Quality Control, Assurance and Performance Management cheat sheet

Key terms

Quality

The degree to which a set of inherent characteristics of an object fulfils requirements (KS ISO 9000). Requirements may be stated, generally implied or obligatory.

Quality control (QC)

The part of quality management focused on fulfilling quality requirements. It is operational and detective: inspection, testing, measurement and the actions taken on output that already exists.

Quality assurance (QA)

The part of quality management focused on providing confidence that quality requirements will be fulfilled. It is systemic and preventive: procedures, competence, calibration, audits and documented evidence applied before and during the work.

Quality planning

Setting quality objectives and specifying the operational processes and resources to achieve them (Quality Planning, Risks and Opportunities Management).

Quality improvement

Increasing the ability to fulfil requirements, that is, raising the level of performance rather than maintaining it.

Quality management

Coordinated activities to direct and control an organisation with regard to quality: planning, control, assurance and improvement together.

Inspection

Determination of conformity by observation and judgement, accompanied where appropriate by measurement, testing or gauging.

Verification and validation

Verification confirms that specified requirements have been fulfilled (did we build it right); validation confirms that requirements for a specific intended use have been fulfilled (does it work in use).

Quality management system

The organising framework: KS ISO 9001, with its clause structure, its documented information and its management review.

Procedures and work instructions

Standardised methods, which are the primary assurance instrument.

Quality plans

Applying the system to a specific product, project or contract (Quality Planning, Risks and Opportunities Management, in its introduction to quality planning).

Failure mode and effects analysis (FMEA)

Systematic anticipation of how a design or process could fail, with severity, occurrence and detection scored to prioritise prevention (Quantitative Skills and Data Analytics).

Statistical process control

Monitoring the process rather than the product, so that drift is detected before nonconformity occurs.

Supplier qualification and audit

Assurance of inputs, which is where a large proportion of failures originate.

Calibration programmes

Assurance that measurements are trustworthy, without which every control decision rests on an unverified instrument.

Competence management

Assurance that the person doing the work can do it, evidenced under clause 7.2.

Internal audit

Assurance that the system operates as designed (Management Systems Audits).

Management review

Assurance that top management has considered performance and directed action (clause 9.3).

Validation of special processes

Where the output cannot be verified by subsequent inspection, for example welding, sterilisation or heat treatment, the process itself is validated.

Certification

External attestation that the system conforms, which is assurance to the market rather than to the organisation.

Conformance

Fulfilment of a requirement, whether that requirement comes from a customer, a standard or the organisation itself. Conformance is the technical question.

Compliance

Fulfilment of a requirement imposed by an external authority, typically a statute or regulator. Compliance is the legal question.

The relationship

All compliance is conformance to a legal requirement, but not all conformance is compliance: a product can conform to a voluntary standard nobody requires. A product can also comply with the law and fail the customer's specification, which is conformance failure without non-compliance.