BRC Global Standard for Consumer Products Issue 4

Self-Assessment Tool
BRC Global Standard for Consumer Products Issue 4

CP423 Auditor Checklist – PCH Higher BRC Global Standard for Consumer Products, Issue 4
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CP423 Auditor Checklist – PCH Higher BRC Global Standard for Consumer Products, Issue 4
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 BRC GLOBAL STANDARD 4 SELF-ASSESSMENT TOOL
Welcome to the BRC Global Standards Self-Assessment tool
We hope that you will find this useful when preparing your site for an audit against the BRC Global Standard for Consumer Products Issue 4.
How to use the BRC Global Standards Self-Assessment tool
This tool is designed to help you assess your operation against the requirements of the Standard and help prepare you for your certification audit.
The checklist covers each of the requirements of the Standard and may be used to check your site’s compliance with each of these requirements. The
checklist also allows you to add comments or identify areas of improvement in the empty boxes provided at the end of each section.
While we hope that this tool is useful in helping you prepare for your audit it should not be considered as evidence of an internal audit and will not be
accepted by auditors during an audit.
Training
The BRC Training Academy has courses available to improve the understanding of the requirements for the BRC Global Standard for Consumer Products
Issue 4 and may be useful for the person using the BRC Global Standards Self-Assessment Tool. For further information on the courses available please
visit www.brctrainingacademy.com
Further Information
If you have any further questions about the BRC Global Standards Self-Assessment Tool or the BRC Global Standard for issue 4 please do not hesitate to
contact the BRC Global Standards team.
Email – [email protected]
Telephone – 020 7854 8900

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 BRC Global Standard for Consumer Products Auditor Checklist Personal Care and Household - Higher

Clause Requirements BRC issue 4 ISO 9001:2015 FSC STD 40- Actions Completion
004 V3-0 date

1 Senior management commitment

1.1 Senior management commitment and
continual improvement
Fundamental Statement The site’s senior management shall
of Intent 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 site’s 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 responsibility
for the site
 communicated to all staff.

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1.1.2 The site’s senior management shall
ensure that clear objectives are
defined to maintain safety and legality
and improve the quality of products
manufactured, in accordance with the
site’s product safety and quality policy
and commitment to implementing the
requirements of this Standard. These
objectives shall be clearly
communicated to relevant staff and
monitored, and results reported at
least annually to site senior
management.

1.1.3 Management review meetings

attended by the site’s senior
management shall be undertaken at
appropriate planned intervals, at least
annually, to review the site’s
performance against the Standard
and objectives set in clause 1.1.2.
The review process shall include the
evaluation of:

 previous management review

action plans and timeframes
 results of internal, second-party
and/or third-party audits (relevant
to the scope of this Standard)
 customer complaints and results
of any customer feedback
 product safety and quality
incidents, corrective actions, out-

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 of-specification results and non-
conforming materials
 output of review of the
management of the systems for
product risk assessment, changes
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.

1.1.4 The site’s senior management shall

provide sufficient human and financial
resources required to produce and
improve products safely and in
compliance with the requirements of
this Standard.
1.1.5 Where the site is certificated to the
Standard, it shall ensure that
announced recertification audits occur
on or before the audit due date
indicated on the certificate.
1.1.6 The site shall have a genuine hard
copy or electronic version of the
current Standard available with a
position statement and be aware of

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 any changes to the Standard or
protocol that are published on the
BRC website.
1.1.7 Where required by legislation, the site
shall be registered with or approved
by the appropriate government
agency and evidence of this shall be
available.
1.1.8 The site’s senior management shall
ensure that the root causes of non-
conformities identified at the previous
audit against the Standard have been
effectively addressed to prevent
recurrence.

A system shall be in place to close out

non-conformities raised at internal,
second-party and third-party audits,
with consideration of the root cause.

1.2 Organisational structure, responsibility and management authority

Statement of Intent The site shall have a clear
organisational structure and lines of
communication to enable effective
management of product safety,
legality and quality.
1.2.1 The site shall have an up-to-date
organisation chart for key staff
demonstrating the management
structure of the company. The
responsibilities for the management of
activities which ensure product safety,
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 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.
1.2.2 The site’s senior management shall
ensure that all employees are aware
of their responsibilities. Where
documented work instructions exist
for activities undertaken, the relevant
employees shall have access to these
and be able to demonstrate 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.

2 Product risk management

Fundamental Statement The site shall have a management

of Intent process in place to ensure that a risk
assessment is completed on each
product group to ensure safety,
legality and quality in the regions of
intended sale, where known.

2.1 Legislation and safety requirements

2.1.1 The site shall have a system to
demonstrate knowledge of all

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 applicable legislation, product
standards and product safety issues
in the place of production and
regions of intended sale of each
product. This may be within the
company or by use of external
expertise.
2.1.2 If the site relies on information
concerning product safety, quality and
legality provided by their customer or
a third party, it shall have a process in
place to validate the credibility of the
provider of the information and retain
evidence of this validation.

2.1.3 The company’s senior management

shall have a system in place to ensure
that the site is kept informed of and
reviews:

 changes in legislation
 scientific and technical
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.

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

2.2 Product risk assessment

2.2.1 The company shall ensure that a
product hazard and risk assessment
is undertaken for each product or
product group. The assessment shall
be documented and include:

 a description of the product

assessed (for example, approved
samples or mock-ups, sample
drawings, computer graphics,
photographs, specification)
 the intended use of the product
and foreseeable abuse conditions
 the hazards, the risk level for
each hazard and whether the risk
is acceptable
 the date performed, name of the
person responsible and the
evidence from which the
assessment was derived.

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

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 risk assessment shall be completed
on the modified design.

2.2.2 The risk assessment shall be

produced by suitably trained and
competent internal or external
resources. Evidence of this shall be
available unless the risk assessment
is provided by the customer.

Staff with responsibility for decision-

making shall be trained to ensure they
understand risk assessment
procedures or outcomes necessary
for their activity.
2.2.3 The site shall determine and maintain
up-to-date information about the
legislation and mandatory standards
applicable to each product and to the
materials from which it is made,
relevant in the regions of intended
sale.

2.2.4 The risk assessment shall be

reviewed at least annually, and
following any significant complaints or
incidents, to ensure that the
assessment remains up to date, and
reflects any changes in specification,
manufacturing process and
legislation.
2.2.5 Where there is a legal requirement to
do so or when it is necessary to

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

2.2.6 Where legally required, the identity,

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

2.3 Product labelling and claims

2.3.1 The site shall verify that information
shown on primary (consumer)
package labels and outer cartons is
correct and meets the regulatory and
safety requirements of the region of
intended sale.
2.3.2 The site shall have a process in place
to ensure that any claims made about
a product shall be fully validated to
ensure that products meet the stated
claim.
2.3.3 Where applicable, the site shall
ensure that product-in-use evaluation
(internal or external), reliability trials
and shelf-life tests are validated. It
shall be verified that the production of
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 a safe and legal product is
maintained, taking account of the
category of consumers at risk.

2.4 Packaging materials

2.4.1 Packaging shall be assessed for
fitness for purpose and found suitable
with regard to:
 protecting the product from
damage
 maintaining product integrity
 protecting the consumer from
injury
 preventing contamination.
3.1 General documentation requirements
3.1.1 Product safety and quality management system
Statement of Intent The site’s processes and 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.

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 The QMS shall be fully implemented,
collated in a navigable and readily
accessible way, and translated into
appropriate languages if necessary.

3.2 Documentation control

Statement of Intent The site shall operate an effective
document control system to ensure
that only the correct approved
versions of documents, including
recording forms, are available and in
use.
3.2.1 The site shall have a document
control procedure to ensure that all
key documents which form part of the
product safety and quality system are
effectively managed.

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

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  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.

3.3 Record completion and maintenance

Statement of Intent The site shall maintain original,
accurate, timely and legible records to
demonstrate the effective control of
product safety, legality and quality.

3.3.1 Records shall be maintained in good

condition and retrievable. Any
alterations to records shall be
authorised and justification for
alteration shall be recorded. Where
records are in electronic form these
shall be suitably backed up to prevent
loss.

3.3.2 Records shall be retained for a

defined minimum period with
consideration given to:

 legal requirements
 the shelf life of the product
 customer requirements.

3.4 Internal audit

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Statement of Intent The company shall be able to
demonstrate that it verifies the
effectiveness of the product safety
and quality requirements implemented
from the Global Standard for
Consumer Products.

3.4.1 There shall be a scheduled

programme of internal audits
throughout the year with a scope
which covers the implementation of
the process risk assessment, GMP
and documented procedures to
achieve this standard. The scope and
frequency of the audits shall be
established in relation to the risks
associated with the activity and
previous audit performance.

3.4.2 Internal audits shall be carried out by

appropriately trained, competent
auditors. Auditors shall be
independent (i.e. not audit their own
work).
3.4.3 The internal audit programme shall be
fully implemented and tracked.
Internal audit reports shall identify
conformity as well as non-conformity
and the results shall be reported to
the personnel responsible for the
activity audited. Corrective actions
and timescales for their

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 implementation shall be agreed and
completion of the actions verified.

3.5 Supplier approval and performance monitoring

3.5.1 Management of suppliers of raw materials, components and packaging

Statement of Intent The site shall have an effective
supplier approval and monitoring
system to ensure that any potential
risks from raw materials, components
or packaging to the safety, legality
and quality of the final product are
understood and managed.

3.5.1.1 The site shall have a documented

procedure for supplier approval,
including a list of approved suppliers
for products, materials and services
impacting product safety, legality or
quality.

The approval of these suppliers shall

be based on at least one or a
combination of the following:

 supplier questionnaire
 certificate of analysis
 supplier audits
 supplier certification with a scope
covering the products supplied.

3.5.1.2 Documented procedures shall be

established which include clear

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 criteria for ongoing assessment of the
standards of performance required.
Ongoing assessment may employ
one or more of the following or other
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.

3.5.1.3 Documented procedures shall define

how exceptions are handled; for
example, the use of products where
audit or monitoring has not been
undertaken.

Based on a batch or delivery basis,

the procedure may involve the
assessment of certificates of analysis.

3.5.2 Control and acceptance of incoming raw materials, components and

packaging materials
Fundamental Statement The company shall have an effective
of Intent process to ensure that incoming raw
materials, components and packaging
materials are suitable for use and do

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 not adversely affect the safety, legality
or quality of the finished product.

3.5.2.1 Raw materials, components and

packaging shall have documented
approval procedures to ensure they
conform to agreed specifications and
requirements, and documented
positive batch release.

Incoming goods, including materials

returned to site from subcontractors
(and home workers), shall be subject
to a documented positive batch
release procedure.

3.5.2.2 The company shall have a

documented procedure to ensure that
raw materials, components and
packaging used by home workers
(when used and if authorised by the
customer) are approved.

3.5.2.3 The company shall have in place a

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

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3.6 Specifications and technical files
Statement of Intent A system shall be in place to manage
specifications and technical data for
raw materials, components and
packaging materials.
3.6.1 Suitably detailed and accurate
specifications shall be held for all raw
materials, components, packaging
materials and finished products to
ensure compliance with 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.
3.6.2 A specification shall be available for
each finished product and shall have
been verified to ensure it is fit for
purpose, meets customer
requirements and is compliant with
relevant safety and legislative
requirements in the regions of
intended sale.

As a minimum, the specification may

include the following, although this is
not an exhaustive list:

 product name and description

 composition

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  physical and/or chemical
parameters
 assembly diagrams
 packaging
 labelling
 intended shelf life
 warnings
 instructions for use.

3.6.3 Companies shall maintain the data in

a technical file that is accessible to
relevant staff containing all relevant
data (or details of where such data is
located) to ensure that products meet
the requirements of the specification
and legislative and customer
requirements.

Relevant data may include:

 bill of materials
 safety data sheets on all
chemicals used where relevant to
the safety, legality or quality of the
product
 risk assessment(s)
 description of the conformity
assessment procedure
 test reports
 inspection reports
 list of the legislation and product
standards with which the products
are manufactured to comply

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  production control procedures
and charts
 approvals by any government
body (if applicable)
 declarations of conformity to legal
requirements (if applicable)
 self-inspection reports
 corrective actions.

3.7 Corrective and preventive action

Fundamental Statement The company shall operate an
of Intent effective system for the capture,
recording and timely corrective
actions of non-conformities or matters
reported as possible non-conformities
critical to product safety, legality or
quality.
3.7.1 The company shall operate an
effective documented process for the
capture, recording and timely
investigation of non-conformities or
matters reported as possible non-
conformities critical to product safety,
legality or quality.
3.7.2 An appropriate staff member shall be
identified and assigned the
responsibility and accountability for
each corrective action. This shall be
documented.

3.7.3 The company shall ensure that

effective corrective actions are taken
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 to prevent recurrence of the problem
and shall monitor and record their
completion within an appropriate
timescale.
3.7.4 The company shall review its
processes at least annually and adopt
preventive measures as they become
available.

3.8 Control of non-conforming materials

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

3.8.1 Clear procedures for the control of

non-conforming materials and
products, including customer returns,
shall be in place and understood by
all relevant, authorised personnel.
These shall include effective
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.

3.9 Traceability
Fundamental Statement The site shall be able to trace all raw
of Intent materials, components and packaging

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 from its suppliers through all stages of
processing and dispatch to its primary
customers, and from the customer
back to the supplier.
3.9.1 The site shall have a system in place
which has the ability to trace and
follow all raw materials, components
and packaging materials from the
supplier through all stages of
processing and distribution of the
finished product, and vice versa, in a
timely manner.

3.9.2 Identification of lots/batches of raw

materials, including packaging,
processing aids, intermediate/semi-
processed products, part-used
materials, rework, finished products
and materials pending investigation,
shall be sufficient to ensure
traceability.
3.9.3 Finished product shall be identified
with a unique code such as a batch
code applied to the product or
packaging.

Documented procedures must be in

place to trace a finished product back
to the batch of raw materials or
packaging used.

3.9.4 Subcontracted manufacture of

products or components shall have

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 prior customer approval and shall be
traceable to a level appropriate to the
risk.
3.9.5 The system shall be tested to ensure
traceability can be determined from
raw-material receipt to finished
product and vice versa. This shall
occur at a predetermined frequency,
at least annually, and results shall be
retained. The time taken to complete
the exercise shall be measured and
recorded.
3.9.6 The need for extended traceability
through the chain should be
established on the basis of risk and
any legal or specific customer
requirements. Where required,
extended traceability shall be
implemented.

3.10 Complaint handling

Statement of Intent The company shall operate an
effective system for the capture,
recording and investigation of product
complaints at all levels of severity.

3.10.1 All complaints shall be recorded,

investigated using root analysis and
the results of the investigation
recorded where sufficient information
is provided. Actions appropriate to the
seriousness and frequency of the
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 problems identified shall be carried
out to reduce the likelihood of
recurrence.
3.10.2 The company shall have a process in
place to respond in a timely manner to
consumers and customers regarding
complaints.
3.10.3 Complaint data shall be analysed for
significant trends. This analysis shall
be made available to relevant staff.

3.11 Management of incidents, product withdrawal and product recall

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

3.11.1 The site shall determine and provide

written or other guidance to relevant
staff regarding the type of event that
would constitute an incident or
emergency situation that impacts
product safety, legality or quality, and
a documented reporting procedure
shall be in place which shall include
informing their customers in a timely
manner.

3.11.2 The site shall have a documented

procedure in place to effectively
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 manage product withdrawals and
recalls. Procedures shall exist to
ensure that customers are notified
immediately on issues of significance
to the customer or consumer in terms
of product safety, quality or legality.
3.11.3 The documented product withdrawal
and recall procedures shall include as
a minimum:
 identification of key staff
constituting the incident
management team and their key
responsibilities
 an up-to-date list of key contacts,
with details of agencies providing
advice and support
 a list of persons who can initiate a
recall.
3.11.4 The site shall have written technical
and quality agreements in place with
agents and distributors and other
parties in the supply chain where
these are necessary to ensure
effective withdrawal/recall.
3.11.5 In the event of a product recall, the
certification body issuing the current
certificate and the appropriate
enforcement authorities shall be
informed in a timely manner. The
company shall be aware of and
adhere to any legal reporting
obligations in the regions of sale.

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

3.11.7 The product recall and withdrawal

procedures shall be regularly tested,
at least annually, in a way that
ensures their effective operation.
Results of the test shall include
timings of key activities and shall be
retained.

The company's senior management

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

3.11.8 The company shall develop

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

 disruption to key services (e.g.

water, energy, staff availability)
 events such as flood, fire and
natural disaster

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  malicious contamination or
sabotage.

4 Site standards

4.1 External standards

Statement of Intent Sites used for manufacturing, storage
or distribution shall be of suitable size,
location, construction and design to
facilitate maintenance, prevent
contamination and enable the
production of safe and legal products.
4.1.1 The site to be included in the audit
shall be clearly defined, and shall be
located and maintained so as to allow
the production of safe and legal
products.

The external areas and surroundings

shall be maintained in good order.

A site plan shall be retained and

readily available.

4.4.2 Consideration shall be given to local

activities and the site environment
and measures shall be taken to
prevent contamination.

Where measures have been put into

place to protect the site (from
potential contaminants, flooding, etc.),

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 they shall be regularly reviewed in
response to any changes.

4.2 Security
Statement of Intent Security shall be maintained to
prevent access of unauthorised
persons to production and storage
areas.

4.2.1 Access to the site by employees,

contractors and visitors shall be
controlled and a visitor-reporting
system shall be in place.
4.2.2 Contractors involved in maintenance
or repair shall be qualified or
supervised, and a nominated staff
member shall be responsible for their
activities with regard to potential
effects on the safety, legality or quality
of products.

4.3 Layout, product flow and segregation

Fundamental Statement The factory layout, flow of processes
of Intent and movement of personnel shall be
adequate to prevent the risk of
product contamination and mix-ups
and to comply with relevant
legislation.
4.3.1 The layout process flow of machinery
and equipment shall be arranged to
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 minimise the risk of product
contamination and damage.
4.3.2 Premises shall allow sufficient
working space and storage capacity
to enable all operations to be carried
out and, if necessary, in hygienic
conditions. The necessary level of
hygiene shall be maintained for each
product.

4.3.3 The location of facilities and services,

including toilets, cleaning and catering
facilities, shall be segregated and
separated from production areas and
shall not jeopardise the integrity of the
product.

4.3.4 There shall be effective segregation to

minimise the risk of product cross-
contamination taking into account the
flow of product, nature of materials,
equipment, personnel, waste, airflow,
air quality and utilities.

Documented control procedures shall

be in place.
4.3.5 Where materials or products require
special handling procedures to be in
place, these shall be maintained to
ensure product safety, quality and
legality are not compromised.
4.3.6 The company shall determine whether
allergenic or sensitising materials are
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 used and, if so, documented policies
shall exist for the handling of such
materials including:

 physical or time segregation from

other products
 use of identified, dedicated
equipment if necessary
 adequate labelling of final
products.

4.3.7 Materials and products requiring

segregation (e.g. materials intended
for different geographical regions)
shall have documented control
procedures in place to ensure that
product integrity is maintained.

4.4 Building interiors

Statement of Intent The interior of the site, buildings and
facilities shall be suitable for the
intended purpose.

4.4.1 The site shall be maintained to

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

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 appropriate standard. This shall
include, as defined by the risk
assessment:

 a clean, tidy and organised

factory
 adequate lighting
 adequate ventilation
 walls, floors, windows, doors and
ceilings maintained in a good
condition to prevent foreign body
risks
 suitable and sufficient removal of
any by-products and
contaminants.
4.4.2 Suitable and sufficient lighting shall be
provided for correct operation of
processes, inspection of products,
and effective cleaning.
4.4.3 The site shall be assessed for any
particular requirements relevant to the
products being produced, such as
temperature, humidity and
electrostatic discharge. Any identified
requirements shall be adopted,
calibrated, documented, monitored
and regularly reviewed.
4.4.4 Where water quality presents a risk to
the final product it shall comply with
the required specification (as defined
in the region of intended product
sale), suitably treated to prevent

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 contamination and regularly
monitored.

4.5 Staff facilities

Statement of Intent Staff facilities shall be sufficient to
accommodate the required number of
personnel, and shall be designed and
operated to minimise the risk of
product contamination. The facilities
shall be maintained in a good and
clean condition.
4.5.1 Staff facilities such as washrooms and
break areas must be provided and
maintained in a clean condition and
segregated from production areas to
prevent product contamination.

Where a site provides food service

the food preparation areas must be
clean and fit for purpose and
adequately segregated from
production areas.

4.5.2 Where smoking or use of electronic

cigarettes is allowed under national
law, it shall only be permitted in
designated controlled smoking areas
which shall be isolated from
production and storage areas and
fitted with air extraction to the exterior
of the building. Adequate
arrangements for dealing with
smokers’ waste shall also be provided
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 at smoking facilities, both inside
buildings and at external locations.

4.5.3 Storage facilities of sufficient size to

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

4.5.4 The site shall use risk assessment to

determine where a change to
workwear in different areas is
required. Any required changing
facilities shall be provided for all
personnel: staff, visitors and
contractors. Changing areas should
be sited to allow direct access to the
production, packing or storage areas
without exposure to any external area.
Where this 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.

4.5.5 Suitable and sufficient hand-cleaning

facilities shall be provided at access
to production areas, and at other
appropriate points within these areas,
based on appropriate risk.

4.6 Housekeeping and hygiene

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Fundamental Statement Housekeeping and cleaning systems
of Intent shall be in place which ensure
appropriate standards of hygiene are
maintained at all times and the risk of
product contamination is minimised.
4.6.1 Equipment, production and storage
areas shall be maintained in a state of
cleanliness appropriate to the
operations undertaken. Cleaning
practices shall be completed so as to
minimise risk of contamination and
records kept.
4.6.2 Suitable cleaning chemicals shall be
identified, clearly labelled and
controlled to prevent the risk of
product contamination. Chemicals
shall not be decanted unless into
properly labelled and identified
containers. Adequate storage facilities
shall be provided and sited so as not
to compromise the safety, legality and
quality of the product.
4.6.3 If cleaning services are outsourced,
the service providers shall have
signed a contract which identifies the
scope and frequency of the work, and
records shall be maintained. A
defined company representative shall
be responsible for ensuring that the
work is carried out satisfactorily.
4.6.4 Documented cleaning procedures
shall be in place, validated and

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 maintained for the building, utilities,
plant and all equipment. Where more
than basic cleaning is required,
cleaning procedures shall include the
following information as a minimum:

 responsibility for cleaning

 item/area to be cleaned
 frequency of cleaning
 method of cleaning
 cleaning materials to be used
 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.

4.6.5 The standard of cleaning shall be

appropriate to the product being
manufactured and shall be verified
and 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.

4.7 Waste and waste disposal

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Statement of Intent Waste disposal shall be managed in
accordance with legal requirements
and to prevent accumulation, mix-up,
risk of contamination and the
attraction of pests.
4.7.1 Waste disposal shall be managed in
accordance with legal requirements
and to prevent accumulation, mix-up,
risk of contamination and the
attraction of pests.
4.7.2 Where legally necessary, waste shall
be removed by identified, licensed
contractors, and records of disposal
shall be maintained by the site.
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.

4.7.4 External waste collection containers

and compactors shall be managed in
such a manner as to minimise risk to
the product if necessary.

4.8 Pest control

Statement of Intent The whole site shall have an effective
preventive pest control programme in
place to minimise the risk of pests.
Sufficient resources shall be available
to respond rapidly to any issues that

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 occur, in order to prevent risk to
products.

4.8.1 The pest control programme shall be

based on a documented risk
assessment which should include the
product, the material included, the
location and type of premises, the
possible types of pest, and the
process.

The pest control provider shall be a

specialist or a trained employee.

The pest control programme shall

include a documented inspection
schedule.

4.8.2 The company shall either have a

clearly defined contract with external
contractors which reflects the
activities of the site, 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.

4.8.3 When necessary, materials or

products shall be fumigated, and
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 records of this process shall be kept.
Fumigated goods may not be supplied
to customers without full professional
safety clearance and correct
clearance documentation. All
fumigation operations shall be
controlled by staff with appropriate
professional qualifications and/or
training.
4.8.4 Full material safety data sheets for all
chemical pest control agents used
shall be controlled, available to
relevant staff at all times and kept in a
designated place.

4.9 Product storage, dispatch and transport

Statement of Intent Facilities for the storage and
transportation of products shall be
suitable for purpose and minimise the
risk of product contamination, damage
and malicious intervention
4.9.1 All materials, work in progress and
product shall be properly identified
and protected during storage by
appropriate packaging to protect the
product from contamination.
4.9.2 Where storage of raw materials,
components, packaging, intermediate
or finished product is necessary it
shall be maintained in good condition
and be securely protected from

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 contamination, deterioration and
damage.

All handling operations during storage

shall be managed to prevent product
damage
4.9.3 Vehicles or containers used for
transportation and dispatch of product
shall be inspected prior to loading to
ensure that they are fit for purpose.
Records of inspection shall be
maintained.
4.9.4 Documented procedures to maintain
product safety and quality during
loading and transportation shall be
developed and implemented.

4.9.5 Where product is vulnerable to

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

4.9.6 Where a third-party haulage

contractor is used, all the
requirements shall be defined within a
contract and effectively managed.

5 Product inspection and testing

5.1 Product inspection and laboratory testing

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Fundamental Statement The company shall have a
of Intent programme for product inspection and
testing to control products during and
after production to ensure that
products are safe, legal and meet the
quality specification.
5.1.1 There shall be a scheduled product-
testing programme according to risk
for each product or product group as
defined in the specifications. This
shall be based on information such
as:

 the outcome of the product and

process risk assessments
 any legal requirements for testing
in the regions(s) of intended sale
 the site’s requirements for
demonstrating the production of
safe products.

The methods, frequency and specified

limits of testing shall be clearly
defined.

5.1.2 The testing programme shall be

implemented and records kept of all
test results. Results which are outside
the defined specification shall be
reviewed promptly by an authorised
competent person. The need for
corrective action shall be assessed

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 and documented, and any action
carried out as necessary.
5.1.3 Where the company undertakes or
subcontracts analyses which are
critical to product safety or legality,
the laboratory or subcontractors shall
have gained recognised laboratory
accreditation or operate in
accordance with the requirements and
principles of ISO/IEC 17025.

Documented justification shall be

available where accredited methods
are not undertaken.
5.1.4 Procedures shall be in place to
ensure reliability of test results, other
than those critical to safety and
legality. These shall include:

 use of recognised test methods

and reference standards, where
available
 documented testing procedures
 ensuring staff are suitably
qualified and/or trained and
competent to carry out the
analysis required
 use of a system to verify the
accuracy of test results (e.g. ring
or proficiency testing)
 use of appropriately calibrated
and maintained equipment.

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5.1.5 Test and inspection results shall be
reviewed regularly to identify trends.
The significance of external laboratory
results must be understood and acted
upon accordingly.

Appropriate actions shall be

implemented promptly to address any
unsatisfactory trends.

5.1.6 Where testing is submitted to third

parties, the required testing shall be
clearly defined, including reference to
the number, date and version of the
test standard or method to be used.

In cases where the company relies on

the expertise of third-party testing
organisations to determine
appropriate test requirements, the
company shall ensure that the third
party receives a clear written briefing
on the purpose of the test and that the
testing programme is formally agreed
and documented.

5.2 Quantity control

Statement of Intent 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.

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5.2.1 Where necessary the company shall
operate a quantity control system
which conforms to legal requirements
and/or specified customer
requirements in the region where the
product is available for sale.
Documentary evidence shall be
available on site to substantiate
claims.
5.2.2 Where quantity checking is required,
the frequency and methodology used
based on valid sampling plans shall
meet the minimum requirements of
any legislation governing quantity
verification.
5.3 Product sample control
Statement of Intent The site shall ensure that procedures
are in place for the selection,
handling, storage, approval and use
of reference samples taken from pre-
production, subcontracted and
finished production in accordance with
customer requirements.

5.3.1 Where legally required or specified by

a customer, a sample of the product
which has been approved by the
customer or a representative of the
agreed specification shall be retained.

The company shall document a

process to identify, select and
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 categorise reference samples. If
customers have a defined system of
sealed samples referring to different
stages of sample approval, the
customer’s procedure shall be
documented and followed.

5.3.2 Reference samples shall be stored

and recorded in suitable
environmental conditions to maintain
their original status for a specified
period.
5.3.3 A secure and tamper-evident system
shall be in place for the storage and
tracking of samples, with access by
authorised personnel.

The removal and return of samples to

storage shall be documented and
authorised by a designated
responsible person.

5.3.4 Documented procedures shall be in

place to determine the retention time
for samples. This should normally be
the foreseeable lifetime of the product
unless otherwise justified.

6. Process control

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6.1 Control of operations
Fundamental Statement The site’s programme of process and
of Intent 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.

6.1.1.1 A hazard and risk analysis shall be

carried out by a multi-disciplinary
team including representatives who
are experienced in the particular
activities undertaken by the site. The
team members shall have knowledge
of the hazard and risk analysis
principles.

6.1.1.2 The person responsible for leading

the hazard analysis shall receive
sufficient training to be able to
demonstrate competence in the
understanding of hazard and risk
management principles and their
application.

In the event of the site not having

appropriate in-house knowledge,
external expertise may be sought but
the day-to-day management of the

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 system shall remain the responsibility
of the site.

6.1.1.3 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 hazard and risk analysis
has been verified to meet the specific
activities of the local operation.
Verification activities include internal
audits and complaints analysis.

6.1.1.4 The scope of the hazard and risk

analysis shall be defined in terms of
the products and processes that are
covered.

The site shall establish precise

process flow diagrams identifying
each step in the production of the
products.

6.1.1.5 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

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  product quality or safety issues as
appropriate to the products
manufactured.

The results of this assessment shall

be documented.

6.1.1.6 An analysis of any identified issues

shall be undertaken in order to decide
which need to be controlled. The
following should be considered:

 the likely occurrence of the issue

 the severity of the hazard (e.g.
injurious to health, potential to
cause, rejection or a product
recall)
 existing activities that effectively
prevent or reduce the issue to
acceptable limits.

6.1.1.7 For each issue which requires control,

control points shall be reviewed to
identify those that are critical to
prevent, eliminate or reduce a
significant issue to acceptable limits.

6.1.1.8 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:

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  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.

6.1.1.9 Corrective action shall be taken in the

event of deviation of the process from
specification. This shall be recorded.
6.1.1.10 The hazard and risk analysis shall be
reviewed whenever new product
types are manufactured or significant
changes are made to production
methods.
6.1.1.11 The hazard and risk analysis shall
also be formally reviewed at least
annually and this review shall be
documented.

6.1.2 Line clearance and in-process checks

6.1.2.1 Before the start of any manufacturing
operation, documented checks shall

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 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.

6.2 Equipment and equipment maintenance

Statement of Intent Equipment shall be suitable for the
intended purpose and shall be used in
such a way as to minimise the risk of
contamination of product.

6.2.1 All equipment shall be fit for purpose

and constructed of appropriate
materials.
The design and placement of
equipment shall ensure it can be
effectively cleaned and maintained.
6.2.2 In the case of equipment failure,
procedures shall be in place to
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 establish the safety and legal status of
the product prior to release.

6.2.3 A documented planned preventive

maintenance programme based on
risk assessment and covering all
items of equipment and plant which
are critical to product safety, legality
and quality shall be in place.

6.2.4 Materials (e.g. chemical lubricating

oils and paints) used for equipment
and plant maintenance shall be
assessed to establish whether they
pose a risk by direct or indirect
contact with raw materials,
intermediates, components,
packaging and finished products. If
necessary, they shall be suitably
identified for the intended use and
controlled.
6.2.5 Repairs or servicing of equipment
shall be completed by competent
maintenance personnel.
6.2.6 When possible, equipment shall be
positioned so as to give access
beneath, inside and around it for ease
of cleaning and servicing.

6.3 Product contamination control

Statement of Intent Appropriate facilities and procedures
shall be in place to control the risk of

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 foreign body, chemical or biological
contamination.

6.3.1 Identification and prevention of risk of product contamination

6.3.1.1 The site shall ensure that all
necessary steps are taken to identify
and prevent the risks of foreign body,
chemical and biological contamination
as identified by risk assessment. This
shall include any contamination
potentially 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. 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.

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6.3.3 Metal control
6.3.3.1 Tools and other sharp metal
implements including knives, cutting
blades, needles, perforation blades
and wires used in production shall be
controlled where there is a risk of
product contamination. Methods such
as, but not limited to, the following
may be used:

 tools permanently attached to

equipment to prevent loss
 items controlled by an issue listing
and registration procedure
 recovery of all parts of broken
needles before the issue of a
replacement needle.

Snap-off-blade knives shall be

prohibited.
6.3.3.2 Staples, paper clips and drawing pins
shall not be used in open product
areas.

Where staples or other items are

present as packaging materials or
closures, appropriate precautions
shall be taken to minimise the risk of
product contamination.

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6.3.4 Glass, brittle plastic, 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.

6.3.4.2 Where there is a potential risk to

product all glass, ceramic, wood and
brittle-plastic items in production
areas (except where the item is part
of the product) shall be included in the
risk assessment and listed in a
register. Documented procedures for
handling 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.

6.3.5 Foreign body detection and removal equipment

Statement of Intent The risk assessment shall identify the
potential use of equipment to detect
or remove foreign body
contamination.

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6.3.5.1 Filters and sieves
6.3.5.1.1 Filters and sieves used for 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 regularly

inspected and tested for damage at a
documented frequency 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 equipment

6.3.5.2.1 Where a metal or other 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.

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6.3.5.2.2 The metal detector or X-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 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 documented
procedure to examine product
rejected 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.

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6.3.5.3 Magnets
6.3.5.3.1 The type, location and 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.
6.3.5.3.2 Optical sorting equipment shall be
checked on the basis of the
manufacturer’s instructions or
recommendations.

Records of all checks shall be

maintained.

6.4 Calibration and control of measuring and monitoring devices

Statement of Intent Measuring equipment used to monitor
product safety, quality and legality
shall be calibrated and of suitable
accuracy for its intended purpose.

6.4.1 The site shall identify equipment used

to make measurements relevant to
product safety, legality and quality.

6.4.2 The equipment used to accept or

reject a product shall be calibrated to

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

6.4.3 The calibration of identified equipment

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

6.4.4 Records of the results of calibration

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

6.4.5 Adjustment of identified equipment by

unauthorised staff shall be prevented
and the equipment shall be marked to
show its 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.

6.5 Final product packing and control

Statement of Intent The company shall ensure that
products are packed in accordance
with customer-specified requirements
and any relevant safety criteria,
quality and legal requirements.

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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.

6.5.2 The company shall have a validated,

documented procedure for the
packing of products taking particular
account of customer requirements.

This shall include methods of

ensuring that the correct product(s)
and components are correctly
packaged and placed in the correct
outer packaging.

6.5.3 The quantity of product should match

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

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6.6 Stock control and product release
Statement of Intent The company shall ensure that stock
and finished product are not released
unless all agreed procedures have
been followed and the release is
suitably controlled
6.6.1 Controls shall be in place to ensure
correct stock rotation and that
materials and products are used in
the correct order and within the
allocated shelf or usage life as
applicable.
6.6.2 The company shall ensure that
product brought in from off-site
subcontractors shall be included in
the product release procedure.

6.6.3 A documented procedure shall be in

place to ensure that only products
conforming to specification are
released for dispatch. Procedures
may include, but are not limited to:

 positive final release by

authorised staff
 online test methods
 automatic rejection process
(which shall be validated and
monitored).

If a risk assessment determines that

no such control is required, the
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 company shall have a full justification
for its absence, which is documented
in the customer agreement and shall
be reviewed at least annually.

7 Personnel

7.1 Training and competency

Fundamental Statement The company shall ensure that
of Intent personnel performing work that
affects product safety, legality and
quality are demonstrably competent to
carry out their activity, through
training, work experience or
qualification
7.1.1 The company shall ensure that all
employees are able to demonstrate
competence with regard to their
activity.

The company shall:

 identify the need for training

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

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

7.2 Protective clothing

Statement of Intent The company's standards shall be
documented and adopted by all
personnel, including contractors and
visitors to the production facility.

7.2.1 The company shall use risk

assessment to determine the need for
protective clothing.

Where a need for protective clothing

has been identified by the risk
assessment, this shall not pose a
contamination risk to the product.
7.2.2 Based on the assessment of risk to
the product integrity, suitable footwear
shall be worn within the factory
environment.

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

Disposable protective clothing, if

used, shall be subject to adequate
control to avoid product
contamination.

7.3 Hygiene practices

Statement of Intent Standards of hygiene shall be applied
with due regard to the risk of product
contamination.

7.3.1 The company shall have a policy to

control the wearing of jewellery so
that it poses no risk of product
contamination.
7.3.2 All cuts and grazes on exposed skin
shall be covered by a contrasting
coloured plaster that is issued and
monitored by the site, to avoid
contamination of product.
7.3.3 Where metal foreign body detection is
in place, detectable plasters shall be
used and shall be regularly tested
through the detector.
7.3.4 Hand-cleaning shall be performed at a
suitable frequency to maintain
hygienic conditions.

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7.3.5 Eating, drinking or smoking shall only
be permitted within designated areas
and where there is no risk of
contamination of products.

7.3.6 The company shall use risk

assessment to determine the need for
all head and facial hair to be covered
and fully contained to prevent product
contamination.

7.3.7 Where there is a risk to product safety

and quality, fingernails shall be kept
short, clean and unvarnished.

False fingernails shall not be

permitted.

7.3.8 The site shall have a documented

procedure for the notification by
personnel, including temporary
personnel, visitors and contractors, of
any relevant infections, diseases or
conditions which they may have been
in contact with or be suffering from.

CP423 Auditor Checklist – PCH Higher BRC Global Standard for Consumer Products, Issue 4
Issue 1: November 2016 Page 65 of 65