Title Page
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Conducted on
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Prepared by
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Location
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Auditee's signature : I agree with the audit findings
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Auditee's name
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Auditee's Job title
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Fundamental<br>SOI<br>Housekeeping and cleaning systems shall be in place which ensure appropriate standards of hygiene are maintained at all times and the risk of product contamination is minimised.
4.11.1 Premises and equipment
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The premises and equipment shall be maintained in a clean and hygienic condition.
4.11.2 Documented cleaning and disinfection procedures
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Documented cleaning and disinfection procedures shall be in place and maintained for the building, plant and all equipment.
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Cleaning procedures for the processing equipment and food contact surfaces shall, at a minimum, include:
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responsibility for cleaning
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item/area to be cleaned
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frequency of cleaning
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method of cleaning, including dismantling equipment for cleaning purposes where required
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cleaning chemicals and concentrations
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cleaning materials to be used
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cleaning records (including records for completion and sign-off) and responsibility for verification.
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The frequency and methods of cleaning shall be based on risk.
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The procedures shall be implemented to ensure appropriate standards of cleaning are achieved.
4.11.3 Limits of acceptable and unacceptable cleaning performance
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Limits of acceptable and unacceptable cleaning performance shall be defined for food contact surfaces and processing equipment.
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These limits shall be based on the potential hazards relevant to the product or processing area (e.g. microbiological, allergen, foreign-body or product-to-product contamination). Therefore, acceptable levels of cleaning may be defined by visual appearance, ATP bioluminescence techniques (see glossary), microbiological testing, allergen testing or chemical testing as appropriate.
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The site shall define the corrective action to be taken when monitored results are outside of the acceptable limits.
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Where cleaning procedures are part of a defined prerequisite plan to control the risk of a specific hazard, the cleaning and disinfection procedures and their frequency shall be validated and records maintained.
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This shall include the risk from cleaning chemical residues on food contact surfaces.
4.11.4 Resources for undertaking cleaning
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The resources for undertaking cleaning shall be available.
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Where it is necessary to dismantle equipment for cleaning purposes or to enter large equipment for cleaning, this shall be appropriately scheduled and, where necessary, planned for non-production periods.
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Cleaning staff shall be adequately trained or engineering support provided where access within equipment is required for cleaning.
4.11.5 Checks on equipment's cleanliness.
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The cleanliness of equipment shall be checked before equipment is released back into production.
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The results of checks on cleaning, including visual, analytical and microbiological checks, shall be recorded and used to identify trends in cleaning performance and to instigate improvements where required.
4.11.6 Cleaning equipment shall be:
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hygienically designed and fit for purpose
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suitably identified for intended use (e.g. colour-coded or labelled)
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cleaned and stored in a hygienic manner to prevent contamination.
4.11.7 Cleaning in place (CIP)
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Do you use CIP?
- Yes. We use Cleaning in place
- No. We fully dismantle the equipment
4.11.7.1 CIP equipment
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All CIP equipment shall be designed and constructed to ensure effective operation. This shall include:
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validation confirming the correct design and operation of the system
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an up-to-date schematic diagram of the layout of the CIP system
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where rinse solutions are recovered and re-used, an assessment of the risk of cross-contamination (e.g. due to the re-introduction of an allergen or the existence of different production risk zones within the site).
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Alterations or additions to the CIP system shall be authorised by a suitably competent individual before changes are made. A record of changes shall be maintained.
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The system shall be revalidated at a frequency based on risk, and following any alteration or addition.
4.11.7.2 Limits of acceptable and unacceptable performance for key process parameters
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Limits of acceptable and unacceptable performance for key process parameters shall be defined to ensure the removal of target hazards (e.g. soil, allergens, micro-organisms, spores). At a minimum these parameters shall include:
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times for each stage
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detergent concentrations
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flow rate and pressure
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temperatures.
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These shall be validated and records of the validation maintained.
4.11.7.3 Ensuring effective cleaning
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The CIP equipment shall be maintained by suitably trained staff to ensure effective cleaning is carried out. This shall include:
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routine checking of detergent concentrations
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monitoring of recovered post-rinse solutions for build-up of carry-over from the detergent tanks
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cleaning and inspection of filters, where fitted, at a defined frequency
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storing flexible hoses (where used) hygienically when not in use, and inspecting them at a defined frequency to ensure that they are in good condition.
4.11.7.4 CIP facilities monitoring
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CIP facilities, where used, shall be monitored at a defined frequency based on risk. This may include:
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monitoring of process parameters defined in clause 4.11.7.2
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ensuring correct connections, piping and settings are in place
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confirming the process is operating correctly (e.g. valves are opening/closing sequentially, spray balls are operating correctly)
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ensuring effective completion of the cleaning cycle
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monitoring for effective results, including draining where required.
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Procedures shall define the action to be taken if monitoring indicates that processing is outside the defined limits.
4.11.8 Environmental monitoring
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SOI<br>Risk-based environmental monitoring programmes shall be in place for relevant pathogens or spoilage organisms. At a minimum, these shall include all production areas with open and/or ready-to-eat products.
4.11.8.1 Environmental monitoring programme
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The design of the environmental monitoring programme shall be based on risk, and at a minimum include:
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sampling procedures
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identification of sample locations
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frequency of tests
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target organism(s) (e.g. pathogens, spoilage organisms and/or indicator organisms)
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test methods (e.g. settle plates, rapid testing and swabs)
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recording and evaluation of results.
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The programme and its associated procedures shall be documented.
4.11.8.2 Control or action limits for the environmental monitoring programme.
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Appropriate control or action limits shall be defined for the environmental monitoring programme.
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The company shall document the corrective action to be taken when monitored results indicate a failure to meet a control limit, or when monitored results indicate an upward trend of positive results (i.e. a trend towards a control or action limit).
4.11.8.3 Review the environmental monitoring programme
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The company shall review the environmental monitoring programme at least annually and whenever there are:
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changes in processing conditions, process flow or equipment which could impact the environmental monitoring programme
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new developments in scientific information (e.g. new pathogens of concern)
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failures of the programme to identify a significant issue (e.g. regulatory authority tests identifying positive results which the site programme did not)
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product failures (products with positive tests)
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consistently negative results (e.g. a site with a long history of negative results should review its programme to consider whether the correct parts of the factory are being tested, whether the testing is being conducted correctly, whether the tests are for the appropriate organisms, etc.).
