Canadian Grain Sampling Program Audit Manual

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

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

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:

space
Greg Wolff, Chief Plant Health Officer
space
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

  • ISO Guide 8402, Quality Systems Terminology.
  • ISPM. No. 5 Glossary of Phytosanitary Terms, FAO (updated annually).
  • D-10-02, The Canadian Grain Sampling Program (CGSP).

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:

  • Maintain written procedures and records in compliance with requirements of the CGSP.
  • Assist the CFIA with audit activities including provision of copies of written procedures and records for review as requested, answer Auditor's inquiries related to the implementation of written programs and other procedures used in the company.
  • Identify and correct non-conformances in a timely and appropriate manner.

4.2 Auditor

The responsibilities of the Auditor are to:

  • Ensure the program requirements of the CGSP are being met by participants.
  • Ensure all documents used in the conduct of audit activities (including audit procedures) are current by using the latest versions available on the CFIA website.
  • Conduct audit in accordance with the national frequency.
  • Ensure the condition of all tools and safety equipment is suitable for their intended use (e.g., clean, functioning).
  • Seek guidance and clarification of program and audit through appropriate channels as required.
  • Advise Supervisor/Regional Program Officer of problems or concerns regarding audit.
  • Communicate audit results to the company/operator in a professional manner using the correct documentation.
  • Assess the company's corrective action submitted in response to CARs.
  • Follow-up on company's corrective action plan implementation in response to CARs.
  • Ensure that complete record of audit is available (some records exist only electronically, others are available as hard copy).
  • Maintain all audit notes.

4.3 CFIA Regional Program Officer

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

  • Provide clarifications to audit staff in relation to program or policy.
  • Seek advice on questions related to the audit process, program or policy issues from the CFIA Area Grains and Oilseeds Program Specialist.
  • Provide support to audit staff in relation to non-compliance or enforcement issues.
  • As required, conduct evaluation audits and recommend companies to the Area Program Specialist for inclusion in the CGSP.
  • As required, verify recommendations from the field for the suspension of a company and forward their assessment to the Area Program Specialist.

4.4 CFIA Area Grains and Oilseeds Program Specialist

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

  • Respond to policy and program questions received from CFIA RPO and management.
  • Review proposed revisions, additions or deletions to the audit process, program or policy issues received from RPO.
  • Verify information and make recommendations to the National Manager, Grains and Oilseeds, for the inclusion or suspension of companies in the CGSP.
  • Provide support and advice to the RPO as required.

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
  • Step 2 – Gathering of Information
  • Step 3 – Determining the level of compliance
  • Step 4 – Communication of the audit results
  • Step 5 – Follow-up audit
  • Step 6 – Closing the audit and documentation

Step 1 – Preparation for the Audit

Initiate Audit (Team Leader/Inspector)

  • Review annual Grains and Oilseeds audit work plan (CGSP company audit should be a minimum of once a year)
  • Identify company requiring audit
  • Determine audit team and ensure staff have required competencies and designation (i.e. CFIA Understanding Audit course or equivalent).

Determine the Scope of the Audit

  • Review company file including the Manual and results of previous audits
  • Review issues or actions since the last audit

Set up an Appointment with the Company

  • Contact company manager to arrange date and time for audit
  • Determine safety equipment requirements.
  • Confirm audit date, time and scope with the company by letter, fax or email

Review Current Regulatory and Reference Documents

  • Review any relevant reference documents available on the CFIA website including CGSP Directive and CGSP Audit Manual

Gather Required Audit Documents, Tools and Protective Equipment

  • Audit documents
  • Safety Equipment (as required by company)
    • Safety boots
    • Hard hat
    • Gloves
    • Dust mask
    • Ear plugs
    • Safety glasses/goggles

    Additional equipment may be required depending on the company's safety policy

  • Miscellaneous Supplies and Tools
    • Flashlight (class II, group G, division 1, approved)
    • Clipboard
    • Calculator
    • Pen, pencils
    • Digital camera (optional)

Step 2 – Gathering of Information

Conduct Opening Meeting

  • Introduce all audit staff and explain roles
  • Define objective and the scope of the audit
  • Confirm details of the company's operation
  • Outline audit schedule and procedures
  • Discuss changes in program design and/or regulations
  • Review any outstanding non-conformances
  • Explain process for Corrective Action Request (CAR)
  • Identify company staff and resources required
  • Confirm company contact – official communications link
  • Confirm safety requirements
  • Discuss date and time for the closing meeting
  • Keep complete and accurate notes of all items discussed

Gather Audit Information

  • Collect facts through audit observations, staff interviews and document reviews (procedures and records)
  • Confirm company's records and procedures by utilizing a second audit method: cross-audit through company staff interviews and/or observations (This will allow the auditor to cross-reference the information gathered for an item).

Review the Company's Procedures

  • Assess procedures based on the CGSP
  • Audit comments on the CGSP Audit Report (Appendix 1) must contain:
    • Information which clearly identifies specific procedures assessed (how, where, when, etc.)
    • Name and title/area of responsibility of company staff interviewed
    • Description of any non-conformance observed

Review the Company's Records

  • Select and assess records based on the company's Manual
  • Audit comments must contain:
    • Information which clearly identifies the specific records assessed
    • Name and date of record
    • Number of records
    • Name, title and area of responsibility of the company staff interviewed
    • Description of any non-conformance observed

Interview Company Staff

  • Interview company staff as necessary to confirm company procedures and records
  • Conduct interviews using effective interview techniques
  • Audit comments must contain:
    • Name, title and area of responsibility of company staff interviewed
    • Information which clearly identifies specific procedures and/or records verified per above
    • Description of any non-conformance observed

Observe Conditions in the Company and Practices Employed

  • Observe company staff at work
  • Audit comments must contain:
    • Area of the company/procedure observed
    • Name, title and area of responsibility of the personnel observed
    • Information which clearly identifies specific procedures and/or records verified
    • Description of any non-conformance observed

Record Audit Comments on CGSP Audit Report

  • At the time of audit, record audit comments as outlined in A through D above, on the CGSP Audit Report (Appendix 1)
  • Develop audit comments based on information gathered at the time of audit
  • Keep any rough notes in the audit file
  • Ensure recorded audit comments are clear, concise, accurate, complete and contain sufficient detail to support conformance level

Identification of Non-Conformance that Requires Immediate Control Actions

  • If during the course of an audit, the auditor encounters non-conformance that may seriously impact on phytosanitary certification, the CFIA must immediately initiate actions to control the affected product and inform the company
  • Communicate non-conformance to the CFIA supervisor/RPO to inform them of the situation.
  • Complete the task and assign a compliance level supported by clear, concise, accurate and complete audit comments
  • A CGSP Corrective Action Request (CAR) (Appendix 2) is issued if a corrective action is required before the closing meeting
  • If too serious to correct right away the company should be suspended and a CGSP Notice of Suspension from the Canadian Grain Sampling Program (Appendix 3) should be issued

Step 3 – Determining Level of Compliance

Critical Non-Conformance

  • Audit findings that indicate the integrity of the CGSP is in jeopardy are considered to be critical non-conformances. The company is immediately suspended from the CGSP if any critical non-conformances are found. For suspended companies, the only option available for export sampling will be product sampling by CFIA or another CGSP company with CFIA approval.

Major Non-Conformance

  • Major non-conformances are isolated incidents of non-conformance, which do not immediately impact the integrity of the certified product but may become a problem over time. Corrective actions must be carried out to the satisfaction of the CFIA within10 business days of receiving the CAR. The corrective actions will generally require a change to the Manual and will include measures to prevent a reoccurrence.
  • If two or more major non-conformances are detected during an audit, or if the company fails to carry out the required corrective actions within the specified time period, the non-conformances will be assessed as critical and the company will be immediately suspended from the CGSP.

Minor Non-Conformance

  • Minor non-conformances are those that do not immediately or significantly affect the status of the product, but could lead to a major non-conformance if not addressed. Corrective actions must be undertaken by the company within a time limit specified by the CFIA.
  • If three minor non-conformances are detected in any one audit this is considered equivalent to one major non-conformance (e.g. four minor non-conformances are equal to one major non-conformance and one minor non-conformance. Similarly, six minor non-conformances are equal to two major non-conformances, which constitutes a critical and the company would be immediately suspended from the CGSP).

Observations

  • Observations are points or practices, which could be used to improve the company's Quality Management System. An observation may be used to identify a situation of concern that does not warrant a CAR, or to highlight, suggest or reinforce particular practices. Observations should be recorded on the Audit Report (Appendix 1).

Step 4 – Communication of Audit Results

Prepare Corrective Action Request (CAR)

  • Complete CGSP - Corrective Action Request (CAR) Form (Appendix 2)
  • Identify the deadlines for completion of corrective measures

Closing Meeting

  • At the closing meeting, provide a verbal report of audit results followed by a copy of the Audit Report.
  • Respond to questions and note feedback from company management
  • Review all non-conformance rating and confirm the dates specified for implementation of corrective action
  • Sign CAR(s) and ask company to sign the CAR (s) acknowledging they received the CAR
  • Ask company representative to complete how they will address the Corrective Action and sign the CAR(s). The company may want to take some time to decide what the action plan will be. The time limit to provide the solution should be discussed with the lead auditor.
  • If company representative refuses to sign the CAR, note that the request was made and refused. Advise the company that they may be suspended for refusal to acknowledge the non-conformances. In this situation, discuss with RPO to determine the next course of action.
  • Keep complete and accurate notes of the discussion, including feedback and information provided by company staff
  • Schedule a follow-up audit to confirm implementation of corrective actions. If no CARs were issued a follow up audit is not required

Step 5 – Follow-up Audit (if required)

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

  • The following activities must be completed prior to carrying out the follow-up audit:
    • Review the details of the non-conformance from the last audit conducted at this company
    • Review any corrective actions plans provided
    • Contact the manager of the company in advance to arrange the date and time for the follow-up audit
    • Confirm safety equipment requirements
    • Assemble the audit and safety equipment as required to conduct the follow-up audit
    • Conduct a follow-up audit within a maximum of 10 calendar days after the corrective actions were to be implemented

Conduct Follow-Up Audit to Reassess Identified Non-Conformances

  • Go on-site and confirm the following:
    • Proposed corrective measure has been implemented within the agreed time frames;
    • Areas of non-conformance identified during last audit have been fully addressed; and
    • Company has implemented corrective measures that effectively prevent recurrence of the non-conformance

Follow-Up Audit – Unacceptable Implementation of Corrective Action

  • If during the follow-up audit, it is observed that the implementation of the Corrective Action has not corrected the non-conformance, add additional comments in the appropriate box on the CAR that corrective actions taken are not satisfactory. It is important to date and initial each added comments on both document.
  • If the company fails to carry out the required corrective actions for major non- conformance within the specified time period, the non-conformances will be assessed as critical and the company will be immediately suspended from the CGSP.
  • If the company fails to carry out the required corrections for minor non-conformances within the specified time period, the non-conformances will be assessed as major non-conformances.
  • Additional follow-up audit may be required

Follow-Up Audit – Acceptable Implementation of Corrective Actions

  • If during the follow-up audit, it is observed that the implementation of the corrective action has corrected the non-conformance, enter comments in the appropriate box for which the non-conformance was noted. This must be linked with the Audit Report from the initial audit.
  • Close, sign, date the CAR and provide copy of the CAR form to company, indicating that the corrective action taken by the company is acceptable.

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:

  • Confirmation of audit (letter, fax, email)
  • Audit rough notes (includes audit form used on site)
  • Copies of records related to non-conformance
  • Other records copied for review to be kept in file until the next audit at that company
  • Closing meeting notes
  • Completed CGSP Audit Report (Appendix 1)
  • Completed CGSP Corrective Action Request (CAR) (Appendix 2)
  • CGSP Notice of Suspension from the Canadian Grain Sampling Program (Appendix 3) if applicable

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
space

Reference: space

Deadline for Corrective Action: space

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

B) Description of Corrective Action (CA)

Description of Corrective Action: space
space
space
space

Date of Completion of CA: space

space
Representative's Name
space
Representative's Signature
space
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
space
space
space

Can this CAR be closed? Yes or No

If no, give reasons: space
space
space
space

space
Auditor's Name
space
Auditor's Signature
space
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"

Date modified: