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BRC Global Standard for Consumer Products 4: Key Changesglobal standard cp key changes

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Global Standard
Consumer Products Issue 4

Guide to Key Changes


BRC Trading Limited

October 2016

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Liability
BRC Trading Limited publishes information and expresses opinions in good faith, but accepts no
liability for any error or omission in any such information or opinion, including any information or
opinion contained in this publication.

Whilst BRC Trading Limited has endeavoured to ensure that the information in this publication is
accurate, it shall not be liable for any damages (including without limitation damages for pure
economic loss or loss of business or loss of profits or depletion of goodwill or otherwise in each case,
whether direct, indirect or consequential) or any claims for consequential compensation whatsoever
(howsoever caused) arising in contract, tort (including negligence or breach of statutory duty),
misrepresentation, restitution or otherwise, in connection with this publication or any information
contained in it, or from any action or decision taken as a result of reading this publication or any such
information.

All warranties, conditions and other terms implied by statute or common law are, to the fullest extent
permitted by law, excluded.

Nothing excludes or limits the liability of BRC Trading Limited for death or personal injury caused by
its negligence, for fraud or fraudulent misrepresentation or for any matter which it would be illegal for
it to exclude or attempt to exclude liability for.

The Global Standard for Consumer Products Issue 4: Guide to Key Changes and the terms of the
disclaimer set out above shall be construed in accordance with English law and shall be subject to the
non-exclusive jurisdiction of the English Courts.

Copyright
BRC Trading Limited 2016

All rights reserved. No part of this publication may be transmitted or reproduced in any form (including
photocopying or storage in any medium by electronic means) without the written permission of the
copyright owner. Application for permission should be addressed to the Commercial Director of Global
Standards at BRC Trading Limited (contact details below). Full acknowledgement of the author and
source must be given.

The contents of this publication cannot be reproduced for the purposes of training or any other
commercial activity.

No part of this publication may be translated without the written permission of the copyright owner.

Warning: Any unauthorised act in relation to a copyright work may result in both a civil claim for
damages and criminal prosecution.

For more information about BRC, contact:

BRC Trading Limited


Fourth Floor
2 London Bridge
London
SE1 9RA

Tel: +44 (0) 20 7854 8900


Fax: +44 (0) 20 7854 8901

Email: enquiries@brcglobalstandards.com
Website: www.brcglobalstandards.com

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Contents
Detailed changes to the requirements
1 Senior management commitment and continual improvement
2 Risk management
3 Management system
4 Site standards
5 Product control
6 Product conformity assessment
7 Process control
8 Personnel

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Detailed changes to the requirements


Order and naming of sections and clauses are as per Issue 3 (on the left); changes made in Issue 4
(General Merchandise, higher level) are shown on the right.

1 Senior management commitment and continual improvement


(now 1 Senior management commitment)
Issue 3 Issue 4 (GM higher)
Comments
Clause Requirements Clause Requirements

Statement The companys senior


of intent management shall
demonstrate that they are
fully committed to the
implementation of the
requirements of the
Global Standard for
Consumer Products.
This shall include
provision of adequate
resources, effective
communication, systems
of review and actions
taken to identify and
effect opportunities for
improvement.

1.1 Senior management


commitment and
continual improvement
Statement The sites senior
of intent management shall
demonstrate they are
fully committed to the
implementation of the
requirements of the
Global Standard for
Consumer Products and
to processes which
facilitate continual
improvement of product
safety and quality
management.

1.1.1 The site shall have a


documented policy
which states the sites
intention to meet its
obligation to produce
safe and legal products to
the specified quality and
its responsibility to its
customers. This shall be:
authorised and
signed by the person
with overall

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responsibility for the


site
communicated to all
staff.

1.1 The companys senior 1.1.2 The sites senior Objective of the
management shall management shall ensure clause has
ensure that product that clear objectives are become setting
safety and quality defined to maintain objectives to
objectives are safety and legality and assure the safety,
established, documented, improve the quality of quality and
monitored and reviewed products manufactured, legality of
at least annually. in accordance with the products
sites product safety and manufactured at
quality policy and the site.
commitment to
implementing the Communication
requirements of this of the objectives
Standard. These is required, with
objectives shall be results reported to
clearly communicated to site senior
relevant staff and management.
monitored, and results
reported at least annually
to site senior
management.

1.2 The review process shall 1.1.3 Management review


be documented and shall meetings attended by the
include an evaluation of: sites senior management
shall be undertaken at
Internal, customer appropriate planned
and external audits intervals, at least
Previous annually, to review the
management review sites performance
documents, against the Standard and
corrective action objectives set in clause
plans and 1.1.2. The review process
timeframes shall include the
Customer evaluation of:
performance
indicators, previous
complaints and management review
feedback action plans and
Incidents, non- timeframes
conforming results of internal,
materials and second-party and/or
corrective actions third-party audits
An assessment of (relevant to the
process scope of this
performance Standard)
A review of the customer complaints
product risk and results of any
assessment system customer feedback
A review of the product safety and
results of quality incidents,
monitoring and corrective actions,
testing out-of-specification
results and non-

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Developments in conforming
legal requirements materials
or scientific output of review of
information the management of
associated with the the systems for
products in scope product risk
Resource assessment, changes
requirements. in legal requirements
and process
performance
resource
requirements.

Records of the meeting


shall be documented and
used to revise the
objectives. The decisions
and actions agreed within
the review process shall
be effectively
communicated to
appropriate staff and
actions implemented
within agreed timescales.

1.3 The decisions and Moved to clause


actions agreed shall be 1.1.3.
effectively
communicated to
appropriate staff and the
actions implemented
within the agreed
timescales. Records
should be updated to
show when actions have
been completed.

1.4 The companys senior 1.1.4 The sites senior Simplified to


management shall management shall ensure the focus
provide the human and provide sufficient human of resource is to
financial resources and financial resources ensure safe
required to implement required to produce and products and
and improve the improve products safely maintain
processes of the quality and in compliance with compliance with
management system, the the requirements of this the requirements
product risk assessment Standard. of the Standard.
plan and to address
legal, product safety and
product quality matters.

1.5 There shall be clear


communication and
regular reporting of the
functioning of, and
compliance with, the
Standard to senior
management by the staff
responsible. This shall

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include suggestions for


improvement.

1.1.5 Where the site is New clause


certificated to the requiring the site
Standard, it shall ensure to maintain
that announced certification
recertification audits according to the
occur on or before the required dates, as
audit due date indicated explored in the
on the certificate. audit protocol.

1.6 The company shall have 1.1.6 The site shall have a A PDF, a
a current, original copy genuine hard copy or subscription to
of the Standard available electronic version of the BRC Participate
on site. current Standard or a hard copy of
available with a position the Standard are
statement and be aware all acceptable.
of any changes to the
Standard or protocol that
are published on the
BRC website.

1.7 Where required by 1.1.7 Where required by


legislation, the site shall legislation, the site shall
be registered with or be registered with or
approved by the approved by the
appropriate government appropriate government
agency and evidence of agency and evidence of
this shall be available. this shall be available.

1.1.8 The sites senior New clause


management shall ensure requiring all non-
that the root causes of conformities
non-conformities raised at a BRC
identified at the previous audit to be
audit against the addressed using
Standard have been root cause
effectively addressed to analysis.
prevent recurrence.
Subsequent BRC
A system shall be in audits will check
place to close out non- the non-
conformities raised at conformities
internal, second-party raised at the
and third-party audits, previous audit to
with consideration of the ensure that the
root cause. corrective and
preventive actions
are adequate and
implemented.

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2 Risk management (now Product risk management)


Issue 3 Issue 4 (GM higher) Comments

Statement The company shall have a Statement The site shall have a Legislation has
of intent management process in of intent management process in been moved to
place to assure product place to ensure that a risk new section 2.1.
safety, legality and assessment is completed
quality, based on risk on each product group to
assessment principles. ensure safety, legality and
Sites must be aware of quality in the regions of
and refer to up-to-date intended sale, where
legislation, product known.
standards, codes of
practice and
developments in science
or technology that may
impact the risk
concerning their products
and packaging where
these exist in the regions
of intended sale.

2.1 Product scope and group determination (now removed)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

2.1.1 The company shall Obsolete


identify the range of
products it wishes to
include in the scope of
certification and the
countries/states or regions
for which the products are
to be made available for
sale.

2.1.2 The company shall Obsolete


establish and document
the product group(s)
assigned to the products
in scope, derived from
application of the
questions indicated in the
decision tree (see Section
II, 3.4).

2.2 Legislative and safety requirements (now 2.1 Legislation and safety
requirements)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

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2.2.1 The company shall have 2.1.1 The site shall have a
and use a system, which system to demonstrate
may comprise internal knowledge of all
and/or external resources, applicable legislation,
to demonstrate knowledge product standards and
of all legislation, product product safety issues in
standards, product safety the place of production
issues, scientific and and regions of intended
technical developments, sale of each product. This
and industry/customer may be within the
codes of practice in the company or by use of
regions of intended sale external expertise.
relevant to the products in
scope.

2.2.2 If the company relies on 2.1.2 If the site relies on


information concerning information concerning
product safety, quality product safety, quality
and legality provided by and legality provided by
their customer or related their customer or a third
party, it shall validate the party, it shall have a
information received and process in place to
document the validation validate the credibility of
process. the provider of the
information and retain
evidence of this
validation.

2.2.3 A documented process 2.1.3 The companys senior


shall exist for management shall have a
incorporating changes in system in place to ensure
legislation, standards etc. that the site is kept
into the companys informed of and reviews:
procedures in a timely
fashion, which shall be changes in legislation
before any official scientific and
implementation date of technical
the relevant change. developments
industry codes of
practice
new risks to raw
materials,
components,
packaging and
finished product.

Any changes shall be


implemented in a timely
and controlled manner or
as defined by legal
requirements.

2.2.4 Copies of applicable 2.1.4 Copies of applicable


legislation, standards, legislation, standards,
codes of practice and codes of practice and
similar documents shall similar documents shall
be available to relevant be available to relevant
staff. staff.

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2.3 Risk assessment prior to production (now 2.2 Product risk


assessment)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

2.3.1 A design specification 3.6.2 A specification shall be Moved to section


covering each product available for each finished 3.6
shall be documented, product and shall have Specifications
dated and authorised. This been verified to ensure it and technical
shall include all relevant is fit for purpose, meets files
information. customer requirements
and is compliant with
As a guide, this may relevant safety and
include the following, legislative requirements
although this is not an in the regions of intended
exhaustive list: sale.

composition, size, As a minimum, the


colour specification may include
bill of materials the following, although
assembly diagrams this is not an exhaustive
primary packaging list:
intended shelf life
warnings or product name and
instructions for use description
use, misuse, usage composition
patterns physical and/or
production volumes. chemical parameters
assembly diagrams
Any changes to the packaging
product design shall be labelling
documented and dated. intended shelf life
warnings
instructions for use.

2.3.2 The company shall 2.2.3 The site shall determine Moved to section
determine and list the and maintain up-to-date 2.2 Product risk
legal statutes and information about the assessment.
mandatory standards legislation and mandatory
applicable to each product standards applicable to
and to the materials from each product and to the
which it is made, relevant materials from which it is
in the regions of intended made, relevant in the
sale. regions of intended sale.

2.3.3 The company shall ensure 2.2.1 The company shall ensure Moved to section
that a product hazard and that a product hazard and 2.2 Product risk
risk assessment is risk assessment is assessment.
available and clearly undertaken for each
identifies: product or product group.
The assessment shall be
The hazards, the risk documented and include:
level for each hazard
and whether the risk a description of the
is acceptable product assessed (for
example, approved
samples or mock-ups,

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The person sample drawings,


responsible for the computer graphics,
assessment photographs,
The date performed specification)
and the evidence (for the intended use of
example, sample the product and
drawings, computer foreseeable abuse
graphics) from which conditions
the assessment was the hazards, the risk
derived. level for each hazard
and whether the risk
This risk assessment may is acceptable
be provided by internal or the date performed,
external resources. name of the person
responsible and the
If the product requires evidence from which
modification, a new risk the assessment was
assessment shall be derived.
completed on the
modified design. If the assessment
indicates that a product
may present an
unacceptable risk to
consumers, that product
shall not be produced by
the site. If the product
requires modification, a
new risk assessment shall
be completed on the
modified design.

2.3.4 No products deemed to


present an unacceptable
risk by the assessment
described in clause 2.3.3
shall be produced.

2.4 Verification of the product risk assessment (now moved to 2.2 Product
risk assessment)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

2.4.1 The company shall ensure 2.2.2 The assessment shall be


that risk assessments have undertaken by suitably
been carried out by trained and competent
competent staff (internal internal or external
or external) and shall resources. Evidence of
document the way in this shall be available
which this is assessed. unless the assessment is
provided by the customer.

2.4.2 The risk assessment shall 2.2.4 The risk assessment shall
be regularly, and at least be reviewed, at least
annually, reviewed (while annually, to ensure that
the products are still in the assessment remains
production) to ensure that up to date, takes account

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the assessment remains up of complaints or incidents


to date, takes account of with the product or
complaints or incidents similar products and
with the product or reflects any changes in
similar products and specification,
reflects any changes in manufacturing process
legislation. and legislation.

2.4.3 The risk assessment shall


be carried out before
production begins, and
completion shall be
verified by a designated
responsible person. If
customer sign-off is part
of the contract of sale, this
shall be obtained.

2.4.4 Where there is a legal 2.2.5 Where there is a legal


requirement to do so or requirement to do so or
when it is necessary to when it is necessary to
confirm its safety or confirm its safety or
legality, a representative legality, a representative
product should be product should be
submitted for testing to a submitted for testing to a
suitably qualified and suitably qualified and,
accredited laboratory where applicable, an
(internal or external). The accredited laboratory
results of the test should (internal or external). The
form part of the risk results of the test should
assessment. form part of the risk
assessment.

2.4.5 Aspects of the product


design/materials that are
critical to safety and
which must be maintained
in production shall be
established with the risk
assessment provider and
the control limits set on
these features or
materials.

2.4.6 Where legally required, 2.2.6 Where legally required,


the identity, qualifications the identity, competence,
and/or licence of the qualifications and/or
person producing the licence of the person
safety review or risk producing the safety
assessment shall be review or risk assessment
documented and verified. shall be documented and
verified.

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3 Management system (now Product safety and quality


management)
3.1 Policy statement (now Product safety and quality management system)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

3.1.1 The policy shall state the Moved to clause


companys intention to 1.1.1.
produce safe and legal
products to the specified
quality (and to meet its
responsibility to its
customers). This shall
include the commitment
for review and continual
improvement.

3.1.2 The companys senior Moved to clause


management shall ensure 1.1.1.
the policy statement is
communicated to and
understood by all staff
involved with activities
relating to product safety,
legality and quality.

Statement The sites processes and


of intent procedures to meet the
requirements of this
Standard shall allow
consistent application,
facilitate training, and
support due diligence in
the production of a safe
and legal product to
agreed quality.

3.1.1 The site shall have an


established quality
management system
(QMS) in place which is
appropriate to the size of
business and risk
associated with the
products.

The QMS shall be fully


implemented, collated in
a navigable and readily
accessible way, and
translated into appropriate
languages if necessary.

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3.2 General documentation requirements (now Documentation control)


3.2.1 Documentation control
Issue 3 Issue 4 (GM higher)
Comments
Clause Requirements Clause Requirements

Statement The companys senior Statement The site shall operate an


of intent management shall ensure of intent effective document
that all documents, control system to ensure
records and data critical that only the correct
to the management of approved versions of
product safety, legality documents, including
and quality are in place recording forms, are
and effectively available and in use.
controlled.

3.2.1.1 All documents in use 3.2.1 The site shall have a


shall be the current document control
versions, authorised and procedure to ensure that
dated, and a procedure all key documents which
shall be in place to ensure form part of the product
that obsolete safety and quality system
documentation is are effectively managed.
removed from use.
This shall include:

a list of all controlled


documents indicating
the latest version
number
the method for the
identification and
authorisation of
controlled documents
a record of the reason
for any changes or
amendments to
documents
the system for
replacement of
existing documents
when these are
updated.

Documents which are in


electronic form shall be
suitably protected to
prevent loss or malicious
intervention.

3.2.1.2 Documents shall be Moved and


clearly legible, consolidated
unambiguous, in with clause 3.2.1.
appropriate languages
and sufficiently detailed
to enable their correct
application by staff. They
shall be readily accessible

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to relevant staff at all


times.

3.2.1.3 Changes or amendments Moved and


to documents shall be consolidated
authorised and dated and with clause 3.2.1.
the reason for the change
recorded.

3.2.2 Record completion and maintenance (now 3.3)


Issue 3 Issue 4 (GM higher)
Comments
Clause Requirements Clause Requirements

Statement The company shall Statement The site shall maintain


of intent maintain records to of intent original, accurate, timely
demonstrate the effective and legible records to
control and achievement demonstrate the effective
of product safety, legality control of product safety,
and quality. legality and quality.

3.2.2.1 The records shall be 3.3.1 Records shall be Includes records


legible, genuine, maintained in good in electronic
appropriately authorised condition and retrievable. format.
and retained in good Any alterations to records
condition for a period shall be authorised and
which takes account of justification for alteration
the product lifetime and shall be recorded. Where
is consistent with the records are in electronic
legal requirements in the form these shall be
country of manufacture suitably backed up to
or sale. Customer- prevent loss.
specific requirements
relevant to record
retention shall be
respected.

3.2.2.2 The companys senior 3.3.2 Records shall be retained


management shall ensure for a defined minimum
that procedures are period with consideration
operated for the collation, given to:
review, maintenance,
storage and retrieval of legal requirements
all records relating to the shelf life of the
product safety, legality product
and quality. customer
requirements.

3.2.2.3 Any alterations to records Moved into


shall be visible and clause 3.3.1.
authorised, and the
justification for alteration
shall be recorded.

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3.2.3 Specifications and technical information dossiers (now 3.6 Specifications and
technical files)
Issue 3 Issue 4 (GM higher)
Comments
Clause Requirements Clause Requirements

Statement The company shall ensure Statement A system shall be in place


of intent that specifications exist of intent to manage specifications
for raw materials, and technical data for raw
components and bought- materials, components
in components including and packaging materials.
packaging,
intermediate/semi-
processed and finished
products and any product
or service that could
affect the integrity of the
finished product. A
technical dossier shall be
established for each
product.

3.2.3.1 Specifications shall be 3.6.1 Suitably detailed and


adequate and accurate, accurate specifications
and shall ensure shall be held for all raw
compliance with relevant materials, components,
safety, legislative and packaging materials and
customer requirements. finished products to
They shall be accessible ensure compliance with
to relevant staff. relevant safety,
legislative, quality and
customer requirements.
The specifications shall
be accessible to relevant
staff and the company
shall seek formal
agreement of
specifications with
relevant parties.

3.2.3.2 Companies shall maintain 3.6.3 Companies shall maintain


a technical dossier the data in a technical file
containing all relevant that is accessible to
data (or details of where relevant staff containing
such data is located) to all relevant data (or
ensure that products meet details of where such data
the requirements of the is located) to ensure that
Standard. For example: products meet the
requirements of the
detailed product specification and
specification (see legislative and customer
clause 2.3.1) requirements.
bill of materials
safety data sheets on Relevant data may
all chemicals used include:
where relevant to the
safety, legality or bill of materials
quality of the product safety data sheets on
risk assessment(s) all chemicals used

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description of the where relevant to the


conformity safety, legality or
assessment procedure quality of the product
test reports, risk assessment(s)
inspection reports description of the
list of the legislation, conformity
product standards assessment procedure
with which the test reports
products are inspection reports
manufactured to list of the legislation
comply and product
production control standards with which
procedures and charts the products are
approvals by any manufactured to
government body (if comply
applicable) production control
declarations of procedures and charts
conformity to legal approvals by any
requirements (if government body (if
applicable). applicable)
declarations of
conformity to legal
requirements (if
applicable)
self-inspection
reports
corrective actions.

3.2.3.3 The company shall seek Moved into


formal agreement of clause 3.6.1.
specifications with
relevant parties. Where
specifications are not
formally agreed, then the
company shall be able to
demonstrate that they
have taken steps to seek
formal agreement.

3.2.3.4 There shall be a


documented procedure for
the amendment and
approval of specifications
for all parts of the process
including regular reviews
to ensure adequacy and
status.

3.3 Organisational structure, responsibility and management authority (now


1.2 Organisational structure, responsibilities and management authority)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

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Statement The company shall have a Statement The site shall have a clear
of intent clearly defined and of intent organisational structure
documented and lines of
organisational structure communication to enable
that ensures the effective management of
awareness of job product safety, legality
function, responsibilities and quality.
and reporting
relationships of key staff.

3.3.1 The company shall have 1.2.1 The site shall have an up-
an organisation chart to-date organisation chart
demonstrating the for key staff
structure of the company. demonstrating the
management structure of
the company. The
responsibilities for the
management of activities
which ensure product
safety, legality and
quality shall be clearly
allocated and understood
by the managers
responsible. There shall
be clear evidence of who
deputises in the absence
of the responsible person.

3.3.2 Documented, clearly


defined responsibilities
shall exist and be
communicated to key
staff with responsibility
for product safety,
legality, product quality,
and management systems.

3.3.3 A named individual with 1.2.2 The sites senior


relevant experience and management shall ensure
qualifications shall be that all employees are
responsible for the aware of their
management of the legal, responsibilities. Where
quality and safety documented work
requirements laid out in instructions exist for
this Standard. This activities undertaken, the
responsibility should not relevant employees shall
present a conflict of have access to these and
interest with any other be able to demonstrate
responsibilities. that work is carried out in
accordance with the
instructions.

A senior member of staff


should be identified with
responsibility and
authority to stop
production, if required.

3.3.4 There shall be appropriate


documented

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arrangements in place to
cover for the absence of
key staff.

3.3.5 The companys senior


management shall ensure
that a description of
general duties or work
instructions is in place
and communicated to all
staff involved with
activities relating to
product safety, legality
and quality.

3.4 Internal audit

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement The company shall audit Statement The company shall be


of intent the management system of intent able to demonstrate that it
to ensure that it is verifies the effectiveness
complied with and of the product safety and
appropriate. quality requirements
implemented from the
Global Standard for
Consumer Products.

3.4.1 Internal audits shall cover 3.4.1 There shall be a


all aspects associated scheduled programme of
with the Standard. They internal audits throughout
shall be scheduled and the year with a scope
their scope and frequency which covers the
shall be established implementation of the
commensurate with the process risk assessment,
risks associated with the GMP and documented
activity. Audits of aspects procedures to achieve this
that directly affect safety, standard. The scope and
legality or quality shall be frequency of the audits
conducted at least shall be established in
annually. Exceptions relation to the risks
resulting in audit intervals associated with the
of more than one year activity and previous
shall be justified by audit performance.
documented risk
assessment.

3.4.2 Internal audits shall be 3.4.2 Internal audits shall be


carried out by competent carried out by
auditors, who shall be appropriately trained,
independent of the area of competent auditors.
operation being assessed. Auditors shall be
Auditors shall not audit independent (i.e. not audit
their own work. their own work).

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3.4.3 Corrective actions shall 3.4.3 The internal audit


be formally agreed by the programme shall be fully
person responsible for the implemented and tracked.
action and implemented Internal audit reports shall
within appropriate and identify conformity as
agreed timescales. well as non-conformity
and the results shall be
reported to the personnel
responsible for the
activity audited.
Corrective actions and
timescales for their
implementation shall be
agreed and completion of
the actions verified.

3.4.4 A record of all Moved into


programmed internal clause 3.4.3.
audits and associated
corrective actions shall be
maintained with both
conformity and non-
conformity with the
requirements
documented. All
corrective actions shall be
verified to ensure
satisfactory completion.

3.5 Purchasing, supplier approval and performance monitoring (now 3.5


Supplier approval and performance monitoring)
3.5.1 Management of suppliers of raw materials, components and packaging
Issue 3 Issue 4 (GM higher)
Comments
Clause Requirements Clause Requirements

Statement The company shall Statement The site shall have an


of intent control all purchasing of intent effective supplier
processes which are approval and monitoring
critical to product safety, system to ensure that any
legality and quality to potential risks from raw
ensure that procured materials, components or
products and services packaging to the safety,
conform to defined legality and quality of the
requirements. In this final product are
context suppliers shall understood and managed.
include subcontractors
and home workers.

3.5.1 The site shall have a 3.5.1.1 The site shall have a
documented supplier- documented procedure for
approval procedure, supplier approval,
including a list of including a list of
approved suppliers for approved suppliers for
products, materials and products, materials and
services impacting services impacting

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product safety, legality or product safety, legality or


quality. quality.

Procedures shall be The approval of these


established which include suppliers shall be based
clear criteria for ongoing on at least one or a
assessment and the combination of the
standards of performance following:
required. Ongoing
assessment may take the supplier
form of monitoring questionnaire
performance through one certificate of analysis
or more of the following, supplier audits
although there may be supplier certification
other acceptable methods: with a scope covering
the products
in-house checks supplied.
certificates of
analysis
certificate of
conformity
supplier audits
traceability checks.

Records of this
monitoring shall be
retained for at least the
lifetime of the product.

3.5.2 The company shall 3.5.1.2 Documented procedures New clause


review the performance shall be established which separating
of new suppliers against include clear criteria for supplier approval
defined criteria within a ongoing assessment of the from ongoing
specified trial period standards of performance assessments.
and thereafter at a required. Ongoing
specified frequency to assessment may employ
decide the level of one or more of the
ongoing supplier following or other
performance monitoring. acceptable methods:

in-house checks
certificate of
conformity
supplier audits
traceability checks.

Records of this
monitoring shall be
retained with
consideration given to
legal requirements,
product shelf life and
customer requirements.

3.5.3 The procedures shall 3.5.1.3 Documented procedures


identify whether the use shall define how
of unapproved suppliers exceptions are handled;
is acceptable under any for example, the use of
emergency or unusual products where audit or

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situations. If this is the monitoring has not been


case, the procedure shall undertaken.
define how exceptions
are recorded and how Based on a batch or
they are handled to delivery basis, the
maintain safety, legality procedure may involve
and quality of the the assessment of
products. certificates of analysis.

3.6 Customer-supplied property (now removed)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement The company shall


of intent exercise care with
customer property
(including intellectual
property) while it is under
the companys control or
is being used by the
company.

3.6.1 The company shall


identify, verify, protect
and safeguard customer
property including
software, intellectual
property and products. If
any customer property is
lost, damaged or
otherwise found to be
unsuitable for use, this
shall be reported to the
customer and records
maintained.

3.7 Corrective and preventive action

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement The companys senior Statement The site shall be able to


of intent management shall ensure of intent demonstrate that it uses
that procedures exist to the information from
record, investigate, identified failures in the
analyse and correct the product safety and quality
cause of non-conforming management system to
products or failure to make necessary
meet standards, corrections and prevent
specifications and recurrence.
procedures which are
critical to product safety,
legality and quality.

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3.7.1 The company shall 3.7.1 The company shall


operate an effective operate an effective
system for the capture, documented process for
recording and timely the capture, recording and
investigation of non- timely investigation of
conformities or matters non-conformities or
reported as possible non- matters reported as
conformities critical to possible non-conformities
product safety, legality or critical to product safety,
quality. legality or quality.

3.7.2 Customer complaints Moved into


concerning actual or clause 3.8.1.
potential product non-
conformity shall be
included in the system.

3.7.3 An appropriate staff 3.7.2 An appropriate staff


member shall be member shall be
identified and allocated identified and assigned
the responsibility and the responsibility and
accountability for each accountability for each
corrective action. This corrective action. This
shall be documented. shall be documented.

3.7.4 The company shall ensure 3.7.3 The company shall ensure
that effective corrective that effective corrective
actions are taken to actions are taken to
prevent recurrence of the prevent recurrence of the
problem and shall problem and shall
monitor and record their monitor and record their
completion within an completion within an
appropriate timescale. appropriate timescale.

3.7.5 The company shall 3.7.4 The company shall


review its processes at review its processes at
least annually, least annually and adopt
incorporate industry best preventive measures as
practice and adopt they become available.
preventive measures as
they become available.

3.8 Traceability (now 3.9)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement The company shall have a Statement The site shall be able to
of intent system to identify and of intent trace all raw materials,
trace product lots/batches components and
including raw materials, packaging from its
components and suppliers through all
packaging materials and stages of processing and
follow this from the dispatch to its primary
source of the incoming customers, and from the
material through all stages
of processing to supply of

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the product to the primary customer back to the


customer and vice versa supplier.
in a timely manner.

Materials identified as
low risk to the safety,
legality or quality of the
final product may be
exempted from lot
traceability.

3.8.1 Companies shall be able 3.9.1 The site shall have a


to identify the immediate system in place to enable
source of all raw all raw materials,
materials, components components and
and packaging materials. packaging materials to be
traced to the supplier and
the batch or order
number.

3.8.2 The products that Moved into


constitute a lot/batch shall clause 3.9.3.
be defined and
documented. This shall
include products made by
continuous production
methods.

3.8.3 Identification of 3.9.2 Identification of


lots/batches of raw lots/batches of raw
materials including materials, including
packaging, processing packaging, processing
aids, intermediate/semi- aids, intermediate/semi-
processed products, part- processed products, part-
used materials, finished used materials, rework,
products and materials finished products and
pending investigation, materials pending
shall be adequate to investigation, shall be
ensure traceability. sufficient to ensure
traceability.

3.8.4 Final products shall be 3.9.3 Finished product shall be


suitably marked, at least identified with a unique
on their outer packaging code such as a batch code
to allow adequate applied to the product or
identification and packaging.
traceability.
Documented procedures
must be in place to trace a
finished product back to
the batch of raw materials
or packaging used.

3.8.5 Traceability must, in all


cases, be available for
each lot/batch from
source of raw material to
supply to the primary
customer.

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3.8.6 The traceability system Moved into


shall be maintained when clause 3.9.2.
rework or any reworking
operation is performed.

3.8.7 The company shall test 3.9.5 The company shall test
the traceability system to the traceability system to
ensure traceability can be ensure traceability can be
determined from raw- determined from raw-
material receipt to material receipt to
finished product and vice finished product. This
versa. This shall occur at shall occur at a
a predetermined predetermined frequency,
frequency, at least at least annually, and
annually, and results shall results shall be retained.
be retained. The time The time taken to
taken to complete the complete the exercise
exercise shall be shall be measured and
measured and recorded. recorded.

3.8.8 When the same Moved into


component or material is clause 3.9.1.
sourced from more than
one supplier, the
traceability system shall
ensure that the
lots/batches from each
supplier can be identified
if the component/material
is identified as critical to
safety, quality or legality.

3.8.9 Changes in materials,


processes or components
shall be traceable if they
could affect the safety,
quality or legality of the
product and formally
agreed by the customer if
contractually required.

3.8.10 Subcontracted 3.9.4 Subcontracted


manufacture of products manufacture of products
or components (including or components shall have
home working) must be prior customer approval
traceable to a level and shall be traceable to a
appropriate to the risk. level appropriate to the
risk.

3.8.11 The need for further 3.9.6 The need for extended
traceability through the traceability through the
chain should be chain should be
established, based on the established on the basis of
risk assessment and any risk and any legal or
legal or specific customer specific customer
requirements. requirements. Where
required, extended
traceability shall be
implemented.

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3.8.12 For continuous


production processes,
methods of defining
traceability levels must be
documented and based on
the risk assessment.

3.9 Management of product withdrawal and product recall (now 3.11


Management of incidents, product withdrawal and product recall)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement The company shall have a Statement The company shall have a
of intent plan and system in place of intent plan and system in place
to effectively manage to manage incidents
product withdrawal and effectively and enable the
product recall procedures. withdrawal and recall of
products should this be
required.

3.9.1 The company shall have a 3.11.1 The site shall determine
product recall procedure and provide written or
in place to effectively other guidance to relevant
manage product staff regarding the type of
withdrawals and recalls. event that would
Procedures shall exist to constitute an incident or
ensure that customers are emergency situation that
notified immediately on impacts product safety,
issues of significance to legality or quality, and a
the customer or consumer documented reporting
in terms of product safety, procedure shall be in
quality or legality. place which shall include
informing their customers
in a timely manner.

3.9.2 The company shall have 3.11.4 The site shall have
written agreements in written technical and
place with distributors quality agreements in
and other parties in the place with agents and
supply chain where these distributors and other
are necessary to ensure parties in the supply chain
effective where these are necessary
withdrawal/recall. to ensure effective
withdrawal/recall.

3.9.3 In the event of a product 3.11.5 In the event of a product


recall, the certification recall, the certification
body issuing the current body issuing the current
certificate and the certificate and the
appropriate enforcement appropriate enforcement
authorities shall be authorities shall be
informed in a timely informed in a timely
manner. The company manner. The company
shall be aware of and shall be aware of and
adhere to any legal adhere to any legal

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reporting obligations in reporting obligations in


the regions of sale. the regions of sale.

3.9.4 The product recall and 3.11.2 The site shall have a
withdrawal procedures documented procedure in
shall be documented and place to effectively
regularly tested, at least manage product
annually, in a way that withdrawals and recalls.
ensures their effective Procedures shall exist to
operation. Results of the ensure that customers are
test shall include timings notified immediately on
of key activities and shall issues of significance to
be retained. the customer or consumer
in terms of product safety,
quality or legality.

3.9.5 The companys senior 3.11.7 The product recall and


management shall ensure withdrawal procedures
that results of this test shall be regularly tested,
shall be used to at least annually, in a way
implement improvements that ensures their
as necessary. effective operation.
Results of the test shall
include timings of key
activities and shall be
retained.

The companys senior


management shall ensure
that results of this test
shall be used to
implement improvements
as necessary.

3.10 Management of incidents and business continuity (now moved to


section 3.11)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement The company shall have


of intent procedures in place to
identify methods of
ensuring business
continuity in the case of
incidents and/or
informing their customers
when incidents occur.

3.10.1 The company shall Moved into


provide written guidance clause 3.11.1.
to relevant staff regarding
the type of event that
would constitute an
incident or emergency
situation that impacts
product safety, legality or

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quality, and a documented


reporting procedure shall
be in place which shall
include informing their
customers in a timely
manner.

3.10.2 The company shall 3.11.8 The company shall


develop contingency develop contingency
planning for business planning for business
continuity in the event of continuity in the event of
major incidents such as: major incidents such as:

disruption to key disruption to key


services e.g. water, services (e.g. water,
energy, staff energy, staff
availability availability)
events such as flood, events such as flood,
fire and natural fire and natural
disaster disaster
malicious malicious
contamination or contamination or
sabotage. sabotage.

3.10.3 The procedures shall 3.11.3 The documented product


include as a minimum: withdrawal and recall
procedures shall include
identification of key as a minimum:
staff constituting the
incident management identification of key
team and their key staff constituting the
responsibilities incident management
an up-to-date list of team and their key
key contacts, with responsibilities
details of agencies an up-to-date list of
providing advice and key contacts, with
support. details of agencies
providing advice and
support
a list of persons who
can initiate a recall.

3.11 Contract review and customer focus (now removed)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement The companys senior


of intent management shall ensure
that processes are in place
to determine any
customer requirements
and expectations with
regard to product safety
and quality, and ensure
that these are fulfilled.

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3.11.1 Customer requirements


shall be documented,
reviewed and confirmed
on a suitable
predetermined frequency.
Any resulting changes
shall be documented and
communicated to relevant
departments.

3.11.2 In the case where


customers have set
particular performance
indicators to be
monitored, these
requirements shall be
communicated, adhered
to and reviewed at least
annually.

3.11.3 The company shall


clearly identify those
individuals responsible
for communication with
customers and shall have
an effective system for
communication.

3.11.4 Performance indicators


relating to customer
satisfaction shall be
established and
communicated to relevant
staff, and performance
reviewed against these
targets.

3.12 Complaint handling (now 3.10)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement The company shall Statement The company shall


of intent operate an effective of intent operate an effective
system for the capture, system for the capture,
recording and recording and
investigation of product investigation of product
complaints. complaints at all levels of
severity.

3.12.1 A system shall be in place 3.10.1 All complaints shall be


to capture, record and recorded, investigated
investigate all complaints using root analysis and
relating to product safety, the results of the
legality and unusual or investigation recorded
critical quality defects, where sufficient
and the results of the information is provided.

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investigation shall be Actions appropriate to the


recorded. seriousness and frequency
of the problems identified
shall be carried out to
reduce the likelihood of
recurrence.

3.12.2 Where complaints are 3.10.2 The company shall have a


investigated externally on process in place to
behalf of the company, respond in a timely
the responsibilities of the manner to consumers and
parties shall be defined customers regarding
and the process shall be complaints.
documented. Companies
shall seek to obtain the
results of any
investigations carried out
by such parties.

3.12.3 Actions appropriate to the


seriousness and frequency
of the problems identified
shall be carried out
promptly and effectively
by trained staff.

3.12.4 Complaint data shall be 3.10.3 Complaint data shall be


analysed and used to analysed for significant
implement ongoing trends. This analysis shall
improvements to product be made available to
safety, legality and relevant staff.
quality, and to avoid
recurrence. This analysis
shall be made available to
relevant staff.

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4 Site standards
4.1 Location, perimeter and grounds (now 4.1 External standards)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement Sites used for Statement Sites used for


of intent manufacturing, storage or of intent manufacturing, storage or
distribution shall be of distribution shall be of
suitable size, location, suitable size, location,
construction and design construction and design
to facilitate maintenance, to facilitate maintenance,
prevent contamination prevent contamination
and enable the production and enable the production
of safe and legal of safe and legal
products. products.

4.1.1 The site to be included in 4.1.1 The site to be included in Site plan
the audit shall be clearly the audit shall be clearly required.
defined, and shall be defined, and shall be
located and maintained so located and maintained so
as to allow the production as to allow the production
of safe and legal of safe and legal
products. products.

The external areas and


surroundings shall be
maintained in good order.

A site plan shall be


retained and readily
available.

4.1.2 Consideration shall be 4.1.2 Consideration shall be


given to local activities given to local activities
and the site environment, and the site environment
which may have an and measures shall be
adverse impact on taken to prevent
product integrity. contamination.

Measures adopted at the Where measures have


site to protect the product been put into place to
from any potential protect the site (from
contaminants shall be potential contaminants,
regularly reviewed to flooding, etc.), they shall
ensure that they continue be regularly reviewed in
to be effective. response to any changes.

4.1.3 The external areas and Moved into


surroundings shall be clause 4.1.1.
maintained in good order.

4.1.4 External traffic routes


that are under site control
shall be maintained in
good repair to avoid

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contamination of the
product.

4.1.5 There shall be no


evidence of facility
damage due to inadequate
drainage.

4.2 Internal site: factory layout, product flow and segregation (now 4.3
Layout, product flow and segregation)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement Premises and plant shall Statement The factory layout, flow
of intent be suitably designed, of intent of processes and
constructed and movement of personnel
maintained so as to shall be adequate to
control the risk of product prevent the risk of
contamination and to product contamination
comply with all relevant and mix-ups and to
legislation. comply with relevant
legislation.

4.2.1 The building shall be Moved into


maintained to minimise section 4.4.
potential for product
contamination.

4.2.2 The machinery and 4.3.1 The layout process flow


equipment shall be of machinery and
positioned to allow an equipment shall be
efficient product flow arranged to minimise the
from incoming to risk of product
outgoing and shall be contamination and
arranged to minimise the damage.
risk of product
contamination and
damage.

4.2.3 A process flow diagram Moved into


shall be available. clause 6.1.1.3.

4.2.4 Premises shall allow 4.3.2 Premises shall allow


sufficient working space sufficient working space
and storage capacity to and storage capacity to
enable all operations to be enable all operations to be
carried out under safe carried out and, if
and, if necessary, necessary, in hygienic
hygienic conditions. conditions. The necessary
level of hygiene shall be
maintained for each
product.

4.2.5 There shall be effective 4.3.4 There shall be effective


segregation to minimise segregation to minimise
the risk of product cross- the risk of product cross-

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contamination taking into contamination taking into


account the flow of account the flow of
product, nature of product, nature of
materials, equipment, materials, equipment,
personnel, waste, airflow, personnel, waste, airflow,
air quality and utilities. air quality and utilities.

When critical to product Documented control


safety, legality, quality or procedures shall be in
customer requirements, place.
controls shall be in place
to ensure that raw
materials, work in
progress, rework,
packaging and finished
products of different
specifications are not
inadvertently mixed.

4.2.6 The location of facilities 4.3.3 The location of facilities


and services, including and services, including
toilets, cleaning and toilets, cleaning and
catering facilities, shall catering facilities, shall
not jeopardise the not jeopardise the
integrity of the product. integrity of the product.

4.3 Building interiors (now 4.4)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement The internal site, Statement The interior of the site,


of intent buildings and facilities of intent buildings and facilities
shall be suitable for the shall be suitable for the
intended purpose. All intended purpose.
utilities to and within the
production and storage
areas shall be designed,
constructed, maintained
and monitored to
effectively control the
risk of product
contamination.

4.3.1 The quality and finish of 4.4.1 The site shall be


site buildings and maintained to minimise
facilities, including potential for product
drainage when required, contamination. The
shall be suitable for the quality and finish of site
intended purpose with buildings and facilities,
due regard to the risk of including any pipework
product safety, legality and drainage, shall be
and quality, and shall be suitable for the intended
maintained to an purpose with due regard
appropriate standard. to the risk to product
safety, legality and
quality, and shall be

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This shall include: maintained to an


appropriate standard. This
A clean, tidy and shall include, as defined
clutter-free factory by the risk assessment:
Adequate lighting
Suitable and a clean, tidy and
sufficient removal of organised factory
any by-products and adequate lighting
contaminants adequate ventilation
Impervious floors, in walls, floors,
good repair and able windows, doors and
to withstand cleaning ceilings maintained
procedures. in a good condition
to prevent foreign
body risks
suitable and
sufficient removal of
any by-products and
contaminants.

4.3.2 Potential contamination


risk from buildings and
overhead structures,
including building voids,
shall be controlled
through regular
documented inspections,
and corrective action shall
be taken to prevent the
risk of product
contamination.

4.4.2 Suitable and sufficient New


lighting shall be provided
for correct operation of
processes, inspection of
products, and effective
cleaning.

4.3.3 The site shall be assessed 4.4.3 The site shall be assessed
for any particular for any particular
requirements relevant to requirements relevant to
the products being the products being
produced, such as produced, such as
temperature, humidity temperature, humidity
and electrostatic and electrostatic
discharge. Any identified discharge. Any identified
requirements shall be requirements shall be
adopted, documented, adopted, calibrated,
monitored and regularly documented, monitored
reviewed. and regularly reviewed.

4.3.4 Walls, floors, ceilings,


pipe-work and overhead
structures shall be
designed, constructed,
finished and maintained
to reduce condensation
and mould growth, and

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shall have access to


facilitate cleaning.

4.3.5 All water used as an 4.4.4 Where water quality


ingredient of the products presents a risk to the final
or preparation of the product it shall comply
products where it may with the required
come into direct contact specification (as defined
with the product shall be in the region of intended
potable (as defined in the product sale), suitably
region of intended treated to prevent
product sale), or suitably contamination and
treated to prevent regularly monitored.
contamination, and shall
be regularly monitored.

4.3.6 Water in the form of Moved into


water, ice or steam used clause 4.4.4 to
for cleaning or in cover where
connection with any water is used in
operation in the any aspect that
manufacture of products could affect
shall comply with legal product integrity.
requirements in the
country of use and
present no risk to the
safety, legality or quality
of the products.

4.4 Staff facilities (now 4.5)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement Staff facilities shall be Statement Staff facilities shall be


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

4.4.1 Staff facilities such as 4.5.1 Staff facilities such as


washrooms, canteens and washrooms and break
break areas shall be areas must be provided
designed and operated so and maintained in a clean
as to minimise the risk of condition and segregated
product contamination. from production areas to
prevent product
contamination.

Where a site provides


food service the food

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preparation areas must be


clean and fit for purpose
and adequately
segregated from
production areas.

4.4.2 Where smoking is 4.5.2 Where smoking or use of Includes


allowed under national electronic cigarettes is electronic/e-
law, designated allowed under national cigarettes
controlled smoking areas law, designated
shall be isolated from controlled smoking areas
production areas to an shall be provided and
extent that ensures smoke isolated from production
cannot reach the product. and storage areas to an
Adequate arrangements extent that ensures smoke
for dealing with smokers cannot reach the product.
waste shall be provided Adequate arrangements
both internally and for dealing with smokers
externally. waste shall also be
provided at smoking
facilities, both inside
buildings and at external
locations.

4.4.3 Storage facilities of 4.5.3 Storage facilities of


sufficient size to sufficient size to
accommodate all accommodate all
reasonable personal items reasonable personal items
shall be provided for all shall be provided for all
personnel who work in personnel who work in
areas where they are areas where they are
unable to keep unable to keep
possessions with them. possessions with them.

4.4.4 Where specific work- 4.5.4 The site shall use risk
wear is required, assessment to determine
designated changing where a change to
facilities shall be workwear in different
provided for all areas is required. Any
personnel: staff, visitor or required changing
contractor. These shall be facilities shall be
sited to allow direct provided for all
access to the production, personnel: staff, visitors
packing or storage areas and contractors.
without recourse to any Changing areas should be
external area. Where this sited to allow direct
is not possible, a risk access to the production,
assessment shall be packing or storage areas
carried out and without exposure to any
procedures implemented external area. Where this
accordingly. is not possible, the site
shall use the risk
assessment to help
determine the activities
required to mitigate any
risk. This procedure shall
be documented.

4.4.5 Outdoor clothing and


other personal items shall

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be stored separately from


work-wear within the
changing facilities.

4.4.6 Suitable and sufficient 4.5.5 Suitable and sufficient


hand-cleaning facilities hand-cleaning facilities
shall be provided at shall be provided at
access to, and at other access to production
appropriate points within, areas, and at other
production areas. appropriate points within
these areas, based on
Information on how to appropriate risk.
clean hands shall also be
provided near hand-
cleaning points.

4.4.7 All food brought into Provision made


manufacturing premises in clause 4.5.1.
by staff shall be stored in
a clean and hygienic
state. No food shall be
taken into storage,
processing or production
areas.

4.5 Cleaning procedures (now 4.6 Housekeeping and hygiene)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement Housekeeping and Statement Housekeeping and


of intent cleaning systems shall be of intent cleaning systems shall be
in place which ensure that in place which ensure
adequate standards of appropriate standards of
cleanliness and tidiness hygiene are maintained at
are maintained at all all times and the risk of
times and the risk of product contamination is
contamination is minimised.
minimised.

4.5.1 Cleaning practices shall 4.6.1 Equipment, production


be completed so as to and storage areas shall be
minimise risk of maintained in a state of
contamination. cleanliness appropriate to
the operations
undertaken. Cleaning
practices shall be
completed so as to
minimise risk of
contamination and
records kept.

4.5.2 Cleaning and, where


necessary, disinfection
procedures shall be
revalidated following
building or maintenance

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work, changes to
equipment or introduction
of new product types.

4.5.3 Cleaning, pest control and 4.6.2 Suitable cleaning


process-aid chemicals chemicals shall be
shall be suitably identified, clearly labelled
identified and controlled and controlled to prevent
to prevent the risk of the risk of product
product contamination. contamination. Chemicals
They must be clearly shall not be decanted
labelled and no chemicals unless into properly
shall be decanted unless labelled and identified
into properly labelled and containers. Adequate
identified containers. storage facilities shall be
Adequate storage provided and sited so as
facilities shall be not to compromise the
provided and sited so as safety, legality and
not to compromise the quality of the product.
safety, legality and
quality of the product.

4.5.4 If cleaning services are 4.6.3 If cleaning services are


outsourced, the service outsourced, the service
providers shall have providers shall have
signed a contract which signed a contract which
identifies the scope and identifies the scope and
frequency of the work, frequency of the work,
and a log book shall be and records shall be
maintained as a record of maintained. A defined
work done. A defined company representative
company representative shall be responsible for
shall be responsible for ensuring that the work is
ensuring that the work is carried out satisfactorily.
carried out satisfactorily.

4.5.5 Documented cleaning 4.6.4 Documented cleaning


procedures shall be in procedures shall be in
place and maintained for place, validated and
the building, utilities, maintained for the
plant and all equipment. building, utilities, plant
Cleaning procedures shall and all equipment. Where
include the following more than basic cleaning
information as a is required, cleaning
minimum: procedures shall include
the following information
responsibility for as a minimum:
cleaning
item/area to be responsibility for
cleaned cleaning
frequency of cleaning item/area to be
method of cleaning cleaned
cleaning materials to frequency of cleaning
be used method of cleaning
cleaning records and cleaning materials to
responsibility for be used
verification.

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cleaning records and


responsibility for
verification.

Cleaning and
housekeeping shall be
carried out by trained
personnel in accordance
with documented
procedures, and records
shall be maintained.

4.5.6 Cleaning and Moved into


housekeeping shall be clause 4.6.4.
carried out by trained
personnel in accordance
with documented
procedures, and records
shall be maintained.

4.5.7 The effectiveness of 4.6.5 The standard of cleaning


cleaning and sanitation shall be appropriate to the
shall be verified and product being
documented. Corrective manufactured and shall be
actions shall be verified and documented
documented. and, where relevant,
agreed with the customer.
Corrective actions shall
be documented.

Cleaning procedures shall


be revalidated following
building work,
maintenance, changes to
equipment or new product
introduction.

4.6 Waste/waste disposal (now 4.7 Waste and waste disposal)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement There shall be adequate Statement Waste disposal shall be


of intent systems for the collection, of intent managed in accordance
collation and disposal of with legal requirements
waste material. and to prevent
accumulation, mix-up,
risk of contamination and
the attraction of pests.

4.6.1 Systems shall be in place 4.7.1 Waste disposal shall be


to prevent the managed in accordance
accumulation of waste in with legal requirements
production areas, and to and to prevent
prevent the use of unfit or accumulation, mix-up,
defective materials.

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risk of contamination and


the attraction of pests.

4.6.2 Waste shall be 4.7.2 Where legally necessary,


categorised according to waste shall be removed
legislative requirements by identified, licensed
based on the intended contractors, and records
means of disposal, of disposal shall be
segregated if necessary maintained by the site.
and collected in suitably
designated waste
containers.

4.6.3 Where legally necessary,


it shall be removed by
identified, licensed
contractors, and records
of disposal shall be
maintained by the
company.

4.6.4 Products which are to be 3.11.6 Products which are to be


disposed of on safety disposed of on safety
grounds, as the result of a grounds, as the result of a
recall or withdrawal or as recall or withdrawal or as
substandard trademarked substandard trademarked
materials, shall be materials, shall be
disposed of securely. This disposed of securely. This
may be delegated to a may be delegated to a
specialist in secure waste specialist in secure waste
disposal. Records of such disposal. Records of such
material destruction or material destruction or
disposal shall be disposal shall be
maintained. maintained.

4.7.3 Waste materials shall be


controlled, clearly
labelled and where
necessary quarantined to
ensure that they are not
reintroduced into non-
waste production flows.

4.6.5 Waste materials shall be 4.7.4 External waste collection


suitably quarantined and containers and
routed to ensure that they compactors shall be
are not reintroduced into managed in such a
non-waste production manner as to minimise
flows. risk to the product if
necessary.

4.7 Pest control (now 4.8)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

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Statement The company shall be Statement The whole site shall have
of intent responsible for of intent an effective preventive
minimising the risk of pest control programme
pest infestation on the in place to minimise the
site. risk of pests. Sufficient
resources shall be
available to respond
rapidly to any issues that
occur, in order to prevent
risk to products.

4.7.1 The company shall be 4.8.1 The company shall be


responsible for responsible for
identifying and identifying and
controlling the risk of controlling the risk of pest
pest infestation and shall infestation and shall
operate pest control operate pest control
procedures. If no pest procedures.
control is conducted the
company shall have a full If no pest control is
justification for its conducted the company
absence, including its shall have a full
customers acceptance. justification for its
The justification shall be absence, including its
reviewed at least customers acceptance.
annually. (Note: If there The justification shall be
is a justified absence of reviewed at least
pest control then the other annually. (Note: If there
clauses in this section are is a justified absence of
not applicable.) pest control then the other
clauses in this section are
not applicable.)

4.7.2 The company shall either 4.8.2 The company shall either
have a clearly defined have a clearly defined
contract with external contract with external
contractors which reflects contractors which reflects
the activities of the site, the activities of the site,
or have trained staff. or have trained staff.

During each visit


activity/action reports
shall be completed. These
should include
observations of pests or
evidence of pest activity
and recommendations for
action by the site.

4.7.3 Written procedures and Covered by


inspection documentation clause 4.8.2.
for pest control shall be
maintained including a
log book of work
completed.

4.7.4 In the event of


infestation, immediate
action shall be taken to
eliminate the hazard and

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this shall be documented.


Action shall be taken to
identify, evaluate and
authorise the release of
any product potentially
affected.

4.7.5 Full material safety data 4.8.4 Full material safety data
sheets (MSDS) for all sheets for all chemical
chemical pest control pest control agents used
agents used must be shall be controlled,
available to relevant staff available to relevant staff
at all times and kept in a at all times and kept in a
designated place. designated place.

4.7.6 Bait stations shall be


robustly constructed,
operational and effective
in killing the target pests
and be positioned to
avoid potential
contamination of
materials and products.

4.7.7 When necessary, 4.8.3 When necessary,


materials or products materials or products
shall be fumigated, and shall be fumigated, and
records of this process records of this process
shall be kept. Fumigated shall be kept. Fumigated
goods may not be goods may not be
supplied to customers supplied to customers
without full professional without full professional
safety clearance and safety clearance and
correct clearance correct clearance
documentation. All documentation. All
fumigation operations fumigation operations
shall be controlled by shall be controlled by
staff with appropriate staff with appropriate
professional professional
qualifications. qualifications and/or
training.

4.7.8 Drains should be fitted


with screens and traps to
prevent pest entry.

4.7.9 Fly-killing devices and/or


pheromone traps shall be
correctly sited and be
operational.

The design and location


of flying-insect detectors,
killers and traps used
shall not cause
contamination of
products in production.

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4.7.10 Bait stations shall be


tamper resistant.

4.8 Product transport, storage and distribution (now 4.9 Product storage,
dispatch and transport)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement All facilities used for the Statement Facilities for the storage
of intent storage and transportation of intent and transportation of
of product, movement products shall be suitable
around the site, and for purpose and minimise
dispatch of finished the risk of product
product shall be suitable contamination, damage
for the purpose and and malicious
maintained in good intervention.
repair.

4.8.1 The company shall ensure


that the transport and
storage of products is
within its control, from
delivery of raw materials
and components to
finished product.
Dispatch shall be
undertaken in such a way
as to prevent the risk of
contamination and
damage.

4.9.1 All materials, work in New


progress and product
shall be properly
identified and protected
during storage by
appropriate packaging to
protect the product from
contamination.

4.8.2 Where storage is 4.9.2 Where storage of raw Now covers all
necessary, at any stage, materials, components, stages in the
all items shall be securely packaging, intermediate manufacture of
protected from or finished product is the product.
contamination, necessary it shall be
deterioration and damage. maintained in good
condition and be securely
protected from
contamination,
deterioration and damage.

All handling operations


during storage shall be
managed to prevent
product damage.

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4.8.3 All transportation shall be 4.9.3 Vehicles or containers


in good repair and in a used for transportation
clean/hygienic condition and dispatch of product
as necessary depending shall be inspected prior to
on the product group. loading to ensure that
they are fit for purpose.
Records of inspection
shall be maintained.

4.8.4 Where the product 4.9.5 Where product is


transported is susceptible vulnerable to weather
to weather damage, damage, vehicles and
vehicles shall be loaded containers for
and unloaded so as to transportation shall be
protect the product. loaded and unloaded so as
to protect the product.

4.8.5 Where the product needs 4.9.4 Documented procedures


specific environmental to maintain product safety
requirements to prevent and quality during
degradation, the loading and transportation
appropriate conditions shall be developed and
shall be documented, implemented.
maintained and
monitored.

4.8.6 When products are


susceptible to hazards
arising from transport
conditions or subject to
transport restrictions, the
required conditions of
transport shall be
documented,
implemented and subject
to regular review. Any
necessary product
labelling shall be
documented and
monitored.

4.8.7 Where the company 4.9.6 Where a third-party


employs third-party haulage contractor is
contractors, there shall be used, all the requirements
an agreement between the shall be defined within a
company and the contract and effectively
contractor. All the managed.
requirements specified in
this section shall be
clearly defined in the
contract.

4.9 Site security (now 4.2 Security)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

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Statement Security shall be Statement Security shall be


of intent maintained to prevent of intent maintained to prevent
access of unauthorised access of unauthorised
persons to production and persons to production and
storage areas. storage areas.

4.9.1 Access to the site by 4.2.1 Access to the site by


employees, contractors employees, contractors
and visitors shall be and visitors shall be
controlled and a visitor- controlled and a visitor-
reporting system shall be reporting system shall be
in place. in place.

4.9.2 Contractors involved in 4.2.2 Contractors involved in


maintenance or repair maintenance or repair
shall be qualified or shall be qualified or
supervised, and a supervised, and a
nominated staff member nominated staff member
shall be responsible for shall be responsible for
their activities with their activities with
regard to potential effects regard to potential effects
on the safety, legality or on the safety, legality or
quality of products. quality of products.

4.9.3 Staff shall be trained in


site security procedures
and encouraged to
question or report
unidentified or unknown
visitors.

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5 Product control
5.1 Pre-production reference samples (now 5.3 Product sample control)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement Documented procedures Statement The site shall ensure that


of intent shall be in place for the of intent procedures are in place
selection, handling, for the selection,
storage, approval and use handling, storage,
of reference samples as approval and use of
well as for component reference samples taken
samples and samples of from pre-production,
subcontracted work subcontracted and
where relevant. finished production in
accordance with customer
requirements.

5.1.1 The company shall 5.3.1 Where legally required or


document a process to specified by a customer, a
identify, select and sample of the product
categorise reference which has been approved
samples. If customers by the customer or a
have a defined system of representative of the
sealed samples referring agreed specification shall
to different stages of be retained.
sample approval, the
customer procedure shall The company shall
be documented and document a process to
followed. identify, select and
categorise reference
samples. If customers
have a defined system of
sealed samples referring
to different stages of
sample approval, the
customers procedure
shall be documented and
followed.

5.1.2 As a minimum, a sample Moved into


of the product which has clause 5.3.1.
been approved by the
customer or, if customer
approval is not possible, a
sample representative of
the agreed specification
shall be retained.

Procedures shall be in
place to record the
selection, use, approval
and storage of reference
and/or component
samples.

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5.1.3 Reference samples shall 5.3.2 Reference samples shall


be held and stored in be stored and recorded in
suitable environmental suitable environmental
conditions to maintain conditions to maintain
their original status. their original status for a
specified period.

5.1.4 A secure and tamper- 5.3.3 A secure and tamper-


evident system shall be in evident system shall be in
place for the storage of place for the storage and
samples. Temporary tracking of samples, with
removal of samples must access by authorised
be documented and personnel.
authorised by a
designated responsible The removal and return of
person. samples to storage shall
be documented and
authorised by a
designated responsible
person.

5.1.5 Records shall be 5.3.4 Documented procedures


maintained of reference shall be in place to
samples supplied to other determine the retention
parties, including the date time for samples. This
supplied and details of the should normally be the
sample. foreseeable lifetime of the
product unless otherwise
justified.

5.1.6 Exceptions to the need to


store samples shall be
made when such storage
is impractical, provided
that an alternative means
of achieving the same
objective is documented,
justified and maintained.

5.2 Chemical formulation control (now removed)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement The chemical


of intent composition of products
and chemicals used in the
manufacture or
processing of products
shall be identified,
monitored and recorded
as required by legislation
in the country of sale
and/or manufacture.
Where approvals for use

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need to be obtained, these


shall be in place.

5.2.1 Where companies use


materials or preparations
for which the supplier
does not wish to divulge
confidential formulations,
they must have a
procedure in place to
ensure the safety and
legality of such materials
(for example, through an
independent third-party
review) and must assure
themselves that any
information which may
be legally required will be
made available to the
authorities in a timely
fashion.

5.2.2 Companies shall review,


document and justify the
use of any substances
classified as dangerous or
of very high concern in
the country of sale.

5.2.3 Written (and/or


diagrammatic), authorised
procedures for the
handling of chemicals
shall be available at the
point of use.

5.2.4 Companies shall identify


and document the use of
any nanomaterials.

5.3 Product packaging materials (now moved into sections 2.4 and 6.3)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement Product packaging


of intent materials shall be suitable
for the intended use and
stored under conditions to
minimise the risk of
contamination and
deterioration.

5.3.1 Product packaging shall


conform to an agreed and
documented specification
and shall meet the legal

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requirements of the
regions of sale with
regard to composition,
recyclability and
minimising excessive use
of packaging material.

5.3.2 Packaging shall be 2.4.1 Packaging shall be


assessed for fitness for assessed for fitness for
purpose and found purpose and found
suitable with regard to: suitable with regard to:

protecting the protecting the


product from damage product from damage
maintaining the maintaining product
integrity of the integrity
product protecting the
protecting the consumer from injury
consumer from injury preventing
preventing contamination.
contamination.

5.3.3 Packaging materials shall


be effectively protected
before being returned to
storage.

5.3.4 Where staples or other 6.3.3.2 Staples, paper clips and


metal closures are used drawing pins shall not be
for packaging, appropriate used in open product
precautions shall be taken areas.
to prevent the risk of
contamination, damage or Where staples or other
injury to the product or items are present as
consumer. packaging materials or
closures, appropriate
precautions shall be taken
to minimise the risk of
product contamination.

5.3.5 Where there is a risk of


product contamination
from transit packaging
that could compromise
product safety, legality
and quality, such
packaging shall be
removed from production
areas.

5.4 Control of non-conforming materials (now 3.8)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

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Statement The company shall ensure Statement The company shall ensure
of intent that non-conforming of intent that non-conforming raw
materials, components materials, packaging,
and products are clearly components and products
identified, labelled, are clearly identified,
quarantined, investigated labelled, quarantined,
and documented. investigated and
documented.

5.4.1 Clear procedures for the 3.8.1 Clear procedures for the
control of non- control of non-
conforming materials and conforming materials and
products, including products, including
rejection, segregation, customer returns, shall be
acceptance by concession in place and understood
or regrading for an by all relevant, authorised
alternative use, shall be in personnel. These shall
place and understood by include effective
all authorised personnel. identification and
quarantining before a
decision has been made
on the final disposition of
the non-conforming
product by rejection,
acceptance by concession
or regrading for an
alternative use.

5.4.2 The company shall have a


procedure in place for the
secure disposal of non-
conforming products and
their packaging according
to the nature of the
problem and/or the
specific requirements of
the customer and any
legal requirements.

5.5 Handling requirements for specific materials (moved to 4)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement Where materials or 4.3.5 Where materials or


of intent products require special products require special
handling procedures to be handling procedures to be
in place, these shall be in place, these shall be
maintained to ensure maintained to ensure
product safety, quality product safety, quality
and legality are not and legality are not
compromised. compromised.

5.5.1 Materials and products 4.3.7 Materials and products


requiring segregation requiring segregation (e.g.
procedures (e.g. materials materials intended for
intended for different different geographical

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geographical regions) regions) shall have


shall have control documented control
procedures in place to procedures in place to
ensure that product ensure that product
integrity is maintained. integrity is maintained.

5.5.2 The company shall 4.3.6 The company shall


determine whether determine whether
allergenic or sensitising allergenic or sensitising
materials are used (or materials are used and, if
likely to be contaminants so, documented policies
of materials used) and shall exist for the
shall identify any such handling of such
materials used on site. materials including:

physical or time
segregation from
other products
use of identified,
dedicated equipment
if necessary
adequate labelling of
final products.

5.5.3 Documented policies Moved to clause


shall exist for the 4.3.6.
handling of allergenic or
sensitising materials
including:

physical or time
segregation from
other products
use of identified,
dedicated equipment
if necessary
adequate labelling of
final products.

5.6 Stock control and product release (now 6.6)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement The company shall ensure Statement The company shall ensure
of intent that the finished product of intent that stock and finished
is not released unless all product are not released
agreed procedures have unless all agreed
been followed and the procedures have been
release is suitably followed and the release
controlled. is suitably controlled.

5.6.1 A procedure shall be in 6.6.3 A documented procedure


place to ensure that only shall be in place to ensure
products conforming to that only products
specification are conforming to
dispatched. If no such specification are released

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control is conducted, the for dispatch. Procedures


company shall have a full may include, but are not
justification for its limited to:
absence, which shall be
reviewed at least positive final release
annually. Procedures may by authorised staff
include, but are not online test methods
limited to: automatic rejection
process (which shall
positive final release be validated and
by authorised staff monitored).
online test methods
automatic rejection If a risk assessment
process (which must determines that no such
be validated and control is required, the
monitored). company shall have a full
justification for its
absence, which is
documented in the
customer agreement and
shall be reviewed at least
annually.

5.6.2 Companies shall ensure 6.6.2 The company shall ensure


that work carried out by that product brought in
home workers or from off-site
subcontracted off site subcontractors shall be
shall be included in included in the product
procedures described in release procedure.
clause 5.6.1.

5.6.3 Controls shall be in place 6.6.1 Controls shall be in place


to ensure correct stock to ensure correct stock
rotation and that materials rotation and that materials
and products are used in and products are used in
the correct order and the correct order and
within the allocated shelf within the allocated shelf
or usage life if applicable. or usage life as
applicable.

5.6.4 Procedures shall be in


place for disposal of
excess stock or obsolete
inventory where such
situations routinely occur.
If such disposal is an
isolated instance,
measures taken shall be
documented.

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6 Product conformity assessment (now 5 Product inspection


and testing)
6.1 Product analysis/testing (now 5.1 Product inspection and laboratory
testing)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement A suitable, sufficient and Statement The company shall have a


of intent validated testing regime of intent programme for product
shall be in place to ensure inspection and testing to
the safe, legal production control products during
of products to the and after production to
required conformance of ensure that products are
safety, legality and safe, legal and meet the
quality. Results from the quality specification.
programme shall be
recorded, reviewed and
stored securely.

6.1.1 Companies shall adopt a 5.1.1 There shall be a


product-testing scheduled product-testing
programme based on programme according to
information such as: risk for each product or
product group as defined
the outcome of the in the specifications. This
risk assessment shall be based on
procedure including information such as:
any defined control
points the outcome of the
any legal product and process
requirements for risk assessments
testing in the any legal
regions(s) of requirements for
intended sale testing in the
customer regions(s) of
requirements intended sale
regarding supply of the sites
test reports or other requirements for
information demonstrating the
their own production of safe
requirements for products.
demonstrating the
production of safe The methods, frequency
products and specified limits of
information needed testing shall be clearly
to confirm defined.
composition of
materials
historical data on
problems or
complaints.

In cases where it is
established that no testing
is required, this shall be

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justified, documented and


reviewed at least
annually. (Note: If there
is a justified absence of
testing then the other
clauses in this section are
not applicable.)

6.1.2 The company shall


identify the different
stages (for example, pre-
production, production) at
which testing is to be
performed.

6.1.3 A documented sampling 5.1.2 The testing programme


plan, testing programme shall be implemented and
and test specification, records kept of all test
including the pass or fail results. Results which are
criteria, shall be produced outside the defined
for each product or specification shall be
product type as required. reviewed promptly by an
authorised competent
Testing procedures person. The need for
carried out as a result of a corrective action shall be
complaint, product failure assessed and documented,
or other ad hoc reason and any action carried out
shall be clearly as necessary.
documented.

6.1.4 Testing shall be


undertaken by the
company, the
subcontractor, a
competent third party, a
laboratory designated by
government authorities or
the customers designated
testing laboratories, as
agreed.
6.1.5 For tests which are 5.1.3 Where the company
critical to product safety undertakes or
or legality, the laboratory subcontracts analyses
used shall have gained which are critical to
recognised laboratory product safety or legality,
accreditation against ISO the laboratory or
17025 for the tests to be subcontractors shall have
carried out. If accredited gained recognised
facilities are not used, the laboratory accreditation
laboratory conducting the or operate in accordance
tests must be able to with the requirements and
provide verifiable principles of
evidence that it is ISO/IEC 17025.
complying with the
requirements of Documented justification
ISO 17025. shall be available where
accredited methods are
not undertaken.

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6.1.6 Procedures shall be in


place to ensure the
security of samples and
test results.
6.1.7 Where testing is 5.1.6 Where testing is
submitted to third parties, submitted to third parties,
the required testing shall the required testing shall
be clearly defined be clearly defined,
including, for example, including reference to the
reference to the number, number, date and version
date and version of the of the test standard or
test standard or method to method to be used.
be used. In cases where
the company relies on the In cases where the
expertise of third-party company relies on the
testing organisations to expertise of third-party
determine appropriate test testing organisations to
requirements, the determine appropriate test
company shall ensure that requirements, the
the third party receives a company shall ensure that
clear written briefing on the third party receives a
the purpose of the test and clear written briefing on
that the testing the purpose of the test and
programme is formally that the testing
agreed and documented. programme is formally
agreed and documented.

6.1.8 For tests other than those 5.1.4 Procedures shall be in


specified in clause 6.1.5, place to ensure reliability
procedures shall be in of test results, other than
place to ensure validity of those critical to safety and
all test results: legality. These shall
include:
use of documented,
validated test use of recognised test
methods methods and
use of correctly reference standards,
calibrated and where available
maintained test documented testing
equipment procedures
incorporation of ensuring staff are
quality control suitably qualified
checks in the tests and/or trained and
use of systems such competent to carry
as proficiency testing out the analysis
to verify the accuracy required
of results where use of a system to
available verify the accuracy of
use of suitably test results (e.g. ring
qualified and/or or proficiency
trained staff, testing)
competent to carry use of appropriately
out the analyses calibrated and
required. maintained
equipment.

6.1.9 Test results which are 5.1.5 Test and inspection


outside the defined results shall be reviewed
specification shall be regularly to identify

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reviewed in a timely trends. The significance


manner by the nominated of external laboratory
person responsible for results must be
safety, legality and understood and acted
quality, and the need for upon accordingly.
corrective action
assessed, documented and Appropriate actions shall
carried out as necessary. be implemented promptly
to address any
unsatisfactory trends.

6.1.10 Where testing Covered in


laboratories are present clause 5.1.3.
on a manufacturing site,
they shall be located,
designed and operated to
eliminate potential risks
to product safety.
Controls shall be
documented,
implemented and shall
include consideration of
the following:

design and operation


of drainage and
ventilation systems
access and security of
the facility
movement of
laboratory personnel
protective clothing
arrangements
processes for
obtaining product
samples
disposal of laboratory
waste.

6.2 Inspections

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement When product inspections Need for


of intent are deemed necessary to inspections is
assure delivery of a safe, reviewed under
legal product of the section 2 Product
required quality, they risk
should be carried out management.
following defined
procedures that are
documented, reviewed and
authorised.

6.2.1 Companies shall assess the


need for product

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inspections, which, if
required, shall have a
defined purpose and
operate to a defined list of
parameters to be
examined, with defects
and defect types clearly
identified.

In cases where it is
established that no
inspections are necessary,
this shall be justified,
documented and reviewed
at least annually. (Note: If
so, then the other clauses
in this section are not
applicable.)

6.2.2 Sampling procedures shall


be defined, documented
and justifiable.

The appropriateness must


be demonstrable and based
on considerations of risk,
type of product, inspection
frequency, statistical
rationale etc.

6.2.3 Sampling plans, where


required, shall be
documented and approved
and reviewed when
changes in production
methods or materials
occur.

They shall include as a


minimum:

the sample size to be


taken
the
acceptance/rejection
criteria
defined acceptable
quality limit (AQL)
the defect
classification
the actions to be taken
in the case of
rejection.

6.2.4 Inspections shall be


conducted at a level and/or
frequency to assure
product quality is at an
AQL level that is

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acceptable to the
customer.

6.2.5 The company shall have a


defined policy and
procedure covering the
handling of inspected
goods; for example:

policy on returning
inspected goods to
production
repacking
requirements
disposal.

6.2.6 Procedures shall be in


place to ensure inspections
are carried out in suitable
conditions and with
sufficient space and
lighting to avoid the
introduction of hazards
into the products.

6.2.7 Personnel undertaking


inspections shall be
suitably qualified and/or
trained, and shall be
competent to carry out the
work required.

6.2.8 When external contractors


are used for inspections,
they shall be subjected to
the usual
supplier/subcontractor
approval processes.

6.2.9 Inspection results which


are outside the defined
acceptance level shall be
reviewed in a timely
manner by a competent
person and the need for
corrective action assessed,
documented and
completed.

6.3 Product claims (now 2.3 Product labelling and claims, and 5.2 Quantity
control)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

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Statement The company shall have


of intent procedures in place to
validate any declared
product information or
claims made for the
products and monitor
compliance with such
claims if necessary.

5.2 The company shall


operate a quantity control
system which conforms to
the legal requirements in
the country where the
product is sold and any
additional customer
requirements.

6.3.1 Where necessary the 5.2.1 Where necessary the


company shall operate a company shall operate a
quantity control system quantity control system
which conforms to legal which conforms to legal
requirements and/or requirements and/or
specified customer specified customer
requirement in the region requirements in the region
where the product is where the product is
available for sale. available for sale.

Documentary evidence
shall be available on site
to substantiate claims.

6.3.2 Where quantity checking 5.2.2 Where quantity checking


is required, the frequency is required, the frequency
and methodology used and methodology used
shall meet the minimum based on valid sampling
requirements of any plans shall meet the
legislation governing minimum requirements of
quantity verification. any legislation governing
quantity verification.

6.3.3 Any claims about a 2.3.2 The site shall have a


product, e.g. a weight process in place to ensure
limit for a trampoline or that any claims made
sun protection factor on a about a product shall be
cream, shall be fully fully validated to ensure
validated to ensure that that products meet the
products meet the stated stated claim.
claim.

6.3.4 The company shall 2.3.3 Where applicable, the site


undertake product-in-use shall ensure that product-
evaluations, testing and/or in-use evaluation (internal
reliability trials and/or or external), reliability
shelf-life evaluations to trials and shelf-life tests
validate and verify that are validated. It shall be
production of a safe and verified that the
legal product is production of a safe and
maintained, taking legal product is
maintained, taking

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account of the category of account of the category of


consumers at risk. consumers at risk.

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7 Process control (now 6)


7.1 Control of operations (now 6.1)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement The company shall be


of intent able to demonstrate
effective control of all
operations undertaken, to
ensure product safety,
legality and quality and
ensure that the processes
and equipment employed
are capable of producing
consistently safe and
legal product with the
desired quality
characteristics.

6.1.1 Process risk assessment

Statement The sites programme of


of intent process and quality
controls to ensure the
production of safe and
legal products of
consistent quality shall be
based on a risk
assessment of the
production process and
the potential for product
contamination.

7.1.1 The company shall 6.1.1.1 A hazard and risk analysis


conduct a risk assessment shall be carried out by a
of hazards potentially multi-disciplinary team or
introduced during the demonstrably competent
production, packaging or manager. In the event of
storage processes. the company not having
appropriate in-house
knowledge, external
expertise may be sought
but the day-to-day
management of the
system shall remain the
responsibility of the site.

6.1.1.2 Where the hazard and risk


analysis study has been
undertaken centrally by
the head office, accurate
flow diagrams shall be
available on site.

It must be possible to
demonstrate that a central

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hazard and risk analysis


has been verified to meet
the specific activities of
the local operation.
Verification activities
include internal audits and
complaints review or
analysis.

7.1.2 The company shall 6.1.1.3 The site shall establish


establish precise process precise process flow
flow(s) and a control plan diagrams identifying each
which identifies the step in the production of
critical control points (if the products.
any), control limits,
monitoring points and the
records required. The
company shall define
how changes to the
control plan are approved
and implemented.

6.1.1.4 The site shall consider the


potential product safety
and quality issues which
could occur at each
process stage. This should
include:

physical or chemical
product
contamination
microbiological
contamination
product quality or
safety issues as
appropriate to the
products
manufactured.

The results of this


assessment shall be
documented.

6.1.1.5 Each potential issue shall


be assessed to determine
the level of risk and
appropriate controls to
reduce or eliminate the
risk.

Where an issue is
considered to present a
significant risk to the
safety, legality or quality
of the products produced
a documented control plan

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shall be developed and


implemented.

7.1.3 Pre-production meetings


shall be conducted prior
to new or substantially
changed products being
produced, to evaluate and
approve the processes.

7.1.4 Process monitoring shall 6.1.1.6 Where any significant


be established and product safety or quality
adequately controlled to issues are controlled by
ensure products are process monitoring the
produced within the process parameters shall
required process be defined and records
specification. retained of checks of the
process.

6.1.1.7 If there are identified


critical control points
(CCPs) where product
safety and legality require
control measures to be in
place, then for each CCP
the site shall:

establish and validate


critical limits
establish a system to
monitor control of the
CCPs
establish the
corrective action to
be taken when
monitoring indicates
that a particular CCP
is not under control
establish procedures
of validation and
verification to
confirm that the
system is working
effectively, including
auditing of the
system
establish appropriate
documentation
concerning all
procedures and
records.

7.1.5 Corrective action shall be 6.1.1.8 Corrective action shall be


taken in the event of taken in the event of
deviation of the process deviation of the process
from specification. This from specification. This
shall be recorded. shall be recorded.

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6.1.1.9 The hazard and risk


analysis shall be reviewed
whenever new product
types are manufactured or
significant changes are
made to production
methods.

7.1.6 The company shall have


a fully implemented and
maintained process risk
assessment system, based
on established principles.

7.1.7 In circumstances where Covered in


process parameters are clause 6.1.1.6.
controlled by in-line
monitoring devices, these
shall be linked to a
suitable failure alert
system and routinely
tested.

6.1.2 Line clearance and in- New


process checks

6.1.2.1 Before the start of any


manufacturing operation,
documented checks shall
be carried out to ensure
that the production line
and the relevant areas
around it have been
cleared and, where
necessary, cleaned, to
avoid mixing with
materials from the
previous operations.

All documentation, raw


materials, components
and packaging with the
necessary equipment shall
be available for use.

It shall be possible to
identify the production
line with its name or
identifying code as
determined by the risk
assessment.

7.2 Control of incoming components and raw materials (now 3.5.2 Control
and acceptance of incoming raw materials, components and packaging
materials)

Issue 3 Issue 4 (GM higher) Comments

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Clause Requirements Clause Requirements

Statement The company shall have Statement The company shall have
of intent procedures to specify, of intent an effective process to
validate and approve ensure that incoming raw
incoming materials, materials, components
which shall include any and packaging materials
testing, inspection or are suitable for use and
review of certificates of do not adversely affect
analysis. the safety, legality or
quality of the finished
product.

7.2.1 Raw materials or 3.5.2.1 Raw materials,


components critical to components and
product safety, legality or packaging shall have
quality shall have documented approval
documented approval procedures to ensure they
procedures to assure conform to agreed
conformance to agreed specifications and
specifications and requirements, and
requirements and documented positive
documented positive batch release.
batch release.
Incoming goods,
including materials
returned to site from
subcontractors (and home
workers), shall be subject
to a documented positive
batch release procedure.

7.2.2 The requirement for


documented approval
procedures as described
in clause 7.2.1 shall also
apply to subcontracted
work or work performed
outside the site being
audited.

7.2.3 The company shall have a 3.5.2.2 The company shall have a
documented procedure to documented procedure to
ensure that materials or ensure that raw materials,
components used by components and
home workers (when packaging used by home
used) are approved. (See workers (when used and
also home-worker if authorised by the
requirements in clause customer) are approved.
5.6.2.)

3.5.2.3 The company shall have New


in place a documented
procedure to ensure the
authenticity of raw
materials, components,
packaging and
documentation to prevent
fraud.

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7.3 Equipment and equipment maintenance (now 6.2)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement Equipment shall be Statement Equipment shall be


of intent suitably designed for the of intent suitable for the intended
intended purpose and purpose and shall be used
shall be maintained and in such a way as to
used so as to minimise the minimise the risk of
risk to product safety, contamination of product.
legality and quality.

7.3.1 All equipment shall be 6.2.1 All equipment shall be fit


properly specified before for purpose and
commission, and constructed of
operating parameters for appropriate materials.
production equipment and
tooling shall be The design and placement
determined, validated and of equipment shall ensure
implemented as part of it can be effectively
the control plan. cleaned and maintained.
Validation records
pertinent to safety or
legality shall be kept for
the lifetime of the
equipment.

7.3.2 In the case of equipment 6.2.2 In the case of equipment


failure or deviation of the failure, procedures shall
process from be in place to establish
specification, procedures the safety and legal status
shall be in place to of the product prior to
establish the safety status release.
of the product prior to
release.

7.3.3 A documented system of 6.2.3 A documented planned


planned maintenance preventive maintenance
shall be in place, covering programme based on risk
all items of equipment assessment and covering
and plant which are all items of equipment
critical to product safety, and plant which are
legality and quality. This critical to product safety,
shall include, but not be legality and quality shall
limited to, records of: be in place.

periodic maintenance
schedules and
completion
preventative
maintenance
required safety
checks
spare-parts listings
and replacements

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contingency plans for


failure of essential
equipment.

7.3.4 Materials (for example, 6.2.4 Materials (e.g. chemical


lubricating oils and lubricating oils and
paints) used for paints) used for
equipment and plant equipment and plant
maintenance shall be maintenance shall be
assessed to establish assessed to establish
whether they pose a risk whether they pose a risk
by direct or indirect by direct or indirect
contact with raw contact with raw
materials, intermediate materials, intermediates,
and finished products. If components, packaging
necessary, they shall be and finished products. If
suitably identified for the necessary, they shall be
intended use and suitably identified for the
controlled. intended use and
controlled.

7.3.5 Engineering workshops


shall be controlled to
prevent contamination
risks to the product and
be organised, clean and
tidy to allow safe,
efficient and quality
work.

6.2.5 Repairs or servicing of New


equipment shall be
completed by competent
maintenance personnel.

7.3.6 When possible, 6.2.6 When possible,


equipment shall be equipment shall be
positioned so as to give positioned so as to give
access beneath, inside and access beneath, inside
around it for ease of and around it for ease of
cleaning and servicing. cleaning and servicing.

7.3.7 In addition to any planned


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

7.3.8 Certificates of conformity


or other evidence to
confirm suitability for use
shall be available for

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equipment in direct
contact with products,
raw materials and work in
process.

7.3.9 On completion of any


maintenance work,
machinery and equipment
shall be clean and free
from contamination
hazards. A documented
hygiene clearance
procedure shall exist.

7.4 Foreign-body detection and control (now 6.3 Product contamination


control)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement Where deemed necessary Statement Appropriate facilities and


of intent by the documented risk of intent procedures shall be in
assessment, the company place to control the risk of
shall have systems for foreign body, chemical or
foreign-body detection in biological contamination.
place and ensure its
effective operation.

6.3.1 Identification and


prevention of risk of
product contamination

7.4.1 The company shall ensure 6.3.1.1 The site shall ensure that
that all necessary steps all necessary steps are
are taken to identify and taken to identify and
prevent the risks of prevent the risks of
foreign-body foreign body, chemical
contamination as and biological
identified by risk contamination as
assessment. This shall identified by risk
include any assessment. This shall
contamination potentially include any
introduced by the contamination potentially
packaging. introduced by raw
materials, components or
packaging.

6.3.2 Chemical and biological


control

6.3.2.1 Processes shall be in


place to manage the use,
storage and handling of
non-production chemicals
and biological materials
to prevent contamination.

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These shall include as a


minimum:

a list of approved
chemicals for
purchase
availability of
material safety data
sheets
the labelling and/or
identification of
containers of
chemicals and
biological materials
at all times
a designated storage
area with access
restricted to
authorised personnel.

6.3.3 Metal control

7.4.2 Tools and other sharp 6.3.3.1 Tools and other sharp
objects used in metal implements
production shall be including knives, cutting
controlled. Methods such blades, needles,
as, but not limited to, the perforation blades and
following may be used: wires used in production
shall be controlled where
snap-off-blade there is a risk of product
knives prohibited contamination. Methods
tools permanently such as, but not limited to,
attached to benches the following may be
items controlled by a used:
listing and
registration tools permanently
procedure attached to
needle policy where equipment to prevent
all parts of broken loss
needles have to be items controlled by
returned prior to new an issue listing and
issue. registration
procedure
recovery of all parts
of broken needles
before the issue of a
replacement needle.

Snap-off-blade knives
shall be prohibited.

7.4.3 Where a metal or foreign- 6.3.5.2.1 Where a metal or other


body detector is required foreign body detector is
or specified by the required based on risk
customer, the company assessment, the company
shall establish shall establish
documented procedures documented procedures
specifying its use, specifying the methods
location, critical limits for and frequency of testing,

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detection and recording critical limits for


of results. detection, and recording
of test results.

6.3.4 Glass, brittle plastic, New


ceramics, wood and
similar materials control

6.3.4.1 Glass or other brittle


materials shall be
excluded or protected
against breakage in areas
where there is a risk of
product contamination.

7.4.4 Except when used as part 6.3.4.2 Where there is a potential


of the product, the risk to product all glass,
presence and location of ceramic, wood and brittle-
all glass, ceramic and plastic items in
brittle-plastic material in production areas (except
raw-material handling, where the item is part of
preparation, processing, the product) shall be
and packing and storage included in the risk
areas shall be listed in a assessment and listed in a
register. Checks of the register. Documented
condition of these procedures for handling
materials should be these materials shall
carried out at a specified include:
frequency and the results
recorded. regular checks of the
condition of these
materials carried out
at specified intervals
and recorded
recording of all
breakages in an
incident report
segregation of
contaminated product
recording details of
cleaning or
replacement to
minimise potential
for product
contamination.

7.4.5 Where they constitute a 6.3.4.2 Where there is a potential


risk to the product, a risk to product all glass,
management system that ceramic, wood and brittle-
shall include written plastic items in
procedures shall be in production areas (except
place for all glass, brittle where the item is part of
plastics and ceramics to the product) shall be
ensure the necessary included in the risk
precautions are taken. assessment and listed in a
Breakages shall be register. Documented
recorded and records procedures for handling
retained.

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these materials shall


include:

regular checks of the


condition of these
materials carried out
at specified intervals
and recorded
recording of all
breakages in an
incident report
segregation of
contaminated product
recording details of
cleaning or
replacement to
minimise potential
for product
contamination.

7.4.6 Except when used in the


product, the use of wood
within raw material
handling, preparation,
processing, packing and
storage areas shall be
eliminated except for
wooden pallets where any
risks should be evaluated
and controlled.
6.3.5 Foreign body detection
and removal equipment

Statement The risk assessment shall New


of intent identify the potential use
of equipment to detect or
remove foreign body
contamination.

6.3.5.1 Filters and sieves New

6.3.5.1.1 Filters and sieves used for New


foreign body control shall
be of a specified mesh
size or gauge and
designed to provide the
maximum protection that
is practical for the
product. Material retained
or removed by the system
shall be examined and
recorded to identify risks.

6.3.5.1.2 Filters and sieves shall be New


regularly inspected and
tested for damage at a
documented frequency

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determined by the risk


assessment.

Defective sieves and


filters shall be segregated
and appropriate action
taken to replace them.

Records shall be
maintained.

6.3.5.2 Metal detectors and X-ray New


equipment

6.3.5.2.1 Where a metal or other New


foreign body detector is
required based on risk
assessment, the company
shall establish
documented procedures
specifying the methods
and frequency of testing,
critical limits for
detection, and recording
of test results.

6.3.5.2.2 The metal detector or X- New


ray equipment shall
incorporate one of the
following:

an automatic
rejection device
a belt stop system
with an alarm where
the product cannot be
automatically
rejected (e.g. for very
large packs)
in-line detectors
which identify the
location of the
contaminant to allow
effective segregation
of the affected
product.

6.3.5.2.3 Systems shall be in place New


to segregate product
rejected by the metal
detector to prevent
accidental reintroduction
and allow investigation of
the source of the metal
contaminant.

6.3.5.2.4 There shall be a New


documented procedure to
examine product rejected

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by the metal detector and


to retain any metal
contaminant.

The source of the


contamination shall be
investigated and
appropriate corrective
action taken to minimise
the risk of further
contamination.

Records shall be
maintained.

6.3.5.3 Magnets New

6.3.5.3.1 The type, location and New


strength of magnets shall
be recorded in a register.

Documented procedures
shall be in place for
inspection, cleaning,
strength testing and
integrity checks. Records
of all checks shall be
maintained.

7.5 Calibration and control of measuring and monitoring devices (now 6.4)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement Measuring equipment Statement Measuring equipment


of intent used to monitor product of intent used to monitor product
safety, quality and safety, quality and
legality shall be legality shall be
identified. The identified calibrated and of suitable
measuring equipment accuracy for its intended
shall be calibrated to a purpose.
recognised national or
international standard.
Where a traceable
calibration is not possible,
the company shall verify
the basis by which
calibration is declared.

7.5.1 The company shall 6.4.1 The site shall have a list
identify equipment used of equipment used to
to make measurements make measurements
relevant to product safety, relevant to product safety,
legality and quality. legality and quality.

7.5.2 The equipment used in 6.4.2 The equipment used to


accept or reject activity accept or reject a product

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shall be calibrated to a shall be calibrated to a


specified accuracy and specified accuracy and
precision at a defined precision at a defined
frequency (or before use). frequency (or before use).

7.5.3 The calibration of 6.4.3 The calibration of listed


identified equipment shall equipment shall be
be traceable to a traceable to a recognised
recognised national national standard. Where
standard. Where such a such a standard does not
standard does not exist, exist, the basis by which
the basis by which calibration is declared
calibration is declared shall be verified.
shall be verified.

7.5.4 Records of the results of 6.4.4 Records of the results of


calibration and calibration and
verification shall be verification shall be
maintained for a suitable maintained for a suitable
period, taking account of period, taking account of
the life of the products the life of the products
being produced. being produced.

7.5.5 Identified equipment shall 6.4.5 Adjustment of listed


be prevented from being equipment by
adjusted by unauthorised unauthorised staff shall
staff and shall be marked be prevented and the
to show the calibration equipment shall be
status and period of marked to show its
validity. calibration status and
period of validity.

Procedures shall be in
place for actions to be
taken if equipment is
found not to be operating
within specified
tolerances and/or limits.

7.5.6 The company shall define


suitable test pieces and
operate a defined
monitoring and testing
procedure to identify any
failure of metal/foreign-
body detectors (if used).

7.5.7 Procedures shall be in Moved into


place for actions to be clause 6.4.5.
taken if equipment is
found not to be operating
within specified
tolerances and/or limits.

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7.6 Retained production samples (now moved into 5.3 Product sample
control)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement The company shall ensure Now in section


of intent the adequate and secure 5.3.
retention of production
samples to assist in the
investigation of
complaints and to verify
that production is in
conformity with the
agreed specification.

7.6.1 The company shall retain Moved into


a fully representative clause 5.3.1.
production sample of
each product as received
by the customer
(including the packaging).
Exceptions may be made
for products that are
impractical to store,
provided the information
usually provided by a
production sample can
still be identified.

A designated person shall


authorise retained
production samples
and/or component
samples (see also
requirements in 5.1 Pre-
production reference
samples).

7.6.2 Procedures shall be in Moved into


place to determine the clause 5.3.4.
retention time of retained
samples. This should
normally be the
foreseeable lifetime of the
product unless otherwise
justified.
7.6.3 Retained samples shall be Moved into
securely held and stored clause 5.3.2.
in suitable conditions to
maintain their original
status.

7.7 Final product packing and control (now 6.5)

Issue 3 Issue 4 (GM higher) Comments

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Clause Requirements Clause Requirements

Statement The company shall Statement The company shall ensure


of intent establish a procedure for of intent that products are packed
the packing of products to in accordance with
ensure that products are customer-specified
supplied which meet requirements and any
relevant safety criteria, relevant safety criteria,
taking account of legal quality and legal
requirements and requirements.
customers specific
requirements.

6.5.1 Before the start of the


packaging operation,
documented checks shall
be carried out to ensure
that the packing line and
the relevant areas around
it have been cleared, and
where necessary cleaned,
to avoid mixing with
materials from the
previous operations.

All documentation and


packaging materials shall
be available for use.

The packing line shall be


identifiable by its name or
identifying code as
determined by the risk
assessment.

7.7.1 The company shall define 6.5.2 The company shall have
and validate the packing documented instructions
procedure for products for the packing of
taking particular account products taking particular
of customer requirements. account of customer
This shall include requirements.
methods of ensuring that
the correct product(s) and This shall include
components are correctly methods of ensuring that
packaged with and placed the correct product(s) and
in the correct outer components are correctly
packaging. packaged and placed in
the correct outer
packaging.

7.7.2 Quantity markings on the 6.5.3 The quantity of product


product or pack should be should match the quantity
accurate, verified and in markings, which should
accordance with the legal be accurate, verified and
requirements in the in accordance with the
country of sale. legal requirements in the
country of sale.

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7.7.3 The company shall verify 2.3.1 The site shall verify that Included in
that information shown information shown on product risk
on primary (consumer) primary (consumer) assessment prior
package labels and outer package labels and outer to production.
cartons is correct and cartons is correct and
meets the regulatory and meets the regulatory and
safety requirements of the safety requirements of the
region of intended sale. region of intended sale.

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8 Personnel (now 7)
8.1 Training and competency (now 7.1)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement The company shall ensure Statement The company shall ensure
of intent that personnel performing of intent that personnel performing
work that affects product work that affects product
safety, legality and safety, legality and
quality are demonstrably quality are demonstrably
competent to carry out competent to carry out
their activity, through their activity, through
training, work experience training, work experience
or qualification. or qualification.

8.1.1 The company shall ensure 7.1.1 The company shall ensure
that all employees are that all employees are
able to demonstrate able to demonstrate
competence with regards competence with regard
to their activity. to their activity.

The company shall: The company shall:

identify the need for identify the need for


training training
document training document training
procedures and procedures and
records to records to
demonstrate that demonstrate that
training is effective training is effective
and regularly and regularly
reviewed reviewed
ensure that training ensure that training
includes both general includes both general
information on the information on the
company and specific company and specific
job training. job training
retain all training
records.

8.1.2 Employees having a Part of this


direct effect on the safety, clause has been
quality or legality of moved into
products shall be trained clause 2.2.2.
to ensure understanding
of risk assessment
procedures or outcomes
as necessary for their
activity. Those
conducting or
participating in risk
assessments shall be
adequately trained in risk
assessment methods.

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8.1.3 Training records should 7.1.2 Training records shall be


be stored such that stored in such a way as to
privacy of personnel is ensure privacy of
protected and legal personnel is protected and
compliance with data legal compliance with
protection laws in the data protection laws in
country of operation are the country of operation
respected whilst also are respected, while also
allowing auditors access allowing auditors access
to necessary information. to necessary information.
Training shall be Training shall be
traceable to an individual traceable to an individual
employee. employee.

8.2 Protective clothing

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement The companys standards Statement The companys standards


of intent shall be documented and of intent shall be documented and
adopted by all personnel, adopted by all personnel,
including contractors and including contractors and
visitors to the production visitors to the production
facility. facility.

8.2.1 Where a need for 7.2.1 The company shall use


protective clothing has risk assessment to
been identified by the risk determine the need for
assessment, this shall not protective clothing.
pose a contamination risk
to the product. Where a need for
protective clothing has
been identified by the risk
assessment, this shall not
pose a contamination risk
to the product.

8.2.2 Based on the assessment 7.2.2 Based on the assessment


of risk to the product, of risk to the product
suitable footwear shall be integrity, suitable
worn within the factory footwear shall be worn
environment if necessary. within the factory
environment.

8.2.3 Protective clothing, 7.2.3 Protective clothing,


where provided, shall be where provided, shall be
effectively laundered at effectively laundered at
an appropriate frequency. an appropriate frequency.

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

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8.2.4 Disposable protective Now moved to


clothing, if used, shall be clause 7.2.3.
subject to adequate
control to avoid product
contamination.

8.3 Hygiene practices (now 7.3)

Issue 3 Issue 4 (GM higher)


Comments
Clause Requirements Clause Requirements

Statement Standards of hygiene Statement Standards of hygiene


of intent shall be formulated with of intent shall be applied with due
due regard to the risk of regard to the risk of
product contamination. product contamination.

8.3.1 Where metal foreign- 7.3.3 Where metal foreign


body detection is in place, body detection is in place,
detectable plasters shall detectable plasters shall
be used and shall be be used and shall be
regularly tested through regularly tested through
the detector. the detector.

8.3.2 The company shall have a 7.3.1 The company shall have a
policy to control the policy to control the
wearing of jewellery so wearing of jewellery so
that it poses no risk of that it poses no risk of
product contamination. product contamination.

8.3.3 All cuts and grazes on 7.3.2 All cuts and grazes on
exposed skin shall be exposed skin shall be
covered by a contrasting covered by a contrasting
coloured plaster that is coloured plaster that is
company issued and issued and monitored by
monitored. the site, to avoid
contamination of product.

8.3.4 Hand-cleaning shall be 7.3.4 Hand-cleaning shall be


performed at a suitable performed at a suitable
frequency to maintain frequency to maintain
hygienic conditions. hygienic conditions.

8.3.5 No eating, drinking or 7.3.5 Eating, drinking or


smoking shall be smoking shall only be
permitted within permitted within
production or packaging designated areas and
areas. where there is no risk of
contamination of
products.

8.3.6 All head and facial hair


shall be fully contained to
prevent product
contamination.

8.3.7 The company shall be 7.3.6 Where there may be a


vigilant concerning risk to product safety and

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employees, including legality, the site should


temporary employees, have a procedure for the
when they may be notification by personnel,
suffering from or have including temporary
been in contact with any personnel, visitors and
relevant infectious contractors of any
disease or condition. The relevant infectious
company should have a diseases or conditions
procedure for the which they may have
notification by employees been in contact with or be
where this is legally suffering from.
allowable.

8.3.8 Where the company


becomes aware of a
person who has entered
the premises suffering
from a relevant infectious
disease, steps shall be
taken to minimise any
risk to product safety.

8.3.9 Where there may be a


risk to product safety, and
where legally allowable,
visitors and contractors
shall be required to
complete a health
questionnaire prior to
entering the raw-material,
preparation, processing,
packing and storage
areas. If necessary, these
persons shall undergo
medical screening before
permission is granted to
enter the raw-material,
preparation, processing,
packing and storage
areas.

8.3.10 Fingernails shall be kept


short, clean and
unvarnished. False
fingernails are not
permitted.

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