Self-Assessment Tool
BRC Global Standard for Consumer Products Issue 3
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 3.
How to use the BRC Global Standards Self-Assessment tool
This tool is a checklist designed to help you assess your operation against the requirements of the Standard
and help to highlight any gaps so that you can prepare 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 in each section.
Remember that it is not necessary to meet the requirements of all of the clauses unless you have a site
making Group 1 products. The clauses are shaded so that you can easily identify if they are relevant to your
Product Group. At the end of the self- assessment tool there is a copy of the decision trees used to
determine which Product group is appropriate for the site (see also The Standard pp11-15 for further detail
on this topic). It is recommended that sites study this carefully and are clear about which Product Group
they are using before they use the self-assessment tool
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 3 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 Consumer Products issue 3 please do not hesitate to contact the BRC Global
Standards team
Email – enquiries@brcglobalstandards.com
Telephone – +44 20 7854 8939
CP030
Released 1/8/2012
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Page 1
Section 1
Senior Management Commitment and Continual Improvement
Fundamental Clause
The company's senior management shall demonstrate that they are fully committed to the
implementation of the requirements of the Global Standard for Consumer Products (referred to as The
Standard). This shall include provision of adequate resources, effective communication, systems of
review, and actions taken to identify and effect opportunities for improvement.
Requirement
Comments
Clause
Prod Group
1.1
All
The company's senior management shall ensure that product safety and
quality objectives are established, documented, monitored and reviewed at
least annually.
1.2
All
1.3
All
The senior management review process shall be documented and shall
include an evaluation of: Internal, customer, and external (third party)
audits; previous management review documents, corrective action plans,
and timeframes; customer performance indicators, complaints, and
feedback; incidents, non-conforming materials and corrective actions; an
assessment of process performance; a review of the product risk
assessment system; a review of the results of monitoring and testing;
developments in legal requirements or scientific information associated with
the products in scope; resource requirements.
The decisions and actions agreed shall be 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
All
CP030
Released 1/8/2012
The company's senior management shall provide the human and financial
resources required to implement and improve the processes of the quality
management system, the product risk assessment plan, and to address
legal, product safety, and product quality matters.
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1.5
All
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 include suggestions for improvement.
1.6
All
The company shall have a current, original copy of the Standard available
on site.
1.7
1&2
Where required by legislation, the site shall be registered with or approved
by the appropriate government agency and evidence of this shall be
available.
Section 2
Risk Management
Fundamental Clause
The company shall have a management process in place to assure
product safety, legality and quality, based on risk assessment
principles. Sites must be aware of and refer to up-to-date legislation,
product standards, codes of practice, and developments in science or
technology that may impact risk concerning their products and
packaging where these exist in the regions of intended sale.
Product Scope and group determination
2.1
2.1.1
All
The company shall 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
All
The company shall 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 The Standard Section II, 3.4).
CP030
Released 1/8/2012
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2.2
Legislative and safety requirements
The company shall have and use a system, which may comprise internal
and/or external resources, to demonstrate knowledge of all legislation,
product standards, product safety issues, scientific and technical
developments, and industry/customer codes of practice in the regions of
intended sale relevant to the products in scope.
2.2.1
All
2.2.2
All
If the company relies on information concerning product safety, quality, and
legality provided by their customer or related party, it shall validate the
information received and document the validation process.
2.2.3
All
A documented process shall exist for incorporating changes in legislation,
standards, etc. into the company’s procedures in a timely fashion, which
shall be before any official implementation date of the relevant change.
2.2.4
All
Copies of applicable legislation, standards, codes of practice, and similar
documents shall be available to relevant staff.
2.3
2.3.1
CP030
Released 1/8/2012
Risk assessment - prior to production
All
A design specification covering each product shall be documented, dated,
and authorized. This shall include all relevant information. As a guide, this
may include the following, although this is not an exhaustive list:
composition, size, color; bills of materials; assembly diagrams; primary
packaging; intended shelf life; warnings or instructions for use; use, misuse,
usage patterns; productions volumes. Any changes to the product design
shall be documented and dated.
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2.3.2
All
The company shall determined and list the legal statutes and mandatory
standards applicable to each product and to the materials from which it is
made, relevant in the regions of intended sale.
2.3.3
All
2.3.4
All
The company shall ensure that a product hazard and risk assessment is
available and clearly identifies: the hazards, the risk level for each hazard
and whether the risk is acceptable; the person responsible for the
assessment; the date performed and the evidence (for example, sample
drawings, computer graphics) from which the assessment was derived.
This risk assessment may be provided by internal or external resources. If
the product requires modification, a new risk assessment shall be
completed on the modified design.
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
2.4.1
All
The company shall ensure that risk assessments have been carried out by
competent staff (internal or external) and shall document the way in which
this is assessed.
2.4.2
All
The risk assessment shall be regularly, and at least annually, reviewed
(while the products are still in production) to ensure that the assessment
remains up to date, takes account of complaints or incidents with the
product or similar products, and reflects any changes in legislation.
2.4.3
1&2
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.
CP030
Released 1/8/2012
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2.4.4
1&2
Where there is legal requirement to do so or when it is necessary to confirm
its safety or legality, a representative product should be submitted for
testing to a suitably qualified and accredited laboratory (internal or external).
The results of the test should form part of the risk assessment.
2.4.5
1&2
2.4.6
1&2
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.
Where legally required, the identity, qualifications, and/or license of the
person producing the safety review or risk assessment shall be documented
and verified.
Management System
Section 3
3.1
Policy statement
3.1.1
All
3.1.2
All
3.2
3.2.1
Statement of Intent
CP030
Released 1/8/2012
The policy shall state the company's intention to 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.
The company's senior management shall ensure the policy statement is
communicated to and understood by all staff involved with activities relating
to product safety, legality, and quality.
General Documentation requirement
Documentation Control
The company's senior management shall ensure that all documents
records, and data critical to the management of product safety,
legality and quality are in place and effectively controlled.
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3.2.1.1
All
All documents in use shall be the current versions, authorized and dated,
and a procedure shall be in place to ensure that obsolete documentation is
removed from use.
3.2.1.2
All
Documents shall be clearly legible, unambiguous, in appropriate languages,
and sufficiently detailed to enable their correct application by staff. They
shall be readily accessible to relevant staff at all times.
3.2.1.3
All
Changes or amendments to documents shall be authorized and dated and
the reason for the change recorded.
Record Completion and Maintenance
3.2.2.1
All
3.2.2.2
All
The records shall be legible, genuine, appropriately authorized, and
retained in good condition for a period which takes account of the product
lifetime and is consistent with the legal requirements in the country of
manufacture or sale. Customer-specific requirements relevant to record
retention shall be respected.
The company's senior management shall ensure that procedures are
operated for the collation, review, maintenance, storage, and retrieval of all
records relating to product safety, legality, and quality.
3.2.2.3
All
3.2.2
3.2.3
Statement of Intent
3.2.3.1
CP030
Released 1/8/2012
All
Any alterations to records shall be visible and authorized, and the
justification for alterations shall be recorded.
Specification & Technical information dossiers
The company shall ensure that specifications exist for raw materials,
components, and bought-in components including packaging,
intermediate/semi-processed, and finished products and any product
or service that could affect the integrity of the finished product. A
technical folder shall be established for each product.
Specifications shall be adequate and accurate, and shall ensure compliance
with relevant safety, legislative, and customer requirements. They shall be
accessible to relevant staff.
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3.2.3.2
All
3.2.3.3
1&2
3.2.3.4
1&2
3.3
Companies shall maintain a technical folder containing all relevant data (or
details of where such data is located) to ensure that products meet the
requirements of the Standard. For example: detailed product specification
(see clause 2.3.1); 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, product standards with
which the products are manufactured to comply; production control
procedures and charts; approvals by any government body (if applicable);
declarations of conformity to legal requirements (if applicable).
The company shall seek formal agreement of specifications with relevant
parties. Where specifications are not formally agreed, then the company
shall be able to demonstrate that they have taken steps to seek formal
agreement.
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.
Organizational structure, responsibility, and management authority
Statement of Intent
The company shall have a clearly defined and documented
organizational structure that ensures the awareness of job function,
responsibilities, and reporting relationships of key staff.
3.3.1
All
3.3.2
All
3.3.3
All
A named individual with relevant experience and qualifications shall be
responsible for the management of the legal, quality, and safety
requirements laid out in this Standard. This responsibility should not
present a conflict of interest with any other responsibilities.
3.3.4
All
There shall be appropriate documented arrangements in place to cover for
the absence of key staff.
CP030
Released 1/8/2012
The company shall have an organization chart demonstrating the structure
of the company.
Documented, clearly defined responsibilities shall exist and be
communicated to key staff with responsibility for product safety, legality,
product quality, and management systems.
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3.3.5
All
3.4
The company's 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.
Internal Audit
Statement of Intent
The company shall audit the management system to ensure that it is
complied with and appropriate.
Internal audits shall cover all aspects associated with the Standard. They
shall be scheduled and their scope and frequency shall be established
commensurate with the risks associated with the activity. Audits of aspects
that directly affect safety, legality, or quality shall be conducted at least
annually. Exceptions resulting in audit intervals of more than one year shall
be justified by documented risk assessment.
3.4.1
All
3.4.2
All
Internal audits shall be carried out by competent auditors, who shall be
independent of the area of operation being assessed. Auditors shall not
audit their own work.
3.4.3
All
3.4.4
All
Corrective actions shall be formally agreed by the person responsible for
the action and implemented within appropriate and agreed timescales.
A record of all programmed internal audits and associated corrective
actions shall be maintained with both conformity and nonconformity with the
requirements documented. All corrective actions shall be verified to ensure
satisfactory completion.
3.5
Statement of Intent
CP030
Released 1/8/2012
Purchasing, Supplier Approval and performance Review
The company shall control all purchasing processes which are critical
to product safety, legality, and quality to ensure that procured
products and services conform to defined requirements. In this
context suppliers shall include subcontractors and home workers.
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3.5.1
All
3.5.2
All
3.5.3
All
3.6
All
3.7
Fundamental Clause
CP030
Released 1/8/2012
The procedure shall identify whether the use of unapproved suppliers is
acceptable under any emergency or unusual situations. If this is the case,
the procedure shall define how exceptions are recorded and how they are
handled to maintain safety, legality, and quality of the products.
Customer supplied property
Statement of Intent
3.6.1
The site shall have a documented supplier-approval procedure, including a
list of approved suppliers for products, materials, and services impacting
product safety, legality, or quality. Procedures shall be established which
include clear criteria for ongoing assessment and the standards of
performance required. Ongoing assessment may take the form of
monitoring performance through one or more of the following, although
there may be other acceptable methods: in-house checks; 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.
The company shall review the performance of new suppliers against
defined criteria within a specified "trial" period and thereafter at a specified
frequency to decide the level of ongoing supplier performance monitoring.
The company shall exercise care customer property (including
intellectual property) while it is under the company's control or is
being used by the company.
The company shall identify, verify, protect and safeguard customer property
including software, intellectual property, tooling, fixtures, test equipment 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.
Corrective and Preventive Action
The company's senior management shall ensure that procedures exist
to record, investigate, analyze, and correct the cause of
nonconforming products or failure to meet standards, specifications,
and procedures which are critical to product safety, legality, and
quality.
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3.7.1
All
The company shall operate an effective system for the capture, recording,
and timely investigation of nonconformities or matters reported as possible
nonconformities critical to product safety, legality, or quality.
3.7.2
All
3.7.3
All
3.7.4
All
Customer complaints concerning actual or potential product nonconformity
shall be included in the system.
An appropriate staff member shall be identified and allocated the
responsibility and accountability for each corrective action. This shall be
documented.
The company shall ensure that effective corrective actions are taken to
prevent recurrence of the problem and shall monitor and record their
completion within an appropriate timescale.
3.7.5
All
3.8
Fundamental Clause
3.8.1
All
3.8.2
All
3.8.3
All
3.8.4
All
CP030
Released 1/8/2012
The company shall review its processes at least annually, incorporate
industry best practice, and adopt preventative measures as they become
available.
Traceability
The company shall have a system to identify and trace product
lots/batches including raw materials, components, and packaging
materials and follow this from the source of the incoming material
through all stages of processing to supply of the product to the
primary customer, and vice versa, 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)
Companies shall be able to identify the immediate source of all raw
materials, components, and packaging materials.
The products that constitute a lot/batch shall be defined and documented.
This shall include products made by continuous production methods.
Identification of lots/batches of raw materials including packaging,
processing aids, intermediate/semi-processed products, part-used
materials, finished products and materials pending investigation, shall be
adequate to ensure traceability.
Final products shall be suitably marked, at least on their outer packaging, to
allow adequate identification and traceability.
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3.8.5
All
Traceability must, in all cases, be available for each lot/batch from source of
raw material to supply to the primary customer.
3.8.6
All
The traceability system shall be maintained when rework or any reworking
operation is performed.
3.8.7
All
The company shall test the traceability system 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.
3.8.8
All
When the same component or raw material is 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
All
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
All
Subcontracted manufacture of products or components (including
homeworking) must be traceable to a level appropriate to the risk.
3.8.11
1&2
The need for further traceability through the chain should be established,
based on the risk assessment and any legal or specific customer
requirements.
3.8.12
1&2
For continuous production processes, methods of defining traceability levels
must be documented and based on the risk assessment.
CP030
Released 1/8/2012
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3.9
Management of Product withdrawal and product recall
Statement of Intent
The company shall have a plan and system in place to effectively
manage product withdrawal and product recall procedures.
3.9.1
All
The company shall have a product recall procedure in place to effectively
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.
3.9.2
All
The company shall have written agreements in place with distributors and
other parties in the supply chain where these are necessary to ensure
effective withdrawal/recall.
3.9.3
All
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 countries of sale.
3.9.4
1&2
3.9.5
1&2
3.10
Statement of Intent
CP030
Released 1/8/2012
The product recall and withdrawal procedures shall be documented and
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?
Management of incidents and business continuity
The company shall have procedures in place to identify methods of
ensuring business continuity in the case of incidents and/or informing
their customers when incidents occur.
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3.10.1
All
3.10.2
1&2
3.10.3
1&2
The 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.
Contract review and customer focus
Statement of Intent
The company's senior 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.
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
The company shall provide written 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.
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, or natural disaster;
malicious contamination or sabotage.
3.11.1
All
3.11.2
All
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
1&2
3.11.4
1&2
The company shall clearly identify those individuals responsible for
communication with customers and shall have an effective system for
communication.
Performance indicators relating to customer satisfaction shall be
established and communicated to relevant staff, and performance reviewed
against these targets.
Complaint handling
3.12
Statement of Intent
CP030
Released 1/8/2012
The company shall operate an effective system for the capture,
recording, and investigation of product complaints.
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3.12.1
All
A system shall be in place to capture, record, and investigate all complaints
relating to product safety, legality, and unusual or critical quality defects,
and the results of the investigation shall be recorded.
3.12.2
All
Where complaints are investigated externally on behalf of the company, the
responsibilities of the parties shall be defined and the process shall be
documented. Companies shall seek to obtain the results of any
investigations carried out by such parties.
3.12.3
All
3.12.4
1&2
Actions appropriate to the seriousness and frequency of the problems
identified shall be carried out promptly and effectively by trained staff.
Complaint data shall be analyzed and used to implement ongoing
improvements to product safety, legality, and quality, and to avoid
recurrence. This analysis shall be made available to relevant staff.
Site Standards
Section 4
4.1
Location, Perimeter and Grounds
Statement of Intent
4.1.1
All
4.1.2
All
4.1.3
4.1.4
All
All
4.1.5
All
4.2
CP030
Released 1/8/2012
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.
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.
Consideration shall be given to local activities and the site environment,
which may have an adverse impact on product integrity. Measures adopted
at the site to protect the product from any potential contaminants shall be
regularly reviewed to ensure that they continue to be effective.
The external areas and surroundings shall be maintained in good order.
External traffic routes that are under site control shall be maintained in good
repair to avoid contamination of the product.
There shall be no evidence of facility damage due to inadequate drainage.
Internal Site: Factory layout, Product Flow and Segregation
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Fundamental Clause
4.2.1
All
4.2.2
All
4.2.3
4.2.4
All
All
4.2.5
All
4.2.6
1&2
4.3
Statement of Intent
4.3.1
CP030
Released 1/8/2012
All
Premises and plant shall be suitably designed, constructed, and
maintained so as to control the risk of product contamination and to
comply with all relevant legislation.
The building shall be maintained to minimize potential for product
contamination.
The machinery and equipment shall be positioned to allow an efficient
product flow from incoming to outgoing and shall be arranged to minimize
the risk of product contamination and damage.
A process flow diagram shall be available.
Premises shall allow sufficient working space and storage capacity to
enable all operations to be carried out under safe and, if necessary,
hygienic conditions.
There shall be effective segregation to minimize the risk of product crosscontamination taking into account the flow of product, nature of materials,
equipment, personnel, waste, airflow, air quality, and utilities. When critical
to product safety, legality, quality, or customer requirements, 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.
The location of facilities and services, including toilets, cleaning facilities,
and catering facilities, shall not jeopardize the integrity of the product.
Building interiors
The internal site, buildings, and facilities shall be suitable for the
intended purpose. All utilities to and within the production and
storage areas shall be designed, constructed, maintained, and
monitored to effectively control the risk of product contamination.
The quality and finish of site buildings and facilities, including drainage
when required, shall be suitable for the intended purpose with due regard to
the risk of product safety, legality, and quality, and shall be maintained to an
appropriate standard. This shall include: A clean, tidy and clutter-free
factory; adequate lighting; suitable and sufficient removal of any byproducts and contaminants; impervious floors, in good repair, and able to
withstand cleaning procedures.
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4.3.2
1&2
4.3.3
1&2
4.3.4
1
Walls, floors, ceilings, pipework, and overhead structures shall be designed,
constructed, finished, and maintained to reduce condensation and mold
growth, and shall have access to facilitate cleaning.
4.3.5
1
All water used as an ingredient of the products or preparation of the
products where it may come into direct contact with the product shall be
potable (as defined in the region of intended product sale), or suitably
treated to prevent contamination, and shall be regularly monitored.
4.3.6
1
Water in the form of water, ice, or steam used for cleaning or in connection
with any operation in the manufacture of products shall comply with legal
requirements in the country of use and present no risk to the safety, legality,
or quality of the products.
4.4
Staff Facilities
Statement of Intent
4.4.1
All
4.4.2
1&2
4.4.3
1&2
CP030
Released 1/8/2012
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
production contamination.
The site shall be assessed for any particular requirements relevant to the
products being produced, such as temperature, humidity, electrostatic
discharge. Any identified requirements shall be adopted, documented,
monitored, and regularly reviewed.
Staff facilities shall be sufficient to accommodate the required number
of personnel, and shall be designed and operated to minimize the risk
of product contamination. Such facilities shall be maintained in good
and clean condition.
Staff facilities such as washrooms, canteens, and break areas shall be
designed and operated so as to minimize the risk of product contamination.
Where smoking is allowed under national law, designated controlled
smoking areas shall be isolated from production areas to an extent that
ensures smoke cannot reach the product. Adequate arrangements for
dealing with smokers' waste shall be provided both internally and externally.
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.
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4.4.4
1
Where specific workwear is required, designated changing facilities shall be
provided for all personnel: staff, visitor, or contractor. These shall be sited
to allow direct access to the production, packing, or storage areas without
recourse to any external area. Where this is not possible, a risk
assessment shall be carried out and procedures implemented accordingly.
4.4.5
1
4.4.6
1
Outdoor clothing and other personal items shall be stored separately from
workwear within the changing facilities.
Suitable and sufficient hand-cleaning facilities shall be provided at access
to, and at other appropriate points within, production areas. Information on
how to clean hands shall also be provided near hand-cleaning points.
4.4.7
1
4.5
Cleaning procedures
Fundamental Clause
4.5.1
All
4.5.2
All
4.5.3
All
4.5.4
All
CP030
Released 1/8/2012
All food brought into manufacturing premises by staff shall be stored in a
clean and hygienic state. No food shall be taken into storage, processing,
or production areas.
Housekeeping and cleaning systems shall be in place which ensure
that adequate standards of cleanliness and tidiness are maintained at
all times and the risk of contamination is minimized.
Cleaning practices shall be completed so as to minimize risk of
contamination.
Cleaning and, where necessary, disinfection procedures shall be
revalidated following building or maintenance work, changes to equipment,
or introduction of new product types.
Cleaning, pest control, and process-aid chemicals shall be suitably
identified and controlled to prevent the risk of product contamination. They
must be clearly labelled and no chemicals shall 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.
If cleaning services are outsourced, the service providers shall have signed
a contract which identifies the scope and frequency of the work, and a
logbook shall be maintained as a record of work done. A defined company
representative shall be responsible for ensuring that the work is carried out
satisfactorily.
Self-Assessment Tool
Page18
4.5.5
1&2
4.5.6
1&2
4.5.7
1
4.6
Waste/Waste disposal
Statement of Intent
4.6.1
All
4.6.2
All
4.6.3
All
4.6.4
All
4.6.5
All
4.7
CP030
Released 1/8/2012
Documented cleaning procedures shall be in place and maintained for the
building, utilities, plant, and all equipment. Cleaning procedures shall
included 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.
The effectiveness of cleaning and sanitation shall be verified and
documented. Corrective actions shall be documented. Cleaning
procedures shall be revalidated following building work, maintenance,
changes to equipment or new product introduction.
There shall be adequate systems for the collection, collation, and
disposal of waste material.
Systems shall be in place to prevent the accumulation of waste in
production areas, and to prevent the use of unfit or defective materials.
Waste shall be categorized according to legislative requirements based on
the intended means of disposal, segregated if necessary, and collected in
suitably designated waste containers. Where legally necessary, it shall be
removed by identified, licensed contractors, and records of disposal shall be
maintained by the company.
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.
Waste materials shall be suitably quarantined and routed to ensure that
they are not reintroduced into non waste production flows.
External waste collection containers and compactors shall be managed in
such a manner as to minimize risk to the product if necessary.
Pest control
Self-Assessment Tool
Page19
Statement of Intent
The company shall be responsible for minimizing the risk of pest
infestation on the site.
The company shall be responsible for identifying and controlling the risk of
pest infestation and shall operate pest control procedures. If no pest control
is conducted the company shall have a full justification for its absence,
including its customers’ acceptance. The justification shall be reviewed at
least annually. (NOTE: If there is a justified absence of pest control then the
other clauses in this section are not applicable)
4.7.1
All
4.7.2
All
4.7.3
All
4.7.4
All
In the event of infestation, immediate action shall be taken to eliminate the
hazard and this shall be documented. Action shall be taken to identify,
evaluate, and authorize the release of any product potentially affected.
4.7.5
All
4.7.6
All
Full material safety data sheets (MSDS) for all chemical pest control agents
used must be available to relevant staff at all times and kept in a
designated place.
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
All
When necessary, materials or products shall be fumigated, and 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.
4.7.8
4.7.9
1
1
Drains should be fitted with screens and traps to prevent pest entry.
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.
4.7.10
1
4.8
Bait stations shall be tamper resistant.
Product transport, storage and distribution
CP030
Released 1/8/2012
Self-Assessment Tool
Page20
The company shall either have a clearly defined contract with external
contractors which reflects the activities of the site, or have trained staff.
Written procedures and inspection documentation for pest control shall be
maintained including a logbook of work completed.
Statement of Intent
All facilities used for the storage and transportation of product,
movement around the site, and dispatch of finished product shall be
suitable for the purpose and maintained in good repair.
4.8.1
All
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.
4.8.2
All
4.8.3
All
4.8.4
All
4.8.5
All
Where storage is necessary, at any stage, all items shall be securely
protected from contamination, deterioration, and damage.
All transportation shall be in good repair and in a clean/hygienic condition
as necessary depending on the product group.
Where the product transported is susceptible to weather damage, vehicles
shall be loaded and unloaded so as to protect the product.
Where the product needs specific environmental requirements to prevent
degradation, the appropriate conditions shall be documented, maintained,
and monitored.
4.8.6
All
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
All
Where the company employs third-party contractors, there shall be an
agreement between the company and the contractor. All the requirements
specified in this section shall be clearly defined in the contract.
4.9
Site Security
Statement of Intent
4.9.1
All
4.9.2
All
CP030
Released 1/8/2012
Security shall be maintained to prevent access of unauthorized
persons to production and storage areas.
Access to the site by employees, contractors, and visitors shall be
controlled and a visitor-reporting system shall be in place.
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.
Self-Assessment Tool
Page21
4.9.3
1&2
Staff shall be trained in site security procedures and encouraged to
question or report unidentified or unknown visitors.
Product Control
Section 5
5.1
Preproduction reference samples
Statement of Intent
5.1.1
All
5.1.2
All
5.1.3
All
5.1.4
All
5.1.5
All
5.1.6
All
5.2
CP030
Released 1/8/2012
Documented procedures shall be in place for the selection, handling,
storage, approval, and use of reference samples as well as for
component samples and samples of subcontracted work where
relevant.
The company shall document a process to identify, select, and categorize
reference samples. If customers have a defined system of sealed samples
referring to different stages of sample approval, the customer procedure
shall be documented and followed.
As a minimum, a sample of the product which has 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.
Reference samples shall be held and stored in suitable environmental
conditions to maintain their original status.
A secure and tamper-evident system shall be in place for the storage of
samples. Temporary removal of samples must be documented and
authorized by a designated responsible person.
Records shall be maintained of reference samples supplied to other parties,
including the date supplied and details of the sample.
Exceptions to the need to store samples shall be made when such storage
is impractical, provided that an alternate means of achieving the same
objective is documented, justified, and maintained.
Chemical formulation control
Self-Assessment Tool
Page22
Statement of Intent
The chemical 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 need to be obtained, these
shall be in place.
5.2.1
All
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
All
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
All
Written (and/or diagrammatic), authorized procedures for the handling of
chemicals shall be available at the point of use.
5.2.4
1&2
5.3
Statement of Intent
5.3.1
All
5.3.2
All
5.3.3
All
5.3.4
All
CP030
Released 1/8/2012
Companies shall identify and document the use of any nanomaterials.
Product packaging materials
Product packaging materials shall be suitable for the intended use and
stored under conditions to minimize the risk of contamination and
deterioration.
Product packaging shall conform to an agreed and documented
specification and shall meet the legal requirements of the regions of sale
with regard to composition, recyclability, and minimizing excessive use of
packaging material.
Packaging shall be assessed for fitness for purpose and found suitable with
regard to: protecting the product from damage; maintaining the integrity of
the product; protecting the consumer from injury; preventing contamination.
Packaging materials shall be effectively protected before being returned to
storage.
Where staples or other metal closures are used for packaging, appropriate
precautions shall be taken to prevent the risk of contamination, damage, or
injury to the product or consumer.
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Page23
5.3.5
1
5.4
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.
Control on nonconforming materials
Statement of Intent
5.4.1
All
5.4.2
All
5.5
Statement of Intent
The company shall ensure that nonconforming materials,
components, and products are clearly identified, labeled, quarantined,
investigated, and documented.
Clear procedures for the control of nonconforming materials and products,
including rejection, segregation, acceptance by concession, or re-grading
for an alternate use, shall be in place and understood by all authorized
personnel.
The company shall have a procedure in place for the secure disposal of
nonconforming products and their packaging according to the nature of the
problem and/or the specific requirements of the customer and any legal
requirements.
Handling requirements for specific materials
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.
5.5.1
All
5.5.2
1&2
The company shall determine whether allergenic or sensitizing materials
are used (or likely to be contaminants of materials used) and shall identify
any such materials used on site.
5.5.3
1&2
Documented policies shall exist for the handling of allergenic or sensitizing
materials including: physical or time segregation from other products; use of
identified, dedicated equipment if necessary; adequate labelling of final
products.
Stock Control and product release
5.6
CP030
Released 1/8/2012
Materials and products requiring segregation procedures (e.g., materials
intended for different geographical regions) shall have control procedures in
place to ensure that product integrity is maintained.
Self-Assessment Tool
Page24
Statement of Intent
The company shall ensure that the finished product is not released
unless all agreed procedures have been followed and the release is
suitably controlled.
5.6.1
All
A procedure shall be in place to ensure that only products conforming to
specification are dispatched. If no such control is conducted, the company
shall have a full justification for its absence, which shall be reviewed at least
annually. Procedures may include, but are not limited to: positive final
release by authorized staff; online test methods; automatic rejection
process (which must be validated and monitored).
5.6.2
All
5.6.3
1&2
Companies shall ensure that work carried out by homeworkers or
subcontracted off-site shall be included in procedures described in clause
5.6.1.
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 if applicable.
5.6.4
1&2
Section 6
6.1
Fundamental Clause
CP030
Released 1/8/2012
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.
Product Conformity Assessment
Product Analysis/Testing
A suitable, sufficient, and validated testing regime shall be in place to
ensure the safe, legal production of products to the required
conformance of safety, legality, and quality. Results from the program
shall be recorded, reviewed, and stored securely.
Self-Assessment Tool
Page25
6.1.1
All
6.1.2
All
6.1.3
All
6.1.4
All
Testing shall be undertaken by the company, the subcontractor, a
competent third party, a laboratory designated by government authorities, or
the customer’s designated testing laboratories, as agreed.
6.1.5
All
For tests which are critical to product safety or legality, the laboratory used
shall have gained recognized laboratory accreditation against ISO 17025 for
the tests to be carried out. If accredited facilities are not used, the laboratory
conducting the tests must be able to provide verifiable evidence that it is
complying with the requirements of ISO 17025.
6.1.6
All
6.1.7
All
Procedures shall be in place to ensure the security of samples and test
results.
Where testing is submitted to third parties, the required testing shall be
clearly defined including, for example, 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 organizations 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 program is formally agreed and documented.
CP030
Released 1/8/2012
Companies shall adopt a product-testing program based on information
such as: the outcome of the risk assessment procedure including any
defined control points; any legal requirements for testing in the regions(s) of
intended sale; customer requirements regarding supply of test reports or
other information; their own requirements for demonstrating the production
of safe products; information needed to confirm composition of materials;
historical data on problems or complaints. In cases where it is established
that no testing is required, this shall be 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.)
The company shall identify the different stages (for example, preproduction,
production) at which testing is to be performed.
A documented sampling plan, testing program, and test specification,
including the pass or fail criteria, shall be produced for each product or
product type as required.
Testing procedures carried out as a result of a complaint, product failure, or
other ad hoc reason shall be clearly documented.
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Page26
6.1.8
All
For tests other than those specified in clause 6.1.5, procedures shall be in
place to ensure validity of all test results: use of documented, validated test
methods; use of correctly calibrated and maintained test equipment;
incorporation of quality control checks in the tests; use of systems such as
proficiency testing to verify the accuracy of results where available; use of
suitably qualified and/or trained staff, competent to carry out the analyses
required.
6.1.9
All
Test results which are outside the defined specification shall be reviewed in
a timely manner by the nominated person responsible for safety, legality,
and quality, and the need for corrective action assessed, documented, and
carried out as necessary.
6.1.10
1&2
6.2
Inspections
Statement of Intent
6.2.1
CP030
Released 1/8/2012
Where testing laboratories are present 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 to and security of the facility; movement of
laboratory personnel; protective clothing arrangements; processes for
obtaining product samples; disposal of laboratory waste.
All
When product inspections are deemed necessary to assure delivery of
a safe, legal product of the required quality, they should be carried out
following defined procedures that are documented, reviewed, and
authorized.
Companies shall assess the need for product 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.)
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Page27
6.2.2
All
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
All
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
All
6.2.5
All
Inspections shall be conducted at a level and/or frequency to assure
product quality is at an AQL level that is acceptable to the customer.
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
All
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
All
6.2.8
All
Personnel undertaking inspections shall be suitably qualified and/or trained,
and shall be competent to carry out the work required.
When external contractors are used for inspections, they shall be subjected
to the usual supplier/subcontractor approval processes.
6.2.9
All
Product claims
6.3
Statement of Intent
6.3.1
CP030
Released 1/8/2012
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.
All
The company shall have procedures in place to validate and declared
product information or claims made for the products and monitor
compliance with such claims if necessary.
Where necessary the company shall operate a quantity control system
which conforms to legal requirements and/or specified customer
requirement in the region where the product is available for sale.
Self-Assessment Tool
Page28
6.3.2
All
6.3.3
All
6.3.4
1&2
Where quantity checking is required, the frequency and methodology used
shall meet the minimum requirements of any legislation governing quantity
verification.
Any claims about a product, e.g., a weight limit for a trampoline or sun
protection factor on a cream, shall be fully validated to ensure that products
meet the stated claim.
The company shall undertake product-in-use evaluations, testing and/or
reliability trials, and/or shelf-life evaluations to validate and verify that
production of a safe and legal product is maintained, taking account of the
category of consumers at risk.
Process Control
Section 7
7.1
Control of operations
Fundamental Clause
7.1.1
All
7.1.2
All
7.1.3
All
7.1.4
All
7.1.5
All
7.1.6
1&2
CP030
Released 1/8/2012
The company shall be 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.
The company shall conduct a risk assessment of hazards potentially
introduced during the production, packaging, or storage processes.
The company shall establish precise process flow(s) established and a
control plan which identifies the critical control points (if any), control limits,
monitoring points and the records required. The company shall define how
changes to the control plan are approved and implemented.
Preproduction meetings shall be conducted prior to new or substantially
changed products being produced, to evaluate and approve the processes.
Process monitoring shall be established and adequately controlled to
ensure products are produced within the required process specification.
Corrective action shall be taken in the event of deviation of the process from
specification. This shall be recorded.
The company shall have a fully implemented and maintained process risk
assessment system, based on established principles.
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Page29
7.1.7
1&2
7.2
In circumstances where process parameters are controlled by in-line
monitoring devices, these shall be linked to a suitable failure alert system
and routinely tested.
Control of incoming components and raw materials
Fundamental Clause
7.2.1
All
7.2.2
All
7.2.3
All
7.3
The company shall have procedures to specify, validate, and approve
incoming materials, which shall include any testing, inspection, or
review of certificates of analysis.
Raw materials or components critical to product safety, legality, or quality
shall have documented approval procedures to assure conformance to
agreed specifications and requirements and documented positive batch
release.
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.
The company shall have a documented procedure to ensure that materials
or components used by homeworkers (when used) are approved. (See
also homeworker requirements in clause 5.6.2)
Equipment & equipment maintenance
Statement of Intent
Equipment shall be suitably designed for the intended purpose and
shall be maintained and used so as to minimize the risk to product
safety, legality, and quality.
7.3.1
All
All equipment shall be properly specified before commission, and operating
parameters for production equipment and tooling shall be determined,
validated, and implemented as part of the control plan. Validation records
pertinent to safety or legality shall be kept for the lifetime of the equipment.
7.3.2
All
In the case of equipment failure or deviation of the process from
specification, procedures shall be in place to establish the safety status of
the product prior to release.
CP030
Released 1/8/2012
Self-Assessment Tool
Page30
7.3.3
All
A documented system of planned maintenance shall be in place, covering
all items of equipment and plant which are critical to product safety, legality,
and quality. This shall include, but not be limited to, records of: periodic
maintenance schedules and completion; preventative maintenance;
required safety checks; spare-parts listings and replacements; contingency
plans for failure of essential equipment.
7.3.4
All
7.3.5
All
Materials (for example, 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, intermediate products, and
finished products. If necessary, they shall be suitably identified for the
intended use and controlled.
Engineering workshops shall be controlled to prevent contamination risks to
the product and be organized, clean, and tidy to allow safe, efficient, and
good-quality work.
7.3.6
All
7.3.7
1&2
7.3.8
1
Certificates of conformity or other evidence to confirm suitability for use
shall be available for equipment in direct contact with products, raw
materials, and work in process.
7.3.9
1
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
Statement of Intent
7.4.1
CP030
Released 1/8/2012
When possible, equipment shall be positioned so as to give access
beneath, inside, and around it for ease of cleaning and servicing.
In addition to any planned maintenance program, 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.
All
Where deemed necessary by the documented risk assessment, the
company shall have systems for foreign-body detection in place to
ensure its effective operation.
The company shall ensure that all necessary steps are taken to identify and
prevent the risks of foreign-body contamination as identified by risk
assessment. This shall include any contamination potentially introduced by
the packaging.
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7.4.2
All
Tools and other sharp objects used in production shall be controlled.
Methods such as, but not limited to, the following may be used: snap-offblade knives prohibited; tools permanently attached to benches; items
controlled by a listing and registration procedure; needle policy where all
parts of broken needles have to be returned prior to new issue.
7.4.3
All
Where a metal or foreign-body detector is required or specified by the
customer, the company shall establish documented procedures specifying
its use, location, critical limits for detection, and recording of results.
7.4.4
1&2
Except when used as part of the product, the presence and location of all
glass, ceramic, and brittle-plastic material in raw material handling,
preparation, processing, and packing and storage areas shall be listed in a
register. Checks of the condition of these materials should be carried out at
a specified frequency and the results recorded.
7.4.5
1&2
Where they constitute a risk to the product, a management system that
shall include written procedures shall be in place for all glass, brittle
plastics, and ceramics to ensure the necessary precautions are taken.
Breakages shall be recorded and records retained.
7.4.6
1
7.5
Statement of Intent
7.5.1
All
7.5.2
All
CP030
Released 1/8/2012
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.
Calibration and control of measuring and monitoring devices
Measuring equipment used to monitor product safety, quality, and
legality shall be identified. The identified measuring equipment shall
be calibrated to a recognized national or international standard.
Where a traceable calibration is not possible, the company shall verify
the basis by which calibration is declared.
The company shall identify equipment used to make measurements
relevant to product safety, legality, and quality.
The equipment used in accept-or-reject activity shall be calibrated to a
specified accuracy and precision at a defined frequency (or before use).
Self-Assessment Tool
Page32
7.5.3
All
The calibration of identified equipment shall be traceable to a recognized
national standard. Where such a standard does not exist, the basis by
which calibration is declared shall be verified.
7.5.4
All
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.
7.5.5
All
7.5.6
All
7.5.7
All
Identified equipment shall be prevented from being adjusted by
unauthorized staff and shall be marked to show the calibration status and
period of validity.
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).
Procedures shall be in place for actions to be taken if equipment is found
not to be operating within specified tolerances and/or limits.
Retained production samples
7.6
Statement of Intent
7.6.1
All
7.6.2
All
7.6.3
All
7.7
Statement of Intent
CP030
Released 1/8/2012
The company shall ensure the adequate and secure retention of
production samples to assist in the investigation of complaints and to
verify that production is in conformity with the agreed specification.
The company shall retain a fully representative 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 authorize retained production samples and/or
component samples (see also requirements in 5.1 'Preproduction reference
samples').
Procedures shall be in place to determine the retention time of retained
samples. This should normally be the foreseeable lifetime of the product
unless otherwise justified.
Retained samples shall be securely held and stored in suitable conditions to
maintain their original status.
Final product packing and control
The company shall establish a procedure for the packing of products
to ensure that products are supplied which meet relevant safety
criteria, taking account of legal requirements and customers' specific
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requirements.
7.7.1
All
The company shall define and validate the packing procedure for products
taking particular account of customer requirements. That shall include
methods of ensuring that the correct product(s) and components are
correctly packaged with and placed in the correct outer packaging.
7.7.2
All
Quantity markings on the product or pack should be accurate, verified, and
in accordance with the legal requirements in the country of sale.
7.7.3
All
The company 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.
Personnel
Section 8
8.1
Training and competency
Fundamental Clause
The company shall ensure that personnel performing work that affects
product safety, legality, and quality are demonstrably competent to
carry out their activity, through training, work experience, or
qualification.
8.1.1
All
The company shall ensure that all employees are able to demonstrate
competence with regards 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.
8.1.2
All
Employees having direct effect on the safety, quality, or legality of products
shall be trained 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.
CP030
Released 1/8/2012
Self-Assessment Tool
Page34
8.1.3
All
8.2
Protective clothing
Statement of Intent
8.2.1
All
8.2.2
1&2
8.2.3
1&2
8.2.4
1&2
8.3
Statement of Intent
8.3.1
1&2
8.3.2
1&2
8.3.3
1
8.3.4
1
8.3.5
1
8.3.6
1
CP030
Released 1/8/2012
Training records should be stored such that privacy of personnel is
protected and legal compliance with data protection laws in the country of
operation are respected whilst also allowing auditors access to necessary
information. Training shall be traceable to an individual employee.
The company's standards shall be documented and adopted by all
personnel, including contractors and visitors to the production
facility.
Where a need for protective clothing has been identified by the risk
assessment, this shall not pose a contamination risk to the product.
Based on the assessment of risk to the product, suitable footwear shall be
worn within the factory environment if necessary.
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.
Hygiene practices
Standards of hygiene shall be formulated with due regard to the risk of
product contamination.
Where metal foreign-body detection is in place, detectable plasters shall be
used and shall be regularly tested through the detector.
The company shall have a policy to control the wearing of jewellery so that
it poses no risk of product contamination.
All cuts and grazes on exposed skin shall be covered by contrasting
coloured plasters that are company issued and monitored.
Hand-cleaning shall be performed at a suitable frequency to maintain
hygienic conditions.
No eating, drinking, or smoking shall be permitted within production or
packaging areas.
All head and facial hair shall be fully contained to prevent product
contamination.
Self-Assessment Tool
Page35
8.3.7
1
The company shall be vigilant concerning employees, including temporary
employees, when they may be suffering from or have been in contact with
any relevant infectious disease or condition. The company should have a
procedure for the notification by employees where this is legally allowable.
8.3.8
1
Where the company becomes aware of a person who has entered the
premises suffering from a relevant infectious disease, steps shall be taken
to minimize any risk to product safety.
8.3.9
1
Where there may be 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
1
Fingernails shall be kept short, clean, and unpolished. False fingernails are
not permitted.
CP030
Released 1/8/2012
Self-Assessment Tool
Page36
Product Group Decision Tree - Manufacturer
Is this product defined as a
pharmaceutical or cosmetic. Is it
used invasively* or contain
nanomaterials?
Product Group 1
Does the product have product
specific legislation requiring hygienic
manufacture (e.g. GMP)?
Product Group 1
Is there potential for contamination
of the product which could cause
major injury* or harm?
Biological
Radiation
Product Group 1
Chemical
Physical
Product Group 2
Does the product have any product
specific legal requirements
concerning safety or harmonised* or
mandatory* standards?
Product Group 2
Does the product require risk or
safety warning on the product
packaging, labeling or instructions?
Product Group 2
Is the product on contact with skin*
during foreseeable use?
Is the product
subject to
mandatory labelling
of ingredients or
components
Product Group 2
Can this product type cause death or
major injury* if it fails during
foreseeable use?
Physical, Chemical,
Electrical,
Flammability,
Magnetism,
Acoustics, Radiation
Product Group 2
Is the product designed or clearly
intended for vulnerable* or very
vulnerable* user groups?
Product Group 2
Product Group 3
Product Group Decision Tree – Assembly Packer