Quality nonconformance report

Purpose

Turn a confirmed or suspected quality deviation into a traceable nonconformance report. The report distinguishes observed defect from hypothesis, identifies affected product and records, documents immediate containment, and turns verified cause into corrective and preventive actions with owners and effectiveness criteria.

Scope

Cover inspection and test results, product specifications, drawings, work instructions, batch or lot genealogy, supplier records, complaint records, deviation permits, containment logs, investigation notes, and CAPA procedures. Include severity, recurrence, and customer impact when evidenced. Excluded: changing specifications, releasing quarantined product, approving concessions, and declaring an action effective without supplied evidence.

Data basis

• Nonconformance register with nc_id, detected_at, source, product, lot, quantity, defect_code, severity, and status.
• Inspection results with sample_id, characteristic, observed_value, unit, result, method, and operator.
• Specification records with revision, characteristic, lower_limit, upper_limit, nominal, and acceptance_rule.
• Genealogy, supplier, complaint, containment, root-cause, CAPA, owner, due_date, and verification records.

Result

Produce a nonconformance report and CAPA action sheet. Each finding includes the requirement, observed condition, affected scope, evidence citation, severity rationale, containment state, cause status, action owner, due date, and effectiveness test.

Quality criteria

• Every defect compares an observed value or event with the exact requirement revision.
• Affected lots, quantities, samples, and customer or supplier links reconcile to source records.
• Containment is separate from correction, corrective action, and preventive action.
• Root cause is labelled confirmed, suspected, or unconfirmed and cites supporting evidence.
• Severity and closure status follow the supplied quality procedure.

Instructions

Use the specification revision effective at detection, not the latest revision by default. Preserve units and measurement method; do not compare rounded values to tighter limits without noting precision. Treat missing genealogy as a scope gap. Do not call an action preventive unless its recurrence mechanism and affected process are named. An effectiveness check needs a measurable pass condition and a review window. Keep customer complaint wording distinct from internal defect classification.

Adapt before use

• Add the quality manual, severity matrix, CAPA procedure, and closure criteria.
• Map inspection, specification, lot genealogy, supplier, complaint, and action fields to the named columns.
• Define the evidence standard for root-cause confirmation and effectiveness.
• Set responsible roles and due-date rules for containment and CAPA actions.