code of practice version 2 prevention of foreign body

Code of Practice Version 2

Prevention of Foreign Body Contamination

© 2018 Woolworths Ltd. Authorised External Distribution

COMMERCIAL IN CONFIDENCE

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Issue Date: 19/02/2019 Version Number: 02

Document: Woolworths Supplier Excellence Code of Practice- Prevention of Foreign Body Contamination

Contents Page No.

1. Introduction & Objective 2

2. Risk Assessment & General Requirements 3

3. Glass, Glass Like Material & Hard (Brittle) Plastic 6

4. Wood 8

5. Metal 9

6. Plastic 10

7. Paper/Cardboard 11

8. Verification & Monitoring of Elimination/Detection Systems 11

1. INTRODUCTION & OBJECTIVE

Foreign Bodies are one of the leading causes of customer complaints. They have the ability to harm customers, can cause choking, severe pain and potentially death. The aim of this COP is to ensure appropriate risk assessments, preventative measures and controls are in place to prevent foreign body contaminants entering Woolworths’ products.

As a minimum the site must have documented risk assessments and corresponding policies and procedures for potential foreign body hazards, including glass and glass like material (hard & brittle plastic), metal, wood, paper & cardboard, maintenance debris, personal effects, insects & pests, soft plastic is required. Irrespective of the use of foreign object detection systems, and a suitable complaint investigation and trend monitoring system must be in place. Foreign body audits must be completed at a frequency based on risk.

A full documented risk assessment should be used to identify potential foreign matter hazards as part of the factory HACCP system and the corresponding policies and procedures drawn up to control the potential hazards.

This document supports the Supplier Excellence Program and is intended to provide further clarity and guidance on implementation of these requirements. The intention of this document is that it is not to be used in isolation but as a supplement to the full requirements of the Supplier Excellence Program (or if you have a GFSI Standard in place, to that standard).



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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.

Section Clause

No. P R O Requirement

Compliance (Y/N add

comments)

2 Risk Assessment & General Requirements

2.1 Risk Assessment

2.1.1 P R The Supplier must carry out as a minimum a risk assessment of: ● Glass and Hard (Brittle) Plastic in production & storage areas ● The use of wood within the sites production and storage areas ● The type, use and positioning of metal tools, implements and equipment in the production and

storage areas, this may include metal that is used within the product i.e. metal cans, bag clips etc ● Plastic films and bags i.e. raw materials films, disposable PPE, WIP bags, product bags, etc ● The use of cardboard and paper ● Maintenance procedures, including tools, lubricants, cloths, gloves ● Hygiene procedures for personal effects ● Insects, rodents and other smaller live or dead contaminants ● Intrinsic foreign matter; e.g. bone fragments, seeds, etc.

The risk assessment should include details of the location of the material, its condition and proximity to ingredients/raw materials, product, packaging or production equipment, and likelihood of product contamination in the event of breakage or deterioration.

The expectation is that this risk assessment will be completed using HACCP principles and be documented in the HACCP plan.

2.1.2 R O All steps must be taken to identify, avoid, eliminate and control the risks of foreign object contamination. ● The risk assessment will determine the requirement for a foreign object detection and removal

system that is appropriate for the product being processed. E.g. metal detection for solids or filters for liquids.

● Processes must be designed to prevent foreign object contamination of the finished product. Examples may include enclosing the product, rinsing or washing the product, and inverting finished product packaging prior to filling.

Where elimination/detection systems are used the company must apply Industry best practice and establish



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limits for detection based on the type of product and its packaging as well as the position of the detector in the process.

● The system must operate at the optimum setup and validation records must be available to

demonstrate how the optimum setup is established.

● Systems that rely on other external factors such as line speed must consider optimum set up in the

validation process.

● Where multiple detection systems are utilised (such as sieves and metal detector), validation records

must include both systems and it should demonstrate how the limitation of one detection system is

being covered by the other.

● The system must be located at the appropriate point of the process to effectively remove the target

foreign body and this location recorded.

● The setup can be maintained without periodic adjustment. ● Other external factors that may affect the efficiency of the system must also be able to be

maintained without periodic adjustment (e.g. orbital force on the vibrating screen and temperature).

2.2 Equipment Controls

2.2.1 R O All pens used in production, storage and packing areas must be site issued, one piece and of a contrasting colour.

Staples, hole punches, drawing pins etc. Must not be used in production, packing or storage areas.

The number of miscellaneous items should be kept to a minimum and must retained in a closed container with an inventory.

Required miscellaneous items and utensils must be of a contrasting colour, detectable where possible and managed e.g. calculators, rulers, scoops.

2.2.2 R O The site must develop a register of necessary items permitted to be used in specified processing areas. ● Controls must be implemented to manage compliance to the list, including compliance by visitors

and contractors.

2.2.3 O Equipment used in the process must be suitable for use, durable, and used in the way originally designed. ● Unauthorised modified equipment can present a foreign object risk and must not be permitted. ● Multiple use containers must be assessed for suitability prior to each re-use.

2.2.4 R O Use of pressurised air lines must be risk assessed to ensure it is not a risk to product integrity and/or cross contamination.

2.3 Foreign Object Identification & Reporting

2.3.1 P R There must be a system in place for all staff to report a foreign object finding.

A detailed procedure must be in place to handle incidents when a foreign body is found in product (e.g. during a GMP audit or reported as a complaint) or the potential for foreign object contamination is discovered. As a minimum the following must happen.



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● All reported incidents must be documented and resolved as appropriate such that product is protected from the contamination risk, all investigations must involve liaison with raw material suppliers where appropriate.

● A full documented investigation must take place to ensure the source of the contamination is identified and that the risk of other materials being contaminated is assessed.

● Foreign object findings must be documented and trended to establish any common sources. ● Corrective actions must be put in place to prevent a reoccurrence, the root cause and corrective

actions must be documented.

2.3.2 P R Audits of Foreign Object Controls and management plans derived from risk assessment must be implemented.

● The foreign object audits must incorporate a “bag/bucket audit”. ● The frequency of this assessment must be based on risk i.e. nature of product/process, type and

history of contaminants found, levels of complaint etc. ● The results of the assessment must be documented and subject to management review. ● The results of bag/bucket audits must be trended to monitor progress and targets set to drive

continuous improvement. ● Where a risk is identified, the product must be protected and short-term and long-term corrective

action implemented and documented.

2.3.3 R O Checks for the presence of foreign objects on the production line and the immediate environment must be carried out at the start and end of production, or more often where a risk has been identified.

The items to be checked must be based on the risk assessment and may include for example: ● Condition of glass like/glass like and brittle materials ● Line cleanliness ● Machinery present and functioning: with no loose nuts, bolts, screws, etc. Conveyors will be

checked to ensure no missing pieces or shredding along their sides. Any missing pieces will be recorded, monitored and their replacement planned by maintenance

● Required people dressed as per site policy for the product about to be produced ● Any WIP (Work in Progress) & raw material containers have been checked for integrity (and where

applicable, identified and removed from the production area for disposal). The start-up check is to be documented and signed by the manager responsible for the area.



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Section Clause


Compliance (Y/N add

comments)

3 Glass, Glass Like Materials & Hard (Brittle) Plastic

3.1 General Requirements

3.1.1 O Glass, Glass Like Materials and Hard (Brittle) Plastic in production and storage areas must be replaced with suitable alternatives where possible.

Where this is not possible the item must be protected and monitored.

3.1.2 P R O A site risk assessment must be completed for the prevention of contamination of product with Glass, Glass Like Materials and Hard (Brittle) Plastic. Controls must be developed, documented and implemented to address the risks identified. These must include the following as a minimum:

● Policies for exclusion of risk materials into open food processing areas ● Procedures for maintenance and cleaning of risk materials to prevent accidental breakage e.g.

changing of a glass light fitting (globe) or cleaning light fittings ● All Glass, Glass Like Materials and Hard (Brittle) Plastic in production and storage areas must be listed

on a register and how they are controlled must be developed and maintained ● The register must show the location, number of items, type of item and its condition e.g. lights on

ceiling in a defined area and whether they are intact, cracked, piece missing ● The condition of all items on the register must be regularly assessed on a frequency derived from the

site risk assessment. This check must be recorded. Photographic evidence may be used of any existing damage, if immediate repairs are not possible

● The use of sealed breakage kits ● Breakage kits must contain all items readily required in the event of a breakage such as copies of the

breakage procedures, cleaning equipment suitable for use, and sign off documentation ● Conditions of glass and hard plastic items on machinery or immediately above or around a process line

may be checked as part of the pre-op daily start up sheet, this would be acceptable as part of a daily audit. Any issues raised must be investigated to establish if the glass breakage procedure has been followed and if not, whether product has been put at risk.

3.2 Handling Glass & Hard, Brittle Plastic Containers

3.2.1 P R O Where product packaging materials pose a safety risk (e.g. glass jars), special handling procedures must be in place to prevent product contamination covering:

● Intake checks ● General handling e.g. inversion using air or water blow/wash steps and coverage of line to prevent

broken glass being spread around area. Specific cleaning methods must be detailed for the packing line where breakages occur before the packs are sealed or during the sealing process.

● Records must be maintained of packaging failures and corrective actions taken. ● The records must include the time of the breakage and the exact location.



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● The quantity of product disposed must be recorded. ● For plastic packaging material, abuse/challenge test on packaging at different stages (e.g. frozen

state, during transit, thawed state, etc) must be conducted, drop height and drop weight must be considered as well to determine if the packaging can withstand the possible mishandling during the end to end supply chain.

(Exception: Product crates.) ● Where plastic crates are used for storage or distribution of raw materials, work in progress or finished

product, the Supplier must demonstrate crate condition and use controls are implemented to prevent contamination risk of product.

3.2.2 O Where raw materials are supplied in high risk packaging (e.g. glass jars or bottles and it is demonstrated as unavoidable) controls must be implemented to prevent product contamination.

● There must be dedicated, segregated areas for the storage of these containers both as raw materials in the warehouse, in production and packed finished product.

● Consideration must be given to the movement of these materials to and from storage areas i.e. material and product flow and how breakage incidents can be minimised during the movement of risk materials.

3.3 Glass Breakage

3.3.1 P R A detailed procedure must be in place for the management of Glass, Glass Like Materials & Hard (Brittle) Plastic breakages. This must include:

● Details of cleaning methods and equipment ● Stopping of production ● Restriction of movement through the affected area ● Quarantine of all food and packaging materials possibly contaminated. A record of product, codes, and

quantities to be logged for reference ● Designation of the size of area to be isolated and searched for fragments of glass or glass-like materials

(depending on location and type of breakage) ● Report to management ● Clean up of breakage and disposal/cleaning of cleaning equipment ● Safe removal of glass from area ● Repair or replacement of damaged item ● The checking of PPE (including footwear) and changing if necessary ● Completion of an incident log and sign off that production can restart, by a responsible/senior person. ● Where practical, piecing fragments back together to try to determine whether all of the glass has been

accounted for. ● A sample of broken glass must be retained in a safe manner ● Corrective action to prevent reoccurrence.

High pressure water, compressed air hoses or vacuum cleaners are not to be used as these are known to increase the dispersion of the broken material.



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3.4 Glass Replacement

3.4.1 P R Where possible, glass replacement must be carried out outside production hours.

Records should be kept of any glass replacement work in production areas.

Section Clause


Compliance (Y/N add comments)

4 Wood


4.1.1 O The use of Wood in production and storage areas where possible must be eliminated (e.g. hand tools, pencils, clip boards, furniture, brooms, etc.).

Where this is not possible the use must be minimised and suitably controlled.

4.2 Wood in the Product Zones

4.2.1 P R O Policies for the exclusion of wood into open food handling or processing areas must be documented and implemented.

Wood must not be permitted in open food areas unless it is an integral part of the product e.g. skewers in a kebab, cheese ripening shelves, wood chips for smoking.

Where this is the case, procedures must be developed and implemented for the specific control of this hazard.

All wood items in open product areas must be free from damage and splinters.

Where the use of wooden items is unavoidable and suitable alternatives are not available, it must be demonstrated all other options have been considered, and subsequent control measures must be documented and implemented.

Controls for wood used in processing must be based on risk assessment and must include as a minimum

Intake checks

Inspection for splinters or other damage

Procedures for handling a breakage.

4.3 Pallets 4.3.1 O Pallets, destined for Woolworths’ depots, must be in a good condition and not pose a contamination risk, e.g. protruding nails etc.

Wooden pallets and pallet debris must be controlled to prevent contamination risk of product.

● Where wooden pallets are utilised, product must be protected from contamination by wood or wood splinters e.g. by use of a slip sheet or other physical barrier.

● Areas where wood is allowed must be clearly marked.



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Section Clause



5 Metal


5.1.1 P R O There must be appropriate measures in place for the prevention of metal contamination.

Where metal is used in the process or integral to the product (e.g. bag clips, cans, lids, or other packaging/containers) then it must be suitably controlled. Controls may include:

Reconciliation of numbers

Inspection of conditions before and after production runs.

5.1.2 P O If canned ingredients are required to be opened for use, there must be a documented and implemented procedure to manage risks associated with this process.

5.1.3 R O Raw materials must be purchased in packaging free from metal closures e.g. staples.

5.2 Equipment 5.2.1 P R O A policy must document and describe the procedures implemented for the control of metal objects used in production e.g. knives, needles, cutting blades, stirring implements.

A record of inspection for damage of these items must be completed and documented.

Safe storage for this equipment must be available and used for equipment not in use.

5.2.2 R O Knife, blade, scissors, needle and sharp implement controls must be in place and include:

Company issued, captive, identified and registered knives blades and scissors must be used, all knives/scissors will be numbered to ensure that they can be accounted for.

No snap blade knives to be used.

Knives, blades and scissors must only be used for the task which they were designed for.

Equipment must be accounted for and the condition checked and recorded by a suitably qualified independent person (minimum start and end of production)

Procedures for handling a breakage and disposing of used/damaged equipment

Knife and blade sharpening should take place away from production areas. Knife sharpening with steels is acceptable in production areas provided they are not used over product, where sharpening devices are fixed within butchery/processing areas, the location and use must not pose a risk of contamination. Knives must been cleaned and sanitized prior to use after grinding or sharpening.

Knives and blades must not be stored in personal lockers, ideally shadow boards, magnetic holders or secure clean storage areas should be used.

Knife blocks or plastic scabbards, may only be used for temporary storage

5.3 Engineering 5.3.1 P R O Engineering activities must be controlled to avoid compromising product safety or quality. The following controls must be in place:

Startup checks of equipment must identify damaged or missing parts

In the event of damage or loss, all parts must be accounted for and the incident logged, Corrective Action must be taken to prevent re-occurrence



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Potential transfer of metal contamination from engineering areas must be suitably controlled (e.g. swarf mats)

Wire brushes and scourers must be in good condition and stored away from production process or below product height when not in use

After use the area where the wire brushes or scourers were used must be inspected

Mobile engineering workstations must not be used in open food areas.

Section Clause



6 Plastic


6.1.1 R O Where soft / flexible plastics are used for disposable protective clothing, in production, or for packaging of raw materials these must be risk assessed for potential plastic contamination of the finished product.

Plastics must be contrast coloured.

Film gauges to be specified to avoid the potential for entrapment or tearing.

Opening and resealing methods must minimise the risk of potential contamination e.g. the use of scissors or sharp knife and not tearing, linked to a bag opening procedure.

The site must work with its raw material suppliers to ensure raw materials are delivered in the most appropriate packaging for use.

Where frozen raw materials are wrapped in plastic the frozen goods must be tempered or defrosted for the whole and complete removal of the plastic before use in a product or process.

The correct type, grade and colour and quality of material must be selected for each application (e.g. WIP containers, PPE) consideration should be given to :

o Freezing o Blast chilling o Abrasion or impact damage o Washing o Exposure to hygiene chemicals (acids and alkalis).

6.2 Packaging 6.2.1 O The use of food containers (e.g. product trays, bags etc.) to store other materials must not be permitted.

6.2.2 P R O Where packaging materials pose a product safety risk, special handling procedures must be in place to prevent product contamination or spoilage.

Records must be maintained of packaging failures and appropriate corrective actions.



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Section Clause



7 Cardboard/Paper

7.1 Cardboard 7.1.1 O Cardboard must be minimised on site and not used in open product handling areas unless unavoidable e.g. cores for sealing film.

Where raw materials are packaged into cardboard, safe knives must be provided for opening product such that cardboard is not torn.

7.2 Paper/Labels 7.2.1 P R O The use of paper packaging in processing areas must be minimised and controlled.

A paper sack opening and resealing or decanting procedure must be developed, documented and implemented to prevent the contamination of product with packaging materials during opening.

7.2.2 O The type, condition and location of any labels used in production areas must not pose a risk of contamination.

Tags (of any materials) used in production areas must be controlled and detectable where possible.

Paper labels must be kept to a minimum, controlled and must be of a contrasting colour to product.

Section Clause



8 Verification & Monitoring of Elimination/Detection Systems

8.1 Verification & Monitoring

8.1.1 P R O All checks on the elimination/detection system must be documented and signed by the trained personnel who have carried out the check. THE ACTUAL TIME OF THE CHECK MUST BE RECORDED, the checks should include:

● Date, Shift, Operator responsible

● Product name, size, quantity of run, identification (batch or date code)

● Start of production, during production (at a defined frequency) and end of production

● Details of the checks (e.g. what was checked? How was it checked?). The strength or size details must

also be recoded

● Amount of rejects (count, weight or volume)

● Corrective actions for any failed checks. Investigation on any rejected product from production.

● Magnets must be kept magnetically clean.

8.2 Training 8.2.1 R All employees must be briefed on the material handling procedures during induction.

All production/hygiene managers and engineers must be trained to understand and apply these procedures and those of any elimination/detection systems used.



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Amendments

1. Introduction & Objective No change

Document - formatting

2. Risk Assessment & General Requirements 2.2.4 Use of pressurised airlines included.

2.3.1 Aspirational requirement removed

2.3.2 Aspirational requirement removed, reuse of plastic buckets removed.

General clarification and removal of redundant terminology and criteria that is covered elsewhere

3. Glass & Hard (Brittle) Plastic No change

4. Wood No change

5. Metal No change

6. Plastic No change

7. Paper & Cardboard No significant change, removal of criteria covered elsewhere

8. Verification & Monitoring of Elimination / Detection Systems 8.1 Renamed this Section – Verification & Monitoring and removed specific criteria that relates to elimination / detection systems and test pieces

code of practice version 2 prevention of foreign body

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