Control of Nonconforming Outputs
ISO 9001:2015 – Section 8.7
Our consultancy supports organizations in establishing effective controls for identifying, documenting, and addressing nonconforming outputs. This ensures that products and services not meeting requirements are detected before use or delivery, preventing customer dissatisfaction, regulatory issues, and reputational risks.
Scope of Work
1. Identification & Segregation
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• Implement systems to identify and label nonconforming outputs.
• Use physical or digital segregation to prevent unintended use.
• Define clear workflows for reporting detected issues.
2. Control & Disposition
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• Establish documented procedures for handling nonconformities.
• Define disposition options (correction, rework, concession, or scrap).
• Obtain customer or authority approval where required.
3. Documentation & Records
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• Maintain detailed records of nonconformance, root cause, and disposition.
• Ensure traceability for audit and compliance purposes.
• Provide evidence of conformity before re-release.
4. Corrective & Preventive Action Linkage
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• Integrate nonconformance management with corrective action processes.
• Analyze trends to identify systemic issues.
• Drive continual improvement through lessons learned.
Deliverables
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• Nonconformance reporting procedures.
• Segregation and labeling guidelines.
• Disposition approval forms and records.
• Root cause analysis templates.
• Corrective and preventive action tracking reports.
Pricing & Timeline
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• Fee: $3,150.00/month per facility (6-month engagement)
• Estimated Duration: 180 business days
Completion timeline may vary based on client responsiveness and documentation turnaround.
Sample Milestone Plan
| Phase | Key Activities | Core Deliverables |
|---|---|---|
| Month 1 – Planning | Kick-off, scope definition, project charter |
✓ Implementation Plan ✓ Scope Statement & Team Roles |
| Months 1–2 – Design | FSMS drafting, PRP setup, document control systems |
✓ SOPs, PRPs ✓ Controlled Document Framework |
| Months 2–3 – Execution | Competency training, system rollout, records logging |
✓ Training Logs ✓ First Cycle Recordkeeping Evidence |
| Months 3–6 – Validation | Internal audits, reviews, performance monitoring |
✓ Internal Audit Reports ✓ CAPA Logs ✓ Management Review |
| Month 6 – Readiness | Final system check, CB coordination, mock audit |
✓ Pre-Audit Summary ✓ Final CAPA Log ✓ Audit-Day Prep |
Certification Audit Support
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• On-site or remote audit-day presence
• Real-time response to auditor inquiries
• Post-audit support and non-conformance response drafting
Deliverables:
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✓ Audit Representation
✓ NC Response Support
✓ Audit Day Documentation
Project Closure
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• Final FSMS documentation handover
• Executive summary outlining system status and sustainability plan
• Option to transition into maintenance & continuous improvement support
Deliverables:
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✓ Final Document Handover
✓ Close-Out Report
✓ Maintenance Plan Proposal
Additional Compliance Support Options
| Service | Description | Fee |
|---|---|---|
| Nonconformance Control Framework | Full set of procedures, forms, and workflows for handling nonconformities. | $1,500/system |
| Root Cause Analysis Workshop | Training on effective RCA techniques (5 Whys, Fishbone, FMEA). | $1,200/session |
| Corrective Action Monitoring Toolkit | Templates and dashboards for tracking effectiveness of actions taken. | $950/project |
| Digital Nonconformance Register | Cloud-based platform for recording, tracking, and reporting issues. | Starting at $99/month |
