Here are some definitions to introduce you into the wonderful world of quality, quality assurance (QA), and quality control (QC). Please note that these definitions are intended to help those readers who are not familiar with QA/QC.

Accreditation:   Certification of an individual or group, by a duly recognized body to provide the specific service or operation needed.

Accuracy:   The closeness of agreement between a test result and an accepted reference value. The term accuracy, when applied to a set of observed values, will be a combination of a random component and of a common error or bias component.

Alpha (a ):   The probability of making a Type I error

Analysis:    The first phase in the design of instruction in which data gathered to verify gaps between actual and desired organizational performance.

ANSI American National Standards Institute:     An organization, founded in 1918, for the purpose of eliminating redundancies and conflicts among the standards developed within industry.

Assessment:     The process of obtaining information on an entity to evaluate its conformance or non-conformance with specified criteria.

ASQ:    American Society for Quality.

Audit:    A planned, independent, and documented assessment to determine whether agreed upon requirements are met.

Audit Program:     The organizational structure, commitment, and documented methods used to plan and perform audits.

Audit Program Management:    Organization, or function within an organization, given responsibility to plan and carry out a programmed series of quality system audits.

Audit Standard:     The authentic description of essential characteristics of audits that reflects current thought and practice.

Auditee:     The organization/unit to be audited.

Auditor:    The individual who carries out the audit.

Benchmarking:     An improvement process in which a company measures its performance against that of the best-in-class companies, determines how those companies achieved their performance levels, and uses the information to improve its own performance. The subjects that can be benchmarked include strategies, operations, processes, and procedures.

Beta (b ):    The probability of making a Type II error

Bias:    The difference between the population mean of the test results and an accepted reference value; a characteristic of measurement that refers to a systematic difference.

Calibration:     The comparison of a measurement instrument or system of unverified accuracy to a measurement instrument of system or known accuracy to detect any variation from the required performance specification.

Cause-and-effect diagram:    A tool for analyzing process dispersion. Also referred to as Ishikawa diagram or fishbone diagram. The diagram illustrates the main causes and sub-causes leading to an effect. One of the seven tools of quality.

Certification:    A procedure by which a third party gives written assurance that a product, process, or service conforms to specified requirements.

Checklist:     A tool to ensure that all important steps or actions in an operation have been taken. Checklists contain items that are important or relevant to an issue or situation (for example, audit checklist).

Check sheet:     A simple data recording device. The check sheet is custom designed by the user, which allows him/her to readily interpret the results. One of the seven tools of quality.

Coefficient of Variation (CV) :    Standard deviation divided by the mean. The concept of variation states that no two observed items will ever be identical.

Company culture:    A system of values, beliefs, and behaviors inherent in a company. To optimize business performance, top management must define and create the necessary culture.

Competence:    Refers to a person’s ability to learn and perform a particular activity. Competence generally consists of skill, knowledge, aptitude, and temperament components.

Compliance:    An affirmative indication or judgment that the supplier (of service or product) has met the requirements of the relevant specifications, contract, or regulation; also the state of meeting the requirements.

Conformance:    An affirmative indication or judgment that the service or product (of service or product) has met the requirements of the relevant specifications, contract, or regulation; also the state of meeting the requirements.

Continuous Improvement:     The ongoing improvement of products, services, or processes through incremental and breakthrough improvements.

Control Chart:     Control charts are graphs that display a dynamic picture of process behavior over time. To be considered in control, data points must fall within the upper and lower control limits. One of the seven tools of quality.

Corrective Action:    Action taken to eliminate the root cause(s) and symptom(s) of an existing undesirable deviation or non-conformity to prevent recurrence.

Corrective Action Request:     A formal document noting audit findings and requesting resolution.

Correlation Coefficient (r):   Correlation coefficient is used to judge to what degree with which the independent variable and its partner move either together or in opposition. A positive result indicates direct correlation; conversely, a negative result indicates an inverse correlation. If r = 0, there is no correlation, if r = 1, there is perfect correlation.

Cost of (poor) Quality (COQ) :     A term coined by Philip Crosby referring to the cost of poor quality. The costs associated with providing poor-quality products or services. There are four categories of cost: internal failure costs (costs associated with defects found before the customer receives the product or service), external failure costs (costs associated with defects found after the customer receives the product or service), appraisal costs (costs incurred to determine the degree of conformance to quality requirements), and prevention costs (costs incurred to keep failure and appraisal costs to a minimum).

CQA:    Certified Quality Auditor (ASQ).

CQT:    Certified Quality Technician (ASQ).

Customer satisfaction:    The result of delivering a product or service that exceeds customer requirements.

Customer satisfaction measurement:    A process, typically owned by executive management, in which customer satisfaction data are continuously gathered through customer surveys, interviews, sales force feedback, telemarketing feedback etc.) and analyzed to identify both levels and trends in customer satisfaction with the organization’s services or products.

Deviation:    Any nonconformance in a product or service from the specifications for that product or service.

Distribution:    In statistical applications, the pattern that randomly collected data displays when depicted graphically. Types of distributions include, normal, binomial, and skewed.

80-20:    A term referring to the Pareto principle. This principle suggests that most effects come from relatively few causes – 80 percent of the effects come from 20 percent of the possible causes.

Error:    Act or instance of deviation from procedures or methods of work that result in defects, scrap, rework, waste, injury, or any non-value-adding natural consequence.

Exit meeting:    The meeting at the end of the audit between the auditors and the representative auditees, at which time a discussion of major audit findings takes place.

Feedback:    A return of information in interpersonal communication; it may be based on fact or feeling and helps the party receiving the information judge how well he/she is being understood by the other party.

Finding:    A conclusion of importance based on observation(s).

Flow Chart:    Flow charts describe a process with symbols, arrows and words without the clutter of sentences. Flow charts are particularly useful to outline procedures and processes prior to generation of procedures, forms, and work instructions. One of the seven tools of quality.

Follow-up Audit:    An audit whose purpose and scope are limited to verifying that corrective action has been accomplished as scheduled and determining that the action prevented recurrence effectively.

Gantt Chart:    A chart that uses horizontal bars to depict planned and completed work activities on a time scale.

Gap analysis:    A technique that compares a company’s existing state to its desired state (as expressed by its long-term plans) and determines what needs to be done to remove or minimize the gap.

GLP:    Good Laboratory Practice.

GMP:    Good Manufacturing Practice.

Goal:    A non-quantitative statement of general intent, aim, or desire; it is the end point toward which management directs its efforts and resources.

Hawthorne Effect:    A term referring to experiments conducted by Bell Laboratories in the 1920s, which demonstrated that mere management interest in employees and their working conditions affects the productivity of the employees.

Histogram:    A graphic summary of variation in a set of data. The pictorial nature of the histogram lets people see patterns that are difficult to see in a simple table of numbers. One of the seven tools of quality.

In-control process:    A process in which the statistical measure being evaluated is in a state of statistical control, i.e. the variations among the observed sampling results can be attributed to a constant system of chance causes.

Information:    Data transferred into an ordered format that makes it usable and allows one to draw conclusions.

ISO:    International Organization for Standardization. A worldwide federation, based in Geneva, Switzerland, of national standards organizations for more than 100 countries.

Job description:    A narrative explanation of the work, the work process, the work setting, and the organizational culture.

Job specification:    The list of important functional and quality attributes (knowledge, skills, aptitudes, and personal characteristics) needed to succeed in the job.

Lead Auditor:    The individual who supervises auditors during an audit as a team leader.

Lower Control Limit (LCL) :    This is calculated as the mean minus 3 standard deviations.

Lower Warning Limit (LWL) :    This is calculated as the mean minus 2 standard deviations.

Mean:    A measure of central tendency; the mean is the arithmetic average of all measurements in a data set.
The mean of the data set 14, 22, 16, 21, 17 is18 (total/5).

Median:    The median is the middle number or center value of a data set when all the data are arranged in an increasing or decreasing sequence.
The median of the data set 3, 9, 2, 7, 5, 4, 3, 9, 8 is 5 (middle number)
(2, 3, 3, 4, 5, 7, 8, 9, 9).

Mode:  The mode is the most frequently occurring number in a data set.
The mode of the data set 5, 3, 7, 9, 8, 3, 4, 3, 5 is 3 (most frequent number).

Nonconformity:    A non-fulfillment of a specific requirement.

Objective Evidence:    Quantitative or qualitative information, records, or statements of fact pertaining to an item or service or to the existence and implementation of a quality system element, which is based on observation, measurement, or test and which can be verified.

Observation:  A statement of fact made during an audit and substantiated by objective evidence.

Off-the-job training:     Training that takes place away from the actual work site.

Out-of-control process:     A process in which the statistical measure being evaluated is not in a state of statistical control, i.e, the variations among the observed sampling results cannot be attributed to a constant system of chance causes.

Pareto Diagram:     Pareto diagrams are specialized forms of column graphs and are used to prioritize problems. One of the seven tools of quality.

Performance appraisal:    A formal method of measuring employees’ progress against performance standards and providing feedback to them.

Performance test:    An assessment device that requires candidates to complete an actual work task in a controlled situation.

Plan-do-check-act:    A four step process for quality improvement. Sometimes referred to as the Shewhart cycle or the Deming cycle.

1. Plan – a plan to effect improvement is developed.
2. Do – the plan is carried out, preferably on a small scale.
3. Check – the effects of the plan are observed.
4. Act – the results are studied to determine what was learned and what can be predicted.

Policy:    A statement of principle that exists to direct a specific course of action by the employees of a company.

Population:     A group of people, objects, observations, or measurements about which one wishes to draw conclusions.

Precision:    A characteristic of measurement that addresses the consistency or repeatability of a measurement system when the identical item is measured a number of times.

Pre-audit Meeting:    Introductory meeting between the auditors and the representative auditees, at which time the overview of the planned audit is presented.

Prevention:    Avoidance of non-conformances in products and services; not allowing an error or defect to occur.

Preventive Action:   Action taken to eliminate the causes of a potential nonconformity, defect, or other undesirable situation in order to prevent occurrence.

Procedure:    A document that specifies the way to perform an activity. Also a specific way to perform an activity.

Process:    An activity or group of activities that takes an input, adds value to it, and provides an output to an internal or external customer.

Process Flow Map:    A process map is similar to a flowchart and is defined as "a graphical representation of a process, showing the sequence of tasks; uses a modified version of standard flowcharting symbols". Mapping creates a detailed flowchart of a work process showing its inputs, tasks, and activities in sequence.

Project Plan:    The blueprint for process improvement and the first step in changing a process. It includes a step-by-step description of how the process works, including current inputs, transformations, and outputs.

Quality:    A subjective term for which each person has his or her own definition. In technical usage, quality can have two meanings:

1. the characteristic of a product or service that bear on its ability to satisfy stated or implied needs, and
2. a product or service free of deficiencies.

Quality assessment:    The process of identifying business practices, attitudes, and activities that are enhancing or inhibiting the achievement of quality improvement in an organization.

Quality Assurance (QA) :    All those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given quality requirements.

Quality audit:     A systematic, independent examination and review to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve the objectives.

Quality Control (QC) :    The operational techniques and activities that are used to fulfill requirements of quality.

Quality manual:    A document stating the quality policy, quality system, and quality practices of an organization.

Quality plan (Quality assurance plan) :    The document setting out the specific quality practices, resources, and sequence of activities relevant to a particular product, project, or contract.

Quality policy:    The overall intentions and direction of an organization regarding quality, as formally expressed by top management.

Quality principles:    The rules or concepts that an organization believes in collectively. The principles have been formulated by senior management with input from others and are communicated and understood at every level of the organization.

Quality system:    The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

Random Sampling:   The selection of units for a sample size (n) in such a manner that all combinations of (n) units under consideration have an equal chance of being selected.

Range:    The range of a data set is the difference between the largest and the smallest values.
The range of the data set 5, 3, 6, 10, 5, 1, 5, 2 is 9 (10-1).

Range Chart:    (R chart). A control chart in which the subgroup range, R, is used to evaluate the stability of the variability within a process.

Regression Analysis:    A study used to understand the relationship between two or more variables. Regression analysis makes it possible to predict one variable from knowledge about another. The relationship can be mathematically determined and expressed as a correlation coefficient.

Root Cause:     A fundamental deficiency that results in a nonconformance that must be corrected to prevent recurrence of the same or similar nonconformance.

Run Chart:     A form of trend analysis that uses a graph to show process measurement against time, with a reference line to show the average of the data. A trend is indicated when a series of collected data points head up or down.

Sample:     A finite number of items of a similar type taken from a population for the purpose of examination to determine whether all members of a population would conform to quality requirements or specifications.

Sample size:     Refers to the number of units in a sample randomly chosen from the population.

Scatter diagram:    A graphical technique to analyze the relationship between two variables. Two sets of data are plotted on a graph, with the y-axis being used for the variable to be predicted and the x-axis being used for the variable to make the prediction. The graph will show possible relationships. One of the seven tools of quality.

SDCA cycle:    Standardize-do-check-act cycle. Similar to the plan-do-check-act cycle, except that the plan element is replaced with a standardize element.

1. Standardize – an SOP is developed.
2. Do – SOP is implemented.
3. Check – the effectiveness of the SOP is assessed.
4. Act – return to the standardize phase and make changes to the SOP if necessary. If the SOP does not require changes, implement it across all applicable areas.

Seven tools of quality:     Tools that help organizations understand their processes in order to improve them. The tools are cause-and-effect diagrams, check sheet, control chart, flowchart, histogram, Pareto chart, and scatter diagram.

Shewart/Deming cycle:    An improvement methodology attributed to Shewart and Deming. The methodology includes four (4) phases:

1. Assessment. Data gathering and analysis to identify baseline performance and opportunities for improvement.
2. Design and testing. Producing a validated improvement that is ready to be deployed, using standard design and testing methodologies.
3. Deployment. The implementation of the improvement across the spectrum of possible applications is developed.
4. Integration. Integration of the improved processes with other processes throughout the organization.

Sigma:    The standard deviation of a population

Six-sigma quality:    A program developed by Motorola to emphasize process variation and defects. This program contains these key ingredients:

1. A superordinate goal of total customer satisfaction.
2. Common, and uniform quality metric for all business areas.
3. Identical improvement rate goals for all business areas.
4. Goal-directed incentives for both management and employees.
5. Coordinated training in why and how to achieve the goal.

Specification:    A document that states the requirements to which a given product or service must perform.

Standard Deviation:    Standard deviation is the positive root of the mean of the squared deviations and provides information about variation in a data set, and how the data are spread out around the mean.. s = population standard deviation, s = sample standard deviation

Standard Operating Procedure:   SOP. A written document that describes the methods and procedures a worker uses to perform specific tasks.

System:    A network of connecting processes that work together to accomplish the aim of the system.

Team:    A set of two or more people who are equally accountable for the accomplishment of a purpose and specific performance goals. Also defined as a small number of people with complimentary skills who are committed to a common purpose.

Top-management commitment:    Participation of the highest-level officials in their organization’s quality  improvement efforts. Their participation includes establishing and serving on a quality committee, establishing quality policies and goals, deploying those goals to lower levels of the organization, providing the resources and training that lower levels need to achieve the goals, participating in quality improvement teams, reviewing progress organization-wide; recognizing those who have performed well, and revising the current reward system to reflect the importance of achieving the quality goals.

Total Quality Management (TQM):    TQM is a management approach for  long-term success through customer satisfaction. TQM is based on the participation of all members of an organization in improving processes, products, services, and the culture they work in.

Traceability:    The ability to trace the history, application, or location of an item or activity and like items or activities by means of record identification.

Training:    Refers to the skills that employees need to learn in order to perform or improve their performances of their current jobs or tasks.

Trend analysis:    Refers to charting of data over time to identify a tendency or direction.

Type I error:    An incorrect decision to reject a hypothesis when it is really true

Type II error:   An incorrect decision to accept a hypothesis that is really false.

Upper Control Limit (UCL) :    This is calculated as the mean plus 3 standard deviations. Assuming a normal distribution, 99.73 % of data points will fall between the upper and lower control limits.

Upper Warning Limit (UWL) :    This is calculated as the mean plus 2 standard deviations. Assuming a normal distribution, 95.46% of data points will fall between the upper and lower warning limits.

Validity:    The process of substantiating specified performance criteria.

Variables data:   Measurement information. Control charts based on variables data include average chart, range chart, and sample standard deviation (s) chart.

Variance:   Variance is the square of the standard deviation. Variance of the population is known as σ². Variance is the guaranteed existence of a difference between any two items or observations. 

X-chart:    Average chart.