Open-Package Inspection (OPI) Procedure is a quality control process that involves the physical examination of packaged goods to detect any defects or deterioration that may not be apparent from external inspection and ensure compliance with regulatory requirements and good manufacturing practices (GMPs).

This procedure is typically performed after a Closed-Package Inspection (CPI), which assesses the condition of the packaging material and signs of pest infestation without opening the package.

Purpose and Scope

The primary objective of OPI is to identify defects or deterioration within the package that could affect the quality, safety, or usability of the contents.

The procedure helps in maintaining quality control, reducing the risk of accepting defective or incorrect products, and ensuring compliance with purchasing agreements. Effective implementation of OPI can lead to cost savings, improved product quality, and higher customer satisfaction.

“Package inspection is the cornerstone of efficient logistics, ensuring every product reaches its destination in perfect condition.”

When OPI is Conducted

OPI is conducted in various situations, including:

• Warranty Inspections: To verify the quality of products during the warranty period.
• Maximum Shelf Life: When products reach their maximum shelf life to ensure they are still fit for consumption or use.
• Customer Request: At the request of the customer verify the quality of the products.
• Isolated Lots: For lots of unknown storage history or with no record of inspection.
• Inspector’s Discretion: Based on the findings of the inspector, OPI may be conducted to investigate any suspicions of defects or deterioration further.

Procedure

The OPI procedure typically involves opening the package and inspecting the contents for any signs of defects or deterioration. This may include checking for spoilage, contamination, or damage to the product. The inspection may also involve testing the product to ensure it meets the required standards.

Classification of Defects

Defects found during OPI are classified into two categories:

• Critical Defects: Defects that make the product unfit for its intended use or unfit for human consumption.
• Minor Defects: Defects that do not affect the usability or safety of the product but may impact its quality or appearance.