Corporate Internal Audit

Title Page

Document No.
Audit Title
Client / Site
Conducted on
Prepared by
Location
Personnel

Section 1 ( BRC 1, WSEP 1-3, CFMSR 2,5) Senior Management Commitment

Section 1 ( BRC 1, WSEP 1-3, CFMSR 2,5) Senior Management Commitment The sites senior management shall demonstrate they are fully committed to the requirements of the Global standard for food safety and to processes which facilitates continual improvement of food safety and quality management

The site shall have a documented policy (QA-003) which states the sites intention to meet this obligation. * signed by the person with overall responsibility for the site * communicated to all staff (QA-003-T)
Signed copy of the national quality policy and site quality policy displayed
Evidence that all staff have read the policy
The site’s senior management shall define and maintain a clear plan for the development and continuing improvement of a food safety and quality culture. This shall include: • defined activities involving all sections of the site that have an impact on product safety • an action plan indicating how the activities will be undertaken and measured, and the intended timescales • a review of the effectiveness of completed activities.
The site shall have available current copies of registration and certification, * registration as a food business * certificate of product claims
The senior management shall ensure the clear objectives are defined to maintain and improve the safety, legality and quality of its products. These objectives include * targets or clear measures of success * communicated to relevant staff * monitor and report at least quarterly to site senior management
A certificate of currency evidencing product and Public Liability Insurance equivalent to 10 million dollars must be available as a controlled record
Management review meetings attended by sites senior management shall be undertaken at appropriate planned intervals (annual as a minimum). The review process shall include, * previous management review actions with planned timeframes * results of internal and third party audits * customer complaints and results * incidents, corrective actions, out of spec an non conforming products * resource requirements * HACCP plans * pest monitoring * withdrawals recalls * foreign object controls
The site shall have a demonstrable meeting schedule which enables food safety, legality and quality issues to be brought to the attention of senior managers (at least monthly) MS-002.
The company shall provide human and financial resource required to produce safe food. The site shall have a technically competent staff member who holds responsibility for the day to day management of the quality system
The company shall have a confidential reporting system to enable staff to report concerns relating to product safety, integrity, quality and legality. QA-030
The company's senior management shall have a system in place to ensure that the site is kept informed of, * scientific and technical developments * industry codes of practice * New risks to authenticity of raw materials * relevant legislation
The site shall ensure that root causes of non-conformances identified at the previous audit have been effectively addressed MO-029-A.
The company shall have an organisation chart demonstrating the management structure of the company. The responsibilities for the management activities which ensure food safety, legality and quality shall be clearly allocated an understood. The site shall also have a document with deputies in the absence of the responsible person.
The site shall ensure all staff are aware of their responsibilities. Where work instruction exist for activities the relevant staff shall have access.
The site must review the business continuity plan at least annually and more often if key resources and personal change.
Formal exemptions must be in place, current, managed and controlled

Section 2 (BRC 2, WSEP 2, CFMSR 2) HACCP - The Food Safety Plan

Section 2 (BRC 2, WSEP 2, CFMSR 2) The Food Safety Plan The company shall have a fully implemented and effective food safety plan based on Codex Alimentarius HACCP principles.

The HACCP food safety team - Step 1

The HACCP plan shall be developed and managed by a multi-disciplinary food safety team that includes those responsible for quality/technical, production, engineering and other relevant functions. Team leaders shall have an in-depth knowledge of HACCP and be able to demonstrate competence and experience.
The Scope of each HACCP plan shall be defined
The HACCP team leader shall have successfully completed formal HACCP training (no less than 16 hours duration). This shall be re-done every 3 years. HACCP team members shall undergo annual internal training.
The site shall establish and maintain environmental and operational programmes necessary to create an environment suitable to produce safe and legal food products (prerequisite programmes). As a guide these may include the following, although this is not an exhaustive list: • cleaning and sanitising • pest management • maintenance programmes for equipment and buildings • personal hygiene requirements • staff training • purchasing • transportation arrangements • processes to prevent cross-contamination • allergen controls. The control measures and monitoring procedures for the prerequisite programmes must be clearly documented and shall be included within the development and reviews of the HACCP or food safety plan. HA-006
The supplier shall undertake an assessment against the arrangements and configuration of the CFMSR to determine their base, medium and high areas of the facility
A facility map shall be written showing, * site boundary * site building and access points * vehicle and pedestrian traffic flows * the flow through the factory * the nominated areas of base, medium and high

Describe the Product - Step 2

A full description of each product or group of products shall be developed. This description should include, * composition * origin of ingredients * physical, chemical properties * treatment and processing * packaging technology * storage and distribution * target shelf life found in the product specification
All relevant information needed to conduct the hazard analysis shall be collected, maintained, documented and updated. HA-004 & HA-005 These I may include, * scientific literature * historical and know hazards * codes of practice * recognised guidelines * food safety legislation * customer requirements

Intended Use - Step 3

The indented use of the product must be stated defining, * consumer target groups * suitability to vulnerable groups

Construct a Process Flow Diagram - Step 4

A flow diagram shall be prepared to cover each product, product category or process. This shall set out all aspects of the food process operation within the HACCP or food safety plan scope, from raw material receipt through to processing, storage and distribution. As a guide, this should include the following, although this is not an exhaustive list: • plan of premises and equipment layout • raw materials, including introduction of utilities and other contact materials (e.g. water, packaging) • sequence and interaction of all process steps • outsourced processes and subcontracted work • potential for process delay • rework and recycling • low-risk/high-risk/high-care area segregation finished products, intermediate/semi-processed products, by-products and waste.
The flow diagram shall also identify where the physical barriers between high, medium and base exist in the process (Coles only)

Verify Flow Path - Step 5

The HACCP team shall verify the accuracy of the flow diagram by on-site audit and challenged at least yearly. Records of this review must be sighted (all plans)

Conduct a Hazard Analysis and list Controls - Step 6

The HACCP food safety team shall identify and record all the potential hazards that are reasonably expected to occur at each step in relation to product, process and facilities. This shall include hazards present in raw materials, those introduced during the process or surviving the process steps, and consideration of the following types of hazard: • microbiological • physical contamination • chemical and radiological contamination • fraud (e.g. substitution or deliberate/intentional adulteration) • malicious contamination of products • allergen risks (see clause 5.3).
The HACCP team shall conduct an hazard analysis to identify hazards which need to be prevented, eliminated or reduced to acceptable levels. HA-003
The HACCP team shall conduct an analysis to identify quality defects that need to be prevented, eliminated, or reduced The defect analysis must include * issues that could lead to product damage, defect or downgrade * likely occurrence an severity Coles only

Determine the Critical Control Points (CCP) - step 7

For each hazard that requires control, control points shall be reviewed to identify those that are critical. Decision trees must be used to determine if a hazard is a CP or CCP (these must be sighted)
The site must determine and document the methodology used to identify QCP's The decision tree must be used Coles only

Establish Critical Limits for each CCP - step 8

For each CCP, the appropriate critical limits shall be defined in order to identify clearly whether the process is in or out of control. Critical limits shall be, * measurable * supported by clear guidance
The HACCP team shall validate each CCP. Documented evidence shall show that the control measures selected and critical limits are capable of consistently controlling the hazard.
Quality limits for each QCP must be defined and validated to ensure that the product is compliant with specification Quality limits must be measurable and justification for their use must be documented. Coles only

Establish a Monitoring System of each CCP - step 9

A monitoring procedure shall be written for each QCP and CCP to ensure compliance with critical limits. The procedure shall be able to detect loss of control and information about corrective actions. Online, offline and continuous measurement shall be used.
Records associated with the monitoring of each CCP shall include, * date * time * result of measurement * sign by responsible person * verified by an authorised person

Establish a Corrective action Plan - step 10

The HACCP team shall specify and document the corrective action to be taken when monitored results indicate a failure. This shall include the actions to be taken by nominee personal.

Establish Verification Procedures - step 11

Verification activities shall be established to confirm that the HACCP plan, controls and prerequisite programs continue to be effective. These shall include, * internal audits * review of records * review of complaints * review of incidents Results of review shall be recorded and communicated - HA-002.
HACCP verification activities must be verified to confirm that it is effective. This may include, * Internal audit findings * observations of employees conducting monitoring activities * review of customer complaints * laboratory results * review of incidents * review of deviations

HACCP Documentation and Record Keeping - step 12

Documentation and records must be sufficient to enable the site to verify HACCP controls - These must include prerequisite programs

Review the HACCP Plan

The HACCP team shall perform reviews on the HACCP plans and prerequisite programs - at least annually or when any changes occur which may effect food safety. Site to develop a HACCP review program and use HA-003-B

Section 3 (BRC 3, WSEP 1, 5, 7, 19, 21, CFMSR 2,6,7,8,21,22,23,24,25) Food Safety and Quality Management Systems

Section 3 (BRC 3, WSEP 1, 5, 7, 19, 21, CFMSR 2,6,7,8,21,22,23,24,25) Food Safety and Quality Management Systems The company's processes and procedures shall be documented to allow consistent application, facilitate training and support due diligence in the production of a safe food

The site shall have access to the current Woolworths Supplier Excellence Program standard and the relevant Code of Practice documents
The site shall have a current copy of the CFMSR and be aware of the relevant Coles brand policies and requirements.
All procedures shall be clearly legible with sufficient detail to enable their correct application. This should include photos, diagrams or other pictorial instructions where written communication alone is not sufficient.
The company shall have a procedure to manage documents which form part of the food safety system. * does the site have a list of controlled documents (when last reviewed) * the method of identification an authorisation * records of the reason for any change * a system for replacement of existing documents
Records shall be legible, maintained in a good condition and retrievable.
Records shall be retained for a defined period with consideration to, * legal or customer requirements * shelf life
Each document must be referenced with sufficient information to enable traceability, Each record requiring confirmation of a task completion must be documented by way of signature - not a tick Tick sheets are not to be used
There shall be a schedule programme of internal audits throughout the year with scope to cover, Does the site follow the Corporate Internal audit program - Are the audits saved in the QA national folder
A process of change management shall be defined and documented. The change management program shall be used prior to any changes that can have an impact on food safety, legality or quality. * description of change * planning change * reviewed by the HACCP team * identification of any documentation that needs updating * notification to suppliers * changes to equipment or location * how changes will be monitored to ensure food safety has not been compromised
Internal audits must be carried out by appropriately trained personal. Auditors must be independent.
In addition to the internal audit program there shall be a program of documented factory inspections * gmp audit * safety housekeeping audit

Supplier and Raw Material Approval The company shall have an effective supplier approval and monitoring system to ensure that any potential risks from raw materials to the safety, authenticity and quality of the final product are understood and managed.

The company shall undertake a documented risk assessment of each raw material (group of raw materials) including packaging to identify potential risks to food safety. * allergen contamination * foreign body risks * microbiological contamination * chemical contamination * substitution / fraud * historical trends This risk assessment shall for, the basis for the raw material acceptance. Risk assessments shall be reviewed annually. Sites to verify their own raw materials are being risk assessed
The company shall have a documented supplier approval an ongoing monitoring procedure to ensure that all suppliers of raw materials effectively manage risks. * certification GFSI * supplier audits Low risk suppliers only require a desk audit Where approval is based on a questionnaire, these shall be reissued at least every 3 years.
Where raw materials are purchased from agents - the site shall know the identity of the last manufacturer
The company shall have a documented procedure for acceptance of raw materials an packaging on receipt MO-018-01. * product sampling * visual inspection * certificate of analysis * certificate of conformance There shall also be a list of raw materials including packaging - parameters for acceptance and frequency shall be defined
There shall be a documented procedure for the approval and monitoring of suppliers of services. * pest control * laundry services * contract cleaners * transport * off site storage * laboratory testing * waste management
Contracts or formal agreements shall exist with suppliers of service that clearly define service expectations.
The raw material specifications must include * product type * ingredient statement * packaging spec * transport and storage * shelf life * quality and regulatory parameters
Part used raw materials must be effectively re-sealed or adequately covered and labelled.

Specification

Specification for raw materials and packaging shall be adequate and accurate and ensure compliance with relevant safety and legislative requirements. The spec shall also include limits for relevant attributes that may affect the quality or safety of the final product.
Accurate and up to date specification shall be available for all finished products. These shall include key data to meet customer and legal requirements
The company shall seek formal agreement of specification with relevant parties.
Specifications shall be reviewed whenever products change or at least every 3 years. Contracted labels must be reviewed every 12 months

Corrective Action and Non Conformance

The site shall have a documented procedure for handling and correcting failures identified in the food safety system * customer complaints * customer rejections * internal rejection * non conformance identified through internal an external audits
Where a non conformance places the safety, legality or quality of products at risk this shall be investigated and recorded including, * clear documentation of the issue * assessment of consequences * action to address the immediate issue * timescale of correction * person responsible * verification that the correction has been implemented * identification of root cause
There shall be a documented procedure for managing non conformance * the requirement for staff to identify and report issues * clear identification of non conforming product * secure storage to prevent accidental release * referral to the brand owner * defined responsibilities for decision making * records of decisions
Procedures must be implemented for any food which covers * dropped on the floor * dropped onto other non food grade or unsanitised surface

Traceability

The site shall have a procedure implemented such that all inputs are traceable throughout all stages of the sites processes. * quality systems records and all relevant production records * finished product identification
Identification of raw materials, including primary and any other relevant packaging, processing aids, intermediate / semi processed products, part used materials, finished products and materials pending investigation shall be adequate to ensure traceability
The site shall test the traceability system across the range of product groups to ensure traceability can be determined from raw material including primary packaging to finished products. This should include a mass balance Full traceability should b achieved within 4 hours
Where rework or any reworking operation is performed, traceability shall be maintained.
All raw inputs must be forward traced - WIP must be forward an backward traced - all finished product must be backwards traced This should be tested via internal audit.

Complaints

The company shall have a procedure in place for management of customer complaints * how the complaints are managed * feedback including positive and complaints * complaints must include rejections from Woolworth as well as individual customer contacts
All complaints shall be recorded, investigated and results of the investigation of the issue recorded. Actions appropriate to the seriousness and frequency of the problem identified shall be carried out promptly
Complaint data shall be analysed for trends. Where there has been a significant increase in a complaint or a serious complaint, root cause analysis shall be used to implement on going improvements.
Each complaint shall have a unique reference number and complaint logs include, * source of complaint * nature of complaint * product information * product code - used-by * whether product sample has been requested * corrective action * communications
The sites complaint reduction targets shall be agreed with the Coles technologist. If actual complaint trends don't meet these target the site shall inform Coles Coles only

Recall and withdrawal

The company shall have documented procedures designed to report and effectively manage incidents and potential emergency situations that impact food safety. This shall include contingency plans to maintain product safety, quality and legality
The company shall have a documented product withdrawal and recall procedure For contract pack customers this shall describe in detail * how to notify the customer * the full process of traceability * how the product will be recalled / withdrawn * contact information for all key stakeholders
The product recall and withdrawal procedure shall be tested, at least annually. Results of the test shall be retained and shall include timings of key activities. The results of the test and any actual recall shall be used to review the procedure.

Section 4 (BRC 4, WSEP 7,11,12,13,16, CFMSR 9,10,13,14,15,17,18,19,20) Site Standards

Section 4 (BRC 4, WSEP 7,11,12,13,16, CFMSR 9,10,13,14,15,17,18,19,20) Site Standards The production site shall be of suitable size, location and construction and be maintained to reduce the risk of contamination.

External areas shall be maintained in good order. Where buildings are surrounded by grass or planted areas they shall be regularly tended and well maintained. External traffic routes under site control shall be suitably surfaced and maintained.
The building fabric shall be maintained to minimise potential product contamination.
The company shall undertake a documented risk assessment of the security arrangements and potential risks to the product from deliberate attempt to inflict contamination or damage. Areas shall be assessed according to risk. Reviewed yearly
A scale plan must be Available showing the site boundaries and production area * the plan must be able to show building rooms and process flow * the site perimeter must be identified and must be securely fenced
Measures shall be in place to ensure only authorised personal have access to production and storage areas and access to the site by employees, contractors and visitors shall be controlled. A visitor reporting system shall be in place. Staff shall be trained in site security procedures and encouraged to report unidentifiable persons
External tanks, silos, intake pipes shall be locked
External drainage shall be visually identified to show type of waste and direction of flow
The site shall have an environmental policy in place stating the company's meet the local legislative requirements. This policy must be signed by senior management and communicated to all staff

Layout, Product Flow and Segregation

There shall be a map of the site which designates areas (zones) where product is at different levels of risk from contamination * high risk * high care * ambient high care * low risk * enclosed product * non product
The site map shall define * access points for personal * access points for raw materials * routes of movement for personal * routes of movements for raw materials * routes from removal of waste * routes for the movement of rework * location of any staff facilities * production process flow
Contractors and visitors shall be made of all procedures for access to premises and the requirements of the areas they are visiting. Contractors working in a processing area shall be the responsibility of a nominated person.
The movement of personal, raw materials, packaging, rework and waste shall not compromise the safety of products. The process flow, together with the use of demonstrably effective procedures shall be in place to minimise the risk.
Premises shall allow sufficient working space and storage capacity to enable all operations to be carried out.
Temporary structures constructed during building work shall be designed and located to avoid pest harbourage.

Building Fabric, Raw Material Handling

Walls shall be finished and maintained to prevent the accumulation of dirt, minimise condensation and mound and facilitate cleaning.
Floors shall be suitably hard wearing to meet the demands of the process and withstand cleaning materials and methods. They shall be impervious, be maintained in good repair and facilitate cleaning.
Drainage shall be designed and maintained to minimise risk of product contamination and not compromise food safety. Machinery and piping shall be arrange so that wherever feasible process waste water directly to drain. Floors shall have adequate falls to cope with the flow of any water or effluent towards suitable drains
Where the site includes high risk or high care facilities there shall be a map of the drains for these areas which show the direction of flow and locations of any equipment fitter to prevent back up of waste water.
Ceilings and over heads shall be constructed, finalised and maintained to prevent the risk of product contamination.
Where suspended ceilings or ceiling voids are present adequate access to the void shall be provided to facilitate inspection for pest control.
Where there is a risk to product, Windows and roof glazing which is designed to be opened for ventilation - they shall be adequately screened to prevent pest ingress
Where they pose a risk to product - glass windows shall be protected against breakage
Doors shall be maintained in good condition * external doors and door locks shall be close fitting and adequately proofed * external doors shall not be opened during production periods except in emergencies.
Suitable an sufficient lighting shall be provided for correct processes and effective cleaning
Where they constitute a risk to product, bulb and strip lights shall be adequately protected.
Adequate ventilation and extraction shall be provided in product storage and processing environments
High risk areas shall be supplied with sufficient changes to filtered air. The filter specification used and frequency of air a changes shall be documented. Check Coles requirements

Utilities

Water used as a raw material in the manufacture of processed food, preparation, hand washing or for plant cleaning shall be supplied in sufficient quantity, be potable at point of use or pose no risk of contamination. The microbiological an chemical quality of water shall be analysed at least annually.
Potable water testing must be competed by an accredited laboratory covering chemical, microbiological and physical parameters- this shall occur annually
An up to date schematic diagram shall be available of the water distribution system - this diagram shall be used as a basis for water sampling
All incoming service lines such as gas, electricity, hot an cold water must, * be adequately protected * clearly identified * be indicated on the site map
Air or other gas and steam used directly in contact with or as an ingredient shall be monitored to ensure this does not represent a contamination risk.
Steam must be part of the water sampling schedule based on risk Document shall also be made available that the boiler components meet the boiler standard.

Equipment

All equipment shall be constructed of appropriate materials. The design and placement of equipment shall ensure it can be effectively cleaned
Equipment which is in direct contact with food shall be suitable for food contact and meet legal requirements.
New equipment shall be subject to a documented approval system by suitable qualified members of the HACCP team.
Stored equipment must be kept in a clean and safe manner * equipment which is out of use or unsuitable for use must be tagged or labelled as such * must be protected from contamination and pests * must be cleaned and sanitised upon re-commissioning * food containers must not be used to store chemicals, equipment, parts or tools
Mobile equipment must be clean, maintained and stored in a suitable area when not in use (forklift, pallet jack etc)
Equipment must be cleaned off the floor - cleaned equipment must be stored in a manner which prevents re-contamination
Stored change parts must be re-sanitised prior to use

Maintenance

There shall be a documented planned maintenance schedule which includes all plant and processing equipment.
In addition to any planned activities, where there is a risk of product contamination by foreign object arising from damage. The equipment shall be inspected at predetermined intervals, results recorded and appropriate action taken
Where temp repairs are made, these shall b controlled to ensure the safety of a product is not jeopardised.
The site shall ensure that the product is not jeopardised during maintenance activities. A risk assessment shall be used to identify possible sources of contamination (hand over hand back)
Maintenance activities undertaken in high risk / high care zones shall respect the segregation requirements. Tools shall be dedicated for use an retained in the area
Materials used for equipment and plant maintenance shall be food grade and of a known allergen status.
Engineering workshops shall be kept clean and tidy and controls shall be in place to prevent debris entering production areas
Parts must be washed and decontaminated prior to moving into high areas
Tool boxes shall be made from either metal or plastic and have an items list. Cleaning of the tool box must be done at a defined frequency Checking the inventory must be done at a defined frequency

Staff Facilities

Designated changing facilities shall be provided for all personal. These shall be sited to allow direct access to the production, packing areas without recourse to any external area. If this is not possible a risk assessment shall be carried out and procedures implemented accordingly. (Foot wear cleaning)
Storage facilities of sufficient size shall be provided for all personal.
Outdoor clothing and other personal items shall be stored separately from production clothing. Facilities shall be available to separate clean and dirty production clothing.
Suitable and sufficient hand washing facilities shall be provided at access to production areas ( an appropriate points within). * advisory signs to prompt * sufficient quantity of water at a suitable temperature * hands free taps * liquid soap * Single use towel
Toilets shall be adequately segregated and shall not open directly into production zones. Toilets shall have hand wash zone that comply with the above point
Where smoking is allowed under the national law, designated controlled smoking areas shall be provided. These need to be isolated from production zones to ensure smoke cannot reach the product
All food Brought into the site by staff shall be appropriately stored in a clean and hygienic state. No food is to be brought into the production zone.

Chemical Control

Processes shall be in place to manage the use, storage and handling of food and non food chemicals to prevent contamination. These shall include, * approved list of chemicals to purchase * availability of material safety data sheet * confirmation of suitability * avoidance of strongly scented products * labelling of containers at all times * designated storage areas with restricted access * use by trains personal
Access to chemicals shall only be given to appropriately trained staff
All staff shall be given basic chemical handling training

Foreign Body Controls

The site must have effective procedures in place to eliminate potential foreign body hazards
Bag audits shall occur as part of the foreign object controls - these shall occur daily Any issues raised must be investigated to establish if product has been put at risk.
Cardboard must be managed / controlled Storage areas must be regularly swept to remove excess hards of packaging
De-bagging procedure must be in place for the de-bagging, be-boxing of raw ingredients and packaging with the aims of reducing foreign object generation

Metal Control

There shall be a documented policy for the control of use of sharp metal implements. This shall include a record of inspection for damage and the investigation of any lost items. Snap off blades shall not be used
Knives, blades, scissors and needle controls need to be in place. * personal knives must not be stored in lockers * only company issued and registered knives shall be used * equipment must be accounted for, condition checked and recorded * an incident log is to be generated in the event of knife loss or breakage. * disposal procedure must be written
Cleaning procedure must be written for knives with special mention of when they are in contact with allergens
The purchase of ingredients or packaging which use staples or other foreign body hazards as a part of the packaging shall be avoided

Glass, Brittle Plastic, Ceramics and similar materials

Glass or other brittle materials shall be excluded or protected against breakage in areas where open products are handled.
Documented procedures for handling glass and other brittle materials shall be in place where open products are handled. * a list of items detailing location, number, type and condition * recorded checks of condition of item - included a specific frequency of checks * details on cleaning or replacing items to minimise potential for product contamination
Documented procedures detailing the action to be taken in case breakage of glass or other brittle items shall be implemented * quarantining the products * cleaning the production area * inspecting the production zone and authorisation to continue production * changing work wear * specifying those staff authorised to Cary out the above points * record of the breakage

Wood

Wood should not be used in open product areas except where this is a process requirement. Where the use of wood can not be avoided the condition of wood shall be continually monitored to ensure it is in good condition and free from damage or splinters.

Foreign Body Detection and Removal Equipment

A documented assessment using HACCP shall be carried out on each production process to identify the potential use of equipment to detect or remove foreign object contamination. Eg filters, sieves, metal detector, magnet etc
The type, location and sensitivity of the detector and/or removal method shall be specified as part of the sites documented system.
The site shall ensure that the frequency of the testing of the foreign body detection / removal equipment is defined and takes into consideration * specific customer requirements * the sites ability to identify, hold and prevent the release of any affected materials.
Where detection equipment identifies unexpected material this shall be investigated. Information on rejected materials shall be used to identify trends and where possible instigate preventative action
Filters and Sieves used for foreign object control shall be of a specified mesh size or gauge and designed to provide the maximum practical protection. Materials retained or removed from the system shall be examine and recorded to identify contamination risks
Filters and Sieves shall be regularly inspected or tests for damage on a documented frequency. Records shall be maintained of the checks.
X-ray Detectors shall be in place unless risk assessment demonstrate that this does not improve the precious of the final product. Where metal detectors are not used justification shall be documented.
The x-ray equipment shall incorporate one of the following * automatic rejection * belt stop
The site shall establish and implement documented procedure for the operation and testing of the metal detection equipment. This shall include * responsibilities for the testing equipment * the operating effectiveness and sensitivity * methods and frequency of checking
Metal detector checking procedures shall be based on good practices and shall include * use of test pieces of metal from known diameter * the test pieces shall be marked with the size an type * tests carried out using separate test pieces containing ferrous metal, stainless and typically non ferrous * a test that both detection and rejection mechanism are working * checks that test the memory/reset function of the metal detector by passing successive test packs through the unit at running speed * checks of fail safe system fitted to the detection and rejection system
The site shall establish and implement corrective action and reporting procedures in the event of the testing procedure identifying any failure of the foreign body detector. Action shall include a combination of quarantining and re-inspection.

Housekeeping and Hygeine

The premises and equipment shall be maintained in a clean and hygienic condition. A clean as you go policy with a persons responsible for maintaining a clean and tidy work area
Documented cleaning procedure shall be in place and maintained for the building, plant and all equipment. Cleaning procedures for processing equipment, food contact surfaces and environmental cleaning shall include * responsibility for cleaning * item/area to be cleaned * frequency of cleaning * method of cleaning * cleaning chemicals and concentrations * cleaning materials * cleaning records * numbers of cleaners * key inspection points for cleaning verification
Raw materials, packaging and finished product shall be removed or protected before the commencement of cleaning tasks
As a minimum for food contact surfaces, processing equipment and for environmental cleaning in high care / risk areas. Limits of acceptable and unacceptable cleaning performance shall be defined. Acceptable levels cleaning may be defined by visual appearance, ATP, microbiological and chemical techniques. Where cleaning forms a part of a defined perquisite plan to control the risk of a specific hazard the cleaning procedures and frequency shall be validated and records maintained. This shall include the risk from cleaning chemical residue on food contact surfaces
The resources for cleaning tasks shall be available. Where it's necessary to dismantle equipment for cleaning purposes this shall be appropriately scheduled and where necessary planned for non production periods. Cleaning staff shall be adequately trained.
The cleanliness of equipment shall be checks before equipment is released back into production. The results of checks on cleaning, including visual analytical and microbiological checks shall be recorded and used to identify trends.
Cleaning equipment shall be, * hygienically designed *suitably identified for intended use (colour coded cleaning equipment) * cleaned an stored in a hygienic manner to prevent contamination
A summary document shall be available of the sites cleaning activities - cleaning matrix This must list all cleaning activities for each areas
Cleaning equipment must be fit for purpose, Cleaning cloths shall be single use Cleaning equipment shall be stored off the floor Where food contact equipment is wall mounted it must be at a suitable height that poses no risk of contamination The floor contact end of the equipment must be kept below knee height Cleaning equipment must be returned in a clean condition Where cleaning equipment is wall mounted it must, * handled up for floor cleaning * handles down for food contact Ingredient buckets must not be used as cleaning buckets
String mops are not permitted - the use of any other mop must be risk assessed
Retractable hoses shall be on a cleaning schedule to ensure any dirt or debris retracted into the roll is routinely cleaned
Pre-operational checks of equipment shall be completed by trained personal. Personal conducting these checks shall be independent of both the cleaning crew an production departments

Cleaning in Place (CIP)

A schematic diagram of the layout of the CIP system including process piping circuits shall be available. There shall be an inspection report or other validation that, * systems are hygienic ally designed with no dead areas * scavenge pimps are operated to ensure that there is no build up of CIP solution in the vessels * spray balls effectively clean vessels by providing full surface coverage and are periodically inspected * CIP equipment has adequate separation from active product lines ( through double seated valve , proxy switch and make/ break connections * the system shall be revalidated following alterations or additions. A lot of change to the CIP shall be maintained
The CIP equipment shall be operated to ensure effective cleaning is carried out * the process parameters, times, detergent concentrations, flow rate and temperature * detergent concentrations shall be checked routinely * CIP process verification shall be undertaken by analysis of rinse water or by ATP * detergent tanks shall be kept stocked up an a log maintained of when these are drained, cleaned, filled and emptied. Recovered post rinse solutions shall be monitored for build up of carry over from the detergent tanks * filters shall be cleaned and inspected at a defined frequency
There shall be a report, records, verification and validation to demonstrate that the CIP system is hygienically designed with no dead ends Validation shall be conducted annually
Procedures must be in place for the monitoring of chemical concentration, time, flow rate and temperature Documented test results must be available to demonstrate that the chemicals have been effectively flushed from pipes and tanks

Waste / Waste Disposal

All non conforming products which may have a food safety concern must be destroyed securely and records of the secure destruction maintained
External waste collection containers and rooms housing waste facilities shall be managed to minimise risk * clearly identified * designed for ease of use and effective cleaning * well maintained to allow disinfection * emptied at appropriate frequencies * covered or doors kept closed
If unsafe products or substandard trademarked materials are transferred to a third party for destruction or disposal that third party shall be a specialist in the secure product or waste disposal. Records shall be maintained of quantity of waste collected for destruction or disposal

Pest Control

The site and buildings must be effectively pest proofed to prevent the ingress of pests into internal areas * closed fitting doors * brush strips * screens on external windows * bird netting
If pest activity is identified it shall not present a risk of contamination to product, raw materials or packaging. The presence of infestation on site shall be indemnified in the pest control records and be part of an effective pest management program to eliminate or manage the infestation.
The site shall contract the service of a competent pest control organisation for the regular inspection and treatment of the site to deter and eradicate infestation. The frequency of inspections shall be determined by risk assessment and shall be documented.
Pest control documentation and records shall be maintained * an up to date full site plan, identifying numbered pest control device location * identification of the bait and or monitoring device * clearly defined responsibilities for site management and for contractors * details of pest control products used * any observed pests * details of treatment
Bait stations or other rodent control devices shall be appropriately located and maintained to prevent contamination risk to product. Toxic baits shall not be used within production or storage areas. All toxic bait stations must be secure Any missing stations must be investigated
Fly killing devices shall correctly sited and operational. No insectutors allowed
In the event of infestation immediate action shall be taken to identify at risk product and to minimise the risk of product contamination.
Records of pest control inspections, pest proofing and hygiene recommendations and actions taken shall be maintained. It shall be the responsibility of the site to ensure that all of the relevant recommendations made are carried out in a timely manner
An in-depth documented pest control survey shall be undertaken at a frequency based on risk but as a minimum annually.
Results of pest control inspections shall be assessed and analysed for trend in a regular basis * in the event of infestation * annually
Employees shall understand the signs of pest activity and be aware of the need to reports any evidence of pest activity to a designated manager
Six monthly audits on the program shall be conducted by a trained person Items to cover are, * inspection of site * effectiveness of program * quality of service by pest contractor * documentation is accurate * details of corrective action effectiveness These audit shall be conducted by a field biologist

Storage Facilities

Documented procedures to maintain product safety during storage shall be developed, understood by relevant staff and implemented accordingly. * managing chilled frozen product * segregation of product where necessary to avoid cross contamination * storing materials off floor am away from walls * specific handling or stacking requirements to prevent product damage
Where appropriate packaging shall be stored away from other raw materials and finished product. Any part used packaging materials suitable for use shall be effectively protected from contamination and clearly identified to maintain traceability before being returned to an appropriate storage area. Obsolete packaging shall be stored in a separate area and systems shall be in place to prevent accidental use
Where temperature control is required the storage area shall be capable of maintaining product temperature within specification. Temperature recording equipment with suitable temperature alarms shall be fitted to all storage facilities or there shall be a system of recorded manual temperature checks - typically 4 hourly basis
Where storage outside is necessary, items shall be protected from contamination and deterioration. Items shall be checks for suitability before being brought into the factory For the Coles this need to be agreed to with Coles and managed via the exemption process
The site shall facilitate correct stock rotation of raw materials, intermediate products and finished product to ensure the correct order of use.
Physical markings shall be in place to indicate where ingredients, packaging and products can and cannot be stored
Condensate drainage must be constructed and designed so as to minimise the risk of microbiological contamination. There shall be a break just prior to the floor and a funnel to prevent suck back

Dispatch and Transport

Documented procedures to maintain product safety during loading and transportation shall be developed and implemented. These may include, * controlling temperature of loading dock * the use of covered bays for chicle loading or unloading * securing loads on pallets to prevent movement during transit * inspection of loads prior to dispatch
All vehicles or containers used for the despatch of product shall be inspected prior to loading to ensure that they fit for purpose. This shall ensure that they are, * In a clean condition * free from strong odours which may cause taints * in suitable condition * equipped to ensure any temperature requirements can be maintained
Where temperature control is required, the transport shall be capable of maintaining product temperature with specification, under minimum and maximum load.
Where the company employs a third party contractors - all requirements specified in this section shall be clearly defined in the contract and verified or contracted company shall be certified to the Global Standard for storage and distribution or similar GFSI scheme
Where temperature control is required data loggers must be used to confirm temperature conditions If a data logger isn't used, personal must verify temperature using a calibrated device and NOT rely on the temperature unit display.

Section 5 ( BRC 5, WSEP 4, 6,7, CFMSR 26) Product Control

Section 5 ( BRC 5, WSEP 4, 6,7, CFMSR 26) Product Control Product design and development procedures shall be in place for new products or processes and any changes to product, packaging or manufacturing process to ensure that safe and legal products Se produced.

Product Design/Development

The company shall provide clear guidelines on any restrictions to the scope of new product developments to control the introduction of hazards which would be unacceptable to the site or customers - glass, allergens, microbiological
All new products and changes to product formulation, packaging or methods of processing shall be formally approved by the HACCP team leader or authorised HACCP committee member. This shall ensure the hazards have been assessed and suitable controls implemented.
Trials using production equipment shall be carried out where it is necessary to validate that product formulation and manufacturing process are capable of producing a safe product
Production trial samples must be submitted to Woolworths and approved prior to launched to market
Shelf life trails shall be undertaken using documented protocols reflecting condition experienced during storage, transport and handling. Results shall be recorded and retrained and shall confirm Compliance and with relevant microbiological, chemical and organoleptic criteria.

Product Labelling

All products shall be labelled to meet legal requirements for designated country of use and shall include information to allow safe handling, display, storage, preparation and use of the product within the food supply chain.
There shall be effective processes in place to ensure that labelling information is reviewed whenever change occurs, * the recipe * raw materials * the supplier of raw materials * the country of origin * legislation
Where a product is designed to enable a claim to be made to satisfy a consumer group, the company shall ensure that the product formulation and production process is fully validated to meet the stated claim

Management of Allergens

The site shall carry out an assessment of raw materials to establish he presence and likelihood of contamination by allergens. This shall include review of raw material specification and where required obtain additional information from suppliers.
The company shall identify and list allergen containing materials handled in site. This shall include raw materials, processing aids and finished products.
A documented risk assessment shall be carried out to identify routes of contamination and establish document policies and procedures for handling raw materials, intermediates and finished products o ensure cross contamination is avoided. * consideration of the physical stay of the allergenic material * identification of potential cross contamination points through the process flow * assessment of the risk of allergen Criss contamination at each step * identification of suitable controls
Documentation procedures shall be established to ensure effective management of allege if materials to prevent cross contamination into products not containing allergens. * physical or time segregation * the use of separate or additional clothing when handling allergen * use of identified equipment and utensils * scheduling of production to reduce the chances unintentional contamination * systems to restrict the movement of dust * waste handling and spillage control * restrictions of foods being brought into site by staff
Where rework is used or reworking operations are carried out, procedures shall be implemented to ensure rework containing allergens is not used in products that do not already contain the allergen
Where a claim is made regarding he suitability of a food for allergy or food sensitivity sufferers the site shall ensure that the production process is fully validated and the effectiveness of the process is routinely verified.
Personal moving between the production of allergen and non-allergen products and products containing different allergens must change their uniform.

Product Authenticity, Claims and Chain of Custody

The company shall have processes in place to access information on historical and developing threats to the supply chain which may present a risk of adulteration or substitution or raw materials.
A documented vulnerability assessment shall be carried out on all food raw materials or groups of raw materials to assess the potential risk of adulteration or substitution. This shall take into account, * historical evidence of substitution or adulteration * economic factors which may make adulteration or substitution more attractive * ease of access to raw materials through the supply chain * sophistication of routine testing to identify adulterants * nature of raw material
Where raw materials are Identified as being at particular risk of adulteration or substitution appropriate assurances and testing processes shall be in place to reduce the risk
Where products are labelled or claims are made on finished packs which are dependent on a status of a raw material including * specific provenance or origin * breed * assured status * genetically modified * identify preserved * named specific trade mark ingredient The status of each batch of the raw material shall be verified The facility shall maintain purchasing records, traceability of raw material usage and final product packing records to substantiate claims. The site shall undertake documented mass balance tests at a least 6 monthly
Where claims are made about methods of production (organic, Halal, Kosher) the site shall maintain the necessary certification status in order to make such a claim

Product Packaging

When purchasing or specifying food contact packaging the supplier of packaging materials shall be made aware of any particular characteristics of the food. Certificates of conformity or others evidence shall be available for product packaging to confirm it complies with the relevant food safety legislation
Product lines and bags used in direct contact with ingredients shall be appropriately coloured and resistant to tearing

Product Inspection and Laboratory Testing

There shall be a schedule program of testing covering products and the processing environment which may include microbiological, chemical, physical and organoleptic testing
Testing an inspection results shall be recorded and reviewed regularly to identify trends. Appropriate actions shall be implemented promptly to address any unsatisfactory results or trends
The site shall ensure that a system of ongoing shelf life assessments is in place. Records and results from shelf life tests shall verify the shelf life of the product.

Laboratory Testing

Pathogen testing shall be subcontracted to an external laboratory or when conducted internally the laboratory facility shall be fully segregated from production and storage to prevent any risk of product contamination.
Where routine testing laboratories are present on a manufacturing site, they shall be located, designed and operated to eliminate potential risks to product safety. Controls shall be documented, implemented and shall include, * design and operation of drainage and ventilation * access and security of the facility * movement of laboratory personal * protective clothing * processes for obtaining samples * disposal of waste
Where the company subcontract analysis which is critical to product safety the subcontracted company shall have gained recognise laboratory accreditation ISO/IEC 17025.
Procedure shall be in place to ensure reliability of laboratory results, * use of recognised test methods * documented testing procedures * ensuring staff are suitably qualified * use of a system to verify the accuracy of test results
Analytical testing should be conducted on all new or reformulated products NIP data must be calculated from a composite of 3 individual product samples via an external NATA accredited laboratory. At a minimum samples shall be taken - start, mid and last off

Product Release

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

Section 6 ( BRC 6, WSEP 14, CFMSR 16) Process Control

Section 6 ( BRC 6, WSEP 14, CFMSR 16) Process Control The site shall operate to documented procedure and or work instructions that ensure he production of consistently safe and legal product with the desire quality characteristics, in full compliance with the HACCP food safety plan.

Documented process specifications and work instructions shall be available for the key process in production of products to ensure product safety. The specifications as appropriate shall include, * recipes * mixing instructions * equipment an process settings * cooking times and temperatures * labelling * coding an shelf life * any additional HACCP information
Process monitoring such as temperature, time, pressure and chemical properties shall be implemented, adequately control and recorded to ensure that product is produced within the required process specification.
If process parameters are linked by in-line monitoring devices, these shall be linked to a suitable failure alert system
Where variation in processing conditions may occur within equipment critical to the safety of products, the processing characteristics shall be validated and verified at a frequency based on risk.

Calibration and Control of Measuring and Monitoring Devices

The site shall identify and control measuring equipment used to monitor critical control point, product safety and legality. This shall include, * a documented list of equipment and its location * an identification code and calibration date * prevention from adjustment * protection from damage
All identified measuring devices, including new equipment shall be checked and where necessary adjusted * at a predetermined frequency * to a defined method of traceable to a national standard Results shall be documented
Reference measuring equipment shall be calibrate and traceable to a recognised national or international standard. The uncertainty of calibration shall be considered when equipment is used to assess critical limits.
Procedures shall be in place to record actions to be taken when the prescribed measuring devises are found not to be operating within specified limits. Where the safety of products is based on equipment found to be inaccurate, action shall be taken to ensure at risk product is not offered for sale.
Temperature probes shall be calibrated / verified at temperature ranges at which their used.
Scales used for trade weight, laboratory analysis, in process testing and ingredients preparation shall be verified Test weights used must represent the test weight range for the products being assessed on that equipment. Current calibration certificates must be available

Quantity Weight, Volume and Number Control

The frequency and methodology of quantity checking shall meet the requirement of appropriate legislation - records of checks shall be retained

Labelling and Pack Control

There shall be a formal process for the allocation of packaging materials to packing lines and controls in the packing area which ensures that one the packaging for immediate use is available to the packing machines. Where off line coding or printing of packaging materials occurs, checks shall be in place that onl correctly printed material is available at the packaging machine.
Documented checks of the production line shall be carried out before commencing production and following changes of product. Here shall ensure that the lines have been suitably cleared and are ready for production. Documented checks shall b carried on at the product changes to ensure all products and packaging from the previous production have been removed from the line before changing to the next production
Documented procedures shall be in place to ensure that products are packed into the correct packaging and correctly labelled, * start of packaging * during packing * when changing batches *'at the end of run Checks shall also verify * date code * batch code * quantity indication * bar code * country of origin

Section 7 ( BRC 7, WSEP 13, CFMSR 1, 26) Personnel

Section 7 ( BRC 7, WSEP 13, CFMSR 1,26) Personnel The company shall ensure that all personal performing work that affects product safety, legality and quality are demonstrably competent to carry out their activity, through training, work experience or qualification.

The company shall ensure that all personal performing work that affects product safety, legality and quality are demonstrably competent to carry out their activity, through training, work experience or qualification.

All relevant personal, including agency staff, temporary staff an contractors shall be appropriately trained prior to commencing work and adequately supervised throughout the working period. * food hygiene * allergens * illness reporting * glass breakage
Where personal are engaged in activities relating to critical control points training an competency assessments shall be in place
The site shall put in place documented program covering the training needs of relevant personal * identifying the competencies of specific roles * providing training to ensure staff have the necessary competencies * review the effectiveness of training
All relevant personal shall receive general allergen awareness training and be trained in the sites allergen handling procedures
Records of all training shall be available * the name of the trainee * date an duration * title of course * training provided
The company shall routinely review the competencies of its staff. As appropriate it shall provide relevant training.
A training matrix must be developed showing staff competencys
Site personal responsible for monitoring QCP's and CPP's must have an understanding of food safety and quality attributes. Specific training must be conducted on the latest versions of the relevant CCP / QCP procedures and corrective actions.

Personal Hygiene The site personal hygiene standards shall be developed to minimise the risk of products contamination, be appropriate to the products produced and be adopted by all personal including agency, contractors and visitors.

The requirements for personal hygiene shall be documented and communicated to all personal. This shall include, * watches shall not be worn * jewellery shall not be worn (except plain wedding band) * rings, studs shall not be worn * fingernails shall be kept short * false nails are not permitted * excessive perfume shall not be worn * compliance to this shall be checked routinely
Hand washing shall be performed on entry
All cuts and grazes to exposed skin shall be covered by an appropriately coloured plaster and be metal detectable. These shall be site issued and monitored
Where metal detection equipment is used a sample from each batch of plaster shall be successfully tested and records shall be maintained
A written procedure shall be developed to instruct staff on storage of personal medication.

Medical Screening The company shall have procedures in place to ensure the employees are not a source of transmission of food borne diseases to products.

The site shall make employees aware of the symptoms of infection, disease or condition which would prevent a person working with open food.
Where there may be a risk to product safety, visitors shall be made aware of types of symptoms of infections and diseases. A questionnaire shall be completed to confirm hey are not suffering from any symptoms.

Protective Clothing Suitable site issued protective clothing shall be worn by employees

The company shall document and communicate the rules regarding the wearing of protective clothing in specific work areas. This shall also include polices relating to the wearing of protective clothing away from production environment.
Protective clothing shall be available that, * is provided in sufficient numbers for each employee * is of suitable design to prevent contamination of the product * fully contains all scalp hair * include snoods for facial hair
Laundering of protective clothing shall take place by an approved contracted or in house laundry using defined criteria to validate the effectiveness of the process. * adequate segregation between dirty and cleaned cloths * effective cleaning of protective cloths * clean cloths are protected prior to use Washing of protective clothing by the employees is exceptional but shall be acceptable where the protective the employee from the products handled and the clothing is worn in enclosed product or low risk areas only.
Where protective clothing for high care / risk areas is cleaned by a contracted laundry this shall be audited either directly or third party.
Protective clothing shall be changed at an appropriate frequency- at least daily
Clean footwear must be suitable to the production area and job, * washable * cleaning facilities must be provided and monitored

Findings

Auditor Signature