Corrective and Preventive Action
Systematic process to investigate and resolve quality issues and prevent recurrence.
Definition
CAPA is a quality system process for identifying, investigating, and addressing the root causes of nonconformities, complaints, and other quality events, and for preventing their recurrence. A typical CAPA flow is: identify and document the issue, assess risk, investigate root cause (with tools such as 5 Whys, fishbone diagrams or fault trees), define actions, implement them, and verify effectiveness. Corrective actions address an existing problem; preventive actions address a potential one. Inputs include complaints, nonconformances, audits, service records and trend data. CAPA is one of the most frequently cited areas in FDA Form 483 observations.What this means in practice
CAPA is one of the most frequently cited subsystems in FDA inspections and forms one of the four Quality System subsystems FDA reviews under QSIT. Regulators expect a documented procedure covering identification of quality data sources, investigation, root cause analysis, action planning, implementation, verification of effectiveness, and communication of information to management review.Examples
- A complaint trend showing repeated battery under-performance triggering a CAPA that redesigns the charge circuit and updates the risk file.
- An internal audit finding on inconsistent supplier evaluation records leading to a preventive action that revises the supplier control procedure.
Use cases
1 scenarioPattern of pump occlusion complaints
QA / Complaint handlingTrending shows occlusion complaints rising 30% quarter over quarter. A CAPA is opened: root cause traced to a tubing supplier change, corrective action requalifies the prior supplier, preventive action adds incoming inspection criteria for tubing durometer.
- •Treating CAPA as a paperwork exercise without verification of effectiveness (VoE). VoE is what regulators look for first when reviewing closed CAPAs.
- •Jumping to a corrective action without a documented root cause analysis (5 Whys, fishbone, fault tree).
- •Opening a CAPA for every nonconformance. CAPA should be reserved for systemic issues; individual NCRs are handled through the nonconformance process.
- •Not feeding CAPA outputs into management review, risk management, and design controls.
Frequently asked questions
Cross-references
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsProcess for receiving, evaluating, and responding to device complaints.
FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference.
FDA's current good manufacturing practice (cGMP) requirements for medical devices.
International standard for medical device quality management systems.
QMS Foundations
· From this learning pathCompilation of records describing the design history of a finished device.
Structured process governing the design of medical devices.
Notice of inspectional observations issued at the conclusion of an FDA inspection.
Confirming design outputs meet inputs (V) and that devices meet user needs (V).
Post-Market Mastery
· From this learning pathClinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data.
Action taken to reduce a risk of serious deterioration in health associated with a device.
Removal or correction of a marketed device that violates FDA law.
FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions.
Where this term appears across MedTech Terms.
- QMS FoundationsLesson 7 of 10
- Post-Market MasteryLesson 8 of 9
Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 121 CFR 820.100 (CAPA)Tier 1 VerifiedeCFRecfr.gov
- 2FDA Inspections Observations DataTier 2 UncheckedFDAfda.gov
- 3MDIC Case for QualityTier 4 VerifiedMDICmdic.org
Inline markers like [1] jump to the matching reference above.