1. Introduction to Project Management
Quality Management
Welcome to Introduction to Project Management: Quality Management. This is Lecture a.
Quality is an elusive but essential component and consideration in any project. This unit will cover quality management planning and key characteristics of quality assurance as well as its impact on project management.
The lecture will focus on all three objectives.
Lecture a
This material (Comp 19 Unit 10) was developed by Johns Hopkins University, funded by the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology under Award Number IU24OC This material was updated in 2016 by Johns Hopkins University under Award Number 90WT0005.
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2. Quality Management Learning Objectives—Lecture a
Develop a quality management plan.
Perform quality assurance.
Apply quality tools.
The Objectives for Quality Management are to:
Develop a quality management plan.
Perform quality assurance.
Apply quality tools.

3. What is Quality?
Institute of Medicine defines six characteristics of high-quality care:
Care must be safe
Care must be effective and reliable
Care must be patient-centered
Care must be timely
Care must be efficient
Care must be equitable
What is Quality? There are many definitions of the term quality. This section will provide several definitions.
Quality is the suitability of procedures, processes, and systems in relation to the strategic objectives.
Quality is the ongoing process of building and sustaining relationships by assessing, anticipating, and fulfilling stated and implied needs.
Wikipedia correctly states: Quality in business, engineering and manufacturing has a pragmatic interpretation as the non-inferiority or superiority of something. Quality is a perceptual, conditional and somewhat subjective attribute and may be understood differently by different people. Consumers may focus on the specification quality of a product/service, or how it compares to competitors in the marketplace. Producers might measure the conformance quality, or degree to which the product/service was produced correctly.
The Institute of Medicine defines six characteristics of high-quality care:
Care must be safe;
Care must be effective and reliable;
Care must be patient-centered;
Care must be timely;
Care must be efficient
And care must be equitable.

4. Quality Control vs. Quality Assurance
Quality Assurance applies to a process. It is a set of activities designed to ensure that the development and/or maintenance process is adequate to ensure a system will meet its objectives. Quality Control applies to a product. It is a set of activities designed to evaluate a developed a work product.
Many people and organizations are confused about the difference between quality assurance (QA) and quality control (QC). They are closely related, but they are different concepts:
Quality Assurance applies to a process. It is a set of activities designed to ensure that the development and/or maintenance process is adequate to ensure a system will meet its objectives.
Quality Control applies to a product. It is a set of activities designed to evaluate a developed work product.
The quality assurance system is used to monitor and develop the operations in a systematic way. A quality assurance system describes the operational starting points and processes, the operation-related matters to be monitored and evaluated and the methods, procedures and tools to be used in development activities.
Your product is care of your patients. Controlling cost to the patient by designing the best system that you can is an example of quality control. Quality assurance is reviewing charts of patients for opportunities to change the system for the benefit of the patients and the organization.

5. Total Quality Management Theory
TQM Model
Customer Focus
Planning Process
Process Management
Process Improvement
Total Participation
Total Quality Management or TQM is based on the buy-in and participation of an organization’s members. It’s goal is the long-term organization success through customer satisfaction. If properly implemented, TQM benefits all members of the organization and society in general.
The TQM Model on this slide provides an overview of key elements of TQM. Customers Focus, TQM expands on the concept of customer to include suppliers, partners and even co-workers. Planning Process, essential processes must be planned and mapped out before they can be managed and improved. Process Management, key processes are monitored and managed. Process Improvement, based on the constant attention to quality improvement processes are continuously refined and improved. Total Participation, buy-in from the entire company or organization is essential from top to bottom from leadership to line workers.
This section will provide a historical and theoretical basis for TQM. It further discusses leading TQM theorists and the tools they apply to create Project Quality Management.
Just as in any area of business, healthcare has to take into consideration customer satisfaction. If you have the choice between two hospitals, you will go to the one that you think gives the best care. The Centers for Medicare and Medicaid Services (CMS) grades hospitals. This information can be found on the internet by anyone. If your local hospital has a lower grade than the hospital 50 miles away, why not go to that one. Many hospitals now offer valet service for car parking, mix-and-match menu choices and on-demand movies in the room just to increase customer satisfaction.

6. Dr. W. Edwards Deming System of Profound Knowledge:
Appreciation of a system
Knowledge of variation
Theory of knowledge
Knowledge of psychology
(Deming, 2000)
Dr. W. Edwards Deming taught that by “adopting appropriate principles of management, organizations can increase quality and simultaneously reduce costs. This is done by reducing waste, rework, staff attrition and litigation and at the same time increasing customer loyalty. The key is to practice continual improvement and think of manufacturing as a system, not as bits and pieces.” (Magrab, Gupta, McCluskey, & Sandborn, 2010)
Deming advocated that all managers need to have what he called a System of Profound Knowledge, consisting of four parts and providing the foundation of his 14 points which will be addressed on the next slide. The four key points of the System of Profound Knowledge are:
Appreciation of a system, this involves understanding the overall processes involving suppliers, producers, and customers (or recipients) of goods and services.
Knowledge of variation, this involves understanding the range and causes of variation in quality, and the use of statistical sampling in measurements.
Theory of knowledge, this refers to the concepts explaining knowledge and the limits of what can be known.
Knowledge of psychology, this area refers to concepts of human nature and their importance in impacting quality. (Deming, 2000)

7. Deming’s 14 Points Create constancy of purpose towards improvement
Adopt the new philosophy
Cease dependence on inspection
Move towards a single supplier for any one item
Improve constantly and forever.
Institute training on the job
Institute leadership
Drive out fear
Break down barriers between departments
Eliminate slogans
Eliminate management by objectives
Remove barriers to pride of workmanship
Institute education and self-improvement
The transformation is everyone's job (Deming, 2000).
The System of Profound Knowledge is the basis for application of Deming's famous 14 Points for Management.
Deming offered fourteen key principles for management for transforming business effectiveness. The points were first presented in his book Out of the Crisis.
Create constancy of purpose towards improvement
Adopt the new philosophy
Cease dependence on inspection
Move towards a single supplier for any one item
Improve constantly and forever.
Institute training on the job
Institute leadership
Drive out fear
Break down barriers between departments
Eliminate slogans
Eliminate management by objectives
Remove barriers to pride of workmanship
Institute education and self-improvement
The transformation is everyone's job

8. Deming Cycle
PDCA was made popular by Dr. W. Edwards Deming, who is considered by many to be the father of modern quality control; however it was always referred to by him as the "Shewhart cycle". Later in Deming's career, he modified PDCA to "Plan, Do, Study, Act" so as to better describe his recommendations.
The Plan-Do-Check-Act or PDCA model for Performance Improvement initiatives. This model provides a consistent problem solving approach for all Performance Improvement activities. Only when effective quality planning, process design, performance measurement, and performance improvement activities are integrated does the organization’s performance improvement initiative become integrated into the organization’s culture. The key elements of the PDCA model are:
PLAN
Establish the objectives and processes necessary to deliver results in accordance with the expected output. By making the expected output the focus, it differs from other techniques in that the completeness and accuracy of the specification is also part of the improvement. DO
Implement the new processes. Often on a small scale if possible.
CHECK or STUDY
Measure the new processes and compare the results against the expected results to ascertain any differences.
ACT
Analyze the differences to determine their cause. Each will be part of either one or more of the PDCA steps. Determine where to apply changes that will include improvement. When a pass through these four steps does not result in the need to improve, refine the scope to which PDCA is applied until there is a plan that involves improvement.
You can also think of health care as a system not just the bits and pieces. The admission process, the lab collection process, food selection and delivery process and the discharge process are the bits and pieces of a hospital stay. Together with all the other bits and pieces they create a hospital system. How can these bits and pieces work together and be improved to increase quality and reduce costs?
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9. Joseph Juran
Widely credited for adding the human dimension to quality management
Human relations problems are the ones to isolate.
Cultural resistance, is the root cause of quality issues.
(Juran, 1992)
Joseph Juran is widely credited for adding the human dimension to quality management. For him, human relations problems were the ones to isolate. Resistance to change, or in his terms, cultural resistance, was the root cause of quality issues. Compare Juran’s 10 Steps to Quality Improvement to Deming’s 14 points for business survival and prospering.

10. 10 Steps to Quality Improvement
Build awareness of opportunity to improve
Set-goals for improvement
Organize to reach goals
Provide training
Carryout projects to solve problems
Report progress
Give recognition
Communicate results
Keep score
Maintain momentum by making annual improvement part of the regular systems and processes of the company (Juran, 1992).
Ten steps to Quality Improvement. Juran defines quality as fitness for use in terms of design, conformance, availability, safety, and field use. Thus, his concept more closely incorporates the viewpoint of customer. He is prepared to measure everything and relies on systems and problem-solving techniques. Unlike Deming, he focuses on top-down management and technical methods rather than worker pride and satisfaction. The following slide illustrates Juran’s 10 steps to quality improvement.
Build awareness of opportunity to improve:
Set-goals for improvement
Organize to reach goals
Provide training
Carryout projects to solve problems
Report progress
Give recognition
Communicate results
Keep score
Maintain momentum by making annual improvement part of the regular systems and processes of the company

11. Pareto Principle
The Pareto Principle states that completing 20 percent of a job provides 80 percent of the benefit to accomplishing all of the work. In applying this principle to quality improvement, we can say that 20 percent of reasons create 80 percent of the problems that occur on a project. Pareto analysis uses the Pareto Principle to identify a small number of activities that strongly impact the project as a whole.
By employing this type of analysis, a project manager can address 80 percent of a project’s roadblocks by isolating 20 percent of all reasons for the roadblocks, and then applying such tools as the Ishikawa or Cause and Effect diagram to pinpoint the roadblocks’ origins.
Joseph Juran, one of the father's of the quality movement, restated the Pareto Principle as the difference between the "vital few and the trivial many.”

12. The Juran Trilogy Quality Planning Quality Control Quality Improvement
The Juran Trilogy provides a model of how an organization can better understand the relationship between processes that plan, control and improve quality and produce better business results.
Dr. Juran created this model in the 1950s. It defines managing for quality as three basic quality-oriented, interrelated processes:
Quality Planning - the process for designing products, services and processes to meet new breakthrough goals
Quality Control - the process for meeting goals during operations
Quality Improvement - the process for creating breakthroughs to unprecedented levels of performance
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13. Six Sigma The DMAIC project methodology has five phases:
Define the problem, the voice of the customer, and the project goals, specifically.
Measure key aspects of the current process and collect relevant data.
Analyze the data to investigate and verify cause-and-effect relationships.
Improve or optimize the current process based upon data analysis using techniques
Control the future state process
(Wikipedia,Six Sigma.)
Created by the Motorola company in 1981, Six Sigma is now deployed in many areas of business as a quality management approach to enhance the value of results or deliverables. It isolates and eliminates the sources of problems, while ensuring consistency in organizational processes, through a number of quality management techniques. These techniques include statistical analyses performed by experts within the organization and a specific phased approach that focuses on goals identified by the client. Such goals can focus on such areas as financial, safety, or delivery time improvement.
The term, “sigma,” defines the percentage of a process’s error-free outcomes, so, “Six Sigma,” indicates a healthy process that should provide outcomes that are nearly 100 percent devoid of defect.

14. QM vs. TQM
TQM is proactive and takes place largely prior to production:
Customer focus
Obsession with quality
Scientific approach to decision making and problem solving
Long-term commitment
Teamwork
Employee involvement
Continual process improvement
Bottom up education and training
Freedom through control
Unity of purpose
Traditional views of quality
After the fact inspection
Quality Management versus Total Quality Management. It is important to understand the difference between quality management and total quality management. The list on this slide illustrates the differences.
TQM includes both an empirical component associated with statistics, and an explanatory component that is associated with management, of both people and processes. The terms "hard" and "soft" are commonly used to represent these two components. TQM brought recognition to the fact that tasks can be categorized as value adding or not. The obvious corollary is that non-value adding tasks would be eliminated and the value adding ones improved. Many process design and operation tools have been highlighted in TQM, such as statistical process control, and the need for flexible organization.
The main task that the quality control methodology sets out to accomplish is to insure that only good items were acceptable for further production, and bad parts were rejected. To have the concept of good and bad parts means that standards of some type must be in place, so comparisons can be made. The fact that good and bad parts could exist was not the main concern (and is still not) of quality control. Any activity that is related to measuring product parameters against criteria and passing judgment on whether the product can be used or sold based on meeting the criteria is considered a quality control task. This covers final goods, intermediate work-in-progress or services being delivered.

15. Creating a Quality Culture
Culture of Quality Governance
Strategic Planning
Enterprise Innovation
Collaboration and Training
Performance Management
Creating a Quality Culture. Quality culture includes quality improvement measures as well as the individual and collective commitment to quality maintenance and improvement.
Quality experts all agree that, in order for Total Quality Management to be successfully implemented, the organization must have a quality culture. A quality culture helps us understand that a positive internal environment and the creation of delighted customers go together. It is a culture that naturally emphasizes continuous improvement of processes, one that results in a healthy workplace, satisfied customers, and a growing profitable company. A quality culture values fair play, and knowing this, we can understand that they will not do anything to deceive us in our dealings with them. In a business, employees will behave in ways that are consistent with the core values of the culture.
Healthcare IT can support the quality culture and core values of the institution by providing to the user the information at the time it is needed, in the amount that can be ingested, and in the place that it is needed most. An example of displaying information at the time it is needed and in the correct place in the workflow is in drug alert warnings. A warning that is displayed at the time of order entry is far better than a warning that displays after the prescriber has finished filling out all the required fields on the medication form. An example of the correct amount of information presented is who gets the warnings. Why should the chief of cardiology get a warning about a common drug interaction every time he or she opens the electronic patient chart? Showing that warning once a day could be enough to remind that provider about the interaction. A medical student with less experience may need those warnings more frequently.

16. Components of Org Culture
Business environment
Change-oriented culture vs. don’t-rock-the-boat culture
Organizational values
What the organization thinks is important
The heart and soul of organizational culture
Cultural role model
Employees who personify the organizations values
Organizational rites, rituals, and customs
The unwritten rules about how things are done
Enforced by peer pressure
Cultural transmitters
Vehicles through which culture is passed down through successive generations of employees
There are various components of an organizational culture that one must consider and understand. First, the business environment, which could be a change-oriented culture or a culture in which change is frowned upon. What are the organizational values? What does the organization consider to be important, and what is at its core? Who are the cultural role models in the organization? Who truly embodies and personifies the values of the organization? Each organization has a set of unwritten rules about how things are done. These are typically enforced by peer pressure, as opposed to an official company policy. And finally, what are the cultural transmitters in the organization? How are new employees indoctrinated into the unwritten rules about how things are done? All of these components make up an organization’s culture.

17. Total Quality and ISO 9000
When discussing quality management it is important to mention the standards that are used in quality management systems. ISO 9000, (where ISO stands for International Organization for Standardization) – is a group of standards developed and maintained by the ISO, but administered by various other certification and accreditation groups. Just as with any standard, they are not set in stone in perpetuity. There is a continual and ongoing need for modification and updating which the ISO undertakes on a routine basis. These standards are regularly published by ISO, which, in the case of Quality Management System standards, is most currently instantiated in the publication of David Hoyle called ISO 9000: Quality Systems Handbook, published in 2009 by Elsevier. In this book, Hoyle discusses the changes that were instituted as the ISO 9000 was updated to the current standard applicable to Quality Management Systems – now known as ISO 9001:2008 standard. The new requirements include a set of procedures that include all of the essential business processes such as “monitoring processes to ensure they are effective; keeping adequate records; checking output for defects with appropriate and corrective action where necessary; regularly reviewing individual processes and the quality system itself for effectiveness; and facilitating continual improvement. “
Applying the title of, "ISO 9001 certified," or, "ISO 9001 registered," can only be used by an organization or company if it has been independently audited by a certifying group to be in compliance with the standard. It is important to note that simply having the moniker of ISO 9001 certified does not imply that the end product is of high quality. It simply certifies that the agency adhered to the ISO standard.

18. Eight Principles (Directly From TQM)
Customer Focus
Leadership
Involvement of People
Process Approach
System Approach
Continual Improvement
Factual Approach
Mutually Beneficial Supplier Relationships (ISO 9001:2008)
While ISO 9000 is not TQM and it does not directly refer to it, it is important to note the influence that TQM has had on ISO The latest iteration of ISO 9000 uses eight key principals which are directly relatable back to TQM. The key principals are:
Customer Focus
Leadership
Involvement of people
Process approach
System approach
Continual improvement
Factual approach
Mutually beneficial supplier relationships

19. Process for Registration
Develop Quality Manual
Document Procedures
Evidence of Management Commitment
Insurance that customer requirements are met
Accredited Registrar Audit
Internal Audits
Periodic registrar Audits (ISO 9001:2008)
The following requirements are all part of standard language from the ISO.
“In order to qualify for ISO 9000 registration, an organization must complete the following processes:
Develop Quality Manual
Document Procedures
Evidence of Management Commitment
Insurance that customer requirements are met
Accredited Registrar Audit
Internal Audits
And Periodic registrar Audits
The standards for the ISO 9000 family deal with the following areas:
Quality management systems - establishing and monitoring the process whereby product and service quality are maintained.
Management responsibility - how the management establish, maintain, monitor and communicate their commitment to the standards.
Resource management - how the business provides the resources - both physical and human - to enable the standards to be met and maintained.
Product realization requirements - how businesses establish and monitor quality from concept to final product or service delivery.
Measurement, analysis and improvement requirements - how businesses use data to monitor their quality control and how this data is used to improve quality provision.”

20. Quality Management Summary—Lecture a
Total Quality Management and the theorists behind TQM
Quality culture and approaches for creating a quality culture
TQM and ISO 9000 family of certifications
This concludes Lecture a of Quality Management. In summary, we have discussed Total Quality Management and the theorists behind TQM, the importance of a quality culture and approaches for creating a quality culture, and TQM and its relationship to the ISO 9000 family of certifications.

21. Quality Management References—Lecture a—1
Bennett-Staub A. Helping Residents Cope with a Patient Suicide. (2011). American Psychiatric Association.
Deming W. (2000) The new economics: for industry, government, education. 2nd ed. Boston: MIT Press.
Deming W. Out of the Crisis. (2000) 2nd ed. Boston: MIT Press.
DoIT. Project Management Advisor. Develop Quality Management Plan Available from:
Fezeu L. Project Quality Management. Central Michigan University: Software Project Management.
Hoyle D. ISO 9000 Quality Systems Handbook. (2009) 6th ed. Elsevier Ltd.
ISO 9001:2015; Quality management systems – Requirements; ISO Press
Juran J. (1992). Juran on Quality by Design. New York: Simon & Schuster.
Magrab E, Gupta S, McCluskey F, & Sandborn P. (2010) Process Design and Development: The Product Realization Process. 2nd ed. Boca Raton, FL.: CRC Press;
A Guide to the Project Management Body of Knowledge: (pmbok Guide). 5th ed. Newtown Square, Pa.: Project Management Institute, 2013

22. Quality Management References—Lecture a—2
Schwalbe K. Information technology project management. 8th ed.; Cambridge, MA: Course Technology; 2015.
Scribd. Line Balancing What is it? Available from:
Scribd. Seven Tools of Quality Control. Available from:
Six Sigma. Wikipedia. Available from:
Total Quality and ISO 9000 Series. Wikimedia by Alkazzi. Available from:
Wikipedia. PDCA. Available from:
Wikipedia. Six Sigma. Available from:
No audio.
Charts, Tables, Figures
Chart 10.1 Pareto Principle. Creative Commons: MetaComet. Wikimedia.com. Available from:
Images
Slide 8: The Deming Cycle. Creative Commons, Wikimedia. Available from:
Slide 17: Total Quality and ISO 9000 Series. Wikimedia by Alkazzi. Available from:

23. Introduction to Project Management Quality Management Lecture a
This material (Comp 19 Unit 10) was developed by Johns Hopkins University, funded by the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology under Award Number IU24OC This material was updated in 2016 by Johns Hopkins University under Award Number 90WT0005.
No audio.
Health IT Workforce Curriculum Version 4.0