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,) BRCIIOP

High Hygiene Risk Category

The requirements relate to packaging factories producing packaging materials for products that require the highest hygiene standards during manufacture. They involve packaging that comes into direct contact with food products (or other designated hygiene-sensitive products*). This includes primary packaging used for food or other hygiene-sensitive products where there is no absolute barrier in place. "Those produets intended for human consumption or which come into contact w ith the body, such as application to the sk in.

D 1.1

Senior Management Commitment and Continual Improvement

Product safety and quality management policy

The company's senior management shall develop and document a product safety and quality policy, which is authorised, reviewed, signed and dated by an appropriate senior manager.

aause Requlrements

1.11 The policy shall state the company's intention to meet its obligation to produce safe and legally compliant products to the specified quality, and its responsibility to its customers. This shall include a commitment to a process of continuo us improvement.

1.12 The company's senior management shall ensure the policy is communicated to all staff involved with activities relating to product safety, legality, regulatory compliance and quality.

17 ___ _

BRC Global Standard for packaging & Packaging Materials ruit!] r InforrnJtlon dV811abie at wwwbreglobalstanddlJs COlli

1.2 Senior management commitment FUNDAMENTAL

o

ClaUH

1.2.1

1.2.2

1.2.3

1.2.4

1.2.5

1.2.6

1.2.7

1.2.8

18

The company's senior management shall demonstrate that they are fully committed to the implementation of requirements of the Global Standard for Packaging & Packaging Materiais. This shall include provision of adequate resources, effective communication and systems of management review to effect continual improvement. Opportunities for improvement shall be identified, implemented and fully documented.

Requirements

The company's senior management shall ensure that product safety and quality objectives are measurable, established, documented, monitored and reviewed.

The company 's senior management shall provide the human and financial resources required to implement the processes of the quality management system and product safety programme.

Clear communication and reporting channels shall be in place to report on and monitor compliance with the Standard.

The company's senior management shall have a system in place to ensure that the company is kept informed of all relevant legislative requirements in the country of manufacture and, where known, the country in which the packaging material will be sold . The company shall also be aware of any scientific and technical developments and industry codes of practice applicable.

The company shall ensure that the materials manufactured comply w ith the relevant legislation (including any legislation concerning the use of recycled content) in the country of manufacture and in which the products are intended to be sold and/or ultimately used, where known.

The company's senior management shall ensure that non-conformities identified at the previous audit against the Standard are effectively actioned.

The company shall have a current, original copy of the Standard available on site.

Where the company is certificated to the Standard they shall ensure that recertification audits occur on or before the audit due date indicated on the certificate.

BRCIlOP

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1.3 Organisational structure, responsibilities and management authority

The company shafl have a clear organisational structure and define the responsibilities, reporting relationships and job functions of those personnel whose activities affect product safety, legality, regulatory compliance and quality.

Clause Requirements

1.3.1 The company shall have an up-to-date organisation chart demonstrating the structure of the company.

1.3.2 Within the management team there shall be a designated competent manager and deputy with the responsibility for coordinating compliance with the Standard.

1.3.3 Documented, clearly defined responsibilities shall exist and be communicated to key staff with responsibility for product safety, legality, regulatory compliance and quality systems.

1.34 There shall be appropriate documented arrangements in place to cover for the absence of key staff.

1.3.5 The company's senior management shall ensure a description of general duties or work instructions are in place and communicated to all those members of staff involved with activities relating to product safety, legality, regulatory compliance and quality.

1.4 Management review

The company's senior management shall ensure th at a management review is undertaken to ensure that the product safety and quality programme is fully implemented, effective and that opportunities for improvement are identified.

Clause Requirements

141 The review process shall be undertaken at appropriate planned intervals; as a minimum annually.

14.2 The review process shall include the evaluation of:

previous management review documents and action plans

internal, second-party and third-party audits

customer performance indicators, complaints and feedback

incidents, corrective actions, out-of-specification results and non-conforming materials

resource requirements.

14.3 The review process shall set objectives and continual improvement targets. 144 Records of management reviews and action plans shall be documented.

14.5 The decisions and actions agreed within the review process shall be effectively communicated to appropriate staff and actions implemented within agreed timescales.

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D Hazard and Risk Management System 2.1 Hazard and risk management team

A multidisciplinary hazard and risk management team shall be in place to develop and manage the hazard and risk analysis system and ensure this is fully implemented.

aause Requiremenu

2,1,1 The hazard and risk management system shall be developed, reviewed and managed by a multidisciplinary team th at includes those responsible for quality/technical, engineering/ maintenance, production operations, and other relevant functions,

In the event that the company does not have the appropriate expertise in-house, extern a I expertise shall be sought and used to develop and review the hazard and risk management system, However, the day-to-day management shall remain the responsibility of the company,

2,1,2 The multidisciplinary team shall have a designated team leader who shall be able to demonstrate competence and experience of hazard and risk analysis.

2,1.3 The team shall be suitably trained in hazard and risk analysis principles and kept up to date with factory changes and customer requirements as they occur.

2.2 Hazard and risk analysis FUNDAMENTAL

o Clause

2,2,1

2,2 ,2

2,2.3

20

A forma I hazard and risk management system shall be in place to ensure that all hazards to product safety and integrity are identified and appropriate controls established.

Requirements

The scope of the hazard and risk analysis shall be clearly defined and shall cover all products and processes included within the intended scope of certification,

The hazard and risk analysis team shall maintain awareness of and take into account:

historical and known hazards associated with specific processes, raw materials or end use of the product

relevant codes of practice or recognised guidelines

,. legislative requirements,

A full description of the product shall be developed, which includes all relevant information on product safety and integrity, A5 a guide this may include:

composition, e,g, raw materiais, inks, varnishes, coatings and other print chemicals

origin of raw materials including use of recycled materials

intended use of the packaging materials and defined restrictions on use; for instance, direct food contact, physical or chemical conditions,

'1:) BRClIOP

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Il;) BRC/IOP

(Iause 2.2.4

Requirements

A process flow diagram shall be prepared for each product. product group or process. This shall include each process step from the receipt of raw materials to despatch to the customer.

The process flow shall as a guide include, as relevant:

receipt and approval of art work

receipt and preparation of raw materials such as additives, inks and adhesives

each manufacturing process step

the use of rework and post-consumer recycled materials

any subcontracted operations

customer returns.

The accuracy of the process flow shall be verified by the hazard and risk analysis team.

2.2.5 The hazard and risk analysis team shall identify and record all potential hazards that are reasonably expected to occur at each step in re lation to the product and process . The hazards considered shall include, where relevant:

microbiological

foreign objects chemical contamination (e.g. taint, odour, allergen, component transfer fram inks,

varnishes and glues) potential problems arising from the use of recycled materials

legality

defects critical to consumer safety

hazards that may have an impact on the functional integrity and performance of the fina l product in use.

2.2 .6 The hazard and risk analysis team shall identify contral measures necessary to prevent, eliminate or reduce each hazard to acceptab le levels.

Where contral is thraugh a prerequisite programme these shall be reviewed to ensure they adequately contral the risk identified and where necessary improvements implemented.

2.2.7 For each hazard that requires control, other than by an existing prerequisite pragramme, the control points shall be reviewed to identify those that are critica! This pracess shall include an assessment of the risk level for each hazard based on the likelihood of the occurrence and the severity of the outcome. Critical control points shall be those control points that are required to prevent, eliminate or reduce a product safety or integrity hazard to acceptable levels.

2.2-8

2.2.9

Where contrals are not classified as critica I and contral may be achieved through a prerequisite programme, a programme shall be developed that is sufficiently specified to effectively control the identified hazards.

For each critical contral point, the appropriate criticallimits shall be defined in order to identify clearly if the process is in or out of contro! Criticallimits shall be measurable where possible and the rationale for their establishment clearly documented. Relevant legislation and codes of practice shall be taken into account when establishing the limits.

For each critical control point a monitoring system shall be defined in order to ensure compliance with criticallimits . Records of the monitoring shall be maintained. Procedures relating to the monitoring of critical controls shall be included in internal audits against the Standard (refer to clause 3.3).

21

BRC Global Standard tor Packaging & Packaging Materials Further I~f, lIrnalion dVilildble at www breglobal,tandards cam

Clluse Requirements

2.2.10 The corrective action that shall be taken when monitored results indicate a failure to meet the controllimit shall be established and documented. This shall indude the procedures for quarantining and evaluating potentia"y out-of-specification products to ensure they are not released until their safety can be established.

2.2 .11 A review of the hazard and risk management system shall be carried out at least once per year and following any significant incidents or when any process changes.

The review shall include a verification th at the hazard and risk analysis plan is effective and may include a review of:

1111 complaints

product failures

" recalls

product withdrawals

results of internal audits of prerequisite programmes

results from external third-party auditors.

2.3 Exemption of requirements based on risk analysis

Claule Requlraments

2.3 .1 The hazard and risk analysis study shall be fu"y supported by the implementation of the prerequisites set out in requirements clauses 4 to 6. However, the hazard and risk analysis may indicate that some of the requirements are not applicable. Exemptions shall be documented and regarded as proposed exemptions for review at audit. Acceptance or rejection of the proposed exemptions shall be recorded in the auditor's report

2.3.2 The company shall keep recorded exemptions to the Standard under review and provide documented evidence of this review at subsequent audit

____ 22 BRClIOP

Further mtormatlOn aV

BRC Global Standard for Packaging & Packaging Materials Furtt cr mtormatlon l'ic1llrlble- al www uregloudlstandards cam

3.3 Internal audits

o Clau ..

3.3 .1

3.3.2

3.3.3

3.3.4

3.3.5

3.4

FUNDAMENTAL

The company shall audit those systems and procedures which cover the requirements of the Standard to ensure they are in place, appropriate and complied with.

Requlrements

Internal audits shall be planned and their scope and frequency shall be established in relation to the risks associated with the activity. Audits shall be scheduled 50 that all aspects of the Standard are audited at least annually.

Internal audits shall be carried out by appropriately trained competent personnel who shall be sufficiently independent from the department being audited to ensure impartiality.

Deficiencies and details of non-conformities shall be notified to appropriate supervisory staff and corrective action implemented within a specified and appropriate time period .

The completion of corrective action shall be recorded and verified.

Internal audit reports shall be sufficiently detailed to ensure th at conformity as weil as non-conformit~ can be clearly identified and verified.

Supplier approval and performance monitoring

The company shall operate procedures for approval and monitoring of its suppliers. This shall include suppliers of materials and services to the company and ensure th at materials and services procured conform to defined requirements.

Clause Requlrements

34.1 The company shall have a documented supplier approval procedure and continua I assessment programme in place, based upon risk analysis.

3.4.2 The procedures shall include clear criteria for the assessment and approval of new suppliers. Assessment may take the form of:

supplier audits

supplier certification with a scope covering the products supplied, e.g. against the appropriate BRC Global Standard

supplier questionnaires.

3.4.3 Records of supplier assessment and necessary actions shall be maintained and reviewed.

344 The procedures shall define how exceptions are hand led, e.g. the use of products or services where audit or monitoring has not been undertaken. Assessment may take the form (on a batch or delivery basis) of: certificate of ana lys is

dec\aration of compliance.

___ 24 Cl BRClIOP

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3.5 Subcontracting of production

Where production processes are subcontracted this shall be with the agreement of customers. Procedures shall be in place for the effective control of subcontractors and the work undertaken.

Clause Requirements

3.5.1 The use of subcontractors and the status of the subcontractor with respect to the Standard shall be notified to the brand owner and/or customer.

3.5.2 Suppliers of subcontracted services shall be approved in accordance with the procedures identified in clause 3.4.

3.5.3 Where any production processes are subcontracted, the risks to the quality and safety of the product shall form part of the hazard and risk analysis and the company's evaluation of the system shall be held on record.

3.5.4 Clear specifications shall be ag reed for all work outsourced to a subcontractor. Controls shall be in place for checks on finished work to ensure the safety and quality meets specification.

3.6 Documentation control

The company's senior management shall ensure that documented procedures and recording forms critica I to the management of product safety, legality and quality are in place and effectively controlled.

Clause Requirements

3.6 .1 All documents in use shall be properly authorised and be the current version.

3.6.2 Documents shall be clearly legible, unambiguous and sufficiently detailed to enable their correct application by appropriate personnel. They shall be readily accessible to relevant staff at all times.

3.6.3 All changes and amendments to documents critica I to product safety, legality or quality system procedures shall be authorised, recorded, and obsolete documentation shall be removed, archived and replaced with the current version.

2S ___ _

eRC Global Standard for Packaging & Packaging M aterials Fwthpr Infolmatlon ilVa,I,lbl" at wwwblcglobalstandardscom

3.7 Specifications

o Claust

3.7.1

3.7.2

3.7.3

3.7.4

3.7.5

3.8

fUNDAMENTAL

The company shall ensure that appropriate specifications exist for raw materiais, intermediate and finished products, and any product or service which could affect the integrity of the finished product and customer requirements.

Requirements

Specifications shall be suitably detailed, accurate and shall ensure compliance with relevant product safety and legislative requirements.

The company shall seek formal agreement of specifications with relevant parties. Where specif ications are not formally agreed then the company shall be able to demonstrate t hat they have taken steps to put an agreement in place.

A declaration of compliance shall be maintained, which enables users of the packag ing materials to ensure compatibility w ith the product with which the materials may be in contact.

The declaration of compliance shall contain as a minimum:

>0 the nature of the materials used in the manufacture of the packaging

confirmation that materials meet relevant legal requ irements

the inclusion of any post-consumer recycled mater ials

this shall identify any limitations of use of the declaration of complianee.

Products shall meet at least minimum legal requirements in the country of manufacture and use, where known.

Trademarks for application on packaging materials shall. where appropriate, be formally agreed between relevant parties.

The company shall operate a specification review procedure.

Record keeping

The company shall maintain records to demonstrate the effective control of product safety, legality and quality.

Clausa Requirements

3.8.1 The records shall be legible, genuine, appropriately authorised and retained in good condition for an appropriate defined time period.

3.8.2 Any alterations to records shall be authorised and justification for the alteration shall be recorded.

3.8.3 The company's senior management sha ll ensure that procedures are operated for the organisation, review, maintenance, storage and retrieval of all records relating to product safety, legality, regulatory compliance and quality.

3.8.4 The period of retention for records shall re late to the usabie life of the packaging and products it is designed to contain and shall respect any customer requirements.

26 ro BRClIOP

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BRC Global Standard for packaging & Packaging Materials Further mfol 11 '1011 dvarldbl .. at wwwbrcglbalstandarrJ, corn

3.11 Management of incidents, product withdrawals and recalls

The company shall have a plan and systems in place to effectively manage incidents, product withdrawals and recalls, in order to ensure that all potential risks to the quality, hygiene and legality of produets are controlled.

Clausa Requirements

3.11 .1 The company shall provide written guidance and training for relevant staff regarding the type of event that would constitute an incident A documented incident reporting procedure shall be in place.

3.11.2 The company shall determine the activity required to effectively manage an incident, based on the risk to the product, to prevent the release of product where safety or quality may have been affected.

3.11.3 A product withdrawal/recall procedure shall be documented, practical to implement and regularly reviewed . This shall indude as a minimum:

~ identification of the key personnel involved in assessing potential withdrawal/recall incidents with dear identified responsibilities

a communications plan including methods of informing customers and, where necessary, regulatory bodies in a timely manner

,. corrective action and business recovery

review of any withdrawals or recalls to implement appropriate improvements as required.

3.11.4 The product withdrawal/recall procedure shall be tested on at least an annual basis and used to evaluate the procedure and implement improvement

3.11 .5 The recall procedure shall be capable of being operated at any time and will take into account notification to the supply chain, stock return, logistics for recovery, storage of recovered product and disposaL

3.11.6 The designated manager shall be responsible for ensuring that preventive action is taken, based on a review of incidents, to implement improvements as necessary.

28 BRCIIOP

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Site Standards

4.1 External standards

All grounds within the site shall be finished and maintained to an appropriate standard.

Clausa Requirements

4 .1.1 Consideration shall be given to local activities and the site environment which may have an adverse impact on the integrity of the finished product or raw materiais, and measures shall be taken to prevent contamination. Where measures have been put in place to protect the site from any potential contaminants, they shall be regularly reviewed to ensure they continue to be effective, e.g. flood controls.

4 .1.2 The external areas shall be maintained in good order. Grounds shall be regularly tended and weil maintained. Where possible, a clean and unobstructed area shall be provided along the external wal Is of the buildings used for production and/or storage.

4.1.3 The building fabric shall be maintained to mini mise potential for pest entry, ingress of water and other contaminants. External silos, pipe work or other access points for the product and/or raw materials shall be appropriately sealed and secured.

4.1.4 Where natural drainage is inadequate, external drainage shall be instalied. Drains shall be properly protected to prevent entry of pests.

4.1.5 External traffic routes, under site control, shall be suitably surfaced to avoid contamination of the product.

4.1.6 Where external storage of raw materials is necessary these shall be protected from contamination.

4.1.7 External storage of refuse shall be in designated areas.

4.2 Building fabric and interiors Raw material handling, preparation, processing and storage areas

The internal site, buildings and facilities shall be suitable for the intended purpose and shall be designed, constructed, maintained and monitored to effectively control the risk of product contamination.

Clause Requlrements

4.2.1 Walis, floors, ceilings and pipe work shall be maintained in good condition and shall facilitate cleaning.

4.2.2 Where suspended ceilings exist they shall be accessible for inspection and cleaning.

4.2.3 Suitable and sufficient lighting shall be provided for a safe working environment, correct operation of processes, effective inspection of the product and cleaning.

4.2.4 All internal drain openings shall be suitably protected against the entry of pests and odour.

4.2.5 Where there is a risk to the product, windows and roof glazing that are designed to be opened for ventilation shall be adequately screened to prevent the ingress of pests.

4.2.6 Where they pose a risk to the product, glass windows shall be protected against breakage.

4.2.7 Suitable and sufficient ventilation shall be provided.

29

BRC Global Standard tor Packaging & Packaging Materials FUI ther Inforrrition ilwlIlable at www br(globdlslilndilrd~ cam

4.3 Utilities

All utilities to and within the production and storage areas shall be designed, constructed, rnaintained and rnonitored to effectively control the risk of product contarnination.

Clause Requirements

4.3.1 All water used in the processing of the products or equipment cleaning shall be potable or suitably treated to prevent contamination.

4.3.2 Based on risk assessment, the microbiological and chemical quality of water, steam, ice, air, compressed air or other gas es, w hich do not constitute an ingredient but come in direct contact with packaging, shall be regularly monitored. These shall present no risk to product safety or quality and comply with relevant legal regulations.

4.4 Security

Security arrangements shall be assessed to ensure the integrity of produets and processes.

Clause Requirements

4.4.1 Based on risk assessment, a procedure shall be in place to address the security of the site and products and establish, implement and maintain a system to reduce or eliminate the identified risk.

4.4.2 Access to the site by employees, contractors and visitors shall be controlled, through designated entrances, and a visitor reporting system shall be in place. Areas shall be assessed according to risk; sensitive or restricted areas shall be defined, clearly marked, monitored and controlled.

4.4.3 Staff shall be trained in site security procedures and encouraged to report or challenge unidentified or unknown visitors.

4.4.4 All new part- and full-time personnel employed on-site on a temporary or permanent basis shall be subject to appropriate reference checks.

4.4.5 Contractors involved in maintenance or repair shall be supervised by a qualified person, and a nominated staff member shall be responsible for their activities.

4.4.6 Access to the site for third-party transport personnel shall be controlled and, where possible, facilities provided to negate the need to enter storage or production areas.

4.4.7 Site IT systems shall be secure, adequately controlled and backed up.

30 BRC/IOP

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4.7 Maintenance

A documented system of planned maintenance shall be in place, covering all items of equipment and plant that are critical to product safety, legality and quality.

Clause Requirements

4.7.1 Equipment, including fixtures and fittings, shall be mainta ined to minimise the risk of product contaminatlon.

4 .7.2 A condition-based or preventative maintenance programme shall be in place, covering all items of equipment and plant that are critical to product safety, legality and quality.

4.7.3 In addition to any planned maintenance programme, where there is a risk of product contamination by foreign bodies arising from equipment failure, the equipment shall be inspected at predetermined intervals, inspection results documented and appropriate action taken.

4.7.4 Maintenance work shall not place the product at risk. There shall be a procedure in place and a recording system to ensure that equipment is checked following maintenance work and cleared to resume production.

4.7.5 Tools and other maintenance equipment shall be cleared away after use and appropriately stored.

4 .7.6 Temporary repairs/modifications using tape, cardboard, etc. shall only be permitted in emergencies and where product contamination is not at risk . Such modifications shall be subject to a time limit and shall be recorded and scheduled for correction.

4.7.7 Wooden equipment including desks, chairs, tables, etc. shall be properly sealed to enable effective cleaning. This equipment shall be kept clean, in good condition and free from splinters or other sources of physical contamination.

4.7.8 Engineering workshops shall be controlled to prevent contamination risks to the product, e.g. provision of swarf mats where workshops open directly into production areas.

4.7.9 When commissioning new equipment and plant, a maintenance programme shall be established and put into place based on risk assessment.

32 '3:) BRC/IOP

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4.8 Staff facilities

Staff facilities shall be sufficient to accommodate the required number of personnel, and designed and operated to minimise the risk of product contamination. Such facilities shall be kept in a good and clean condition.

Qause Requiremenu

4.8.1 Suitable and sufficient hand-washing facilities shall be available to enable cleaning of hands before commencing work, after breaks, and as necessary during the course of work. Such hand-washing facilities shall provide, as a minimum

sufficient quantity of warm water unscented liquid soap single-use towels or suitably designed and located air driers advisory signs to prompt use (including consideration of appropriate languages). Where direct food contact or high-risk contact produets are handled, hand-washing facilities shall be sited at the entrance to the production area.

4.8.2 Toilets shall be adequately segregated and shall not open directly into storage, processing or production areas. Toilets shall be provided with hand-washing facilities comprising:

sufficient quantity of warm water unscented liquid soap single-use towels or suitably designed and located air driers advisory signs to prompt use (including consideration of appropriate languages).

4.8.3 Locker rooms shall be accessed without the need to enter production areas unless appropriately segregated walkways are in place.

4.8.4 Lockers shall be provided for all personnel who work in raw material handling, processing, preparation, packing and storage areas. Lockers shall be of sufficient size to accommodate all reasonable personal items.

4.8.5 Company-issued protective clothing and personal clothing shall not be stored in the same locker or shall be effectively segregated within the locker.

4.8.6 Eating, drinking and smoking shall not be allowed in locker and changing rooms.

4.8.7 Facilities for visitors and contractors shall enable compliance with the company's hygiene policy.

4.8.8 All food brought into manufacturing premises shall be stored in a clean and hygienic state. No food shall be taken into storage, processing or production areas.

4.8.9 Where smoking is allowed under nationallaw, any smoking shall only be permitted in designated controlled smoking areas which shall be isolated from production and storage areas and fitted with extraction to the exterior of the building. Adequate arrangements for dealing with smokers' waste shall also be provided at smoking facilities, both inside buildings and at externallocations.

33

BRC Global Standard for Packaging & packaging Materials Ft.. ther nfvl nntloll ilvadable at www breglobalstandards cam

4.9 Housekeeping and cleaning

FUNDAMENTAL

o Clau.

4 .9.1

4.9.2

4 .9.3

4.9.4

4 .9.5

4 ,9.6

4.10

Housekeeping and cleaning systems shall be in place, which ensure that appropriate standards of hygiene are maintained and that risk of contamination to the product is minirnised.

Requlrements

Good standards of housekeeping shall be maintained, which shall include a 'clean as yOll go' policy.

All internal sLlrfaces of buildings, equipment and vehicles shall be subject to documented scheduled cleaning. Cleaning schedules shall include the following information :

responsibility for c1eaning

item/area to be cleaned

frequency of c1eaning

'I!! method of cleaning

cleaning materials to be used

c1eaning record and responsibility for verification.

Cleaning equipment and materials shall be kept in a secure designated location such as a locked cup board.

Cleaning chemicals shall be fit for purpose, suitably labelled, secured in c10sed containers and used in accordance with manufacturers' instructions.

Chemicals that are strongly scented or could give rise to ta int and odour contamination shall not be used.

Materials and equipment used for cleaning toilets shall be segregated from those used elsewhere.

Waste and waste disposal

Suitable facilities shall be provided for the storage and disposal of process and other waste.

Clause Requirements

4 .10.1 Suitable and sufficient refuse and waste containers shall be provided, which shall be emptied at appropriate frequencies and maintained in an adequately clean condition.

4.10.2 Where appropriate, waste shall be categorised according to legislative requirements based on the intended means of disposal, segregated and collected in appropriate designated waste containers .

4 .10.3 Where ag reed with the customer, substandard trademarked materials shall be rendered unusable through a destructive process. All materia ls disposed of shall be recorded .

4.10A If substandard trademarked materials are transferred to a third party for destruction or disposal, th at third party shall be a specialist in appropriate waste disposal and shall provide records of material destruction.

4 .10.5 Waste streams shall be sorted and segregated to facilitate recycling and waste containers shall be suitably labelled or marked.

34 BRC/IOP

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cr, BRC/IOP

4.11 Pest control

The company shall be responsib le for minimising the risk of pest infestation on the site.

Clause Requirements

411.1 A preventive pest control programme shall be maintained covering all areas of the site under the company's control.

4.11 .2 The company shall either contract the services of a competent pest control organisation or shall have appropriately trained staff for the regular inspection and treatment of the site to deter and eradicate infestation. The frequency of inspections shall be determined by risk assessment and shall be documented. Where the services of a pest control contractor are employed, the service contract shall be clearly defined and reflect the activities of the site.

4.11 .3 Effective precautions shall be in place to prevent pests entering the premises. The building shall be suitably proofed against the entry of all pests via doors, windows, ducts, and cable entry points.

4.11.4 In the event of infestation, immediate action shall be taken to eliminate the hazard. Action shall be taken to identify, evaluate the potential for contamination or damage, and authorise the release of any product potentially affected.

4.11.5 In the event of an infestation and at appropriate intervals, the company shall request a catch analysis from flying insect control devices to help identify problem areas.

4.11.6 Written procedures and detailed records of pest activity, pest control inspections and recommendations shall be maintained. These shall include as a minimum:

an up-to-date, signed and authorised site plan identifying numbered pest control device locations

identification of the baits and/or monitoring devices on site

clearly defined responsibilities for site management and the contractor

details of pest control products used and instructions for their effective use

detailed records of pest control inspections, recommendations and of any pest infestation.

It shall be the responsibility of the company to ensure that all the relevant recommendations made by the contractor or in-house expert are implemented in a timely manner and monitored for effectiveness.

35

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4.12 Transport. storage and distribution

The transport. storage and distribution of raw materials and finished produets shall be undertaken in a manner to minimise the risk of contamination or malicious intervention.

Clause Requirements

4.12.1 All finished products and materials transferred between premises shall be fully identified and protected during transit and storage by appropriate external packaging or transported under conditions to proteet the product from contamination. This shall include the risk of taint or adour and of malicious intervention.

4.12.2 Receipt documents and/or product identification shall facilitate correct stock rotation of goods in storage and, where appropriate, ensure materials are used in the correct order and within the prescribed shelf life.

4.12.3 Incoming goods shall be visually checked for packaging integrity and potential contam ination.

4.12.4 All pallets shall be checked. Damaged, contaminated or unacceptable pallets shall be discarded. Wooden pallets that come into direct contact with finished products or raw materials shall not be allowed to contaminate the product Wooden pallets, if used, shall be sound, dry, clean and free from damage and contamination.

4.12.5 Storage, including oft-site storage, shall be controlled to proteet the product from contamination, including taint or odour and malicious intervention. Where off-site storage is used the same requirements apply as for on-site storage.

4.12.6 In order to prevent contamination, procedures shall be in place to appropriately segregate raw materiais, intermediate and finished products.

4.12 .7 Work in progress shall be suitably labelled and covered to ensure proper identification and prevent damage.

4.12.8 Material intended for recycling shall be appropriately protected against contaminatian hazards.

4.12.9 Vehicle drivers shall comply with the site rules relevant to this Standard.

4.12.10 All vehicles used for deliveries shall be kept clean and in a conditian to minimise the risk of product contamination.

4.12.11 All company-owned vehicles used for deliveries shall be included in the documented cleaning schedules.

4.12.12 All delivery vehicles and shipping containers shall be subject to a documented hygiene-checking procedure before loading.

4.1213 Where the company employs third-party contractors there shall be a contract or agreed terms and conditions. All the requirements specified in this section shall be clearly defined in the contract or the company shall be certificated to the Global Standard for Storage and Distribution. Where this is not possible, with general carriers, the packaging shall be adequate to protect the product against damage, contamination hazards, ta int and odour.

36 BRCfIOP

Further mformatlon available at wwwbrcglobillstilndard, com Section 111 Requirements ____

~! BRC/IOP

11 Product and Process Control 5.1 Product design and development

Product design and development processes shall be in place to ensure the production of safe and legal products to defined quality parameters.

Clause Requirements

5,1,1 Customer design requirements shall be defined and agreed prior to undertaking product design, taking into consideration process requirements and end use, where possible, Any critical use parameters shall be identified and defined; for example, barrier requirements, max/min use temperature, machine running, use of recycled materiais, etc.

Special attention shall be made to any materials that are required or requested to be manufactured from recycled materiais, to ensure that they are both appropriate and lega!.

5,1.2 A product specification shall be prepared and, where possible, agreed with the customer or brand owner before the production process begins,

5,1.3 A process shall be in place to ensure final product concepts and artwork are formally accepted by the specifier, where possible,

5,1,4 Production trials, where appropriate, shall be carried out and testing shall validate th at manufacturing processes are capable of producing a safe and legal product and that agreed product quality/print standards can be consistently achieved,

5.1.5 The company shall ensure that the product design processes, procedures and records of design together result in the development of specifications for each manufacturing process step to ensure the production of safe and legal products of the prescribed quality,

5,1,6 Samples as agreed with the specifier shall be retained for future reference,

37

BRC Global Standard for Packaging & Packaging Materials Further IIltorm'ltlon ilVdllable at 'NWW blLglobdlstdflddfds cam

5.2 Packaging print control

Where packaging is printed with allergenJsafetyJlegal information, procedures shall be in place to ensure that the information is fully legible and correctly printed to the customer's specification.

CIIUH Requiremenu

5.2.1 An assessment shall be carried out of the print process and handling of printed packaging (product) to identify: risks of 1055 of essential information

mixing of printed product.

Controls shall be established and implemented to reduce the risks identified.

5.2.2 Printing plates, other print equipment and reproduction media shall be fully traceable to the customer's approved origination material.

5.2.3 Printing plates shall be appropriately stored.

5.2.4 Each print run shall be approved against the ag reed standard (or master sample). This shall be recorded.

5.2.5 A system shall be in place to detect and identify printing errors during the run, and to sort these errors from the acceptable printed material.

5.2.6 Where composite print is used (a mixture of different designs are printed together), a process shall be in place to ensure effective segregation of differing print variants.

5.2.7 Samples of printed packaging shall be retained together with production records for a period of time to be agreed with the customerlspecifier/brand owner.

5.2 .8 Any unused printed product shall be accounted for and either disposed of or identified and appropriately stored.

5.2.9 Personnel carrying out print quality control shall be appropriately trained, aware of the importance of consumer safety information and adequately supervised.

5.2 .10 Lighting in print inspection cabinets and other means of print/colour checking shall be agreed with the customer or be to accepted industry standards.

38 ltI BRC/IOP

Further Informiltloll avatlable at www brcglooalstdn.JardS com Section 111 Requirements

BRC/IOP

5.3 Process control

o Clause

5.3.1

5.3.2

5.3.3

5.3.4

5.3.5

5.3 .6

5.3.7

5.4

FUNDAMENTAL

Procedures shall be in place to ensure effective quality assurance of operations throughout the process.

Requirements

The company shall undertake a review of the manufacturing and, where applicable, printing process to identify critical manufacturing process control points that could affect the quality of the products produced.

For each critica I manufacturing process control point, machine settings or process limits shall be established and documented - the process specification.

Documented process checks shall be undertaken at start up, following adjustments to equipment, and periodically during product ion, to ensure products are consistently produced to the ag reed quality specification.

A clearance procedure shall be in place to ensure that at start up, the line is clear of all previous work and production documents.

Suppliers of incoming materiais, as appropriate, shall provide evidence of conformity.

Ouality checks shall be carried out to demonstrate that the finished product is within the tolerances laid down in the ag reed product specification and conforms to any critica I technicaillegal requirements.

In the event of changes to product composition, processing methods or equipment, the company shall, where appropriate, re-establish process characteristics and validate product data to ensure product safety, legality and quality are achieved.

Product inspection and analysis

The company shall use appropriate procedures and facilities when undertaking or subcontracting inspection and analyses critica I to product safety, legality and quality.

Clause Requirements

5.4.1 Ouality checks shall be carried out at appropriate stages in production to demonstrate th at the product is within the tolerances laid down in the agreed product specification.

5.4.2 Personnel undertaking quality checks and analyses shall be suitably trained and shall be competent to carry out the work.

5.4.3 Procedures shall be in place to ensure the reliability of test results.

5.4.4 Frequency of checks shall be in accordance with industry-accepted practice or customer requirements and based on risk analysis.

5.4.5 Where the company undertakes or subcontracts analyses critica I to product safety or legality, the laboratory or subcontractors shall have gained recognised laboratory accreditation or operate in accordance with the requirements and principles of ISO 17025 (General Requirements for the Competence of Testing and Calibration Laboratories). Documented justification shall be available wh ere accredited methods are not undertaken.

39 ___ _

BRC Global Standard tor Packaging & Packaging Materials Furl'Jer InfolIn [h)TI d'liiilrlble al wwwbrcglobalstandards(Grn

5.5 In-line testing and measuring equipment

The company shall use hazard and risk analysis principles to determine the need for in-line product testing equipment to ensure the integrity and quality of products.

Clause Requirements

5.5.1 The accuracy of measurement of in-line equipment shall be specified having due regard to the product parameter being controlled.

5.5 .2 The company shall establish and implement procedures for the operation, routine monitoring and testing of equipment. This shall include

,. frequency and sensitivity of checks

authorisation of trained personnel to carry out speCified tasks

ti documentation of test results.

5.5.3 In-line testing equipment critica I to product integrity or safety shall incorporate a system to identify and, where appropriate, divert a non-conforming product out of the product flow or identify it for removal.

5.5.4 The company shall establish and implement corrective action and reporting procedures in the event of the monitoring and testing procedure identifying any failure of the in-line test equipment. Any such failures shall be subject to an assessment of potential risk and subsequent action may include a combination of isolation, guarantine and re-inspection of products produced since the last acceptance test of the equipment.

5.6 Calibration

Measuring equipment used to monitor critica I manufacturing process points and product safety and legality shall be calibrated.

ClauH Requirements

5.6.1 Measuring equipment used to monitor critical manufacturing process points and the product's compliance with relevant legal requirements and specifications shall be identified and calibrated.

5.6 .2 Where possible, calibration shall be traceable to a recognised national standard. Where a traceable calibration is not possible, the company shall demonstrate the basis by which standardisation is carried out.

5.6.3 All identified measuring equipment shall be checked and adjusted at a predetermined frequency, based on risk analysis. This shall be carried out by trained staff to a defined method to ensure accuracy within defined parameters.

5.6.4 The identified measuring equipment shall be prevented from adjustment by unauthorised staff and shall be protected from damage, deterioration and misuse.

5.6.5 Results and any actions taken when measuring equipment is found to be operating outside the specified limits shall be documented.

40 Cl BRCJIOP

Further mformat lon avadable at www brcglobalstandards com Se~tiOf1 j!l Requirements

BRClIOP

5.7 Control of non-conforming product

The company shall ensure that out-of-specification product is clearly identified, labelled and quarantined.

Clause Requirements

5.7.1 Clear procedures for the control of out-of-specification or non-conforming materials shall be in place and understood by all authorised personnel. This shall include the effective labelling or quarantining of materials before a decision has been made on their final disposition.

5.72 Non-conforming materials shall be assessed and a decision taken to reject, accept by concession or authorise to be reworked or for an alternative use. The decision and reasons shall be documented.

5.7.3 Corrective actions shall be implemented to avoid recurrence of the non-conformance. Actions taken shall be documented.

5.8 Foreign body contamination control

All practicabie steps shall be taken to identify, avoid, eliminate or mini mise the risk of foreign body contamination.

5.8.1 Foreign body control

Clause Requirements

5.8.1.1 Based on risk assessment, the company shall identify, control and manage potential risks from physical contamination.

5.8.1.2 There shall be no unnecessary non-production glass or brittie plastic, which may pose a risk of contamination.

5.8.1.3 Based on the likelihood and risk of glass contamination, all bulbs and strip lig hts, including those on flying insect control devices, shall be protected.

5.8.1.4 All glass or brittie plastics other than the product shall be controlied and recorded on a register and checked for damage at an appropriate frequency. The register shall be kept up to date as necessary. The frequency of checks will vary according to risk of damage leading to contamination.

5.8.1.5 Where glass breakage occurs aresponsibie person shall be placed in charge of the clean-up operation and shall ensure th at no other area is allowed to become contaminated due to the breakage. Any product that has become contaminated shall be segregated and disposed of.

All breakages shall be recorded in an incident report.

41

BRC Global Standard for Packaging & Packaging Materials Funher mfollT 3110n dvadable at www brrglobalstandarrJs LOm

5.8.2 Sharps control

a.UH Requirem.nts

5.8 .2.1 There shall be a documented policy for the control of the use of sharps.

5.8.2.2 Sharp blades, equipment and tools shall not be left in a position that allows them to contaminate the product.

5.8 .2.3 Sharp cutting instruments used in the manufacture of packaging materials shall be controlled to prevent product contamination. This shall include control into and out of the factory.

5.8.2.4 Snap-aft blade knives shall not be used.

5.8.2.5 Where open notice boards are present in production areas, loose fastenings, such as drawing pins and staples, shall not be used.

5.8.3 Chemical and biological control

Controls shall be in place to prevent contamination trom chemica I or biological hazards.

(IaUH Requirem.nts

5.8.3.1 Chemicals including cleaning materiais, lubricants and adhesives shall be of the appropriate grade and be suitably controlled to prevent contamination of the product.

5.8.3.2 Through hazard and risk analysis the company shall identify, control and manage any potential risks from microbiological contamination.

____ 42 BRCIIOP

~urther mforrnatlon avalfable at. WWN brcglob.llstandards (Om Section 111 Requirements _

BRC/IOP

11 Personnel Raw materials handling, preparation, processing, packing and storage areas

6.1 Training and competence

FUNDAMENTAL

o Clause

6.1.1

6.1.2

6.1.3

6.1.4

6.1 .5

6.2

The company shall ensure that all employees are adequately trained, instructed and supervised commensurate with their activity and are competent to undertake their job rele.

Requirements

All personnel, including temporary personnel, shall be appropriately trained prior to commencing work and adequately supervised throughout the working period. Induction training shall include the company hygiene rules.

The company shall routinely review the competencies of staff and provide relevant training as appropriate. This shall cover all packaging quality assurance, potential contamination and safety hazards, including those specific to established critica I process steps.

Records of training shall be kept for all current and recent key employees.

A programme of refresher training shall be in place.

The company shall document training procedures and records to demonstrate that training is effective and regularly reviewed.

Access and movement of personnel

The company shall ensure that access and movement of personnel, visitors and contractors shall not compromise product safety and quality.

Clause Requlrements

6.2.1 There shall be a plan of the site, which defines access points for personnel, travel routes and staff facilities.

6.2.2 If it is necessary to allow access through production areas, designated walkways shall be provided that ensure there is adequate segregation from materiais.

6.2 .3 All facilities shall be designed and positioned, where possible, 50 that movement of personnel is by simpie, logical routes.

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BRC Global Standard for Packaging & Packag ing Materials Further Intormatlon avallable at www brcglobalstandard~ com

6.3 Personal hygiene

The company's personal hygiene standards shall be documented and adopted by all personnel, including visitors to the production facility. These standards shall be developed with due regard for risk of product contamination.

Clause Requirement5

6.3.1 The company shall document its jewellery policy. 6.3.2 Jewellery and wrist watches shall not be wom, with the exception of a plain wedding ring, a

wedding wristband and sleeper earrings (continuous loop). 6.3.3 Personal items and belongings including personal mobile telephones shall not be taken into

production areas without the permission of the management.

6.3.4 Procedures shall be in place to control the use of personal medici nes to minimise the risk of contamination of the product

6.3.5 All personnel, visitors and contractors shall wash their hands after using the toilet, eating, smoking or drinking (unless drinking only water in accordance with the conditions set out in clause 6.3.9) and whenever otherwise necessary.

6.3.6 Fingemails shall be kept short and clean. False fingernails and nail varnish/polish shall not be used. Where visitors can not comply, suitable control procedures shall be in place, e.g. non-handling of product, use of gloves.

6.3.7 If gloves are used, they shall be replaced regularly. Where appropriate, gloves shall be of a disposable type, of a distinctive colour, be intact and not shed loose fibres.

6.3.8 Eating (including the eating of confectionery and chewing of gum or tobacco), drinking and smoking shall not be allowed in the production or storage areas. If it is impractical for personnel to leave their work area, local controlled facilities (such as a fully walled area with hand-washing facilities) shall be provided.

6.3.9 Drinking of water from purpose-made dispensers and/or by using disposable conical cups or spill-proof containers may be allowed, provided it is confined to a designated area away from equipment

6.4 Medical screening

Health conditions likely to adversely affect product safety shall be monitored and controlled.

Clause Requlrements

6.4.1 The company shall have a procedure for the notification by personnel, inciuding temporary personnel, of any relevant infections, diseases or conditions with which they may have been in contact or be suffering from. Employees and visitors suffering from any of the above shall be excluded from work involving contact with high-risk packaging for as long as the symptoms persist.

6.4.2 Visitors and contractors shall be required to fill in a health questionnaire prior to being allowed into production areas.

6.4.3 All cuts and grazes on exposed skin shall be covered by an appropriately coloured plaster, different from the product colour (preferably blue), and containing a metal detectable strip. These shali be company issued and monitored when involved in work in contact with high-risk materiais. Where appropriate, in addition to the plaster, a finger stall shall be worn.

____ 44 BRC/IOP

FUrlher mformatlon a'Jdllable at www.brcglooalstandJrds com Section 111 Requirements

BRC/IOP

6.5 Protective clothing

Appropriate protective clothing shall be worn in production and storage areas to minimise the risk of product contamination.

Clause Requirements

6.5.1 Appropriate clean protective clothing that cannot contaminate the product shall be worn.

Where no need for protective clothing has been established by risk assessment in a particular area, it shall be fully justified and shall not pose a contamination risk to the product.

6.5,2 Sufficient sets of clothing shall be provided appropriate to the activities carried out.

6,5.3 Protective clothing wom in production areas shall provide adequate covering of the upper torso.

Where direct food contact or high-risk contact products are handled, the clothing shall have no external pockets on the upper body garments or sewn on buttons. Changes of such clothing shall be available at all times as required.

6.5.4 Based on hazard and risk analysis, a policy shall be documented and implemented to state where protective clothing can be wom away from the production environment.

6.5.5 Based on the assessment of risk to the product, suitable footwear shall be worn within the factory environment.

6.5,6 Based on hazard and risk analysis, snoods for beards and moustaches shall be wom to prevent product contamination,

6.5.7 Based on hazard and risk analysis, all scalp hair shall be fully contained to prevent product contamination.

6.5,8 Protective clothing shall be kept clean and laundered. Laundering shall be carried out by one of the following methods: professionallaundry service, in-house, controlled laundering facilities or self-care.

6.5.9 Where self-care laundry is permitted, it shall be ensured that:

employees have received written instructions regarding the laundering process to be used and these shall be reinforced as part of an induction or other in-house training programme

employees shall be provided with suitable means to safely transport washed garments from home to the workplace

there shall be a defined process within the company for monitoring the effectiveness of the system

there shall be a procedure and system for dealing with any case where employees are unable to perform self-Iaundry effectively, either through lack of diligence or facilities.

6.5.10 Clean and dirty clothing shall be segregated and controlled to prevent cross-contamination.

6.5.11 Disposable protective clothing, if used, shall be subject to adequate control to avoid product contamination.

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