阿尔迪ALDI质量验厂审核清单(英文版)

编辑:上海励奥 来源:ALDI验厂 日期: 2020-8-5 11:07:30

1、Management Systems ALDI质量验厂审核清单 -管理制度

1.1.1 "Food Safety and Quality Policy displayed and communicated.
Certifications/accreditations held by the site are current."

1.1.2 The company's management team shall review the company’s quality management and food safety systems at least annually to ensure its continuing suitability, adequacy and effectiveness. This review shall include an assessment of opportunities for improvement and the need for changes to the quality management system (QMS). Inputs and outputs shall be documented.

1.1.3 Adequate resources are provided for the Quality/Technical functions. Job descriptions are maintained that identify responsibilities for key employees and deputies that are designated to cover for the absence of key personnel. A current organisation chart is maintained.

1.1.4 All procedures and work instructions shall be clearly legible, unambiguous, in appropriate languages and sufficiently detailed to enable their correct application by appropriate staff.

1.1.5 The company shall maintain records to demonstrate effective control of the QMS.

1.2.1 The company shall have a system of Internal Audits. Audits shall be scheduled so that all systems and procedures relating to the QMS, HACCP and Aldi specific requirements such as those detailed in the Aldi Quality Policies are audited at least annually. The internal audit programme shall be fully implemented, conducted by trained personnel and aim to drive continuous improvement.

1.2.2 In addition to the internal audit programme there shall be a programme of documented inspections to ensure that the factory environment and processing equipment is maintained in a suitable condition for food production.

1.3.1 The company shall undertake a documented risk assessment of each raw material or group of raw materials to identify potential risks to product safety, legality and quality at a defined frequency.

1.3.2 The company shall have a documented supplier approval and ongoing monitoring procedure to ensure that suppliers are effectively managing the risks to raw material quality and safety and are operating effective traceability processes. This includes haulage, handling and storage of finished product.

1.3.3 Where raw materials are purchased from agents or brokers, procedures shall be defined, traceability must be maintained, and details of the last manufacturer or packer or consolidator must be held.

1.3.4 A documented vulnerability assessment shall be carried out on all raw materials or groups of raw materials to assess the potential risk of adulteration or substitution.

1.3.5 Where raw materials have been identified as at risk, assurance and or testing processes shall be in place to reduce the risk.

1.3.6 The company shall have a documented procedure for the acceptance of raw materials and packaging on receipt based upon the risk assessment and good manufacturing practices.

1.3.7 Records shall be maintained of all acceptances and rejections of raw materials.

1.3.8 There shall be a documented procedure for the approval and monitoring of suppliers of services.

1.3.9 Aldi must be informed of any outsourced activities. Approval of sub-contractors is either by on-site audit or third-party certification to a GFSI recognised scheme. Inspection and test procedures for outsourced products shall include visual, chemical and/or microbiological testing according to risk assessment.

1.4.1 Agreed specifications / certificates of conformity should be available for all raw materials, processing aids and food contact packaging. Specifications shall be subject to review at any change and at least every two years.

1.4.2 Processes employed, recipes used and quality criteria shall reflect that as detailed in the Aldi specification. Confirm Espec status e.g. Active, collaborative draft supplier etc. for each product.

1.4.3 Aldi specifications shall be up to date, any changes e.g. to product, ingredients, origin, suppliers, allergen status, manufacturing or packing site, packaging or process shall be notified to Aldi immediately.

1.5.1 A documented procedure shall be in place to investigate, identify root cause, correct and prevent the cause of non-conformity as well as procedures for managing non-conforming product.

1.6.1 The company shall have a system in place to trace production lots from raw materials to finished products, including re-work and processing aids.

1.6.2 The system shall be tested forwards and backwards at least annually and records kept of the results, including timings for key activities and any corrective actions resulting from the test.

1.6.3 The company shall ensure the suppliers of raw materials have effective traceability systems in place, this should be by audit or by evidence of a documented test provided by the supplier.

1.7.1 The company shall have a system in place to investigate and record customer complaints. Complaint data shall be analysed and used to implement on-going improvements and prevent re-occurrence.

1.8.1 The company must have a documented crisis and incident management plan. All emergency contact information provided on the product eSpec must be current and correct. A process must be in place to test the effectiveness of the plan at least annually .

1.8.2 The company shall have a documented product withdrawal and recall procedure (RFS/EPW/PPR). The procedure shall be capable of being operated at any time. A review of the effectiveness of the recall procedure must be undertaken in the event of any product withdrawal.

1.9.1 The scope of the HACCP plan shall clearly include manufacture of all products supplied to Aldi. For each Aldi product produced there shall be a documented description, which shall include all factors that affect product safety and legality.

1.9.2 "A HACCP Programme, based on Codex Alimentarius, must be written and implemented.
The HACCP Programme includes the 12 tasks as defined by FAO:
· Establish a HACCP Team
· Describe the Product
· Identify the product's intended use
· Draw up the commodity flow diagram
· Onsite confirmation of the flow diagram
· Identify and analyse hazards
· Determine the critical control points
· Establish critical limits for each CCP
· Validate critical limits at CCPs which define acceptable and unacceptable levels for the prevention, elimination or reduction of identified hazards
· Establish a monitoring procedure
· Establish corrective action for identified deviation
· Verify the HACCP Plan
· Keep records
· Review the effectiveness of the plan on a defined frequency."

1.9.3 Control measures and monitoring procedures for prerequisite programmes must be clearly documented and form part of the development and review of the HACCP programme.

 

2、Site Standards ALDI质量验厂 - 现场标准

2.1.1 External areas should be maintained in good order and be included in the internal audit process (yards, roads and planted areas).

2.2.1 The company shall undertake a documented Food Defence assessment of the security arrangements and potential risks to the products from any deliberate attempt to inflict contamination or damage. This must include all stages of distribution up to stock being accepted into Aldi Regions.

2.2.2 Security shall be maintained to prevent access of unauthorised persons into production and storage areas. Contractors and visitors, including drivers, shall be made aware of all procedures for access to premises and the requirements of the areas they are visiting.

2.3.1 There shall be a plan of the site which identifies areas where product is at different levels of risk from contamination.

2.3.2 "Effective segregation measures are in place to eliminate cross-contamination.
Finished products are effectively segregated from unprocessed raw materials.
High and low risk operations are effectively segregated, transfer points between high and low risk areas do not compromise integrity of the segregation.
There is a disinfection regime in between high and low risk areas"

2.4.1 Building fabric shall be suitably constructed and maintained (walls, floors, drains, ceilings, windows and doors) to provide safe and hygienic conditions. Surfaces should be impervious and easily cleaned. The risk of pest harbourage must be considered.

2.4.2 There is no excessive rust, loosening material, exposed insulation, mould, or old dirt in the facility that could lead to food safety or quality issues.

2.4.3 Drainage, where provided, shall be sited, designed and maintained to minimise risk of product contamination and not compromise product safety.

2.4.4 Where sites include high-care or high-risk facilities, there shall be a plan of the drains for these areas which shows the direction of flow and location of any equipment fitted to prevent the back up of waste water.

2.4.5 Windows and doors should be well maintained close fitting and screened / proofed against pest ingress (external pipe-work and cable ducts sealed).

2.4.6 Sufficient and suitable lighting shall be provided. Where they pose a risk to product bulbs and strip lights including EFK’s should be protected against breakage.

2.4.7 Adequate ventilation and extraction shall be provided. Where appropriate positive air pressure systems shall be in place.

2.4.8 High-risk areas shall be supplied with sufficient changes of filtered air. The filter specification used and frequency of air changes shall be documented.

2.5.1 Documented procedures to maintain product safety and quality during storage including temperature control shall be developed, understood by relevant staff and implemented accordingly.

2.5.2 Where appropriate, packaging shall be stored away from raw materials and finished product. Storage areas should be kept clean and pest free.

2.5.3 Where storage outside is necessary, items shall be protected from contamination and deterioration. Items shall be checked for suitability before being brought inside.

2.5.4 Receipt documents and/or product identification shall facilitate correct stock rotation of raw materials, intermediate products and finished products in storage.

2.6.1 Equipment shall be suitably designed, safe to use and maintained to minimise the risk of product contamination and to facilitate effective cleaning.

2.6.2 Equipment which is in direct contact with food shall be suitable for food contact and meet legal requirements where applicable.

2.7.1 "A documented system of planned and corrective maintenance shall be in place. Work must be prioritised and completed in the agreed timescales.
Procedures must be in place to manage work not completed within agreed timescales."

2.7.2 Where temporary repairs are made, these shall be controlled to ensure the safety or legality of product is not jeopardised.

2.7.3 Tools and small parts should be of the appropriate grade and quality and managed to prevent contamination risks.

2.7.4 Maintenance activities shall respect the segregation requirements for high risk and high care areas, and wherever possible use dedicated equipment in those areas.

2.7.5 Materials used for equipment and plant maintenance and that pose a risk by direct or indirect contact with raw materials, intermediate and finished products must be suitable for use in a food processing environment.

2.7.6 Engineering workshops shall be kept clean and tidy. Controls shall be in place to prevent contamination risks to the storage or production areas.

2.7.7 Engineering activities must be controlled. For example welding, drilling, riveting and soldering must not take place on equipment while it is being used for production or on any equipment immediately adjacent, unless suitable hygienic screening is in place. A documented handover procedure must be in place to manage the return of equipment after maintenance work has been completed.

2.8.1 All water used as a raw material in the manufacture of processed food, the preparation of product, or for equipment or plant cleaning shall be supplied in sufficient quantity, be potable at point of use or pose no risk of contamination.

2.8.2 An up-to-date plan shall be available of the water distribution system on site, including holding tanks, water treatment and water recycling as appropriate.

2.8.3 Where legislation specifically permits the use of water which may not be potable for initial product cleaning the water shall meet the designated legal requirement for this operation.

2.8.4 Air, other gases and steam used directly in contact with or as an ingredient in products shall be monitored to ensure this does not represent a contamination risk.

2.9.1 Key equipment, including reference equipment and those used to monitor site specified quality parameters and CCP's shall be identified on a register and calibrated to a recognised standard.

2.9.2 Procedures shall be in place to record actions to be taken when the prescribed measuring and monitoring devices are found not to be operating within specified limits.

2.10.1 A system must be in place to ensure full control of all foreign bodies.

2.10.2 There shall be a documented policy for sharps (e.g. blades, wires, scissors, and needles) including issue / return, integrity checking and breakage procedures.

2.10.3 Glass or other brittle materials shall be excluded or protected against breakage in areas where open products are handled or there is a risk of product contamination.

2.10.4 Brittle material (including plastic) shall be detailed on a register and audited on a risk-assessed frequency.

2.10.5 Glass/other brittle materials breakage procedures shall be documented and hygiene clearance procedure in place for fabric breakages and on-line (container, bottle, jar) breakages.

2.10.6 "Systems in place to manage container breakages must include, as a minimum, effective documented instructions and records which ensure:
· The line stops, there is removal and disposal of at-risk products.
· The effective cleaning of the line or equipment where the breakage occurred.
· The use of dedicated cleaning equipment and dedicated lidded waste containers.
· A documented inspection and authorisation of production equipment prior to restart.
· The area around the line is kept clear of broken glass.
Where no breakages have occurred during a production period, a positive documented verification must be provided. "

2.10.7 Product contact liners (or raw material/work-in-progress contact liners) purchased by the company shall be appropriately coloured, resistant to tearing to prevent accidental contamination and suitable for contact with food.

2.10.8 Wood must not be used in open product areas except where this is a process requirement (e.g. maturation of products in wood).

2.11.1 A documented assessment in association with the HACCP study shall be carried out on each production process to identify the potential use of equipment to detect or remove foreign body contamination.

2.11.2 The type, location and sensitivity of the detection and/or removal method shall be specified as part of the company’s documented system.

2.11.3 Where foreign material is detected or removed by the equipment, the source of any unexpected material shall be investigated.

2.11.4 Filters and sieves used for foreign body control shall be of a specified mesh size or gauge and designed to provide the maximum practical protection for the product. If the company use multiple mesh or gauge sizes that change dependent on material or product type this must be clearly understood and verified at each change.

2.11.5 Filters and sieves shall be regularly inspected or tested for damage on a documented frequency based on risk. Records shall be maintained of the checks.

2.11.6 Metal detection equipment shall be in place unless risk assessment demonstrates that this does not improve the protection of final products from metal contamination.

2.11.7 The company shall formalise the procedure for the testing of the foreign-body detector and establish corrective action and reporting procedures in the event of failure being identified during a test.

2.11.8 "Metal detector checking procedures shall be based on best practice:
· Pre-start up check.
· Routine tests carried out using separate test pieces containing ferrous metal, stainless steel and typically non-ferrous metal, unless the product is within a foil container.
· Routine tests to ensure that both the detection and rejection mechanisms are working effectively.
· Checks that test the memory/reset function of the metal detector by passing successive test packs through the unit.
· Metal detectors must be tested with the test piece placed in the least sensitive portion of the product flow.
· Any failsafe systems fitted to the unit must be tested at a predetermined frequency, such as start up."

2.11.9 The company shall establish and implement corrective action and reporting procedures in the event of the testing procedure identifying any failure of the foreign body detector.

2.11.10 The type, location and the strength of magnets shall be fully documented, where used. Documented procedures shall be in place for the inspection, cleaning, strength testing and integrity checks. Records of all checks shall be maintained.

2.11.11 Each optical sorting device shall be checked in accordance with the manufacturer’s instructions or recommendations. Checks shall be documented.

2.11.12 Based on risk assessment, procedures shall be implemented to minimise foreign body contamination originating with the packaging container prior to filling.

2.11.13 The effectiveness of any container cleaning equipment shall be, specified, checked and verified during each production run. The specified limits for this equipment should be validated at least annually, this may be via challenge testing.

2.12.1 A chemical control procedure shall be in place which manages the storage and handling of all non-food chemicals (cleaning, engineering, laboratory etc.)

2.13.1 Documented appropriate cleaning procedures shall be in place and maintained for the building, plant and all equipment.

2.13.2 Limits of acceptable and unacceptable cleaning performance shall be defined, based on the potential hazards (e.g. microbiological, allergen or foreign body contamination).

2.13.3 Where it is necessary to dismantle equipment for cleaning purposes or to enter large equipment for cleaning, this shall be appropriately scheduled and, if possible, planned for non-production periods.

2.13.4 The cleanliness of equipment shall be checked before equipment is released back into full production.

2.13.5 Cleaning equipment shall be: Fit for purpose, colour coded or labelled, cleaned, maintained and stored in a hygienic manner to prevent contamination.

2.13.6 Cleaning-in-place (CIP) facilities, where used, shall be monitored, operated and maintained to ensure their effective operation. A schematic plan of the layout of the CIP system shall be available.

2.13.7 There must be an inspection report or other verification that the CIP system is properly maintained and functioning to allow efficient and effective cleaning of product contact surfaces.

2.14.1 Surplus Aldi brand products shall be disposed of in an appropriate manner, and all Aldi brand names and identifying material removed.

2.14.2 External waste containers shall be clearly identified, clean, well maintained, emptied with due frequency, kept closed as appropriate. Surrounding areas must be kept clean and tidy.

2.15.1 A preventative pest control program shall be implemented across the site. (In-house or external contractor).

2.15.2 Any pest infestations must be managed to ensure there is no risk to Aldi products, raw materials or packaging.

2.15.3 The site must be able to demonstrate that pest control operations are undertaken by trained and competent staff.

2.15.4 Pest control documentation and records shall be maintained.

2.15.5 Bait stations shall be robust, tamper resistant and secured in place. Missing bait stations shall be recorded and investigated. Toxic baits shall not be used in open product areas, unless treating an active infestation.

2.15.6 The site must have adequate measures in place to exclude birds from entering or roosting around the buildings.

2.15.7 Fly killer devices and pheromone traps (where applicable) shall be appropriately located and maintained.

2.15.8 In the event of infestation, or evidence of pest activity, immediate action shall be taken to eliminate the hazard.

2.15.9 Pest control evidence maintained shall include current bait plans, records of pest control inspections, recommendations and corrective actions taken.

2.15.10 An in-depth, documented pest control survey shall be undertaken at a frequency based on risk, but as a minimum annually, by a pest control expert to review the pest control measures in place.

2.15.11 Results of pest control inspections shall be assessed and analysed for trends on a regular basis.

2.15.12 There shall be an internal pest sighting programme and employees shall understand the signs of pest activity and be aware of the need to report any signs of pest activity.

2.16.1 Documented procedures to maintain product safety and quality during loading and transportation shall be developed and implemented. All vehicles used for transportation must be well maintained and in good hygienic condition to ensure the product safety, legality and quality of materials is not compromised.

2.16.2 There shall be a clear record of dispatch and receipt of goods and materials demonstrating that sufficient checks have been completed to ensure that they are fit for purpose. Traceability shall be ensured during transportation. Records of traceability and inspections must be maintained.

2.16.3 Where temperature control is required, the transport shall be capable of maintaining product temperature within specification, under minimum and maximum load.

2.16.4 Maintenance systems and documented cleaning procedures shall be maintained for all vehicles and equipment used for loading/unloading (e.g. hoses connecting to silo installations). There shall be records of the measures taken.

2.16.5 Third party haulage companies shall be controlled and monitored (Service contracts formalised).

 

3、 Personnel Standards 阿尔迪ALDI质量验厂审核清单 - 人员标准

3.1.1 The company shall ensure that all staff (Including temporary and agency staff) are competent to carry out their activity through training, work experience or qualification. Training records for all staff should be maintained.

3.1.2 Where personnel are engaged in activities relating to critical control points, relevant training and competency assessments shall be in place.

3.1.3 "The requirements for personal hygiene shall be documented and communicated to all personnel. The requirements should include as a minimum:
· The facility dress code, including high care procedures.
· PPE and PPE storage requirements.
· Jewellery policy.
· Smoking policy.
· Medical screening.
· Illness and accident reporting policy.
· Management of gloves, plasters and personal medicines.
These procedures must be effectively implemented."

3.1.4 Hand cleaning shall be performed on entry to the production areas and at a frequency that is appropriate to minimise the risk of product contamination. Facilities must be provided for this purpose.

3.1.5 All cuts and grazes on exposed skin shall be covered by an appropriately coloured plaster that is different from the product colour (preferably blue) and containing a metal detectable strip that is verified to be rejected by metal detection equipment.

3.1.6 Protective clothing shall be available that is of suitable design, provided and stored in sufficient numbers to prevent contamination of the product. Outdoor clothing and other personal items shall be stored separately from work wear within the changing facilities.

3.1.7 Laundering of protective clothing shall take place by an approved contracted or in-house laundry using defined and verified criteria to validate the effectiveness of the laundering process. Protective clothing for high-care or high-risk areas is provided by a contracted laundry, this shall be audited either directly or by a third party, or should have a relevant certification.

3.1.8 Where an operation includes a high-care area and/or high-risk area, personnel shall enter via a specially designated changing facility with arrangements to ensure that protective clothing will not be contaminated before entry to the high-care and/or high-risk area.

3.2.1 Designated changing facilities shall be provided for all personnel, whether staff, temporary workers, visitor or contractor.

3.2.2 Staff facilities shall be sufficient for the number of personnel and maintained in a suitable condition (lockers, hand-washing, and toilets) and not pose a risk to the production, packing and storage areas.

3.2.3 Where smoking is allowed under national law, designated controlled smoking areas shall be provided which are both isolated from production areas and fitted with sufficient extraction to the exterior of the building.

3.2.4 All food brought into manufacturing premises by staff shall be appropriately stored in a clean and hygienic state. No food shall be taken into storage, processing or production areas.

3.2.5 Where catering facilities are provided on the premises, they shall be suitably controlled to prevent contamination of product.

 

4、 Product Standards 阿尔迪ALDI质量验厂 - 产品标准

4.1.1 "Product design and development procedures shall be documented and include:
· HACCP (including the introductions of new hazards)
· Line trials.
· Suitability of the packaging for the product type.
· Validation of any on pack guidelines.
· Shelf life validation.
This will ensure that the product is prepared safely and remains at the required quality and safety through the storage life and meets Aldi requirements. "
4.1.2 The company must provide sufficient information to Aldi to enable an Aldi brand label to be accurately created.

4.2.1 The company shall have processes in place to ensure they are fully versed in historical and developing threats to their supply chain which could pose a risk to adulteration or substitution of raw materials.

4.2.2 Where labelling or a claim is made relating to the provenance, assured or identity preserved status, breed, varietal, trademarked ingredients, the site shall verify each batch of the raw materials.

4.2.3 Where claims are made about methods of production e.g. hand cooked, organic, the site shall provide documentary evidence to enable the claims to be made.

4.3.1 The company shall undertake or sub-contract inspection and analysis which are critical to confirm product quality, safety and legality.

4.3.2 Where products require positive release, procedures shall be in place to ensure that release does not occur until all release criteria have been completed and release authorised.

4.3.3 Sampling plans (Organoleptic, microbiological & chemical) and testing schedules shall be formalised and records maintained to identify trends and implement corrective actions.

4.3.4 A system of on-going shelf life assessment shall be formalised. Finished product shall be retained until the end of its shelf life.

4.3.5 Where the company undertakes or subcontracts analyses which are critical to product safety or legality, the laboratory or subcontractors shall be accredited to ISO 17025. Pathogen testing shall be subcontracted or remote.

4.3.6 The test methods to be conducted for both product and environmental swabs must be clearly defined in the Service Level Agreement (SLA), confirming that the correct methods are employed and the appropriate swabs used to verify the effectiveness of the cleaning conducted e.g. where a residual sanitiser is present neutralising swabs must be used.

4.4.1 The company shall have systems in place to check packaging/labels etc. against approved artwork for each delivery received.

4.4.2 An effective system of documented checks shall be in place at line start-up, following product changeover and changes in batches/ rolls etc. of packaging and labels to ensure that the packaging/ labels applied are correct for the products being packed.

4.5.1 Documented process specifications and work instructions shall be available for the key processes in the production of products to ensure product safety, legality and quality.

4.5.2 Process monitoring (e.g. temperature, pressure, and chemical) shall be established, adequately controlled and recorded to ensure product is produced within specification.

4.5.3 In the case of equipment failure or deviation of the process from specification, procedures shall be in place to establish the safety status and quality of the product to determine the action to be taken. In-line monitoring devices shall be linked to suitable failure alert systems which are routinely tested.

4.6.1 The frequency and methodology of quantity checking shall meet the requirements of appropriate legislation governing quantity verification, and records of checks shall be maintained.

4.6.2 Where the quantity of the product is not governed by legislative requirements (e.g. bulk quantity), the product must conform to customer requirements and records shall be maintained.

4.7.1 "Documented procedures shall be established to ensure the effective management of allergenic materials to prevent cross-contamination into products not containing the allergen.
Procedures must address:
· Identification and segregation of allergens during storage and handling.
Prevention of cross contact or contamination during processing by using measures such as:
· Production run scheduling,
· Control of rework,
· Dedicated production lines,
· Comprehensive changeover procedures,
· Equipment and utensils management,
· Product label reviews and control,
· Personnel awareness training and education,
· Verification of cleaning procedures for food contact equipment,
· Approved Supplier Program for ingredients."

4.7.2 Where the nature of the production process is such that cross- contamination from an allergen cannot be prevented, a warning shall be included on the label. National guidelines or codes of practice shall be used when making such a warning statement.
Any allergen claims such as gluten free must be verified.

4.7.3 Equipment or area cleaning procedures shall be designed to remove or reduce to acceptable levels any potential cross-contamination by allergens. Validation of cleaning must be recorded.

 

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