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.
On this page
- 1.0 Purpose
- 2.0 Authorities
- 3.0 Reference documents
- 4.0 Definitions
- 5.0 Acronyms
- 6.0 Operational guidance
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.
- Safe Food for Canadians Act (SFCA)
- Safe Food for Canadians Regulations (SFCR)
- Food and Drug Regulations (FDR)
- Food and Drugs Act (FDA)
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
- Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods
- Industry guidance – Cleaning and sanitation program
- Industry guidance – Evidence showing a control measure is effective
- Industry guidance – Preventing cross-contamination
- Industry guidance – Section 5.0 Sanitation, pest control and non-food agents
- Operational guidance – General principles of sampling
- Operational guidance – Inspection of evidence showing that control measures are effective
- Operational Guideline – Food regulatory response guidelines
- Standard inspection (SIP) procedure overview
- Appendix D - PCP sub-element 2. 1 Sanitation, Biosecurity and Biocontainment
Unless specified below, definitions are located in either the:
- Safe Food for Canadians: Glossary of Key Terms
- Integrated Agency Inspection Model (iAIM) - Glossary of Terms (Annex F)
- MyCFIA Glossary of Terms
- 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.
- A continuous loop of processing pipeline and any associated processing equipment that is cleaned as a single unit or system.
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:
- an inspection of the evidence of effectiveness
- a review of the regulated party's written procedures, and record review
- an on-site inspection (observation, interviews and sampling as required)
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
- During the initial walkthrough observe the number and type of CIP / COP systems and determine the number and types of CIP / COP systems to be selected for inspection.
- If there are too many systems to evaluate in one inspection, select a representative number of systems within the facility.
- Prioritize the systems based on their potential risk to food safety proceeding from highest risk to lowest risk over succeeding inspections, for example, evaluation of a High Temperature Short Time (HTST) pasteurizer cleaning system would take priority over a storage tank cleaning system.
- Be vigilant for process lines that run more than one product where allergen concerns might arise or where products are being produced from pasteurized and unpasteurized inputs.
- Use the complaint records to identify any concerns linked sanitation issues such as chemical products (taste defects) or early spoilage due to bacteria, and incorporate those issues into your selection of cleaning systems and subsequent evaluation.
6.2 CIP / COP system documentation and record review
6.2.1 Inspection of evidence of effectiveness of CIP/COP cleaning and sanitation program
- The CIP / COP cleaning and sanitation program is a control measure. It must be designed so as to be effective on a day to day basis in achieving the desired outcome of sanitary cleanliness.
- For the systems selected for inspection, verify that the regulated party's PCP identifies the evidence that shows the sanitation system and program are effective by applying the Operational guidance – Inspection of evidence showing that control measures are effective.
- As explained in the Industry guidance – Evidence showing a control measure is effective, evidence required for these hygiene-based control measures may be a reference to industry guidance on Good Hygienic Practices (GHPs). Typical sources may be government, industry associations, academia or industry itself, such as professional sanitation companies.
- In the case of more complex processing systems such as aseptic processing, the regulated party may treat the sanitation system/program as a critical control point and then validation would be required as per the Industry guidance – Evidence showing a control measure is effective.
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:
- contact time
- physical action (turbulent cleaning solution velocity, pressure)
- cleaning chemical concentration, and
- solution temperature
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
- If monitoring records are maintained, review and evaluate a representative number of cleaning monitoring records. For example, cleaning charts, temperature and chemical concentration records for completeness, accuracy, and authorization. Cleaning records should also include equipment tear down records to verify continuous program effectiveness.
- Review verification records for the CIP/COP system to confirm if they demonstrate the achievement of the desired outcomes. This would include testing for cleanliness of the system, reduction or absence of food safety microorganisms and of cleaning agent (chemical) residues. Examples of specific records might include rinse water analysis for cleaning chemical concentration verifications, ATP test results, microbiological test results, visual inspection results.
- Determine if the verification records available demonstrate:
a satisfactory microbiological condition of food contact surfaces, that is, laboratory analysis for relevant pathogens, indicator organisms or bio indicators, for example, ATP.
Note: ATP sanitation monitoring systems detect the amount of organic matter that remains on food contact surfaces, in liquids, or on pipes, tanks, etc., after a company has completed its sanitation program. A baseline comparison value is required for effective use.
- a satisfactory chemical condition of food contact surfaces, that is, laboratory analysis for residues associated with the cleaning agents within the cleaning program.
- Confirm that records to support verification of effectiveness address all relevant parameters and technical guidelines such as those identified in 6.2.2 and demonstrate repeated satisfactory results.
- In the event of deviations ensure that appropriate corrective actions took place according to company's PCP, and that the source of the deviation has been appropriately corrected as described in SIP section 4.4.1 Document and record review.
6.3 On-site inspection
Conduct an on-site inspection of the CIP / COP system(s) selected for inspection and of processing equipment cleaned and sanitized using these systems.
- Evaluate system(s) for general sanitary design and system effectiveness design. For example, suitable materials (stainless), no unprotected cross connections, suitable pumping capacity.
- Possible sources of non-compliant and ineffective CIP / COP systems may relate to
- design and installation: for example, pumping capacity or speed, presence of dead-legs, inappropriate materials such as galvanized metal or tin, and/or valves that do not protect against cross contamination to name a few.
- For CIP system(s) the possibility for cross contamination of product by a cleaning agent in piping systems where one line may be in sanitation mode, and another line may be in processing mode needs to be taken into consideration and evaluated for adequate protective measures, such as flow boards or mix proof valves.
- Select components of the processing system for dismantling (by the processor) and physically examine for cleanliness. Surfaces need to be visibly clean. Focus on elements of the system that are difficult to clean, for example, plates in an HTST or elbows in a piping system or valves. Compare to the operators swabbing program. When surfaces do not appear to be visibly clean or there are reasonable doubts, environmental swabs as described in Operational Guidance - General principles of sampling may be conducted by the inspector to confirm cleaning effectiveness.
- Identification of deficiencies may require an expansion of the scope to include evaluation of similar systems in the establishment, for example, if a product holding tank is found to be unclean after CIP, other holding tanks within the facility may be examined to determine the extent of the deficiency.
- Where a single CIP system is used to clean raw and pasteurized product circuit verify if the pasteurized is cleaned before the raw product.
Interview on items such as:
- an operator of significant pieces of equipment may be asked whether or not any modifications or repairs have been made, and whether or not the operator is aware if the change has been confirmed to have been completed properly without any adverse consequences to the CIP / COP program effectiveness
- an operator may be asked to describe the implication of altering the CIP/COP program. The response should address the potential impact on its effectiveness and the possible need for verification of modified parameters and/or technical guidelines
- items not able to be assessed during on site sanitation operations, for example, what is being dismantled for sanitation
- what tests are used to verify the effectiveness of CIP/COP cleaning, and how are they performed, for example, swabs, water rinse samples, ATP. Is data analysis, for example, trending, performed on the results
- if a complaint file indicates food safety concerns attributable to equipment/material cleaning and sanitation (CIP / COP), questions can be asked about the related source of the problem, for example, a specific piece of equipment, and why the verification was unable to identify the concern, and what measures were taken to correct the issue
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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