INTERNAL AUDIT CHECKLIST - CLEANING (AU-001-Z)

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General Cleaning CFMSR V2 26.1 – 26.2 Hygiene Management; WSEP16.1; CFMSR V2 26.3 Cleaning Schedules; Export Control Orders S4 C1.1; CFMSR V2 26.4, 26.5 Cleaning Equipment and Cleaning protective Clothing; WSEP 16.15 Equipment Storage; BRC 4.11.6; CFMSR V2 26.6 Cleaning Chemicals; BRC 4.11.2 - 4.11.3; CFMSR V2 26.7 – 26.8.2 Cleaning Procedures; Export Control Orders S4 C 2.2, 3.1; WSEP 16.2-16.4 Cleaning and Sanitation.

• There must be a trained member of the site management team accountable for production cleaning and the standards achieved.<br>Where cleaning contractors are utilised, all related sections such as training, personal hygiene, medical screening, etc. are still applicable.<br>There must be a formal handover each day of the site to the contractor.<br>Cleaning schedules must be in place for all areas including equipment, production, overhead services, refrigeration units, storage, maintenance, employee facilities, and external areas. (A wall planner or electronic system may be used to plan periodic cleaning).<br>Risk assessment must determine the different types and levels of cleaning required on equipment, shifts, daily, weekly, monthly, etc.<br>Site is to have a defined frequency for emptying and cleaning bulk CIP tanks.<br>Cleaning equipment protective clothing, used in Base and Medium areas, shall not be used in High areas, and equipment used in High areas shall not be used in Base and Medium areas. Cleaning equipment and cleaning protective clothing shall be visually distinctive and stored separately.<br>Cleaning equipment shall be included in the GMP checklist and the condition and correct storage of equipment routinely inspected.<br>Floor contact squeegees, brooms and other cleaning equipment must be stored head down, off the floor. (Double bladed squeegees are not used in High Areas)<br>Ceiling cleaning equipment must be stored head up and off the floor.<br>Cleaning equipment used on product contact surfaces must be stored clean, head up, off the floor and at least 1 meter above the floor.<br>Review MO-022 Colour Coded Cleaning Equipment.<br>Best Practice:<br>Floor contact cleaning equipment is stored head down, with heads lower then knee height. <br>Food contact surface cleaning equipment is stored head up, with heads higher than waist height.<br>Cleaning equipment such as brushes or water hoses must be replaced on signs of wear or damage.<br>(Best Practice: Brushes and brooms are constructed with bonded bristles). <br> Steel wool (including cleaning pads) or wire brushes are not permitted.<br>Where coloured scouring pads are used to assist with manual cleaning, procedures must be in place to prevent product contamination.<br> Porous items including sponges and cloths should not be used; if these items are used they must be single use only<br>Squeegees should be of single blade construction.<br> Wooden handled equipment and string mops are not permitted. <br>Mops should not be used in production or storage areas unless the mop head is renewed after each use occasion

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  N/A

• The cleaning procedures must have been fully validated with records retained. (Cleaning procedures must be validated initially, then annually or after any change to product formulation, process or chemicals).<br>The site must have documented cleaning procedures for equipment, production, Base / Medium / High areas, overhead services, storage, maintenance, employee facilities, building structures (e.g. floors, ceilings, walls, drains, etc.), and external areas.<br>High areas shall be cleaned before Base / Medium areas.<br>Objective must be removal of physical, microbiological and allergen contamination.<br>Cleaning procedures must contain the following:<br>• Item/Area to be cleaned<br>• Who is responsible, frequency of cleaning, number of cleaners, equipment and chemicals (concentration and contact time)<br>• Methodology and requirements for use of hot water <br>(min 55°C)<br>• Protective clothing required e.g. cleaning suits, boots, gloves, safety glasses / face shields, etc.<br>• Details on how to strip equipment and to what level<br>• Required equipment and chemicals (including dilution, contact time, and temperature)<br>• The order of items and areas to be cleaned, e.g. High areas before Medium areas before Base areas<br>• Cleaning methods - clean equipment from top to bottom<br>• How to re‐assemble equipment and change parts if necessary<br>• The replacement of damaged O‐rings / gaskets where fitted.<br>• Cleaning records and responsibility for verification<br>Cleaning procedures should ideally include photographs showing key inspection points and have a unique reference number that links to site cleaning schedules / records. <br>Note and review site cleaning schedule and procedures.<br>

  Yes

  No

  N/A

Utilities, Resources and Drain Cleaning WSEP 16.8 – 16.10; Air and Water; CFMSR V2 26.9 Cleaning Resources; BRC 4.11.4 CFMSR V2 26.10 Drain Cleaning

• Pressurised air lines must be risk assessed to ensure no risk to product integrity.<br>High pressure water use must be risk assessed for formation of aerosols. Reduce water pressure if aerosols are generated.<br>Water hosing must not be carried out in filling areas while production is in progress.<br>Water hoses must be shortest practicable length for performance. Storage points must be available to ensure hose nozzles are not on floor or in contact with parts of hose line that has contacted floor. (Best practice is to have hose lines on retractable reels).<br>Cleaning water must be minimum 55°C.

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• Sufficient personnel and production downtime must be provided to ensure the cleaning schedule can be completed in full.<br>The necessary resources to complete the cleaning operation in an effective manner must be provided e.g. personnel, cleaning equipment, chemicals, and protective clothing.<br>Cleaning personnel must be trained in the use / handling of chemicals and performance of cleaning procedures.<br>Cleaning schedule must be fully integrated in the production scheduling / planning process.

  Yes

  No

  N/A

• The site must have a documented procedure for handling blocked drains.<br>Drain cleaning equipment must be controlled and cleaned before being taken into the factory and prior to being removed from the drain area (to prevent the equipment contaminating other areas.

  Yes

  No

  N/A

Cleaning Assessment CFMSR V2 26.12 Cleaning Assessment; Export Control Orders S4 C1.1 – C5.1; WSEP 16.24 and16.26; BRC 4.11.5; CFMSR V2 26.13, 26.14 Pre-operational Inspections.

• It must be the responsibility of the management or delegate to verify cleaning is completed to specified schedules and standards.<br>Cleaning activities must be assessed and recorded to ensure they have been carried out effectively, according to procedures, including the use of appropriate cleaning equipment and cleaning protective clothing.<br>Checklists (including data logging charts for CIP systems) must be completed to demonstrate the cleaning that has been completed and by whom.<br>Pre‐operation cleaning activities must be assessed and recorded by a trained and authorised person and documented prior to production being allowed to commence. Includes visual, analytical and microbiological. <br>Findings shall be trended with corrective action evident for adverse trends. <br>All re‐cleans and corrective actions following visually unsatisfactory cleaning or out of specification swab results must be clearly documented.

  Yes

  No

  N/A

CLEAN IN PLACE ( CIP) CFMSR V2 26.15 CIP Systems; BRC 4.11.7.2; WSEP 16.11 – 16.13; 16. CLEAN OUT OF PLACE (COP) WSEP 16.20; CFMSR 26.15.1- 26.17.1 CIP Systems; BRC 4.11.7.2 - 4.11.7.3; CFMSR 26.18 CIP Documents; Export Control Orders S4 C8.1; and 9.1; CFMSR 6.19 CIP Training; CFMSR 26.20 CIP Maintenance; CFMSR 26.21 CIP Calibration.

• Clean In Place (CIP) systems for pipe work, inline sieves, tanks, and instrumentation must be designed by specialist engineers. There shall be a report (provided by a CIP engineer or CIP chemical company), records, verification, and validation to demonstrate that the CIP system is hygienically designed with no dead ends. Evidence must be available of commissioning and cleaning process validation.<br>Where a CIP system has been in place for a number of years and commissioning documentation evidence is not available or where the system has not been designed by a specialist, then third‐party validations must be available.<br>Ensure:<br>• Circuits are designed so that employees cannot manually advance or skip CIP cycles or steps<br>• If CIP circuits are stopped for any reason, the cycle must be reset and not skipped. The flow rate, temperature, chemical concentration (conductivity) and time must be reset to meet the CIP parameters<br>• Scavenger pumps are operated to ensure no build‐up of cleaning chemicals in the vessels.<br>• Spray ball functionality fully covers areas to be cleaned/inspected for blockages periodically. <br>• All parts of the product circuit, including divert valves, buffer tanks, mobile tanks, etc. are included in the CIP circuit.<br>• Where sieves are removed for the CIP, they shall be included in the COP activity<br>• Instrumentation for measuring conductivity, temperature, flow rates, and time are validated<br>• CIP instrumentation (sensors), equipment for reading time, temperature, chemical concentration (conductivity), and flow rate shall be taken at the end of the CIP circuit and not at the beginning of the circuit<br>• No dead ends<br>• Data Logging of all CIP functions<br>• Prevention of accidental mixing, where routing valves are used the CIP control system must have the feedback mechanisms to ensure the valves are in the correct position at all times<br>• Prevention of potential product contamination by cleaning chemicals, all routing valves must be mix proof or there must be a physical break between product and CIP circuits such as a swing bend on a flow plate<br>• Flow plates or flow bends are used to route the cleaning fluids, proximity switches must be fitted that feed back to the CIP control system to ensure that bends are in the correct position before CIP begins.<br>Review MO-010 Minimum Requirements for CIP/Cleaning.<br>Review site procedures associated with Pasteurisers, lines and vats to ensure chemicals and parameters are still relevant.<br>Review test results (concentration, temperature, flowrate, time) are in spec and signed by authorised person with corrective actions noted for any out of spec results.<br>Hard piping, product, and CIP piping shall not transition from a smaller diameter pipe to a larger diameter pipe. If the site is unable to design the process in this manner, then a booster pump shall be installed at the transition point to provide adequate flow.<br>Pipe work must be identified as raw or heat-treated product.<br>The flow rate used in the CIP cycle must be based on the largest pipe diameter in the system.<br>The CIP cycle must be verified as complete and residue free before food processing recommences.

  Yes

  No

  N/A

Effectiveness of CIP Process CFMSR 26.15.1- 26.17.1 CIP Systems; BRC 4.11.7.3 CFMSR 26.18 CIP Documents; Export Control Orders S4 C8.1 and 9.1; CFMSR 26.19 CIP Training WSEP 16.27

• The effectiveness of CIP Systems shall be validated annually (See National Validation Template MO-010-A) or following alteration or addition to the CIP equipment. A log of changes shall be maintained.<br>CIP connections for filler heads are inspected to ensure they are properly installed and seated to ensure the effectiveness of the CIP process on the filler heads.<br>A schematic of the CIP System shall be available.<br>The cleaning parameters – time detergent concentration, flowrate and temperature shall be validated and records maintained .<br>CIP verification process shall be undertaken by analysis of rinse waters and/or first product through the line for the presence of cleaning fluids or by ATP test - allergens or micro-organisms as appropriate.<br>A log is to be maintained for CIP tank emptying, cleaning and filling. <br>Recovered post rinses shall be monitored for a build-up of carry-over from the detergent tanks.<br>Filters shall be cleaned and inspected at a defined frequency.<br>Procedures must be in place for the monitoring of chemical concentration (conductivity), time, flow rate, and temperature.<br>All records must be readily available.<br>Documented test results must be available to demonstrate that chemicals have been effectively flushed from pipes and tanks.<br>The CIP system is operated by trained personnel. Training is updated and recorded when modifications are made.<br>Traditional microbiological and allergen swabs must be used as part of the validation of cleaning methods and verification of effectiveness.<br>A swab schedule must be developed and defined by risk and historical data.<br>A suitable neutralizer for the disinfectant/sanitiser must be used on each swab.<br>Corrective action must be applied and documented for any out of specification result and followed up by a retest.

  Yes

  No

  N/A

CIP Maintenance and Calibration CFMSR 26.20 CIP Maintenance; CFMSR 26.21 CIP Calibration

• Spray balls, valves, gaskets, etc. are removed and inspected as per manufacturer’s recommendations and results recorded.<br>Spray balls are cleaned at a set frequency and when required.<br>A gasket inspection program shall be in place for hard piping or where gaskets aren’t broken down on a regular basis.<br>Calibration of CIP instrumentation is carried out at least annually or more frequently if defined by risk assessment and / or the manufacturer. Calibration of CIP systems shall include equipment used to measure:<br>• Time<br>• Temperature<br>• Chemical concentration / conductivity<br>• Flow rate.<br>

  Yes

  No

  N/A

COP Tanks CFMSR 26.23 COP Tanks; CFMSR 26.24 COP Systems; WSEP 16.11 – 16.13;

• Where Clean Out of Place (COP) tanks are required to clean removable parts, these shall be designed for this purpose. Buckets and plastic tubs shall not be used.<br>A stainless steel COP tank with a heated recirculation unit is normally used

  Yes

  No

  N/A

• Cleaning procedures for COP systems must contain the following:<br>• Protective clothing required e.g. cleaning suits, boots, gloves, safety glasses / face shields, etc.<br>• Details of equipment to be cleaned in a COP Tank<br>• Required cleaning equipment (identified and captive to area) and chemicals (including dilution, contact time, and temperature)<br>• Cleaning methods<br>• Minimum contact time for equipment in COP tanks<br>• How to re‐assemble equipment and change parts if necessary<br>• Draining and storage of parts (air dried or in sanitising solution) after COP<br>• The replacement of damaged O‐rings / gaskets where fitted.<br>(Cleaning procedures include photographs showing key inspection points and methods to ensure parts are properly submerged in the COP tank and U‐bends do not trap air (allowing all surfaces to come into contact with COP solutions).<br>Separate cleaning equipment is to be used for food contact and non food contact.<br><br>There shall be a procedure for monitoring and recording the temperature and concentration of solutions used in COP tanks.<br>Where parts are stored in COP tanks and removed for use throughout the shift, the concentration of the COP tank must be monitored throughout the shift.<br>

  Yes

  No

  N/A

Chemical Control CFMSR 27.1 Chemical Control; BRC 4.9.1.1; WSEP 16.17 – 16.18; CFMSR 27.2 Chemical List; CFMSR V2 26.6 Cleaning Chemicals; BRC 4.11.3; CFMSR 27.2 Chemical List; BRC 4.9.1.1; CFMSR 27.3 Chemical Control; CFMSR 27.4 Storage; CFMSR 27.5 - 27.5.2 Training; CFMSR 27.6 Chemical Waste

• The site shall have procedures in place to control:<br>• All food and non‐food grade chemicals used (e.g. food grade and non‐food grade lubricants, pest control, etc.)<br>• The bunded storage of chemicals to contain spillages<br>• A chemical usage matrix available in all areas where chemicals are stored and mixed<br>• Chemicals used onsite are food grade and suitable to be used in a food manufacturing site and for food contact areas<br>• Cleaning and sanitation chemicals must be validated on site for the use in which employed.<br>• That chemicals purchased are not strongly scented (e.g. orange oil based cleaners, phenolic compounds).<br>Cleaning chemicals must be kept in a ventilated, designated storage area with restricted access. Chemicals must be separated in storage to prevent accidents e.g. acids / chlorine based chemicals. Clear signage must be in place.<br>All chemicals shall be controlled and stored in an area secured with a lock, and with limited access to prevent contamination. This includes non‐food grade chemicals used in maintenance, production, storage, laboratory, and employee areas.<br>All secondary chemical containers shall be properly labelled.<br>Chemical containers must not be reused for other purposes.<br>Empty chemical containers shall be stored separate from raw materials, packaging and finished product.<br>Containers of chemicals must be labelled/identified at all times.<br>Personnel using chemicals must be trained. <br>Dilution rates, contact times, temperatures and storage conditions must be recorded for each cleaning chemical used.<br>Sanitisers and disinfectants must be rotated periodically if this is part of the validation requirements.<br>Records must be maintained. All chemicals, lubricants, and pest control chemicals shall be approved by the HACCP / Food Safety Team prior to use.<br>The site shall maintain a complete and current list of all food and non‐food grade chemicals.<br>Safety data sheets must be less than 5 years old, available for all chemicals used on the site and easily accessible by hygiene and First Aid staff.<br>The site must be able to demonstrate how chemicals were selected.

  Yes

  No

  N/A

• The site must have a documented chemical usage matrix indicating where chemicals can be used, e.g. Food contact surfaces, non‐food contact surfaces, maintenance shops, suitability to be used in food manufacturing sites, etc.<br>The chemical matrix must be available to staff and displayed in chemical storage and mixing areas.<br>The site shall have a usage log showing:<br>• Chemical used and where<br>• Quantity used<br>• Date used<br>• Batch (lot code) of chemical used.<br>Chemical waste must be controlled to prevent risk of spillage and contamination.

  Yes

  No

  N/A

• Access to chemicals shall only be given to staff that have been properly trained and require the chemicals to perform their jobs.<br>Chemicals shall only be issued in quantities sufficient to perform the task. Personnel performing cleaning shall be trained in the processes for dismantling of equipment for effective cleaning, inspection, and the proper re‐assembly of equipment after cleaning.<br>The effectiveness of training and competence in dismantling, cleaning, inspection, and re‐assembly of equipment shall be assessed.<br>Personnel performing tasks involving chemicals shall be given specific training on chemical handling and use.<br>All personnel shall be given general training on chemical control.

  Yes

  No

  N/A

• Signature

  Sign