STANDARD OPERATING PROCEDURE (SOP)

Control of Non-Conforming Products After Inspection

Issued By: ICS INTERNATIONAL CERTIFICATION LLP

1. Purpose

To establish a systematic process for identification, control, and disposition of non-conforming products to prevent unintended use or delivery.

2. Scope

This procedure applies to all products inspected at:

• Incoming stage
• In-process stage
• Final inspection stage

3. Responsibility

• Inspector / Quality Control (QC): Identification and reporting
• Quality Manager: Review and disposition approval
• Production Team: Rework / correction
• Top Management (if required): Approval for concession

4. Procedure

4.1 Identification of Non-Conforming Product

• Products failing to meet specified requirements shall be identified during inspection.
• Non-conformity may include:
  • Dimensional deviation
  • Visual defects
  • Functional failure

4.2 Segregation

• Non-conforming products shall be:
  • Clearly marked as “REJECTED / HOLD”
  • Physically segregated in a designated Quarantine Area

4.3 Documentation (NCR)

• A Non-Conformance Report (NCR) shall be raised including:
  • Product details
  • Batch / Lot number
  • Nature of non-conformity
  • Quantity affected
  • Inspection details

4.4 Evaluation & Root Cause Analysis

• The Quality team shall analyze the cause using:
  • 5 Why Analysis
  • Fishbone Diagram
• Root cause must be identified before disposition.

4.5 Disposition of Non-Conforming Product

The product shall be reviewed and one of the following actions taken:

• Rework: Correct the defect
• Reprocess: Repeat the process
• Use as-is: With documented approval (concession)
• Return to Supplier: If supplier-related issue
• Scrap: If unusable

All decisions must be approved by authorized personnel.

4.6 Correction & Re-Verification

• Reworked or reprocessed products shall be re-inspected.
• Only conforming products shall be released.

4.7 Corrective and Preventive Action (CAPA)

• Corrective actions shall be implemented to eliminate root causes.
• Preventive measures shall be defined to avoid recurrence.

4.8 Customer Communication

• If non-conforming product is already delivered:
  • Customer shall be informed immediately
  • Necessary actions shall be taken (recall / replacement)

4.9 Records & Closure

Maintain records of:

• NCR
• Root Cause Analysis
• Disposition decision
• CAPA actions
• Final approval

All records shall be retained as per document control requirements.

5. Reference

• ISO 9001:2015 – Clause 8.7 (Control of Non-Conforming Outputs)

6. Process Flow

Inspection → Identification → Segregation → NCR → Analysis → Disposition → Correction → Re-Inspection → Closure

7. Approval

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