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Glossary

Term Acronym Definition
8D Problem Solving Process “Eight Disciplines” is a methodology used to approach and resolve problems through team synergy.
Action Item A documented event, task, activity or action that needs to take place. Action items also track investigations, root-cause analyses and resolutions.
Alert Signals job constraints, such as liens, or part or tool delays.
As-Built Instructions that reflect the shop floor changes made during manufacturing, which can be different from the original design.
As-Designed Data that depicts the original plan for the manufacturing of a unit.
As-Maintained Supports the current configuration of a unit.
AS9100 Unified quality standard for the aerospace industry.
ASME American Society of Mechanical Engineers Promotes collaboration, knowledge sharing, career enrichment and skills development across all engineering disciplines.
Audit Requirement An obligation that must be met during an audit. An audit’s purpose is to test, validate and confirm that policies are being followed.
Audit Trail The complete step-by-step history of a manufacturing process from the initiation to the completion of a product.
Authoring To create content.
BOM Bill of Materials The list of materials, sub-assemblies, components, parts and the quantities of each needed to manufacture a product.
Buyoff Point Occurrence in the online instructions that requires an electronic stamp of completion or approval.
Buyoff Signature Electronic stamp of completion or approval online.
CAD Computer-Aided Design Software used to create physical, 3D designs.
CAPA Corrective and Preventive Actions Improvements to an organization’s processes to eliminate nonconformances. It focuses on the systematic investigation of the root cause of a nonconformance to prevent its recurrence and occurrence.
Change Control The formal process used to ensure that alterations to a product or system are introduced in a coordinated manner with minimal disruptions.
Change History The complete history for each changed object in every work-plan revision and work-order alteration.
Change Management Process of creating, reviewing and gaining approval for engineering change requests.
Closed-Loop Process An integrated information flow that determines and eliminates the root cause of a problem to prevent its recurrence.
Conformance An affirmative indication or judgement that a product meets the requirements of relevant specifications, contract or regulation.
Corrective Action Action taken to eliminate the root cause and symptom of an existing  deviation or non-conformity to prevent recurrence.
Cycle Time The period required to complete an operation, function, job or task from start to finish.
Defect A departure from a quality characteristic that causes a product not to meet requirements.
DHR Device History Record A collection of records containing the production history for medical devices, including data for each batch, lot and unit  produced.
Discrepancy Deviation in any quality characteristic that is rejected or out of limits.
Dispatch List An electronic list of manufacturing orders in priority sequence.
Disposition Manner in which an item or material is disposed of, such as rework, repair or scrap.
Disposition Instructions Instructions on how an item or material is disposed.
DMR Device Master Record A collection of records that contains the procedures and specifications to manufacture medical devices.
DoD Department of Defense US federal department charged with coordinating and supervising all agencies and functions relating to national security and the armed forces.
DoE Department of Energy Cabinet-level department of the US government concerned with policies regarding energy and safety in handling nuclear material.
DPMO Defects per Million Opportunities An accurate representation of the defects with respect to all of the opportunities within a sample.
DPPM Defective Parts per Million An accurate representation of the defects within a sample.
eBOM Engineering Bill of Materials A list of items that make up the physical product being engineered.
Effectivity Intended or expected effect.
Electronic Signature Electronic sound, symbol or process that is executed by an operator with the intent to validate a record.
Engineering Change Electronic document that records or authorizes a change to a design.
Enhanced Work Instructions Easy-to-follow instructions that reduce learning curves and errors. The instructions for simpler jobs can be as basic as text descriptions linked to illustrations and bookmarked drawings; instructions for more difficult jobs can include animated slideshows with incorporated marked-up drawings, 3D models and videos.
ERP Enterprise Resource Planning Integrates internal and external management information across an entire organization and facilities the flow of information amongst all business functions.
FAA Federal Aviation Administration National aviation authority of the US. It regulates and oversees all aspects of civil aviation.
FAI First Article Inspection The testing and inspecting of a pre-production sample from a vendor. FAI will determine if the product meets acceptance and quality control requirements.
FDA Food and Drug Administration Agency of the US Department of Health and Human Sciences that is responsible for protecting and promoting public health through the regulation and supervision of medical devices, among other segments.
FDA 21 CFR Part 11 FDA criteria under which electronic records and electronic signatures are considered trustworthy, reliable and equivalent to paper records.
FGI Finished Goods Inventory Amont of manufactured product on hand that awaits the sale to customers.
Gantt Chart Shows priorities, the master schedule, the revised schedule and actual dates.
GMP Good Manufacturing Practices Manufacturing and testing guidelines that medical device companies, among others, must follow. GMP guidelines safeguard the health of patients and ensure good quality medical devices are produced.
Histogram Graphically displays the assigned load for each employee or team.
Information Kit Technician’s resource that includes all of the necessary information to complete work orders online.
Inspection Operation All of the activities for an inspection of one or more characteristic with specific test equipment at a particular work center.
Inspection Order All of the characteristic data collections that must be performed.
Inspection Oversight Pre-established, dynamic rules for different types of parts. The system tightens or relaxes oversight requirements as quality decreases or increases, respectively.
Inspection Plan Prescribe how to verify that each product is built or serviced to engineering specifications.
Inspection Point A record of inspection results that is assigned to a work or inspection operation.
Inspection Requirement Measurements and observations created internally or by an inspector that must be met during an inspection. Inspection requirements are part of work instructions, and includes data collection and certification requirements.
Inspection Verification Confirmation that inspectors recorded their results at specificed inspection points.
ISO International Organization for Standardization Network of national standards institutes.
ISO13485 International Standards Organization 13485 Requirements for a comprehensive QMS for the design and manufacture of medical devices.
ISO9000 International Standards Organization 9000 Family of standards for QMS. It is designed to help organizations meet the needs of customers and other stakeholders.
ISO9001 International Standards Organization 9001 Set of standards for QMS and management systems, in general.
ITAR International Traffic in Arms Regulations Set of US government regulations that control the import and export of defense-related articles and services.
Lean Production practice that considers the expenditure of resources for any goal other than the creation of value for the end customer to be wasteful.
Lien Holds or virtual red tags on units with open discrepancies, rework or incomplete work.
Manufacturing Cell Machines, often grouped in semicircles, that produce a given product.
Material Information Flow Delivery of materials and information required to bring a product to a customer.
mBOM Manufacturing Bill of Materials A list of items organized into sub-assemblies that represents the physical product, packaging and included documentation. It contains all of the components required to build a product.
MCAD Mechanical Computer-Aided Design Software used to develop concepts and designs of mechanical systems.
MES Manufacturing Execution System A system that controls and manages production in factories.
MOM Manufacturing Operations Management Methodology for viewing an end-to-end manufacturing process in real time to optimize efficiency.
MRO Maintenance, Repair and Overhaul Retaining or restoring an item to a state in which it can perform its required function.
Nonconformance A departure from a quality characteristic that causes an associated product not to meet a specification requirement.
Non-Routine Disposition Discrepancies and deviations to the typical manner that an item or material is disposed of.
Non-Routine Operation (a.k.a non-routine task card) A task or activity that is unplanned.
Non-Routine Process Handling Ability to author in-plan work instructions on non-routine operations.
Non-Routine Repair Restoring discrepancies and deviations within accustomed maintenance tasks and inspections.
Non-Routine Task Instructions Specifications and requirements for a task or activity that is unplanned. Work instructions for routine and non-routine tasks have the same capabilities.
Non-Routine Work A task or activity that is unplanned.
Non-Routine Work Instructions Specifications and requirements for a task or activity that is unplanned. Work instructions for routine and non-routine tasks have the same capabilities.
NRC Nuclear Regulatory Commission Independent agency of the US government that oversees nuclear safety and security.
NUPIC Nuclear Procurement Issues Committee Committee that evaluates suppliers’ quality standards within the nuclear industry.
OEM Original Equipment Manufacturer The company that originally manufactured the product. OEMs manufacture products that may be sold or marketed by another company.
Online Data Collection Process of preparing and collecting data via the web.
Online Work Instructions Web-based instructions that reduce learning curves and errors. The instructions for simpler jobs can be as basic as text descriptions linked to illustrations and bookmarked drawings; instructions for more difficult jobs can include animated slideshows with incorporated marked-up drawings, 3D models and videos.
Operational Flow Diagram A graphical representation of the general flow of plant processes and equipment.
Paperless Publishing A paper-free environment that synchronizes companies’ enterprise data in real time.
PCA Packaged Composite Application Manages events in real time across the ERP and MES applications, consolidating information and eliminating the extra steps users perform when switching back and fourth among multiple applications.
PDM Product Data Management Often within PLM, it is responsible for the creation, management and publication of product data.
Planned Operation A task or job prepared for in advance.
Planned Service Procedures A repair task or job prepared for in advance.
PLM Product Lifecycle Management The process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service and disposal.
Preventive Action A change implemented to address a weakness that is not yet responsible for causing a nonconforming product.
Process Configuration Activities that must be performed for the installation of software packages on a system.
Process Control A system that measures, controls and regulates manufacturing processes.
Process Execution Provides visibility to the shop floor in real time and gives users control of each operational step.
Process Management The collection of activities that plan and monitor the performance of a process.
Process Planning Element in project management that selects resources for the use in the execution and completion of a project.
Process Qualification Evaluates the adequacy of the product design and determines if the product can be manufactured at the projected cost and quality.
Process Quality System for the documentation, tracking and disposition of discprepancies, and for the management of corrective actions. It also tracks and analyzes continuous process improvement.
Product Configuration A tool to simplify order entry, routing and BOM design based on features and options selected by a customer.
Product Genealogy Collection and storage of data that includes all of the materials, components and subassemblies used for each unit.
Product Qualification Evaluates the adequacy of the product and determines if it can be manufactured at the projected cost and quality.
Production Control Information Board Display that shows all pertinent information for smooth production and makes the most efficient use of production cycles.
Production Control System to create a quality product in accordance with the specifications determined by monitoring the shop floor.
Production Flow The manufacturing of a predetermined number of products through a standardized process.
Production Lot Production quantity of an assembly that is produced together and referenceable by number.
Production Unit Assembled materials or items in the production cycle.
Project Plan A statement of how and when a project’s objectives are to be achieved.
QA Quality Assurance The systematic monitoring and evaluation of a service or facility to ensure that quality standards are met.
QCS Quality Control System Process that reviews the quality of all factors involved in production.
QMS Quality Management System Organizational structure, procedures, processes and resources needed to implement and maintain consistent quality on the shop floor.
Quality Hold Prevents any further work from being done on an inspection order.
Quality Metrics Data measurements that track the performance of production with a spotlight on quality.
Receiving Inspection An initial review of a delivered product.
Red-Decal Hold An issue that cannot be resolved at a supplier’s site.
Regulatory Compliance The efforts to ensure that users and companies are aware of and take steps to comply with laws and regulations.
Rework Process to complete or retrofit scrapped or shelved units.
Root Cause A fundamental deficiency that results in a nonconformance and must be corrected to prevent recurrence of the same or similar nonconformances.
Root-Cause Analysis/Investigation A problem-solving method to identify the cause or source of a problem. The analysis aims to eliminate the root cause, instead of only addressing the symptoms.
Root-Cause Corrective Action Structured approach aimed at identifying the initial cause of a problem and steps to eliminate the problem from recurring.
Salvage The removal or recycling of components or subassemblies from scrapped units.
Sampling Rule Predetermined rules based on a suppliers’ part history.
Scrap Units or materials left over from production.
Shelve A product that is not completed temporarily or permanently.
Six Sigma Seeks to improve the quality of process outputs by identifying and removing the causes of defects and minimizing variability.
Source Inspection An initial inspection initiated by the customer.
SPC Statistical Process Control The process of monitoring production quality and process performance through the use of statistical methods.
SQMS Supplier Quality Management System Systematic and dynamic approach to managing quality with suppliers.
Squawk A discrepancy.
Standard Text A frequently used, standard operating procedure that is independent of an order.
Supply Chain A sequence of operations through which supplies move from the supplier source to the customer.
Test Operation Confirmation that inspectors measured the quality, performance and reliability at specificed inspection points.
Third-Party Contract Inspection An inspector or company besides the manufacturer or supplier that reviews source inspection data.
Tooling Management Management of tools and gages that require periodic service and calibration.
Unit History All collected data on a unit.
Unit History Record A specific data measurement for a unit.
Unplanned Operation A task or job not prepared for in advance.
Value Stream Lean manufacturing technique used to analyze and design the flow of materials and information required to bring a product to a customer.
Vendor-Specific Integration Packages Specific integrations available for PDM, ERP and labor reporting solutions.
Verification Point Confirms that a particular action or job has taken place or verifies the state of a unit.
Web Portal Point of access to online information.
WIP Work in Process Unfinished items for products in the production process.
Work Order An order that specifies a task to perform on the shop floor.
Work Plan An outline of all of the tasks that need to be completed to finish a project. A work plan also includes user assignments.
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