Non-Conforming Product SOP: Quality Management Guide

STANDARD OPERATING PROCEDURE: NON-CONFORMING PRODUCT MANAGEMENT

Document ID: [___________]
Effective Date: [___________]
Revision Number: [___________]
Department: Quality Assurance / Operations

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1. PURPOSE

The purpose of this Standard Operating Procedure (SOP) is to establish a formal protocol for the identification, documentation, segregation, evaluation, and disposition of non-conforming products (NCP) to prevent unintended use or delivery to the end customer.

2. SCOPE

This procedure applies to all raw materials, work-in-progress, and finished goods that fail to meet the established specifications or quality standards set forth by [Company Name].

3. RESPONSIBILITIES

• Quality Control (QC) Inspector: Responsible for the identification and initial tagging of non-conforming items.
• Quality Manager: Responsible for final disposition approval and oversight of the Corrective and Preventive Action (CAPA) process.
• Operations Manager: Responsible for ensuring the physical segregation and disposal/rework of affected inventory.

4. PROCEDURAL STEPS

4.1 Identification and Tagging

Upon discovery of a product that does not meet specified requirements, the inspecting personnel shall:

1. Immediately remove the item from the production line or inventory.
2. Complete a Non-Conformance Report (NCR), ID: [___________].
3. Affix a "NON-CONFORMING" hold tag to the product/lot.
4. Place the item in the designated quarantine area located at: [_________________________________].

4.2 Non-Conformance Documentation

The following data must be captured for each incident:

• Date of Discovery: [___________]
• Product Name/SKU: [___________]
• Lot/Batch Number: [___________]
• Quantity Affected: [___________]
• Detailed Description of Deficiency: [________________________________________________]

4.3 Disposition Options

The Quality Manager shall review the incident and select one of the following dispositions:

• [ ] Rework: Restore to meet specifications via [_________________________].
• [ ] Use-As-Is: Authorized by [Name/Title] on [Date].
• [ ] Return to Vendor: Return to [Vendor Name] via [Shipping Method].
• [ ] Scrap/Disposal: Authorized destruction method: [_________________________].

4.4 Verification of Disposition

Post-disposition, the Quality Assurance team must verify that the product has been processed according to the selected disposition and that the inventory records in [ERP/System Name] have been updated accordingly.

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5. REGULATORY COMPLIANCE

This document adheres to the standards set by [Relevant Standard, e.g., ISO 9001:2015] and internal governance policies of [Company Name].

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6. AUTHORIZATION AND APPROVAL

Prepared By:
Name: [___________________________]
Title: [___________________________]
Signature: __________________________ Date: [___________]

Reviewed/Approved By (Quality Manager):
Name: [___________________________]
Title: [___________________________]
Signature: __________________________ Date: [___________]

Final Authorization (Operations/Executive):
Name: [___________________________]
Title: [___________________________]
Signature: __________________________ Date: [___________]

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End of Document