GMP Audit Checklist

Company Name | Site NameHARPS Example Template – Internal Audit ChecklistDate Issued

Date:
Start Time:
Finish Time
Auditor:
Role:
NC Count
Excellent – AnnualInternal Audits / 0-5
Good – 6-Monthly Internal Audits / 5-10
Acceptable – Re-Audit Within 3Months / 10-20
Unacceptable – Re-Audit Within 1 Month / >20
Audit Comparison / NC Count
This Audit
Last Audit …../…../…..

Legend:C: Conformance; NC: Non-conformance

HARPS Food Safety Elements

HARPS Requirements

1.0 Documentation / C/NC / Comments
Is the site certified to an approved base food safety scheme?
Is certification current?
Does the scope include all products supplied to all retail customers participating in HARPS?
2.0 Approved Suppliers / C/NC / Comments
If you are a direct supplier, do all domestic and international sub-contracted / co-packer suppliers (involved in the growing, packing or in-process storage of produce) destined for sale to the customerhave access to a copy of the relevant finished product specification/s, including name, location, activities and products supplied?
If you are a direct supplier, are all sub-contracted /co-packers suppliers progressing towards compliance with HARPS requirements in line with the agreed HARPS implementation timeline?
If you are a direct supplier, are all international,indirect suppliers involved in the growing, bulk packing or end storage of produce destined for sale to the customer documented and managed?
3.0 Specifications / C/NC / Comments
Are all products supplied to the customer documented and are all the corresponding current finished product specification/s (either supplier developed and approved by the customer, or customer generated) available?
Do all thesupplier developed finished product specificationsinclude all relevant information required by the customer and do they comply with Australian legislation including the Food Standards Code, National Trade Weight Measurement regulations and Australian Competition and Consumer Law?
Have all finished product specification been reviewed whenever the product or process changed, or at least in the last 12 months?
Have any changes to the finished product specifications been approved in writing by the Customer before implementation?
Are all supplier copies of customer branded artwork on file?
4.0 Retention Samples and Shelf-life / C/NC / Comments
Has shelf-life validation of finished product in final packaging been conducted on all new products (bulk and pre-pack) prior to first sale or when unit size, packaging materials or format of a finished product is altered, or when a significant change to the process has occurred?
Has product challenge testing based on risk assessment been conducted and also been undertaken as part of shelf-life validation, including elements such as elevated temperatures and transport?
Is supporting documentation available and have records of validation been maintained?
Has shelf-life verification been conducted annually for pre-packed products and have records of validation been maintained?
Have retention samples been retained for the entirety of the shelf-life of the product under the recommended storage conditions?
Has a risk assessment been undertaken based on product safety, risk and volume of product supplied to determine the number of retention samples retained?
Has this determination of the number of product samples been retained over the nominated shelf-life?
Has this been reviewed at least annually or when a change in safety, risk or significant volume occurred?
5.0 HACCP Training / C/NC / Comments
Has a representative of the organisation and who is a member of the HACCP Team completed HACCP training by a recognised industry training body that is RTO / TPECS certified (or an international equivalent)? Is the statement of competency confirming successful completionavailable?
Has a representative of the organisation undertaken refresher HACCP training in the last three years and is evidence available?
Was this provided by an internal or external training provider that is a RTO/TPECS training body?
Has evidence of the trainer/training body qualification been provided?
6.0 Labelling and Packaging / C/NC / Comments
Have all label claims, including nutritional, marketing and sustainability claims,been validated during product development and verified throughout the contracted supply period?
Has the customer approved, in writing, the use of all label claims in both own brand and generic brand products prior to packaging being used?
Are all allergen related claims being verified at a frequency based on a documented risk assessment and does this include as a minimum raw material testing (i.e. fruit waxes), cleaning verification and full allergen screen testing?
Is supporting documentation in relation to label and allergen claims maintained?
Is a procedure in place to ensure that packaging and labelling materials are assessed for compliance to specification and are records kept demonstrating that materials are correct on receipt?
Are documented checks of packaging, labelling and date coding, undertaken to ensure information is legible, correct and clear?Is this available foreach production line on each production day and when packaging replenishment occurs during a production or packing run?
Are records of packaging and labelling checks maintained including a copy of the label being applied?
Is all packaging and labelling, both customer and vendor branded, reviewed for legal and customer compliance on an annual basis (unless otherwise specified by the Customer)?
Is all packaging be stored within a secure and dedicated area?
Are procedures in place to ensure packaging and labelling materials are appropriately identified, maintained in a clean and secure condition and used as intended?
Does the procedure ensure that only authorised personnel have access to packaging and labelling?
Is only the packaging and labelling specific to the product being packed made available for use at the time of packing?
Is this stored in a clearly identified location in close proximity to its point of use?
Is packaging fully covered when returned to stock?
Is any left-over pre-coded packaging destroyed and the volume of packaging disposed of documented?
For suppliers that print their own labels or code packaging off-line, are checks conducted to ensure the correct coding has been applied at the point of printing?
Has a “packing ahead” procedure been documented clearly explaining the accurate application of date coding?
7.0 Personal Hygiene / C/NC / Comments
Do all employees, visitors, and contractors wear a hairnet and other suitable protective clothing when working around exposed product where a risk to product is identified?
If workers, visitors or contractors have facial hair, is all facial hair covered when inspecting or packing product (final packed product)? Are beard nets worn to cover both the beard and moustache?
Is a return to work policy documented and implemented for staff returning to work after suffering a communicable disease?
Has a documented procedure been implemented detailing actions to be taken when illness or injury results in a contamination incident? Are incidents being documented?
Do all sites have handwashing facilities that are easily accessible to all personnel and visitors?
Are the number of facilities for all produce handlers adequate and stocked at all times with consumables (i.e. soap and paper towel)?
For packhouses, are these facilities separate to those used as toilet handwashing facilities?
Are all handwashing facilities connected to or otherwise provided with a supply of water which is tested as <1cfu/ml E. coli?
8.0 Recall / C/NC / Comments
Have all customers, CB’s and base schemes (as per their own regulations) notified of the intention to recall product from sale within sixty (60) minutes of the decision to recall?
Have all relevant customers, CB’s and base schemes (as per their own regulations) notified of the intention to withdraw product from sale within sixty (60) minutes of the decision to withdraw product being made?
Has a mock recall, including mass balance check, been completed on product supplied to each customer in the last year?
Hasone hundred percent of product been 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 / C/NC / Comments
Where applicable, has the most recent VITAL tool been used and VITAL assessments and associated documentation been maintained?
Do allergen statements on product labels comply with customer allergen labelling policies (where applicable)?
Has approval been sought from the customer when the allergen status of a product has changes or allergen statements on product labels have been altered?
Did the Customer approve changes in writing before implementation occurring?
Are records of approval on file?
10.0 Equipment and Maintenance / C/NC / Comments
Has a log of all equipment been developed and maintained, with multiple pieces of the same equipment individually identified?Does this apply to product contact equipment (i.e. washing baths and conveyors), measuring and detection equipment, processing tools and maintenance tools?
Is equipment maintained and frequently assessed to ensure it is in good condition?
Are workshops, storage areas and tools in good condition, stored in a clean and safe manner and do not present a risk to product?
Are procedures in place to ensure that wooden tools, field bins and pallets are regularly inspected to assess the condition and suitability for use? Are damaged wooden items which present a risk to product removed from use?
Is all equipment used to store product cleaned to prevent further contamination?
Is all equipment in contact with produce smooth, impervious and appropriate for use in production and packing?
Are procedures in place to minimise the risk of contamination to product from any scheduled or unscheduled maintenance?
Is all cleaning and maintenance equipment used in production / packing facilities accounted for upon return?
Is all equipment used in production / packing suitable for the use in which it is employed, designed and accessible to facilitate effective cleaning and part of a planned maintenance schedule?
11.0 Cleaning / C/NC / Comments
Is a nominated member of the management team responsible for managing the cleaning program?
Are wire brushes, steel wool, sponges and other porous items not used in storage or packing areas of the facility?
Where scouring pads are considered necessary for cleaning, are they of a contrasting colour and replaced after each use?
Are only clean mops used in storage or packing areas, unless mop heads are replaced after each use?
Are squeegees of single blade construction and maintained in a clean condition?
Are compressed air lines and high-pressure water hoses not be used in the cleaning process unless it can be demonstrated that compressed air and high-pressure water have benefits that outweigh the risk of equipment and environmental contamination?
Are documented records of use maintained?
Are records kept demonstrating staff training and assessment of competence in cleaning effectively?
Are cleaning records maintained and verified by a senior staff member / supervisor?
Are procedures in place to ensure facilities, including product storage areas, are effectively cleaned at a suitable frequency?
Does this procedure ensure appropriate segregation of product to prevent contamination?
Has a procedure been developed showing deep cleaning activities, the frequency of activity and verification at the commencement and end of each season?
12.0 Foreign Object Control / C/NC / Comments
Has a documented procedure for foreign object control been implemented covering activities from harvest through to packing, storage and dispatch (or as per process scope)?
Does the procedure include details of how control is maintained of soft (flexible) plastics, hard and brittle plastics, wood, cardboard and paper, glass and metal?
Has a register of necessary items permitted for use in specified packing and storage areas been developed, and controls been implemented to manage compliance to the list, including compliance by visitors and contractors?
Is product subjected to foreign object detection as defined by the customer?
Are all foreign object detection systems appropriate and validated for the process employed and do they have an effective rejection device i.e. belt stops, air-jet etc.?
Where metal detectors or other foreign object detection systems are used, are checks of the equipment conducted using a method defined and documented by the equipment manufacturer?
Is the frequency based on risk?(When required by the customer, this determination of risk shall be demonstrable.)
Are knives controlled in packing and storage areas?
Is cardboard packaging opened using safe knives?
Is knife and blade sharpening conducted away from product and packaging?
Are used knives or blades disposed of in a way that prevents further contamination?
Are knives signed in and out of production for each shift and checked for integrity?
Has a sack and bag opening, transfer and resealing procedure been developed, documented and implemented to prevent the contamination of product with packaging materials during opening?
Are detectable versions of equipment required in processing areas in use (where available) i.e. pens, clipboards etc.?
Are the following items excluded from production and storage areas, including offices located within these areas:
metal office staples, paper clips or other metal office fastenings, drawing or map pins, snap blades and hole punches?
Have foreign object audits implemented and conducted?
Has the frequency of audits been defined, with this frequency based on risk?
Are findings of foreign object audits investigated with the results of the investigation and corrective actions documented?
Does this include reported items, findings from detection systems and foreign object audits?
Are foreign object findings documented and trended to establish any common sources?
Do investigations involve liaison with raw material suppliers where appropriate?
13.0 Verification and Validation / C/NC / Comments
Has a documented assessment and testing program been implemented?
Has the assessments and/or tests of microbiological, chemical and physical parameters been undertaken as per the criteria and frequency outlined by the customer?
Has testing been completed by an ISO 17025 (or equivalent) certified laboratory accredited by NATA (or equivalent) for the product category and test/s being undertaken?
Have records of testing been maintained?
Has chemical residue testing of produce destined for sale to the customer been undertaken against maximum residue limits (MRLs) as detailed in the Food Standards Code?
Has testing been completed by a laboratory certified to ISO 17025 and NATA accredited for the product category and test(s) being undertaken?
Have records of testing been maintained?
Where product is purchased from multiple growers, has testing of each supplier’s produce been completed at a minimum frequency of once per year/season, or at the frequency defined by the customer?
Has microbial, chemical and heavy metal testing been undertaken as per the requirements of the base standard (including any local regulations) and additional customer requirements / specifications in regard to frequency and nature of testing?
If microbiological, chemical or heavy metal testing indicates a breach of critical limits as per customer specifications or regulations, have customers been notified within 1 hour of the site receiving the results?
Have product assessments been completed as per the frequency defined by the customer?
If no frequency has been defined, has assessments occurred at a minimum of twice per product, per production day, at the beginning and end of each run?
Has non conformance to criteria been documented and corrective action undertaken, with the results made available to the customer upon request?
Have customers been immediately advised of food safety issues?Have further action been taken as agreed between the supplier and the customer?
Have documented checks of packaging, labelling and date coding been undertaken on each production line on each production day and when packaging replenishment occurs during a production or packing run?
Have these checks been completed as per the frequency defined by the customer?
If no frequency has been defined, have checks occurred at the start and end of each product variant or pack size run?
Have records of the packaging checks been maintained?
Are current supporting and validation data for the finished product specification information including Nutrition Information Panel (NIP) test results, shelf-life test results, raw material specification and packaging material specifications, being maintained?
14.0 Growing / C/NC / Comments
Has a risk assessment been conducted and documented for each growing site to ascertain the suitability for growing fresh produce?
Have risk assessments been reviewed and updated when changes occurred that may have impact the likelihood or severity of the hazards?
Has raw manure and un-composted green waste not applied within 365 days of harvest for crops that may be eaten uncooked and where the harvestable part of the crop is grown in or within 1 metre of the ground surface or in harvested from the ground?
Has livestock not been permitted on growing sites within 365 days of harvest for crops that may be eaten uncooked and where the harvestable part of the crop is grown in or within 1 metre of the ground surface or in harvested from the ground?
Have exemptionsbeen obtained for the application of raw manure and un-composted green waste or the presence of livestock between 90 and 365 days of harvest?
Has an application been submitted and agreed with each applicable HARPS retail customer individually prior to first harvest of each site?
Has documented evidence of the following been provided?
To permit livestock on growing sites:

Records of movement, including livestock growing site and movement (date in, date out)
Each single site preparation, with parameters agreed between grower and customer, must be cleared for harvest by having a microbial test that demonstrates E. coli <10/g and Salmonella not detected in 25g.

Has documented evidence of the following been provided?
For the use of raw manure and un-composted green waste:

Provide records of product used, including: origin, content, batch details and consignment information relating to the applied materials.
Storage sites for all raw manure and un-composted green waste must be off-site or located, constructed and maintained to minimise the risk of contaminating produce. If on-site, storage must be indicated on a farm map.
Application records, including date, area/s and method of application.
Raw manure and un-composted green waste applied to growing sites are incorporated into the soil immediately after application, and for annual crops, prior to sowing or transplanting.
Equipment used to apply raw manure and un-composted green waste must be dedicated for this purpose or thoroughly cleaned after use. Cleaning records are kept.
Each site, with parameters agreed between grower and customer, must be cleared for harvest by having a microbial test demonstrates E. coli <10/g and Salmonella not detected in 25g.
Produce that comes into contact with floodwater shall not be sold unless it meets limits of E. coli <10/g and Salmonella not detected in 25g.

Has a risk assessment been conducted for each in-use water source, taking potential contamination situations and the characteristics of the crop, irrigation technique and other factors into account?
Has microbial water quality been verified at a frequency dependent upon the level of risk identified?

HARPS Regulatory Elements

15.0 Calibration and Weight Checks / C/NC / Comments
Has the Customer defined the frequency and method of verifying finished product weight?
If the requirements are not defined by the Customer, does all finished product meet the minimum net label weight / volume / count at the end of shelf-life (considering weight loss over life)?
Has a procedure been implemented to ensure scales and check weigher (used for retail prepacks and bulk loose product) are verified for accuracy at a defined frequency (no less than once per day before commencement of the production day)?
Have records of verification been maintained?
Are procedures in place to calculate and verify packaging tares used at a suitable frequency to ensure the actual product net weight/ volume is measured accurately?
Are certified test weights being used to verify scale and check weigher accuracy?
If in-line or check weigher do not allow for the use of test weights, are the certified test weight used as part of a cross reference method?
16.0 Product Sold or Given to Staff / C/NC / Comments
Is customer branded product excluded from sale through staff, factory or other retail outlets unless branding is removed?
Is customer branding removed completely when product is given freely to staff?
If customer branding cannot be removed from staff giveaways, is customer branding defaced and / or marked as “factory second – not for sale”?
Does all product sold or given freely to staff comply with relevant Federal and State Legislation?
If the business wishes to donate customer branded product to a charity, has written authorisation been obtained from the customer/s prior to the donation?
Does the business maintain a logbook which records the date of donation, 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 / C/NC / Comments
Has a risk assessment been conducted to identify any potential or known risks to the integrity of the product supplied on a global scale?
(Issues such as adulteration, counterfeiting, mislabelling and dilution of product, either knowingly or not,are considered critical non-conformances.)
18.0 Insurance / C/NC / Comments
Is a certificate of currency evidencing product and public liability insurance of such an amount as considered acceptable by the customer being maintained as a controlled document?
Has each relevant customer confirmed any variation to this requirement in writing?

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