Why Clause 8.3.4 Rework is Important in ISO 13485 (8.3.4)
Rework involves altering a product after a nonconformance is detected. Without structured procedures, rework can introduce new risks or inconsistencies.Your Quality Management System (QMS) must include step-by-step rework instructions, validated tools, and approved methods to ensure consistency and traceability.
Why Rework matters
Rework might affect product functionality, material integrity, sterility, or regulatory status. ie: re-soldering a PCB might damage nearby components or change electrical characteristics. Manufacturer must evaluate whether rework introduces new hazards, and possibly revise your risk management file per ISO 14971 by averting few additional steps.
Maintains the original safety and performance characteristics post-rework.Identifies trends in rework that can feed into CAPA (Clause 8.5).
Frequently Asked Questions
Types of Rework Records to Maintain?
- Identification of the Nonconforming Product: Product name, model, batch/lot/serial number. Unique nonconformance ID or report number
Description of the Nonconformance What was wrong? (e.g., missing label, dimension out of tolerance, solder defect). How was it detected? (inspection, test, customer complaint, etc. - Reference to Rework: Procedure Document number and version of the approved rework SOP. Description of rework method used.
Confirmation that the rework does not adversely affect product safety, performance, or regulatory compliance. Risk review or engineering approval (especially if critical components are reworked) - Date and Personnel Involved: Who authorized the rework? Who performed it? Date(s) of rework and verification.
- Rework Verification Results: Evidence that the reworked product was re-tested or re-inspected. Inspection or test data showing conformance to original acceptance criteria. Signature of QA or independent verifier
- Final Disposition: Was the product accepted and released?. Was it rejected after rework?. Any special labeling or tracking required?