A complete NCR form for documenting nonconforming product or process outputs. Covers NCR header, part and lot details, nonconformance description, disposition decision (use-as-is / rework / repair / scrap / return to vendor), root cause, corrective action reference, and sign-off. Compliant with ISO 9001:2015 Clause 8.7 and FDA 21 CFR 820.90. Generated instantly in your browser.
ISO 9001 / FDA 820 Note: Nonconforming product must be identified, documented, segregated, and evaluated before disposition (ISO 9001:2015 Clause 8.7; FDA 21 CFR 820.90). Use-as-is dispositions for safety-critical or regulated products may require customer or regulatory concurrence before implementation.
NCR Header
NCR number, date opened, originator, department, customer, and source (incoming/in-process/final/customer return/audit)
Part / Lot Details
Part number, revision, part name, lot/batch number, quantity affected, purchase/work order, and operation where NC was detected
Description of Nonconformance
Specification/requirement not met, observed condition/deviation, NC category, HOLD tag number, and detailed description field
Disposition
MRB-authorized disposition: Use-As-Is / Rework / Repair / Scrap / RTV — with rationale, rework instructions, and concession reference
Root Cause
Brief root cause statement, root cause category, and CAPA reference if full investigation is required
Corrective Action Reference
Corrective action description, owner, target date, and CAPA/8D reference number
Sign-Off
QA Engineer and MRB/customer approval signatures with dates and NCR closure status
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