Académique Documents
Professionnel Documents
Culture Documents
Issue 4
ISSUE 4
February 2011
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Contents
Section I Introduction
1 Background
1 Preparation Time
2 Product Categories
11
13
15
Categories
15
15
Fundamental requirements
15
Exclusion of Requirements
15
Non-applicable clauses
15
Risk-based exemptions
16
17
17
17
18
19
19
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20
20
20
22
23
23
23
24
24
25
25
3.7 Specifications
26
26
3.9 Traceability
27
27
28
4 Site Standards
29
29
29
4.3 Utilities
30
4.4 Security
30
31
4.6 Equipment
31
4.7 Maintenance
32
33
34
34
35
36
37
37
38
39
39
40
5.6 Calibration
40
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41
41
6 Personnel
43
43
43
44
44
45
46
46
46
46
47
47
48
48
48
49
50
50
50
50
51
51
52
3.7 Specifications
52
52
3.9 Traceability
53
53
53
4 Site Standards
54
54
54
4.3 Utilities
55
4.4 Security
55
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55
4.6 Equipment
56
4.7 Maintenance
56
56
57
57
58
58
59
59
60
61
61
62
5.6 Calibration
62
62
63
6 Personnel
64
64
64
64
65
67
1 Introduction
69
2 Getting Started
69
69
70
70
70
70
70
72
72
72
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73
74
9.1 Non-conformities
74
74
9.3 Revisits
75
75
76
76
76
12.1 Reporting
76
12.2 Certification
77
12.3 Appeals
78
78
79
80
80
80
80
80
81
83
2 Technical Governance of the Global Standard for Packaging & Packaging Materials 85
85
85
86
86
86
86
Appendices 87
Appendix 1
The Standard and its Relationship with other BRC Global Standards
89
Appendix 2
90
Appendix 3
92
Appendix 4
94
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Appendix 5
Certificate Template
95
Appendix 6
96
Appendix 7
Glossary
97
Appendix 8
Acknowledgements
viii
100
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Section I Introduction
SECTION I
INTRODUCTION
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Section I Introduction
Section I
Introduction
1 Background
Welcome to the fourth issue of the Global Standard for Packaging & Packaging Materials (henceforward
referred to as the Standard). Originally published by the British Retail Consortium (BRC) and Institute of
Packaging in 2001, it was designed to protect the consumer by providing a common basis for the certification
of companies supplying packaging to own-brand food producers.
The Standard has been updated at regular intervals to reflect the latest thinking and the scope expanded
to include packaging for consumer products. The emphasis of the Standard has also changed reflecting
the needs of customers to ensure that not only is the packaging produced in a hygienic environment but
that the quality and performance (functional properties) are effectively managed to meet specifications.
The Standard has now established worldwide usage as a framework for businesses to assist in the
production of safe packaging for use both for food and for consumer products. In response to considerable
demand, the Standard has been translated into many languages to facilitate implementation by businesses
across the world. This fourth issue has been developed with advice and input from a wide range of
international stakeholders.
The Standard specifies the safety, quality and operational criteria required within packaging manufacturing
organisations to fulfil obligations with regard to legal compliance and protection of the consumer. The format
and content of the Standard are designed to allow an assessment of company premises, operational systems
and procedures by a competent third party (the certification body) against the requirements of the Standard.
Compliance to the Standard will establish conformity with management procedures and factory standards
used by manufacturers of packaging and packaging materials.
The Standard applies to the manufacture of packaging and packaging materials used in food packaging and
filling operations and to packaging and packaging materials for cosmetics, toiletries and other consumer
products and materials. It is also intended to apply to:
operations that are supplying packaging material from stock where additional product processing or
repacking occurs; this has been demonstrated to require the same level of control as a final/integrated
converting operation
packaging manufacturers who also produce consumer-disposable goods that come into contact with
food; for example, paper plates and disposable plastic drinking cups, aluminium foil, food-grade
parchment paper, cling film and disposable cutlery. These products may also be audited under the BRCs
Global Standard for Consumer Products where the primary operation of the factory is the production of
consumer products and not packaging manufacture
the manufacture and supply of other materials that are unconverted or semi-converted and used or
incorporated, e.g. coatings and adhesives, where this is based on a risk analysis and mutually agreed
between those involved.
Companies that meet the requirements of a satisfactory quality management system for example, one
conforming to that specified in ISO9001:2008 may already meet many of the requirements of the Standard.
It is in the interest of the company to bring these points to the attention of the certification body. The auditor
will verify that the procedures are adequate for the purpose of compliance with this Standard.
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A business must have a full understanding of the processes and products manufactured and have systems in
place to ensure that products are produced within a hygienic environment and consistently meet the quality
and product safety expectations of their customers. The Standard is based on the following key components:
senior management commitment; risk assessment of the product and manufacturing process; and a
systematic approach to managing product quality and safety.
There are a number of benefits arising from the adoption of the Standard. These include:
providing a single audit report that is recognised by many customers in place of their own audits saving
time and cost
operating under an accreditation framework that ensures the results of certification have international
credibility and recognition
a comprehensive scope, covering areas of quality, hygiene and product safety, that meets most customer
requirements when assessing and approving suppliers
providing a framework for the development of quality and hygiene management systems in companies
that encourages continuous improvement, reduction in waste and increased efficiency
addressing part of the legislative requirements of the packaging manufacturer/supplier, packer/filler and
retailer. Packaging manufacturers may also use this Standard to ensure their suppliers are following good
manufacturing practices and are fulfilling legal requirements
certificated sites making use of the marketing opportunities provided, through recognition on the public
BRC Global Standards Directory website and use of the BRC logo.
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Section I Introduction
The Standard is a process and product certification scheme. In this scheme, packaging businesses are
certificated upon completion of a satisfactory audit by an auditor employed by an independent third party
the certification body. Certification bodies in turn will have been assessed and judged as competent by a
national accreditation body.
In order for a packaging business to receive a valid certificate on completion of a satisfactory audit, the
organisation must select a certification body approved by the BRC. The BRC lays down detailed requirements
that a certification body must satisfy in order to gain approval. As a minimum, the certification body must
be accredited to ISO Guide 65/EN45011 by a national accreditation body affiliated to the International
Accreditation Forum.
A list of certification bodies approved by the BRC is available on the BRC Global Standards Directory:
www.brcdirectory.com.
The BRC is the trade association representing retailers in the UK. The Packaging Society (a division of
the Institute of Materials, Minerals and Mining) was formerly the Institute of Packaging (IOP) and is the
professional membership body for the packaging industry in the UK. It is referred to throughout this
document as IOP and has joined with the BRC in developing the Standard. It is recognised that the packaging
industry is diverse in its materials, processing and technologies. Trade associations representing the paper
and board, plastic, aluminium, steel and glass packaging industry sectors have all been consulted during the
development of this Standard.
The BRC and IOP wish to acknowledge all those packaging industry experts who have contributed to the
preparation of the Global Standard for Packaging & Packaging Materials (Issue 4). A list of those who have
contributed is detailed in Appendix 7.
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SECTION II
PREPARATION AND PLANNING
FOR SUCCESS
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Section II
Preparation Time
In order for everyone to gain the most value from certification to the Standard, retailers and other specifiers
should have a clear understanding of the demands it places on their suppliers and the benefits that ensue.
Equally, manufacturers need to plan carefully to achieve certification.
Both specifiers and companies seeking certification should understand that considerable effort may be
needed to work towards certification, especially for companies that have no previous experience of third-party
certification schemes or quality management systems certification.
It is important to set realistic timescales in which to gain certification and have a clear project plan to ensure
that all the necessary actions are completed before the certification audit visit.
After the audit visit, there is a short timescale allowed to correct any failures to meet the requirements of
the Standard, which are identified by the audit report as non-conformities. This is 28 days (extended to 90
days for major non-conformities at initial audits). There is a limit to the number of non-conformities that are
allowed before certification is refused (see Section IV, 11 Grading of the Audit, for details). If the number of
non-conformities exceeds that allowed or the non-conformities are not corrected within the allowed time
frame, a complete re-audit will be needed before certification can be obtained. It is therefore not advisable to
attempt an audit without adequate preparation.
1.1
For specifiers
Retailers and others contemplating specifying the use of the Standard by their suppliers are advised to inform
their suppliers and the certification bodies well in advance of the implementation requirement. This will ensure
that the companies have time for adequate planning and the certification bodies have suitable infrastructure,
such as auditor capacity, in place in the countries of demand and for the correct packaging fields. Retailers
may want to organise internal training to ensure that there is a good understanding of the Standard and
it may be helpful to arrange supplier briefings or other training events to explain the requirements of the
scheme and other steps to implementation. Assistance with such matters is available from the BRC.
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Stage 1
Learn
Stage 2
Plan
What needs to be done? Carry out a gap analysis to identify the parts of
the Standard which are not adequately covered
Assemble and train a team of people to participate in risk assessment and
other safety and quality matters
Identify the product scope to be included in BRC certification
Obtain consultancy if required
Stage 3
Preparation
Carry out hazard and risk analysis and ensure that control points in the
process have been established
Prepare procedures
Check the site is capable of meeting BRC requirements
Undertake internal audits
Stage 4
Pre-assessment*
Select suitable CB
Arrange a pre-assessment visit (*optional but recommended)
Implement any identified corrective actions
Stage 5
Audit and
certification
Stage 6
Maintenance
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Product Categories
The packaging industry produces a wide variety of packaging, involving an extensive range of materials
for use in many diverse industries. Given the scope of this activity, it is essential that the audit against the
Standard is appropriate for the nature of material produced and its intended use. Customers expect that all of
the packaging materials they purchase are safe for their intended use and produced to the quality agreed in
the specification. It is recognised, however, that the production of packaging for some particular uses, e.g. for
direct food contact, necessitates more stringent and demanding hygiene requirements of the manufacturer.
The requirements of the Standard for Issue 4 are divided into two categories depending upon the intended
use of the packaging and consequent standards of hygiene under which the packaging is produced.
The Standard contains a decision tree (Figure 2), which helps to define the appropriate category for any
particular use.
In general, the two categories can be considered as follows:
Packaging that comes into direct contact with food products (or other designated
hygiene-sensitive products*). Primary packaging used for food or other hygienesensitive products where there is no absolute barrier in place.
Packaging for consumer products and the secondary and tertiary packaging for
all uses.
*Those products intended for human consumption or which come into contact with the body, such as application to the skin.
For further guidance, consult the decision tree in Figure 2 and Appendix 2, which provides examples of
products for each category.
It is recognised that many manufacturers or suppliers may produce packaging in both categories. In these
circumstances they may either choose to use one category for the entire factory or separate them by areas. It
is not envisaged that more than one category would apply within the same area.
The final packaging category determination is a matter of discussion between the company and their
customer. Examples given in Appendix 2 are not an exhaustive list and are only provided as a guide. Where
there is any doubt, the more demanding hygiene risk category should be adopted.
If there is no clear definition of product category, referral shall be made by the company to the BRC for
clarification at brcglobalstandards@brc.org.uk.
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Is the packaging
intended for a food
product or hygienesensitive product, e.g.
cosmetic product?
Category
Yes
Is the packaging
intended for direct
contact with a food
or hygiene-sensitive
product?
Yes
No
No
No
Yes
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SECTION III
REQUIREMENTS
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Section III
Requirements
Layout and Use of the Requirements of the Standard
Categories
The requirements to be met for certification differ between the two categories (high hygiene risk and low
hygiene risk) for food and consumer products. The requirements for the two categories are set out separately
within this section. All applicable requirements for that category shall be met in order to achieve certification.
Fundamental requirements
In line with the other BRC Global Standards, the concept of fundamental requirements has been introduced
to the Standard to identify particular systems or operations within it that need to be in place at the time of
the audit. The fundamental requirements are marked with the word FUNDAMENTAL immediately after the
section heading and denoted with the star symbol . The clauses deemed to be fundamental are:
Failure to comply with the statement of intent of a fundamental clause leads to non-certification. This will
require a further full audit to demonstrate evidence of compliance.
Exclusion of Requirements
Non-applicable clauses
The majority of the requirements of the Standard will apply to all packaging material manufacturers within the
category. There are however some requirements that would not apply to some industry sectors or operations;
for example, the requirements of clause 5.2 are not applicable where printing of materials is not carried out.
Any such specific requirements may be excluded and will be marked as not applicable (N/A) in the final audit
report. The auditor will assess and decide on the applicability of any requirements that the site believes are
not applicable.
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Risk-based exemptions
The requirements have been written to reflect expectations typical of the particular product category
across a range of packaging formats, e.g. board, glass, metals, etc. There may be occasions where a
requirement may not be appropriate in a particular operation. On the basis of risk some requirements may
be excluded, however, in each case a documented risk assessment must be provided for the auditor to
evaluate (clause 2.3).
The final audit report will include comments on any clauses deemed as not applicable or excluded on the basis
of risk analysis.
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The companys senior management shall develop and document a product safety and
quality policy, which is authorised, reviewed, signed and dated by an appropriate
senior manager.
Clause
Requirements
1.1.1
The policy shall state the companys 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 continuous improvement.
1.1.2
The companys senior management shall ensure the policy is communicated to all staff
involved with activities relating to product safety, legality, regulatory compliance and quality.
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1.2
Clause
Requirements
1.2.1
The companys senior management shall ensure that product safety and quality objectives
are measurable, established, documented, monitored and reviewed.
1.2.2
The companys senior management shall provide the human and financial resources
required to implement the processes of the quality management system and product
safety programme.
1.2.3
Clear communication and reporting channels shall be in place to report on and monitor
compliance with the Standard.
1.2.4
The companys 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.
1.2.5
The company shall ensure that the materials manufactured comply with 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.
1.2.6
The companys senior management shall ensure that non-conformities identified at the
previous audit against the Standard are effectively actioned.
1.2.7
The company shall have a current, original copy of the Standard available on site.
1.2.8
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.
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1.3
The company shall 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.
1.3.4
There shall be appropriate documented arrangements in place to cover for the absence of
key staff.
1.3.5
The companys 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
Requirements
1.4.1
1.4.2
1.4.3
The review process shall set objectives and continual improvement targets.
1.4.4
1.4.5
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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2.1
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.
Clause
Requirements
2.1.1
The hazard and risk management system shall be developed, reviewed and managed by
a multidisciplinary team that 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,
external 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
Clause
Requirements
2.2.1
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.
2.2.2
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.
2.2.3
A full description of the product shall be developed, which includes all relevant information
on product safety and integrity. As a guide this may include:
composition, e.g. raw materials, 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.
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Clause
Requirements
2.2.4
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 relation to the product and process. The
hazards considered shall include, where relevant:
microbiological
foreign objects
chemical contamination (e.g. taint, odour, allergen, component transfer from 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 final
product in use.
2.2.6
The hazard and risk analysis team shall identify control measures necessary to prevent,
eliminate or reduce each hazard to acceptable levels.
Where control is through a prerequisite programme these shall be reviewed to ensure they
adequately control the risk identified and where necessary improvements implemented.
2.2.7
For each hazard that requires control, other than by an existing prerequisite programme,
the control points shall be reviewed to identify those that are critical. This process 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.
Where controls are not classified as critical and control may be achieved through a
prerequisite programme, a programme shall be developed that is sufficiently specified to
effectively control the identified hazards.
2.2.8
For each critical control point, the appropriate critical limits shall be defined in order to
identify clearly if the process is in or out of control. Critical limits 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.
2.2.9
For each critical control point a monitoring system shall be defined in order to ensure
compliance with critical limits. 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).
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Clause
Requirements
2.2.10
The corrective action that shall be taken when monitored results indicate a failure to meet
the control limit shall be established and documented. This shall include the procedures for
quarantining and evaluating potentially 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 that the hazard and risk analysis plan is effective and
may include a review of:
complaints
product failures
recalls
product withdrawals
results of internal audits of prerequisite programmes
results from external third-party auditors.
2.3
Clause
Requirements
2.3.1
The hazard and risk analysis study shall be fully 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 auditors 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.
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3.1
The company shall have a manual which describes how the requirements of the
Standard are met. These requirements shall be fully implemented, reviewed at
appropriate planned intervals and improved where necessary.
Clause
Requirements
3.1.1
The product safety and quality manual shall contain an outline of working methods and
practices or references to where such an outline is documented.
3.1.2
3.2
The companys senior management shall ensure that processes are in place to
determine customer needs and expectations with regard to quality and safety and
ensure these are fulfilled.
Clause
Requirements
3.2.1
The company shall clearly identify those job titles responsible for communication with
customers and shall have an effective system for communication.
3.2.2
3.2.3
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3.3
Internal audits
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.
Clause
Requirements
3.3.1
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 so that all aspects
of the Standard are audited at least annually.
3.3.2
Internal audits shall be carried out by appropriately trained competent personnel who shall
be sufficiently independent from the department being audited to ensure impartiality.
3.3.3
3.3.4
3.3.5
Internal audit reports shall be sufficiently detailed to ensure that conformity as well as nonconformity can be clearly identified and verified.
3.4
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 that
materials and services procured conform to defined requirements.
Clause
Requirements
3.4.1
The company shall have a documented supplier approval procedure and continual
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.
3.4.4
The procedures shall define how exceptions are handled, 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 analysis
declaration of compliance.
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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
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 companys evaluation of the
system shall be held on record.
3.5.4
Clear specifications shall be agreed 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.
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 critical 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.
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3.7 Specifications
Fundamental
The company shall ensure that appropriate specifications exist for
raw materials, intermediate and finished products, and any product or
service which could affect the integrity of the finished product and
customer requirements.
Clause
Requirements
3.7.1
Specifications shall be suitably detailed, accurate and shall ensure compliance with relevant
product safety and legislative requirements.
3.7.2
The company shall seek formal agreement of specifications with relevant parties. Where
specifications are not formally agreed then the company shall be able to demonstrate that
they have taken steps to put an agreement in place.
3.7.3
3.7.4
3.7.5
3.8
Record keeping
The company shall maintain records to demonstrate the effective control of product
safety, legality and quality.
Clause
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 companys senior management shall 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 relate to the usable life of the packaging and
products it is designed to contain and shall respect any customer requirements.
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3.9 Traceability
Fundamental
The company shall have a system in place to identify product batches and
to trace and follow all raw materials through processing to the distribution
of the finished product to the customer. Records shall be retrievable in a
timely manner.
Clause
Requirements
3.9.1
The company shall have a system which has the ability to trace and follow all raw materials
from the supplier through all stages of processing and distribution of the finished product
and vice versa. Where continuous processes are used or raw materials are in bulk silos,
traceability shall be achieved to the best practical level of accuracy.
3.9.2
An appropriate system shall be in place to ensure the customer can identify a product or
production lot number for the product, for the purposes of traceability.
3.9.3
The system shall be tested to ensure traceability can be determined from raw material to the
finished product and vice versa. This shall take place on a predetermined frequency, at least
on an annual basis, and results retained for inspection.
Requirements
3.10.1
3.10.2
Complaint data shall be analysed on a predetermined frequency to identify trends and used
to implement ongoing improvements.
3.10.3
Actions appropriate to the seriousness and frequency of the problems identified shall be
carried out promptly and effectively by appropriately trained staff.
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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
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.
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Site Standards
4.1
External standards
All grounds within the site shall be finished and maintained to an appropriate standard.
Clause
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 materials, 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
well maintained. Where possible, a clean and unobstructed area shall be provided along the
external walls of the buildings used for production and/or storage.
4.1.3
The building fabric shall be maintained to minimise 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 installed. 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
4.2
Requirements
4.2.1
Walls, 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
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4.3 Utilities
All utilities to and within the production and storage areas shall be designed,
constructed, maintained and monitored to effectively control the risk of
product contamination.
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 gases, which 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 products
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
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
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4.5
Premises and plant shall be logically designed, constructed and maintained. Procedures
shall be in place to control the risk of product contamination and to comply with all
relevant legislation.
Clause
Requirements
4.5.1
The process flow from intake to despatch shall be arranged to minimise the risk of
contamination or damage to the product.
4.5.2
Premises shall allow sufficient working space and storage capacity to enable all operations
to be carried out properly under safe and hygienic conditions.
4.5.3
4.5.4
Sorting or other activities involving the direct handling of the product shall take place in
areas that have, as a minimum, the same standards as production areas.
4.5.5
Activities that could produce a contamination risk, such as the removal of outer packaging,
shall be carried out in a designated, segregated area.
4.6 Equipment
Equipment shall be suitably designed for the intended purpose and shall be
maintained and used so as to minimise the risk to product safety, legality and quality.
Clause
Requirements
4.6.1
Equipment shall be designed for the intended purpose and shall minimise the risk of
contamination to the product.
4.6.2
Newly installed equipment shall be properly specified before purchase. Equipment shall
be constructed of appropriate materials and be of a suitable design to ensure it can be
effectively cleaned and maintained. New equipment shall be tested and commissioned prior
to use and a maintenance programme established.
4.6.3
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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 maintained to minimise the risk of
product contamination.
4.7.2
4.7.3
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
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
4.7.9
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4.8
Staff facilities
Requirements
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 products 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 companys
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 national law, 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 external locations.
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4.9
Clause
Requirements
4.9.1
Good standards of housekeeping shall be maintained, which shall include a clean as you
go policy.
4.9.2
All internal surfaces of buildings, equipment and vehicles shall be subject to documented
scheduled cleaning. Cleaning schedules shall include the following information:
responsibility for cleaning
item/area to be cleaned
frequency of cleaning
method of cleaning
cleaning materials to be used
cleaning record and responsibility for verification.
4.9.3
Cleaning equipment and materials shall be kept in a secure designated location such as a
locked cupboard.
4.9.4
Cleaning chemicals shall be fit for purpose, suitably labelled, secured in closed containers
and used in accordance with manufacturers instructions.
4.9.5
Chemicals that are strongly scented or could give rise to taint and odour contamination shall
not be used.
4.9.6
Materials and equipment used for cleaning toilets shall be segregated from those used
elsewhere.
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
4.10.3
Where agreed with the customer, substandard trademarked materials shall be rendered
unusable through a destructive process. All materials disposed of shall be recorded.
4.10.4
4.10.5
Waste streams shall be sorted and segregated to facilitate recycling and waste containers
shall be suitably labelled or marked.
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Requirements
4.11.1
A preventive pest control programme shall be maintained covering all areas of the site under
the companys 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.
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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 protect the product from contamination. This shall include the risk of taint or
odour 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
contamination.
4.12.4
4.12.5
Storage, including off-site storage, shall be controlled to protect 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
4.12.7
Work in progress shall be suitably labelled and covered to ensure proper identification and
prevent damage.
4.12.8
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 condition 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 hygienechecking procedure before loading.
4.12.13
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5.1
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 materials, etc.
Special attention shall be made to any materials that are required or requested to be
manufactured from recycled materials, to ensure that they are both appropriate and legal.
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 that
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.
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5.2
Requirements
5.2.1
An assessment shall be carried out of the print process and handling of printed packaging
(product) to identify:
risks of loss 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
customers approved origination material.
5.2.3
5.2.4
Each print run shall be approved against the agreed 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 customer/specifier/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.
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5.3
Process control
Fundamental
Procedures shall be in place to ensure effective quality assurance of operations
throughout the process.
Clause
Requirements
5.3.1
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.
5.3.2
For each critical manufacturing process control point, machine settings or process limits shall
be established and documented the process specification.
5.3.3
5.3.4
A clearance procedure shall be in place to ensure that at start up, the line is clear of all
previous work and production documents.
5.3.5
5.3.6
Quality checks shall be carried out to demonstrate that the finished product is within
the tolerances laid down in the agreed product specification and conforms to any critical
technical/legal requirements.
5.3.7
5.4
The company shall use appropriate procedures and facilities when undertaking or
subcontracting inspection and analyses critical to product safety, legality and quality.
Clause
Requirements
5.4.1
Quality checks shall be carried out at appropriate stages in production to demonstrate that
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
5.4.4
5.4.5
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5.5
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
documentation of test results.
5.5.3
In-line testing equipment critical 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, quarantine and re-inspection of
products produced since the last acceptance test of the equipment.
5.6
Calibration
Requirements
5.6.1
Measuring equipment used to monitor critical manufacturing process points and the
products compliance with relevant legal requirements and specifications shall be identified
and calibrated.
5.6.2
5.6.3
5.6.4
5.6.5
Results and any actions taken when measuring equipment is found to be operating outside
the specified limits shall be documented.
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5.7
Requirements
5.7.1
5.7.2
5.7.3
5.8
All practicable steps shall be taken to identify, avoid, eliminate or minimise the risk of
foreign body contamination.
5.8.1
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 brittle 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 lights, including
those on flying insect control devices, shall be protected.
5.8.1.4
All glass or brittle plastics other than the product shall be controlled 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 a responsible person shall be placed in charge of the clean-up
operation and shall ensure that 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.
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5.8.2
Sharps control
Clause
Requirements
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
5.8.2.4
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
Requirements
5.8.3.1
Chemicals including cleaning materials, 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.
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Personnel
6.1
Clause
Requirements
6.1.1
6.1.2
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 critical process steps.
6.1.3
Records of training shall be kept for all current and recent key employees.
6.1.4
6.1.5
The company shall document training procedures and records to demonstrate that training
is effective and regularly reviewed.
6.2
The company shall ensure that access and movement of personnel, visitors and
contractors shall not compromise product safety and quality.
Clause
Requirements
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
6.2.3
All facilities shall be designed and positioned, where possible, so that movement of
personnel is by simple, logical routes.
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6.3
Personal hygiene
Requirements
6.3.1
6.3.2
Jewellery and wrist watches shall not be worn, 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 medicines 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
Fingernails 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
Requirements
6.4.1
The company shall have a procedure for the notification by personnel, including 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 shall be company issued and monitored when involved in work in contact with highrisk materials. Where appropriate, in addition to the plaster, a finger stall shall be worn.
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6.5
Protective clothing
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 worn 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 worn 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 worn 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: professional laundry service, in-house, controlled laundering
facilities or self-care.
6.5.9
6.5.10
Clean and dirty clothing shall be segregated and controlled to prevent cross-contamination.
6.5.11
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The senior management shall commit the company to producing products to the
specified quality and which are safe and legally compliant.
Clause
Requirements
1.1.1
The policy shall state the companys 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 the commitment for review and continuous improvement.
1.1.2
The companys senior management shall ensure the policy is communicated to all staff
involved with activities relating to product safety, legality, regulatory compliance and quality.
1.2
Clause
Requirements
1.2.1
The companys senior management shall ensure that product safety and quality objectives
are measurable, established, documented, monitored and reviewed.
1.2.2
The companys senior management shall have a system in place to ensure that the company
is kept informed of all relevant legislative, scientific and technical developments, and
industry codes of practice applicable in the country of manufacture and, where known, the
country in which the packaging material will be sold.
1.2.3
The company shall ensure that the materials manufactured comply with 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.
1.2.4
The companys senior management shall ensure that non-conformities identified at the
previous audit against the Standard are effectively actioned.
1.2.5
The company shall have a current, original copy of the Standard available on site.
1.2.6
Where the company is certificated to the Standard they shall ensure that recertification
audits occur on or before the audit due date indicted on the certificate.
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1.3
The organisational structure shall be clear, with defined responsibilities, and key staff
shall be aware of their responsibilities with regard to packaging safety 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.
1.4
Management review
Requirements
1.4.1
1.4.2
1.4.3
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2.1
The hazard and risk management system shall be managed by a multidisciplinary team
competent in hazard and risk analysis.
Clause
Requirements
2.1.1
The multidisciplinary team shall have a designated team leader who shall be able to
demonstrate competence and experience of hazard and risk analysis.
In the event that the company does not have the appropriate expertise in-house,
external 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.
2.2
Clause
Requirements
2.2.1
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.
2.2.2
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.
2.2.3
A full description of the packaging produced by product or product group and its intended
use shall be documented.
2.2.4
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.
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Clause
Requirements
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 relation to the product and process. The
hazards considered shall include, where relevant:
foreign objects
chemical contamination (e.g. taint, odour, allergen, component transfer from inks,
varnishes and glues)
hazards that may have an impact on the functionality of the final product in use.
2.2.6
The hazard and risk analysis team shall identify control measures necessary to prevent,
eliminate or reduce each hazard to acceptable levels.
2.2.7
For each hazard that requires control, the control points shall be reviewed to evaluate if
existing prerequisites are effective in providing control.
Where greater controls are required to the prerequisite programmes, improvements shall be
implemented to ensure control is achieved.
2.2.8
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 that the hazard and risk analysis plan is effective and
may include a review of:
complaints
product failures
recalls
product withdrawals
results of internal audits of prerequisite programmes
results from external third-party auditors.
2.3
Clause
Requirements
2.3.1
The hazard and risk analysis study shall be fully 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. These shall be documented
and regarded as proposed exemptions for review at audit. Acceptance or rejection of the
proposed exemptions shall be recorded in the auditors 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.
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3.1
The company shall have a manual that describes how the requirements of the Standard
are met. These requirements shall be fully implemented, reviewed at appropriate
planned intervals and improved where necessary.
Clause
Requirements
3.1.1
The product safety and quality manual shall contain an outline of the working methods and
practices or references to where such information is documented.
3.1.2
3.2
The company shall ensure that customer needs and expectation with respect to quality
and safety are identified and met, and that communication channels are clear.
Clause
Requirements
3.2.1
3.3
Internal audits
Fundamental
The company shall establish through a programme of internal audits that the
implementation of the requirements of the Standard are in place, appropriate
and complied with.
Clause
Requirements
3.3.1
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 so that all aspects
of the Standard are audited at least annually.
3.3.2
Audits shall be conducted by personnel who are competent, and sufficiently independent
from the department being audited to ensure impartiality.
3.3.3
3.3.4
3.3.5
Conformity as well as non-conformity shall be clearly identified and verified within the
internal audit report.
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3.4
The company shall ensure that suppliers of goods and services are operating in
a manner that ensures that product quality and safety is not compromised and
specifications can be achieved.
Clause
Requirements
3.4.1
The company shall have a documented supplier approval procedure and continual
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.
3.4.4
The company shall define how exceptions are handled, e.g. the use of products or services
where assessment or approval has not been undertaken. Assessment may take the form (on
a batch or delivery basis) of:
certificate of analysis
declaration of compliance.
3.5
Subcontracting of production
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
3.5.3
Where any production processes are subcontracted, the risks to the quality and safety of
the product shall be assessed. Any risks shall be communicated to relevant personnel and
effectively managed.
3.5.4
Clear specifications shall be agreed 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.
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Requirements
3.6.1
3.6.2
All changes and amendments to documents critical 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.
3.7 Specifications
Fundamental
Appropriate specifications shall exist for raw materials, intermediate and
finished products, and any product or service that could affect the integrity of
the finished product.
Clause
Requirements
3.7.1
Specifications shall be suitably detailed, accurate and shall ensure compliance with relevant
product safety and legislative requirements.
3.7.2
The company shall seek formal agreement of specifications with relevant parties. Where
specifications are not formally agreed then the company shall be able to demonstrate that
they have taken steps to put an agreement in place.
3.7.3
3.8
Record keeping
The company shall maintain records to demonstrate the effective control of product
safety, legality and quality.
Clause
Requirements
3.8.1
The records shall be legible, genuine, appropriately authorised and retained in good
condition for an appropriate defined time period.
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3.9 Traceability
Fundamental
The company shall have a system in place to identify product batches and
to trace and follow all raw materials through processing to the distribution
of the finished product to the customer. Records shall be retrievable in a
timely manner.
Clause
Requirements
3.9.1
An appropriate system shall be in place to ensure that the customer can identify a product
or production lot number for the product for the purposes of traceability.
3.9.2
The system shall be tested to ensure traceability can be determined from raw materials to
the finished product and vice versa. This test shall take place at least annually.
Requirements
3.10.1
Actions appropriate to the seriousness and frequency of the problems identified shall be
carried out promptly and effectively by appropriately trained staff.
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 effectively manage the incident to prevent release of product where
safety or quality may have been affected.
3.11.3
3.11.4
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The product withdrawal/recall procedure shall be tested on at least an annual basis and
used to evaluate the procedure and implement improvement.
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Site Standards
4.1
External standards
All grounds within the site shall be finished and maintained to an appropriate standard.
Clause
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. Measures shall be taken to
prevent contamination.
4.1.2
The external areas shall be maintained in good order. Grounds shall be regularly tended and
well maintained and potential pest-harbouring areas shall be identified and monitored.
4.1.3
The building fabric shall be maintained to minimise 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 installed. Drains shall be
properly protected to prevent entry of pests.
4.1.5
External traffic routes, under site control, shall be maintained in good repair to avoid
contamination of the product.
4.1.6
Where external storage of raw materials is necessary these shall be protected from
contamination as required.
4.2
Requirements
4.2.1
Walls, floors, ceilings (including suspended ceilings) and pipe work shall be maintained in
good condition and shall facilitate cleaning.
4.2.2
Suitable and sufficient lighting shall be provided for a safe working environment, correct
operation of processes, effective inspection of the product and cleaning.
4.2.3
Potential sources for the ingress of pests, such as drain openings or windows opened for
ventilation, shall be suitably pest proofed.
4.2.4
Where they pose a risk to the product, glass windows shall be protected against breakage.
4.2.5
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4.3
Utilities
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
Air, compressed air or other gases that come into direct contact with the packaging shall
present no risk to product safety or quality and comply with any relevant legal regulations.
4.4
Security
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.
4.4.3
Staff shall be trained in site security procedures and encouraged to report or challenge
unidentified or unknown visitors.
4.4.4
4.4.5
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.
4.4.6
4.5
Requirements
4.5.1
The process flow from intake to despatch shall be arranged to minimise the risk of
contamination or damage to the product.
4.5.2
Premises shall allow sufficient working space and storage capacity to enable all operations
to be carried out properly under hygienic conditions.
4.5.3
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4.6
Equipment
Product safety, legality and quality shall be ensured through the use of appropriate
equipment that shall be properly designed and maintained.
Clause
Requirements
4.6.1
Newly installed equipment shall be properly specified before purchase. Equipment shall
be constructed of appropriate materials and be of a suitable design to ensure it can be
effectively cleaned and maintained. New equipment shall be tested and commissioned prior
to use, and a maintenance programme established.
4.7
Maintenance
Proper maintenance and monitoring of all equipment critical to product safety, quality
and legality shall ensure consistent high levels of product safety, functionality and
quality.
Clause
Requirements
4.7.1
4.7.2
Maintenance work shall not place the product at risk. After breakdown or maintenance,
machinery shall be thoroughly checked before re-commencing production.
4.7.3
4.7.4
4.8
Staff facilities
Requirements
4.8.1
Suitable and sufficient hand-washing facilities shall be available to enable cleaning of hands
before commencing work and as necessary during the course of work.
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
Eating, drinking and smoking shall not be allowed in locker and changing rooms.
4.8.4
Facilities for visitors and contractors shall comply with the companys hygiene policy.
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4.9
Clause
Requirements
4.9.1
Good standards of housekeeping shall be maintained, which shall include a clean as you
go policy.
4.9.2
The cleaning of production equipment and internal surfaces of storage and production
facilities shall be effectively managed using cleaning schedules.
4.9.3
Cleaning chemicals shall be fit for purpose, suitably labelled, secured in closed containers
and used in accordance with manufacturers instructions. Materials and equipment used for
cleaning toilets shall be segregated from those used elsewhere.
Requirements
4.10.1
4.10.2
Where agreed with the customer, substandard trademarked materials shall be rendered
unusable through a destructive process. If transferred to a third party for destruction or
disposal, that third party shall be a specialist in appropriate waste disposal and shall provide
records of material destruction.
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Requirements
4.11.1
A preventive pest control programme shall be maintained covering all areas of the site under
the companys 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.
4.11.3
4.11.4
In the event of infestation, immediate action shall be taken to eliminate the hazard. Action
shall be taken to evaluate the potential for contamination or damage to packaging and
checks instigated before release.
Requirements
4.12.1
All finished products and materials transferred between premises shall be fully identified and
protected during transit and storage.
4.12.2
Receipt documents and/or product identification shall facilitate correct stock rotation of
goods in storage.
4.12.3
Deliveries of incoming goods shall be visually checked for packaging integrity and potential
foreign body contamination.
4.12.4
4.12.5
Work in progress shall be suitably labelled and covered to ensure proper identification and
prevent damage.
4.12.6
4.12.7
All vehicles used for deliveries shall be in a condition to minimise the risk of
product contamination.
4.12.8
All company-owned vehicles used for deliveries shall be visually checked for cleanliness
before loading. Unsatisfactory lorries shall not be loaded.
4.12.9
4.12.10
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5.1
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
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 that
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.
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5.2
Processes shall be in place to ensure that print quality meets agreed specifications
and critical print content such as allergen/safety/legal information is fully legible and
correctly printed.
Clause
Requirements
5.2.1
An assessment shall be carried out of the print process and handling of printed packaging
(product) to identify:
risks of loss 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
customers approved origination material.
5.2.3
5.2.4
Each print run shall be approved against the agreed 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 (where 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 customer/specifier/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.
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5.3
Process control
Fundamental
The production process shall be controlled through effective quality assurance
of operations to ensure packaging materials can be consistently produced to
the quality specified by customers.
Clause
Requirements
5.3.1
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.
5.3.2
For each critical manufacturing process control point, machine settings or process limits shall
be established and documented the process specification.
5.3.3
5.3.4
A clearance procedure shall be in place to ensure that at start up, the line is clear of all
previous work and production documents.
5.3.5
5.4
The company shall use appropriate procedures and facilities when undertaking or
subcontracting inspection and analyses critical to product safety, legality and quality.
Clause
Requirements
5.4.1
Quality checks shall be carried out at appropriate stages in production to demonstrate that
raw materials, work in progress and the finished product are 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
5.4.4
5.4.5
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5.5
In-line measuring or product testing equipment, where used, shall be tested and
maintained to ensure it is effective in ensuring product safety integrity and quality.
Clause
Requirements
5.5.1
The accuracy of in-line equipment shall be specified having due regard to the product
parameter being measured and controlled.
5.5.2
The company shall establish and implement procedures for the operation, routine
monitoring and testing of equipment.
5.6
Calibration
Where specialist measuring is required to assess compliance with product safety and
legality, the devices shall be maintained and calibrated.
Clause
Requirements
5.6.1
Measuring equipment used to monitor critical manufacturing process points and the
products compliance with relevant legal requirements and specifications shall be identified
and calibrated.
5.6.2
5.7
Requirements
5.7.1
5.7.2
5.7.3
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5.8
The company shall be able to demonstrate that effective controls are in place to
ensure product is protected from contamination during production and storage.
5.8.1
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
Based on the likelihood and risk of glass contamination, all bulbs and strip lights, including
those on flying insect control devices, shall be protected.
5.8.1.3
Where glass breakage occurs a responsible person shall be placed in charge of the clean-up
operation and shall ensure that 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.
5.8.2
Sharps control
Clause
Requirements
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
5.8.3
Chemical control
Requirements
5.8.3.1
Chemicals including cleaning materials, lubricants and adhesives shall be of the appropriate
grade and be suitably controlled to prevent contamination of the product.
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Personnel
6.1
Clause
Requirements
6.1.1
6.1.2
The company shall routinely review the competencies of staff and provide relevant training
as appropriate. Records of training shall be maintained.
6.2
The company shall ensure that access and movement of personnel, visitors and
contractors shall not compromise product safety and quality.
Clause
Requirements
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
6.3
Personal hygiene
Requirements
6.3.1
6.3.2
Personal items and belongings including personal mobile phones shall not be taken into
production areas without the permission of the management.
6.3.3
Eating (including the eating of confectionery and chewing of gum or tobacco), drinking and
smoking shall not be allowed in production or storage areas.
6.3.4
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.
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6.4
Protective clothing
The risk of product contamination from clothing, hair or personal items shall
be minimised.
Clause
Requirements
6.4.1
Appropriate clean protective clothing that cannot contaminate the product shall be worn.
Where no need for protective clothing has been established by risk assessment, it shall
be fully justified and guidance provided to staff on any limitations to personal clothing to
prevent a contamination risk to the product.
6.4.2
Where protective clothing is used it shall be kept adequately clean. Changes of clothing shall
be available as required.
6.4.3
Where protective clothing is used, clean and dirty clothing shall be segregated and
controlled to prevent cross contamination.
6.4.4
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SECTION IV
AUDIT AND CERTIFICATION PROCESS
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Section IV
Getting Started
Obtaining BRC certification is often a challenging step for companies, and it is vital that the company is well
prepared for the audit, otherwise substantial unnecessary cost may be incurred and disappointment is likely.
Some considerations that should be addressed by companies interested in obtaining certification are outlined
in this section.
Many of the certification bodies offer an optional pre-assessment visit. Certification bodies are not allowed
to act as consultants since this could potentially result in them auditing their own work, but such a visit can
help and allows sites to obtain a clear understanding of where they need to improve their processes and
procedures. A pre-assessment visit is not a part of the certification process and is not taken into consideration
during the actual certification audit.
If a site is working with a specific customer, it would be advisable to discuss an implementation programme
with the sites technical team to ensure that the steps being taken are appropriate with regard to the
customers requirements and timescales.
It is a requirement of BRC certification that the company has an original copy of the current issue of the
Standard, which can be obtained in either electronic or paper format. Either format is acceptable. The current
issue of the Standard in the required language is available from www.brcbookshop.com. The Standard
should be obtained as the first stage of preparation for certification.
The Standard should be read and understood and a preliminary self-assessment should be conducted by the
company against the Standard. Any areas of non-conformity should be addressed by the company. Further
information and guidance to ensure compliance with the Standard, including an interpretation guideline, audit
tools and training courses, are available on the website: www.brcglobalstandards.com.
Companies who meet the requirements of a satisfactory quality management system (for example, one
conforming to that specified in ISO9001:2008) may already meet many of the requirements of the Standard.
It is in the interest of the company to bring these points to the attention of the certification body. The auditor
shall, however, verify that all the procedures are adequate for the purpose of compliance with the Standard.
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Once a self-assessment has been completed and any non-conformities addressed, the company must select a
certification body. The BRC cannot advise on the selection of a specific certification body, but the BRC Global
Standards Directory lists BRC-approved certification bodies. Visit www.brcdirectory.com.
In selecting a certification body, the company should consider the following:
Confirmation that the auditor proposed by the certification body meets the qualification and training
requirements specified by the BRC as documented in Appendix 3.
The scope of accreditation of the certification body. It is essential that the certification body is accredited
to assess companies for the range of products produced. Clarification of the fields of packaging against
which the certification body can audit should be obtained either by confirmation from the certification
body concerned or accreditation schedules published by the national accreditation body. A list of
packaging fields is provided in Appendix 4.
A contract shall exist between the company and the certification body, detailing the scope of the audit and
reporting requirements. This contract will be formulated by the certification body.
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Pre-assessment (optional)
On-site audit
Closing meeting
Confirmation of any non-conformities
INITIAL AUDIT
Corrective action
submitted or revisit within
90 calendar days
Corrective action
submitted or
revisit within 28
calendar days
Evidence assessed
inadequate
Evidence assessed
Clarification required
Additional clarification
provided
Critical non-conformity
or fundamental
No non-conformities
identified
No corrective action
submitted within 28
days
Evidence assessed
compliant
No certificate issued
Report issued
specifying status
Process/certification
suspended
Corrective action
status documented
Certification
documentation
collated
No certificate issued
Report issued
specifying status
Process/certification
suspended
Evidence assessed
inadequate
Certification and
grading decision
made by certification
decision manager
On-going compliance
Audit in accordance
with required
frequency
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product/processes to be added to the scope. The certification body will assess the aspects of the required
extension to scope and seek assurances that the management of the new product/process are in compliance
with the Standard. This will often take the form of a site visit. The current certificate will be superseded by any
new certificate issued using the same expiry date detailed on the original certificate.
For the initial audit, the company shall agree a mutually convenient date, with due consideration given to
the amount of work required to meet the requirements of the Standard. For subsequent audits, the mutually
agreed date must allow sufficient time to ensure the company does not go out of the certification time frame
as detailed in Section IV, 13 Ongoing Audit Frequency and Certification, and with reference to Table 2.
There is a requirement on the company to plan carefully for the audit, to have appropriate documentation for
the auditor to assess, and to have appropriate staff available at all times during the on-site audit.
The company shall ensure that the production programme at the time of the audit covers products for the
intended user(s) of the certification. Where possible, the widest range of these products shall be in production
for the auditor to assess. Where the product range is large or diverse, the auditor has to continue the audit
until sufficiently satisfied that the intended scope of the certification has been assessed.
The company shall provide the certification body with any information such as risk analysis documentation,
details of recent quality issues, withdrawals or customer complaints, and other relevant performance data
when requested, to assist the auditor in conducting an effective audit.
Companies are free to change certification bodies at any time, but it is a requirement that the company shall
make the previous BRC audit report available to the auditor and the certification body.
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audit not carried out in first language of the auditor or the company
quality of company preparation, e.g. documentation, hazard analysis, quality management system.
the opening meeting to confirm the scope and process of the audit
review of production facilities inspection to verify and conduct further documentation checks
final review of findings by the auditor preparation for the closing meeting
closing meeting to review the findings of the auditor with the company. Note that
non-conformities and consequent grade are subject to subsequent independent verification by
the certification body management.
There is no requirement for the auditor to carry out the audit in the order listed above but the audit must
include all elements.
The company will fully assist the auditor at all times. It is expected that at the opening and closing
meetings those attending on behalf of the company will be senior managers who have the appropriate
authority to ensure that corrective action can be progressed if non-conformities are found. The most
senior operations manager on site, or their nominated deputy, shall be available at the audit and attend
the opening and closing meetings.
During the audit, detailed notes shall be made regarding the companys conformities and non-conformities
against the Standard and these will be used as the basis for the audit report. The auditor will assess the nature
and severity of any non-conformity.
At the closing meeting, the auditor shall present his/her findings, and discuss all non-conformities that have
been identified during the audit, but shall not make comment on the likely outcome of the certification
process. Information on the process and timescales for the company to provide evidence to the auditor of the
corrective action to close non-conformities must be given. A summary of any non-conformities discussed at
the closing meeting will be documented by the auditor either at the closing meeting or within one working
day after completion of the audit.
The decision to award certification will be determined independently by the certification body management,
following a technical review of the audit report and the closing of non-conformities. The company will be
informed of the certification decision following this review.
All information viewed during the audit is regarded as confidential between the auditor and the site, except
as detailed in the audit report. No brand names or similar identifiers of product will be released in the audit
report or certificates, although it will be necessary to describe, in general terms, the types of materials and
technologies used.
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9.1 Non-conformities
There are three levels of non-conformity:
Critical
Where there is a critical failure to comply with a product safety or legality issue.
Where there is a substantial failure to meet the requirements of a statement of intent or
any clause of the Standard
Major
and/or
A situation is identified that would, on the basis of available objective evidence, raise
significant doubt as to the conformity of the product being supplied.
Where absolute compliance to the statement of intent has not been met, but on the
basis of objective evidence the conformity of the product is not in doubt
Minor
and/or
A clause has not been fully met but on the basis of objective evidence, the conformity of
the product is not in doubt.
The objective of the audit is to provide a true reflection of the standards of the operation, and level of
conformity with the Standard. Consideration should therefore be given to awarding a single major nonconformity where minor non-conformities are repeatedly raised against a particular clause of the Standard in
the current or previous audits. Clustering of a significant number of minor non-conformities against a clause
and recording this as a single minor non-conformity is not permitted.
Any non-conformities from the previous audit should be checked during the current audit to confirm that
corrective action has been taken and is operating effectively. Any repetition of these same non-conformities in
the current audit shall be highlighted by an asterisk (*) and consideration should be given to raising the status
of minor non-conformities to a major.
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9.3 Revisits
Where revisits are required to review the action taken in response to the non-conformities identified at the
audit, this will be scheduled to be completed within the timescales for certification i.e. 28 calendar days for
certificated sites, and 90 calendar days for initial audits. The visit will primarily review the effectiveness of the
corrective actions taken; however, if new non-conformities are identified during the course of the visit, these
must also be satisfactorily resolved before a certificate can be issued. The action taken to correct the nonconformities will be recorded on the final audit report.
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such further reviews by the certification body. The ultimate decision to suspend or withdraw certification
remains with the certification body.
If there is no intention by the company to take appropriate corrective actions or the corrective actions are
deemed inappropriate, certification shall be withdrawn.
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Grade
Critical or
major nonconformity
against the
statement of
intent of a
fundamental
requirement
Critical
Major
Minor
Corrective action
10 or
fewer
Objective evidence in 28
calendar days
12 months
10 or
fewer
Objective evidence in 28
calendar days
12 months
11 to 20
Objective evidence in 28
calendar days
12 months
20 or
fewer
6 months
Fewer
than 2
Up to
30
6 months
1 or more
Certification not
granted.
Re-audit required
1 or
more
Certification not
granted.
Re-audit required
3 or
more
Certification not
granted.
Re-audit required
21 or
more
Certification not
granted.
Re-audit required
Fewer
than 2
31 or
more
Certification not
granted.
Re-audit required
Audit
frequency
12.2 Certification
After a successful review of the audit report and documentary evidence provided in relation to
non-conformities identified, a certification decision shall be made by the designated independent
certification manager and a certificate issued by the certification body, typically within 42 calendar days of
the audit. The certificate shall conform to the format shown in Appendix 5 using BRC and accreditation
body logo usage rules.
The certificate shall contain the six-digit BRC registration number of the auditor. This number refers to a
register of qualified auditors kept by the BRC and enables it to cross-check auditor competence against
the audit carried out. This register is not publicly available.
All dates specified on the certificate shall be in the format of day, month, year, e.g. 11 November 2011.
The certificate will detail the scope of the audit as agreed in Section IV, 5.2 above and the hygiene
risk category.
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Where the audit has been undertaken by an auditor trained by the BRC who has been issued with a BRC
third-party auditor certificate, the BRC trained auditor logo may be added to the certificate and shall
comply with the BRC logo usage rules.
The date of audit specified on the initial certificate shall be the date of the audit relating to the granting
of that certificate (i.e. the date of the initial audit) irrespective of whether further audits were made to
verify corrective action arising from the initial audit.
The users of certificates are advised that they should verify that the scope of the certificate is clearly stated
and that this information is consistent with their own requirements.
Whilst the certificate is issued to the company, it remains the property of the certification body, which control
its ownership, use and display.
12.3 Appeals
The company has the right to appeal to the certification body against the certification decision of the
certification body and this should be made in writing within seven calendar days of receipt of the decision.
The certification body shall have a documented procedure for the consideration and resolution of appeals
against the certification decision. These investigative procedures shall be independent of the individual auditor
and certification manager. The certification bodys documented appeals procedure will be made available to
suppliers on request. Appeals will be finalised within 30 calendar days of receipt. A full written response will
be given after the completion of a full and thorough investigation into the appeal.
In the event of an unsuccessful appeal, the certification body has the right to charge costs for conducting
the appeal.
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Table 2 Worked example of an initial audit followed by 6- and 12-month recertification audits
Audit
Event
Date
Initial audit
(audit 1)
1 February 2012
Certificate issue
date
7 April 2012
Explanation
Recertification
audit (audit 2)
Certificate expiry
date
14 March 2013
1 February 2013
Actual re-audit
visit
26 January 2013
Certificate issue
date
25 February 2013
Certificate expiry
date
14 September
2013
or
14 March 2014
Recertification
audit due date
1 August 2013
or
1 February 2014
The company has corrected nonconformities and the certification body has
issued the certificate within the 42-day
window.
the site is situated in a specific country or an area within a specific country where there is government
advice to not visit and there is no suitable local auditor
the site is in an area that has suffered a natural or unnatural disaster, rendering the site unable
to produce.
If the renewal of the certificate is prevented due to these exceptional circumstances, a major nonconformance will not be raised against clause 1.2.8/1.2.6. The Standard user may still decide to take products
from that site for an agreed time, as it may still demonstrate legal compliance by other means, such as risk
assessment and complaints records, which show that the site is still competent to continue production until
another audit can be arranged.
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a searchable list of certificated companies including contact details, the Standard against which they are
certified, scope and website links
a searchable list of approved certification bodies, including local offices and contact details.
The Global Standards Directory provides additional functionality to key user groups including companies,
customers and certification bodies. This includes user-specific access to certification information, audit reports
and management reporting, further enhancing the value of obtaining BRC certification.
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SECTION V
MANAGEMENT AND GOVERNANCE OF
THE SCHEME
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Section V
The Global Standard for Packaging & Packaging Materials is a process and product certification scheme. In
this scheme, businesses are certificated upon completion of a satisfactory audit by an auditor employed by an
independent third party the certification body. The certification body in turn shall have been assessed and
judged as competent by a national accreditation body.
The process of certification and accreditation is outlined in Figure 4.
In order for a business to receive a valid certificate on completion of a satisfactory audit, the organisation
must select a certification body approved by the BRC. The BRC lays down detailed requirements, which a
certification body must satisfy in order to gain approval.
As a minimum, the certification body must be accredited to ISO/IEC Guide 65/EN45011 by a national
accreditation body affiliated to the International Accreditation Forum and recognised by the BRC.
Further details are available in the document Requirements for Organisations Offering Certification against the
Criteria of the BRC Global Standards available from the BRC on request.
Companies looking to become certificated to the Standard should assure themselves that they are using
a genuine certification body approved by the BRC. A list of all certification bodies approved by the BRC is
available on the BRC Global Standards Directory: www.brcdirectory.com.
The BRC recognises that in certain circumstances, such as for new certification bodies wishing to commence
auditing against the Standard, accreditation may not yet have been achieved. This is because the accreditation
process itself requires some audits to have been completed that will then be reviewed as part of the
accreditation audit of the certification body. The certification body must be able to conduct audits as part of
achieving accreditation and so some unaccredited audits will be performed. This will be permitted where the
organisation can demonstrate:
an active application for accreditation against ISO/IEC Guide 65/EN45011 from an approved national
accreditation body
that accreditation will be achieved within 12 months of the date of application and the experience
and qualifications of the auditors in the relevant product category are consistent with those specified by
the BRC
that a contract is in place with the BRC and all other contracted requirements have been met.
The acceptability of audit reports generated by certification bodies awaiting accreditation but meeting the
above criteria is at the discretion of individual specifiers.
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Supporting
documentation
International
accreditation
forum and regional
accreditation forums
ISO/IEC 17011
General requirements for
accreditation bodies
National
accreditation body
ACCREDITATION
ISO/IEC Guide 65:1996 (EN45011)
Certification body
CERTIFICATION
Company
Company
Company
BRC Directory
www.brcdirectory.com
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The BRC/IOP Standard and associated scheme is managed by the BRC and is governed through a number of
committees, each of which works to a set of defined terms of reference.
2.1
The technical management and operation of the Standard is governed by the BRC Governance and Strategy
Committee consisting of senior technical representatives of international retail businesses.
The functions of the Governance and Strategy Committee are to:
ensure measures are in place to monitor compliance by companies, certification bodies and
accreditation bodies
2.2
Each BRC Global Standard is supported by at least one Technical Advisory Committee (TAC) which meets
regularly to discuss technical, operational and interpretational issues related to the Standard. The BRC and The
Packaging Society provide the technical secretariat for these groups.
The TAC is made up of senior technical managers representing the users of the Standard and includes
representatives of retailers, packaging trade associations for each sector, certification bodies and independent
technical experts.
The Standard is reviewed every three years to assess the need for updating or production of a new issue. This
work is undertaken by the TAC, which is expanded for the purpose to include other available expertise.
The TAC also reviews auditor competence requirements, proposed training materials and supplementary
technical documents supporting the Standards.
BRC executive
Scheme management
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The BRC scheme may only be certificated by certification bodies registered and approved by the BRC
and accredited by a BRC-recognised accreditation body. The BRC recognises that the quality of the audits
undertaken, the consistency of assessment of the application of the requirements, and the standards of
performance in the management of the certification process are all essential to the confidence of users of
the scheme.
To support the Standard, the BRC runs a compliance programme which reviews the performance
of the certification bodies, samples the quality of audit reports and levels of understanding of the
scheme requirements, and investigates any issues or complaints. As part of this programme, the BRC
provides feedback on the performance of each certification body through a key performance indicator
programme.
On occasions the BRC may audit the offices of certification bodies and accompany auditors on audits at sites
to observe the performance of auditors.
3.1.1 Feedback
Companies audited against the Standard may wish to provide feedback to the certification body or the BRC
on the performance of the auditor. Such feedback sent to the BRC will be considered in confidence. Feedback
provides a valuable input to the BRC monitoring programme for certification body performance.
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Appendices
APPENDICES
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Appendices
Appendix 1
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Appendix 2
Direct contact with products that are consumed or applied to the skin
Packaging that is in direct contact with a food product that has a natural barrier
Packaging that will be used for a product that is already in an impermeable pack
Corrugated case for film over wrapped biscuits where the case is filled in a different area to the
biscuit wrapping
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Appendices
Packaging for products that are not consumed or applied to the skin
Automotive products
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Appendix 3
1 Education
Auditors will be drawn generally from two distinct disciplines: those with expertise and a qualification in food
or biosciences, and those with expertise and a qualification in packaging technology. This main qualification
will be supported by a minimum secondary qualification in the other disciplines as appropriate. Where
equivalence of qualification is unclear, this shall be referred to the BRC for review.
The auditor shall have:
a degree or diploma in packaging and have successfully completed a food safety/hygiene qualification at
least equivalent to a UK Level 3 qualification (see www.brcglobalstandards.com for information), or
a degree or diploma in a food or bioscience-related discipline and have successfully completed the PIABC
EQIPT examination in packaging.
Work Experience
The auditor shall have a minimum of three years post-qualification experience related to their main
qualification discipline. This shall involve work in quality assurance, technical management or risk
management functions within manufacture, retailing, inspection or enforcement, and the auditor shall be
able to demonstrate an understanding and knowledge of specific fields of packaging for which they are
approved. The verification to carry out work within specific fields of packaging will be carried out by the
certification body.
3 Qualifications
The auditor must have:
92
passed a registered management system lead assessor course (e.g. IRCA) or the BRC third-party auditor
course delivered by a BRC-approved trainer
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Appendices
completed a training course in HACCP, based on the principles of Codex Alimentarius, of at least
two days duration, or be able to demonstrate competence in the understanding and application of
HACCP principles. It is essential that the HACCP course is recognised by the industry as being
appropriate and relevant.
Audit Training
Auditors must have successfully completed a period of supervised training in practical assessment including
witnessed assessment of a minimum of three audits at a variety of organisations against the Standard.
Certification bodies must be able to demonstrate that every auditor has appropriate training and experience
for the particular fields, for which they are considered competent. Auditor competence shall be recorded at
the level of each field of audit as indicated in Appendix 4.
Certification bodies must establish a training programme for new auditors, which will incorporate:
a Global Standard for Packaging & Packaging Materials awareness course delivered by a
BRC-approved trainer
a period of initial training covering product safety, hazard and risk management, and prerequisite
programmes that will include access to relevant laws and regulations
a period of supervised training to cover management systems, audit techniques and specific fields of
audit knowledge
Each auditors training programme shall be managed and approved by an assessor who can demonstrate that
they are technically competent in the packaging fields in which training is given.
Full detailed training records of the individual must be maintained by the certification body throughout the
term of employment, and retained for a minimum period of five years after leaving the employment of the
certification body.
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Appendix 4
Glass
Paper
Paper bags
Paper sacks
Paper labels, tags and neck collars
Board cartons
Board sleeves
Chipboard cartons and layer pads
Corrugated cases and trays
Corrugated fitments
Metals
Cans
Aerosol containers
Tubes
Closures
Aluminium foil
Foil trays
Plastics
Pallets
Boxes and crates
Decorative wooden boxes
Natural cork
Wood for food and cosmetic use
Hessian sacks
Wooden utensils
Composites shall be categorised by the component that contributes the highest percentage composition of
the product.
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Appendices
Appendix 5
Certificate Template
Trained thirdparty auditor
logo
Auditor number
has been audited by certification body name and accreditation body registration number
and found to meet the requirements of
GLOBAL STAndARd FOR PACKAGInG & PACKAGInG MATERIALS
ISSUE 4: February 2011
Date of audit:
Certificate issue date:
Re-audit due date:
Certificate expiry date:
Authorised by
Accreditation
body logo
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Appendix 6
records supporting product compliance and suitability for food/cosmetics/toiletries (including the
presence and extent of recycled content) use
management review
training
internal auditing
traceability
supplier monitoring
non-conforming goods
calibration of equipment.
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Appendices
Appendix 7
Glossary
Accreditation
Audit
Brand owner
The owner of a brand logo or name who places the said logo or name on to
retail products.
Branded product
Products bearing the logo, copyright or address of a company that is not a retailer.
Calibration
Certificate
suspension
Where certification is revoked for a given period, pending remedial action on the
part of the company.
Certificate
withdrawal
Certification
Clause
A group of requirements and statement of intent that a site must comply with in
order to achieve certification.
Company
The business name and the site seeking certification against the Global Standard for
Packaging & Packaging Materials.
Consumer
Contamination
Contractor or
supplier
Control
Corrective action
Customer/client
Exemption
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Good hygiene
practice
Good
manufacturing
practice
Hazard
High-risk product
Those products intended for human consumption or that will come into close
contact with the body, such as application to the skin, or are intended for infants.
Hygiene
Hygiene-sensitive
product
Those products intended for human consumption or that will come into close
contact with the body, such as application to the skin, or are intended for infants.
Incident
An event that has occurred that may result in the production or supply of unsafe,
illegal or non-conforming products.
Initial audit
The first Global Standard for Packaging & Packaging Materials audit at a
company/site.
Inspection
Internal audit
General process of audit, for all the activity of the company. Conducted by or on
behalf of the company for internal purposes.
Legality
Meeting all relevant legislation in the country (or countries) where the product(s) is/
are intended to be sold.
Non-conformity
Positive release
Primary packaging
That packaging which constitutes the unit of sale, used and disposed of by the
consumer, e.g. bottle, closure.
Product integrity
The ability of the packaging material to provide an effective protective barrier for
the product it is designed to contain.
Product recall
Product
withdrawal
Quarantine
The status given to any material or product set aside while awaiting confirmation of
its suitability for intended use or sale.
Raw material
Any base material or semi-finished material used by the organisation for the
manufacture of a product.
Requirement
Those statements comprising a clause with which compliance will allow sites to
be certificated.
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Retailer
Retailer-branded
product
Products bearing a retailers logo, copyright, address, or products that are legally
regarded as the responsibility of the retailer.
Risk
Safety
Schedule
Secondary
packaging
Packaging that is used to collate and transport sales units to the retail environment,
e.g. corrugated case.
Senior
management
Shall
Site
The area (and its boundaries) containing the activity being audited.
Specification
Specifier
Standard, the
Subcontractor
Tertiary
packaging
Also known as transport packaging, used to facilitate the handling and transport of
products, e.g. pallets and stretchwrap.
Testing
Traceability
User
Validation
Confirmation through the provision of objective evidence that the requirements for
the specific intended use or application have been fulfilled.
Verification
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Appendix 8
Acknowledgements
The British Retail Consortium and The Packaging Society are grateful to the members of the BRC/
The Packaging Society Working Group who prepared this document.
John Bentham
Printpack Ltd
David Brackston
Alan Campbell
Campden BRI
Adam Chappell
Phil Davidson
Smurfit Kappa UK
Roy Dixon
Henry Emblem
Iain Ferguson
The Co-operative
Mark Gallen
Duncan Goodwin
NSF-Cmi Ltd
Joanna Griffiths
Graham Hardcastle
British Glass
Martin Hodgson
British Glass
Clive Manvell
NSF-Cmi Ltd
Neil Milvain
SGS
Andrew Parkin
John Revell
Terry Robins
Gordon Stewart
Christopher Suter
Terence Wilde
Tesco
Liz Wilks
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Appendices
The British Retail Consortium and The Packaging Society are also pleased to acknowledge the helpful
contributions provided by individuals and organisations from across the globe.
Bart Baelus
Hans Bjrck
Paolo Confalonieri
DNV, Italy
Kath Cotterill
Boxes GH Ltd, UK
Christine Floeter
Ralph Geyer
DI Alfred Greimel
qualityaustria, Austria
Dr Ahmed Hammad
ISOQAR, Egypt
Vivi Konetes
HJ Heinz
Niek Oosterkamp
IsaCert
Glenn Pike
Adriano Zamarian
Intertek, UK
Knight International
QA International Certification Ltd, UK
SAI Global
TUV Rheinland, Germany
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ISBN 978-1-78490-169-1
9 781784 901691