Quality glossary

62 terms in plain English. Our own definitions, not quotes from any standard.

APQP: Advanced Product Quality Planning: a phased way to plan a new part launch so quality problems are prevented, not found.
AQL: Acceptance Quality Limit: the worst average percent defective that a sampling plan treats as acceptable over many lots.
AS13100: Quality requirements for aero engine suppliers, used by several engine makers.
AS9100: The quality management system standard for aviation, space and defense organizations, built on ISO 9001 with added requirements.
AS9102: The aerospace standard for documenting first article inspection.
AS9145: Aerospace standard for APQP and PPAP.
Attribute data: Pass/fail or count data, as opposed to measurements.
Audit finding: A documented gap between what is required and what was observed.
Balloon drawing: A drawing with every characteristic numbered so it can be traced to an inspection result.
Bias: The difference between the average measurement and the true (reference) value.
C3PAO: An organization authorized to perform CMMC Level 2 certification assessments.
Calibration: Comparing a measuring instrument to a known standard and adjusting or recording its error.
CAPA: Corrective and Preventive Action: finding and removing the cause of a problem, or of a potential one.
Certificate of Conformance (CoC): A supplier's signed statement that the product meets the order requirements.
Characteristic: Any feature on a drawing or spec that can be inspected: a dimension, a note, a material requirement.
CMMC: Cybersecurity Maturity Model Certification: DoD's program to verify contractors protect sensitive information.
Concession: Customer permission to use or ship product that doesn't fully meet requirements.
Containment: Immediate actions to stop a problem reaching the customer while the cause is found.
Control chart: A time-ordered plot of process data with limits that show normal variation.
Control plan: A document listing how each important characteristic is controlled, measured and reacted to.
Counterfeit part: A part misrepresented as genuine, such as a copy, remarked part or used part sold as new.
Cp: Process potential: how many times the process spread fits into the tolerance, ignoring centering.
Cpk: Process capability index that accounts for both spread and centering, using short-term variation.
CUI: Controlled Unclassified Information: government information that needs safeguarding but isn't classified.
DDTC: Directorate of Defense Trade Controls: the State Department office that administers ITAR.
Deemed export: Releasing controlled technical data to a foreign person inside the U.S.
DHF: Design History File: the record of a medical device's design and development.
DHR: Device History Record: the production record for a medical device lot or unit.
DMR: Device Master Record: the instructions and specs needed to build a medical device.
Empowered Official: The person a company authorizes to sign export license applications and stop exports.
FAI: First Article Inspection: full verification that the production process makes a conforming part.
FMEA: Failure Mode and Effects Analysis: a structured look at what can go wrong, how bad it would be and how to prevent it.
FOD: Foreign Object Debris: anything that doesn't belong in the product, and the damage it causes.
Gage R&R: A study of how much measurement variation comes from the gage (repeatability) and the people (reproducibility).
GIDEP: Government-Industry Data Exchange Program: a database where suspect counterfeit and nonconforming parts are reported.
Internal audit: An audit of your own system by your own trained people.
ISO 13485: The quality management system standard for medical devices.
ISO 14971: The standard for applying risk management to medical devices.
ISO 9001: The general international standard for quality management systems.
ITAR: International Traffic in Arms Regulations: U.S. rules that control defense articles, services and technical data.
Key characteristic: A feature whose variation significantly affects fit, function, safety or life.
Management review: Top management's planned review of how the quality system is performing, ending in decisions.
MSA: Measurement Systems Analysis: studies that check a measurement system is good enough for the job.
NCR: Nonconformance Report: the record of a product or process that doesn't meet requirements.
ndc: Number of distinct categories: how many groups of parts a gage can reliably tell apart. Five or more is the usual target.
NIST SP 800-171: The NIST publication listing 110 security requirements for protecting CUI.
Objective evidence: Records or observations that prove something was done.
POA&M: Plan of Action and Milestones: a list of security gaps with owners and dates to fix them.
PPAP: Production Part Approval Process: a package proving a supplier's process can consistently make good parts.
Ppk: Process performance index using overall (long-term) variation.
Process indicator: A condition that isn't a defect but signals a process to watch (IPC term).
PSW: Part Submission Warrant: the summary sign-off document of a PPAP.
Repeatability: Variation when one person measures the same part several times with the same gage.
Reproducibility: Variation between different people measuring the same parts.
Risk-based thinking: Considering what could go wrong, and its effects, when planning and running processes.
Root cause: The underlying reason a problem happened, which, once removed, stops it recurring.
SPC: Statistical Process Control: using data and control charts to keep a process stable.
SPRS: Supplier Performance Risk System: the DoD system where contractors post their NIST 800-171 scores.
SSP: System Security Plan: describes the system boundary and how each security requirement is met.
TCP: Technology Control Plan: how a company keeps controlled technical data away from unauthorized people.
Traceability: Being able to follow a part's history: materials, processes, inspections and where it went.
Western Electric rules: Run rules for control charts that flag patterns suggesting a special cause.