Quality management glossary

QMS (quality management system)

The documented set of processes, responsibilities and records an organisation uses to deliver products or services that meet customer and regulatory requirements, and to improve them over time. ISO 9001 is the best-known QMS standard. Related →

QMS software

Software that runs the QMS processes digitally: document control, records, corrective actions, audits and approvals, with an audit trail instead of paper and spreadsheets. Related →

Document control

The process that makes sure documents are reviewed and approved before use, that only the current revision is available where work is done, and that changes and obsolete versions are controlled. Related →

Controlled copy

A copy of a document that is numbered and recorded, so it can be recalled or replaced when the document changes. Related →

Record

Evidence that an activity was carried out, such as a filled inspection form or a calibration certificate. Records are kept for a defined retention period and are not changed afterwards. Related →

8D (eight disciplines)

A structured problem-solving method with eight steps: team, problem description, containment, root cause, corrective action, implementation and verification, prevention of recurrence, and closure. Widely required by automotive and electronics customers. Related →

CAPA

Corrective and preventive action: finding the root cause of a non-conformity, acting so it does not happen again, and checking that the action was effective. Related →

Containment

Immediate action to protect the customer while the root cause is investigated, for example sorting stock at the plant, in transit and at the customer. Related →

Root cause analysis

Finding the underlying reason a problem occurred and why it was not detected, using methods such as 5 Why or a fishbone diagram. Related →

Internal audit

A planned, independent check of whether the management system is followed and effective, carried out by trained auditors from inside the organisation. Related →

Non-conformity

Failure to meet a requirement. In audits, findings are usually graded as major or minor non-conformities, or observations. Related →

PPAP

Production Part Approval Process: the automotive method for showing a customer that a part and its production process meet all requirements, submitted as up to 18 elements with a Part Submission Warrant. Related →

PSW (Part Submission Warrant)

The summary document of a PPAP submission, signed by the supplier, that declares the parts meet all customer requirements. Related →

ECN (engineering change note)

A record of a change to a product or process, showing what changed, which parts and documents are affected, who reviewed it and who approved it. Related →

APQP

Advanced Product Quality Planning: a structured plan for launching a new part, in phases from planning to production, with defined deliverables such as FMEA, control plan and PPAP. Related →

SPC (statistical process control)

Using control charts to monitor a process over time and react when it shows signs of instability, before defects are produced. Related →

Cp and Cpk

Process capability indices. Cp compares the specification width with the process spread; Cpk also takes into account how well the process is centred. Many customers expect a Cpk of at least 1.33. Related →

MSA (measurement systems analysis)

Studies that check whether a measurement system is good enough for its purpose, for example by measuring the same parts several times with different operators. Related →

Gauge R&R

A measurement study that separates variation caused by the gauge (repeatability) from variation caused by the people using it (reproducibility). The total, %GRR, is compared with the tolerance. Related →

Calibration

Comparing a measuring instrument with a known reference and adjusting or recording its error, at defined intervals, so measurements can be trusted. Related →

Cost of quality

The total cost of preventing, finding and fixing quality problems, usually split into prevention, appraisal, internal failure and external failure costs. Related →

FMEA

Failure Mode and Effects Analysis: a structured way to identify how a design or process can fail, how serious that would be, and which controls prevent or detect it. Related →

Control plan

A document that lists the characteristics to be checked in production, how, how often and what to do when a check fails. Related →

ISO 9001

The international standard for quality management systems, used by organisations of every size and sector. Related →

IATF 16949

The quality management standard for the automotive supply chain, used together with ISO 9001 and customer-specific requirements. Related →

ISO 13485

The quality management standard for medical device manufacturers and their suppliers. Related →

ISO/IEC 27001

The international standard for information security management systems. Related →

Audit trail

A complete, unchangeable history of who did what and when, used as evidence in audits. Related →

Free downloads: 8D, CAPA, PPAP and audit checklist templates →