The ASQ Certified Quality Improvement Associate Handbook

THE ASQ CERTIFIED QUALITY IMPROVEMENT ASSOCIATE HANDBOOK

Fourth Edition

Grace L. Duffy and Sandra L. Furterer, Editors

Supports preparation for the ASQ Certified Quality Improvement Associate (CQIA) certification

ASQExcellence

Milwaukee, Wisconsin

Published by ASQExcellence, Milwaukee, WI

Produced and distributed by Quality Press, ASQ, Milwaukee, WI

Publisher’s Cataloging-in-Publication Data

Names: Duffy, Grace Landis, 1949– editor. | Furterer, Sandra L, 1960– editor.

Title: The ASQ certified quality improvement associate handbook, fourth edition / Grace L. Duffy and Sandra L. Furterer, editors

Description: Includes bibliographical references and index. | Milwaukee, WI: ASQ Excellence (produced and distributed by Quality Press), 2020

Identifiers: LCCN: 2020934312 | ISBN: 978-1-951058-09-8 (Quality Press Hardcover) | 978-1-951058-10-4 (Quality Press epub) | 978-1-951058-11-1 (Quality Press pdf) | 978-1-952236-03-7 (ASQ Excellence Hardcover) | 978-1-952236-04-4 (ASQ Excellence epub) | 978-1-952236-05-1 (ASQ Excellence pdf)

Subjects: LCSH Quality control—Handbooks, manuals, etc. | Quality assurance—Handbooks, manuals, etc. | BISAC TECHNOLOGY & ENGINEERING / Quality Control | STUDY AIDS / Professional | BUSINESS & ECONOMICS / Quality Control | BUSINESS & ECONOMICS / Organizational Behavior

Classification: LCC TS156.Q3 A77 2020 | DDC 658.5/62—dc23

No part of this book may be reproduced in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.

Publisher: Seiche Sanders

Managing Editor: Sharon Woodhouse

Sr. Creative Services Specialist: Randall L. Benson

ASQ and ASQExcellence advance individual, organizational, and community excellence worldwide through learning, quality improvement, and knowledge exchange.

Attention bookstores, wholesalers, schools, and corporations: Quality Press and ASQExcellence books, are available at quantity discounts with bulk purchases for business, trade, or educational uses. For information, please contact Quality Press at 800-248-1946 or books@asq.org.

To place orders or browse the selection of ASQExcellence and Quality Press titles, visit our website at http://www.asq.org/quality-press.

Preface

Members and leaders of the Quality Management Division (QMD) of the American Society for Quality (ASQ) acknowledge the continuing evolution of integration and use of organizational and process improvement throughout nearly every type of industry, organization, and organization level. However, at the same time, numerous occurrences of loss of quality focus are highlighted in the news media, such as the following:

Continued reports of automotive failures and safety issues

CEO and top management career derailments through poor leadership behavior

Lack of employee engagement, despite the plethora of leadership training programs

Instability of investment markets caused by negative corporate performance

Inadequate controls in the importing of food products, allowing tainted product to be sold

Building collapses throughout the world, killing hundreds

Clearly, much needs to be done to fully integrate quality into every process and aspect of life. In 2000, ASQ introduced the Certified Quality Improvement Associate (CQIA) certification. It is designed to introduce the basics of quality to organizations and individuals not currently working within the field of quality. This book and the Body of Knowledge it supports are intended to form a foundation for further study and application of proven quality principles and practices worldwide. Additionally, preparing for the CQIA exam and becoming certified may be viewed as the first step toward ultimately qualifying for one or several of the ASQ certifications available to ASQ members. If you are not yet a member of ASQ, we encourage you to consider joining, either you as an individual member or your entire organization as a member. Among other things, an ASQ professional member is entitled to the following:

ASQ Section Membership—Membership in one of ASQ’s local sections in the United States, Canada, and Mexico helps you meet and learn from people who work and live near you

ASQ Technical Communities—Participation in any or all of ASQ’s 26 technical communities

A wide range of technical community choices are available. These communities, often called Divisions, range from those representing a holistic approach to quality management (QMD, the sponsor of the CQIA certification and this book) to those representing industries, quality functions, and quality standards. Contact information follows:

ASQ—800-248-1946, http://www.asq.org—Visit the website for a membership application, to learn more about ASQ and all the benefits of membership, and to explore a plethora of information on quality principles and practices.

ASQ Quality Management Division—https://my.asq.org/communities/home/28/

Coeditors’ e-mail addresses—grace683@outlook.com and sfurterer@att.net

The ASQE Certification office has developed a certification pathway to help career quality professionals advance their skills within the discipline. The following graphic is intended to help quality practitioners choose the correct pathway for their career development. The certification section of the ASQ.org website provides detailed information on the content and qualifications for each of the career paths identified in the graphic.

Notes to the Reader

HIGHLIGHTS IN THE EVOLUTION OF QUALITY

The history of quality reaches back into antiquity.¹ This short overview starts with the current quality movement, which began in the 1920s. The quality profession, as it is called, started with Walter Shewhart of Bell Laboratories. He developed a system known as statistical process control (SPC) for measuring variance in production systems. SPC is still used to help monitor consistency and diagnose problems in work processes. Shewhart also created the Plan-Do-Check-Act (PDCA) cycle, which is a systematic approach to improving work processes. When the PDCA cycle is applied consistently, it can result in continuous process improvement.

During World War II, the U.S. War Department hired W. Edwards Deming, a physicist and U.S. Census Bureau researcher, to teach SPC to the defense industry. Quality control and statistical methods were considered critical factors in a successful war effort. Unfortunately, many companies in the United States stopped using these statistical tools after the war. Following World War II, the U.S. occupation forces in Japan invited Deming to help Japan with its census. He was also invited to present lectures to business leaders on SPC and quality. The Japanese acceptance and use of Deming’s techniques had a profound, positive effect on Japan’s economic recovery.

Two other American quality experts, Joseph M. Juran and Armand V. Feigenbaum, also worked with the Japanese. Both Deming and Juran (a former investigator at the Hawthorne Works experiments) drew on Shewhart’s work and recognized that satisfying the customer’s needs was important and that system problems could be addressed through three fundamental managerial processes: planning, control, and improvement. Feigenbaum stressed the need to involve all departments of a company in the pursuit of quality, a concept he called total quality control. The Japanese expanded Juran’s customer concept to include internal customers, those people within the organization who depend on the output of other workers.

Kaoru Ishikawa, a Japanese engineer and manager, expanded Feigenbaum’s ideas to include all employees, not just department managers, in the total quality control concept. Ishikawa also helped create quality circles, which are small teams of managers, supervisors, and workers trained in SPC, the PDCA cycle, and group problem solving. Applying these techniques created a flow of new ideas for improvement from everyone in the organization and continual incremental improvements that led to better performance. The quality circles were the original model for our current process improvement teams. By the 1970s, most large Japanese companies had adopted what Ishikawa called company-wide quality control (CWQC), resulting in a changed perception that Japan produced world-class quality products.

The Japanese success prompted American organizations to embrace the teachings of Deming, Juran, Feigenbaum, and other quality gurus and to apply their successful quality management techniques in many types of businesses. In the mid-1980s, American organizations began to experience improved quality results and enhanced customer satisfaction. In 1987, the criteria for the first Malcolm Baldrige National Quality Award were published. Within the same time period, ISO 9001, Quality systems—Model for quality assurance in design, development, production, installation, and servicing was published. These initiatives resulted in profound changes in the way the quality profession applies its principles and practices. Millions of copies of the Malcolm Baldrige National Quality Award criteria have been distributed, and many state and local quality award programs have developed their own programs that are based on the national award criteria. Although relatively few organizations actually apply for the national award, they use the criteria to evaluate and improve their quality management systems. Healthcare, Business/Nonprofit, and Education versions of the award criteria are now available, further expanding the use and value of the criteria.

In the 1980s, Motorola initiated a Six Sigma methodology. In the mid-1990s, companies such as General Electric and AlliedSignal launched their own Six Sigma initiatives. Since then, many companies have embraced the Six Sigma methodology. The term alludes to focusing on achieving a process that has no more than 3.4 defects per million opportunities. As a philosophy, Six Sigma is the belief that it is possible to produce totally defect-free products and services. This fourth edition of The Certified Quality Improvement Associate Handbook expands coverage of both Six Sigma and lean methods.

STRUCTURE OF THIS BOOK

The book follows the CQIA Body of Knowledge (BoK) in both content and sequence. The intent is that this book will serve as a guide for preparing the reader to take the CQIA examination given by ASQE. Each chapter stands alone, and the chapters may be read in any order. Some material reaching beyond the content of the BoK has been added. Supplemental reading suggestions are provided.

DIVERSITY

The use of the terms quality and continuous improvement is not considered solely applicable to manufacturing and the traditional engineering and production environment. Most professionals entering the workforce today are required to analyze situations, identify problems, and provide solutions for improved performance. Newer challenges have emerged, such as evolving technology, connectivity, and Quality 4.0. Improving the organization is considered everyone’s job. The service industry has embraced the value of quality strongly over the past 30 years. Teamwork is critical, requiring the participation of members of all cultures, educational levels, and career aspirations.

An attempt has been made to balance the use of personal pronouns as well as provide examples from a variety of organizations. The use of the term organization means that the content is considered generic—applicable to any type of entity. Where the term company is used, the content is more applicable to a for-profit enterprise.

PRACTICE

The 2020 CQIA BoK is presented in Appendix A and indicates the number of questions that will be asked about each major BoK segment and the maximum cognitive level to which the questions may be asked. Derived from Bloom’s taxonomy, the levels are as follows:²

Remember (Knowledge)

Understand (Comprehension)

Apply (Application)

Analyze (Analysis)

Evaluate (Evaluation)

Create (Synthesis)

It is recommended that you use the CQIA BoK as a guide for preparing for the examination. Use the topics, subtext, and the cognitive levels of Bloom’s taxonomy to perform a self-assessment of the required knowledge. Study this Certified Quality Improvement Associate Handbook and other references from which examination questions are developed so that you may gain a strong knowledge of the topics identified in the BoK. Having performed this initial study, use the BoK to focus on your level of comfort with the detailed information included in the subtext of each topic. Pay special attention to the cognitive level of knowledge required for each topic. Remembering requires much less familiarity with a topic than does a requirement to Apply or Analyze.

In addition to the content supporting the BoK, you are expected to be familiar with the ASQ Code of Ethics, found in Appendix B.

AVAILABILITY OF REFERENCE MATERIALS

All of the texts referenced in this handbook should be readily available from normal book sources, many from ASQ’s Quality Press. A website search will add a wealth of additional information. The U.S. government is an excellent source of quality-related materials that are available for downloading. Appendix D provides additional reading suggestions to enhance information shared in the ASQ CQIA website listing.

The list of references from which the certification exam test items are developed can be accessed at the following location: https://asq.org/cert/quality-improvement-associate/references.

NOTES

1. J. M. Juran, ed., A History of Managing for Quality (Milwaukee, WI: ASQC Quality Press, 1995).

2. B. S. Bloom, ed., Taxonomy of Educational Objectives: The Classification of Educational Goals, Handbook I, Cognitive Domain (New York: Longmans, Green, 1956). Additional information about Bloom’s taxonomy may be obtained from http://www.coun.uvic.ca/learning/exams/blooms-taxonomy.html.

About the Certified Quality Improvement Associate Exam

Each certification candidate is required to pass an examination that consists of multiple-choice questions that measure comprehension of the BoK:

Computer delivered—The CQIA examination is a one-part, 110-question, three-and-a-half-hour exam, and is offered in English only. One hundred questions are scored, and 10 are unscored.

Paper and pencil—The CQIA examination is a one-part, 100-question, three-hour exam, and is offered in English and, in certain locations, Spanish. View available translated exams, dates, and locations at the following link: https://asq.org/cert/dates-translated.

All examinations are open book. Each participant must bring his or her own reference materials. Use of reference materials and calculators is explained in the Frequently Asked Questions section of the ASQE certification web pages at https://asq.org/cert/faq.

Acknowledgments

Much gratitude is extended to those who contributed to the fourth edition:

John E. Bauer—coeditor, first and second editions

Grace L. Duffy—coeditor, first through fourth editions

Russ Westcott—coeditor, first through third editions

Sandra L. Furterer—coeditor, fourth edition

Sharon Woodhouse—managing editor, Quality Press

ASQ Quality Management Division, original sponsor of the CQIA BoK and The Certified Quality Improvement Associate Handbook

A Message from the ASQ QMD Chair

Welcome to the fourth edition of The ASQ Certified Quality Improvement Associate Handbook. The QMD supports this book as part of our mission to convey lifelong quality-related knowledge through information methods and tools that add value to organizations, society, and individuals. The CQIA BoK was originally developed through a partnership between ASQE Certification and the QMD. We continue this partnership by sponsoring the editors of this text and The ASQ Certified Manager of Quality/Organizational Excellence Handbook. Our desire is that all who study this material will grow their personal abilities and the excellence of the organizations they serve.

We applaud these editors who give tirelessly of their talents, expertise, and time to bring this resource to the quality community for the betterment of their fellow quality professionals and their organizations.

—Peggy Milz

Chair, ASQ Quality Management Division

Niceville, Florida, 2020

—Denis Devos

Chair Elect, ASQ Quality Management Division

London, ON, Canada, 2020

Part I

Quality Basics

Look beneath the surface, let not the quality nor its worth escape thee.

—Marcus Aurelius

We are what we repeatedly do. Excellence, then, is not an act, but habit.

—Aristotle

Quality is about making products that don’t come back for customers that do.

—Margaret Thatcher

Quality is free. It’s not a gift, but it’s free. What costs money are the unquality things—all the actions that involve not doing jobs right the first time.

—Philip B. Crosby

Defects are not free. Somebody makes them and gets paid for making them.

—W. Edwards Deming

Chapter 1

Terms, Concepts, and Principles

QUALITY DEFINITIONS

Describe and distinguish between the common definitions of quality. (Apply)

CQIA BoK 2020 I.A.1

There are many definitions of quality, such as the following:

Quality is a subjective term for which each person has his or her own definition. In technical usage, quality can have two meanings: (1) the characteristics of a product or service that bear on its ability to satisfy stated or implied needs, and (2) a product or service free of deficiencies.¹

Quality is the degree to which a set of inherent characteristics fulfills requirements.²

Quality is conformance to requirements.

Quality is fitness for use.

Quality is meeting customer expectations.

Quality is exceeding customer expectations.

Quality is superiority to competitors.

Quality—I know it when I see it.

In addition to these various meanings, quality may also be viewed from several dimensions:

Characteristics such as reliability, maintainability, and availability

Drivers of quality, such as standards

Quality of design versus quality of conformance to customers’ requirements

Quality planning, control, and improvement

Little q and Big Q quality (product or functional quality versus improvement of all organizational processes)

Quality as an organizational strategy

Many other quality-related terms are defined in Appendix C, Quality Glossary.

The two quality management system models most frequently used by quality professionals are (1) the Baldrige Performance Excellence Program Criteria³ and (2) the International Organization for Standardization (ISO) family of quality management system standards.⁴ These quality models provide an insight into the components of a quality management system and define quality as it is practiced today.

The Baldrige Framework and Performance Excellence Program (2019–2020): Criteria (Business Version)

The business version of the criteria can be used for profit as well as nonprofit organizations.

1 Leadership

1.1 Senior Leadership

1.2 Governance and Societal Contributions

The Leadership category examines how the personal actions of your organization’s senior leaders guide and sustain your organization. Also examined are the organization’s governance system and how your organization fulfills its legal, ethical, and societal contributions and supports its key communities.

2 Strategy

2.1 Strategy Development

2.2 Strategy Implementation

The Strategy category examines how your organization develops strategic objectives and action plans. Also examined are how your chosen strategic objectives and action plans are implemented and changed if circumstances require, and how progress is measured.

3 Customers

3.1 Customer Expectations

3.2 Customer Engagement

The Customers category examines how your organization engages its customers for long-term marketplace success. This engagement strategy includes how your organization listens to the voice of its customers, builds customer relationships, and uses customer information to improve and identify opportunities for innovation.

4 Measurement, Analysis, and Knowledge Management

4.1 Measurement, Analysis, and Improvement of Organizational Performance

4.2 Information and Knowledge Management

The Measurement, Analysis, and Knowledge Management category is the main point within the criteria for all key information about effectively measuring, analyzing, and reviewing performance and managing organizational knowledge to drive improvement and organizational competitiveness.

5 Workforce

5.1 Workforce Environment

5.2 Workforce Engagement

The Workforce category examines your ability to assess workforce capability and capacity and build a workforce environment conducive to high performance. Also examined are how your organization engages, manages, and develops your workforce to utilize its full potential in alignment with your organization’s overall mission, strategy, and action plans.

6 Operations

6.1 Work Processes

6.2 Operational Effectiveness

The Operations category examines how your organization designs, manages, and improves its work systems and processes to deliver customer value and achieve organizational success and sustainability. Also examined is your readiness for emergencies.

7 Results

7.1 Product and Process Results

7.2 Customer Results

7.3 Workforce Results

7.4 Leadership and Governance Results

7.5 Financial, Market, and Strategy Results

The Results category examines your organization’s performance and improvement in all key areas—product and process results; customer results; workforce results; leadership and governance results; and financial, market, and strategy results. Performance levels are examined relative to those of competitors and other organizations with similar product offerings.

In recent years the Baldrige Performance Excellence Program has been expanded to include criteria covering healthcare and educational organizations. Figure 1.1 is an overview of the integrated processes which comprise the Baldrige Performance Excellence Framework. Information on the program is available at https://www.nist.gov/baldrige. Other business excellence models/quality awards have also been developed internationally, such as The European Foundation for Quality Management (EFQM) and the Deming Award.

ASQ/ANSI/ISO/ Q9000 Quality Management Systems Principles

A quality management principle is a comprehensive and fundamental rule or belief for leading and operating an organization; it is aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all other stakeholders. There are seven quality management principles that form the basis of current international quality management requirements. These principles are paraphrased as follows:

Customer Focus—The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations

Leadership—Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization’s quality objectives

Engagement of People—Competent, empowered, and engaged people at all levels throughout the organization are essential to enhance the organization’s capability to create and deliver value

Process Approach—Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system

Improvement—Successful organizations have an ongoing focus on improvement

Evidence-Based Decision Making—Decisions based on the analysis and evaluation of data and information are more likely to produce desired results

Relationship Management—For sustained success, organizations manage their relationships with interested parties, such as providers

A side-by-side review of the Baldrige and ISO 9000:2015 quality models reveals many similarities. They both stress strong organizational leadership; a focus on customers; the development and involvement of the organization’s people; gathering, analyzing, and using information to make decisions; and process management. Together these characteristics define quality as it is practiced in many successful organizations. The Baldrige Performance Excellence Award and ISO 9000 have distinctly different purposes and approaches; however, they can be mutually reinforcing when properly used. The Baldrige criteria encompass the whole organization and its stakeholders as a total system, and the Malcolm Baldrige Performance Excellence Program is a business model for achieving world-class excellence. ISO 9000 focuses on the minimum requirements for a quality system needed to produce products and services that meet customer requirements. Many organizations use both the Baldrige award criteria and the ISO 9000 series standards to achieve their business strategic plans and goals.

QUALITY PLAN

Define a quality plan, describe its purpose and objectives to achieve the quality mission or policy. Identify the various functional areas and people having responsibility for contributing to its development. (Understand)

CQIA BoK 2020 I.A.2

A quality plan is defined as documented information that provides the activities or methods to be undertaken to achieve objectives and meet specified requirements. Another, more operational definition is the document, or documents, setting out the specific quality practices, resources, specifications, and sequence of activities relevant to a particular product, project, or contract.

A quality plan helps you schedule all the tasks needed to make sure that the product or service meets the needs of your customer. It is composed of two parts:

The quality assurance plan lists the independent/external reviews needed

The quality control plan lists the internal reviews needed to meet your quality targets

Quality assurance (QA) plans are planned, systematic, documented activities necessary to provide adequate confidence that the product or service will meet the given requirements. These plans may be voluntary, such as partnering with other like companies in the community to provide independent audits of processes, documentation, or service delivery. More often, QA plans include scheduled and required external audits, such as those carried out by ISO 9001:2015 auditors, the Joint Commission for Healthcare, or the Public Health Accreditation Board.

Quality control (QC) plans provide techniques and perform activities that focus on controlling or regulating processes and materials to fulfill requirements for quality. The focus is on preventing defective products or services from being passed on. An example of a QC plan would be a checklist of features and criteria for incoming inspection of parts to be used for production of a manufactured device.

Creating a quality plan is essential if you want to generate customer confidence that you will produce a solution that meets their needs. Quality planning is the process of developing a master plan linked to organizational strategy, goals, and objectives that pertain to the quality of products or services to be delivered to customers. The quality plan includes key requirements, performance indicators, and commitment of resources to ensure that customer needs are met. The quality plan often consists of several related documents.

Although it is separate from the three phases of organizational planning (strategic, tactical, and operational), quality planning is dependent on the decisions made and processes established by management during these phases. Key quality requirements and performance indicators must be established in the design, development, and implementation of all products and services for final customer delivery. Quality initiatives must be understood in their relation to all three levels of the organization: strategic planning, tactical planning, and operational planning. Figure 1.2 provides an overview of the scope of planning activities for each of the three levels.

Strategic planning deals with developing the long-range strategies of the organization:

The organization’s overall strategic mission, goals, policies, and objectives

External customers’ needs and expectations

The needs and expectations of internal stakeholders (employees, shareholders, and so on)

Risks that must be considered

Regulatory requirements

Competitors’ capabilities

Business systems, including quality, security, and safety systems needed to operate the organization effectively and efficiently

Strategic planning is conducted by the senior executive leadership of the organization. Corporate strategic planning will include the chief executive officer, chief operating officer, chief financial officer, chief quality officer, and senior vice presidents of all core functions, as well as human resources, facilities, supply chain, and marketing within the corporate organization. In a publicly held organization, the senior members of the board of directors may also be included. Occasionally, senior executives from key client organizations may be asked to contribute to the long-range plans for product and service development.

Tactical planning (sometimes called action or project planning) deals with translating strategic objectives into actionable activities that must occur, on a short-term basis, to support the achievement of the strategic plans. There are measurable steps and events that result from the downward deployment of the strategic plans:

The achievement of strategic mission, policies, and objectives

Measurable quality and safety indicators and targets

Product and service features

Process capability

Quality control points

Unique tools or equipment required

Typical short-term plans

Quality of new products/process introduction

Impact of digitization aspects

Impact of critical outsourcing on the process capability of the main supplier

Operational planning deals with developing day-to-day operating procedures that ensure the quality of individual products and services. Operational plans address numerous areas:

Resources needed to develop and create the organization’s products and services

Materials and supplies required for creating and delivering the products and services

Knowledge and skills required of employees

Processes and procedures required to create the organization’s products and services as well as to run the business effectively in transactional areas such as finance, human resources, and legal

Unique tools or equipment required

Documentation (specifications, standards, drawings, visual aids, and so on) required

Examination, inspection, or testing requirements

Administrative support and follow-up for customer communication

Records required to document the creation of the organization’s products and services

Process improvement methods to continually improve the organization’s deliverables

Customer-Specific Quality Planning

At the day-to-day level, meeting a specific customer’s requirements sometimes requires a quality plan for an individual contract or purchase order. To develop such a working plan means looking at the particular requirements of the order and determining the resources (time, materials, equipment, process steps, skills, and so on) that will be required to complete the individual transaction to the customer’s satisfaction and provide an adequate return on the resource investment. This type of quality plan is usually completed as part of an organization’s process for providing quotes on new or repeat work for its customers.

Overall, a consistent planning, monitoring, and reviewing approach is required for organizations using established quality systems based on criteria such as the Baldrige Performance Excellence Program or the ISO 9001:2015 standard. The approach taken by an organization becomes the guiding policy in producing a valued product or service that remains competitive in the marketplace. The planning must include the following:

A comprehensive focus on customer needs and expectations

Support of quality goals and strategies by upper management

A balance of resources between short-term and long-term requirements, including capital expenditures, training, and continual improvement

The assessment of risk based on decisions concerning the balance of resources allocated within the organization

Ongoing interpretation of long-term goals and tactical and operating plans

Development and execution of processes for evaluation and process improvement

Integration of quality activities into the daily work of the front-line associates

QUALITY SYSTEMS

Understand the difference and relationship between quality assurance, quality control, and continuous quality improvement. (Understand)

CQIA BoK 2020 I.A.3

Continuous quality improvement (CQI) is beneficial no matter what stage of organizational maturity we are in. If we are just picking out the bad stuff as in inspection, we improve by reworking the product or by apologizing and providing the service again to the client. Quality control (QC) is improved by adding error-proofing, so that we catch the process degrading before we ruin too much product or harm too many clients. Quality assurance (QA) does more training to anticipate that the process may degrade or that we may have errors occurring in our processes. Quality planning (QP) is the best way to design the process right the first time and then put the other QA, QC, and QI safeguards in place once the quality plan has been tested and validated. We can improve what we do at any of the stages of inspection, control, assurance, or planning. The most cost-effective and best for customer satisfaction is to do it as early as possible so that we are not wasting resources or annoying stakeholders.

Historically, quality authors have used the term QI for two conflicting activities. The preferred use of QI is to refer to continuous quality improvement. Modern quality approaches seek to reduce the use of quality inspection in deference to more preventive activities such as QA and QC. Note that this text uses QI to refer to both continuous quality improvement and quality inspection because both approaches must be explained in this section. Differentiation is made by the reader based on context.

Quality Improvement or Continuous Quality Improvement—(QI or CQI)— refers to analyzing capabilities and processes and improving them repeatedly to achieve customer satisfaction:

QI involves both prospective and retrospective reviews

QI is aimed at improvement—measuring where you are, and figuring out ways to make things better

QI specifically attempts to avoid attributing blame

QI pursues ways to prevent errors from happening

QI exists harmoniously with both QA and QC

As we become less preventive and more reactive, the cost of making it right goes up immensely in either dollars or reputation. The worst is to make an error in front of the client or community. Less worse is to catch the error as it happens or pick out the bad product before anybody sees it. The best approach is to never make the mistake to begin with. The following statements contrast (continuous) quality improvement with quality inspection:

Quality improvement is by far the preferred function

Inspection catches only errors that have already been made

Improvement studies the process as it is designed to correct or redesign activities before an error is made or resources are wasted

One definition of quality assurance is all the planned and systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality.

Quality assurance (QA) is proactive, tactical, and preventive in nature:

QA activities are focused on the design of the process used to create the deliverable

QA must be performed to ensure that the deliverables meet your customer’s quality requirements before resources are expended to create the product or service

The following are QA functions:

Identifying customer requirements

Gaining customer agreement with the targets set

Documentation planning

Measurement planning

Risk management planning

Problem resolution planning

Configuration management planning

Product/service development planning

Test planning

Subcontractor management planning

Audit/review of product and service plans to ensure they follow the defined process

Approval of deviations from defined standards

Process improvement assessments

One definition of quality control is the operational techniques and activities used to fulfill requirements for quality.

Quality control (QC)—sustains the quality of a product or service:

QC activities focus on appraising the process as it creates the deliverable

QC is an operational level activity to observe the creation of products or services to keep the process from degrading

QC verifies that deliverables are created using acceptable quality methods and meet design requirements

QC may not always occur in real time; error-proofing is part of QC when parts are manufactured to go together in a specific way

Verification and validation activities identify where action may be required

The following are QC functions:

Develop sampling plans

Train inspectors

Develop checklists

Set quality acceptance levels

Identify and dispose of defective products

Quality inspection is the activity of searching for errors or defects after the product or service has been created. Usually most or all of the resources required to produce the product or service have been expended, and either rework or waste is generated to correct the errors.

Quality Inspection (QI)—assesses the finished product or service against specified requirements:

Measuring, examining, testing, and gauging one or more characteristics of a product or service and comparing the results with specified requirements to determine whether conformity is achieved for each characteristic

The recent ability to rapid prototype and print in 3D has broadened opportunities for inspection without incurring the traditional waste of resources experienced in the past

The following are quality inspection functions:

Inspecting products and services, including gathering information for current state analysis

Removing defective product from inventory

Observing service errors experienced by the customer

Segregating bad product from good product

Disposing of wasted resources through recycling, discounting, or trash

Sometimes quality assurance and quality control are used interchangeably, referring to the actions performed to ensure the quality of a product, service, or process. This is not accurate, as quality assurance addresses the prevention of defects through designing quality into the product or service before resources are committed to making the product or providing the service, and quality control describes activities that are performed to maintain process requirements during the manufacture of product or delivery of service. Control is more operational than assurance.

Continuous quality improvement