1. Have management practices been documented to include: (EXPORT SPECIFIC REQUIREMENTS)
The organisational structure?
Roles & Responsiblities of staff at the establishment?
Duty statements for key staff?
Is there a management review process that ensures that all elements of the Approved Arrangement are reviewed on an annual basis? How is it addressed? (e.g. management review meetings)
The following items should be covered as part of the management review process: Importing Country Requirements? Operational Hygiene? Production Standards? Corrective actions? Structual requirements? Trade descriptions, Transport, Internal audits & Records of meetings.
2. Has the occupier's (management's commitment) been documented and does it include: (EXPORT SPECIFIC REQUIREMENTS)
A commitment to food safety?
Compliances with the requirements of the orders?
Compliance with importing country requirements?
Statement of committing to compliance with export legislation.
As a minimum need statement re "complience with export legislation"
3. Is there a documented requirement that all Approved Arrangements records or documents made and recieved by the occupier that is releveant to meeting the requirements of the orders and retained for nkot less than 3 years? (EXPORT SPECIFIC REQUIREMENTS)
4. Is there a procedure in place for conducting internal audits/reviews? What elements are covered in the intrnal audits and do they cover all aspects of the establishment and its operations e.g. (EXPORT SPECIFIC REQUIREMENT)
It is an expection that the company has a documented internal audit program that covers all elements of the approved arrangement (food safety program) it is expected that the internal program will :
Cover all documented procedures associated each element of the food safety program and being reviewed at a minimum of annually.
Evidence will be viewed to supporrt that the review was undertaken and implementing its internal audit program as per its documented schedule?
Check where audits are not covered as per schedule, are there notes/explanations to explain why
Check that there are sufficient records available for the internal audits conducted i.e. the records must support that the internal audits has been conducted, (just ticks and crosses on a checklist is not sufficent)
Corrective actions are issued where non-complience is found and that rectification dates are reflective of risk and are being met, if not why not?
5. Is there a procedure for documenting corrective actions where an internal audit or an audit undertken by 3rd party identifies non-conformance and does the procedure include actions to be taken?
Correct the non-conformance ?
record the timeframe for actions?
Allocate responsibilities for management and action?
Escalate when corrective action is not done within the allocated timeframe?
Does the system cover corrective action needed to be taken for external audits (e.g. SRA? Department of Agriculture audits)?
The auditors will review the corrective action procedure and ensure CAR's are following the documented process. In addition, the auditor will:
Check a number of the non-conformances and sight records/documents associated to support actions undertaken.
Check those non-conformances that are not closed out are being managed and that someone has resonsibility for following up outstanding CAR's
Checks that ensure that closed CAR'S are being reported.
Checks to ensure that closed CAR's have been verified as effective.
Check to see non actioned CAR's are being highlighted at management meetings.
Ensure that the CAR register exists and is up to date and includes all audit results, e.g. SRAs/Department of Agriculture/Third Party/internal
6. Are plans of the establishment available, accurate, legible and do they include: (EXPORT SPECIFIC REQUIREMENT)
The water supply, stormwater and waste water drainage?
The layout and floor plan of the structure?
Plans are requires to be available and accurate however we won"t necessarily assess them. Advise Establlishments that if the plans need to be reviewed by any authority (including the Department of Agriculture) they should be available and they should be in sufficient detail to identify water, effluent and establishment layout.
7. Is there a documented cleaning procedure/program in place? Is it accurate, does it over all relevant areas and equipment including storage areas, is it suitable and does it match what is occurring?
Ensure that there is a documented cleaning and sanitation program in place and the prpcedures are being complied with.
Review records to ensure WI's, SOP's and procedures to ensure that activities are conducted are in accordance with state frequencies and in acordance with state objectives.
Interview key personnel on their knowledge, training, understanding of procedures and HACCP requirements where applicable.
8. What systems are in place to support that the cleaning (non CIP) is effective:
Are records made?
Where environmental testing takes place does the programe stipulate what is tested?
The limits to be met?
When, who, where and how?
Do procedures include triggers for corrective action, reporting ect?
Check the internal audits records/dailycleaning records/GMP records ect. to ensure that the cleanning and hygiene programs are being implemented as documented.
Review recorda of the enviromental testing program, e.g. lab records of testing for Listeria and other pathogens.
Ensure that verification of cleaning includes evidence of sanitation of heat treatment equipment, titration checks for effectiveness of chemical stengths, cleaning logs/records etc.
9. If applicable what systems are in place to support CIP cleaning is effective:
testing to ensure no residual chemicals? Flushing of system?
Monitoring of chemical amounts used?
10. Are there procedures in place for ensuring water is potable and does not contain E. coli? (EXPORT SPECIFIC REQUIREMENT)
It is expected that the following are covered in documented procedures::
Taking water samples? Who takes them? (Responsibility)
How often are they taken? (Frequency)
Where are the samples taken?(Location and rotation of sites, Samples containers used ect.)
What is the water tested for? Micro limits?
Is the lab undertaking the testing NATA accredited? Is Trainng provided to samplers?
Triggers for corrective action.
11. What chemical/physical limits are used to ensure tht the water is potable? (EXPORT SPECIFIC REQUIREMENT)
As a minimume it is expected that company will obtain a copy of the annual testing results from the water authority. If there is no town water supply, there should be chemical testing as per the Austrralian Drinking Water Guidelines.
12. Is there any use of non-potable water and/ or recyled water and is it identified in the approved arrangement
The use of non-potable and/or recyled water must have undergone a risk assessment and be covered by appropriate procedures. Risk assesments should indicate the nature of the water and in what circumstanes it can be used.
13. Is there a pest control program in place
What systems are in place to support that the program is effective?
Pest incidence register
The information should include:
Pest control reports available
Recommendations from the report are being acted upon
The chemicals and baits being used are as per the documented program,
Bait stations are accessible and in accordance with location map
The pest control program is covered through the internal audit program.
There is a pest sighting register in place and is being used by staff and management?
14. Is there a documented system in place that ensures that hazardous material (e.g. Chemicals, Inedible product, Allergens, Waste and Non-conforming product) are adequately stored and identified to prevent cross contamination?
Are systems in place that effectively ensure that all waste is adequetly stored, handled and disposed of?
The aim is prevention of cross contamination to dairy products. Chemicals should be stored appropriately. Have suitable segregation. Do not pose a cross contamination risk. waste. inedible material and hazardous substances should be seperated and identiified. This needs to be supported by work instructions, training and GMP audits.
15. Where applicable are there procedures in place to ensure product is not contaminated through the use of :
Examples of controls: Identification of boiler chemicals, used to ensure steam is of culinary quality: air source and filtering systems are in place (where applicable); and risk analysis undertaken to that any other gases used are suitable for contact with food.
16. Are there non export eligible products being manufactures or stored at the establishment such as: (EXPORT SPECIFIC REQUIREMENT)
Domestic Milk & Milk Products?
Animal food (stock food)?
Manufacturing Grade Milk and Milk Products?
Products not fit for human consumption?
Products other than Milk and Milk Products? (EXPORT SPECIFIC REQUIREMENT)
The auditor will ensure that products other than export eligiable products( e.g. stock food, domestic product, downgradraded products etc.) are identified , stored and labelled appropriately and in accordance with documented systems to ensure non export eligible products are labelled correctly. Where product has been identified as not fit for huan consumption or downgraded and it is not disposed of is ther a system in place for management and labelling?
Where product is of manufacturing grade and being exported are systems in place to ensure it is appropriately identified?
17. Are there documented procedures in place that ensure protective clothing and footware at the establishment is:
Does not present a risk of contanination?
Maintained in good repair?
Clean and sanitary?
Is worn in all food handling areas?
Does the procedure include visitors?
Examples of Controls:
That uniforms are stored and protected
There is adequate facilities for staff clothing/storage
The amenities are clean and hygenic
Protective clothing is covered by staff induction and training
18. Are ther documented procedures in place at the establishment that ensures the personal hygiene of staff in food handling areas meet the requirements of the orders? and do the procedures include :
Storage of personal items
ickness and cconditions
Contamination from jewellery, clothing, behaviour etc.
Hand washing with warm water?
Training in personnel hygiene?
It is expected the auditor will:
Ensure that records are checked and verified to ensure staff are trained in all aspects of food safety, Includinga documented procedures for ongoing training i.e refresher training.
Interview random staff at random to guage effectiveness of the personal hygiene program (Including notification of diseases etc.)
Observe to ensure staff abide by the jewellery policies, hair coverings ect.
Ensure that hand washing facilities are supplied with hot water, soap and hand drying equipment
19. Are all checks in place to ensure staff are complying with socumented procedures and wearing suitable protective clothing and observing good hygienic and manufacturing practices?
Are all areas of the premises and surrounds including storage areas included in the company's internal audit/GMP and housekeeping systems?
It is an expectation that checks are in place to ensure staff are following documented procedures and the establishment is maintained to a standard of cleanloness that is in complience with schedule 3 & 4 of the milk products orders.
20. Does the company have a documented HACCP program in place and is the program supported by:
Accurate and effective Hazard Audit Tables
CCPs identified and include limits, corretive action, responsibility, records of monitoring,work instructions etc.
Internal audit and ongoing review
Training for key staff
Validation to support processing parameters
Notification to DA/SRA regarding changes in the HACCP system
It would be expected the auditor will:
Ensure each different product line has an associated HACCP program.
Checks are made to ensure each of the HACCP programs has been reviewed at least on an annual basis and that it has been verified.
That as a minimum one HACCP program is checked by the audito and that controls are in place to manage critical limits and that the records associated to critical limits are checked to ensure they comply
Evidence is sought to support critical limits e.g. Reference material, scientific studies or data such as the ANZDAC heat treatment document etc.
21. All products produced at the establishments must meet the microbiological limits for food specified by the Food Standards Code and in accordance with the companies approved arrangements.
The documented sampling product must:
Identify that every product line must be samoked at a minimum of 5 sub samples per fortnight (or per month for low risk products.)
I dentify the minimum testing requirements as per the food standard code, state requirements, their internal risk assessment etc.
Identify the limits that must be achieved and the corrective action should the limits be exceeded (include notification)
Identify any specific importing country requirements that are over and above the standard testing requirements .
Identify the AS test method used.
Identify when product must be tested in a NATA accredited laboratory.
Provide details of training required for staff to take samples.
Be linked to the corrective action program, internal audit program and manageent review.
22. The system should provide evidence, through procedures and records, of:
Induction training, prior to commencemenet of work in the food processing enviroment
Content of induction training including:
Personal health and hygiene
resonsibilities for notification of illness.
General and on-going training
Competency assesment of training program and staff
Inclusion of all key staff
Who is responsible for delivering training?
Supported by adequate records
Assessed for ongoing effectiveness
Linked to corrective action, internal audit and management review
The auditor may interview worker to verify training provided and to ensure that key staff e.g. Pasteurier operators/recall coordinators are aware of their duties and training appropriately.
23. The system in place at the establishment must be such that full Production Records are kept enabling trace back to the lot of food & ingredients including:
A description of the food.
Quantity in the lot
Unique lot identity
Date of production
Full details of all inputs (ingredients)
Trace back to te supplier of the ingredients
Explanation of codes and ciphers used?
The auditor will check production records for completeness and where farm milk is recieved at the establishment product must be able to be traced back to the tanker run used to produce the batch.
Where re-work product is blended into a batch of product it must be traceable to its original batch. Ingredients must be traceable in both non reworked product.
24. The company must have a documented recall procedure in place.
The auditor will assess the recall procedure to ensure the following:
Responsibilities have been allocated for the variouse tasks.
Alternative delegations have been assigned.
Details of the recall procedure comply with the requirements of the FSANZ recall guidelines.
Procedure includes notification to key goverment agencies, incluing the State Regulatory Authority and The Department of Agriculture.
That the recall protocol is tested at least annually and that records are available to support activitiy.
Linked to corrective action, internal, audit and management review
25. The company must have a documented approved supplier program in place.
There is a procedure in place that ensures dairy ingredients used to manufacture dairy products at the premises are only sourced from registed establishments?
Elements of the approved supplier program must include:
A complete llist of all companies approved to supply product/packaging etc.
A supporting procedure that outlines the conditions under which a company becomes an approved supplier and the ongoing checks conducted to ensure companies meet supply conditions.
Identify what documents must be provided on delivery of the goods e.g. Certificate of Analysis, Transfer documents etc..
For dairy specific ingredients there must be systems in place that ensure that the goods are only sourced from a Department of Agriculture registered establishment, this includes all storage facilities.
Approved suppliers must be able to demonstrate that they manufacture gooods in aaccordance with the Food Standards Code.
Covered by corrective actions in the event that some elements are nkot complied with, internal audits and management review.
26. Are imported ingredients used in the manufacture of the milk and milk products?
Note: if yes does the labelling meet the requirements of the Trade Practices Act 1974 which contains prohibittions on engaging in conduct that is misleading or deceptive or is a likely to mislead or decieve (section 52) and prohibitations on making false or misleading representations, incuding and about the country of origin of milk and milk products (section 53 and setion 75AZC).
27. Is there a procedure in place to ensure that transfer declerations accompanies the delivery of dairy ingredients recieved at the establishment?
Program must include all raw material, packaging and ingredients and include:
Records of training and work instructions for all relevent staff
Checks to ensure and Corrective actions procedures in the event of Goods are delivered outside set requirements (temp limits, lack of paperwork, un-hygienic truck, outside approved supplier program)
List of forms etc. that will be used for this activity and the records made to verify any actions or checks made.
28. Is there a documented procedure in place to ensure that transfer declerations accompany the delivery of dairy ingredients recieved at the establishment?
The inwards goods procedure must include :
That transfer declerations must be provided and are available for all dairy ingredients recieved at the establishment and that the product is made at and recieved from a registered dairy establishment.
Identify what happens when deliveries are recieved and no transfer declerations accompany the delivery.
Detail what are the minimum details required on a reccieved transfer document.
Relevant informationn for imported dairy ingrdients such as CofA's Quarantine clearances etc..
Where milk and milk products are recieved and not for use in milk and milk products for export what systems are in place to ensure they are suitably identified.
29. Does the company have a documented program in place for each consignment of milk and milk products despatched from the establishment to ensure transfer are issued ( where applicable)?
There is an expectation that the companies dispatch system will identify the following:
Identify when a transfer document is required.
Identifies the format that the transfer document will take and what is the minimum information that it must contain
Who has been autherised by the company to sign these documents.
Evidence that nominated staff have recieved trainig and or information about the responsibiities associated with signing these documents.
Identifies that export product can only be sent to an department of Agriculture Dairy registered establishment.
Idetify how the company know the recieving establishment is registered for dairy
30. Does the company have a documented system in place for issuing decleration of comlience ?
The system must ensure that for each consignment of milk and milk products exported from the establishment (or provided to a third part for exporter) a decleration of complience must be issued.
The system must ensure that there is evidence to support the issuing of a declerationof comlience, namely;
Must be signed by an autherised person (as listed in the company,s program);
That staff signing these documents understand on what basis the Deleration is issued (staff could be questioned on this point)
How export staff verify complience with specific importing requirements such as somatic cell counts in farm milk for EU destined product;
The importing country requirements identified in the Approved Arrangement are met;
The importing country requirements are complied with
That all the information is true and complete
Minimum details to be included in the decleration.
Identify the circumstances when a Dec. of Complience cannot be issued
31. Are there documented procedures and training in place for ensuring complience with identified importing country reequirements are being met?
It is expected that the documented system will identify the following:
How importing country requirements are identified.
What records have been kept to ensure these requirements have been met.
A list of coutries identified as export markets and their specific requirements, e.g. EU, Korea, Milk powder to the US, Hong Kong, Alergeria etc.
Specific shipments will be provided to the auditor who will be able to ensure all requirements have been met, e.g. declerations of complience, transfer documents, product testing, source ingredients, maintenance in the export chain.
32. Does the company load directly into sea/air freight containers? N/A
If yes, there is a documented procedure i place to ensure containers are:
fit for the purpose
Clean & free of extraneous matter & residues?
Free of objectionable odours, taints and other toxic substances?
Free of dirt, rust, flaky paint, algae growth & moisture?
Free of insects and other pests
There are no protruding fixtures which could penetrate & damage packaging containing the milk and milk products?
The floor is sound, vents are checked and where temperature control is required it is checked & working?
There is a record to support that these checks have been carried out ?
33. Applying department of Agriculture seals. N/A
If there is a self- sealing system in place there is an expectaion that the program will include the following:
Evidence that the sealing system has been approved by the Department of Agriculture
Evidence that seals only used for USA and liquid milk to Fiji
Seals are reconciled on a regular basis & held in a secure location.
Staff allocated responsibilities for seal management are aware of the procedures and work instructions.
Covered by corrective action, internal audidt and management review, records are available to support the seals used, damaged etc.
34. Is there a documented system in place for ensuring that export labels are accurate, current and in accordance with minimum export requirements?
It is expected that the system will identify that the trade description will meet the requirements of schedule 7 clause 4.1 and contain:
A description of the milk and milk products
Where milk and milk products contain more than one ingredient, a list of ingredients in accordance with the requirements specified in standard 1,2,4 of the Food Standard Code
The net contents (the quantity of the milk & milk products in the container)
The country of origin
The registration number of the establishment at which the milk and milk products are last prepared (other than handled, loaded or stored)
The name and address of the exporter, occupier or consignee
The identity of the lot for the milk product
The directios for the use of storage if the milk and milk products are of a nature as to warrant such directions for reasons of food safety
Criteria to meet of foreign languages are used?
Specific importing country requirements?
Compositional claims verified
Shelf life validation.
35. Does the company have a documented preventative Maintenance program in place?
It is an expectation that the preventative maintenance program will cover systems that ensure that :
The premises are maintained in good repair?
The equipment used in the premises is maintained in goos repair?
The vehicles used by the premises are maintained in good repair?
There is a schedule of regular maintenance activities, including frequency and resonsibility
There is a link to corrective action, internal audit and management review.
Does the company have a documented calibration program?
It is an expectaion the calibration program will ensure that:
There is a list covering all equipment requiring on going calibration.
There is a schedule of calibration activities, including frequency, resonsibility and tolerance limits.
There is a link to corrective action i the event that items are missed or tolerance limits are exceeded.
included in the internal audit program and managment review.