Equipment Design and Storage WSEP 12.1 Equipment design; CFMSR V2 21.1 Equipment and Facilities ; WSEP 12.1.2; Equipment Approval; WSEP 12.2 Equipment Storage
All equipment used to process, pack, or cool product must be:
• Suitable for the use in which it is employed.
• Designed and accessible to facilitate effective cleaning.
• Maintained and frequently assessed to ensure it is in good condition.
• Part of a planned preventative maintenance plan.
• Specified before purchase, commissioned after delivery and validated before commercial use ( whether new or reconditioned).
• Subjected to a documented approval system by suitably qualified members of the sites HACCP team;
Maintenance shall include documented methods for quick strip down of equipment for detailed cleaning, e.g. with quick release belts, etc.
Ease of access. All walkways or steps over production equipment shall have back plates and enclosed sides to prevent contamination of items adjacent or underneath.
The maintenance requirements must be defined when commissioning new equipment.
Pipes and tanks shall be inspected to ensure there are no dead spots, any changes in the pipe flow must be reassessed for the presence of dead spots.
New equipment shall not be taken into the area until the cleaning method can be validated and the risk assessment completed
A system must be in place to prioritise repairs that may impact food safety, legality, and quality. All repairs must be completed in agreed timeframes.
The conveyor shall be designed such that full access is available for cleaning and that there are no areas where access is restricted.
Equipment must be stored in a clean and safe manner.
Equipment which is out of use or unsuitable for use must be tagged or labelled as such.
Equipment must be stored in a clean condition and placed where it is protected from contamination and pests.
Equipment must be cleaned and disinfected upon recommissioning.
Food containers must not be used to store chemicals, equipment, parts or tools.
Equipment in food processing areas must be stored off the floor on clean racking, shelving, or shadow boards.
If shadow boards are used, the equipment must be stored as high as practicable from the floor.
Preventative Maintenance Program, Servicing and Maintenance Scheduling CFMSR 21.2,21.3 Preventative Maintenance and Records; WSEP 12.3 Maintenance Scheduling; BRC 4.7.1; Export Control Orders S4 C3.4, S4 C4.2; WSEP 12.4. Equipment Practices; CFMSR V2 21.6, 21.7 Maintenance; BRC 4.7.4 Maintenance; WSEP 12.4.2 Post Maintenance Activities; WSEP 12.4.3 Cleaning; CFMSR V2 21.13.1 Permit to Work (MEDIUM AREAS); CFMSR V2 21.14 Line Clearance
A planned Preventative Maintenance (PM) program must cover all equipment critical to safety, legality, and quality.
A log of all equipment must be developed and maintained. Multiple pieces of the same equipment on site, must be individually identified.
The maintenance schedule must include equipment condition inspection as well as physical maintenance requirements.
A system must be in place to record all maintenance work requested and PMs conducted. Records must be signed on completion of the work by maintenance and production / storage personnel. Work must be completed in the agreed time frames.
Procedures must be in place to manage work not completed within agreed timeframes.
An effective maintenance process must be documented and implemented to ensure:
Tools, equipment and materials used or byproducts of maintenance are identified and removed prior to recommencement of manufacture.
A physical count /reconciliation of all tools equipment and materials used is undertaken and all items are accounted for prior to recommencement of manufacture.
MEDIUM AREA - A permit to work system must be in operation if the maintenance work required poses a potential risk to product (e.g. welding, cutting, etc.) or entry of individuals (e.g. into confined spaces such as tanks or machines)
Repairs to or servicing of equipment must be completed by trained maintenance personnel, approved contractors, or the equipment manufacturer.
Risk assessments must be completed prior to work commencing to ensure raw materials, packaging, and product is not put at risk. Work shall be approved by the Food Safety or Quality Team prior to work commencing.
Maintenance work shall be followed by a documented hygiene clearance procedure, which records that product contamination hazards have been removed from machinery and equipment (including temporary repairs).
A system must be in place to assess cleaning requirements prior to use in production or storage areas.
This must be undertaken before work in the area commences.
Equipment must be inspected and signed back to production or area personnel / QA / Cleaning Team at the conclusion of work (depending on site procedures) by the maintenance staff following work and any necessary cleaning defined.
Where no QA team are available on shift, a senior person independent of the task (e.g. night shift supervisor) shall inspect the equipment.
If maintenance work is carried between shifts, there must be a system in place to ensure a full clean and inspection is still carried out.
Suitable operations representative must accept the clean and maintained equipment back from the engineering work and be satisfied it is fit for use in the manufacture of food.
This process is irrespective of whether the maintenance is planned or emergency in nature and must be documented.
A handover to and approval by Q.A. representatives is conducted as per procedure.
Review Procedure MO-019 Handover and Handback of Production Plants and ensure Maintenance is keeping a completed record of each Handover / Handback (MO-019-A).
Foreign Body Risks CFMSR V2 21.4; WSEP 12.1.1; BRC 4.7.2
A system must be in place to identify and correct potential sources of foreign bodies or hygiene hazards e.g. flaking paint, damaged surfaces, cracked welds, worn gaskets, etc.
Plastic items must be suitable for food contact use, marked as food contact suitable or documentation must be available to demonstrate suitability.
Parts susceptible to normal wear during use e.g. scrapers, conveyors etc. must be inspected frequently and replaced before signs of wear become evident or a foreign object risk. Details of the equipment and the results of the inspection must be recorded and appropriate action taken.
Maintenance Area Practices CFMSR V2 21.7; WSEP 12.5; BRC 4.7.7; WSEP 12.7; CFMSR V2 21.16 Clothing ; CFMSR V2 21.17 Cloths and Rags
Maintenance areas must have restricted access to unauthorised personnel.
No food or drink with the exception of water in an approved container shall be stored or consumed within the maintenance area.
Coats, hair coverings, gloves, and shoes worn by maintenance personnel must be distinguishable from normal site protective clothing (ideally a different colour). Maintenance garments shall be changed when entering production areas.
Where personnel move from one area to another, attention shall be given to changing clothing and protective clothing between one line and another or one activity to another (e.g. unpasteurised to pasteurised, allergen line to non‐allergen line).
These garments are laundered separately to site protective clothing.
Maintenance cloths and rags must be in a contrasting colour to the ingredients and finished product(s), and other production cloths (such as cleaning cloths), and must be laundered separately.
Rags must not contain any foreign body hazards such as loose threads, buttons, etc. and must not be from recycled clothing are not permitted.
Food containers must not be used to store chemicals, equipment, parts or tools.
Maintenance workshops and engineering stores must be controlled, clean and pest proofed.
Maintenance debris, waste and surplus parts must be controlled to prevent risk to product; this may include the use of swarf mats on exit of maintenance.
Hot Work CFMSR V2 21.8 Hot Work
Welding, drilling, riveting, and soldering, etc. must not take place on equipment being used for production or on any equipment immediately adjacent, unless suitable hygienic screening is in place.
The Food Safety or Quality Team shall assess the work required and approve the foreign body controls to be put in place prior to the commencement of work by maintenance personnel.
Swarf mats are to be located at lathes and drill presses.
Temporary Repairs CFMSR V2 21.9; BRC 4.7.3;
Temporary repairs must be controlled and inspected daily to ensure product is not put at risk.
Timeframes for permanent repair shall be documented in the work order system.
The material used must be suitable e.g. no sticky tape, cardboard.
Temporary repairs shall be approved by the Food Safety or Quality Teams, and added to a schedule with a timeframe agreed of when a permanent fix is to be completed.
Add location and type of temporary repair to the site GMP review and assess during GMP inspections until a permanent fix has been completed.
Best Practice: Temporary repairs shall be marked with the date they were installed and the name of the person approving.
Temporary repairs can be registered as a PMO1 in SAP system and reviewed daily as a task from Maintenance scheduler.
Tools and Trolleys CFMSR V2 21.16 Clothing; CFMSR V2 21.17 Cloths and Rags; CFMSR V2 21.10.2, 21.10.3; Tools and Parts in High Risk Area BRC 4.7.5; CFMSR V2 21.12, 21.12.1, 21.12.2 Tools and Parts; WSEP 12.6 Tools and Parts CFMSR V2 21.11, 21.11.1, 21.11.2 Toolboxes and Carriers;
Tools and trolleys must be kept clean and replaced when necessary.
Toolboxes must only be placed on a tool bench or trolley.
Tools and trolleys must be adequately cleaned prior to transferring into open product and packaging areas.
Where tools and trolleys are used within an area, attention shall be given to cleaning of tools between one line and another or one activity to another
they are used (e.g. unpasteurised to pasteurised, allergen line to non-allergen line, etc.
Best Practice: Tools and trolleys are colour coded for the area in which they are used.
HIGH RISK AREAS ONLY: Tools must be captive to High-care or high-risk areas and cleaned as required. If tools are introduced to the area, tools must be sanitised upon entry into the area.
Where tools are used within an area, attention shall be given to cleaning of tools between one line and another or one activity to another (e.g. allergen line to non allergen line)
In the event of electrical tools being required to complete repairs, these must be clean and sanitised prior to entry to the High area.
All tools and parts must be controlled. A system must highlight and initiate an investigation if a tool or part is missing.
A system must be in place to identify and carry adequate stocks of critical equipment parts.
Whilst maintenance work is conducted on production equipment, small parts must be stored in sealed marked containers, magnetic mats, or trays to reduce the risk of product contamination.
Maintenance staff and contractor’s tools and tool boxes must be clean and controlled to prevent contamination of production.
Tools must not present a risk to product and must be in good condition. Wooden tools must not be used.
The use of tools must be restricted to maintenance or other identified staff.
Suitable protective clothing and hand washing facilities must be provided for maintenance staff.
Maintenance personnel and contractors completing repairs in production and storage areas must have a lockable metal or plastic tool box.
No cloth or leather tool carriers or belts shall be used.
Toolboxes must contain an inventory of items they contain.
Toolboxes must be cleaned at a defined frequency or more often as needed based on the risk of contamination.
Tool box contents must be checked at a defined frequency against the inventory.
All small items must be separately contained within the tool box.
Maintenance Contractors CFMSR V2 21.13 Maintenance Contractors WSEP 12.4 Maintenance Practices CFMSR V2 21.14.1 Line Clearance (HIGH AREAS)
Maintenance personnel and maintenance contractors must not present a risk of contamination and must comply with necessary health and safety requirements and operational GMP of the site, including wearing of protective clothing.
A list of approved contractors who have been briefed on site controls must be in place.
All work carried out by contractors in production and storage areas shall be inspected and approved by the Food Safety or Quality Team prior to commencing work.
Contractors and inhouse maintenance teams must adhere to company hygiene, clothing and staff movement procedures.
Maintenance contractors must be supervised or their actions otherwise controlled.
The use of temporary screening structures must be used during building works and/or where appropriate during equipment maintenance to prevent product contamination.
Temporary (tape) engineering repairs must be minimised.
These must not affect product safety, quality or legality and the use of temporary fixes must be promptly documented and rectified with permanent solutions as soon as possible and within a defined time.
If the site is in total shutdown for an extended period (e.g. Annual maintenance, replacement of floors etc.), then High area clothing protocols may not be required during the maintenance provided no production is taking place and no packaging or materials remain in the area.
A total cleaning, sanitising, inspection and line clearance activity must be undertaken to return the area to High status prior to recommencing production.
Maintenance Chemicals WSEP 12.4.1 Maintenance Chemicals; BRC 4.7.6
Chemicals used in maintenance processes must be identified, stored in a secure area and must not present a risk to product.
Machinery lubricants must be suitable for use on food equipment and assessed for any allergenic components.
Used lubricant must be disposed of as per local regulations.
Lubricants must not contain known allergens.
A copy of the SDS for lubricants must be available.
All food and non‐food lubricants are clearly labelled, are stored separately and secured with lock.
Lubricating equipment (e.g. grease guns) must be segregated, dedicated, labelled / visually distinctive as food grade or non‐food grade lubricant.
Non‐food grease guns shall be securely stored separately from food grade grease guns.