Glossary

Say what the inspector means

The vocabulary of deviation management, grouped by stage of the process. Definitions are ours; the source clause is given where one exists.

Events

Deviation: Any departure from an approved instruction, procedure, specification or established standard. Defined by the relationship to the instruction, not by size.EU GMP 5.15; 1.4(xiv)
Planned deviation: A pre-approved, temporary, one-off departure from a procedure. Widely misused as a way to make changes without change control; if kept, needs QA approval, a risk assessment and a hard end date.EU GMP 5.15; Annex 15 s.11
Incident / event: Terms some sites use for an occurrence pending a first assessment of whether it is a deviation. Acceptable if the first assessment is documented and time-bound.
Nonconformance: The ISO 13485 term for product, process or system that does not meet requirements. Functionally equivalent to a deviation in a device QMS operating under ISO 13485 and the MDR.ISO 13485 8.3; MDR 2017/745 Art. 10(9)
Out of specification (OOS): A test result outside the registered or approved specification. Investigated under a laboratory investigation procedure (EU GMP Chapter 6 and PIC/S guidance) which feeds a deviation when a manufacturing cause is confirmed.EU GMP 6.35, 6.36; PIC/S PE 009 Ch. 6
Out of trend (OOT): A result within specification but inconsistent with the expected trend or history. A signal that should be evaluated, often before it becomes an OOS.
Excursion: Departure of a monitored parameter (temperature, pressure, humidity, particle count) from its set limits. An excursion against an established limit is a deviation.

Classification

Critical deviation: An event that has or could have a direct effect on patient safety, product quality or data integrity, or is a serious GMP breach. Triggers immediate QA and senior management notification and a full cross-functional investigation.ICH Q9 (R1)
Major deviation: An event that could affect product quality or the validity of a record, where the effect is not immediate or is contained. Full investigation with QA approval.
Minor deviation: An isolated event with no reasonable potential for product impact and no data integrity implication. Short investigation, but still investigated and still trended.
Worst credible effect: The most serious consequence that could reasonably follow from an event if undetected. The basis for classification; distinct from the worst imaginable effect and from the actual outcome.ICH Q9 (R1)
Recurrence escalation: A procedural rule that raises the classification of a deviation when the same failure mode recurs within a defined window, and requires the previous investigations to be reviewed together.

Investigation

Problem statement: A one-paragraph statement of the requirement, the observation, when, where, by whom and how detected. Contains no causes or conclusions.
Containment / immediate action: Actions taken in the first hours to stop the event spreading and preserve evidence: quarantine, line stop, sample retention, securing logs and parts.
Timeline analysis: Reconstruction of the sequence of events from objective records and interviews, with timestamps, marking where records and accounts disagree and where the event could last have been prevented or detected.
Root cause: The underlying condition that, if removed, would prevent recurrence. Must be something that can be changed; 'operator error' fails this test.EU GMP 1.4(xiv); ICH Q10 3.2.2
Contributing factor: A condition that made the event more likely or harder to detect but would not alone have caused it. Recorded separately from the root cause and usually also addressed by CAPA.
5 Whys: Iterative questioning from the event toward the underlying condition. Effective when it branches at each step and stops at something changeable; ineffective as a single chain that stops at the first fixable thing.
Ishikawa (fishbone) diagram: A prompt structure for considering cause categories (method, machine, material, measurement, environment, people). Not evidence in itself; attach what was used to rule each category in or out.
Human error: A description of what happened rather than why. Acceptable as a conclusion only after a documented contributing-factor analysis has ruled out procedure, equipment, environment and process design causes.EU GMP 1.4(xiv)

Impact and disposition

Impact assessment: The evidenced evaluation of whether an event could have affected product quality, patient safety, the validated state, data integrity or regulatory commitments, across every batch, product and system in scope.EU GMP 1.4(xiv), 8.16
Scope: The set of batches, products, materials, equipment, systems and records potentially affected by an event. The most common assessment failure is a scope that stops at the batch number on the form.
Batch disposition: The decision to release, reject, rework, reprocess or hold affected material, made by the quality unit or Qualified Person on a documented basis.EU GMP Annex 16
Qualified Person (QP): In the EU, the named individual legally responsible for certifying each batch before release. Must be informed of deviations affecting batches they certify.EU Directive 2001/83/EC Art. 48; Annex 16

CAPA and closure

Correction: Action to eliminate the detected nonconformity itself (reject, rework, recalibrate). Prevents nothing.ISO 9000 3.12.3
Corrective action: Action to eliminate the cause of a detected nonconformity so it does not recur.ICH Q10 3.2.2; ISO 9000 3.12.2
Preventive action: Action to eliminate the cause of a potential nonconformity before it occurs, typically by applying a lesson from one event elsewhere.ICH Q10 3.2.2
Effectiveness check: Verification, after a defined period, that a CAPA achieved its intended outcome, measured against named evidence. Distinct from a completion record.ICH Q10 3.2.2
Trending: Periodic analysis of deviations by failure mode, area, product and cause to detect recurrence and systemic weakness. An expectation of Chapter 1 and ICH Q10 and an input to the PQR and management review.EU GMP 1.10; ICH Q10 4.1
Extension: A documented, QA-approved revision of a deviation's target closure date with a rationale. Late with an extension is controlled; late without one is a finding.