820.198 – Complaint Files
Returned products often come in via a complaint.
You must analyze complaints and, if necessary, investigate and document the findings.
If you rework based on a return due to failure, that whole process falls under your complaint handling procedures.
✅ Even if the customer just returned it without much info, you still need to evaluate if it was a complaint.
820.70 – Production and Process Controls
You need documented procedures for rework activities.
Ensure that equipment, environment, and personnel are controlled during rework like they are during original manufacturing.
✅ Treat rework like production—it’s not a second-class activity.
820.100 – Corrective and Preventive Action (CAPA)
If rework is performed in response to a systematic issue (e.g., many units returned for the same problem), CAPA applies.
You must identify root causes and take actions to prevent recurrence.
✅ Trend analysis of returns can trigger CAPAs.
820.90 – Nonconforming Product
If the product is returned due to being nonconforming, your nonconformance procedure must include rework.
Rework activities must be documented and verified to meet original specifications.
Reworked products must undergo the same controls as the original product, including revalidation where necessary.
✅ Make sure you document the rework process, including inspections and test results.
820.75 – Process Validation
If the rework process includes any special processes (e.g., bonding, welding, sterilization) that can’t be fully verified by inspection and testing, they must be validated.
If the original process was validated, rework may require revalidation or documented rationale for not needing it.
✅ Think about whether you’re reusing validated processes or doing something new.
820.184 – Device History Record (DHR)
The reworked product must have an updated DHR.
Document what was done, who did it, test results, and any revalidation or retesting.
✅ Every unit’s traceability must be intact post-rework.
820.200 – Servicing
If you consider the return and rework as part of servicing, you’ll need to maintain service records.
Applies more if the product is fielded and has ongoing maintenance.
Each manufacturer shall analyze service reports with appropriate statistical methodology in accordance with §820.100.
820.60 – Identification
Each manufacturer shall establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mixups.
If the reworked device is significantly modified or reintroduced to the market, you may need to evaluate if relabeling or a new UDI is required conform 21CFR801 / 830 UDI and Labeling
820.65 – Traceability
Manufacturers shall establish and maintain procedures for identifying product by control number to ensure that only products conforming to specifications are distributed.
When required by regulation or necessity (e.g., if their failure could affect the product’s safety or effectiveness), traceability to components, materials, and environmental conditions must be maintained.
✅ Make sure the Device History Record (DHR) captures all traceability data.
The Device Master Record (DMR) should define how traceability is maintained for each product type.
Related Supporting Requirements
- §820.60 – Identification – Products must be identified throughout manufacturing.
- §820.80 – Receiving/In-process/Final inspection records must identify the product.
- §820.90(b)(2) – Reworked products must be traceable and documented.
- §820.184 – DHR must contain traceability to lots, batches, rework, test results.
- §820.181 – DMR defines how traceability is handled for a given product.
- §820.198 – Complaint files must link complaints to specific product units.