Description:
This CAPA Procedure defines how we initiate, implement, monitor, and close actions to prevent the occurrence or recurrence of non-conformity within our QMS.

• Start every CAPA using FORM-CAPA-001 with ID CAPAYYYY-XXX.

• Log and track status in LOG-CAPA-001 for management visibility.

• Follow the 5 phases: Identification, Investigation, Action Plan, Effectiveness Evaluation, Closure.

• Assign named owners for initiation, evaluation, investigation, root-cause analysis, implementation, and closure.

• Use risk-based evaluation for safety, performance, and regulatory compliance (including ISO 13485).

• Apply priority timelines (Critical/Major/Minor/Non-significant) to define due dates.

• Use Ishikawa (6M) and 5-Why to confirm root causes and prevent recurrence.

Your needs:

• CAPA procedure

• CAPA procedure for ISO 13485 and MDR compliance

• Reduce rework, control timelines, and improve audit readiness.

Use this procedure when issues are found through audits, complaints, PMS, supplier controls, nonconforming products, or management review, to ensure actions are proportionate, documented, and traceable.

It defines what “good CAPA” looks like. Root-cause analysis identifies why the problem happened; it matters because fixes that don’t address causes will recur. Effectiveness evaluation verifies measurable outcomes; it matters because closure must be evidence-based.

• Define CAPA type (corrective vs preventive) and origin traceability.

• Assess recurrence and perform risk assessment for safety/performance/compliance.

• Set priority level and action plan timelines using the decision tree.

• Document investigation evidence (DHF/DHR/DMR, testing, suppliers, QMS).

• Define containment and action plan with owners, dates, and evidence.

• Verify no adverse impact from actions, with scientific justification.

• Apply acceptance criteria and record effectiveness evidence before closure.

At Lexqara, we align CAPA workflows with complaint handling, PMS, audits, and design documentation—supporting QMS implementation, training, and inspection support. Resource Center [https://lexqara.com/resource-center] and Audit & Inspection Support [https://lexqara.com/services/audit-and-inspection-support]. ISO 13485 [https://www.iso.org/standard/59752.html]. Request a short gap assessment.