--- title: "CAPA, Corrective and Preventive Action | MedTech Terms" description: "Systematic process to investigate and resolve quality issues and prevent recurrence. 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Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## 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. What the regulation says FDA lists inadequate CAPA procedures and inadequate investigations among the most frequent Form 483 observations year after year. Under QSMR (which incorporates [ISO 13485](/terms/iso-13485):2016), CAPA obligations are effectively unchanged from 21 CFR 820.100. ## 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](/terms/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 scenario 1 ### Pattern of pump occlusion complaints QA / Complaint handling Trending 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. Outcome Complaint rate returns to baseline; the CAPA closes after effectiveness checks across three production lots. Common pitfalls - • 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 What is the difference between corrective and preventive action? Corrective action addresses the root cause of an existing nonconformity to prevent recurrence. Preventive action addresses the root cause of a potential nonconformity (identified from trends, risk analysis, or audits) to prevent occurrence. When should I open a CAPA? What is verification of effectiveness (VoE)? How long can a CAPA stay open? ## Cross-references ### Part of A larger framework or document this term belongs to. - [ ISO 13485 ](/terms/iso-13485) ### Precedes Comes before in a typical workflow or lifecycle. - [ CAPA Effectiveness Check ](/terms/capa-effectiveness) ### Follows Comes after in a typical workflow or lifecycle. - [ Nonconformance (NCR)(NCR) ](/terms/nonconformance) - [ Complaint Handling ](/terms/complaint-handling) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. ](/terms/complaint-handling)[ Quality & Risk Quality Management System Regulation(QMSR) FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference. ](/terms/qmsr)[ Quality & Risk Quality System Regulation(QSR / 21 CFR 820) FDA's current good manufacturing practice (cGMP) requirements for medical devices. ](/terms/qsr)[ Standards ISO 13485 International standard for medical device quality management systems. ](/terms/iso-13485) ### QMS Foundations · From this learning path [ Quality & Risk Design History File(DHF) Compilation of records describing the design history of a finished device. Adjacent lesson ](/terms/design-history-file?from=qms-foundations)[ Quality & Risk Design Controls Structured process governing the design of medical devices. ](/terms/design-controls?from=qms-foundations)[ Quality & Risk FDA Form 483 Notice of inspectional observations issued at the conclusion of an FDA inspection. ](/terms/form-483?from=qms-foundations)[ Quality & Risk Verification & Validation(V&V) Confirming design outputs meet inputs (V) and that devices meet user needs (V). ](/terms/verification-validation?from=qms-foundations) ### Post-Market Mastery · From this learning path [ Clinical & Trials Real-World Evidence(RWE) Clinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data. Adjacent lesson ](/terms/real-world-evidence?from=post-market-mastery)[ Post-Market Field Safety Corrective Action(FSCA) Action taken to reduce a risk of serious deterioration in health associated with a device. ](/terms/fsca?from=post-market-mastery)[ Post-Market Medical Device Recall Removal or correction of a marketed device that violates FDA law. ](/terms/recall?from=post-market-mastery)[ Post-Market Medical Device Reporting (FDA)(MDR) FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions. ](/terms/mdr-reporting?from=post-market-mastery) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [QMS Foundations](/paths/qms-foundations)Lesson 7 of 10 - [Post-Market Mastery](/paths/post-market-mastery)Lesson 8 of 9 Ecosystems (1) - [Quality System](/ecosystems/quality-system) ## Primary references 3 sources Link health: 1 verified 2 unchecked · last checked 2026-06-20 eCFR· 1 FDA· 1 MDIC· 1 1. [1 21 CFR 820.100 (CAPA) Unchecked eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-J/section-820.100) 2. [2 FDA Inspections Observations Data Unchecked FDA · fda.gov ](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations) 3. [3 MDIC Case for Quality Verified MDIC · mdic.org ](https://mdic.org/program/case-for-quality/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Tying cybersecurity into your QMS? We help align cybersecurity activities with ISO 13485 design controls and ISO 14971 risk management. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Quality & Risk Acronym CAPA Sources 3 Use cases 1 Updated 5/5/2026 [Compare with another term](/compare?a=capa) Learn in 60 seconds Card Lesson Quiz Systematic process to investigate and resolve quality issues and prevent recurrence. - · 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. Remember this Watch out: Treating CAPA as a paperwork exercise without verification of effectiveness (VoE). VoE is what regulators look for first when reviewing closed CAPAs. Related terms - [Quality System Regulation(QSR / 21 CFR 820) ](/terms/qsr) - [Quality Management System Regulation(QMSR) ](/terms/qmsr) - [Complaint Handling ](/terms/complaint-handling) - [Nonconformance (NCR)(NCR) ](/terms/nonconformance) - [ISO 13485 ](/terms/iso-13485) - [Management Review ](/terms/management-review) You may also need Auto-suggested from Quality & Risk and shared keywords. - [CAPA Effectiveness Check ](/terms/capa-effectiveness) - [Failure Mode and Effects Analysis(FMEA) ](/terms/fmea) - [Quality Manual ](/terms/quality-manual) - [Servicing (21 CFR 820.200) ](/terms/servicing) - [Change Control ](/terms/change-control) - [Post-Production Information (Risk) ](/terms/post-production-info) [All Quality & Risk terms](/terms?cat=Quality%20%26%20Risk) From the Blue Goat network Related resources and services on this topic. - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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