Pre-assessment Checklist · The HARPS pre-assessment checklist has been designed to assist with the...

© HARPS Pre-assessment Form Version 1.2 1

Pre-assessment Checklist

The HARPS pre-assessment checklist has been designed to assist with the upcoming HARPS audit. The document will be provided to you by your selected Certification Body

at the point of audit scheduling and shall be returned to the Certification Body nominated representative no later than two weeks prior to the HARPS audit. The document

shall be completed by the most suitable/ responsible representative of the direct supplier site. The completed document will be reviewed by the HARPS auditor prior to the

on-site visit.

Company Name (and Trading name if applicable)

Company Address

Contact Telephone Landline: Mobile:

Email

Name of the individual/s completing this form and position title

Name: Position Title

Product Lines Produced

Scope of activities

Supplier Type Grower Grower/Packer Packer Ripening warehouse Distributor Agent/Broker

Date of Completion

Planned audit date and Certification Body

Audit date: Certification Body:

Base Scheme (Option/level if applicable)


Section 1 - Food Safety Elements

Element Name & Number

Element Description Meets/ Partially Met/ Does Not Meet

/ Not Applicable

Evidence/ Notes / Comments

1.0 Documentation The supplier shall maintain current certification to a customer approved GFSI benchmark (or in progress) scheme. The scope of certification shall include all products supplied to all retail customers participating in HARPS. Evidence of certification shall be maintained.

2.0 Approved Suppliers

I. The direct supplier, i.e. those that are responsiblefor the final pack, shall be responsible for ensuringall domestic and international Sub-contracted /Co-packer suppliers (involved in the growing,packing or in-process storage of produce)destined for sale to the customer meet thefollowing requirements.

These external suppliers shall:

have access to a copy of the relevant finishedproduct specification/s, including name, location,activities and products supplied

Ensure that sub-contracted /co-packers suppliersare progressing towards compliance with HARPSrequirements in line with the agreed HARPSimplementation timeline

II. The Direct supplier shall manage and documentall international indirect suppliers involved in thegrowing, bulk packing or end storage of producedestined for sale to the Customer.

3.0 Specifications I. A current list of all products supplied to theCustomer shall be documented and thecorresponding current finished productspecification/s (either supplier developed and


approved by the Customer, or Customer generated) shall be maintained.

II. Where the supplier develops a finished productspecification, the specification shall include allrelevant information required by the Customerand shall comply with Australian legislationincluding the Food Standards Code, NationalTrade Weight Measurement regulations andAustralian Competition and Consumer Law.

III. Finished product specification shall be reviewedwhenever the product or process changes, or atleast every 12 months. Changes to the finishedproduct specifications shall be approved in writingby the Customer before implementation occurs.

IV. Supplier copies of Customer Branded artworkshall be maintained.

4.0 Retention Samples and Shelf-life

I. Shelf-life validation of finished product in finalpackaging shall occur on all new products (bulkand pre-pack) prior to first sale or when unit size,packaging materials or format of a finishedproduct is altered, or when a significant change tothe process has occurred.

Product challenge testing, based on risk assessment, shall also be undertaken as part of shelf-life validation, including elements such as elevated temperatures and transport. Supporting documentation shall be made available.

II. Where no alterations have been made shelf-lifeverification shall be conducted annually for pre-packed products.

© HARPS Pre-assessment Form Version 12 4

Retention samples of each pre-packed product shall be maintained. This information shall include weight loss trials

5.0 HACCP Training I. A representative of the organisation that is amember of the HACCP Team shall completeHACCP training by a recognised industry trainingbody that is RTO / TPECS certified (or aninternational equivalent). A statement ofcompetency confirming successful completionshall be maintained.

II. A representative of the organisation shallundertake refresher HACCP training at least everythree years. Internal or external training providersmay conduct refresher training as long as they areconducted by an RTO/TPECS training body orcertified trainer. Evidence of such shall beprovided.Refresher training may be conducted in aclassroom environment or as an on-line course.Evidence of refresher training shall be maintained.

6.0 Labelling and Packaging

I. Label claims, including nutritional, marketing andsustainability claims shall be validated duringproduct development and verified throughout thecontracted supply period.

II. Prior to packaging being used, the Customer shallapprove, in writing, the use of all label claims inboth own brand and generic brand products.

III. Allergen related claims shall be verified at afrequency based on a documented riskassessment and include as a minimum rawmaterial testing (i.e. fruit waxes), cleaningverification and full allergen screen testing.


IV. Supporting documentation in relation to label andallergen claims shall be maintained.

V. Signed copies of Customer branded artwork shallbe maintained.

VI. A procedure shall be developed to ensure thatpackaging and labelling materials are assessed forcompliance to specification and records keptdemonstrating that materials are correct onreceipt.

VII. Documented checks of packaging, labelling anddate coding, to ensure information is legible,correct and clear shall be undertaken on eachproduction line on each production day and whenpackaging replenishment occurs during aproduction or packing run.

VIII. Records of packaging and labelling checks shall bemaintained including a copy of the label beingapplied.

IX. All packaging and labelling, both customer andvendor branded shall be reviewed for legal andcustomer compliance on an annual basis unlessotherwise specified by the Customer.

X. All packaging shall be stored within a secure anddedicated area.

XI. Procedures shall be developed to ensurepackaging and labelling materials areappropriately identified, maintained in a cleanand secure condition and used as intended.


XII. The procedure shall ensure that only authorisedpersonnel have access to packaging and labelling.

XIII. Only the packaging and labelling specific toproduct being packed should be made availablefor use at the time of packing and should bestored in a clearly identified location in closeproximity to its point of use.

XIV. Packaging shall be fully covered when returned tostock.

XV. Any left-over pre-coded packaging shall bedestroyed and the volume of packaging disposedof documented.

XVI. For suppliers that print their own labels or codepackaging off-line, checks shall be conducted toensure the correct coding has been applied at thepoint of printing.

XVII. A “Packing ahead” procedure shall bedocumented clearly explaining the accurateapplication of date coding.

7.0 Personal Hygiene

I. All employees, visitors, and contractors shall weara hairnet and other suitable protective clothingwhen working around exposed product where arisk to product is identified. If workers, visitors orcontractors have facial hair, all facial hair shall becovered when inspecting or packing product (finalpacked product). Beard nets shall be worn andshall cover both the beard and moustache.


II. A return to work policy shall be documented andimplemented for staff returning to work aftersuffering a communicable disease.

III. A documented procedure shall be implementeddetailing actions to be taken when illness or injuryresults in a contamination incident. Incidents shallbe documented.

IV. All sites shall have Handwashing facilities availablein a location that is easily accessible to all producehandlers.

V. The number of Handwashing facilities shall beadequate to facilitate all produce handlers.

VI. Handwashing facilities shall be connected to orotherwise provided with a supply of warm,running potable water.

8.0 Recall I. All Customers, CB’s and base schemes (as pertheir own regulations) shall be notified of theintention to recall product from sale within sixty(60) minutes of the decision to recall productbeing made.

II. Relevant Customers, CB’s and base schemes (asper their own regulations) shall be notified of theintention to withdraw product from sale withinsixty (60) minutes of the decision to withdrawproduct being made.

III. A mock recall, including mass balance check, shallbe completed on product supplied to eachCustomer at least annually. One hundred percentof product shall be accounted for within two


hours. An actual recall conducted within the last twelve (12) months may be used provided the process and product have not changed.

9.0 Allergens I. Where applicable, the most recent VITAL toolshall be used and VITAL assessments andassociated documentation shall be maintained.

II. Allergen statements on product labels shallcomply with Customer allergen labelling policies(where applicable). Approval shall be sought fromthe Customer when the allergen status of aproduct changes or allergen statements onproduct labels are altered. The Customer shallapprove changes in writing beforeimplementation occurs. Records of approval shallbe maintained.

10.0 Equipment and Maintenance

I. A log of all equipment shall be developed andmaintained, with multiple pieces of the sameequipment individually identified. This applies toproduct contact equipment (i.e. washing bathsand conveyors), measuring and detectionequipment, processing tools and maintenancetools. Equipment shall be maintained andfrequently assessed to ensure it is in goodcondition.

II. Workshop, storage areas and tools shall be ingood condition, stored in a clean and safe mannerand shall not present a risk to product.

III. Procedures should be in place to ensure woodentools, field bins and pallets are regularly inspectedto assess the condition and suitability for use.


Damaged wooden items which present a risk to product shall be removed from use.

IV. Any equipment used to store product shall becleaned to prevent further contamination.

V. Equipment in contact with produce shall besmooth, impervious and appropriate for use inproduction and packing.

VI. Procedures shall be in place to minimise the riskof contamination to product for any scheduled orunscheduled maintenance.

VII. All cleaning and maintenance equipment used inproduction / packing facilities shall be accountedfor upon return.

VIII. All equipment used in production / packing shallbe:

Suitable for the use in which it is employed

Designed and accessible to facilitate effectivecleaning

Part of a planned maintenance schedule

11.0 Cleaning

I. A nominated member of the Management Teamshall be responsible for managing the cleaningprogram.

II. Wire brushes, steel wool, sponges and otherporous items shall not be used in storage orpacking areas of the facility. Where scouring padsare considered necessary for cleaning, they shallbe of a contrasting colour and replaced after eachuse. Only clean mops shall not be used in storageor packing areas, unless mop heads are replaced


after each use. Squeegees shall be of single blade construction and maintained in a clean condition.

III. Compressed air lines and high-pressure waterhoses shall not be used in the cleaning processunless it can be demonstrated that compressedair and high-pressure water have benefits thatoutweigh the risk of equipment andenvironmental contamination. Documentedrecords of use shall be maintained.

IV. Records shall be kept demonstrating staff trainingand assessment of competence in cleaningeffectively. Cleaning records shall be maintainedand verified by a senior staff member /supervisor.

V. Procedures shall be in place to ensure facilities,including product storage areas, are effectivelycleaned at a suitable frequency. This procedureshall ensure appropriate segregation of product toprevent contamination.

VI. A procedure shall be developed showing deepcleaning activities, the frequency of activity andverification at the commencement and end ofeach season.

12.0 Foreign Object Control

I. A documented procedure for foreign objectcontrol shall be implemented covering activitiesfrom harvest through to packing, storage anddispatch (or as per process scope). The procedureshall include details of how control is maintainedof soft (flexible) plastics, hard and brittle plastics,wood, cardboard and paper, glass and metal.


II. A register of necessary items permitted for use inspecified packing and storage areas shall bedeveloped, and controls shall be implemented tomanage compliance to the list, includingcompliance by visitors and contractors.

III. Product shall be subjected to foreign objectdetection as defined by the Customer. All foreignobject detection systems shall be appropriate andvalidated for the process employed and have aneffective rejection device i.e. belt stops, air-jetetc.

IV. Where metal detectors or other foreign objectdetection systems are used, checks of theequipment shall be conducted using a methoddefined and documented by the equipmentmanufacturer. The frequency shall be based onrisk when required by the Customer, thisdetermination of risk shall be demonstrable.

V. Knives shall be controlled in packing and storageareas. Cardboard packaging shall be opened usingsafe knives. Knife and blade sharpening shall beconducted away from product and packaging.Used knives or blades shall be disposed of in away that prevents further contamination. Knivesshall be signed in and out of production for eachshift and checked for integrity.

VI. A sack and bag opening, decanting and resealingprocedure shall be developed, documented andimplemented to prevent the contamination ofproduct with packaging materials during opening.


VII. Detectable versions of equipment required inprocessing areas shall be in use (where available)i.e. pens, clipboards etc.

VIII. The following items are not permitted to be usedin production and storage areas, including officeslocated within these areas:

Metal office staples, paper clips or othermetal office fastenings

Drawing or map pins, snap blades

Hole punches

IX. Foreign object audits shall be implemented andconducted. The frequency of audits shall bedefined, with this frequency based on risk.Findings of foreign object audits shall beinvestigated with the results of the investigationand corrective actions documented. This includesreported items, findings from detection systemsand foreign object audits. Foreign object findingsshall be documented and trended to establish anycommon sources. Where appropriateinvestigations should involve liaison with rawmaterial suppliers.

13.0 Verification and Validation

I. A documented assessment and testing programshall be implemented. Assessments and/or testsof microbiological, chemical and physicalparameters shall be undertaken as per the criteriaand frequency outlined by the Customer. Testingis completed by an ISO 17025 (or equivalent)accredited laboratory for the product categoryand test/s being undertaken. Records of testingare maintained.


II. Chemical residue testing of produce destined forsale to the Customer shall be undertaken against(Maximum Residue Limits) MRLs as detailed in theFood Standards Code. Testing shall be completedby laboratory accredited to ISO 17025 or anational standard for the product category andtest(s) being undertaken. Records of testing shallbe maintained.

Where product is purchased from multiple growers, testing shall be completed at a minimum frequency of once per year/season, or at the frequency defined by the customer.

III. Microbial, Chemical and Heavy Metal testingshall be undertaken as per the requirements ofthe base standard (including any local regulations)and additional customer requirements /specifications in regard to frequency and natureof testing.

IV. Product assessments shall be completed as perthe frequency defined by the Customer. If nofrequency is defined, then assessments shall occurat a minimum of twice per product, perproduction day, at the beginning and end of eachrun. Non Conformance to criteria shall bedocumented and corrective action undertaken,with the results made available to the Customerupon request. Customers shall be immediatelyadvised of food safety issues. Further action shallbe taken as agreed between the supplier and theCustomer

V. Documented checks of packaging, labelling anddate coding shall be undertaken on each


production line on each production day and when packaging replenishment occurs during a production or packing run. These checks shall be completed as per the frequency defined by the Customer. If no frequency is defined, checks shall occur at the start and end of each product variant or pack size run. Records of the packaging checks shall be maintained.

VI. If Microbiological, Chemical or Heavy Metaltesting indicates a breach of Critical Limits as perCustomer Specifications or regulations, Customersshall be notified within 1 hour of the site receivingthe results.

VII. Current supporting and validation data for thefinished product specification informationincluding Nutrition Information Panel (NIP) testresults, shelf-life test results, raw materialspecification, packaging material specifications)shall be maintained.

14.0 Growing

I. Treated and untreated fertilisers and soil additivesmade from human effluent or Biosolids are notpermitted for use on growing sites or potentialgrowing sites. Raw sewage flow into irrigationwater sources is not permitted.

II. All specialised growing media and substrate shallcomply with Section 5 – Managing the GrowingSite and Planting Material from Guidelines forFresh Produce Food Safety, Fresh Produce SafetyCentre Australia and New Zealand - August 2015.

III. If raw manure is being used is shall be compliantwith TBC


IV. Where the harvestable part is growing in or indirect contact with the ground, has an edible skinand is generally eaten uncooked, the period oftime shall be TBC unless the supplier is able tovalidate the safety of an alternate process.

V. Each growing site, new or existing where riskshave changed shall have a documentedassessment to ascertain suitability for growingfresh produce. This assessment shall considercropping, land use history, adjacent land use /industry and the need for soil testing (includingmicrobial testing).

VI. Equipment used to irrigate shall be inspected toensure it is in working order and flushed asrequired before use.

VII. All water sources shall be identified on a site mapor similar. The map shall be updated when watersources change. This includes water for irrigation,spraying and in hydroponic/ indoor systems.Produce that comes into contact with floodwatershall not be sold.

VIII. Each water source used shall be tested based on arisk assessment (but at least annually). The riskassessment shall include potential contaminationsituations where applicable, taking thecharacteristics of the crop into account.


IX. Water sourced from recycled sources andschemes (i.e. class A recycled water) shall beidentified and tested at a frequency defined by arisk assessment.

X. An on-farm foreign object policy that includes allforeign object risks shall be developed andimplemented.

XI. Machinery and equipment used during theharvesting process shall be cleaned andmaintained to avoid contamination of product(includes but is not limited to knives, harvest aids,bins and conveyors).


Section 2 - Quality and Regulatory Elements

Element Name & Number

Element Description Meets/ Partially Met/ Does Not Meet

/ Not Applicable

Evidence/ Notes / Comments

15.0 Calibration and Weight Checks

I. The customer shall define the frequency andmethod of verifying finished product weight. Ifrequirements are not defined by the Customer, allfinished product shall meet the minimum netlabel weight / volume / count at the end of shelf-life (considering weight loss over shelf-life).

II. All Customer-branded packed product shall besubjected to 100% inspection to verify labelweight using check-weighing systems.

III. For all other packed product, when product issubject to 100% weigh check records shall be keptto demonstrate compliance on an hourly basis.For product that is not subject to 100% weightchecking, records to demonstrate complianceshall be kept every 15 minutes at minimum.

IV. Where in-line/ automated check weighers offinished product are in use, records of weightchecks shall be maintained for the start, middleand end of every production run for every productpack size.

V. Bulk products shall equal the weight or count asstated on the Customers finished productspecification and the shipper carton / crate.Records of weight checks shall be maintained atthe start, middle and end of each production runof each bulk carton size.


VI. A procedure shall be implemented to ensurescales and check weighers (used for retail pre-packs and bulk loose product) are verified foraccuracy at a defined frequency (no less thanonce per day before commencement of theproduction day). Records of verification shall bemaintained.

VII. Procedures shall be in place to calculate and verifypackaging tares used at a suitable frequency toensure the actual product net weight / volume ismeasured accurately.

VIII. Certified test weights shall be used to verify scaleand check weigher accuracy. If in-line or checkweigher do not allow for the use of test weights,the certified test weight shall be used as part of across reference method.

16.0 Product sold or given to staff

I. Customer branded product shall not be soldthrough staff, factory or other retail outlets unlessbranding is removed. Customer branding shall beremoved completely when product is given freelyto staff. If Customer branding cannot be removedfrom staff giveaways, Customer branding shall bedefaced and / or marked as “factory second – notfor sale”. All product sold or given freely to staffshall comply with relevant Federal and StateLegislation.

II. Where suppliers wish to donate Customerbranded product to a charity, writtenauthorisation shall be obtained from theCustomer/s prior to the donation. The Suppliershall maintain a logbook which records the date ofdonation, product details, batch numbers, use-by


or best before dates, quantities and reason for donation. Donations that have been approved by the Customer and entered into the logbook do not require removal or de-facing of branding.

17.0 Food Fraud I. A risk assessment shall be conducted to identifyany potential or known risks to the integrity of theproduct supplied on a global scale. Issues such asadulteration, counterfeiting, mislabelling anddilution of product either knowingly or not areconsidered critical non-conformances.

18.0 Insurance II. A Certificate of Currency evidencing Product andPublic Liability Insurance of such an amount asconsidered acceptable by the Customer shall bemaintained as a controlled document. Eachrelevant Customer shall confirm any variation tothis requirement in writing.

Overall Summary of Findings / Follow-up Actions required:

Pre-assessment Checklist · The HARPS pre-assessment checklist has been designed to assist with the...

Documents

Transcript of Pre-assessment Checklist · The HARPS pre-assessment checklist has been designed to assist with the...