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Quality Management, Part 2

Monday, November 21, 2011 4:50 PM

Introduction
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 and its impact on project management.

Comparison of ISO 9000 and TQM


ISO 9000 and TQM are really not comparable. They are different things. The following list summarizes the comparison of ISO 9000 and TQM: Not interchangeable Can be viewed as a subset of TQM Frequently implemented in non-TQM environment Can improve operations in a traditional environment May be redundant in a mature TQM environment

Is not in competition with TQM

Quality Management Tools


The big 7 Quality Management tools are listed below:

1. Cause-and-effect diagram (also called Ishikawa or fishbone chart): Identifies many possible causes for an effect or problem and sorts ideas into useful categories.
2. Check sheet: A structured, prepared form for collecting and analyzing data; a generic tool that can be adapted for a wide variety of purposes. 3. Control charts: Graphs used to study how a process changes over time. 4. Histogram: The most commonly used graph for showing frequency distributions, or how often each different value in a set of data occurs. 5. Pareto chart: Shows on a bar graph which factors are more significant. 6. Scatter diagram: Graphs pairs of numerical data, one variable on each axis, to look for a relationship. 7. Stratification: A technique that separates data gathered from a variety of sources so that patterns can be seen (some lists replace "stratification" with "flowchart" or "run chart"). We will not cover all of these techniques, but each is worth mentioning.

Flowchart

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A flowchart is a type of diagram that represents an algorithm or process, showing the steps as boxes of various kinds, and their order by connecting these with arrows. This diagrammatic representation can give a step -by-step solution to a given problem. Data is represented in these boxes, and arrows connecting them represent flow / direction of flow of data. Flowcharts are used in analyzing, designing, documenting or managing a process or program in various fields. Creating a flowchart by tying each cause-and effect diagram together greatly aids the identification of quality points where performance to quality can be measured.

In healthcare, flowcharts are used to represent the current state of work and then the future state of work. This helps the staff to understand where and when changes are going to be made in their work process so that they can start to view themselves in that future work state. They help the project team in understanding the process and where additional changes might be needed in the project. Many times in healthcare, processes are handed down from experienced workers to less experienced workers as part of the orientation process. Often they do not know why they are performing these steps in a particular manor other than that is the way they learned the process. Once they see the flowcharts, they can begin to tell you either what was not captured and begin to give you a truer picture of the process.

Exercise
Using paper and pen, draw a flow-chart that describes a process. The process can be something from your work or personal life. Identify places in the process where things can go wrong. What could you do to prevent them? Turn in your chart along with a brief explanation of the process.

Root Cause Analysis (RCA)


Ishikawa / Fishbone

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Ishikawa / Fishbone

Root cause analysis (RCA) is a class of problem solving methods aimed at identifying the root causes of problems or incidents. The practice of RCA is predicated on the belief that problems are best solved by attempting to correct or eliminate root causes, as opposed to merely addressing the immediately obvious symptoms. By directing corrective measures at root causes, it is hoped that the likelihood of problem recurrence will be minimized. However, it is recognized that complete prevention of recurrence by a single intervention is not always possible. Thus, RCA is often considered to be an iterative process, and is frequently viewed as a tool of continuous improvement. RCA, initially is a reactive method of problem detection and solving. This means that the analysis is done after an incident has occurred. By gaining expertise in RCA it becomes a pro-active method. This means that RCA is able to forecast the possibility of an incident even before it could occur. While one follows the other, RCA is a completely separate process to Incident Management. Root cause analysis is not a single, sharply defined methodology; there are many different tools, processes, and philosophies of RCA in existence. However, most of these can be classed into five, very -broadly defined "schools" that are named here by their basic fields of origin: safety-based, production-based, process-based, failure-based, and systemsbased. Safety-based RCA descends from the fields of accident analysis and occupational safety and health. Production-based RCA has its origins in the field of quality control for industrial manufacturing.

Process-based RCA is basically a follow-on to production-based RCA, but with a scope that has been expanded to include business processes.
Failure-based RCA is rooted in the practice of failure analysis as employed in engineering and maintenance. Systems-based RCA has emerged as an amalgamation of the preceding schools, along with ideas taken from fields such as change management, risk management, and systems analysis. Despite the seeming disparity in purpose and definition among the various schools of root cause analysis, there are some general principles that could be considered as universal. Similarly, it is possible to define a general process for performin g RCA. The fishbone diagram helps you explore all potential or real causes that result in a single defect or failure. Once all input s are established on the fishbone, you can use the 5 Whys technique to drill down to the root causes. Using cause-and-effect diagrams to analyze each step in the process flow begins to problem-solve almost immediately. The internal customer-supplier relationship at each step often reveals that the item received by the internal customer frequently doesnt meet that customers need. (This tip refers to key concept #1 - Developing a cause-and-effect diagram for each step in the Project Management process.)

Quality Checklists

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The check sheet is a simple document that is used for collecting data in real -time and at the location where the data is generated. The document is typically a blank form that is designed for the quick, easy, and efficient recording of the desire d information, which can be either quantitative or qualitative. When the information is quantitative, the checksheet is sometimes called a tally sheet. Check lists are used extensively in the healthcare both in the administrative areas and the clinical areas. All staff that yo u will be working with on the project are familiar the check lists. Dont hesitate to develop these. Examples of check lists include: New unit check list designed to remind everyone about things that are easily forgotten, a check list reviewing the needed actions before the go live starting several day before down to the minutes before the go live and team coordination check lists for the day of go live. These types of lists give you team members confidence that you have tried to think of everything possible before the action starts.

Exercise
In Small Groups: Look at a known process. You could use one of your members flow-chart from the last exercise. Draw a cause and effect diagram or create a quality checklist for an element of this process.

Statistical Process Control

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Statistical process control was pioneered by Walter A. Shewhart in the early 1920s. W. Edwards Deming later applied SPC methods in the United States during World War II, thereby successfully improving quality in the manufacture of munitions and other strategically important products. Deming was also instrumental in introducing SPC methods to Japanese industry after the war had ended. Statistical process control (SPC) is the application of statistical methods to the monitoring and control of a process to ensure that it operates at its full potential to produce conforming product. Under SPC, a process behaves predictably to produce as much conforming product as possible with the least possible waste. While SPC has been applied most frequently to controlling manufacturing lines, it applies equally well to any process with a measurable output. Key tools in SPC are control charts, a focus on continuous improvement and designed experiments. Control charts, also known as Shewhart charts or process-behaviour charts, in statistical process control are tools used to determine whether or not a manufacturing or business process is in a state of statistical control.

If analysis of the control chart indicates that the process is currently under control (i.e. is stable, with variation only c oming from sources common to the process) then data from the process can be used to predict the future performance of the process. If the chart indicates that the process being monitored is not in control, analysis of the chart can help determine the sources of variation, which can then be eliminated to bring the process back into control. A control chart is a specific kind of run chart that allows significant change to be differentiated from the natural variability of the process.

Pareto Chart

A Pareto chart, named after Vilfredo Pareto, is a type of chart that contains both bars and a line graph, where individual values are represented in descending order by bars, and the cumulative total is represented by the line. The left vertical axis is the frequency of occurrence, but it can alternatively represent cost or another important unit of measure. The right vertical axis is the cumulative percentage of the total number of occurrences, total cost, or total of the particular unit of measure. Because the reasons are in decreasing order, the cumulative function is a concave function. To take the example above, in order to lower the amount of late arriving by 80%, it is sufficient to solve the first three issue s. The purpose of the Pareto chart is to highlight the most important among a (typically large) set of factors. In quality contr ol,
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The purpose of the Pareto chart is to highlight the most important among a (typically large) set of factors. In quality contr ol, it often represents the most common sources of defects, the highest occurring type of defect, or the most frequent reasons for customer complaints, and so on.

These charts can be generated by simple spreadsheet programs, such as OpenOffice.org Calc and Microsoft Excel and specialized statistical software tools as well as online quality charts generators.

Quality Management Plan

Project Quality Plan can be defined as a set of activities planned at the beginning of the project that helps achieve Quality in the Project being executed. The Purpose of the Project Quality Plan is to define these activities / tasks that intends to deliver products while focusing on achieving customer's quality expectations. These activities / tasks are defined on the basis of the quality standards set by the organization delivering the product. Project Quality Plan identifies which Quality Standards are relevant to the project and determines how they can be satisfied. It includes the implementation of Quality Events (peer reviews, checklist execution) by using various Quality Materials (templates, standards, checklists) available within the organization. The holding of the Quality Event is termed as Quality Control. As an output of the various activities, Quality Metrics or Measurements are captured which assist in continuous improvement of Quality thus adding to the inventory of Lessons Learned. Quality Assurance deals in preparation of the Quality Plan and formation of organization wide standards. In healthcare, part of your quality event could be the review of policies and procedures to insure that they are incorporated into you plan. If a procedure states that a certain checklist is used, the system needs to provide for that checklist or at least point to where it can be found as part of the system checks and alerts. Many quality policies are reportable occurrences to either federal or state regulatory bodies. Building them into you system at the beginning is easier than rebuilding the system after it is in production.

Designing the Quality Management Plan


The Quality Management Plan defines the acceptable level of quality, which is typically defined by the customer, and describes how the project will ensure this level of quality in its deliverables and work processes. Quality management activities ensure that: Products are built to meet agreed- upon standards and requirements Work processes are performed efficiently and as documented

Non-conformances found are identified and appropriate corrective action is taken


Quality Management plans apply to project deliverables and project work processes. Quality control activities monitor and verify that project deliverables meet defined quality standards. Quality assurance activities monitor and verify that the processes used to manage and create the deliverables are followed and are effective. The purpose of developing a quality plan is to elicit the customers expectations in terms of quality and prepare a
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The purpose of developing a quality plan is to elicit the customers expectations in terms of quality and prepare a proactive quality management plan to meet those expectations. The Quality Management Plan helps the project manager determine if deliverables are being produced to an acceptable quality level and if the project processes used to manage and create the deliverables are effective and properly applied.

Identify Quality Objectives


High level quality objectives should be identified and clearly defined. These are generally provided in a descriptive list format. State the quality objectives in terms of the project objectives and/or organizational objectives. Determine quality objectives for the product with the customer. There may be overall organizational quality objectives or policies that the project can reference.

Quality Control

A grid like the one illustrated above can be used to identify: The major deliverables of the project that will be tested for satisfactory quality level. The quality standards and the correctness and completeness criteria established for the project deliverable. Included are any organizational standards that need to be followed. The quality control activities that will be executed to monitor the quality of the deliverables.

How often or when the quality control activity will be performed.


This kind of grid is generally the meat of the project quality control section of the project management plan.

Quality Assurance

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The focus of quality assurance is on the processes used in the project. Quality assurance ensures that project processes are used effectively to produce quality project deliverables. The table identifies:
The project processes subject to quality assurance. The quality standards and stakeholder expectations for that process. The quality assurance activity such as a quality audit or reviews - that will be executed to monitor that project processes are properly followed. How often or when the quality assurance activity will be performed.

Quality Team Roles & Responsibilities

The following identifies the quality-related responsibilities of the project team and lists specific quality responsibilities. The section is meant to:

Identify the quality control and quality assurance roles and responsibilities for the project and actual resources assigned
Identify any quality-related tools used to support quality. Define the quality control and quality assurance problem reporting plan

Quality Tools

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The table above could be used to list the tools to be used to support quality management implementation and the purpose or use of the tool.

Quality Control and Assurance Problem Reporting Plan

Use quality control and quality assurance logs to itemize, document and track to closure items reported through quality management activities.

Exercise
Take each of the described sections and utilize the provided template to create a quality assurance project management plan for the sample health IT scenario in the next slide. Work in small groups. Each group will take 20 minutes to create their plan and 5 minutes to present it to the class.

Clinical Pharmacy Departmental System Scenario


Clinical department must replace / upgrade their current departmental system because the software company is sun setting the current product within 2 fiscal years. They must either move to the current companys next product line or find a new vendor. The system must have 24x7x365 availability. Current personnel: 50 pharmacists, 100 pharmacy technicians, 25 support personnel. Features of the system should include but not be limited to: 1. the ability to unidirectional interface with current admissions, 2. transfer and discharge (ADT) information system, 3. have the ability to admit patient if the ADT system is unavailable, 4. print customized patient medication labels, 5. unidirectional interface with the medication stocking robot for patient medication needs,

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6. bidirectional interfaces with the current billing, inventory control, and reporting systems, 7. medication alerting system for allergies, drug to drug, drug pregnancy, age, and other pharmacological alerts / interactions,

8. ability to attach documentation to any alerts / interactions, and bidirectional interface to 3rd party drug information system, secure backups, reporting for statistical and financial needs, and redundancy for disaster recovery.

Summary

TQM or Total Quality Management is a management concept created by W. Edwards Deming. Its goal is to reduce errors in manufacturing or service processes, increase customer satisfaction, streamline supply chain management, aim for modernization, and ensure that workers are trained to the highest levels. TQM is distinct from other approaches in that it ties to improve quality by ensuring conformance to internal requirements, while many other methods focus on reducing defects. Quality Culture is an important component of TQM and can be defined as a Company where all employees are keenly aware of the important of quality and continuous improvement. Understanding is a key element to introducing a quality culture. Organizational culture is an idea in the field of Organizational studies and management which describes the psychology, attitudes, experiences, beliefs and values (personal and cultural values) of an organization. It has been defined as "the specific collection of values and norms that are shared by people and groups in an organization and that control the way they interact with each other and with stakeholders outside the organization. ISO 9000 is a certification program through the international standards organization. The ISO 9000 family of standards has grown over the years and now includes various elements of the TQM philosophy. ISO 9000 is not full -blown TQM, but it is a valued certification that requires a great deal of diligence and documentation around quality process, assurance, and control within an organization. There are a variety of tools that can be used in conjunction with a project quality management plan in order to provide both quality control and quality assurance in projects. The tools discussed in this chapter can be applied immediately to projects of all types and can be implemented using standard MS Office Software Such as PowerPoint, Excel, Visio, and Project. The Quality Management Plan defines the acceptable level of quality, which is typically defined by the customer, and describes how the project will ensure this level of quality in its deliverables and work processes. This unit has provided a basic overview of each section of a project quality management plan.

References
Bennett-Staub A. Helping Residents Cope with a Patient Suicide. American Psychiatric Association. c2011. Available from: http://www.psych.org/Departments/EDU/ResidentMIT/orgsandterms.aspx

Deming W. The new economics: for industry, government, education. 2nd ed. 2000. MIT Press.
Deming W. Out of the Crisis. 2nd ed. 2000. MIT Press.

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DoIT. Project Management Advisor. Develop Quality Management Plan. c2006. Available from: http://www.pma.doit.wisc.edu/plan/3-2/what.html Fezeu L. Project Quality Management. Central Michigan University: Software Project Management. Available from: http://landconnector.com/SCHOOL/cps_Quality.html
ISO 9001:2008; Quality management systems Requirements; ISO Press. Juran J. Juran on Quality by Design. 1992. Simon & Schuster. Magrab E, Gupta S, McCluskey F, & Sandborn P. Process Design and Development: The Product Realization Process. 2010. CRC Press; Boca Raton, FL. Project Management Institute: A guide to the project management body of knowledge. 4th ed. Newtown Square, PA: PMI; 2008.

Schwalbe K. Information technology project management (with Microsoft Project 2007 CD-ROM). 6th ed.; 2009.
Scribd. Line Balancing What is it? Available from: http://www.scribd.com/doc/39457836/linebal Scribd. Seven Tools of Quality Control. Available from: http://www.scribd.com/doc/24650872/Seven-Tools-ofQuality-Control Stackpole C. A Users Manual to the PMBOK Guide. Wiley; 2010. Stackpole C. A project managers book of forms: a companion to the PMBOK guide. Wiley; 2009.

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