CAPA Procedure

This procedure defines the process for identifying, documenting, investigating, and resolving quality issues through Corrective and Preventive Actions (CAPAs). CAPAs address the root causes of nonconformities to prevent recurrence (corrective action) and to eliminate potential causes of nonconformities to prevent occurrence (preventive action).

This procedure applies to all CAPAs initiated within the QMS, including those arising from: - Customer complaints and product field issues - Internal and external audit findings - Nonconforming product or material - Process deviations and out-of-specification results - Trend analysis and data review - Management Review action items - Supplier quality issues - Regulatory observations or warning letters

CAPA Initiator: Any employee who identifies a quality issue may initiate a CAPA by completing the CAPA Request Form (FRM-CA-001). Critical: Quality Manager reviews all CAPA requests within 3 business days, assigns a severity classification (Critical, Major, Minor), designates a CAPA Owner, and sets target completion dates. CAPA Owner: Responsible for leading the investigation, identifying root cause, developing and implementing corrective/preventive actions, and verifying effectiveness. Quality Manager: Oversees the CAPA system, ensures timely closure, reviews effectiveness checks, and reports CAPA metrics during Management Review. Management Representative: Ensures adequate resources are allocated for CAPA resolution.

4.1 CAPA Initiation - Complete CAPA Request Form (FRM-CA-001) including: description of the issue, date identified, source of the issue, immediate containment actions taken (if any), and affected products/processes/lots - Submit to Quality Manager for review and classification 4.2 Severity Classification - Critical: Patient safety risk, regulatory non-compliance, product recall potential. Target closure: 30 days. - Major: Significant quality system gap, repeated nonconformance, customer impact. Target closure: 60 days. - Minor: Isolated incident, documentation gap, process improvement opportunity. Target closure: 90 days. 4.3 Root Cause Investigation - The CAPA Owner shall conduct a thorough investigation using one or more of the following methods: - 5 Whys Analysis - Fishbone (Ishikawa) Diagram - Fault Tree Analysis - Failure Mode and Effects Analysis (FMEA) - Investigation must go beyond symptoms to identify the true root cause(s) - All investigation activities and findings shall be documented on the CAPA Investigation Form (FRM-CA-002) 4.4 Action Plan - Develop corrective actions (to address the root cause and prevent recurrence) and/or preventive actions (to prevent potential future occurrences) - Each action item must include: description of the action, responsible person, target completion date - Actions may include: procedure revisions, process changes, additional training, design changes, supplier corrective actions - The action plan must be reviewed and approved by the Quality Manager before implementation 4.5 Implementation - Execute all action items per the approved plan - Document completion of each action with objective evidence - If any action cannot be completed by the target date, document the reason and obtain Quality Manager approval for an extension 4.6 Effectiveness Verification - After implementation, the CAPA Owner shall verify effectiveness at a defined interval (typically 30-90 days post-implementation) - Effectiveness criteria must be defined at the time the action plan is approved - Methods may include: data review, audit of the process, review of subsequent complaint/NCR trends, sampling - If the CAPA is not effective, the investigation must be reopened or a new CAPA initiated 4.7 CAPA Closure - The Quality Manager reviews all evidence and approves closure - If the CAPA resulted in a change to a controlled document, verify the change was completed through the Document Control process - Closed CAPAs shall be included in the CAPA Log (FRM-CA-003) and reported during Management Review

- CAPA Request Form (FRM-CA-001) - CAPA Investigation Form (FRM-CA-002) - CAPA Log (FRM-CA-003) - Effectiveness verification records - Related NCRs, complaints, or audit findings

- ISO 13485:2016 Clause 8.5.2 (Corrective Action), 8.5.3 (Preventive Action) - FDA 21 CFR 820.90 Nonconforming Product, 820.198 Complaint Files - SOP-NC-001 Nonconforming Product - SOP-CH-001 Complaint Handling