Quality, Six Sigma, ISO & Lean Glossary of Terms

Lean

Business process focused solely on providing customer-defined value while eliminating all waste activities associated with production and administration activities.

Six Major Losses of TPM (production equipment)

1)downtime, 2)changeover time, 3)minor stops, 4) speed losses, 5)scrap, and 6)rework

Error & Mistake-Proofing (a.k.a. Poka-Yoke)

A manufacturing technique of preventing errors by designing the manufacturing process, equipment, and tools so that an operation literally cannot be performed incorrectly.

Kanban

A Japanese term that means "signal." It is a JIT tool that signals a cycle of replenishment for production and materials, or considered as a "demand" for product. It maintains an orderly and efficient flow of materials through the entire process with low inventory and work in progress. It is usually a printed card that contains specific information such as a description of a part or process.

Catch-Ball

A Lean system to improve bi-directional feedback and ownership especially for complex decision making and policy deployment. Playing catch-ball ensures that everyone who should give input, at all levels, does. It builds consensus among stakeholders.

DMAIC

A Six Sigma structured problem solving methodology: define, measure, analyze, improve and control.

Yellow Belt

A Yellow Belt typically has a basic knowledge of Six Sigma, but does not lead projects on his own, as does a Green Belt or Black Belt. A Yellow Belt participates as a core team member or subject matter expert (SME) on a project. Yellow belts may be responsible for running smaller process improvement projects using the PDCA methodology.

Standard Deviation

A measure of the spread of the process output or the spread of a sampling statistic from the process, denoted by the Greek letter sigma.

Range

A measure of variation in a set of data. It is calculated by subtracting the lowest value in the data from the highest value in the same data set.

Blitz

A blitz is a fast and focused process for improving some component of business; a product line, a machine or a process. It utilizes a cross-functional team of employees for a quick problem-solving exercise, where teams focus on designing solutions to meet some well-defined goals.

Future State Map

A blueprint for lean implementation. Your organization's vision, which forms the basis of your implementation plan by helping to design how the process should operate. The future state map deploys the opportunities for improvement, identified in the current-state map, to achieve a higher level of performance at some future point.

Sub-optimization

A condition where gains made in one activity are offset by losses in another activity; created by the same actions creating gains in the first activity.

Distribution

A distribution describes a population from which observations are drawn, categorized into cells and forming identifiable patterns. It is based on the concept of variation that states that anything measured repeatedly will arrive at different results. These results will fall into statistically predictable patterns. A bell-shaped curve (normal distribution) is an example in which the greatest number of observations fall in the center with fewer and fewer observations falling evenly on either side of the average.

Internal Quality Audit

A documented activity performed to verify, by examination of objective evidence, that applicable elements of the quality system are suitable and have been developed, documented, and effectively implemented in accordance with specified requirements.

Corrective Action Request (CAR)

A form used in internal auditing to notify a department of non-conformance in a quality system.

Lower Control Limit

A horizontal dotted line plotted on a control chart which represents the lower process limit capabilities of a process. The line is set at 3 standard deviations from the mean which represents the expected variation in the data.

Upper Control Limit

A horizontal line on a control chart (usually dotted) which represents the upper limits of process capability. The line is set at 3 standard deviations from the mean which represents the expected variation in the data.

Control Limit

A line (or lines) on a control chart used as a basis for judging the significance of the variation from subgroup to subgroup. Control limits reflect the expected variation in the data. Variation beyond a control limit is evidence that special causes are affecting the process. Control limits are calculated from process data and are not to be confused with engineering specifications.

Flow

A main objective of the Lean production effort, and one of the important concepts that passed directly from Henry Ford to Toyota. Ford recognized that, ideally, production should flow continuously all the way from raw material to the customer and envisioned a production system that acted as one long conveyor.

Total Quality Management (TQM)

A management approach in which all departments, employees, and managers are responsible for continuously improving quality so that products and services meet or exceed customer expectations. The Total Quality Control (TQC) methodology relies on plan-do-check-act (PDCA) cycle to manage processes and, when problems arise, statistical tools to solve them. The methodology and tools are used often by employees during kaizen activities and together from an important subsystem of Lean.

Theory of Constraints (TOC)

A management philosophy and a set of tools for organizational change developed by Israeli physicist Dr. Eliyahu Goldratt and popularized in the 1984 book The Goal. TOC concentrates on improving profits by removing or managing constraints - those factors that prevent a company from achieving its goals. Its primary focus is on throughput, while Lean focuses on the identification and removal of waste to improve flow of value. Both Lean and TOC emphasize improving the whole system rather than individual parts.

Pull Production/Pull System

A method of production in which downstream activities signal their needs to upstream activities, striving to eliminate overproduction. Pull is one of the three major components of a complete JIT production system. Nothing is produced by the upstream supplier process until the downstream customer process signals a need.

5S

A method of workplace organization and visual controls developed by Hiroyuki Hirano. It is a structured and disciplined method of organizing and running the workplace for improved productivity, safety and quality at reduced cost and higher efficiency. The five terms, with Japanese phrase and meaning followed by American are 1) Seiri(organization)/Sort; 2) Seiton(tidiness)/Set in order; 3)Seiso(purity)/Shine; 4) Seiketso(cleanliness)/Standardize; 5) Shitsuke(discipline)/Sustain

Hoshin Kanri or Planning (HP)

A methodology that ensures that everyone in the organization knows the strategic direction of the company. Creating a working communication system means everyone is working toward a common goal. Also known as Management by Policy or Policy Deployment. Goals are established and measures are created to ensure progress toward those goals. HP keeps activities at all levels of the organization aligned with its overarching strategic plans. HP typically begins with the "visioning process" which address the key questions: Where do you want to be in the future? How do you want to get there? When do you want to achieve your goal? And who will be involved in achieving the goals? HP then systematically explores the what's, who's and how's throughout the organization.

Bath Reduction

A philosophy that rejects batch, lot or mass processing as wasteful. Product should move (flow) from operation to operation only when it is needed, in the smallest increment, one piece being the ultimate.

Root Cause Analysis (RCA)

A problem solving methodology that focuses on resolving the underlying problem instead of applying quick fixes that only treat immediate symptoms of the problem. A common approach is to ask why five times - each time moving a step closer to discovering the true underlying problem. Root cause analysis helps to ensure that a problem is truly eliminated by applying corrective action to the "root cause" of the problem.

Value

A product or service provided to a customer at the right time at an appropriate price, as defined in each case by the customer. In Lean thinking, an activity or process has value to a customer only if he/she is willing to pay for it.

Statistical Control

A quantitative condition which describes a process that is free of assignable/special causes of variation such as with central tendency and variance; most commonly displayed on a control chart.

Dashboard

A set of metrics, usually not more than five or six, that provides an "at-a-glance" summary of an organization's or project's status. Every participant in the organization/project from the CEO to worker can have his own dashboard with function/level appropriate data summaries.

Total Productive Maintenance (TPM)

A set of techniques, originally pioneered by Denso in the Toyota Group in Japan, to ensure that every machine in a production process always is able to perform its required task. 1) requires total employee participation - line managers, engineers, quality and operators 2)focuses on six major losses 3) addresses the total life cycle of equipment - different from preventive maintenance in the level of involvement with operators in maintenance, improvement and simple repairs.

Value Stream Mapping

A simple diagram of every step involved in the material and information flows needed to bring a product from order to delivery. Value-stream maps can be drawn for different points in time as a way to raise consciousness of opportunities for improvement. A current-state map follows a product's path from order to delivery to determine the current conditions. A future-state map deploys the opportunities for improvement identified in the current-state map to achieve a higher level of performance at some future point.

Master Black Belt

A six Sigma Quality expert responsible for the strategic implementation within an organization. A Master Black Belt trains and mentors

Common Cause

A source of variation that is always present; part of the random variation inherent in the process itself. Its origin can usually be traced to an element of the system which only management can correct.

Random Cause

A source of variation which is random and in which case a change in the source will not produce a highly predictable change in the response (dependent variable) because no correlation exists.

Just-In-Time (JIT)

A system for producing and delivering the right items at the right time, in the right amounts. The key elements of JIT are flow, pull, standard work, and takt time. Principles that are fundamental to time-based competition include waste elimination, process simplification, set-up and batch-size reduction, parallel processing and layout redesign.

Push System

A system wherein products are pushed into a process, regardless of whether it is needed. Inventory is created through a push system.

Plan, Do, Check, Act - PDCA Cycle (1 of 2)

A systematic series of steps for gaining valuable learning and knowledge for the continual improvement of a product or process. Also known as the Deming Wheel, or Deming Cycle, the concept and application was first introduced to Dr. Deming by his mentor, Walter Shewhart of the famous Bell Laboratories in New York.

Failure Modes & Effects Analysis (FMEA)

A systematic/structured approach for determining the seriousness of potential failures and for identifying the sources of each potential failure. The goal of FMEA is to identify potential failures and implement corrective actions to prevent failures from occurring. "PFMEA focuses on identifying and remediating process failures.

Force Field Analysis

A technique, developed by Kurt Lewin, for analyzing what aids or hinders an organization in reaching an objective. An arrow pointing to an objective is drawn down the middle of a piece of paper. The factors that will aid the objective's achievement, called the "driving forces," are listed on the left side of the arrow. The factors that hinder its achievement, called the "restraining forces," are listed on the right side of the arrow.

Value Package

A total package of products and services that we offer to customers. This package includes competitive cost, excellent service, and high product quality to ensure high customer satisfaction and retention.

Current State Map

A value stream map of the process as it is currently being done in order to identify opportunities for reducing non-value-added activities and other sources of waste.

Cause and Effect Diagram

A visual problem-solving tool used to logically organize possible causes for a specific problem or effect by graphically displaying them in increasing detail. It helps to identify root causes and ensures common understanding of the causes. Also called an Ishikawa Diagram.

Corrective Action

Actions taken to eliminate the cause of a detected non conformance within a product, service, or quality management system and those measures taken by management to prevent its recurrence.

Non-Value Added

Activities or actions taken that add no real value to the product or service making such activities or action a form of waste.

Document Control

Activities which ensure that the review, approval, issuance, amendment, retrieval, storage, and destruction of documentation and data are performed, providing recipients with only approved documents of the latest revision at all locations where they apply.

Quality Management

Activities which include strategic planning, allocation of resources and systematic activities for quality assurance such as planning, operations and evaluation. These activities are the responsibility of senior management.

Experience-Based Design (EBD)

An approach that takes into consideration the experiences that patients, the public and healthcare staff have when they receive or deliver healthcare services as a valuable source of information that can be used to improve or transform those services.

Experience-Based co-Design (EBCD)

An approach to improving healthcare services that borrows from participatory design and user experience design to bring about quality improvements in healthcare organizations.

Desk Audit

An audit which is conducted on documentation only. These determine that all elements of the quality system are documented and compliant with the requirements of ISO 9001, but do not address implementation.

Malcolm Baldrige National Quality Award

An award established by the U.S. Congress in 1987 to raise awareness of quality management and recognize U.S. companies that have implemented successful quality management systems. Awards can be given annually in six categories: manufacturing, service, small business, education, healthcare and nonprofit. The award is named after the late Secretary of Commerce Malcolm Baldrige, a proponent of quality management. The U.S. Commerce Department's National Institute of Standards and Technology manages the award, and the American Society of Quality (ASQ) administers it.

Waste

Any activity that consumes resources but creates no value for the customer. Most activities are waste - muda - and fall into one of two types. 1) Muda that creates no value but is unavoidable given current technologies and production assets. 2) Muda that creates no value and can be eliminated immediately.

A3

Based on the principles of Edward Deming's PDCA (Plan-Do-Check-Act) cycle, A3 is a structured problem solving methodology which is known for putting all the information relative to the problem on a single piece of paper (11x17). It provides a consistent and common approach to solving problems throughout organizations which helps to embed a robust business problem solving culture.

Critical to Quality (CTQ)

CTQ's are the internal critical quality element of a process or practice which has a direct impact on its perceived quality.

Variables

Characteristics of a part which can be measured.

Attribute

Qualitative data that can be counted for recording and analysis. These include characteristics of occurrence, or number of times per cycle, etc.

Calibrations

Comparison of a measurement standard or instrument of known accuracy with another instrument to detect, correlate, report or eliminate by adjustment any variation in the accuracy of the item being compared to minimize errors.

Control Chart

Control charts show how a process changes over time. It is a graphical tool for monitoring changes that occur within a process, by distinguishing variation that is inherent in the process (common cause) from variation that shows a change to the process (special cause). This change may be a single point or a series of points in time - each is a signal that something is different from what was previously observed and measured.

Cycle Time

The time it takes to do one repetition of any particular task typically measured from "start to start," the starting point of one task until the start of another similar task within the same process.

Design for Six Sigma (DFSS)

DFSS is a systematic methodology utilizing tools, training, and measurements to enable companies to design products and processes that meet customer expectations and can be produced at Six Sigma quality levels.

Detection

Detection or inspection is a part-oriented strategy that attempts to identify unacceptable output after it has been produced and to separate it from the good output.

Standardize Work

Establishing precise procedures for each operator's work in a production process, based on three elements: 1)Takt time, which is the rate at which products must be made in a process to meet customer demand; 2)The precise work sequence in which an operator performs tasks within takt time; 3)The standard inventory, including units in machines, required to keep the process operating smoothly. Benefits of standardized work include documentation of the current process for all shifts, reductions in variability, easier training of new operators, reductions in injuries and strain, and a baseline for improvement activities.

Pareto Diagram

Focuses on efforts or the problems that have the greatest potential for improvement by showing relative frequency and/or size in a descending bar graph. Based on the proven Pareto principle: 20% of the sources cause 80% of any problems.

Green Belt

Green Belts are trained on basic Six Sigma improvement methodology and will lead a process improvement or quality improvement team as part of their full-time job. Green Belts are coached by Black Belts.

One-Piece Flow

In the simplest terms, one-piece flow means that parts are moved through operations from step to step with not work-in-process (WIP) in between each piece.

KAIZEN

KAI (to modify, to change) + ZEN (think, make good, make better) = KAIZEN Non-value-added waste (Muda) exists everywhere, related to people, materials, facilities and production set up. KAIZEN refers to the series of activities whereby instances of waste are eliminated one by one at minimal cost, by workers pooling their wisdom. The whole secret to KAIZEN is to create an atmosphere, a culture of continuous improvement, by focusing people on problems. In short, KAIZEN means continuous improvement through incremental improvement.

Work in Progress (WIP)

Material that has entered the production process, but is not yet a finished product - partly finished products in various stages of completion, other than the inventory of raw materials required to produce the product and whatever is left over after the production cycle is complete.

Mistake Proofing

Methods that help operators avoid mistakes in their work caused by choosing the wrong part, leaving out a part, installing a part backwards, etc. Also called poka-yoke (error-proofing) and baka-yoke (fool-proofing)

Clinical Process

NQMC uses an adaptation of the structure, process, outcome framework for quality measures created by Donabedian. In NQMC, a clinical process is defined as "a health care-related activity performed for, on behalf of, or by a patient."

Normal Distribution

Normal distribution is the spread of information (such as product performance or demographics) where the most frequently occurring value is in the middle of the range and other probabilities tail off symmetrically in both directions. Normal distribution is graphically categorized by a bell-shaped curve, also known as a Gaussian distribution. For normally distributed data, the mean and median are very close and may even be identical.

Sample

One or more individual events or measurements selected from the output of a process for the purpose of identifying characteristics and performance of the whole.

Plan, Do, Check, Act - PDCA Cycle (2 of 2)

Plan: involves identifying a goal or purpose, formulating a theory, defining success metrics and putting a plan into action; Do: components of the plan are implemented; Check: outcomes are monitored to test the validity of the plan for signs of progress and success, or problems and areas for improvement; Act: Closes the cycle, integrating the learning generated by the entire process, which can be used to adjust goals, change methods, or even reformulate a theory altogether.

Strategic Planning Process

Process whereby goals are set through internal and external assessment and deployed to resources for performance and improvement activities.

Six Sigma

Six Sigma is a methodology that provides businesses with the tools to improve the capability of their business processes. This increase in performance and decrease in process variation leads to defect reduction and vast improvements in profits, employee morale and product quality.

Non-conformance

Something went wrong; a problem occurred and requires attention often through corrective action.

Nonconformities

Specific occurrences of a condition that does not conform to specifications or other inspection standards; sometimes called discrepancies or defects. An individual nonconforming unit can have the potential for more than one nonconformity. Generally a "c" or "u" chart is used to analyze systems producing nonconformities.

Eight Wastes

Taiichi Ohno's original seven wastes typically found in mass production: 1)over production 2)waiting 3)transportation excess 4)over-processing 5)inventory 6)unnecessary motion 7)defects AND an eighth waste commonly recognized as underutilized resources or human imagination.

Constraint

Taken from the theory of constraints (TOC), a constraint is anything that limits a system from achieving higher performance versus its goal.

Enterprise Resources Planning (ERP)

Taking the needs of an entire organization into account, ERP allows companies to standardize their data, streamline the analysis process, and manage long-term business planning with greater ease.

Takt Time (2 of 2)

Takt Time is calculated by taking the total available production time divided by the customer and requirement (including all demand activities such as clean-up, safety meetings, etc.). (1) 8 hour shift = 480 minutes - (2) 10 minute break = 460 minutes minutes. 1840 pieces per day customer requirements TAKT time = 0.25 minutes or 15 seconds per piece

Quality

Term that describes the condition which exists when a product's performance and/or characteristics satisfy the stated or implied needs of the customer.

Sigma

The Greek letter s (sigma) refers to the standard deviation of a population. Sigma, or standard deviation, is used as a scaling factor to convert upper and lower specification limits to Z. Therefore, a process with three standard deviations between its mean and a spec limit would have a Z value of 3 and commonly would be referred to as a 3 sigma process.

Muda

The Japanese for waste; any activity that consumes resources but creates no value for the customer.

Sensei

The Japanese term for "teacher." An inspiring and easily understood outside master or teacher that assists in implementing Lean practices.

National Quality Measures Clearinghouse (NQMC)

The NQMC is a database and Web site for information on specific evidence-based health care quality measures and measure sets. The NQMC is sponsored by AHRQ to promote widespread access to quality measures by the health care community and other interested individuals.

Process

The combination of people, machine/equipment, raw materials, methods and environment that produces a given product or service.

Process Management

The cycle of continuous review, re-examination, and renewal of fundamental work processes that contribute to an organization's performance and productivity. Itself a continual process, process management must at all times challenge a process's fit with other processes, and may result in a radical change to work methods and practices.

Variation

The inevitable fluctuation in process output. It is quantified by standard deviation, a measure of the average spread of the data around the mean. The sources of variation are grouped into two major classes: common causes and special causes.

Takt Time (1 of 2)

The pace of production (i.e., manufacturing one piece every 34 seconds) that aligns production with customer demand. Calculated as planned production time divided by customer demand. This helps provide a simple, consistent and intuitive method of pacing production. Is easily extended to provide an efficiency goal for the plant floor (actual pieces divided by target pieces).

Trends

The patterns in a run chart or control chart that feature the continued rise or fall in a series of points. Like runs, attention should be paid to such patterns when they exceed a predetermined number.

Functional Layout

The practice of grouping activities by type of operation performed.

Stratification

The process of classifying data into subgroups based on characteristics or categories.

Benchmarking

The process of measuring products, services and practices against those organizations known to be leaders in one or more aspects of their operations.

Batch and Queue

The process of producing more than one piece of an item (a batch) before they are actually needed. When the batch is transferred to a downstream process, it sits in line (the queue) waiting to be processed.

Bottleneck

The slowest operation (choke point) in a manufacturing process. Do not confuse this with a company's "constraint" taken from TOC (Theory of Constraints), which is the slowest operation in an entire manufacturing system that, if remedied, would increase overall company throughput.

Primary Outcome Measure

The specific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.

Distribution(s)

The tendency of large numbers of observations to group themselves around some central value with a certain amount of variation or "scatter" on either side.

Throughput Time

The time required for a product to proceed from order to delivery. When a scheduling and production system is running at or or below capacity, throughput time and lead time are the same. When demand exceeds the capacity of a system, there is additional waiting time before the start of scheduling and production, and lead time exceeds throughput time.

Lead Time

The time that is required from receipt of order until shipped to customer.

Population

The universe of data under investigation from which a sample is extracted.

Gage R&R (Gage Repeatability and Reproducibility)

This is a statistical tool that measures the amount of variation in the measurement system from the device used, the people taking the measurement, the interaction between the device and the person, and the error seen from the parts.

International Organization for Standardization (ISO)

This is an independent non-governmental organization formed in 1946 in Geneva, Switzerland. ISO comes from the Greek word "isos" which means to be "the same." It is a voluntary system that holds all companies to the same standards and must be certified by a third party.

Black Belt

Trained in Six Sigma and Lean principles. Black Belts lead teams responsible for measuring, analyzing, improving and controlling key processes that influence customer satisfaction and/or productivity growth. Black belts train and coach project teams.

Point-of-Use-Storage (POUS)

What you need where you need it. All material is stored where it is going to be used in the process, reducing material handling requirements.

Frequency Distribution

a statistical table that presents a large volume of data in such a way that the central tendency (average/mean/median) and distribution are clearly displayed.