21 CFR 820.200 - Servicing (QMSR)

What it says

Where servicing is a specified requirement, procedures must be established for performing and verifying servicing meets specified requirements, with service reports analysed for trends that could indicate the need for corrective and preventive action, and service reports treated as a required quality system record.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Service reports are an explicit, named data source feeding into the CAPA system under 820.100, meaning field servicing data occurring long after manufacture is expected to inform the same systemic quality analysis as in-house complaint and nonconformity data.
• This creates a data feedback loop connecting real-world device performance and failure modes, observed during servicing, back to the manufacturer's quality system, rather than treating field service as a purely operational, disconnected activity.
• Servicing procedures and verification requirements must be documented with the same rigor as other quality system procedures, not managed informally simply because servicing occurs after the device has left the manufacturing facility.

What FDA inspectors look for

• Whether service reports are genuinely analysed for trends, not simply filed after each individual servicing event without aggregate review.
• Whether trends identified in service data are fed into the CAPA system, connecting field performance data to the same corrective action framework as other quality data sources.
• Whether servicing procedures are documented and verification of servicing quality is genuinely performed, not assumed based on the servicing technician's general competence.

Related regulations