The Ultimate Guide to Quality Acronyms
Given the intricacies of quality management and its critical importance in manufacturing and operational processes, it’s no wonder that an entire forest of acronyms has grown up around it. As a leader in the quality management software market, we at Veeva created this glossary to help you identify any “trees” you may not have encountered yet (...without having to ask Sue at the next desk).
Quality Management Terms and Definitions
- AI/ML - Artificial Intelligence/Machine Learning
Artificial intelligence is the broad science of creating machines that can simulate human abilities; machine learning is a subset of AI that involves training machines how to learn and adapt through experience.
- APQP - Advanced Product Quality Planning
A structured in-depth process for developing and manufacturing products that runs from concept approval through production.
- APQR - Annual Product Quality Review
A Good Manufacturing Process (GMP) requirement is used to annually evaluate and verify the consistency and appropriateness of an existing manufacturing process.
- AQL - Acceptable Quality Level
The maximum level of faults allowable in a product sample for the batch to be accepted; a measure of minimally satisfactory quality level.
- ASQ - American Society for Quality
A global organization of quality professionals.
- BOM - Bill of Material
A comprehensive list of all the items — raw materials, parts, assemblies, sub-components, etc. — and quantities needed to manufacture an end product.
- BPM - Business Process Mapping
Visual depiction of the start-to-finish steps to be taken — and their order — in delivering a product or service.
- BRCGS - British Retail Consortium Global Standards
An organization that manages third party audit certification schemes (“audit standards”) in the United Kingdom for the Food industry that meet the GFSI (see GFSI) Benchmark requirements.
- CAPA - Corrective and Preventive Action
Improvements to an organization’s processes taken to eliminate the causes of non-conformities or other problems and prevent their recurrence.
- CFR Part 11
A federal regulation that sets out the criteria U.S. companies must follow for FDA acceptance of electronic quality records and digital signatures in place of paper-based documentation.
- CMM - Coordinate Measuring Machine
A device that uses an electronic probe to accurately measure the geometry of a 3D object by sensing discrete points on its surface.
- COA, CofA, eCofA - Certificate of Analysis
A document — paper or electronic (eCofA) — that confirms a product meets its specifications, generally based on quality control testing results.
- COPQ - Cost of Poor Quality
Costs that are generated as a result of producing or providing poor quality products or services.
- COQ - Cost of Quality
A method for calculating the costs companies incur to ensure their products meet quality standards, including the expenses associated with preventing, detecting, and eliminating defects.
- COTS - Commercial Off the Shelf
Ready-made packaged solutions that are readily available for sale, lease or license to the general public and designed to be used “as is.” Often refers to software and hardware products.
- CP - Control Plan
A written description of systems and standards for controlling quality in parts and processes.
- CIP/COP - Cleaning in Place/Cleaning Out of Place
Equipment cleaning procedures, without (CIP) or with (COP) requiring the dismantling of the process equipment.
- CQI - Continuous Quality Improvement
A quality management approach based on the idea that most processes can be made better; CQI seeks to implement incremental, ongoing improvements based on recommendations from a cross-section of team members.
- DFMEA - Design Failure Mode and Effect Analysis
A methodical approach for identifying potential risks and failures in a new or changed design of a product or service.
- 8D - 8 Disciplines of Problem Solving
A step-by-step problem-solving approach typically used by quality professionals to identify, correct, and eliminate recurring problems.
- DMAIC - Define Measure Analyze Improve Control
A data-driven quality strategy used to improve business processes; the foundational methodology in Six Sigma projects.
- DPPM - Defective Parts Per Million
A standard measure of quality achievement — the number of defective products per million products produced or supplied, as estimated through sampling and inspection. Targeted DPPM rates vary by industry.
- ECM - Enterprise Content Management
A digital solution designed to manage all of an organization’s documents, including Word documents, Excel spreadsheets, PDF files, and scanned images.
- EHS - Environment, Health, and Safety
Umbrella term for all laws, regulations, procedures, and programs dedicated to protecting the health and safety of the environment, employees, and the public from workplace hazards.
- EHSQ - Environment, Health, Safety, Quality
Refers to the four components of a comprehensive approach to responsible enterprise management, the goal of which is to establish compliance with applicable laws or standards and protect employees, customers, and the environment.
- eQMS - Electronic Quality Management System
A software-based approach to Quality Management Systems that employs advanced technology to improve efficiency and minimize errors.
- ERP - Enterprise Resource Planning
Software applications that integrate all of a company’s critical business processes into a single interface, to improve data sharing and decision making.
- FAI - First Article Inspection
Detailed inspection of a random sample of the first production run of a new or revised product, used to compare production results to product design standards.
- FMEA - Failure Modes and Effects Analysis
A step-by-step approach for identifying all possible failures in a design, manufacturing, or assembly process, or a product or service.
- FSMA - Food Safety Modernization Act
The Food Safety Modernization Act overhauled regulations regarding food production and gave the Food and Drug Administration (FDA) more authority to oversee and enforce supply chains. The FSMA shifts the focus from responding to foodborne illnesses to preventing them.
- FSP - Fundamental Science Practices
A set of quality management practices and principles that serve as the foundation for research, monitoring, and publishing activities, data, and software management in U.S. Geological Survey laboratories and other facilities.
- FSSC22000 - Food Safety System Certification 22000An organization that manages third party audit certification schemes (“audit standards”) for the Food industry that meet the GFSI (see GFSI) Benchmark requirements.
- FSVP - Foreign Supplier Verification Program
As part of the Food Safety Modernization Act (see FSMA), the FSVP regulation that requires U.S. importers to verify that their foreign suppliers of food for human and animal consumption meet applicable FDA safety standards.
- GDP - Good Distribution Practice
The minimum regulatory standards that a wholesale distributor must meet to ensure the quality and integrity of pharmaceutical products are maintained throughout the supply chain.
- GFSI - Global Food Safety Initiative
The Global Food Safety Initiative is a Coalition of Action from The Consumer Goods Forum (CGF), bringing together 38 retailers and manufacturers and an extended food safety community to oversee food safety standards for businesses and help provide access to safe food for people everywhere.
- GLP - Good Laboratory Practice
Regulations governing the process and conditions under which non-clinical health and environmental safety studies are conducted and reported, to ensure their validity, integrity, and reliability.
- GMP - Good Manufacturing Practice
Legal regulations that set out the proactive steps manufacturers, processors, and packagers of drugs, medical devices, food, and cosmetics must take to ensure their products are safe, pure, and effective.
- GxP - Good Practice
A general designation for the quality guidelines and legal regulations that govern research, development, testing, manufacturing, and distribution in regulated industries.
- HACCP - Hazard Analysis and Critical Control Point
A systematic approach to the identification, evaluation, and control of food safety hazards. (see also CCP).
- HSE - Health, Safety, and Environment
- ISMS - Information Security Management System
A documented set of security controls that protect an organization’s data assets from threats and vulnerabilities.
- ISO - Surprisingly not an acronym!
An international organization for standardization (referred to as 'ISO' in all languages) that develops and publishes international standards for quality management, health and safety, energy management, food safety, and IT security.
- ISO 27001
An international standard for managing information security.
- ISO 9001
An internationally recognized standard that specifies requirements for a quality management system (QMS).
- JIT - Just In Time
An inventory management strategy that minimizes inventory levels, storage costs, and waste by having materials and parts delivered only as they are needed, not before.
- KPI - Key Performance Indicator
A quantifiable measure of performance that indicates how effectively a company is progressing towards its objectives.
- MOC - Management of Change
A set of best practices used when a company makes changes to facilities, operations, organization, or procedures that could create hazards; MOC includes evaluating and controlling safety, health, and environmental risks.
- MSA - Measurement System Analysis
A method for determining the amount of variation within a measurement process using both experimental and mathematical methods; MSA is used to certify a measurement process for precision and consistency.
- NCMR - Non-Conforming Material Report
A standardized document used to report and describe non-conforming (outside of specifications) material identified through in-process or final inspections.
- NCR - Non-Conformance Report
A formal report that documents the details and addresses issues when a product, process, or procedure falls outside of established specifications.
- NPI - New Product Introduction
The process used within a company to define, develop and launch a new product or service.
- OCR - Optical Character Recognition
Technology that converts images of typed, handwritten, or printed text into editable and searchable machine-encoded text.
- OEE - Overall Equipment Effectiveness
A metric that identifies the percentage of planned manufacturing time that is truly productive, based on levels of quality (conforming parts), speed, and time the line is up and running.
- OSHA - Occupational Safety and Health Administration
An agency within the U.S. Department of Labor tasked with ensuring safe and healthful working conditions for workers by setting and enforcing standards and providing training, outreach, education, and assistance.
- PDCA - Plan Do Check Act
A repetitive process, involving the four listed steps, for continually improving products, processes, and services.
- PDP - Product Development Process
The process of getting a new product to market, including planning, concept development, system-level design, detail design, testing, refinement, and production ramp-up.
- PDM - Product Data Management
The use of software to centrally organize, share and track changes in product and engineering data.
- PFMEA - Process Failure Mode Effects Analysis
A methodical approach for identifying potential risks and failures in new or changed processes. (see FMEA)
- PLM - Product Lifecycle Management
The strategic process of managing the entire life journey of a product from concept through disposal.
- PPAP - Product Part Approval Process
An industry-standard approval process conducted by suppliers to ensure design and production specifications are being met in the components they provide to manufacturers.
- QA - Quality Assurance
The proactive development and monitoring of processes to ensure quality in an organization's output; i.e. to prevent defects in products or avoid problems in delivering services.
- QC - Quality Control
The step in quality management that focuses on testing products and services to ensure that customers consistently receive deliverables that conform to company quality standards.
- QHSE - Quality, Health, Safety, and Environment
- QMS - Quality Management System
A formalized system of business policies, processes, and procedures designed to ensure a company’s products or services meet its quality criteria.
- RCA - Root Cause Analysis
Problem-solving processes used to discover why faults or issues occurred, in order to identify appropriate solutions.
- ROQ - Return on Investment in Quality
A metric that evaluates the financial return of investments in quality management and improvement to determine if specific quality efforts are financially justifiable.
- SCAR - Supplier Corrective Action Report
A document used to inform a supplier of issues/defects in non-conforming (outside of specifications) material received and request corrective action from that supplier.
- SHE- Quality of Safety, Health, and Environment
- SIPOC - Suppliers, Inputs, Process, Outputs, and Customers
A Six Sigma tool that provides a high-level overview of a process by summarizing the inputs and outputs, major steps, and players in table form.
- SNCR - Supplier Non-Conformance Report
A document that records when a supplier’s product or service has not met specifications, for example, in tolerances, material, measurement, testing, procedure, timing, etc.
- SOP - Standard Operating Procedure
A set of step-by-step written instructions for how teams and individual workers should complete routine operations in order to ensure efficiency and quality control.
- SPC - Statistical Process Control
Utilization of statistical analysis to monitor and improve business processes and the resulting products or services.
- SQF - Safe Quality Food Institute
An organization that manages third party audit certification schemes (“audit standards”) for the Food industry that meet the GFSI (see GFSI) Benchmark requirements.
- 5S - Sort, Set in Order, Shine, Standardize, and Sustain
An organization method aimed at creating clean, uncluttered, safe, and productive workspaces by assessing everything in the space, removing what’s unnecessary, organizing, cleaning, and maintaining order once it’s established.
- TQC - Total Quality Control
A system for optimizing performance developed by the Japanese and based on the concept that improvement must be cross-functional and involve everyone in the company — workers and managers — in an integrated effort.
- TQM - Total Quality Management
A multi-faceted, company-wide approach to continually improving the quality of products and processes such as delivery, customer service, marketing, etc. with a goal of customer satisfaction.
- V&V - Verification and Validation
Procedures used in quality management — verification tests if a product meets written requirements and specifications, while validation tests how well it fulfills its intended purpose.
- VoC - Voice of the Customer
Initiatives designed to collect, understand and utilize customer feedback about their experiences with a product or service.
- VSM - Value Stream Mapping
A flowchart methodology for illustrating, analyzing, and improving product/service development and delivery processes, with a focus on optimizing value for the customer.
- WIP - Work in Progress
A company’s partially finished goods waiting for completion.
Our Ultimate Guide to Quality Management is an excellent source of additional information about the benefits of a company-wide quality management system, the standards that might apply to your industry, and the benefits of using modern quality management software.
And if you’re ready to ensure compliance and agility in your quality management program, a unified cloud-based application like Veeva’s QualityOne can help you make that happen — faster and at less total cost.
*The 80 quality definitions in this article are original to Veeva Industries based on a consensus of many research sources and an overall expertise in the industry.