually introduce any new concepts into the practice of quality, it would be hard to deny his talent at communicating parts of the quality message to corporate leaders.(2)  Most importantly, Crosby dispelled (for those who would listen) the notion that the activities that ensure quality in the conduct of operations – such as inspection, training and auditing, only add costs to a process.  Crosby helped leaders understand that the investments made in quality practices led to quick cost savings in reduced scrap and rework, along with huge savings by avoiding accidents, calamities, and lawsuits due to poor quality.  While all of these points had been made in works by earlier quality pioneers in both American and Japan, such as Deming, Juran, and Ishikawa, Crosby was able to express these ideas in terms that some corporate leaders could embrace.

However, in Crosby’s day, most corporate leadership in American industry embraced other cognitive systems that undermined the commitment to radical quality and often led to ruin, so the quality field needed someone who had credibility from working within the corporate system to impress basic truths upon people, such as the fact that it is better to “do things right the first time,” thus avoiding the popular saying that was common within many organizations that “we do things nice because we do things twice.”

If only corporate and government leaders were listening, they might not have committed costly mistakes such as dumping PCBs in the Hudson River, constructing weak earthen dams to contain toxic wastes, and allowing groundwater to be contaminated with radioactive and toxic wastes spread around government facilities.  As we will examine in other areas of this web site, when other cognitive systems are at work, there will be many reasons to not do things right the first time at all.  The costs of poor quality are huge in dollars, human suffering, and the sustainability of organizations and ecosystems.

Control of What?

The need for control of potential changes can have a negative connotation in that it may be interpreted as control over people – keeping their noses to the grindstone, discouraging them from asking questions, or punishing them for pointing out problems.  This misinterpretation of control is bound up in many of the cognitive problems that will explored in the Taxonomy of Root Causes section of this web site.

The control of potential changes does have a dimension related to people in that it includes the processes that ensure that all employees are properly trained and that leaders understand how to empower their workforce and that issues such as endullment, entitlement, and group think do not corrode the organization – all of which appear in other parts of this web site.  As far as the employees in an organization are concerned, the control of potential change is centered around education, training, procedures, clear communication, and empowerment to conduct operations in the manner in which they were designed to be conducted to ensure quality.  Employees must be empowered to understand and control their processes and to participate in efforts to improve processes.  Careful planning must go into the design of work processes to control variation by planning for appropriate materials, equipment, and work spaces.

If a leader wants to protect against undesirable changes in a process or system, then careful attention must be given to the selection, onboarding, education, and training of personnel.  In most organizations – whether a factory, school, hospital, or business – hiring, onboarding, educating and training are critical actions.

While a whole new academic discipline, supply chain management, has emerged in business schools, this practice is wholly dependent on a radical approach to quality to be effective.  A supplier that cannot control the quality characteristics in its products and services cannot meet schedule, undermining the supply chain and any just-in-time inventory management.

Because most quality practitioners are focused on single applications of one slice of the quality body-of-knowledge (such as focusing on inspection, procedure-writing, and training) most do not see the full ramifications of radical quality.  In fact, the quality discipline suffers from the fact that most practitioners do not recognize that their work even falls under the general heading of quality and they do not receive any education or training in their workplace regarding the radical nature of quality.  They sort out bad fruit, complete checklists, take measurements, conduct tests, listen to complaints, and take patients’ temperatures without knowing that they are all part of an orchestrated effort to keep unwanted changes from entering our processes and systems.

Education, training, procedures, communication, and participation are all critical human factors in preventing undesirable changes from influencing work processes and systems.  It is essential for team leaders, supervisors, middle managers, and executives to embrace this thinking paradigm in order to control, fix, improve, and re-invent processes and systems.

Nurturing Systems that Control Quality

Successful organizations, that are able to sustain their success over time, do so by nurturing internal systems that control quality, such as design, construction, procurement, staffing, procedures, testing and measurement, calibration, training, maintenance, inspection, auditing, and corrective action systems.

Leaders who operate outside of radical quality’s cognitive system do not understand how vital these support processes and systems truly are.  These leaders want to rush past understanding and nurturing these activities to get to the bottom line, so they never really understand anything at all about their organizations.

It is leadership’s responsibility to understand the processes and systems that control quality, to review the data from these areas, and to nurture these activities to ensure they continue to function as intended, preventing undesirable changes from entering processes and systems.  From a sports perspective, it is paying attention to the basics – blocking and tackling, keeping the bases covered, or protecting the goal. 

Failure to control the design of hardware and software, after all, can cause airplanes to fall out of the sky.  Failure to control construction can cause buildings to crumble and dams to collapse.  Failure to control procurement leads to poor incoming materials that stop production lines, lead to rework, and potentially allow dangerous products to reach customers and patients.  Failure to control procedures results in incorrect work evolutions, injuries, and fatalities.  Failure to control communications leads to misunderstandings, errors, injuries, fires, and fatalities.  Failure to control tests, measurements, and calibration of testing and measurement equipment generates inaccurate and incomplete data that can have many negative consequences.  Failure to conduct maintenance, using unapproved maintenance procedures results in faulty equipment, damaged product, or injuries, fires, deaths, and environmental failures. 

All of these preventive methods and safeguards must be embedded in an organization, nurtured, and assessed, while attention is given to the data and evidence produced in each system in order to prevent undesired changes.

Methods for Controlling and Avoiding Change

The methods for controlling and avoiding change are probably infinite because the quality principles are fundamental to every mode of human endeavor.  Success and sustainability in every sector depends upon controlling and avoiding undesirable changes.

One approach to discussing methods for controlling and avoiding change within any system is to frame the parts of the system around the system components identified by Dr. Kaoru Ishikawa – people, process, equipment, and materials.  Some have expanded these to include the environment and information. (3)

Methods for controlling and avoiding unwanted change related to people center around the thoughtful use of procedures, appropriate training and education, clearly organized plans (using methods such as Gantt Charts), and clear communications, such as repeat backs, labeling, color coding, and shift change protocols.  Organizations embed controls against unwanted changes related to people by restricting hours of work, formality in shift changeovers, rigorous communications, clarity of procedures, and by maintaining an organizational culture in which rules are understood, respected, and followed.

Process related controls begin with the appropriate review of a process design, the use of statistical process control methods, and the poka yoke concept of mistake-proofing steps in a work process, such as color coding.  The Lean methods, or Five S approach,  can be used to analyze a process in order to enhance the controls that are put in place to avoid unwanted changes.(4)

Control methods for equipment include appropriate preventive maintenance, accurate log keeping, inspection and calibration of equipment, control of standards, proper labeling of valves, lines, buildings, vehicles and other items, lock out and tag out procedures, maintaining repair handbooks, maintaining repair records, and information regarding the amount of time that equipment has been in operation.

Material related controls will include evidence of statistical process control from vendors for incoming materials, incoming material inspection and testing, clear labeling of materials in storage, clear labeling of rejected and scrap materials, and clear labeling of materials that are transferred into containers for lab and field use. 

Controls related to the environment can include control of temperature in buildings, control of air pressure in laboratories, hospital rooms and chemical hoods, humidity in work areas, methods for addressing snow, rain, and freezing temperatures, and understanding of the impact of environmental conditions on equipment, materials, and personnel.

More recently, information itself has gained recognition as a vital component of organizations that requires control to avoid unwanted changes.    The quality of decisions made in an organization, such as whether or not to invest in a new product, purchase equipment, or commit to major environmental projects depends on the quality of the data being used to make a decision.  Methods for ensuring data quality will include ensuring accuracy of the data as it is collected, the efficacy of the systems used to maintain and access the data, the appropriate use of statistical methods for data analysis, and the reliability of the software used to make quick decisions based on the data.

Each of these areas of methodology can comprise an entire discipline in and of itself.  There is a body of knowledge for procedure writing and a body of knowledge for designing and conducting training.  There is a body of knowledge for designing and implementing maintenance programs and for mistake-proofing processes.  Testing and the calibration of test equipment can be a science in itself.  The majority of quality practitioners around the world are engaged in controlling and avoiding unwanted change using these methodologies and quite often they do not really perceive their work as being part of a larger quality discipline.

Control is Driven by Anticipatory Thinking

It is important to delve into the thinking processes that lead to the realizations that these types of methods are needed in specific circumstances.  Thinking in this area can be proactive or reactive and both types of thinking are important.

Proactive thinking about control centers around the willingness to invest time in anticipating what might go wrong.  This anticipatory thinking may not be as common as one might hope because it can be actively discouraged by other factors such as arrogance and the illusion of invulnerability.

The key to anticipatory thinking is the willingness to ask, “What might go wrong?”  This means overcoming many assumptions regarding ourselves and our organization.  “What might go wrong?” is a brave question to ask and it takes great fortitude to dig into the answer.  Based on things that might potentially go wrong, how do we design the process and system so that things that might go wrong do no go wrong.  Or, if they do go wrong, what will we be prepared to do to mitigate the circumstances?

Charles Kepner and Benjamin Tregoe developed a structured approach to anticipatory thinking tht they called Potential Problem Analysis.(5)  The Kepner-Tregoe Potential Problem Analysis methodology aligns closely with a similar systematic approach to anticipatory thinking known as Failure Mode and Effect Analysis.(6) Senders and Moray likewise have offered an approach for proactively considering the potential sources of human errors in work processes.(7)   And an entire field of statistics focuses on reliability, which is devoted to analyzing and anticipating failures.(8)

Every decision can be enhanced by asking what could go wrong before actions are taken to implement the decision.  Every new work process can be flow-charted and the question of what can go wrong can be asked for every step in the process.  New steps can be added to the process so operators cannot make mistakes (mistake-proofing) and new methods of verification can be added to the process.

Safeguard Analysis can be applied proactively to evaluate the adequacy of existing safeguards in a process and to identify points where additional safeguards may need to be added. (9)  This method is covered in the section on Repairing Unwanted Change.

Reactive thinking is also quite valuable to controlling and improving quality when it is evidence based.  Deviations that have occurred are studied, lessons-learned are developed, and work processes are redesigned to keep problems from happening again, as we will examine in the section on Repairing Unwanted Change.  This analysis can be focused on steps within a process, such as Shigeo Shingo’s Poke-Yoke system (10), or it can be approached on a broader level, examining potential causes of deviations in processes, materials, equipment, or human error, as framed in Kaoru Ishikawa’s Cause Enumeration Diagram.11)  Most quality control activities in health care are reactive – taken in response to what evidence has shown to be likely causes of illness, adverse events, and sentinel events, resulting in the introduction of new and better safeguards and preventive actions.

(1) W. Edwards Deming. Quality, Productivity, and Competitive Position. MIT Press, 1986.

(2) Philip Crosby. Quality Is Free. New American Library, 1979.

(3) Kaoru Ishikawa. Guide to Quality Control, Asian Productivity Organization, 1974.

(4) 5S Handbook. Quality Resources Press, 1996.

(5) Charles Kepner and Benjamin Tregoe, The New Rational Manager. Princeton Research Press, 1982.

(6) Joseph Juran and Frank Gryna. Quality Planning and Analysis. McGraw-Hill, 1980.

(7) John Senders and Neville P. Moray. Human Error: Cause Prediction, and Reduction. Lawrence Erlbaum Associates, 1991.

(8) Juran and Gryna.

(9) John R. Dew and Meri Curtis. Diagnosing and Preventing Adverse and Sentinel Events. Opus Communications, 2001.

(10) Shigeo Shingo. Zero Quality Control. Productivity Press. 1986.

(11) Kaoru Ishikawa, Guide to Quality Control, Asian Productivity Center, 1976.