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Canadian Grain Sampling Program Audit Manual

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Table of Contents

Contact and Review

The contact for this document is the Grains and Oilseeds Section of the Canadian Food Inspection Agency (CFIA).

This directive will be updated as required. For further information or clarification, please contact the Canadian Food Inspection Agency (CFIA).

Endorsement

Approved by:

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Greg Wolff, Chief Plant Health Officer
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Date

Distribution

  1. Directive mail list (Regions, Areas, PHRA)
  2. National Industry Organizations (determined by Author)
  3. Internet

Introduction

The Canadian Grain Sampling Program (CGSP) Audit Manual is a supplementary document to CFIA directive D-10-02: The Canadian Grain Sampling Program (CGSP). This audit manual is for use by auditors and outlines the approval and auditing requirements for:

  1. Participating facilities sampling grain for export
  2. Participating third parties sampling grain for export

Facilities or third parties seeking approval under the CGSP will be referred to as company(ies) in this document.

Scope

This document outlines the criteria and procedures used to approve and audit companies participating in the CGSP. It also provides guidelines to determine compliance under the CGSP.

References

Definitions, Abbreviations and Acronyms

Definitions for terms used in this document can be found in the Plant Health Glossary of Terms.

1.0 Audit and Documentation Review

1.1 CGSP Audits

A Quality Management System is a method of operation that incorporates an organizational structure, procedures, processes (e.g. quality management system procedure, quality management system manual(s), quality control protocols, audit procedures, etc.) and resources, needed to implement quality management. A Quality Management System will be utilized to ensure samples taken for phytosanitary purposes meet criteria established by the CFIA. The company must document the procedures that they will be following in their quality management system to meet the conditions of the CGSP. This documentation is the company's Quality Management System Manual, (herein referred to as the Manual).

Audits will be composed of a documentation review and a practical component. The document review will be conducted to verify that the company meets the requirements prescribed in D-10-02 and is operating within the limits of the instructions of their Manual. The practical component will be conducted on location, where sampling takes place.

1.2 Evaluation Audit

Before allowing a company to participate in the CGSP, the CFIA auditor will conduct an evaluation audit. An evaluation audit is a systematic examination to verify the ability of the company to fulfill the requirements of the CGSP as outlined in their Manual. Companies successfully completing an evaluation audit will get a copy of the approved application with a unique CGSP identification number (Appendix 1; D-10-02). If the evaluation audit has identified deficiencies, the Manager of the company will be provided with detailed information in writing on what deficiencies need to be addressed prior to approval. Additional evaluation audits may be required.

1.3 System Audits

The system audit is a review by the CFIA of the organizational structure, procedures, processes and resources used by participating companies in implementing the CGSP. A system audit will be performed by the CFIA at a minimum of once a year but the frequency can be increased at the discretion of the CFIA if any compliance issues arise.

The system audit will involve assessments of how the company meets the requirements of the CGSP, including review of the company's Manual and records. Additional audits may take place as a follow up to corrective actions taken by the company as required by the CFIA. The timing of the system audits will be based on the activity of the company throughout the year. The CFIA will provide a CGSP Audit Report (Appendix 1) as part of the system audit.

2.0 Non-Conformance

Activities or products that are found to be in contravention with the CGSP are considered non-conformances. Non-conformances can be detected during the internal audits conducted by the company or during an audit conducted by the CFIA. A CGSP Corrective Action Request (CAR) will be issued by the CFIA for each non-conformance that is detected during the audit (Appendix 2). Company may need to make changes to their Manual as part of their response to a CAR. Observations on suggested changes or improvements to a company's Manual or procedures will be documented on the CGSP Audit Detail Report (Appendix 1).

All CARs reported must be classified as either being critical, major, or minor in nature. The number and class of non-conformances found will determine the status of the company and the subsequent auditing frequency. Each CAR is numbered consecutively per company and per audit. Classification of non-conformances will be based on an evaluation of the associated risk and whether the integrity of the CGSP has been compromised.

Each CAR must be addressed with a proposed action plan from the company which must include a detailed description of the measures that will be implemented to prevent recurrences of the non-conformances and a time frame for completing the corrective actions. The action plan must be approved and its implementation verified by the Auditor. Failure of the company to implement the approved action plan may result in suspension from the CGSP.

3.0 Suspension

Prior to suspension of a company from the CGSP, the auditor should consult with the Regional Program Officer and the Area Program Specialist. If the company is suspended, they will receive a CGSP Notice of Suspension from the Canadian Grain Sampling Program (Appendix 3) and their name will be removed from the list of approved companies maintained by the CFIA.

A company that has been suspended may re-apply for certification under the CGSP at any time, provided a detailed report of the corrective actions taken to address the previous non-conformances is included with the application form (D-10-02 Appendix 1). The CFIA will conduct an evaluation audit to verify if the corrective actions are adequate. If approved, the CFIA will re-list the company on the CFIA external website.

Suspended companies cannot submit sample(s) for phytosanitary certification to the CFIA or CFIA approved testing bodies. The only option available for export sampling will be product sampling by the CFIA or by a third party company with CFIA approval.

4.0 Roles and Responsibilities

4.1 Company

The responsibilities of the company are to:

4.2 Auditor

The responsibilities of the Auditor are to:

4.3 CFIA Regional Program Officer

The responsibilities of the Regional Program Officer (RPO) are to:

4.4 CFIA Area Grains and Oilseeds Program Specialist

The responsibilities of the CFIA Area Grains and Oilseeds Program Specialist are to:

5.0 CGSP Audit Work Instructions

The company audit process is divided into six separate steps, see diagram below. Each of the six steps is divided into detailed procedures. The Canadian Grain Sampling Program Audit Manual provides direction to the auditor on how to deliver each individual step of the audit process.

The following list outlines the stages of the CGSP Audit:

Step 1 – Preparation for the Audit

Initiate Audit (Team Leader/Inspector)

Determine the Scope of the Audit

Set up an Appointment with the Company

Review Current Regulatory and Reference Documents

Gather Required Audit Documents, Tools and Protective Equipment

Step 2 – Gathering of Information

Conduct Opening Meeting

Gather Audit Information

Review the Company's Procedures

Review the Company's Records

Interview Company Staff

Observe Conditions in the Company and Practices Employed

Record Audit Comments on CGSP Audit Report

Identification of Non-Conformance that Requires Immediate Control Actions

Step 3 – Determining Level of Compliance

Critical Non-Conformance

Major Non-Conformance

Minor Non-Conformance

Observations

Step 4 – Communication of Audit Results

Prepare Corrective Action Request (CAR)

Closing Meeting

Step 5 – Follow-up Audit (if required)

Prepare to Conduct Follow-Up Audit to Reassess Identified Non-Conformances

Conduct Follow-Up Audit to Reassess Identified Non-Conformances

Follow-Up Audit – Unacceptable Implementation of Corrective Action

Follow-Up Audit – Acceptable Implementation of Corrective Actions

Step 6 – Closing the Audit and Documentation

Complete Audit file

This file or part of this file can exist as electronic or hard copy. When the company audit has been concluded, the file is reviewed to ensure it contains all applicable documents required to support the audit, including:

Appendix 1 - CGSP Audit Report and CGSP Audit Detail Report

The CGSP Audit Report

Form - The CGSP Audit Report. Description follows.
Description for form: CGSP Audit Report

The following is intended for the Canadian Grain Sampling Program Audit. It allows the auditor to identify the type of audit, the dates of the reference documents used, and the types and number of non-compliances found. There are fields provided for entering the report number, company information, the audit date, the auditor`s name, and the confirmation of approval.

This form provides brief descriptions of the type of audit that is performed, with its objective being to ensure that there is compliance with the requirements of the D-10-02. It allows the auditor to identify the type of audit, the dates of the reference documents used, and the types and number of non-compliances found. There are fields provided for entering the report number, company information, the audit date, the auditor`s name, the confirmation of approval, as well as comments from what was observed during the audit.

The CGSP Audit Detail Report

Form - The CGSP Audit Detail Report (part 1). Description follows.
Form - The CGSP Audit Detail Report (part 2). Description follows.
Description for form: CGSP Audit Detail Report

The table is intended for a more detailed description of the components of the Canadian Grain Sampling Program Audit. It allows the auditor to record information such as whether general requirements are being fulfilled, if samples are properly taken, if the product is stored properly, if records are being maintained, and if internal audits are also being completed.

This table has five main sections: "General Requirements", "Sampling", "Storage of Product Prior to Export", "Document Control", and "Internal Audits". Each section is comprised of three or more rows with five columns. The headings for the five columns are: "Corresponding Section of D-10-02", "Description", "Rating", "Comment", and "CAR#" or Corrective Action Request number. At the beginning of the form it requires the name of the company being audited, the CGSP ID, the audit number, and the date that the form was completed. It also allows the auditor to identify, rate, comment, and assign a Corrective Action Request Number to the different types of non-compliances including critical, major and minor. Observations and comments can also be recorded on this form.

Appendix 2 - CGSP Corrective Action Request (CAR) form

CAR #: space

Company Name: space

Audit Date(s): space

CGSP ID: space

Type of non-conformance: Critical Minor

A) Description of Non-conformity and Related Observations

Description of Non-conformance: space
space
space
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Reference: space

Deadline for Corrective Action: space

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Auditor's Name
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Auditor's Signature
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Date
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Representative's Name
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Representative's Signature
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Date

B) Description of Corrective Action (CA)

Description of Corrective Action: space
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space
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Date of Completion of CA: space

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Representative's Name
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Representative's Signature
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Date

C) Verification of Corrective Action

Acceptable documentation provided? Yes or No

Non-conformance corrected? Yes or No

Date of any completed follow-up visit (if required) and results: space
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space
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Can this CAR be closed? Yes or No

If no, give reasons: space
space
space
space

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Auditor's Name
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Auditor's Signature
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Date

Filing Information: space

Appendix 3 - SAMPLE CGSP Notice of Suspension from the Canadian Grain Sampling Program

"Date"

"Manager name"
"Company Name"
"Address"

Subject: Notice of Suspension from the Canadian Grain Sampling Program

Dear "manager name":

On "Date" an audit of "company name" "(CGSP Identification number)", "location" was carried out by "auditor" from the Canadian Food Inspection Agency, "Office location". During this audit, serious non-conformances were found and are detailed in the attached audit report "#".

These audit findings indicate that the integrity of the Canadian Grain Sampling Program (CGSP) is in jeopardy and therefore your company is now suspended from this program.

While "company" is under suspension CFIA will no longer accept samples for phytosanitary analysis drawn by your company. Samples for phytosanitary analysis can only be taken by CFIA or an approved CGSP company. A list of CGSP approved companies can be found at "Website".

If you wish to re-apply for participation under the CGSP you must re-submit a Manual and complete an Application for Participation in the Canadian Grain Sampling Program. A detailed report of the corrective actions taken to address the previous non-conformances must also be included with the application. An evaluation audit will be conducted to determine the ability of your company to meet the requirements of the CGSP.

If you wish to discuss this further please contact "name" at "phone number".

Yours sincerely,

"RPO"
"Agency name"
cc "Auditor"
"Program Specialist"

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