An undocumented deviation is a regulatory liability. A nonconforming product without a disposition record is a recall waiting to happen. Affinity QMS Deviations and Nonconformances manages NCR initiation, material disposition, investigation, and CAPA linkage — in a single closed-loop workflow across all six regulated industries.
Material Disposition Options — Configurable Per Vertical
Use As-Is
Documented justification required
Rework
Rework plan and re-inspection documented
Reject / Scrap
Segregation and destruction records
Return to Vendor
Supplier NCR linkage and RMA tracking
Nonconformance Report (NCR) Initiation
Initiate an NCR from any quality event — incoming inspection failure, in-process deviation, finished product rejection, or equipment out-of-specification. NCR forms are configurable by vertical and capture all required fields: product/lot, detection point, description of nonconformance, quantity affected, and immediate containment actions taken.
Material Disposition Workflow
Formal disposition decisions — use as-is, rework, reject, or return to vendor — are documented with the dispositioner's identity, rationale, and electronic signature. For use-as-is dispositions, a documented justification and additional approval are required. Rework dispositions generate a rework plan and re-inspection record automatically.
Investigation and Root Cause
Document the investigation of each nonconformance — what happened, where in the process, what contributed. Built-in investigation templates guide investigators through a systematic analysis. Root cause is formally recorded and linked to the disposition — satisfying the investigation documentation requirements of 21 CFR Part 820.90 and ISO 13485 Clause 8.3.
CAPA Linkage
When an NCR investigation reveals a systemic root cause requiring corrective action, initiate a linked CAPA directly from the deviation record. The NCR and CAPA are cross-referenced — giving auditors traceability from nonconformance detection through corrective action closure. CAPA closure status is visible within the NCR record.
Product Segregation and Hold Management
Place nonconforming material on quality hold with documented hold reason, location, and responsible person. Hold status is visible to all relevant personnel — preventing nonconforming product from being released or used. Release from hold requires explicit approval and documentation of disposition decision.
Trending by Product, Process, and Supplier
Aggregate nonconformance data to identify recurring problems before they escalate. Trend charts show NCR frequency by product, process step, supplier, and nonconformance type. Management review reports include NCR trending data automatically — satisfying the data analysis requirements of ISO 13485 Clause 8.4 and FDA QMSR.
Lot-Specific Deviation History
Every nonconformance is linked to specific lot numbers, batch records, and product identifiers. The complete deviation history for any lot is retrievable in seconds — critical for recall investigations, supplier qualification reviews, and FDA inspections. Lot history is preserved in the audit trail indefinitely.
| Regulation / Standard | Clause / Section | Deviations Coverage |
|---|---|---|
| 21 CFR Part 211.192 | Production Record Review | Batch failure investigations, unexplained discrepancy documentation, distribution controls |
| 21 CFR Part 820.90 | Nonconforming Product | Identification, segregation, disposition, and documentation of nonconforming product |
| ISO 13485:2016 | Clause 8.3 — Control of Nonconforming Product | Identification, documentation, segregation, evaluation, disposition, notifications |
| ISO/IEC 17025:2017 | Clause 7.10 — Nonconforming Work | Responsibility and authority for nonconforming work, corrective actions, resumption criteria |
| 21 CFR Part 111 | Subpart N — Production and Process Controls | Rejected dietary supplement components, investigation, disposition, hold procedures |
| SQF Code | 2.6 — Nonconforming Product and Process Management | Nonconformance identification, quarantine, disposition, review, and CAPA linkage |
| FDA QMSR (2024) | 820.90 — Nonconforming Product | Identification, segregation, disposition documentation with review and approval |
Included in Builder — Starting at
$799/mo
Deviations and Nonconformances is included in the Builder tier ($799/mo) and all tiers above it. Lot-specific deviation history and material disposition workflows are included at no additional cost.
Book a demo and see how Affinity QMS Deviations and Nonconformances handles NCR workflows, material disposition, and CAPA linkage across all six regulated industries.