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CMQ-OE Manager of Quality/Organizational Excellence Certification learner |

CMQ-OE learner - Manager of Quality/Organizational Excellence Certification Updated: 2023

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Exam Code: CMQ-OE Manager of Quality/Organizational Excellence Certification learner November 2023 by team

CMQ-OE Manager of Quality/Organizational Excellence Certification

Exam ID : CMQ-OE


The Certified Manager of Quality/Organizational Excellence is a professional who leads and champions process-improvement initiatives - everywhere from small businesses to multinational corporations - that can have regional or global focus in a variety of service and industrial settings.

A Certified Manager of Quality/Organizational Excellence facilitates and leads team efforts to establish and monitor customer/supplier relations, supports strategic planning and deployment initiatives, and helps develop measurement systems to determine organizational improvement.

The Certified Manager of Quality/Organizational Excellence should be able to motivate and evaluate staff, manage projects and human resources, analyze financial situations, determine and evaluate risk, and employ knowledge management tools and techniques in resolving organizational challenges.

The Certified Manager of Quality/Organizational Excellence evolved from the certified quality manager as a way to broaden the scope of the examination. The Quality Management Division surveyed certified quality managers and other recognized subject matter experts.

A. Organizational Structures Define and describe organizational designs (e.g., matrix, flat, and parallel) and the effect that a hierarchical management structure can have on an organization. (Apply)

B. Leadership Challenges

1. Roles and responsibilities of leadersDescribe typical roles, respon-sibilities, and competencies of people in leadership positions and how those attributes influence an organizations direction and purpose. (Analyze)

2. Roles and responsibilities of managersDescribe typical roles, responsibilities, and competencies of people in management positions and how those attributes contribute to an organizations success. (Analyze)

3. Change managementUse various change management strategies to overcome organiza-tional roadblocks, assess impacts of global changes, achieve desired change levels, and review outcomes for effectiveness. Define and describe factors that contribute to an organizations culture. (Evaluate)

4. Leadership techniques Develop and implement techniques that motivate employees and sustain their enthusiasm. Use negotiation techniques to enable parties with different or opposing outlooks to recognize common goals and work together to achieve them. Determine when and how to use influence, critical thinking skills, or Socratic questioning to resolve a problem or move a project forward. (Create) courses in this new body of knowledge (BoK) include descriptive details (subtext) that will be used by the exam Development Committee as guidelines for writing test questions. This subtext is also designed to help candidates prepare for the exam by identifying specific content within each subject that may be tested. The subtext is not intended to limit the subject matter or be all-inclusive of what might be covered in an exam but is intended to clarify how the courses relate to a managers role. The descriptor in parentheses at the end of each entry refers to the maximum cognitive level at which the subject will be tested. A complete description of cognitive levels is provided at the end of this document.BODY OF KNOWLEDGECertified Manager of Quality/Organizational Excellence (CMQ/OE)

5. Empowerment Apply various techniques to empower individuals and teams. Identify typical obstacles to empowerment and appropriate strategies for overcoming them. Describe and distinguish between job enrichment and job enlargement, job design, and job tasks. (Analyze)

C. Teams and Team Processes

1. Types of teamsIdentify and describe different types of teams and their purpose, including process improvement, self-managed, temporary or ad hoc (special project), virtual, and work groups. (Understand)

2. Stages of team developmentDescribe how the stages of team development (forming, storming, norming, performing) affect leadership style. (Apply)

3. Team-building techniquesApply basic team-building steps such as using ice-breaker activities to enhance team introductions and membership, developing a common vision and agreement on team objectives, and identifying and assigning specific roles on the team. (Apply)

4. Team roles and responsibilities Define and describe typical roles related to team support and effectiveness such as facilitator, leader, process owner, champion, project manager, and contributor. Describe member and leader responsibilities with regard to group dynamics, including keeping the team on task, recognizing hidden agendas, handling disruptive behavior, and resolving conflict. (Analyze)

5. Team performance and evaluation Evaluate team performance in relation to established metrics to meet goals and objectives. Determine when and how to reward teams and celebrate their success. (Evaluate)

D. ASQ Code of EthicsIdentify and apply behaviors and actions that comply with this code. (Apply)

II. Strategic Plan Development and Deployment (22 Questions)

A. Strategic Planning ModelsDefine, describe, and use basic elements of strategic planning models, including how the guiding principles of mission, vision, and values relate to the plan. (Apply)

B. Business Environment Analysis

1. Risk analysisAnalyze an organizations strengths, weaknesses, opportunities, threats, and risks, using tools such as SWOT. Identify and analyze risk factors that can influence strategic plans. (Analyze)

2. Market forces Define and describe various forces that drive strategic plans, including existing competition, the entry of new competitors, rivalry among competitors, the threat of substitutes, bargaining power of buyers and suppliers, current economic conditions, global market changes, and how well the organization is positioned for growth and changing customer expectations. (Apply)

3. Stakeholder analysis Identify and differentiate the perspectives, needs, and objectives of various internal and external stakeholders. Ensure that the organizations strategic objectives are aligned with those of the stakeholders. (Analyze)

4. Technology Describe how changes in technology can have long-term and short-term influences on strategic planning. Identify new and upcoming technologies that may impact business strategy and quality, such as automation, autonomation, Quality 4.0, cloud computing, or machine learning. (Understand)

5. Internal capability analysisIdentify and describe the effects that influence an organizations internal capabilities: human resources, facilities capacity, and operational capabilities. Analyze these factors in relation to strategy formation. (Analyze)

6. Legal and regulatory factors Define and describe how legal and regulatory factors can influence strategic plans. (Understand)

C. Strategic Plan Deployment

1. Tactical plans Identify basic characteristics of tactics: specific, measurable, attainable, relevant, and time-specific, and how these are linked to strategic objectives. Evaluate proposed plans to determine whether they meet these criteria. (Evaluate)

2. Resource allocation and deploymentEvaluate current resources to ensure they are available and deployed in support of strategic initiatives. Identify and eliminate administrative barriers to new initiatives. Ensure that all internal stakeholders understand the strategic plan and have the competencies and resources to carry out their responsibilities. (Evaluate)

3. Organizational performance measurementDevelop measurements and ensure that they are aligned with strategic goals, and use the measures to evaluate the organization against the strategic plan. (Evaluate)

4. Quality in strategic deployment Support strategic plan deployment by applying continuous improvement and other quality initiatives to drive performance outcomes throughout the organization. (Create)

III. Management Elements and Methods (31 Questions)

A. Management Skills and Abilities

1. Principles of managementEvaluate and use basic management principles such as planning, leading, delegating, controlling, organizing, and allocating resources. (Evaluate)

2. Management theories and styles Define and describe management theories such as scientific, organizational, behavioral, learning, systems thinking, and situational complexity. Define and describe management styles such as autocratic, participative, transactional, transformational, management by fact, coaching, and contingency approach. Describe how management styles are influenced by an organizations size, industry sector, culture, and competitors. (Apply)

3. Interdependence of functional areas Describe the interdependence of an organizations areas (human resources, engineering, sales, marketing, finance, research and development, purchasing, information technology, logistics, production, and service) and how those dependencies and relationships influence processes and outputs. (Understand)

4. Human resources (HR) management Apply HR elements in support of ongoing professional development and role in quality system: setting goals and objectives, conducting performance evaluations, developing recognition programs, and ensuring that succession plans are in place where appropriate. (Apply)

5. Financial managementRead, interpret, and use various financial tools including income statements, balance sheets, and product/service cost structures. Manage budgets and use the language of cost and profitability to communicate with senior management. Use potential return on investment (ROI), estimated return on assets (ROA), net present value (NPV), internal rate of return (IRR), and portfolio analysis to analyze project risk, feasibility, and priority. (Analyze)

6. Risk managementIdentify the kinds of risk that can occur throughout the organization, from such diverse processes as scheduling, shipping/receiving, financials, production and operations, employee and user safety, regulatory compliance and changes. (Apply)

7. Knowledge management (KM)Use KM techniques in identifying core competencies that create a culture and system for collecting and sharing implicit and explicit knowledge among workers, stakeholders, competitors, and suppliers. Capture lessons learned and apply them across the organization to promote best practices. Identify typical knowledge-sharing barriers and how to overcome them. (Apply)

B. Communication Skills and Abilities

1. Communication techniquesDefine and apply various modes of communication used within organizations, such as verbal, non-verbal, written, and visual. Identify factors that can inhibit clear communication and describe ways of overcoming them. (Apply)

2. Interpersonal skillsUse skills in empathy, tact, friendliness, and objectivity. Use open-minded and non-judgmental communication methods. Develop and use a clear writing style, active listening, and questioning and dialog techniques that support effective communication. (Apply)

3. Communications in a global economyIdentify key challenges of communicating across different time zones, cultures, languages, terminology, and business practices, and present ways of overcoming them. (Apply)

4. Communications and technology Identify how technology affects communications, including improved information availability, its influence on interpersonal communications, and etiquette for e-communications. Deploy appropriate communication methods within virtual teams. (Apply)

C. Project Management

1. Project management basicsUse project management methodology and ensure that each project is aligned with strategic objectives. Plan the different phases of a project: initiation, planning, execution, monitoring and controlling, and closure. Ensure the project is on-time and within budget. Consider alternate project management methodologies (linear, evolutionary, or iterative) as they apply to the project. (Evaluate)

2. Project planning and estimation tools Use tools such as risk assessment matrix, benefit-cost analysis, critical path method (CPM), Gantt chart, PERT, and work breakdown structure (WBS) to plan projects and estimate related costs. (Apply)

3. Measure and monitor project activity Use tools such as cost variance analysis, milestones, and actual vs. planned budgets to monitor project activity against project plan. (Evaluate)

4. Project documentation Use written procedures and project summaries to document projects. (Apply)D. Quality System1. Quality mission and policyDevelop and monitor the quality mission and policy and ensure that it is aligned with the organizations broader mission. (Create)

2. Quality planning, deployment, and documentation Develop and deploy the quality plan and ensure that it is documented and accessible throughout the organization. (Create)

3. Quality system effectiveness Evaluate the effectiveness of the quality system using various tools: balanced scorecard, internal audits, feedback from internal and external stakeholders (including stakeholder complaints), warranty/return data analytics, product traceability and recall reports, and management reviews. (Evaluate)

E. Quality Models and Theories

1. Quality management standards Describe and apply the requirements and basic principles of ISO 9000-based standards used to support quality management systems. (Apply)

2. Performance excellence modelsDefine and describe common elements and criteria of performance excellence models such as the European Excellence Award (EFQM), Excellence Canada, ASQ International Team Excellence Award (ITEA), or Malcolm Baldrige National Quality Award (MBNQA). Describe how their criteria are used as management models to Improve processes at an organization level. (Understand)

3. Other quality methodologiesDescribe and differentiate methods such as total quality management (TQM), continuous improvement, and benchmarking. (Apply)

4. Quality philosophies Describe and apply basic methodologies and theories proposed by quality leaders such as Shewhart, Deming, Juran, Crosby, Feigenbaum, and Ishikawa. (Apply)

IV. Quality Management Tools (30 Questions)

A. Problem-Solving Tools

1. The seven classic quality tools Select, interpret, and evaluate output from these tools: Pareto charts, cause and effect diagrams, flowcharts, control charts, check sheets, scatter diagrams, and histograms. (Evaluate)

2. Basic management and planning toolsSelect, interpret, and evaluate output from these tools: affinity diagrams, tree diagrams, process decision program charts (PDPCs), matrix diagrams, prioritization matrices, interrelationship digraphs, and activity network diagrams. (Evaluate)

3. Process improvement tools Select, interpret and evaluate tools such as root cause analysis, Kepner-Tregoe, PDCA, six sigma DMAIC (define, measure, analyze, improve, control), and failure mode and effects analysis (FMEA). (Evaluate)

Certified Manager of Quality/Organizational Excellence

4. Innovation and creativity toolsUse various techniques and exercises for creative decision-making and problem-solving, including brainstorming, mind mapping, lateral thinking, critical thinking, the 5 whys, and design for six sigma (DFSS). (Apply)

5. Cost of quality (COQ)Define and distinguish between prevention, appraisal, internal, and external failure cost categories and evaluate the impact that changes in one category will have on the others. (Evaluate)

B. Process Management

1. Process goalsDescribe how process goals are established, monitored, and measured and evaluate their impact on product or service quality. (Evaluate)

2. Process analysisUse various tools to analyze a process and evaluate its effectiveness on the basis of procedures, work instructions, and other documents. Evaluate the process to identify and relieve bottlenecks, increase capacity, Improve throughput, reduce cycle time, and eliminate waste. (Evaluate)

3. Lean tools Identify and use lean tools such as 5S, just-in-time (JIT), kanban, value stream mapping (VSM), quick-changeover (single-minute exchange of die), poke-yoke, kaizen, standard work (training within industry), and productivity (OEE). (Apply)

4. Theory of constraints (TOC)Define key concepts of TOC: systems as chains, local vs. system optimization, physical vs. policy constraints, undesirable effects vs. core problems, and solution deterioration. Classify constraints in terms of resources and expectations as defined by measures of inventory and operating expense. (Understand)

C. Measurement: Assessment and Metrics

1. Basic statistical use Use statistical techniques to identify when, what, and how to measure projects and processes. Describe how metrics and data gathering methods affect resources and vice-versa. (Apply)

2. Sampling Define and describe basic sampling techniques such as random and stratified. Identify when and why sampling is an appropriate technique to use. (Understand)

3. Statistical analysisCalculate basic statistics: measures of central tendency (mean, median, mode) and measures of dispersion (range, standard deviation, and variance). Identify basic distribution types (normal, bimodal, skewed) and evaluate run charts, statistical process control (SPC) reports, and other control charts to make data-based decisions. (Evaluate)

4. Measurement systems analysis Understand basic measurement terms such as accuracy, precision, bias, and linearity. Understand the difference between repeatability and reproducibility in gauge R&R studies. (Understand)

5. Trend and pattern analysisInterpret graphs and charts to identify cyclical, seasonal, and environmental data trends. Evaluate control chart patterns to determine shifts and other trend indicators in a process. (Evaluate)

6. Process variationAnalyze data to distinguish between common and special cause variation. (Analyze)

7. Process capabilityRecognize process capability (Cpand Cpk,) and performance indices (Pp and Ppk). (Understand)

Certified Manager of Quality/Organizational Excellence

8. Reliability terminology Define and describe basic reliability measures such as infant mortality, end of life (e.g. bathtub curve), mean time between failures (MTBF), and mean time to repair (MTTR). Understand the value of estimating reliability to meet requirements or specifications.

NOTE: Reliability calculations will not be tested. (Understand)

V. Customer-Focused Organizations (21 Questions)

A. Customer Identification and Segmentation

1. Internal customers Define internal customers and describe the impact an organizations treatment of internal customers will have on external customers. Evaluate methods for influencing internal customers to Improve products, processes, and services and evaluate the results. (Evaluate)

2. External customers Define external customers and describe their impact on products and services. Evaluate strategies for working with them and integrating their requirements and needs to Improve products, services, and processes. (Evaluate)

3. Customer segmentationDescribe and assess the process of customer segmentation and its impact on aligning service and delivery to meet customer needs. (Evaluate)

4. Qualitative assessmentIdentify subjective information such as verbatim comments from customers, observation records, and focus group output. Describe how the subjective information differs from objective measures and determine when data should be captured in categories rather than numeric value. (Analyze)

B. Customer Relationship Management

1. Customer needs Use quality function deployment (QFD) to capture the voice of the customer (VOC) and examine customer needs in relation to products and services offered. Analyze the results to prioritize future development in anticipation of changing customer needs. (Analyze)

2. Customer satisfaction and loyaltyDevelop systems to capture positive and negative customer feedback and experiences, using tools such as listening posts, focus groups, complaints and warranty data, surveys, and interviews. Use customer value analysis to calculate the financial impact of existing customers and the potential results of losing those customers. Develop corrective actions and proactive methods to Improve customer satisfaction, loyalty, and retention levels. (Create)

3. Customer service principles Demonstrate strategies that support customer service principles: courtesy, politeness, smiles, cheerfulness, attention to detail, active listening, empathy, rapid response, and easy access for information and service. (Apply)

4. Multiple and diverse customer managementEstablish and monitor priorities to avoid or resolve conflicting customer requirements and demands. Develop methods and systems for managing capacity and resources to meet the needs of multiple customers. Describe the impact that diverse customer groups can have on all aspects of product and service development and delivery. (Evaluate)

VI. Supply Chain Management (17 Questions)

A. provider Selection and ApprovalDefine and outline criteria for selecting, approving, and classifying suppliers, including internal rating programs and external certification standards. (Analyze)

B. provider Risk Management Assess and manage provider risk and the impact it may have on various internal processes of the organization. (Evaluate)

C. provider CommunicationsPrepare and implement specific communication methods with suppliers, including regularly scheduled meetings and routine and emergency reporting procedures. Direct, communicate, and confirm explicit expectations so that the provider is aware of critical product and delivery requirements. (Apply)

D. provider PerformanceDefine, assess, and monitor provider performance in terms of quality, cost, delivery, and service levels, and establish associated metrics for defect rates, product reliability, functional performance, timeliness, responsiveness, and availability of technical support. (Evaluate)

E. provider ImprovementDefine and conduct provider audits, evaluate corrective and preventive action plans, provide feedback, and monitor process improvements. (Evaluate)

F. provider Certification, Partnerships, and AlliancesDefine, appraise, and implement provider certification programs that include process reviews and performance evaluations. Outline strategies for developing customer-supplier partnerships and alliances. (Evaluate)

G. provider Logistics and Material AcceptanceDescribe the impact purchased products and services can have on final product assembly or total service package, including ship-to-stock and just-in-time (JIT). Describe the incoming material inspections process. (Understand)

VII. Training and Development (16 Questions)

A. Training PlansDevelop and implement training plans that are aligned with the organizations strategic plan and general business needs, including leadership training and alignment of personal development plans. (Create)

B. Training Needs AnalysisUse various tools and techniques such as surveys, performance reviews, regulatory guidances, and gap analyses to identify and assess training needs. (Evaluate)

C. Training Materials, Development, and DeliveryUse various tools, resources, and methodologies to develop training materials and curriculum that address adult learning principles and the learning needs of an increasingly diverse workforce. Describe various methods of training delivery: classroom, workbooks, simulations, computer-delivered, on-the-job, and self-directed. Use mentoring and coaching to support training outcomes. (Apply)

D. Training Effectiveness and EvaluationAssess training effectiveness and make improvements based on feedback from training sessions, end-of-course test results, on-the-job behavior or performance changes, and departmental or area performance improvements. (Evaluate)
Manager of Quality/Organizational Excellence Certification
ASQ Quality/Organizational learner

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Manager of Quality/Organizational(R) Excellence Certification
Answer: D
Question: 169
A chairperson may be a leader and/or manager, depending much upon the
influence he or she may have on an organization and the decision
authority granted. There are many roles a manager may perform. As an
organizer he/she:
A. Organizes, people, ideas and things to achieve the enterprises
B. Builds an enterprise structure that supports the strategic goals and
C. Embraces the principles, morals, and norms of the society in which
organization impacts
D. Imparts knowledge and teaches skills to others
Answer: A
Question: 170
All organizations have limited resources and opportunities, and must
allocate them so as to best accomplish the mission with high efficiency.
A possible solution is:
A. To ensure the strategic and operational plans clearly indicate the
priorities and strategies for the organization
B. To communicate, communicate, and communicate!
C. To ensure that authority levels are clearly spelled out for typical
D. To have employees go outside the organizational walls
Answer: A
Question: 171
In a typical organization, there are many different strategies and people
put their focus where it seems best placed, but this may not agree with
what is actually expected or desired. A possible solution for such a
situation is:
A. To ensure the strategic and operational plans clearly indicate the
priorities and strategies for the organization
B. To communicate, communicate, and communicate!
C. To ensure that authority levels are clearly spelled out for typical
D. To have employees go outside the organizational walls
Answer: B
Question: 172
Although an organization may have clearly communicated plans and
have good cross functional relationships but because of vertical
communication alignment of goals and activities is often slower. A
possible solution to this issue is:
A. To ensure the strategic and operational plans clearly indicate the
priorities and strategies for the organization
B. To communicate, communicate, and communicate!
C. To ensure that authority levels are clearly spelled out for typical
D. To have employees go outside the organizational walls
Answer: C
Question: 173
In an organization, the members do have generally inward focus. The
day-to-day attention of many members of the organization may not get
external focus to look for ideas, support and feedback. The possible
solution for such a situation may be:
A. To ensure the strategic and operational plans clearly indicate the
priorities and strategies for the organization
B. To communicate, communicate, and communicate!
C. To ensure that authority levels are clearly spelled out for typical
D. To have employees go outside the organizational walls
Answer: D
Question: 174
Managing change is particularly complex due to the fact that much of
what must be changed often consists of intangibles such as beliefs,
behavior s and policies. These types of constraints are more difficult to
identify. We can get help from:
A. GATT chart
B. PERT chart
C. A force-field analysis
D. None of these
Answer: C
Question: 175
A modification of Lewins unfreezing-moving-refreezing model may
provide support for change. According to this model there are following
ways to reduce change resistance Except:
A. Understand the emotional impact of change
B. Understand the impact of change to intellectual property
C. Be consistent in responding to resistance
D. Be flexible, be patient and be supportive
Answer: B
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ASQ Quality/Organizational learner - BingNews Search results ASQ Quality/Organizational learner - BingNews ASQ Learning (American Society of Quality) Lean Six Sigma Online Training & Certifications

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Cost: Purchase

Certification Available: Yes

Course Level: Introductory through Expert

Prerequisites: None

Administered By: ASQ


ASQ (American Society for Quality) is a global professional association that provides resources, certifications, training, and networking opportunities for quality professionals, promoting excellence in quality management and continuous improvement across industries.

What You'll Learn

ASQ offers Quality basics, tools, auditing, management, provider quality, ISO, auditing, certifications. Certifications for Green Belt, Black Belt, and Master Black Belt and associated training.
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Quality & Organizational Structure

Bert Markgraf is a freelance writer with a strong science and engineering background. He started writing technical papers while working as an engineer in the 1980s. More recently, after starting his own business in IT, he helped organize an online community for which he wrote and edited articles as managing editor, business and economics. He holds a Bachelor of Science degree from McGill University.

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Total Quality Organization of All Levels of Management

Carolyn Gray started writing in 2009. Her work history includes line and staff management in the Finance and Controller's Department of New York Telephone and NYNEX. Gray has a Bachelor of Arts in government from Clark University and a Master of Business Administration from New York University's Stern School of Business in Management and Organization Behavior.

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Quality Management Certificate

Poor quality in manufacturing and service can cost companies as much as 20 percent of revenue in rework, scrap, brand switching, and loss of goodwill. Organizations have begun to understand that prevention saves more time and money than the discovery of flaws after the fact.

The school’s management-oriented certificate program focuses on quality as a priority. Developed in cooperation with industry, the courses can help students develop a total quality management environment to combine the theory and practice of statistical quality control with leadership, teamwork, and problem-solving concepts and skills.

The certificate in quality management teaches the nuts and bolts of a quality organization, prepares students to introduce quality concepts to their organization, and teaches how to put quality principles to work. The certificate can prepare students to work as quality trainers, facilitators, team leaders, or managers at various levels of an organization.

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The Rising Economic Power of Quality: How Quality Ensures Growth and Enhances Profitability
The Rising Economic Power of Quality: How Quality Ensures Growth and Enhances Profitability

Summary: Quality may be the essential ingredient that transforms today’s uncertainty into profitability. Entire industries are being disrupted. Rapid time to market is critical to competitiveness, and there is enormous pressure to design, build and ship products at blazing speeds. Thriving in this era of change requires infusing quality thinking into every process across every part of the enterprise. Organizations succeeding in their markets have learned to deliver world-class quality. They harness the enormous economic potential of quality management to attain leadership of their respective markets.

To illuminate the economic power of quality, Forbes Insights partnered with ASQ, a global community of quality professionals, to conduct a global survey of 1,869 senior executives and quality professionals in March 2017. In-depth interviews with top executives and thought leaders were also conducted to add context to the data.

To download a pdf of the study, please fill out the following information. If you experience any trouble, please send an email to:

Notice: By supplying my contact information, I authorize Forbes Insights and the report sponsor to contact me about the sponsor’s products and services. Forbes Insights may use data I have provided in accordance with the Forbes online privacy policy.

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Mon, 01 May 2017 01:06:00 -0500 text/html
Lean Six Sigma Green Belt Certification - Online

Dr. Mary McShane-Vaughn

Dr. Mary McShane-Vaughn has created and delivered Yellow, Green and Black Belt training courses to hundreds of students, both in-person and online. Over the past five years she has enthusiastically delivered more than 45 Yellow, Green and Black Belt courses for her university and corporate clients.

She is currently Principal at University Training Partners, a company that develops and delivers Lean Six Sigma training for corporations and universities. She also serves on the editorial review board for ASQ's Six Sigma Forum and is co-author of The Certified Quality Inspector Handbook, and author of The Probability Handbook, both published by ASQ Quality Press.

Dr. McShane-Vaughn is a senior member of the American Society for Quality and a member of the American Statistical Association and holds ASQ certifications as a Six Sigma Black Belt, Quality Engineer, and Reliability Engineer.

She served as the Six Sigma Black Belt exam Chair for the American Society for Quality (ASQ) from 2010-2012, and was an examiner for the Georgia Oglethorpe Award, Georgia's equivalent of the National Malcolm Baldrige Award.

Previously, Dr. McShane-Vaughn was a tenured faculty member at Southern Polytechnic State University in Marietta, Georgia, now Kennesaw State University. For eight years she directed and grew the Master of Science in Quality Assurance program and taught statistics, statistical quality control, linear regression and design of experiments online in the graduate program. Her research interests include industrial statistics, robust experimental design and distance learning course delivery methods.

Before her career in academics, she worked for 15 years as a quality engineer and statistician in the automotive, medical device manufacturing, consumer products testing, and revenue management industries.

Dr. McShane-Vaughn holds a Ph.D. in Industrial Engineering and an MS in Statistics from the Georgia Institute of Technology, and a B.S. in Industrial Engineering from General Motors Institute (now Kettering University) in Flint, Michigan. 

Mon, 02 May 2022 18:55:00 -0500 en text/html
The Challenge of Organizational Learning

Reinventing the wheel—this well-worn phrase describes one of the oldest of human follies: undertaking a project or activity without tapping into the knowledge that already exists within a culture or community. Individuals are blessed with a brain that, some of the time, remembers what we’ve already learned—or at least that we’ve learned something. But what about organizations?

Consider the views of Kim Oakes, director of sharing and communities of practice at the Knowledge Is Power Program (KIPP), a national network of 99 charter schools serving 27,000 students via 1,900 teachers. Oakes told Bridgespan’s research team: “We know that about 80 percent of our teachers create materials from scratch. … It became increasingly important to connect our teachers, so that they could build upon one another’s ideas rather than work in isolation.”

Or consider World Vision, an international Christian development organization with an annual budget of more than $2 billion operating in 93 countries. World Vision was facing the consequences of rapid growth. In the words of Eleanor Monbiot, its senior director for knowledge management: “We were growing at 10 to 15 percent a year. We had moved from everybody knowing each other vaguely, to a breaking point. … The No. 1 need was to know what people were up to, where the best practices lay.”

KIPP, World Vision, and a host of other nonprofits, large and small, are tackling the challenge of making their organizations as smart as the individuals who constitute them. In short, they are engaging in the hard work of organizational learning: The intentional practice of collecting information, reflecting on it, and sharing the findings, to Improve the performance of an organization.

Authors ranging from the late business historian Alfred D. Chandler Jr. to MIT Sloan School of Management senior lecturer Peter Senge have emphasized the value of knowledge and learning inside organizations. But, to use another well-worn phrase, this is easier said than done. In the fall of 2010, a Bridgespan Group team surveyed 116 nonprofits about how they learn—and how they translate the knowledge gained into practice, to increase their impact and fulfill their missions. We then explored these courses through interviews with more than half a dozen organizations, which were recommended by their peers for their innovative approaches to learning.

The results of the survey indicate that nonprofit leaders care deeply about capturing and sharing knowledge across their programs and fields. But they also identify three significant impediments to organizational learning: a lack of clear and measurable goals about using knowledge to Improve performance; insufficient incentives for individuals or teams to participate in organizational learning activities; and uncertainty about the most effective processes for capturing and sharing learning. These issues also surface in forprofit organizations, according to outside studies, where knowledge hoarding between business units can result from competition for resources.1 In the nonprofit sector, however, 97 percent of survey respondents said their leaders value knowledge sharing as a means to achieve their missions. Still, many of them struggle to do it well.

In this article, we look at the components of organizational learning; explore the challenges surrounding its goals, incentives, and processes; and provide examples of organizations working to address barriers to sharing knowledge. In an age driven by technology and information, organizational learning has not just become part of the successful 21st-century nonprofit; increasingly, it is a key ingredient.

Creating Impact Through Learning

Developing organizational knowledge and integrating that knowledge into everyday practice can be a powerful tool for multiplying an organization’s impact, especially as it grows. But a nonprofit doesn’t have to be a multisite, multimillion-dollar agency, or even have a dedicated knowledge management function, to benefit from clear goals, incentives, and well-developed processes for organizational learning. If you train your staff, circulate meeting minutes, share programmatic best practices across sites, measure the impact of your programs, discuss metrics with your board of directors to inform decisions, or present your results at professional conferences, you are practicing knowledge management. Indeed, one of the tricky aspects of this subject is that learning-related activities are varied and can sit in many different parts of an organization. In some organizations the locus of activity is in staff training; for others it may be in impact assessment or performance management. Wherever learning sits, the key is that it be closely connected to the organization’s mission and impact.

This connection is also the biggest challenge. Although 98 percent of nonprofit organizations reported in our survey that they collected a lot of information, a third of them said that they were unable to reflect on it and integrate it in a meaningful way into program activities. Our research tells us that to be intentional about organizational learning, organizations need to focus on doing four things well.2 (See “Four Elements of Organizational Learning,” below.)

First, leaders must champion organizational learning. They need to demonstrate their commitment by setting a vision and goals for learning connected to furthering the mission. And they must act as role models by participating in learning activities. Second, leaders need to foster a culture of continuous improvement that values organizational learning. The culture reinforces learning by providing incentives for learning behaviors and by measuring and communicating results of learning. Third, the organization needs to define a learning structure that specifies the people who are accountable for capturing, distilling, applying, and sharing knowledge. The structure also should include networks and coordinating tactics that help information flow among the people who need it, when they need it.

Last, the organization must design intuitive knowledge processes that are aligned to how people work. These processes specify how staff members define a learning agenda, and how they capture, distill, and apply knowledge. These processes also include the technology systems for exchanging knowledge, but they need to keep people-to-people interactions at the heart of them.3

Gaps in the Learning Cycle

More than 90 percent of the nonprofit leaders we surveyed reported that they care deeply about learning and actively strive to model knowledge capture and sharing within their organizations. And the majority appeared to be devoting significant resources to this work. The challenge, these leaders report, is defining clear goals for organizational learning, creating adequate incentives to invest the time it takes to capture and share knowledge, and designing intuitive processes that capture and disseminate knowledge.

The Goals Gap

The good news is that leaders say that they care a great deal about learning. But a third of the nonprofit leaders we surveyed report that their senior managers have not defined clear and compelling learning goals. And nearly six in 10 said they don’t track metrics for learning at the organization level. Without clear goals and metrics, it becomes that much harder to effectively deploy knowledge resources, measure progress, and influence behavior across the organization. So how might nonprofit organizations set clearer goals for learning—goals that clearly advance mission?

World Vision considers its mission accomplished when children have access to education and health care, participate in their communities, and experience God’s love in their lives. Following a period of fast growth, its leaders believed that rapidly sharing information on effective practices (and failures) from one field of operation to the next would be a key to changing children’s lives. They translated the broader strategic goals of the organization into a subset of knowledge goals, including the goal of deploying best operating practices across all relief and field operations. And they broke this down into specific activities and tasks necessary to expedite know-how around the world for practices such as training community health workers in AIDS prevention and patient care, increasing yields for subsistence farmers, and boring wells in arid regions.

To devolve ownership of these goals across the networks, the organization focused on strengthening communities of practice (CoPs), virtual gatherings of far-flung World Vision experts in areas such as education, health, agriculture, and water, whose shared experiences could drive institutional learning and change. As of March 2011, World Vision had 23 CoPs with a combined membership of more than 10,000, all using a SharePoint Platform nested within the organization’s global intranet. Each CoP is staffed with a senior leader, who listens to needs across fields and sets a responsive knowledge-sharing agenda, abetted by a dedicated administrator who manages and stimulates ongoing collaboration and discussion around key issues.

CoP members engage in different ways and groupings: Some plug in to listen and learn; others actively develop, review, and collaborate on global documents, including strategies and standards for their respective areas. Ongoing discussions take place around best practices, advice and support for applying them, and research proposals to find better answers. The CoP itself is the one place where members and broader management can find all the knowledge assets for a given sector, analyze them, and use them to manage change. Most CoPs also have regular WebEx meetings, where members can discuss issues in depth, as well as an annual meeting where a subset of members come face-to-face to share and strategize.

According to Monbiot, “We’ve had (CoPs) for years but they’ve been pretty informal. We’re trying to operationalize these and to ensure that all staff are involved.” Now that each of these communities has a formal leader—with a staffing allocation and administrative support—they are making strides. The health care CoP has been particularly successful, attracting 900 members in a matter of months, who now act as champions of effective primary health care practices throughout the system. Monbiot believes that clear leadership and goals are a factor in the group’s size and that most World Vision partner organizations have health certified on staff hungry to share specific technical expertise.

Arizona’s Children Association (AzCA), a near century-old child welfare and behavioral health agency that links organization learning goals to its merger strategy, is another example of an organization that has achieved remarkable results because of its improved organizational learning process. Twelve years ago it decided to move beyond residential treatment for children, adding home-based supports and earlier interventions for families and children to its services. The organization pursued this expansion through mergers and acquisitions, growing its annual budget from $4.5 million to $40 million over 10 years. Throughout the process, AzCA not only acquired staff and programs—it acquired knowledge. As Fred Chaffee, president and CEO, told us: “We gain a nucleus of expertise because we got an agency and brought it in. … Then growth occurred because we have a statewide system and a knowledge base.”

The results of carefully managing the learning and sharing of a knowledge base can be powerful. One AzCA acquisition was the New Directions Institute for Infant and Brain Development, which teaches the science of brain development and specific strategies caregivers can use to enhance children’s learning. AzCA integrated that knowledge into its other services through a series of 13 workshops that New Directions co-founder Jill Stamm and her staff have given to AzCA professionals—about 450 employees—to ensure that they understood the growing emphasis on prevention. To reinforce these ideas, the workshops mirrored community outreach to caregivers and were filled with messages from the neuroscience community that apply directly to very young children and their families. Why teach youth workers about young children? Says Stamm: “Say, for example, a family has an out-of-control 10-year-old. Chances are they have a 2-year-old crawling around, too. We wanted all our staff working with youth to help ensure that the 2-year-old gets a better start and does not spin out of control.” The key is to understand root causes of behavior.

As a result of these workshops, says Stamm, AzCA professionals across Arizona began to incorporate prevention into their jobs. Some of the caseworkers in Prescott and Flagstaff changed their home visitation agendas to include discussions of children’s brain development. Now the regional AzCA offices always include the New Directions curriculum in their new-employee training, and New Directions is training caseworkers in four other states. Chaffee reports that the careful integration of personnel, budgets, and programs, as well as of knowledge from new organizations, has allowed AzCA to more than double the number of clients served and has reduced costs per beneficiary by 11 percent to as much as 40 percent. It’s also allowed AzCA to fundraise for merger efforts, because prevention can demonstrate payback in the cost and quality of a program.

Smaller organizations, too, testify to the impact of clear learning goals tied to mission. Adoption Resources of Wisconsin (ARW) is a $2.2 million statewide organization with 17 staff dedicated to finding a good, permanent home for every child in Wisconsin. It carries out its mission by offering information, training, and support to families and professionals and through ongoing advocacy work. The goal of its learning efforts is to determine which information and training is getting results for kids who need homes. For ARW, this means learning how many people are seeking information from them, what they’re looking for, and whether the information is meeting the needs of adoptive parents or their intermediaries. According to CEO Colleen Ellingson, “We have a massive database, where we log how we’ve serviced anyone over the existence of our organization. We have 60,000 unique visitors per year. Every month we’re looking at data on website usage. What are [current or prospective parents] looking at? What aren’t they looking at?” Program managers study these usage patterns to identify trends and respond to them, continuously improving their services.

Getting the technology right took time. ARW started with several, small, customized data systems in the mid-1980s. Five years ago, it migrated to the Defran data system to track greater volumes of data. Throughout, Ellingson has promoted technology investments as a way to learn more, reduce cost, monitor progress, and develop initiatives.

For staff at World Vision, AzCA, and ARW, the goals of knowledge capture and sharing are championed at the top and connect directly to the impact they hope to create—respectively helping the poorest of the poor toward self-sufficiency, helping youth break out of destructive patterns, and giving kids homes to call their own.

The Incentives Gap

Strategic clarity around the “why” of organizational learning can bridge the first gap in the learning cycle. But creating a culture that motivates each person in an organization to capture and share knowledge actively requires a rewards system beyond the clarity of a compelling goal—and this is where about half of the nonprofits we surveyed experienced a problem. Leaders report that they fail to clarify incentives for individuals, for teams, or for their organization as a whole. Yet incentives at multiple levels are often exactly what it takes to transform a goal into a priority that rises above competing demands.

About half of the nonprofits we surveyed do not evaluate or reward some of the behaviors that support learning. Specifically, four out of 10 nonprofit leaders said they don’t incorporate knowledge capture and sharing into how staff members are evaluated. In our interviews, we heard that measuring and encouraging learning behavior was the area where nonprofits struggled most.

A straightforward incentive strategy builds organizational learning responsibilities directly into the job. The Council on Foundations (COF), a national nonprofit membership association whose members’ collective assets exceed $300 billion, has no dedicated knowledge staff. Instead, knowledge is becoming an explicit part of the job descriptions for their member-facing staff, which make up about half of the organization. COF uses a customer relationship management (CRM) database to track interactions with members. It also uses CRM tracking to inform performance reviews, measure and evaluate staff on how well they capture and pass on learning to colleagues, enable richer services to members, and collaborate across departments to pass on best practices.

FSG, a 70-person nonprofit consulting firm, believes incentives start with whom you hire. The firm uses knowledge sharing as a criterion for recruiting, and evaluates it as part of performance reviews. Hallie Preskill, FSG’s executive director of strategic learning and evaluation, says: “We look for a certain kind of person—smart, humble, and curious. Wanting to share what they learn is part of their DNA.” She notes another motivator: productivity. “People recognize that sharing knowledge saves time and increases productivity,” says Preskill. “When a content area surfaces that we need to understand better, we’ll put a note on the intranet and people respond. Within an hour, you will hear from six colleagues with tangible ideas.”

At the same time, FSG’s human resources system rates performance and recommends pay increases based in part on the extent to which an employee contributes to the firm’s development of intellectual capital. In 2010, FSG hired its first director of knowledge management, who is developing a firm-wide knowledge management system so that people can access, store, and share information comprehensively and in real time. Says Preskill: “It is about people and technology.”

Not all incentives and rewards have to be explicit. KIPP, for example, sees a link between organizational learning, increased staff effectiveness, and intrinsic rewards for effective staff. According to Oakes, the rewards for participating in organizational learning activities are of three types: achieving better student outcomes by leveraging the collective wisdom of KIPP teachers; enabling personal satisfaction by providing a means for teachers to expand their impact beyond their classroom and school; and helping teachers find kindred spirits among fellow teachers, which builds community and can help retain effective teachers. Says Oakes: “We want teachers to build on each others’ work. Giving them a [learning] tool so they don’t have to recreate the wheel is the key. But giving them access to other educators, who think like them and are dedicated like them, helps them really participate in the broader organization and mission.”

The chance to deeply influence an organization or field can provide another intrinsic reward for staff to share what they know. The employees of In My Shoes, a small, peer-mentoring organization for youth aging out of foster care, find motivation there. As a newly acquired unit of AzCA, In My Shoes is using knowledge sharing to further twin goals: tuning the ears of child welfare professionals to the child’s voice in foster care decisions and smoothing the road to independence for fostered youth. At a accurate training of 85 child welfare professionals, In My Shoes founder Christa Drake spoke about how a move into foster care can result in loss of independence, connections with family, and community. It’s frightening, she says, and yet, in the ebb and flow of the system, it is the adults’ voices that are listened to. Through storytelling, testimonials, and role-playing, In My Shoes is getting its message across and reaping policy changes. Arizona child protective services now requires every new social worker to receive training that includes perspectives of foster care youth. And Arizona community colleges have begun designating and training counselors to work with youth coming out of the foster care system, addressing personal needs that go far beyond course recommendations. For Drake, these are huge rewards.

The Process Gap

Once clear learning goals are established that align tightly to the mission, and individuals and teams feel motivated to reach for them, at least one key question remains for many nonprofit staffers: How? Through what processes do we capture knowledge, share it, and use it to increase our impact? The most important first step in closing the how gap is to make these processes intuitive. Identify who needs the knowledge, where the best opportunities lie for learning, and what systems fit best with the way people already work.

For many organizations, the No. 1 goal of organizational learning is to identify, codify, and disseminate best practices to ensure that they are used across the organization. But KIPP goes about things differently. “Knowledge sharing for KIPP is particularly powerful because we don’t have a master curriculum,” says Oakes. “Even within the regions, school leaders and teachers have discretion over how they’re going to run their classroom. We’re not going to tell you, ‘Here is what to do in 3rd-grade math.’ But we know there are fantastic things happening across the board; there are teachers who are getting results through creating an academically rigorous curriculum, but still bringing joy into their classrooms each day. … This past year, we identified 15 of KIPP’s most effective teachers and videotaped them and made their content available online. We’re highlighting the practices of these teachers, but we’re not saying this is the only way to do it.”

The online system, called KIPP Share, which was developed by the Cambridge, Mass., start-up Better Lesson, includes documents and multimedia and was designed to walk the line between highlighting effective practices and out-and-out recommending them. Besides displaying videos that demonstrate the practices of great KIPP teachers, KIPP Share helps new teachers find helpful classroom materials that experienced teachers have already created. And it remedies a major gap in knowledge flows that KIPP had faced: When teachers moved to non-KIPP schools, their precious materials left with them.

But virtual systems tend to become truly useful through painful user feedback, and Oakes was candid about the system’s flaws before developing KIPP Share with Better Lesson. “We found that we had tens of thousands of documents, but it was hard to make the most of them. Also, we learned that teachers want to understand the context of the document. Let’s say I searched for the US Constitution. On the old system, you’d get a laundry list of documents that had something to do with the Constitution. Great, but who is the teacher who created it, how does this document play into broader context? Now you get a list that tells you how the document fits into the curriculum of the teacher who created the material. It isn’t just about resources, but also about who created them.”

Oakes notes the importance of designing systems and processes that align with an organization’s culture. For KIPP, it was important to design a system that respected autonomy in what and how to teach. “We are learning a lot along the way and realize there is no one perfect solution to sharing,” acknowledges Oakes. “We are learning how important it is to continue to support in-person gatherings where teachers can exchange ideas, create relationships, and build community.” KIPP is in the process of creating measures of success for the new system. Ultimately, KIPP is looking to make an impact on students.

Clearly, this kind of national network or multisite entity creates rich opportunities for organizational learning—both virtual and face-to-face. Within such systems, effective tactics can range from the idea-specific to the broad or field-based. The Nature Conservancy, for example, makes extensive use of peer reviews for proposals on significant initiatives—such as mitigating coastal effects of climate change. One peer review tactic involves a board of peer reviewers, who sit in a circle and, one by one, name the proposal’s strengths— until they start to repeat themselves. Then they go around again, this time naming the proposal’s weaknesses. This way, the author of the proposal gets a dose of highly concentrated learning, directly from peer experts, before he or she begins to implement a strategy, which can help avoid missteps.

Getting Better at Organizational Learning

In the early days of the Internet, it was said that the World Wide Web was the globe’s greatest library—only that all the books were on the floor. Many nonprofit leaders and staff no doubt have had similar feelings about their organizations: The organization’s hard-won knowledge is just lying there on the floor—or worse, checked out with the departure of a key employee.

But it doesn’t have to be this way. Ensuring that knowledge flows throughout an organization, informing the quality of service to clients whose lives depend on it, takes hard work. But the steps required of leaders are pretty clear. (See “Creating a Knowledge-Sharing Process,” above.) They need to set learning goals that resonate because they advance the organization’s mission; they need to reinforce a culture that rewards knowledge capture and sharing; and they need to engage staff in creating intuitive processes for making it all happen.

Technology advances may provide the tools for sharing knowledge more broadly and effectively, but as examples like KIPP, World Vision, and the Nature Conservancy show, adoption rates rise when the people-to-people element of shared learning is kept robust. This element provides context and enables advice and collaboration and, well, makes learning satisfying. Indeed, technology becomes a true multiplier of organizational learning when put in service of deeper person-to-person connections and exchanges.

Authors’ note: The authors thank the Alliance for Children and Families, the Boston Foundation, the Charles Stewart Mott Foundation, the Skoll Foundation, and World Vision for inviting their constituents to join the survey. They also thank their research team—Peter Ross, Tessa Bysong, Aaron Pick, Jennifer Sauve, and Kelly Greenwood—and advisors Bradley Seeman, Ann Goggins Gregory, and Nan Stone.

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Read more stories by Katie Smith Milway & Amy Saxton.

Thu, 22 Sep 2016 18:04:00 -0500 en-us text/html
Human Error and Quality Control in Medical Devices

Human error is a broad category that includes the clearly identifiable, easily diagnosable, and seemingly excusable mistakes we all make. Error encompasses all those occasions in which a planned sequence of mental or physical activities fails to achieve its intended outcome, and when these failures cannot be attributed to the intervention of some chance agency. The definition of error may be complex but the outcome in the workplace, where accuracy is paramount, is not.

Human errors are often simple mistakes that can be catastrophic to those responsible, and more importantly, to the user or patient. Avoiding mistakes is an important consideration for companies striving to reduce errors.

Error reduction was addressed more than 30 years ago by W. Edwards Deming, a quality expert. He cited the need to seek a fresh approach to reduce mistakes and defective workmanship.1 Deming noted, that in many organizations, human error accounts for more than half of unnecessary business expenses. Of that portion, the rule of thumb is that about 85% result from automatic errors of execution, the causes of which remain inadequately understood and addressed.2 One of Deming’s quotations is worth repeating: “Defects are not free. Somebody makes them and gets paid for making them.”

There are a number of articles and several accurate books that deal with human errors, how they occur, and what to do about them. Many such resources can be used for training purposes. This article will discuss why we make mistakes, the concept of poka yoke (mistake proofing), and various means to reduce mistakes, including training methods, checklists, and flow charts. The article will also provide suggestions for procedures designed to address a major cause of recalls or other corrective action. 

Why We Make Mistakes

One reason for making mistakes involves the power of first impressions. Most people stay with an initial choice for an answer to a test question at least 70% of the time, even when they learn that the answer is incorrect. Nearly 80 years of research on answer changing shows that most people who change their answers usually Improve their test scores.3 Moreover, most people let their minds wander more often than they might think. According to one study, students reported that their minds wandered an average of 5.4 times in a 45-minute session. Depending on the experiment, people tend to spend up to half their time working on a task thinking about other things, even when they have been explicitly told to pay attention.4 Another reason is that most of us are not equipped for multitasking. The number of things we can do at once is extremely limited. In general, the human memory cannot retain more than five unrelated items at one time; many of us retain even less.  Multitasking is not thinking—it impairs the ability to think. Thinking means concentrating on one thing long enough to develop an idea about it.5 Individuals do their best thinking by slowing down and concentrating. Furthermore, individuals often blame the wrong cause, and thus learn little from a mistake experience.

To develop a quality error reduction program it is critical to understand what constitutes errors of thinking. Some researchers categorize five different types of erroneous thinking, as follows:5

  • Partialism. This occurs when the thinker observes problems through one perspective only.
  • Adversary. This occurs when the thinker believes that because someone else is wrong, he should be right (e.g., some politicians use this to sway voters).
  • Time Scale. This happens when the thinker sees a problem from a limited time frame.
  • Initial Judgment. This occurs whenever the issue or problem is not considered objectively.
  • Arrogance and Conceit. This occurs whenever the thinker believes that his or her solution is absolute and no better one exists.

All of this information should be considered in the company’s training program and accompanied by lessons learned from 483s and other warning letters.

Other reasons for making mistakes in the workplace are similar to those made by healthcare practitioners who use medical devices. The errors are described in an FDA guidance document for human factor engineering.6 Like healthcare personnel, individuals working for medical device companies vary greatly in their physical, sensory, and mental abilities. The latter refers to higher mental phenomena such as memory, information processing, use of rules and strategies, hypothesis formation, and problem solving. An employee’s performance can be compromised by noise, poor lighting, glare-producing surfaces, excessive heat, improperly used cleaning products, electrical interference, poorly written procedures, inadequate training, a wide array of equipment used, stress, and fatigue. Risk influencing factors (RIFs) worsen natural tendencies to make errors.

Poka Yoke and Six Sigma in Device Manufacturing

Quality personnel focusing on defect prevention can use principles embodied in mistake proofing or poka yoke. The system involves the use of any automatic device or method that either makes it impossible for an error to occur or makes the error immediately obvious once it has occurred.7 Unfortunately, poka yoke is not implemented by medical device companies as often as it should be. Neither ISO 13485:2003 nor the quality system regulation (QSR) under corrective and preventive action reference problem solving or error proofing. These courses are, however, included in ISO 16949:2009, the quality management standard that contains particular requirements for the application of ISO 9001:2008 for automotive production and relevant service organizations. The standard suggests that organizations incorporate error-proofing methods into corrective action policies and implement a defined process for problem solving designed to identify and eliminate root causes. No guidance is given for implementation, however. The recently issued final document on corrective and preventive action and related QMS processes from the Global Harmonization Task Force does not directly refer to problem solving or error proofing techniques, however, it does describe a number of statistical and nonstatistical techniques to be used for analysis.8

The training section of the QSR states that personnel should be made aware of device defects that may occur from improper performance of their specific jobs. Personnel who perform verification or validation activities must be made aware of defects or errors that may be encountered as part of their job function.9

Such notification requirements are admirable. But without addressing error proofing, they are insufficient. The Six Sigma problem solving approach known as DMAIC is a road map that can be followed for all projects and process improvements.10 It includes the following steps:

  • D—Define the overall problem.
  • M—Measure the problem to gather accurate and sufficient measurements and data.
  • A—Analyze the data to see if they are consistent with the problem definition and use these data to identify a root cause.
  • I—Improve processes. Once a solution is identified, it must be implemented and the results must be Tested with independent data.
  • C—Control the solution. A verification of control must be implemented. A robust solution will be easier to keep in control than a qualitative one.

Education and Training

Only a few well-established programs that deal with aspects of thinking have taken hold in universities. Critical and creative thinking, reflective and metacognitive thinking (awareness and understanding one’s own thought processes), self-regulation, decision-making, problem solving, and other disciplinary forms of thinking are taught and practiced. Such programs should also be part of career development initiatives and offered to all employees. Problem solving and good quality thinking are essential skills for employees to attain, now more than ever.

Training should be industry specific. Employees should be encouraged to pay attention to detail, avoid behavior that results in unwanted outcomes, and focus on past experiences of dealing with past problems. Once employees become aware of the basic principles they are often able to apply experience of their own work to find practical ways of reducing the risk of error. Recognition that adverse influences (rather than individual shortcomings) are the intent of training reassures employees that the company is concerned with finding constructive ways to avoid error rather than blaming people.2 Training programs could begin with this oft-cited quotation by Voltaire, the noted French philosopher: “No problem can withstand the assault of sustained thinking.”


One of the means to minimize errors is to use a checklist, otherwise known as work procedures or conformation check sheets.7 Checklists are now being aggressively promoted in medical literature and the popular press, and rightly so.11–13
Many hospitals have started to implement more comprehensive checklist procedures in the operating room aimed at increasing compliance with practices known to reduce complications and enhance teamwork. WHO has reported that such checklists cut surgical morbidity and mortality almost in half.14 A accurate controlled study, showed that the implementation of a comprehensive checklist in six regional and tertiary care centers in the Netherlands improved outcomes substantially. The study also provided insights into why checklists work and should be considered by manufacturers of medical devices.15
Quality teams should review each of their processes and reported errors to determine whether a checklist would prove beneficial. When creating a checklist for steps in a process, it is a good idea to first prepare a flow chart to determine what the steps are and how they should be sequenced.

Flow Charts

Flow charts are diagrams that use graphic symbols to depict the nature and flow of steps in a process. They have a number of benefits:

  • They promote the understanding of the process.
  • They provide a tool for training.
  • They can identify problem areas and opportunities for improvement.
  • They depict customer-supplier relationships.

Flow charts are similar in style to cause-and-effect diagrams, which are defined as graphic tools that help identify, sort, and display possible causes of a problem or quality characteristic. A cause-and-effect diagram uses an orderly, easy-to-read format and helps to determine root causes, encourages group participation, indicates possible causes of variation, and most importantly, increases knowledge of the process.

A Procedure for Mistake Proofing. A mistake proofing procedure should be developed to include a flow chart of the process when possible. Each step of a particular process should be reviewed to determine where or when human errors are likely to occur. The procedure should require working back through the process to find the source of each potential error. It may be possible to eliminate an error by omitting the step that causes it or by replacing that step with one that is error-proof. The procedure should also include methods of detecting errors that are impossible to prevent and specify ways to minimize their effects, including inspection levels and techniques. This could include successive inspections of self and source. The procedure should be discussed at each training program to ascertain how it can be used more effectively. The book Quality Toolbox 2nd Edition provides an excellent section on mistake proofing that can be used to write the procedure and to understand inspection methods. It also includes a sample flow chart.10


It is common knowledge that errors committed by employees can be extremely costly from both a regulatory and litigious perspective and can cause irreparable damage to a company’s image. More importantly, these errors can cause injuries to patients or users of devices. It is astonishing that companies spend so little time training employees to think about thinking and to adopt mistake-proofing and problem-solving methods. This is especially perplexing in light of the techniques that are readily available to management. Six Sigma and poka yoke programs are two examples that companies can use to reduce costs and Improve quality. Such programs can also be used to train employees on mistake proof methods and awareness.


1.    WE Deming, Out of the Crisis (Cambridge, MA: MIT Press, 1986).
2.    JM Evans, “Look for Trouble,” Quality Progress  39, no. 12 (December 2006): 56–62.
3.    H Treason, Human Error (Cambridge, UK: Cambridge Univ Press, 1990).
4.    C Zimmer, “The Brain; Stop Paying Attention: Zoning Out is a Crucial Mindset,” Discover Magazine, (July/Aug 2009): 24–25.
5.    A Raghunathan, “How to Improve Your Thinking,”; available from Internet:
6.    “Do It By Design” FDA; available from Internet:
7.    NR Tague, Quality Tool Box 2nd Ed., (Milwaukee, WI: ASQ Quality Press, 2005).
8.    “Quality Management System-Medical Devices-Guidance on Corrective Action and Preventive Action and Related Processes,” Global Harmonization Task Force Final Document, Study Group 3, November 2010.
9.    21 CFR Part 820.25 (b)(1) and (b)(2).
10.    W Brussee, Statistics for Six Sigma Made Easy (New York, NY: McGraw-Hill, 2004).
11.    R Ritchhart, DN Perkins, “Learning to Think: the Challenges of Teaching Thinking” in The Cambridge Handbook of Thinking and Reasoning, ed. KJ Holyoak and RG Morrison, (New York: Cambridge University Press, 2005).
12.    P Pronovost et al., “An Intervention to Decrease Catheter-Related Bloodstream Infections in the ICU,” New England Journal of Medicine 355 (2006):2725–2732.
13.    P Pronovost  and E Vohr, Safe Patients, Smart Hospitals: How One Doctor’s Checklist Can Help Us Change Healthcare from the Inside Out (New York, Hudson Street Press, 2010).
14.    A Gawande, The Checklist Manifesto: How to Get Things Right (New York: Metropolitan Books, 2010).
15.    AB Haynes et al., “A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population,” New England Journal of Medicine 360 (2009):491–499.

Further Reading

Problem-solving techniques are readily accessible. One of the first systematic methods was put forward by in Charles Kepner and Benjamin Tregoe in their work, called the New Rational Manager. In addition, a accurate book by Greg Fainberg, called How to Solve Just About any Problem: Timeless Practices for Solving Problems provides comprehensive practical information useful in solving problems. It includes guidance, insights, checklists, and templates. He believes that teaching people to think effectively, solve problems, and make better decisions are the most important enterprises in the world today. Medical device companies that haven’t already done so should adopt his philosophies and suggestions as part of their training programs.

Sun, 24 Apr 2011 12:00:00 -0500 en text/html
Culture of Quality: Accelerating Growth and Performance in the Enterprise
Culture of Quality: Accelerating Growth and Performance in the Enterprise

Summary: At one end of a continuum are organizations where the quality program is perceived as no more than a set of slogans. At the other end, each and every employee from entry level to the seat of the chief executive embraces the company’s quality vision, values and goals as a way of life. Companies displaying world-class quality can demonstrate that their leadership unwaveringly and visibly supports quality objectives. They are also passionate in their drive to continually identify and address customer needs.

To illuminate the issue of a culture of quality, Forbes Insights partnered with ASQ (American Society for Quality) to conduct a global survey of 2,291 senior executives and quality professionals in April 2014. In-depth interviews with more than 20 senior executives and consultants add context to the data.

Click here to use our interactive benchmarking tool to see how your culture of quality stacks up.

To download a pdf of the study, please fill out the following information. If you experience any trouble, please send an email to:

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Fri, 15 Dec 2017 23:19:00 -0600 text/html

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