Code of Practice

Version 2
High Care and High Risk
 Contents Page No.
1. Introduction & Objective 2

1.1 Definitions 3

2. Determination of HC/HR Products 4

3. HR/HC Process Controls 5

4. Factory Services 8

5. Personal Hygiene Controls 9

6. Change Areas and Changing Procedures 11

7. Cleaning and Sanitation 13

Appendix 1 - Produce Decontamination 16

Appendix 2 - HC/HR Decision Tree 19

Appendix 3 & 4 - Time/Temperature Reference Charts 20 & 21

1. Introduction & Objective

Woolworths formally introduced auditable criteria for the manufacture of High Care and High Risk (HC/HR) products in 2013 as part of WQA version 8. This criteria has been reviewed and
we have developed this Code of Practice to continue ensuring our highest risk food products are manufactured safely.

Facilities can have High Care or High Risk areas or have both, segregated in the one site.

This auditable document supports the Supplier Excellence Program and is intended to further develop the requirements for relevant suppliers and their manufacturing sites.

© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 2 of 23
 1.1 Definitions

A physically segregated area of a manufacturing, processing or storage facility designed and operated to a high standard of hygiene where practices relating
High Care Area to people, ingredients, equipment, maintenance, environment and packaging are managed to minimise microbiological contamination of a ready to eat or
ready to reheat product containing some uncooked ingredients.
A ready to eat or reheat chilled or frozen food product comprising of some or all uncooked ingredients, which have been through a microbiological reduction
step.
High Care Products ● Produced in a High Care area.
● The product is dependent on temperature control and or other hurdles for the duration of its shelf life to minimise the growth of any surviving
pathogens.
A physically segregated area of a manufacturing, processing or storage facility designed and operated to a high standard of hygiene where practices relating
High Risk Area to people, ingredients, equipment, maintenance, environment and packaging are managed to minimise microbiological contamination of a ready to eat or
ready to reheat product comprising only of heat processed ingredients.
An ingredient that has undergone a thermal process designed to achieve a typical 6 log reduction in Listeria Monocytogenes, equivalent to 70°C for 2
Heat processed
minutes (as a minimum). Other thermal processes exceeding a Listeria cook e.g. a psychotropic Clostridium Botulinum cook equivalent to 90°C for 10
ingredient
minutes or sterilisation process may be used.
A ready to eat or re-heat chilled or frozen food product comprising of only cooked ingredients which have been through a heat process step. The product is
High Risk Products
produced in a high risk area and is dependent on temperature control and/or other hurdles for the duration of its shelf life to maintain product safety.
A term used to quantify the reduction of microorganisms after a decontamination process. For example this could apply to produce decontamination or
cooking.
For example; a "2-log reduction" means lowering the number of microorganisms by 100 fold, that is, if a surface has 100 pathogenic microorganisms
Log reduction on it, a 2-log reduction would reduce the number of microorganisms to one.
● 1 log reduction means number of microorganisms is 10 times smaller IE 10,000 to 1000
● 2 log reduction means number of microorganisms is 100 times smaller IE 10,000 to 100
● 3 log reduction means number of microorganisms is 1000 times smaller IE 10,000 to 10.
Decontamination Decontamination is a process of reducing microorganisms to a specified log reduction.
Intended Use Indicates how the end user is expected to use the product e.g. cook, ready to eat, defrost etc.

© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 3 of 23
 To help identify how the requirements must be met for each clause of the Industry Standard - Supply Chain Service Providers a
P, R, O has been indicated in the column between each clause number and the detailed description of the Standard Requirements.
P = Procedure: A documented procedure that has been fully implemented.
R = Record: Documented and accurately completed records have been maintained.
O = Observation: Compliance will be checked through observation of practices or adherence to procedures.

Clause Compliance
Section P R O Requirement
No. (Y/N add comments)
2 Determination of HC/HR Products
2.1 General 2.1.1 R The High Care/High Risk Decision Tree must be used to
Requirements identify the requirement for High Care/High Risk within a
facility.

Suppliers must clearly define and justify whether their

product range requires a High Risk or High Care process.
 This must be documented.

Suppliers must not produce High Risk products in High Care

Areas or vice versa.

(Refer Appendix 2 for full size decision tree diagram)

© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 4 of 23
 Clause Compliance
Section P R O Requirement
No. (Y/N add comments)

3 HR/HC Process Controls

3.1 Factory 3.1.1 O High Care/High Risk factory areas must comply with the below:
Layout ● Segregation of HC/HR to LR areas of production should be by permanent floor to ceiling structures
● If doors are used to segregate LR/HR areas they must not present a risk of contamination into HR/HC area
from the Low Risk environment, people or raw materials. They must not be used for personal access into
HC/HR. They must fit to the floor and should ideally be self-closing and be the rapid open/close style
● Up and over doors must not be used within the HC/HR processing, storage or production areas unless shown
there is no risk to product and existing controls for management of any potential risks identified validated
● To maintain positive air pressure, openings into the HC/HR areas must be minimsed; e.g. as small as practical
● Where panels are in place to allow the transfer of equipment these must be close fitting and sealed after
each opening. A full clean of the HC/HR production area must be carried out after each opening
● Conveyors should not pass from HC/HR into Low risk or vice versa, they should be independently cleanable
on either side. Sites must be able to demonstrate that there is no risk of contamination from Low Risk to
the HR/HC area from the environment, raw materials or people
● Uncooked protein e.g. raw meat or raw chicken must be stored separately from other ingredients that will be
not receiving a full cook prior to transfer to HC/HR; these ingredients must be stored and handled separately
throughout all areas of the factory to prevent cross contamination
● Electric Fly Killer Units/Flying Insect Control Unit must not be placed in high care/high risk area
● Where there is significant maintenance or repairs take place in the HC/HR area on a routine basis, sites should
have separate maintenance and storage facilities for the HC/HR and Low Risk sides of the facility.
3.2 Transfer 3.2.1 P R All ingredients, packaging and other consumable items must be risk assessed to determine that the transfer process
Processes used to enter the HC/HR area has a sufficient microbiological reduction and that the method of transfer prevents
cross contamination from the Low Risk environment, materials or personnel.
● HACCP flow diagrams for a site must show transfer points into and out of the HC/HR area.
● Each transfer process must be risk assessed via the HACCP plan, and must be validated annually as a minimum
and monitored as a CCP or as a pre-requisite control.
3.2.2 P R O Food materials to be passed into High Risk areas without a suitable log reduction step by the site, must have been
subject to a validated log reduction process step as part of the processing by the supplier;
● This must be assessed and documented by the sites HACCP team.
● The following items, (not an exhaustive list), must be restricted from entering the HC/HR due to their lack

© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 5 of 23
 of inherent product safety; unpasteurised meats, sprouting seeds, non heat treated spices, unpasteurised
cheeses.
● Ideally a site should not handle raw protein as well as wash produce. If the site does handle both raw
protein, e.g. raw meat or chicken, as well as decontaminate produce; for use without further cooking, i.e.
into a High Care Area, the site must assess the product flows of each of the materials to ensure that there is
NO crossover and any risk of cross contamination is managed.
― This must be included in the sites HACCP risk assessment.
● Ingredients being transferred into HC/HR without a validated log reduction step by the site must have either a
COA or be positive released. This will depend on the nature of the material and the site must document the
risk assessment for this.
● Sanitised produce that has not been subjected to a cook must not enter High Risk areas.
● Where an ingredient is further handled by the manufacturer prior to arrival at the HC/HR sites, the HACCP
team must reassess the product.
― For example; whole chubb ham will not need to comply with this COP as the whole surface can be
decontaminated on transfer to HC/HR site, however sliced ham would need to be produced in a High
Risk environment at the supplier and comply with this COP.
● Suppliers of raw materials that do not have an inherent safety control, that are transferred into High Care /High
risk, without receiving a full cook by the site must comply with this COP.
3.2.3 P O HC/HR decontamination transfer processes must be in place at the HC/HR barrier with the entry to decontamination in
the low risk area and the exit in the HC/HR area
● Finished packaged product must not return from low risk to a HC/HR area (e.g. for re-packing) without a
decontamination transfer process being in place.
● If it is necessary for work in progress to be stored in Low Risk, it must not be transferred from low risk to a
HC/HR area without a decontamination transfer process being in place.
● Wheels and dollies must not be used to transfer packaged ingredients and/or products from LR to HC/HR
without being fully decontaminated.
● Other items that are not listed and are needed for use in HC/HR, must be subjected to a
decontamination process as appropriate.
― This must be documented as part of the site’s HACCP plan.
3.3 Transfer 3.3.1 P O ● Packaging must be removed from the outer box/wrapper close to the transfer point and not stored at this point.
Methods ● The packaging inner bag must be passed into HC/HR via a hatch/chute/interlock/door that can only be
opened from HC/HR.
● Part packaging should ideally remain in HC/HR, if it has to be returned to Low Risk then it needs to be bagged
in HC/HR prior to transfer.
● The Low Risk transfer area must be maintained to a good level of hygiene so as to prevent contamination
during this step.
© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 6 of 23
 3.3.2 P O The following methods can be used for the transfer of fully packaged items that have been risk assessed and
approved to be passed directly into HR/HC without a cook or decontamination step. The outer packaging is
decontaminated, not the product itself.
Disinfectant spray tunnel or disinfectant dip tanks
● The system used must allow for full coverage of disinfectant onto the exterior of the raw material packaging.
● Sites must validate the transfer of ingredients into HC/HR ensuring that the lowest chemical
concentration still gives a sufficient level of decontamination.
Double Bagging/Hatch Transfer
● This must only be used where submersion of the product is not possible, the sites HACCP team must have
assessed transfer method and specifically deemed that it or the product to not to be a risk to the sites
HC/HR area.
Decontamination controls must be in place for the entry of ‘adhoc’ equipment and tools into the area, including tools
from Contractors, as per section 7.
3.4 Cooking - 3.4.1 P R O Sites must include the following worst case scenarios in the validation study for cooking steps:
validation ● Cold spots in the equipment; the site must demonstrate that they have determined if there are any cold
spots within the cooking vessel, and that the cooking program will still achieve the required product
temperature in these spots
● Where belts are used the site must monitor and record belt speeds
― The correct settings must be documented as part of the procedures and should form part of the
process control records.
● The site must have assessed the raw material and understand that the required core temperature is still
achieved with the largest piece size
― The maximum raw piece size must be documented in the raw material specification and be verified prior
to cooking.
● The validation study must include the maximum loading of the process and have been completed at the
correct batch size
― Methods must document loading parameters for operators.
● Validation must be conducted at the lowest possible ingoing temperature.
3.5 Cooling 3.5.1 P R O Cooked food must be cooled as per validated time/temperature profiles. Where legal requirements exist in regards to
cooling profiles for products, legal requirements shall be met and processing conditions validated to demonstrate
compliance.

© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 7 of 23
3.6 Produce 3.6.1 P R O ● If washing produce and using in High Care, without a full cook, the site must comply with the Produce
Decontamination decontamination requirements in Appendix 1.
● Sites using ready washed produce without any further washing steps must purchase from sites that comply
with this Code of Practice and Appendix 1.

Clause Compliance
Section P R O Requirement
No. (Y/N add comments)

4 Factory Services
4.1. Drainage 4.1.1 P O ● Drains should ideally be separate from Low Risk HC/HR areas.
● Water drainage from floors and equipment must be designed to flow away from the HC/HR barriers and water
must flow directly to drains not across floors to prevent water pooling.
● Where a risk is identified of the possibility of back flow contamination and if high risk, an incident plan is to be
developed.
4.2 Ventilation 4.2.1 R O Air Handling Systems:
and Extraction ● The air handling system must be to be designed to provide positive pressure within the High Care/Risk
Area, the speed of air across the barriers and at openings must be sufficient to ensure that the flow is
moving from the HC/HR environment to Low Risk.
● The positive air pressure must be verified after any change in the facilities that may affect air flows at a
frequency based on risk assessment.
● Return air from non-food processing areas should not be circulated to food processing areas.
● Inlets and exhausts for air handling systems when on the exterior to a building must be proofed to
prevent pest ingress
● Adequate extraction must be in place to ensure that product cross contamination is not able to occur
e.g. from dripping condensation at transfer points.
● Air quality must be carried out to monitoring for microorganisms, using pre-selected agar plates.
― These results must be trended, there must be appropriate actions implemented when levels are trending
up. The method on which the air is being sampled should be documented and consistent.
4.2.2 R O Filtration:
● Air filtration must be in place
● Filters must be regularly inspected and replaced as required in a documented maintenance schedule
● Filtration sizes and specifications shall be documented and effectiveness for control of contaminates
validated
● If air socks are in use they should be made of polypropylene or polyester rather than cotton, they must be
identifiable for use in HC/HR risk areas.
© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 8 of 23
 4.2.3 R O Cleaning:
● Ventilation and extraction systems must be hygienically designed, have access for cleaning and ideally
constructed with stainless or galvanized steel internal surfaces. All services (including air lines, pipework,
cabling, etc.) must be able to be cleaned effectively within the area it is situated
● A cleaning schedule must be in place for the system
● If air socks are in use they should be sited to avoid splashing from products and must be inspected both
internally and externally at a regular frequency, e.g. monthly, and cleaned regularly as a minimum twice
yearly
― This frequency must be determined by environmental contamination and evaluation of air plates
results.
4.2.4 O The formation of condensation must be minimized and managed in order to present no risk to product.
4.3 4.3.1 O For chilled and frozen products, the assembly of finished products should must take place in an environment
Temperature designed to ensure that the temperature of chilled raw materials, components and finished product does not
o
Control exceed 8 C (e.g. shorter time exposure) or as per any stated legislative requirement.

4.4 Waste 4.4.1 R O A system must be in place to ensure that the integrity of the low risk/high risk divide is not compromised during waste
removal.
● Best practice is for waste to be removed from HC/HR through a one way waste disposal system into Low Risk.
● The process of removing waste must not involve passing of dollies/wheels from HC/HR into Low Risk or
the use of ante rooms that allow access to both Low risk and High Risk personnel.
― Staff must be trained on the correct protocols for the facility.
● Where waste bins have lids they must be hands free.
● Waste bins must be dedicated to HC/HR and must be regularly cleaned and sanitised.

Clause Compliance
Section P R O Requirement
No. (Y/N add comments)

5 Personal Hygiene Controls

5.1 Hand 5.1.1 P R O Hand washing controls must be in place at all entrances to HC/HR areas.
Washing ● Due to the risk of aerosol contamination air hand dryers must not be used in HC/HR production areas.
To monitor hygiene practices hand swabs or contact plates, both post washing and online in production must be
undertaken.
● There must be a documented procedure for the swabbing technique.
● The frequency must be a minimum of 6 monthly for each person, who works in or enters the HC/HR area and be
© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 9 of 23
 unannounced.
● The site must have a corrective action procedure, with defined microbiological limits that are appropriate
to the process, degree of handling and other factors that may impact the type of flora that could
contaminate hands. Acceptable target limits:
● Where Coagulase positive Staphylococci is relevant - <100 cfu
● Enterobacteriaceae or Coliforms - <100cfu or E.Coli - < 10 cfu

●The corrective action procedure must assess if the out of target result is due to poor hygiene practices,
touching items that have not been cleaned correctly or if the person is a carrier. Actions can include re
training of staff.
● Results must be trended to check for consistent fails.
5.2 Protective 5.2.1 O Dedicated and easily identifiable protective clothing including boots, protective coats and hair net/mob caps must be
Clothing available for HC/HR areas of the factory.
Requirements ● Protective clothing worn in HC/HR must be visually different to those worn outside these areas.
● Coats should be fabricated in a pale colour to allow for easy identification of food build up and the need to
change coats.
● Protective clothing must not be worn outside of HC/HR production area, including in toilets, smoking area or
canteen.
5.2.2 P O Hair covering:
● Hair must be covered with a disposable/or single use hair net/mob cap identifiable to HC/HR
● These must be worn over the ears and disposed of on exiting the area
● Beard snoods must be worn where required
● If access to HC/HR is through the Low Risk area the Low Risk hair covering must be kept on and the HC/HR
covering placed over the Low Risk as the first step of the changing procedure.
5.2.3 R O Overalls:
● Boiler suits should not be used for HC/HR areas.
● Where boiler suits are worn, sites must formally train and monitor staff to ensure correct method of
putting on the boiler suit is followed.
● Where there is a HC/HR workshop, engineers must wear protective clothing over the HC/HR overalls in this
area.
5.2.4 R O Laundry and Storage of Protective Clothing:
● The process used in laundries supplying HC/HR production environments must be validated to remove
pathogens, e.g. garments must be processed so they are washed at a minimum of 65°C for 10 minutes and
heat dried.
● Laundering of HC/HR protective clothing must be carried out separately from Low Risk protective clothing.
● The process of delivering the coats into HC/HR from the laundry and intermediate storage must protect
© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 10 of 23
 the clean and disinfected clothing from recontamination.
● The method of collecting and storing HC/HR clothing must be controlled such that these items are
segregated from Low Risk clothing.
● The method of restocking the HC/HR area with clean protective clothing must be defined and must reduce
contamination, e.g. the use of double bagging and individually wrapped protective clothing.
5.2.5 P R O Boots:
● HC/HR boots must be clean and easy to identify.
● Boots must be captive to the HC/HR area and boots must be stored on the HC/HR side of the barrier.
● Boots worn in HC/HR area must be visibly clean on entry to HC/HR area.
― Method and frequency of cleaning must be documented and validated.
● If a boot wash or foot bath is used this must be maintained in a clean hygienic operation, and monitored
to ensure the correct dosing of detergent sanitiser.
● Water in HC/HR areas must be kept to a minimum and due to the risk of aerosol contamination, boot washers
/scrubbers are not permitted in HC/HR manufacturing areas.
● Storage of boots must be off the floor, these should ideally inverted to enable inspection, cleaning and drying.
● Environmental swabbing and visual monitoring of boots must be in place to establish controls are being
maintained.
● Where disposable shoe coverings are used these must be kept to a minimum and be of robust enough
design to not become damaged during the wearing of them.
5.2.6 R O Gloves / Disposable PPE:
● Staff must be trained to understand the requirement to wash hands/change gloves after touching sides of
equipment, cleaning utensils, trolleys and racks

Clause Compliance
Section P R O Requirement
No. (Y/N add comments)

6 Change Areas and Changing Procedures

6.1 Change 6.1.1 P O A designated HC/HR changing area must be in place in order to ensure that HC/HR protective clothing is protected
Areas against contamination.
● There must be a physical barrier/raised area in place between Low Risk areas and the HC/HR changing
area, to prevent any contamination occurring in the changing area; this must be a solid bench sealed to
the floor.
● There must be sufficient space in the changing area as to prevent contamination of HC/HR coats by boot.
● There must be adequate segregation between dirty and clean protective clothing.

© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 11 of 23
 ● Hand wash sinks in HC/HR areas must have non-hand contact operations and be designated for hand washing
only.
● Instructions with photographs for each stage of the HC/HR changing procedures must be in place to
include entry and exit from the area.
6.2 Factory 6.2.1 P O The procedure to enter HC/HR must be set out in such a way as to minimise cross contamination from hands, shoes
Entry /Exit and hair.
Procedures ● The staff entry into HC/HR must only be used for entry of people or disposable PPE to the area, not for raw
materials and or other consumables.
● Access to HC/HR production areas must be restricted to personnel required to be present in the area.
Changing sequence:
1. Put on mob cap and/or hairnet
2. Remove low risk shoes/boots
3. Step/wing over barrier between low risk and HC/HR area
4. Put on clean HC/HR risk boots
6.2.2 P O The procedure for leaving the High Care/High Risk area must incorporate the protective clothing being removed in
reverse order from the entry, (with the exception of hair covering).
Changing sequence:
1. Remove protective coat
2. Remove high care/high risk boots
3. Step/ swing over barrier between high care/high risk area and low risk
4. Put on low risk shoes/boots
5. Remove mob cap and/or hairnet
6.2.3 P R O Where a site deviates from the requirements in 6.1 or 6.2 they must demonstrate that their procedure minimises the
risk for their particular layout.

© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 12 of 23
 Clause Compliance
Section P R O Requirement
No. (Y/N add comments)

7 Cleaning and Sanitation

7.1 General 7.1.1 P O HC/HR areas must be maintained to high standards of cleanliness and hygiene; clean as you go principles must be
Requirements in operation at all times.
● Cleaning must be conducted in such a manner as to prevent the generation of aerosols and that product
contamination from the act of cleaning does not occur.
● In line cleaning/CIP systems must be designed to ensure that there is effective removal of debris from
all the internal surfaces.
● The potential for build-up of contamination (i.e. Biofilms) on specific equipment during the normal
production period must be considered and intermediate or full cleans put in place to remove this risk.
7.2 Periodical 7.2.1 R ● Other than single use items such as scoops and knives, periodical cleaning schedules must be in place and
Cleaning maintained for all areas and equipment in the HC/HR environment. This must include floors, walls, cleaning
Schedule areas, equipment storage areas, drains, forced air chillers, ceilings, air socks, air handling system, pipe work,
over heads, moveable items such as mobile trolleys, pump trucks, ladders and engineering tools.
● The frequency of the periodical clean must be stated and the site must be able to demonstrate that
they review this frequency and amend if the time is too long between cleans.
● Sites should review the need to alternate sanitisers in use to help prevent build-up of bacterial resistance to the
routine chemical.
7.3 Equipment 7.3.1 P R O Cleaning equipment for HC/HR areas must be:
― Captive to the area and be colour coded or labelled for use in HC/HR areas only.
― Stored clean and in a way to prevent microbiological contamination, e.g. stored dry or in clean,
monitored sanitiser solution.
― Floor cleaning equipment must be stored blade/bristle down and away from walls and separate
from food contact cleaning equipment.
● Double blade squeegees, foam blade squeegees must not be used.
● Cleaning using compressed air must be risk assessed to show that there is no risk to products and that this
type of clean is appropriate. Where used, compressed air must be filtered to remove contaminates to ISO
8573 or equivalent.
● Material mops must not be used in HC/HR areas.
● Hoses may be used during production where a risk assessment shows there is no risk to product. The pressure
must not cause aerosol generation.
● The occasional use of specialist cleaning equipment must have documented decontamination procedures in
place.

© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 13 of 23
 ●
Dedicated labelled/colour coded brushes/cleaning equipment must be in place for drain cleaning. These must
be stored separately from other cleaning equipment and in such a way as to not contaminate other
items/product etc.
7.4 Dedicated 7.4.1 R O When cleaning occurs during production and no other methods of segregation from potential contamination are
Cleaning / possible, there must be a dedicated HC/HR cleaning area.
Storage Area ● This must be sufficiently segregated from other areas of HC/HR to prevent aerosol contamination and
should ideally have floor to ceiling permanent walls to separate from other areas of HC/HR.
● Aerosols from cleaning areas must be controlled to prevent contamination of production areas, i.e.
contained area, close fitting doors and sufficient extraction.
● Condensation must be ducted away from the room preferably to the outside to prevent the build-up of
condensate.
● All HC/HR movable equipment and machinery must be cleaned in this area.
● Automated cleaning systems, e.g. automated tray washers, must be maintained in a hygienic condition,
monitored to ensure that water temperatures and chemicals being used are within agreed tolerances.
● The layout of the cleaning area/storage area must be such that clean equipment is not contaminated from
dirty equipment, from either entering the room or during cleaning.
● Clean equipment storage areas must be maintained clean and dry.
● Clean equipment not used immediately and stored for a period of time may need to be disinfected prior to
use; sites must have assessed if this is needed.
● Where sites use equipment such as trolleys and bins, there must be in place equipment to allow the cleaning
and inversion of trolleys and bins so that during cleaning food contact surfaces do not touch the floor.
7.5 Post 7.5.1 P R All areas of the HC/HR production environment must be subject to a detailed documented pre-operational
Cleaning examination. (This can incorporate the sign off needed post the cleaning activity)
Inspection ● This should be a cross functional exercise and must be documented with corrective actions taken for
unsatisfactory conditions identified.
● ATP/Rapid swabs can be used to release specific items of equipment but must not replace the regular bacterial
swab program.
7.6 Cleaning 7.6.1 P R A regular environmental swab program must be in place for the purpose of validating controls in the facility and to
Verification verify the continuing effectiveness of cleaning program.
Environmental monitoring results must be promptly reviewed to identify potential routes of contamination, allowing
for implementation of corrections before product contamination occurs.
Swabbing program:
 The environmental monitoring program including swab locations, frequency, target organisms and methods
shall be based on risk assessment.

© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 14 of 23
 
The swab program must be appropriate to the nature of the product and the manufacturing process, (e.g. a
product that will support the growth of Listeria sp. and is open to contamination will need a more in depth
validation program than a product that will not support the growth of Listeria).
 A procedure must be in place for the environmental swab program and must include:
― Target organisms
― Frequency of swabbing, based on risk
― Location of swabbing points based on risk
― Method for swabbing techniques and details on specific sampling equipment and techniques
― Limits of acceptability and corrective action to be taken
― When the samples are taken (i.e., during or at the conclusion of operations).
● The upper count for swab results must be documented and used to assess if a swab is a pass or fail, any
Listeria detection is a fail.
● Listeria swabs must be tested for presence of Listeria, any detection must subsequently be tested for
speciation.
― Listeria sp. detections must be notified to Woolworths as soon as advice received as to the result.
― Results post enumeration and speciation to be advised to Woolworths again immediately on receipt.
7.6.2 P R Sites must have in place a Listeria positive and hygiene swab fail corrective action procedure.
● This must detail the steps to be followed to ensure that the investigation into the controls and procedures
associated with the cleaning and or Listeria control for that point is thorough and sufficient.
● Where there is an increase in environmental positive results sites should undergo a full independent
review of cleaning practices and scheduling.
● The site must include extra swabs as part of the investigation and for verification that corrective actions
have rectified the failure.
● Swab failures and corrective actions must be included in the senior management review report. (Refer Food
Manufacturing Standard Sec 1.6)

© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 15 of 23
 Appendix 1: PRODUCE DECONTAMINATION
Clause Compliance
Section P R O Requirement
No. (Y/N add comments)

1 Risk Assessment
1.1.1 P R O A risk assessment must be in place for produce components that will enter High Care. This must include below, as a
minimum:
 Review of supplier’s accreditation.
 Review of pathogen test results (e.g. Salmonella, Listeria)
 Intended use of produce
 Volume of the supply
 Raw material supplier history
 Intrinsic risk of raw material, e.g. leafy vegetables grown close to soil present greatest concern in terms of
microbiological hazards.
 Potential impact and actions that will be needed for change in growing conditions or grower susceptibility
to weather extremes (rainfall, drought, heatwave floods etc.).
The risk assessment must be undertaken as part of production trials before raw material/product is manufactured for
commercial use. Risk assessment should take place before trial raw material goes into High Care.
This risk assessment must be used to determine:
 The selection and approval of appropriate suppliers
 The frequency of raw material sampling and testing and other forms of verification
 Supplier performance measures and methods
 Appropriate/need for produce decontamination methods.
2 Produce Decontamination Process
2.1 Schedule 2.1.1 P R The schedule of produce decontamination must take into account the nature of the raw material and its
microbiological loading.
2.2 2.2.1 P R O Pre-decontamination processes e.g. removal of calyx, peeling and removal of stems should ideally take place in the
Preparation Low Risk area. Where this is happening in HC, the site must be able to demonstrate that there is no risk of
contamination to the HC environment.
 Any preparation or cutting of the produce item on the Low risk side must be sufficient to give the microbial
log reduction in subsequent washing steps, but not too excessive as to allow for damage or deterioration of
the produce during the washing itself.
© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 16 of 23
2.3 Pre-wash 2.3.1 P R O Suppliers who are washing and preparing produce for further use in ready to eat /ready to reheat products must
follow the below for the initial wash stage:
● Pre-washing must be carried out in clean potable water to remove surface dirt and dust
● Produce must be fully submerged and separated to ensure the wash step is completed effectively
● The time between changes of water must be validated considering worst case scenario for micro loading
● Agitation must occur at the first wash stage to remove soiling and aid foreign body removal. Agitation can be
either automatic or manual but it should be verified as effective in removing soiling
● The agitation method must maximise debris removal and minimise damage. Damage to the product will leave
it more susceptible to microbiological growth and physical deterioration over life of product
● If water from prewash is reused, a biocide must be used to minimise the risk of microbial build.
2.4 Second 2.4.1 P R O The second stage wash must include the addition of a biocide.
Stage Wash ● Produce must be fully submerged and separated to ensure the wash step is completed effectively.
2.5 Drying & 2.5.1 P O To slow down potential product spoilage, processes to ensure the removal of excess water from the surface of the
Removal of decontaminated produce must be employed.
Water
3 Biocide Wash
3.1 Biocidal 3.1.1 P R O ● The specific sanitiser chosen by manufacturing supplier must be chlorine based, paracetic based (PAA) or any
Wash other recognised approved validated biocide.
● Supplier should have sufficient scientific evidence that chosen sanitiser/biocide can actually reduce the levels of
bacteria to acceptable levels.
4 Validation
4.1 Validation 4.1.1 R O The produce decontamination process used must be validated to demonstrate the processes capability of reducing the
microbiological load to a defined acceptable limit (as per product specification or industry standards).
Validation must include the following elements:
● Defined washing / biocide parameters and critical limits of the decontamination chemical and wash medium
● Evidence that the specified frequency of wash water changes allows the microbiological load to be reduced to a
satisfactory level
● Wash tank loading inclusive of maximum volumes of produce
● Consideration of the lowest /worst case scenario for the critical limits and produce quality
● Include a representative range of raw materials varying in complexity, origin and food safety risk
● Any change in process/condition is required to undergo full re-validation.

© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 17 of 23
5 Verification
5.1 Verification 5.1.1 P R O The supplier must develop and document an ongoing monitoring and verification schedule for the produce
Program decontamination process used, including a defined set frequency.
As a minimum the following must be included:
● Verification of the biocide concentration during the operation, per batch, as per the site’s defined
frequency
● Corrective actions for results outside the critical limits and consider results reported both above and below
set limits
● Verification that wash water changes have been undertaken as per validated process.
Records of monitoring and verification checks must be maintained.
5.1.2 P R Sites must have in place an ongoing microbiological testing regime of the raw material, decontaminated produce and
finished product including following as a minimum:
● Enterobactericae/Thermotolerant /Feacal Coliforms
● TPC
● E.coli
● Listeria species
● Salmonella.
Sites shall consider other pathogens as appropriate to their site/process /raw materials/environment.
No pathogen testing shall take place on High Risk or High Care sites – this shall be subcontracted to a third party
accredited laboratory.

© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 18 of 23
 Appendix 2: Decision tree to determine the risk category of Manufactured Food

© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 19 of 23
Appendix 3: Equivalent time / temperature combinations processes to achieve 70 oC for 2 minutes - calculated using a z value of 7.5oC
Temperature (°C) at slowest heating point Lethal rate (equivalent mins to 1 minute at 70oC) Time (mins) required at the reference temperature to
achieve an equivalent process
61 0.063 31.74
62 0.086 23.26
63 0.116 17.24
64 0.158 12.66
65 0.215 9.30
66 0.293 6.83
67 0.398 5.02
68 0.541 3.70
69 0.735 2.72
70 1.00 2.00
71 1.36 1.47
72 1.85 1.08
73 2.51 0.80 (48 seconds)
74 3.41 0.60 (36 seconds)
75 4.64 0.43 (26 seconds)
76 6.31 0.32 (19 seconds)
77 8.58 0.23 (14 seconds)
78 11.66 0.17 (10 seconds)
79 15.85 0.13 (8 seconds)
80 21.54 0.09 (5 seconds)

o
This table is for illustrative purposes only. The equivalent times given are dependent on the z value of the organism in question, which in this example is given as 7.5 C. Z values vary from
one strain to another, and can also change with temperature.

© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 20 of 23
Appendix 4: Equivalent time/temperature combinations for spores of non-proteolytic C. botulinum
Temperature (°C) Time (mins)
80 129
81 100
82 77
83 60
84 46
85 36
86 28
87 22
88 17
89 13
90 10
91 7.9
92 6.3
93 5.0
94 4.0
95 3.2
96 2.5
97 2.0
98 1.6
99 1.3
100 1.0

This table is for guidance purposes only and will require validation for your own products and processes.

© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 21 of 23
 Amendments
1. Introduction & Objective No change
Document - formatting
1.1 Definitions No change
2. Determination of HC/HR 2.1.1 Included graphic of the High Care/High Risk Decision Tree
Products 2.1.1 Removed guidance detail of HC/HR area Risk Assessment. Product Design aspects are covered in Design aspects of COP – WOW Product
Requirements
3. HR / HC Process Controls 3.1.1 Up and over doors not used unless shown there is no risk to product and controls are validated
3.4.1 Definition of cooling to 5oC in 4 hrs removed and stated as per validated time / temperature profiles or as per legal requirements where a legal
requirement exists.
4. Factory Services 4.1.1 Removal of “Backflow Incident” procedure and limited to Incident Plan to be developed.
4.2.1 Removal of prescriptive detail on air flow, positive air pressure and air changes per hour. External ventilation stack height – removed. Guidance on
Fogging removed.
4.2.2 Prescriptive detail on filter gauge removed.
4.2.4 Requirements in regards condensation simplified.
4.3.1 Prescriptive guidance on environment temperature in preparation area removed.
5. Personal Hygiene 5.1.1 Guidance statement on Automated Turnstiles removed. Removed requirement “to identify staph aureus carriers” through hand swabbing. Provided
Controls target limits dependant on the target organism and simplified hand wash verification criteria.
5.2.5 Removed requirement for daily cleaning of boots and replaced with requirement for boots to be clean on entry and that the frequency of cleaning be
documented and validated.
6. Change Areas and No significant change, minor re-organisation of wording.
Changing Procedures
7. Cleaning and Sanitation 7.1.1 Guidance information on listeria, cleaning methodology and biofilms removed and only the criteria for compliance listed.
7.5.1 Simplified to Post Cleaning Inspection verification with requirements for CIP Systems effectively covered in Base Standard.
7.6.1 Guidance statements removed. Location and frequency of swabbing to be risk based.
Appendix 1 – Produce General – Guidance statements around communication removed. Supplier Approval/Audits and raw material storage removed as covered in Base
Decontamination Standard.

© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 22 of 23
 4.4 Criteria for removal of excess water clarified and simplified.
8.1 Validation – Clarification and rewording in regards Validation requirements for Produce Decontamination processes. Removal of some statements that
are guidance and not criteria i.e. Produce Grouping Validation methods etc
9.1 Remove Titration Testing and strip test requirements and leave as a requirement that the biocide concentration be verified at defined frequency as per
HACCP plan.
Appendix 2 - HC/HR No change
Decision Tree
Appendix 3 & 4 – No change
Time/Temperature
Reference Charts

© 2018 Woolworths Ltd. Authorised External Distribution Issue Date: 19/02/2019 Version Number: 02
COMMERCIAL IN CONFIDENCE
Document: Woolworths Supplier Excellence Code of Practice – High Care High Risk
Page 23 of 23