Low-Acid and Acidified Low-Acid Foods In Hermetically Sealed Containers – Visual Inspection Protocol
2.0 Definitions

This page is part of the Guidance Document Repository (GDR).

Looking for related documents?
Search for related documents in the Guidance Document Repository

For the purpose of this document the following definitions apply.

Canned Food:
means a commercially sterile low-acid or acidified low-acid food packed in hermetically sealed containers.
Commercially Sterile:
means the condition obtained in a food which has been processed by the application of heat alone or in combination with other treatments to render the food free from viable forms of microorganisms, including spores, capable of growing in the food at temperatures at which the food is designed normally to be held during distribution and storage.
means the individual can or package containing the food product.
means the removal of containers with serious defects from a lot of low-acid or acidified low-acid foods.
Cull Report:

means the report detailing:

  1. the procedures used to cull the inspection lot;
  2. the number of affected containers that were removed form the lot; and
  3. the number and types of defects found.

This report must be submitted by the legal agent to the Regulatory agency having jurisdiction.

Good Order:
means acceptable to the inspector to that point in the protocol.
Hermetically Sealed Container:
means a container designed and intended to be secure against the entry of micro-organisms including spores.
means the physical examination of a lot of low-acid or acidified low-acid canned foods for the presence of serious defects.
(see note at beginning of document)
means a number of containers limited to one container type and size, one product type and style, originating from one processing establishment.
Note: with respect to fish the lot must be comprised of the same species and bear the same label.
means a person with adequate training who is charged with the responsibility of inspecting a lot of low-acid or acidified low-acid foods in hermetically sealed containers for the presence of serious defects.
means a laboratory acceptable to the regulatory agency having jurisdiction.
Legal Agent:
means the person or company by whom or for whom the food was produced for sale or distribution.
Overview inspection:
means a visual examination of the cases of the lot to determine their condition.
means the examination of a previously inspected lot for the presence of serious defects.
Compliance Sampling and Sample Size:
The sampling plan is based on a two class attribute acceptance plan.
Inspection: sample size (n) is 200 containers and the acceptance number (c) is zero(0) serious defects.
Reinspection: sample size (n) is 1250 containers and the acceptance number (c) is zero(0) serious defects.
Serious defect:

means any container;

  1. which is swollen;
  2. which shows evidence that the hermetic seal is lost or seriously compromised; or
  3. which is unsuitable for distribution and sale as stipulated in the Food and Drugs Act section 4 and/or section 27.003 and 27.005 of the Food and Drug Regulations.

These defects are described in the Metal Can Defects Manual.

means the segregation and control of cases that have been damaged during storage or transportation.
Suspect Codes:
means those codes that may contain defective containers.
Date modified: