Standard Operating Procedure (SOP)

1. Purpose:
To define the procedure for managing and handling non-conforming products (NCP) in order to identify, segregate, and address quality issues, ensuring that only conforming products are released for use, distribution, or sale.

2. Scope:
This procedure applies to all products, whether raw materials, in-process goods, or finished products, that fail to meet the specified quality standards at any stage of production.

3. Responsibility:

1. QC Personnel: Identify, segregate, and document non-conforming products.
2. Production Team: Notify QC about non-conformities found during production.
3. QA Manager: Investigate root causes, decide on corrective actions, and approve rework or disposal.
4. Warehouse Personnel: Segregate and store non-conforming products in the designated area.

4. Procedure:
4.1 Identification of Non-Conforming Products

• Non-conforming products may be identified during various stages, including receiving, in-process, or final testing.
• Causes of non-conformity could include:
• Out-of-specification test results (chemical, physical, microbiological)
• Damage or defective packaging
• Incorrect labeling or documentation
• Contamination
• Improper storage conditions

4.2 Segregation and Labeling

• Upon identification, non-conforming products must be immediately segregated from conforming products.
• Label these products as “Non-Conforming” with clear identification (e.g., “Quarantined,” “Hold for Investigation”).
• Place products in a designated Non-Conforming Product Area (NCPA) to prevent accidental use or distribution.

4.3 Documentation

• Complete a Non-Conformance Report (NCR), documenting:
• Product details (name, batch/lot number, quantity)
• Nature of non-conformity
• Identification number (if applicable)
• Date and personnel identifying the issue
• Initial action taken (segregation, labeling, etc.)
• The NCR should be stored and linked to any subsequent actions (investigation, rework, rejection).

4.4 Investigation and Root Cause Analysis

1. The QA Manager or designated person investigates the root cause of non-conformity.
2. Is the issue a one-time occurrence or a recurring problem?
3. Is the cause related to raw materials, production methods, or equipment?
4. If needed, perform a Corrective and Preventive Action (CAPA) process to address the issue.
5. 4.5 Disposition of Non-Conforming Products

• Based on investigation and root cause analysis, decide on one of the following actions:
• Rework: If feasible, products may be reworked to bring them into specification.
• Reprocess: Some products may require reprocessing through specific production steps.
• Scrap: If the product is irreparable, dispose of it in accordance with company policy.
• Return to Supplier: If raw materials are non-conforming, return them to the supplier with appropriate documentation.

Record the final disposition of all non-conforming products in the NCR.

4.6 Preventive Actions and Corrective Actions

• If recurring non-conformities are identified, develop Corrective Actions to address the root cause.
• Document any Preventive Actions to prevent similar issues in the future.

4.7 Rework and Reprocessing
Reworked products should be retested according to the original product specifications before being approved for release.

Record all rework and reprocessing activities in the NCR and ensure traceability.

5. References:

• Non-Conformance Report (NCR) Form
• Corrective and Preventive Action (CAPA) SOP
• Quality Specifications
• Batch Manufacturing Records (BMR)
• Product Specifications

6. Attachments:

• Non-Conformance Report (NCR) Template
• NCR Review and Disposition Form
• Rework and Reprocessing Log
• Label Templates for Non-Conforming Products.

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