ISO 9001 CompatibleNon-Conformity
Non-Conformity
Quality Sheet Application
Digitize your non-conformity sheets. Detection, root cause analysis, corrective actions, CAPA tracking - all on mobile.
Free 7-Day TrialTypes of Non-Conformities
Production
Product defect, scrap, rework, deviation
Receiving
Supplier NC, raw material, component
Customer
Complaint, return, quality claim
Audit
Internal, external, certification audit gap
Safety
Incident, near-miss, hazard
Environment
Environmental NC, pollution, waste
Process
Procedure non-compliance, documentation
Equipment
Breakdown, malfunction, calibration
NC Management Features
Complete NC Sheet
Template with description, severity, causes, immediate actions.
Root Cause Analysis
5 Whys, Ishikawa, fault tree analysis built-in.
CAPA Actions
Corrective and preventive actions with owners and deadlines.
Photo Evidence
Document each NC with timestamped photos.
KPI Tracking
Number of NCs, closure time, recurrence rate.
PDF Report
Complete NC sheet with action history.
Compatible Standards
Frequently Asked Questions
What is a non-conformity in quality management?+
A non-conformity is the failure to meet a specified requirement (ISO 9000:2015 standard, section 3.6.9). It can relate to a product (out of specification), a process (failure to follow procedure), or the management system (standard requirement not met). Classification: major non-conformity (systemic failure or absence of a required process), minor (isolated deviation), observation/opportunity for improvement (area for progress).
How to write an effective non-conformity sheet?+
Essential elements: factual description of the deviation (what was observed vs what was expected), objective evidence (documents, photos, data), location/date/product/batch involved, NC classification (critical, major, minor), root cause analysis (5 Whys, Ishikawa, 8D), planned corrective actions with responsible person and deadline, effectiveness verification after implementation. The sheet must be traceable and auditable.
What is the difference between corrective action and preventive action?+
Corrective action: eliminates the cause of a detected non-conformity to prevent its recurrence (ISO 9001:2015, clause 10.2). Preventive action: eliminates the cause of a potential non-conformity to prevent its occurrence. Since ISO 9001:2015, the concept of preventive action has been replaced by the risk-based approach (clause 6.1) which integrates prevention into QMS planning.
How to perform a root cause analysis?+
Main methods: 5 Whys (asking "why" in cascade until the fundamental cause is found), Ishikawa diagram (5M: Manpower, Material, Method, Environment, Machine), 8D analysis (structured 8-step methodology), fault tree (logical decomposition of the event). The root cause is the one whose elimination prevents recurrence. Beware of apparent causes ("human error" often hides a training, procedure, or design problem).
What is the cost of non-quality?+
The cost of non-quality (CONQ) includes: internal failure costs (scrap, rework, production stoppages — typically 3-5% of revenue), external failure costs (complaints, returns, recalls, penalties — 1-3% of revenue), detection costs (inspections, tests — 2-4% of revenue). Total CONQ often represents 10-15% of revenue in companies not engaged in a quality approach. The ISO 9001 standard aims to reduce these costs through continuous improvement.