Control nonconforming product before it controls you — templates for 21 CFR 820.90 and ISO 13485 §8.3
Six documents for a complete, inspection-ready nonconforming product system.
Instant download. For QA managers at FDA-registered device companies.
21 CFR 820.90 and ISO 13485 §8.3 require documented procedures for identifying, segregating, evaluating, and dispositioning every nonconforming product. The most common gaps: no physical segregation controls, use-as-is dispositions without documented justification, and reworked product re-entering production without re-inspection evidence.
This toolkit gives you the procedure, the NCP tag, the NCR form, the disposition decision matrix, the rework procedure, and the FDA audit prep guide — everything needed to build a nonconforming product system that holds up under inspection.
From product identification through disposition, rework, and FDA audit readiness.
Complete SOP per 21 CFR 820.90 and ISO 13485 §8.3 covering identification, segregation, evaluation, disposition (use-as-is, rework, scrap, return to supplier), and notification to affected functions. Includes decision trees for disposition authorization and escalation to CAPA.
Physical and digital tag for marking and tracking NCPs from detection through final disposition. Captures product ID, lot/serial, defect description, detection point, quarantine location, and disposition status. Prevents nonconforming product from entering the production stream.
Structured NCR capturing product ID, defect description, quantity affected, detection point, initial containment, root cause summary, disposition decision, and authorization signatures. Designed as a controlled QMS document meeting FDA 820.90 documentation requirements.
Risk-based decision tree for all four disposition paths: use-as-is (with documented justification and concession), rework (with re-inspection requirements), scrap (with destruction verification), and return to supplier (with supplier notification protocol). Includes authorization level requirements by risk tier.
Structured rework authorization and execution template covering rework instructions, required re-inspection criteria, re-testing requirements, acceptance criteria, and documentation of rework effectiveness. Ensures reworked product meets original specifications before re-entry into production or shipment.
What FDA investigators actually look for in nonconforming product systems — 483 observation patterns, common documentation gaps, questions inspectors ask about segregation and disposition controls. Includes a pre-inspection NCP readiness checklist and guidance on presenting your NCP program to investigators.
The most common NCP failure: nonconforming product reaches the customer. The NCP tag, NCR form, and procedure create a closed-loop system that physically and documentarily isolates product from the moment of detection.
The disposition matrix takes the guesswork out of use-as-is, rework, scrap, and return decisions. Every path has defined authorization levels, justification requirements, and documentation requirements that satisfy FDA and ISO auditors.
21 CFR 820.90 and ISO 13485 §8.3 require documented procedures AND records for every nonconforming product event. These templates are structured for the audit trail FDA investigators expect to see.
“I built these templates from 12 years of running a Class II/III medical device manufacturing operation. Every document reflects what FDA investigators actually ask for when they open the NCP binder — not what consultants think they ask for. We use these exact frameworks at AB Medical.”
“The disposition matrix alone is worth the price. Every time we had a use-as-is situation, we were scrambling to document the justification. Now there's a structured process and auditors can see exactly how the decision was made and who authorized it.”
21 CFR 820.90 (Nonconforming Product, now incorporated into the FDA Quality Management System Regulation) requires manufacturers to establish and maintain procedures to control products that do not conform to specified requirements. This includes: identification of nonconforming product, documentation of the nonconformance, evaluation to determine the disposition, segregation to prevent unintended use, disposition (use-as-is with concession, rework, scrap, or return), and notification of affected functions. Use-as-is dispositions require documented justification. All records must be maintained.
A use-as-is concession is acceptable when the nonconformance does not affect device safety, efficacy, or regulatory compliance, AND when the justification is documented and authorized by a qualified individual. FDA investigators scrutinize use-as-is decisions heavily — the justification must demonstrate that the deviation does not affect intended use. The disposition matrix in this toolkit includes the documentation requirements for defensible concessions under both 21 CFR 820.90 and ISO 13485 §8.3.2.
No. 21 CFR 820.90 and ISO 13485 §8.3 require handling the nonconforming product. CAPA under §820.100 / §8.5.2 is required when there is a systemic issue or significant nonconformance requiring root cause investigation to prevent recurrence. The NCP procedure template includes the decision criteria for when an NCR should escalate to a CAPA. FDA investigators expect to see this decision documented — not every NCR needs a CAPA, but the decision must be justified.
The most frequent NCP-related 483 observations include: failure to adequately identify and segregate nonconforming product (product mixed with conforming stock), use-as-is dispositions without documented justification, lack of re-inspection evidence for reworked product, NCR records missing required fields (detection point, authorization, disposition outcome), and failure to notify affected functions of nonconformances. The FDA Audit Prep Guide in this toolkit covers all of these with the actual 483 citation language.
No. This is a practitioner reference toolkit. Consult your regulatory counsel and qualified regulatory affairs professionals for formal compliance opinions.
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Six documents. Instant download. 21 CFR 820.90 + ISO 13485 §8.3.
Also: CAPA Toolkit $247 · Document Control $247 · Supplier Controls $247