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Operational guideline: Inspection of clean-in-place / clean-out-of-place sanitation systems

Although the Safe Food for Canadians Regulations (SFCR) came into force on January 15, 2019, certain requirements may apply in 2020 and 2021 based on food commodity, type of activity and business size. For more information, refer to the SFCR timelines.

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1.0 Purpose

The purpose of this document is to provide guidance to the Canadian Food Inspection Agency (CFIA) inspection staff on conducting an assessment of a Clean-In-Place / Clean-Out-of-Place (CIP/COP) sanitation system to ensure that it has been properly designed, implemented and is effective.

This document is intended to be used in conjunction with other guidance documents as referenced in Section 3.0.

The guidance outlined below should be used when performing a Standard Inspection Procedure (SIP) Preventative Control Plan (PCP) inspection of sub-element 2.1 on sanitation, as part of a food safety investigation or as follow-up to a complaint.

2.0 Authorities

The inspection powers, control actions and enforcement actions authorized by the above legislation are identified and explained in the Operational guideline – Food regulatory response guidelines.

3.0 Reference documents

4.0 Definitions

Unless specified below, definitions are located in either the:

Adenosine Triphosphate (ATP)
The energy source in living cells.
Clean-In-Place (CIP)
A cleaning/sanitation system where equipment and techniques allow cleaning of process equipment circuit without being dismantled.
Clean-Out-Of–Place (COP)
A cleaning/sanitation system where equipment is disassembled for cleaning and inspection. Hand cleaning is performed using utensils such as brushes, and/or the use of a COP tank where circulating cleaning solution creates a turbulent cleaning action.
Circuit
A continuous loop of processing pipeline and any associated processing equipment that is cleaned as a single unit or system.

5.0 Acronyms

Acronyms are spelled out the first time they are used in this document and are consolidated in the Food business line acronyms list.

6.0 Operational guidance

An assessment of a regulated party's CIP/COP sanitation systems consists of three main components:

Refer to section 4.4, sub-sections 4.4.1 – 4.4.4 of the SIP for general guidance on how to conduct an inspection.

6.1 Selection of CIP / COP sanitation systems for inspection

6.2 CIP / COP system documentation and record review

6.2.1 Inspection of evidence of effectiveness of CIP/COP cleaning and sanitation program

6.2.2 Inspection of written CIP/COP procedures

Review the CIP/COP procedures in the regulated party's PCP to ensure that all the relevant parameters and technical guidelines of an effective sanitation system/program have been included such as:

The Industry guidance – Cleaning and sanitation program provides guidance on the recommended components of a sanitation program.

6.2.3 Inspection of records for the CIP/COP program

6.3 On-site inspection

6.3.1 Observation

Conduct an on-site inspection of the CIP / COP system(s) selected for inspection and of processing equipment cleaned and sanitized using these systems.

6.3.2 Interviews

Interview on items such as:

6.4 Determination of compliance

Based on observations from the documentation review and on-site inspection (as per steps 6.1 - 6.5) determine if the cleaning/sanitation system meet PCP performance criteria and outcomes and meet regulatory requirements (SFCA and SFCR, FDA and FDR). Refer to section 4.6 of the SIP for further direction on determining compliance.

For general inquiries related to this Operational Guidance Document, please follow established communication channels, including submitting an electronic Request for Action Form (e-RAF).

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