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Acronyms

CAPA – Corrective and preventive action  

A systematic approach which includes actions needed to: correct (“correction”); prevent recurrence (“corrective action”); and eliminate the cause of potential (“preventive action”) nonconforming product and other quality problems

EHS - Environmental Health and Safety

Internal program measuring and controlling the environmental impact and health consequences of business activities.

ERP - Enterprise Resource Planning

A system which attempts to integrate all departments and functions across a company onto a single computer system that can serve all those different departments' individual needs.

JIT - Just In Time

Management process which makes products and receives supplies and materials just as they are needed.  This process greatly reduces the need for inventory, and increases the agility of a company.

TOC - Theory of Constraints

Management practice whereby the flow of a system is evaluated and bottlenecks are identified and eliminated.  

TQM - Total Quality Management

A system of continuous improvement focusing on the needs of the customer and using participative management.

WCM - World Class Manufacturing

A system of identifying and utilizing best practices to become the best in class in quality, customer service, lead time, cost, price,  flexibility, and innovation.

Definitions

14 Obligations of Management Proposed by Dr. W. Edwards Deming

5 S Process

5 S is the Japanese process for housekeeping.  It consists of 5 simple steps:

1. Seiri (Sort) put things in order by eliminating what isn't needed and keeping what is needed
2. Seiton (Straighten) arrange essential things in an order so that they can be easily accessed when needed
3. Seiso (Shine or clean) keep working environment and equipment clean
4. Seiketsu (Standardize) integrating cleaning and checking into standard operating procedures
5. Shituke (Sustain commitment) continuously improve in disciplined fashion

5 "Why" Process

Process of finding the root cause of a problem by asking "why" 5 times.  An example of a late delivery might unfold like this:

1. Why was the delivery late?  The delivery was late because the clerk didn't ship it out in time.
2. Why didn't the clerk ship it out in time?  The clerk didn't ship it out in time because she was working on an urgent problem.
3. Why didn't someone else ship it?  No one else shipped it because no one else know how to do it.
4. Why didn't anyone else know how to do it?  No one else know how to do it because the second clerk quit last week and hasn't been replaced.  
5. Why hasn't the second clerk been replaced?  The second clerk hasn't been replaced because HR wants to write a new job description before they hire someone else, and they forgot to do it.

At this point, you are likely to be close to finding the real cause of the problem which needs to be addressed (that HR needs to write the job description and hire someone.)  Sometimes you may even have to ask why more than 5 times! (It may be valuable to ask why the HR department forgot!)

7 Deadly Diseases of Management Proposed by Dr. W. Edwards Deming

1. Lack of Constancy of Purpose.  When management doesn't articulate an unambiguous purpose detailing the short and long terms, people have no way of knowing if they are doing the right things.

2. Emphasis on Short Term Profits.  Sole focus on quarterly profits leads to game playing, and undermines the long term health of the organization.
3. Evaluation of Performance, Merit Rating, or Annual Review.  Although commonly believed to improve performance, these activities have the opposite result because they dampen an employee's internal motivation and create awkward situations.  Feedback should be provided in real time.
4. Mobility of Top Management.  When managers jump frequently from company to company, it undermines teamwork and long-term thinking.
5. Running a Company on Visible Figures Alone.  While visible figures are important, they may not be as important as issues such as the impact of a happy (or unhappy customer), or the effect of teamwork between departments.  These are unknown and unknowable, but nonetheless, important.
6. Excessive Medical Costs.  Medical providers need to lower costs by using variation to determine how to provide services that will make a patient as healthy as possible, and no more.
7. Excessive Legal Costs.  Relationships built on pride of workmanship are less likely to breached than those based solely on contracts.

Action Plans

The term “action plans” refers to specific actions that respond to short- and longer-term strategic objectives. Action plans include details of resource commitments and time horizons for accomplishment. Action plan development represents the critical stage in planning when strategic objectives and goals are made specific so that effective, organization-wide understanding and deployment are possible. In the Criteria, deployment of action plans includes creating aligned measures for all departments and work units. Deployment also might require specialized training for some employees or recruitment of personnel.

An example of a strategic objective for a supplier in a highly competitive industry might be to develop and maintain a price leadership position. Action plans could entail designing efficient processes and creating an accounting system that tracks activity-level costs, aligned for the organization as a whole. Deployment requirements might include work unit and team training in setting priorities based on costs and benefits. Organizational-level analysis and review likely would emphasize productivity growth, cost control, and quality.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Activity Based Costing

Activity based costing is an accounting technique which allows organizations to determine the actual cost associated with each of their products or services without regard to organizational structure.  It also provides an organization with important information regarding the contribution each customer makes with regard to overall profitability (as opposed to the percentage of sales or other measures.) 

Alignment

The term “alignment” refers to consistency of plans, processes, information, resource decisions, actions, results, and analyses to support key organization-wide goals. Effective alignment requires a common understanding of purposes and goals. It also requires the use of complementary measures and information for planning, tracking, analysis, and improvement at three levels: the organizational level, the key process level, and the work unit level.  

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Analysis

The term “analysis” refers to an examination of facts and data to provide a basis for effective decisions. Analysis often involves the determination of cause-effect relationships. Overall organizational analysis guides the management of work systems and work processes toward achieving key business results and toward attaining strategic objectives.

Despite their importance, individual facts and data do not usually provide an effective basis for actions or setting priorities. Effective actions depend on an understanding of relationships, derived from analysis of facts and data.  

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Anecdotal

The term “anecdotal” refers to process information that lacks specific methods, measures, deployment mechanisms, and evaluation, improvement, and learning factors. Anecdotal information frequently uses examples and describes individual activities rather than systematic processes.

An anecdotal response to how senior leaders deploy performance expectations might describe a specific occasion when a senior leader visited all of the organization’s facilities. On the other hand, a systematic process might describe the communication methods used by all senior leaders to deliver performance expectations on a regular basis to all organizational locations and workforce members, the measures used to assess the effectiveness of the methods, and the tools and techniques used to evaluate and improve the communication methods.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Annual Review

An evaluation, conducted at least annually, which assesses the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures.

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Approach

The term “approach” refers to the methods used by an organization to address the Baldrige Criteria item requirements. Approach includes the appropriateness of the methods to the item requirements and to the organization’s operating environment, as well as how effectively the methods are used.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Balanced Scorecard

Balanced scorecard is a conceptual framework developed by Drs. Robert Kaplan and David Norton which serves to translate vision into concrete performance indicators.  These indicators are distributed among four perspectives:  learning and growth, business process, customer, and financial.  

Baldrige National Quality Award

The Baldrige National Quality Award is a program of the US National Institute Of Standards and Technology.  It was created in 1987 and named for Malcolm Baldrige, who served as Secretary of Commerce from 1981 until his tragic death in a rodeo accident in 1987.

The Award was created recognizing that US products and services were being challenged abroad, and that improved quality would become essential to maintain competitiveness and for the nation's economic well-being.

The MBNQA is awarded based on the Criteria For Performance Excellence, which focus on the following seven systems:  leadership, strategic planning, customer / market focus, measurement / analysis / knowledge management, human resource focus, process management, and business results.  Specific Criteria are available for Business, Healthcare, and Education.

Basic Requirements

The term “basic requirements” refers to the topic Criteria users need to address when responding to the most central concept of an item. Basic requirements are the fundamental theme of that item (e.g., your approach for strategy development for item 2.1). In the Criteria, the basic requirements of each item are presented as the item title question.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Benchmarks

The term “benchmarks” refers to processes and results that represent best practices and performance for similar activities, inside or outside an organization’s industry. Organizations engage in benchmarking to understand the current dimensions of world-class performance and to achieve discontinuous (nonincremental) or “breakthrough” improvement.

Benchmarks are one form of comparative data. Other comparative data organizations might use include industry data collected by a third party (frequently industry averages), data on competitors’ performance, and comparisons with similar organizations that are in the same geographic area or that provide similar products and services in other geographic areas.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Change Management

Change management is the process of planning and implementing change within an organization in a manner that accounts for the impact of the change for all stakeholders.  Change management will typically attempt to maximize the benefits of the change and minimize the risks.

Coaching

The earliest use of the word coach was derived from the Hungarian word kocsi, after Kocs, a town of northwest Hungary, where carriages (called coaches) were first made. Coaching first meant to transport something from one place to another using such a vehicle.

Today, coaching is also the second step in the GMP Mastery™ “Lifestyle Loop.” Like the first use of the word, coaching at the Artisan Consulting Group is designed to help participants transport themselves from knowing how to do the right things right, to actually doing it in the real world.

Artisan Consulting Group Coaches contract with participants to walk with them through specific projects and processes to help them implement the 10 Commitments of Mastery. Using methods including observation, talking, listening, questioning, reflecting, and providing feedback, Artisan Coaches develop a relationship of trust with participants that allows both parties to learn, grow, and implement GMP Mastery ™ within the context of work. All coaching is individualized, and is a great tool for helping participants Master Performance and Realize Results in the real world.

Collaborators

The term “collaborators” refers to those organizations or individuals who cooperate with your organization to support a particular activity or event or who cooperate on an intermittent basis when short-term goals are aligned or are the same. Typically, collaborations do not involve formal agreements or arrangements.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Consultant

Consultants are people whose job it is to provide information or services to others in an advisory capacity.  Consultants don't have direct control to make changes or implement programs, but they do have influence with people who do have that power.  Consultants are professional staff and advisors (and can be internal or external) including engineering, quality, safety, HR, finance, IT, purchasing, communications, regulatory affairs, and legal and financial advisors.  

Continuous Improvement 

Ongoing activities to evaluate and positively change products, processes, and the quality system to increase effectiveness.  

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Core Competencies

The term "core competencies" refers to your organization’s areas of greatest expertise. Your organization’s core competencies are those strategically important capabilities that are central to fulfilling your mission or provide an advantage in your marketplace or service environment. Core competencies frequently are challenging for competitors or suppliers and partners to imitate, and they may provide a sustainable competitive advantage. Absence of a needed organizational core competency may result in a significant strategic challenge or disadvantage in the marketplace.

Core competencies may involve technology expertise, unique service offerings, a marketplace niche, or a particular business acumen (e.g., business acquisitions).

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Correction

Repair, rework, or adjustment and relates to the disposition of an existing discrepancy.

 Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Corrective Action 

Action taken to eliminate the causes of an existing non-conformity, defect or other undesirable situation to prevent recurrence.

 Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Creating Value

The term "creating value" refers to health care processes that produce benefit to your patients and other customers and for your organization.  They are the processes most important to "running your organization" -  those that involve the majority of your staff and generate your health care services and positive organizational performance results for your patients, other customers, and key stakeholders.

Definition from the Malcolm Baldrige 2005 Health Care Criteria For Performance Excellence

Customer (1st definition)

The term “customer” refers to actual and potential users of your organization’s products, programs, or services (referred to as “products” in the Criteria). Customers include the end users of your products, as well as others who might be their immediate purchasers or users. These others might include distributors, agents, or organizations that further process your product as a component of their product. The Criteria address customers broadly, referencing current and future customers, as well as the customers of your competitors.

Customer-driven excellence is a Baldrige core value embedded in the beliefs and behaviors of high-performing organizations. Customer focus impacts and should integrate an organization’s strategic directions, its work systems and work processes, and its business results.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Customer (2nd definition)

A person or organization (internal or external) that receives a product or service anywhere along the product’s life-cycle.

 Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Customer Engagement

The term "customer engagement" refers to your customers’ investment in or commitment to your brand and product offerings. It is based on your ongoing ability to serve their needs and build relationships so they will continue using your products. Characteristics of customer engagement include customer retention and loyalty, customers’ willingness to make an effort to do business with your organization, and customers’ willingness to actively advocate for and recommend your brand and product offerings.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Cycle Time

The term “cycle time” refers to the time required to fulfill commitments or to complete tasks. Time measurements play a major role in the Criteria because of the great importance of time performance to improving competitiveness and overall performance. “Cycle time” refers to all aspects of time performance. Cycle time improvement might include time to market, order fulfillment time, delivery time, changeover time, customer response time, and other key measures of time.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Deployment

The term “deployment” refers to the extent to which an approach is applied in addressing the requirements of a Baldrige Criteria item. Deployment is evaluated on the basis of the breadth and depth of application of the approach to relevant work units throughout the organization.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Discrepancy

Datum or result outside of the expected range, an unfulfilled requirement; may be called non-conformity, defect, deviation, out-of-specification, out-of-limit, out-of-trend, etc. 

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Diversity

The term “diversity” refers to valuing and benefiting from personal differences. These differences address many variables and may include race, religion, color, gender, national origin, disability, sexual orientation, age and generational differences, education, geographic origin, and skill characteristics, as well as differences in ideas, thinking, academic disciplines, and perspectives.

The Baldrige Criteria refer to the diversity of your workforce hiring and customer communities. Capitalizing on both provides enhanced opportunities for high performance; customer, workforce, and community satisfaction; and customer and workforce engagement.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Effective

The term “effective” refers to how well a process or a measure addresses its intended purpose. Determining effectiveness requires (1) the evaluation of how well the process is aligned with the organization’s needs and how well the process is deployed or (2) the evaluation of the outcome of the measure used.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Empowerment

The term “empowerment” refers to giving people the authority and responsibility to make decisions and take actions. Empowerment results in decisions being made closest to the “front line,” where work-related knowledge and understanding reside.

Empowerment is aimed at enabling people to satisfy customers on first contact, to improve processes and increase productivity, and to improve the organization’s performance results. An empowered workforce requires information to make appropriate decisions; thus, an organizational requirement is to provide that information in a timely and useful way.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Ethical Behavior

The term “ethical behavior” refers to how an organization ensures that all its decisions, actions, and stakeholder interactions conform to the organization’s moral and professional principles of conduct. These principles should support all applicable laws and regulations and are the foundation for the organization’s culture and values. They distinguish “right” from “wrong.”

Senior leaders should act as role models for these principles of behavior. The principles apply to all people involved in the organization, from temporary members of the workforce to members of the board of directors, and they need to be communicated and reinforced on a regular basis. Although the Baldrige Criteria do not prescribe that all organizations use the same model for ensuring ethical behavior, senior leaders should ensure that the organization’s mission and vision are aligned with its ethical principles. Ethical behavior should be practiced with all stakeholders, including the workforce, shareholders, customers, partners, suppliers, and the organization’s local community.

Well-designed and clearly articulated ethical principles should empower people to make effective decisions with great confidence. Some organizations also may view their ethical principles as boundary conditions restricting behavior that otherwise could have adverse impacts on their organizations and/or society.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Goals

The term “goals” refers to a future condition or performance level that one intends or desires to attain. Goals can be both short- and longer-term. Goals are ends that guide actions. Quantitative goals, frequently referred to as “targets,” include a numerical point or range. Targets might be projections based on comparative or competitive data. The term “stretch goals” refers to desired major, discontinuous (nonincremental) or “breakthrough” improvements, usually in areas most critical to your organization’s future success.

Goals can serve many purposes, including

• clarifying strategic objectives and action plans to indicate how you will measure success

• fostering teamwork by focusing on a common end

• encouraging “out-of-the-box” thinking (innovation) to achieve a stretch goal

• providing a basis for measuring and accelerating progress

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Governance

TThe term “governance” refers to the system of management and controls exercised in the stewardship of your organization. It includes the responsibilities of your organization’s owners/ shareholders, board of directors, and senior leaders. Corporate or organizational charters, bylaws, and policies document the rights and responsibilities of each of the parties and describe how your organization will be directed and controlled to ensure (1) accountability to owners/shareholders and other stakeholders, (2) transparency of operations, and (3) fair treatment of all stakeholders. Governance processes may include the approval of strategic direction, the monitoring and evaluation of the CEO’s performance, the establishment of executive compensation and benefits, succession planning, financial auditing, risk management, disclosure, and shareholder reporting. Ensuring effective governance is important to stakeholders’ and the larger society’s trust and to organizational effectiveness.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Health Care Services

The term "health care services" refers to all services delivered by the organization that involve professional clinical/medical judgment, including those delivered to patients and those delivered to the community.

Definition from the Malcolm Baldrige 2004 Health Care Criteria For Performance Excellence

High Performance Work

The term “high-performance work” refers to work processes used to systematically pursue ever-higher levels of overall organizational and individual performance, including quality, productivity, innovation rate, and cycle time performance. High-performance work results in improved service for customers and other stakeholders.
Approaches to high-performance work vary in form, function, and incentive systems. High-performance work focuses on workforce engagement. It frequently includes cooperation between management and the workforce, which may involve workforce bargaining units; cooperation among work units, often involving teams; the empowerment of your people, including self-directed responsibility; and input to planning. It also may include individual and organizational skill building and learning; learning from other organizations; flexibility in job design and work assignments; a flattened organizational structure, where decision making is decentralized and decisions are made closest to the “front line”; and effective use of performance measures, including comparisons. Many high-performing organizations use monetary and nonmonetary incentives based on factors such as organizational performance, team and individual contributions, and skill building. Also, high-performance work usually seeks to align the organization’s structure, core competencies, work, jobs, workforce development, and incentives.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

How

The term “how” refers to the systems and processes that an organization uses to accomplish its mission requirements. In responding to “how” questions in the process item requirements, process descriptions should include information such as approach (methods and measures), deployment, learning, and integration factors.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Innovation

The term “innovation” refers to making meaningful change to improve products, processes, or organizational effectiveness and to create new value for stakeholders. Innovation involves the adoption of an idea, process, technology, product, or business model that is either new or new to its proposed application. The outcome of innovation is a discontinuous or breakthrough change in results, products, or processes.

Successful organizational innovation is a multistep process that involves development and knowledge sharing, a decision to implement, implementation, evaluation, and learning. Although innovation is often associated with technological innovation, it is applicable to all key organizational processes that would benefit from change, whether through breakthrough improvement or a change in approach or outputs. It could include fundamental changes in organizational structure or the business model to more effectively accomplish the organization’s work.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Integration

The term “integration” refers to the harmonization of plans, processes, information, resource decisions, actions, results, and analyses to support key organization-wide goals. Effective integration goes beyond alignment and is achieved when the individual components of a performance management system operate as a fully interconnected unit.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Key

The term “key” refers to the major or most important elements or factors, those that are critical to achieving your intended outcome. The Baldrige Criteria, for example, refer to key challenges, key plans, key work processes, and key measures— those that are most important to your organization’s success. They are the essential elements for pursuing or monitoring a desired outcome.  

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Knowledge Assets

The term “knowledge assets” refers to the accumulated intellectual resources of your organization. It is the knowledge possessed by your organization and its workforce in the form of information, ideas, learning, understanding, memory, insights, cognitive and technical skills, and capabilities. Your workforce, software, patents, databases, documents, guides, policies and procedures, and technical drawings are repositories of your organization’s knowledge assets. Knowledge assets are held not only by an organization but reside within its customers, suppliers, and partners, as well.

Knowledge assets are the “know-how” that your organization has available to use, to invest, and to grow. Building and managing its knowledge assets are key components for your organization to create value for your stakeholders and to help sustain a competitive advantage.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Leadership System

The term “leadership system” refers to how leadership is exercised, formally and informally, throughout the organization; it is the basis for and the way key decisions are made, communicated, and carried out. It includes structures and mechanisms for decision making; two-way communication; selection and development of leaders and managers; and reinforcement of values, ethical behavior, directions, and performance expectations.

An effective leadership system respects the capabilities and requirements of workforce members and other stakeholders, and it sets high expectations for performance and performance improvement. It builds loyalties and teamwork based on the organization’s vision and values and the pursuit of shared goals. It encourages and supports initiative and appropriate risk taking, subordinates organizational structure to purpose and function, and avoids chains of command that require long decision paths. An effective leadership system includes mechanisms for the leaders to conduct self-examination, receive feedback, and improve.  

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Lean Six Sigma

Lean Six Sigma is composed of two different elements.  "Lean" refers to focus on the reduction of waste and non-value added activities.  "Six Sigma" refers to a process of reducing variation in processes while striving for perfection.  Six Sigma was originally developed by Motorolla to mean no more than 3.4 defects per million.  However, as more service organizations implement six sigma, it is sometimes used to refer to the point at which it is no longer feasible or cost effective to pursue higher quality.

Learning

The term “learning” refers to new knowledge or skills acquired through evaluation, study, experience, and innovation. The Baldrige Criteria include two distinct kinds of learning: organizational and personal. Organizational learning is achieved through research and development, evaluation and improvement cycles, workforce and stakeholder ideas and input, best-practice sharing, and benchmarking. Personal learning is achieved through education, training, and developmental opportunities that further individual growth.

To be effective, learning should be embedded in the way an organization operates. Learning contributes to a competitive advantage and sustainability for the organization and its workforce.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Levels

The term “levels” refers to numerical information that places or positions an organization’s results and performance on a meaningful measurement scale. Performance levels permit evaluation relative to past performance, projections, goals, and appropriate comparisons.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Measures and Indicators

The term “measures and indicators” refers to numerical information that quantifies input, output, and performance dimensions of processes, products, programs, projects, services, and the overall organization (outcomes). Measures and indicators might be simple (derived from one measurement) or composite.

The Criteria do not make a distinction between measures and indicators. However, some users of these terms prefer “indicator” (1) when the measurement relates to performance but is not a direct measure of such performance (e.g., the number of complaints is an indicator of dissatisfaction but not a direct measure of it) and (2) when the measurement is a predictor (“leading indicator”) of some more significant performance (e.g., increased customer satisfaction might be a leading indicator of market share gain).

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Mentoring

The word “mentor” was originally inspired by the character Mentor from Homer’s Odyssey. In the story, the goddess Athena took on the appearance of the old man, Mentor, in order to guide young Telemachus through times of difficulty.

Today, mentoring is the fourth step in the Make "It" Happen Mastery™ “Lifestyle Loop,” and it still consists of receiving guidance from a senior, experienced advisor. Mentoring, which has been shown to be one of the most effective methods of helping people develop in their careers, also complements other methods of learning.

Mentoring helps senior managers and leaders make Great Management Practice a lifestyle in their organizations by consistently implementing Great Management of strategy and culture; core organizational practices; and key performance practices. Mentors also help them grow into the roles of being integrators, innovators, and inspirators.

CGMP Mentors are senior leaders with many years of experience. They work with people to develop long-term success by making GMP a Lifestyle and routinely customizing and practicing Make "It" Happen Mastery ™, Profound Knowledge, and the 10 Commitments of Mastery in their organizations.

Metrics

Measurements taken over time that monitor, assess, and communicate vital information about the results of a process or activity. Metrics are generally quantitative, but can be qualitative. 

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Mission

The term “mission” refers to the overall function of an organization. The mission answers the question, “What is this organization attempting to accomplish?” The mission might define customers or markets served, distinctive or core competencies, or technologies used.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Nonconformity 

A deficiency in a characteristic, product specification, process parameter,  record, or procedure that renders the quality of a product unacceptable, indeterminate or not according to specified requirements. 

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Packaging Materials 

As used in the Packaging and Labeling System, excludes container and closures which are covered by 21 CFR 211 Subpart E (preamble comment # 312). 

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Partners

The term “partners” refers to those key organizations or individuals who are working in concert with your organization to achieve a common goal or to improve performance. Typically, partnerships are formal arrangements for a specific aim or purpose, such as to achieve a strategic objective or to deliver a specific product.

Formal partnerships are usually for an extended period of time and involve a clear understanding of the individual and mutual roles and benefits for the partners.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Patient

The term "patient" refers to the person receiving health care, including preventive, promotional, acute, chronic, rehabilitative, and all other services in the continuum of care.  Other terms organizations use for "patient" include member, consumer, client, or resident.

Definition from the Malcolm Baldrige 2004 Health Care Criteria For Performance Excellence

Performance

The term “performance” refers to outputs and their outcomes obtained from processes, products, and customers that permit the organization to evaluate and compare its results relative to performance projections, standards, past results, goals, and the results of other organizations. Performance can be expressed in nonfinancial and financial terms.

The Baldrige Criteria address four types of performance:

1. product,

2. customer-focused,

3. operational, and

4. financial and marketplace.

“Product performance” refers to performance relative to measures and indicators of product and service characteristics important to customers. Examples include product reliability, on-time delivery, customer-experienced defect levels, and service response time. For nonprofit organizations, “product performance” examples might include program and project performance in the areas of rapid response to emergencies, at-home services, or multilingual services.

“Customer-focused performance” refers to performance relative to measures and indicators of customers’ perceptions, reactions, and behaviors. Examples include customer retention, complaints, and customer survey results.

“Operational performance” refers to workforce, leadership, organizational, and ethical performance relative to effectiveness, efficiency, and accountability measures and indicators. Examples include cycle time, productivity, waste reduction, workforce turnover, workforce cross-training rates, regulatory compliance, fiscal accountability, strategy accomplishment, and community involvement. Operational performance might be measured at the work unit level, key work process level, and organizational level.

“Financial and marketplace performance” refers to performance relative to measures of cost, revenue, and market position, including asset utilization, asset growth, and market share. Examples include returns on investments, value added per employee, debt-to-equity ratio, returns on assets, operating margins, performance to budget, the amount in reserve funds, cash-to-cash cycle time, other profitability and liquidity measures, and market gains.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Performance Excellence

The term "performance excellence" refers to an integrated approach to organizational performance management that results in (1) delivery of ever-improving value to customers and stakeholders, contributing to organizational sustainability; (2) improvement of overall organizational effectiveness and capabilities; and (3) organizational and personal learning. The Baldrige Criteria for Performance Excellence provide a framework and an assessment tool for understanding organizational strengths and opportunities for improvement and thus for guiding planning efforts.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Performance Projections

The term "performance projections" refers to estimates of future performance. Projections should be based on an understanding of past performance, rates of improvement, and assumptions about future internal changes and innovations, as well as assumptions about changes in the external environment that result in internal changes. Thus performance projections can serve as a key tool in both management of operations and strategy development and implementation.

Performance projections are a statement of expected future performance. Goals are a statement of desired future performance. Performance projections for competitors or similar organizations may indicate challenges facing your organization and areas where breakthrough performance or innovation is needed. Where breakthrough performance or innovation is intended, performance projections and goals may overlap.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Pre-production

Drug development phase prior to pilot production. 

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Preventive Action

Action taken to eliminate the cause of a potential non-conformity, defect, or other undesirable situation to prevent occurrence.

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Process

The term “process” refers to linked activities with the purpose of producing a product (or service) for a customer (user) within or outside the organization. Generally, processes involve combinations of people, machines, tools, techniques, materials, and improvements in a defined series of steps or actions. Processes rarely operate in isolation and must be considered in relation to other processes that impact them. In some situations, processes might require adherence to a specific sequence of steps, with documentation (sometimes formal) of procedures and requirements, including well-defined measurement and control steps.

In many service situations, particularly when customers are directly involved in the service, process is used in a more general way (i.e., to spell out what must be done, possibly including a preferred or expected sequence). If a sequence is critical, the service needs to include information to help customers understand and follow the sequence. Such service processes also require guidance to the providers of those services on handling contingencies related to the possible actions or behaviors of those served.

In knowledge work, such as strategic planning, research, development, and analysis, process does not necessarily imply formal sequences of steps. Rather, process implies general understandings regarding competent performance, such as timing, options to be included, evaluation, and reporting. Sequences might arise as part of these understandings.

In the Baldrige scoring system, your process achievement level is assessed. This achievement level is based on four factors that can be evaluated for each of an organization’s key processes: approach, deployment, learning, and integration.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Process Management

Process Management is the application of knowledge, skills, tools, techniques and systems to define, visualize, measure, control, report and improve processes with the goal to meet customer requirements profitably.

Product/Service

The intended results of activities or processes; products/services can be tangible or intangible. 

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Productivity

The term “productivity” refers to measures of the efficiency of resource use.

Although the term often is applied to single factors, such as the workforce (labor productivity), machines, materials, energy, and capital, the productivity concept applies as well to the total resources used in producing outputs. The use of an aggregate measure of overall productivity allows a determination of whether the net effect of overall changes in a process—possibly involving resource trade-offs—is beneficial.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Profound Knowledge

Profound Knowledge is a concept developed by W. Edward Deming to articulate a way to apply the best effort to the right tasks.  It is composed of four elements:

• Theory of Knowledge

• Appreciation of a System

• Theory of Variation

• Understanding of Psychology

Project

A project is a temporary endeavor to create a unique product, service, or system.  Projects have defined beginnings and ends.

Project Management

Project management is the function of defining and achieving targets while optimizing the use of resources over the course of a project.

Purpose

The term “purpose” refers to the fundamental reason that an organization exists. The primary role of purpose is to inspire an organization and guide its setting of values. Purpose is generally broad and enduring. Two organizations in different businesses could have similar purposes, and two organizations in the same business could have different purposes.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Quality

A measure of a product’s or service’s ability to satisfy the customer’s stated or implied needs. 

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Quality Assurance

Proactive and retrospective activities that provide confidence that requirements are fulfilled. 

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Quality Control

The steps taken during the generation of a product or service to ensure that it meets requirements and that the product or service is reproducible.  

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Quality Management 

Accountability for the successful implementation of the quality system.  

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Quality Objectives

Specific measurable activities or processes to meet the intentions and directions as defined in the quality policy. 

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Quality Plan

The documented result of quality planning that is disseminated to all relevant levels of the organization.  

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Quality Planning

A management activity that sets quality objectives and defines the operational and/or quality system processes and the resources needed to fulfill the objectives.  

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Quality Policy 

A statement of intentions and direction issued by the highest level of the organization related to satisfying customers’ needs. It is similar to a strategic direction that communicates quality expectations that the organization is striving to achieve.  

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Quality System

Formalized business practices that define management responsibilities for organizational structure, processes, procedures and resources needed to fulfill product/service requirements, customer satisfaction, and continual improvement. In the CGMP regulatory context, the quality system establishes the foundation to promote the effective functioning of the five other major systems. 

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Quality Unit

A group organized within an organization to promote quality in general practice. 

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Results

The term “results” refers to outputs and outcomes achieved by an organization in addressing the requirements of a Baldrige Criteria item. Results are evaluated on the basis of current performance; performance relative to appropriate comparisons; the rate, breadth, and importance of performance improvements; and the relationship of results measures to key organizational performance requirements.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Risk Assessment

A systematic evaluation of the risk of a process by determining what can go wrong (risk identification), how likely is it to occur (risk estimation), and what the consequences are.

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Segment

The term “segment” refers to a part of an organization’s overall customer, market, product offering, or workforce base.

Segments typically have common characteristics that can be grouped logically. In results items, the term refers to disaggregating results data in a way that allows for meaningful analysis of an organization’s performance. It is up to each organization to determine the specific factors that it uses to segment its customers, markets, products, and workforce.

Understanding segments is critical to identifying the distinct needs and expectations of different customer, market, and workforce groups and to tailoring product offerings to meet their needs and expectations. As an example, market segmentation might be based on distribution channels, business volume, geography, or technologies employed. Workforce segmentation might be based on geography, skills, needs, work assignments, or job classifications.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Senior Leaders

The term “senior leaders” refers to an organization’s senior management group or team. In many organizations, this consists of the head of the organization and his or her direct reports.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Senior Management

Top management officials in a firm who have the authority and responsibility to mobilize resources.

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Six Sigma

Quality measure based on standard deviation of 3.4 defects per million units.

Staff

The term "staff" refers to all people who contribute to the delivery of an organization's services, including paid staff (e.g. permanent, part-time, temporary and contract employees supervised by the organization), independent practitioners, (e.g. physicians, physician assistants, nurse practitioners, acupuncturists, and nutritionists not paid by the organization), volunteers, and health profession students (e.g. medical, nursing, and ancillary).  Staff includes team leaders, supervisors, and managers at all levels.

Definition from the Malcolm Baldrige 2005 Health Care Criteria For Performance Excellence

Stakeholders (1st definition)

The term “stakeholders” refers to all groups that are or might be affected by an organization’s actions and success. Examples of key stakeholders might include customers, the workforce, partners, collaborators, governing boards, stockholders, donors, suppliers, taxpayers, regulatory bodies, policy makers, funders, and local and professional communities.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Stakeholders (2nd definition)

An individual or organization having an ownership or interest in the delivery, results and metrics of the quality system framework or business process improvements.

Definition from FDA's Guidance For Industry:  Quality Systems Approach To Pharmaceutical Good Manufacturing Practice Regulations

Strategic Advantages

The term “strategic advantages” refers to those marketplace benefits that exert a decisive influence on an organization’s likelihood of future success. These advantages frequently are sources of an organization’s current and future competitive success relative to other providers of similar products. Strategic advantages generally arise from either or both of two sources:  (1) core competencies, which focus on building and expanding on an organization’s internal capabilities, and (2) strategically important external resources, which are shaped and leveraged through key external relationships and partnerships.

When an organization realizes both sources of strategic advantage, it can amplify its unique internal capabilities by capitalizing on complementary capabilities in other organizations.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Strategic Challenges

The term "strategic challenges" refers to those pressures that exert a decisive influence on an organization’s likelihood of future success. These challenges frequently are driven by an organization’s future competitive position relative to other providers of similar products. While not exclusively so, strategic challenges generally are externally driven. However, in responding to externally driven strategic challenges, an organization may face internal strategic challenges.

External strategic challenges may relate to customer or market needs or expectations; product or technological changes; or financial, societal, and other risks or needs. Internal strategic challenges may relate to an organization’s capabilities or its human and other resources.

See the definitions of "strategic advantages" and "strategic objectives" on this page for the relationship among strategic challenges, strategic advantages, and the strategic objectives an organization articulates to address its challenges and advantages.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Strategic Objectives

The term “strategic objectives” refers to an organization’s articulated aims or responses to address major change or improvement, competitiveness or social issues, and business advantages. Strategic objectives generally are focused both externally and internally and relate to significant customer, market, product, or technological opportunities and challenges (strategic challenges). Broadly stated, they are what an organization must achieve to remain or become competitive and ensure long-term sustainability. Strategic objectives set an organization’s longer-term directions and guide resource allocations and redistributions.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Sustainability

The term “sustainability” refers to your organization’s ability to address current business needs and to have the agility and strategic management to prepare successfully for your future business, market, and operating environment. Both external and internal factors need to be considered. The specific combination of factors might include industrywide and organization-specific components.

Sustainability considerations might include workforce capability and capacity, resource availability, technology, knowledge, core competencies, work systems, facilities, and equipment. Sustainability might be affected by changes in the marketplace and customer preferences, changes in the financial markets, and changes in the legal and regulatory environment. In addition, sustainability has a component related to day-to-day preparedness for real-time or short-term emergencies.

In the context of the Baldrige Criteria, the impact of your organization’s products and operations on society and the contributions you make to the well-being of environmental, social, and economic systems are part of your organization’s overall societal responsibilities. Whether and how your organization addresses such considerations also may affect its sustainability.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Systematic

The term “systematic” refers to approaches that are well-ordered, are repeatable, and use data and information so learning is possible. In other words, approaches are systematic if they build in the opportunity for evaluation, improvement, and sharing, thereby permitting a gain in maturity.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Theory of Constraints

The Theory of Constraints is a method of systems improvement which likens a process to a chain, and works to identify and eliminate weak links in the chain.  By doing so, the overall process (chain) is strengthened.

Theory of Management Transformation

The Theory of Management Transformation provides the basis for Make "It" Happen Mastery™.  It is grounded in the concepts of Dr. W. Edwards Deming, and his concepts of Profound Knowledge, 14 Obligations, and 7 Deadly Diseases. 

Training

At the Artisan Consulting Group, training is the first step in Make "It" Happen Mastery™ “Lifestyle Loop.” It is the interactive process of learning each of the 10 Commitments of Mastery, why they are important, and how to customize and implement them.

The 10 Commitments of Mastery are divided into 5 “Must Know’s” and 5 “Must Be’s”, and each training seminar addresses an aspect of one them. Training is conducted in a group setting (with a maximum of 20 participants), and integrates traditional teaching methods with the principles of adult learning. Participants are expected to contribute from their own unique experiences to enhance group learning. As participants explore the specific “Must Know’s” and “Must Be’s”, they will make knowledge maps and practice maps to use when integrating the new knowledge into their real world.

Training provides the foundation for Make "It" Happen Mastery™ by ensuring that participants know how to do the right things, right.

Trends

The term “trends” refers to numerical information that shows the direction and rate of change for an organization’s results or the consistency of its performance over time. Trends provide a time sequence of organizational performance.

A minimum of three historical (not projected) data points generally is needed to begin to ascertain a trend. More data points are needed to define a statistically valid trend. The time period for a trend is determined by the cycle time of the process being measured. Shorter cycle times demand more frequent measurement, while longer cycle times might require longer time periods before meaningful trends can be determined.

Examples of trends called for by the Criteria include data related to product performance, customer and workforce satisfaction and dissatisfaction results, financial performance, marketplace performance, and operational performance, such as cycle time and productivity.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Value

The term "value" refers to the perceived worth of a product, process, asset, or function relative to cost and to possible alternatives.

Organizations frequently use value considerations to determine the benefits of various options relative to their costs, such as the value of various product and service combinations to customers. Organizations need to understand what different stakeholder groups value and then deliver value to each group. This frequently requires balancing value for customers and other stakeholders, such as your workforce and the community.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Values

behaviors that embody how your organization and its people are expected to operate. Values reflect and reinforce the desired culture of an organization. Values support and guide the decision making of every workforce member, helping the organization accomplish its mission and attain its vision in an appropriate manner. Examples of values might include demonstrating integrity and fairness in all interactions, exceeding customer expectations, valuing individuals and diversity, protecting the environment, and striving for performance excellence every day.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Vision

The term "vision" refers to the desired future state of your organization. The vision describes where the organization is headed, what it intends to be, or how it wishes to be perceived in the future.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Voice of the Customer

The term "voice of the customer" refers to your process for capturing customer-related information. Voice-of-the-customer processes are intended to be proactive and continuously innovative to capture stated, unstated, and anticipated customer requirements, expectations, and desires. The goal is to achieve customer engagement. Listening to the voice of the customer might include gathering and integrating various types of customer data, such as survey data, focus group findings, warranty data, and complaint data, that affect customers’ purchasing and engagement decisions.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Work Processes

The term "work processes" refers to your most important internal value creation processes. They might include product design and delivery, customer support, supply chain management, business, and support processes. They are the processes that involve the majority of your organization’s workforce and produce customer, stakeholder, and stockholder value.

Your key work processes frequently relate to your core competencies, to the factors that determine your success relative to competitors, and to the factors considered important for business growth by your senior leaders.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Work Systems

The term "work systems" refers to how the work of your organization is accomplished. Work systems involve your workforce, your key suppliers and partners, your contractors, your collaborators, and other components of the supply chain needed to produce and deliver your products and your business and support processes. Your work systems coordinate the internal work processes and the external resources necessary for you to develop, produce, and deliver your products to your customers and to succeed in your marketplace.

Decisions about work systems are strategic. These decisions involve protecting and capitalizing on core competencies and deciding what should be procured or produced outside your organization in order to be efficient and sustainable in your marketplace.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Workforce

The term "workforce" refers to all people actively involved in accomplishing the work of your organization, including paid employees (e.g., permanent, part-time, temporary, and telecommuting employees, as well as contract employees supervised by the organization) and volunteers, as appropriate. The workforce includes team leaders, supervisors, and managers at all levels.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Workforce Capability

The term "workforce capability" refers to your organization’s ability to accomplish its work processes through the knowledge, skills, abilities, and competencies of its people.

Capability may include the ability to build and sustain relationships with your customers; to innovate and transition to new technologies; to develop new products and work processes; and to meet changing business, market, and regulatory demands.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Workforce Capacity

The term "workforce capacity" refers to your organization’s ability to ensure sufficient staffing levels to accomplish its work processes and successfully deliver your products to your customers, including the ability to meet seasonal or varying demand levels.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

Workforce Engagement

The term "workforce engagement" refers to the extent of workforce commitment, both emotional and intellectual, to accomplishing the work, mission, and vision of the organization. Organizations with high levels of workforce engagement are often characterized by high-performing work environments in which people are motivated to do their utmost for the benefit of their customers and for the success of the organization.

In general, members of the workforce feel engaged when they find personal meaning and motivation in their work and when they receive positive interpersonal and workplace support. An engaged workforce benefits from trusting relationships, a safe and cooperative environment, good communication and information flow, empowerment, and performance accountability. Key factors contributing to engagement include training and career development, effective recognition and reward systems, equal opportunity and fair treatment, and family-friendliness.

Definition from the Malcolm Baldrige 2011 - 2012 Criteria For Performance Excellence

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