BRC GLOBAL STANDARDS 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/IOP
Global Standard for Packaging and Packaging Materials issue 4. This tool will be applicable for all
BRC/IOP Global Standard for Packaging and Packaging Materials issue 4 audits.
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/IOP Global Standard for Packaging and Packaging Materials 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 – brcglobalstandards@brc.org.uk
Telephone – 020 7854 8939
Global Standard for Packaging and Packaging Materials
Issue 4 : February 2011
BRC Global Standards Low Risk
Self-Assessment Tool
1
Senior Management Commitment and Continual Improvement
1.1
Product safety and quality management policy
Requirement
No
REQUIREMENT
Statement of
Intent
The senior management shall commit the company to producing products
to the specified quality and which are safe and legally compliant.
1.1.1
The policy shall state the company’s intention to meet its obligation to
produce safe and legally compliant products to the specified quality, and
its responsibility to its customers. This shall include the commitment for
review and continuous improvement.
1.1.2
The company’s senior management shall ensure the policy is
communicated to all staff involved with activities relating to product safety,
legality, regulatory compliance and quality
Conforms
Comments/Actions
1.2
Senior management commitment
FUNDAMENTAL
The company’s senior management shall demonstrate that they are fully
committed to the implementation of requirements of the Global Standard
for Packaging & Packaging Materials. This shall include provision of
adequate resources, effective communication and systems of
management review to effect continual improvement. Opportunities for
improvement shall be identified, implemented and fully documented.
Statement of
Intent
1.2.1
The company’s senior management shall ensure that product safety and
quality objectives are measurable, established, documented, monitored
and reviewed.
1.2.2
The company’s senior management shall have a system in place to
ensure that the company is kept informed of all relevant legislative,
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scientific and technical developments, and industry codes of practice
applicable in the country of manufacture and, where known, the country in
which the packaging material will be sold.
1.2.3
The company shall ensure that the materials manufactured comply with
the relevant legislation (including any legislation concerning the use of
recycled content) in the country of manufacture and in which the products
are intended to be sold and/or ultimately used, where known.
1.2.4
The company’s senior management shall ensure that non-conformities
identified at the previous audit against the Standard are effectively
actioned.
1.2.5
The company shall have a current, original copy of the Standard available
on site.
1.2.6
Where the company is certificated to the Standard they shall ensure that
recertification audits occur on or before the audit due date indicted on the
certificate.
Comments/Actions
1.3
Organisational structure, responsibilities and management authority
Statement of
Intent
The organisational structure shall be clear, with defined responsibilities,
and key staff shall be aware of their responsibilities with regard to
packaging safety and quality.
1.3.1
The company shall have an up-to-date organisation chart demonstrating
the structure of the company.
1.3.2
Within the management team there shall be a designated competent
manager and deputy with the responsibility for coordinating compliance
with the Standard.
1.4
Management review
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Statement of
Intent
Opportunities for continuous improvement of the product safety and
quality programme shall be identified and effectively implemented through
management reviews of the product safety system and results.
1.4.1
The review process shall be undertaken at appropriate planned intervals,
as a minimum annually.
1.4.2
The review process shall include the evaluation of:





1.4.3
2
previous management review documents and action plans
internal, second-party and third-party audits
customer performance indicators, complaints and feedback
incidents, corrective actions, out-of-specification results and nonconforming materials
resource requirements.
Records of management reviews and action plans shall be documented.
Hazard and Risk Management System
2.1
Hazard and risk management team
Statement of
Intent
The hazard and risk management system shall be managed by a
multidisciplinary team competent in hazard and risk analysis.
2.1.1
The multidisciplinary team shall have a designated team leader who shall
be able to demonstrate competence and experience of hazard and risk
analysis.
In the event that the company does not have the appropriate expertise inhouse, external expertise shall be sought and used to develop and review
the hazard and risk management system. However, the day-to-day
management shall remain the responsibility of the company.
Comments/Actions
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2.2
Hazard and risk analysis
FUNDAMENTAL
The company shall establish the effectiveness of its prerequisite
programmes through a hazard and risk analysis and identify and
implement any further risks to the safety and legality of products.
Statement of
Intent
2.2.1
The scope of the hazard and risk analysis shall be clearly defined and
shall cover all products and processes included within the intended scope
of certification.
2.2.2
The hazard and risk analysis team shall maintain awareness of and take
into account:



historical and known hazards associated with specific processes,
raw materials or end use of the product
relevant codes of practice or recognised guidelines
legislative requirements.
2.2.3
A full description of the packaging produced by product or product group
and its intended use shall be documented.
2.2.4
A process flow diagram shall be prepared for each product, product group
or process. This shall include each process step from the receipt of raw
materials to dispatch to the customer.
The process flow shall as a guide include, as relevant:






receipt and approval of art work
receipt and preparation of raw materials such as additives, inks
and adhesives
each manufacturing process step
the use of rework and post-consumer recycled materials
any subcontracted operations
customer returns.
The accuracy of the process flow shall be verified by the hazard and risk
analysis team.
2.2.5
The hazard and risk analysis team shall identify and record all potential
hazards that are reasonably expected to occur at each step in relation to
the product and process. The hazards considered shall include, where
relevant:

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foreign objects
chemical contamination (e.g. taint, odour, allergen, component
transfer from inks, varnishes and glues)
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
hazards that may have an impact on the functionality of the final
product in use.
2.2.6
The hazard and risk analysis team shall identify control measures
necessary to prevent, eliminate or reduce each hazard to acceptable
levels.
2.2.7
For each hazard that requires control, the control points shall be reviewed
to evaluate if existing prerequisites are effective in providing control.
Where greater controls are required to the prerequisite programmes,
improvements shall be implemented to ensure control is achieved.
2.2.8
A review of the hazard and risk management system shall be carried out
at least once per year and following any significant incidents or when any
process changes.
The review shall include a verification that the hazard and risk analysis
plan is effective and may include a review of:






complaints
product failures
recalls
product withdrawals
results of internal audits of prerequisite programmes
results from external third-party auditors.
Comments/Actions
2.3
Exemption of requirements based on risk analysis
2.3.1
The hazard and risk analysis study shall be fully supported by the
implementation of the prerequisites set out in requirements clauses 4 to 6.
However, the hazard and risk analysis may indicate that some of the
requirements are not applicable. These shall be documented and
regarded as proposed exemptions for review at audit. Acceptance or
rejection of the proposed exemptions shall be recorded in the auditor’s
report.
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2.3.2
The company shall keep recorded exemptions to the Standard under
review and provide documented evidence of this review at subsequent
audit.
Comments/Actions
3. Product Safety and Quality Management System
3.1
Product safety and quality manual
Statement of
Intent
The company shall have a manual which describes how the requirements
of the Standard are met. These requirements shall be fully implemented,
reviewed at appropriate planned intervals and improved where necessary.
3.1.1
The product safety and quality manual shall contain an outline of working
methods and practices or references to where such an outline is
documented.
3.1.2
The manual or relevant components shall be readily available to key staff.
Comments/Actions
3.2
Customer focus and contract review
Statement of
Intent
The company shall ensure that customer needs and expectation with
respect to quality and safety are identified and met, and that
communication channels are clear.
3.2.1
Customer requirements relating to the design, development, specification,
manufacture and distribution of the product shall have been agreed with
the customer and where appropriate documented and agreed prior to
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order fulfilment.
Comments/Actions
3.3
Internal audits
FUNDAMENTAL
The company shall establish through a programme of internal audits that
the implementation of the requirements of the Standard are in place,
appropriate and complied with.
Statement of
Intent
3.3.1
Internal audits shall be planned and their scope and frequency shall be
established in relation to the risks associated with the activity. Audits shall
be scheduled so that all aspects of the Standard are audited at least
annually.
3.3.2
Audits shall be conducted by personnel who are competent, and
sufficiently independent from the department being audited to ensure
impartiality.
3.3.3
Deficiencies and details of non-conformities shall be notified to
appropriate supervisory staff and corrective action implemented within a
specified and appropriate time period.
3.3.4
The completion of corrective action shall be recorded and verified.
3.3.5
Conformity as well as non-conformity shall be clearly identified and
verified within the internal audit report.
Comments/Actions
3.4
Supplier approval and performance monitoring
Statement of
Intent
The company shall ensure that suppliers of goods and services are
operating in a manner that ensures that product quality and safety is not
compromised and specifications can be achieved.
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3.4.1
The company shall have a documented supplier approval procedure and
continual assessment programme in place, based upon risk analysis.
3.4.2
The procedures shall include clear criteria for the assessment and
approval of new suppliers. Assessment may take the form of:



supplier audits
supplier certification with a scope covering the products supplied
e.g. against the appropriate BRC Global Standard
supplier questionnaires.
3.4.3
Records of supplier assessment and necessary actions shall be
maintained and reviewed.
3.4.4
The company shall define how exceptions are handled, e.g. the use of
products or services where assessment or approval has not been
undertaken. Assessment may take the form (on a batch or delivery basis)
of:


certificate of analysis
declaration of compliance.
Comments/Actions
3.5
Subcontracting of production
Statement of
Intent
Subcontractors shall be effectively managed to prevent any risk of
contamination or damage and ensure product is produced to specification.
3.5.1
The use of subcontractors and the status of the subcontractor with respect
to the Standard shall be notified to the brand owner and/or customer.
3.5.2
Suppliers of subcontracted services shall be approved in accordance with
the procedures in clause 3.4.
3.5.3
Where any production processes are subcontracted, the risks to the
quality and safety of the product shall be assessed. Any risks shall be
communicated to relevant personnel and effectively managed.
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3.5.4
Clear specifications shall be agreed for all work outsourced to a
subcontractor. Controls shall be in place for checks on finished work to
ensure the safety and quality meets specification.
Comments/Actions
3.6
Documentation control
Statement of
Intent
Documentation essential to the management and control of product safety, legality
and quality shall be relevant, controlled and available, as the correct version, to the
appropriate personnel.
3.6.1
Documents shall be sufficiently detailed to enable their correct application
by appropriate personnel. They shall be readily accessible to relevant staff
at all times.
3.6.2
All changes and amendments to documents critical to product safety,
legality or quality system procedures shall be authorised, recorded, and
obsolete documentation shall be removed, archived and replaced with the
current version.
Comments/Actions
Specifications
3.7
FUNDAMENTAL
Statement of
Intent
Appropriate specifications shall exist for raw materials, intermediate and
finished products, and any product or service that could affect the integrity
of the finished product.
3.7.1
Specifications shall be suitably detailed, accurate and shall ensure
compliance with relevant product safety and legislative requirements.
3.7.2
The company shall seek formal agreement of specifications with relevant
parties. Where specifications are not formally agreed then the company
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shall be able to demonstrate that they have taken steps to put an
agreement in place.
3.7.3
Trademarks for application on packaging materials shall, where
appropriate, be formally agreed between relevant parties.
Comments/Actions
3.8
Record keeping
Statement of
Intent
The company shall maintain records to demonstrate the effective control
of product safety, legality and quality.
3.8.1
The records shall be legible, genuine, appropriately authorised and
retained in good condition for an appropriate defined time period.
Comments/Actions
Traceability
3.9
FUNDAMENTAL
Statement of
Intent
The company shall have a system in place to identify product batches and
to trace and follow all raw materials through processing to the distribution
of the finished product to the customer. Records shall be retrievable in a
timely manner.
3.9.1
An appropriate system shall be in place to ensure that the customer can
identify a product or production lot number for the product for the
purposes of traceability.
3.9.2
The system shall be tested to ensure traceability can be determined from
raw materials to the finished product and vice versa. This test shall take
place at least annually.
Comments/Actions
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3.10
Complaint handling
Statement of
Intent
All complaints made by customers and consumers shall be recorded and
investigated. Corrective actions where required shall be implemented and
recorded.
3.10.1
Actions appropriate to the seriousness and frequency of the problems
identified shall be carried out promptly and effectively by appropriately
trained staff.
Comments/Actions
3.11
Management of incidents, product withdrawals and recalls
Statement of
Intent
The company shall have a plan and systems in place to effectively
manage incidents and if required the withdrawal or recall of products, in
order to ensure that all potential risks to the quality and hygiene and
legality of products are controlled.
3.11.1
The company shall provide written guidance and training for relevant staff
regarding the type of event that would constitute an incident. A
documented incident reporting procedure shall be in place.
3.11.2
The company shall effectively manage the incident to prevent release of
product where safety or quality may have been affected.
3.11.3
A product withdrawal/recall procedure shall be documented, practical to
implement and regularly reviewed. This shall include as a minimum:


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identification of the key personnel involved in assessing potential
withdrawal/recall incidents with clear identified responsibilities
a communications plan including methods of informing customers
and, where necessary, regulatory bodies in a timely manner
corrective action and business recovery
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
3.11.4
review of any withdrawals or recalls to implement appropriate
improvements as required.
The product withdrawal/recall procedure shall be tested on at least an
annual basis and used to evaluate the procedure and implement
improvement.
Comments/Actions
4. Site Standards
4.1
External standards
Statement of
Intent
All grounds within the site shall be finished and maintained to an
appropriate standard.
4.1.1
Consideration shall be given to local activities and the site environment
which may have an adverse impact on the integrity of the finished product.
Measures shall be taken to prevent contamination.
4.1.2
The external areas shall be maintained in good order. Grounds shall be
regularly tended and well maintained and potential pest-harbouring areas
shall be identified and monitored.
4.1.3
The building fabric shall be maintained to minimise potential for pest entry,
ingress of water and other contaminants. External silos, pipe work or other
access points for the product and/or raw materials shall be appropriately
sealed and secured.
4.1.4
Where natural drainage is inadequate, external drainage shall be installed.
Drains shall be properly protected to prevent entry of pests.
4.1.5
External traffic routes, under site control, shall be maintained in good
repair to avoid contamination of the product.
4.1.6
Where external storage of raw materials is necessary these shall be
protected from contamination as required.
Comments/Actions
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Building fabric
Raw material handling, preparation, processing, packing and storage areas
4.2
Statement of
Intent
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.
4.2.1
Walls, floors, ceilings (including suspended ceilings) and pipe work shall
be maintained in good condition and shall facilitate cleaning.
4.2.2
Suitable and sufficient lighting shall be provided for a safe working
environment, correct operation of processes, effective inspection of the
product and cleaning.
4.2.3
Potential sources for the ingress of pests, such as drain openings or
windows opened for ventilation, shall be suitably pest proofed.
4.2.4
Where they pose a risk to the product, glass windows shall be protected
against breakage.
4.2.5
Suitable and sufficient ventilation shall be provided.
Comments/Actions
4.3
Utilities
Statement of
Intent
Product cleanliness and integrity shall not be compromised by the
location, construction and delivery of the utilities to and within the
production and storage areas.
4.3.1
All water used in the processing of the products or equipment cleaning
shall be potable or suitably treated to prevent contamination.
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4.3.2
Air, compressed air or other gases that come into direct contact with the
packaging shall present no risk to product safety or quality and comply
with any relevant legal regulations.
Comments/Actions
4.4
Security
Statement of
Intent
Product and process integrity shall be assured through appropriate site
security provision.
4.4.1
Based on risk assessment, a procedure shall be in place to address the
security of the site and products and establish, implement and maintain a
system to reduce or eliminate the identified risk.
4.4.2
Access to the site by employees, contractors and visitors shall be
controlled, through designated entrances, and a visitor reporting system
shall be in place.
4.4.3
Staff shall be trained in site security procedures and encouraged to report
or challenge unidentified or unknown visitors.
4.4.4
Contractors involved in maintenance or repair shall be supervised by a
qualified person, and a nominated staff member shall be responsible for
their activities.
4.4.5
Access to the site for third-party transport personnel shall be controlled
and, where possible, facilities provided to negate the need to enter
storage or production areas.
4.4.6
Site IT systems shall be adequately controlled and backed up.
Comments/Actions
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4.5
Layout and product flow
Statement of
Intent
Premises and plant shall be logically designed, constructed and
maintained.
4.5.1
The process flow from intake to despatch shall be arranged to minimise
the risk of contamination or damage to the product.
4.5.2
Premises shall allow sufficient working space and storage capacity to
enable all operations to be carried out properly under hygienic conditions.
4.5.3
Work in progress shall be identified clearly and adequately protected.
Comments/Actions
4.6
Equipment
Statement of
Intent
Product safety, legality and quality shall be ensured through the use of
appropriate equipment that shall be properly designed and maintained.
4.6.1
Newly installed equipment shall be properly specified before purchase.
Equipment shall be constructed of appropriate materials and be of a
suitable design to ensure it can be effectively cleaned and maintained.
New equipment shall be tested and commissioned prior to use, and a
maintenance programme established.
Comments/Actions
4.7
Maintenance
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Statement of
Intent
Proper maintenance and monitoring of all equipment critical to product
safety, quality and legality shall ensure consistent high levels of product
safety, functionality and quality.
4.7.1
A condition-based or preventative maintenance programme shall be in
place covering all items of equipment and plant that are critical to product
safety, quality and legality.
4.7.2
Maintenance work shall not place the product at risk. After breakdown or
maintenance, machinery shall be thoroughly checked before recommencing production.
4.7.3
Temporary repairs/modifications using tape, cardboard, etc. shall only be
permitted in emergencies and where product contamination is not at risk.
Such modifications shall be subject to a time limit and shall be recorded
and scheduled for correction.
4.7.4
Engineering workshops shall be controlled to prevent contamination risks
to the product, e.g. provision of swarf mats where workshops open directly
into production areas.
Comments/Actions
4.8
Staff facilities
Statement of
Intent
Staff facilities shall be sufficient to accommodate the required number of personnel,
and designed and operated to minimise the risk of product contamination. Such
facilities shall be kept in a good and clean condition.
4.8.1
Suitable and sufficient hand-washing facilities shall be available to enable
cleaning of hands before commencing work and as necessary during the
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course of work.
4.8.2
Toilets shall be adequately segregated and shall not open directly into
storage, processing or production areas. Toilets shall be provided with
hand-washing facilities comprising:




sufficient quantity of warm water
unscented liquid soap
single-use towels or suitably designed and located air driers
advisory signs to prompt use (including consideration of
appropriate languages).
4.8.3
Eating, drinking and smoking shall not be allowed in locker and changing
rooms.
4.8.4
Facilities for visitors and contractors shall comply with the company’s
hygiene policy.
Comments/Actions
4.9
Housekeeping and cleaning
FUNDAMENTAL
Housekeeping and cleaning systems shall be in place, which ensure that
appropriate standards of cleanliness are maintained and that risk of
contamination to the product is minimised.
Statement of
Intent
4.9.1
Good standards of housekeeping shall be maintained, which shall include
a ‘clean as you go’ policy.
4.9.2
The cleaning of production equipment and internal surfaces of storage
and production facilities shall be effectively managed using cleaning
schedules.
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4.9.3
Cleaning chemicals shall be fit for purpose, suitably labelled, secured in
closed containers and used in accordance with manufacturers’
instructions. Materials and equipment used for cleaning toilets shall be
segregated from those used elsewhere
Comments/Actions
4.10
Waste and waste disposal
Statement of
Intent
Suitable facilities shall be in place for the storage and disposal of process
and other waste.
4.10.1
Where appropriate, waste shall be categorised according to legislative
requirements based on the intended means of disposal (such as
recycling) and segregated in appropriate designated waste containers.
4.10.2
Where agreed with the customer, substandard trademarked materials
shall be rendered unusable through a destructive process. If transferred to
a third party for destruction or disposal, that third party shall be a specialist
in appropriate waste disposal and shall provide records of material
destruction.
Comments/Actions
4.11
Pest Control
Statement of
Intent
The company shall be responsible for minimising the risk of pest
infestation on the site.
4.11.1
A preventive pest control programme shall be maintained covering all
areas of the site under the company’s control.
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4.11.2
The company shall either contract the services of a competent pest
control organisation or shall have appropriately trained staff for the regular
inspection and treatment of the site to deter and eradicate infestation.
4.11.3
A pest control manual shall be maintained including:



4.11.4
detailed records of pest control inspections, recommendations
and of any pest activity
details of pest control products used and instructions for their use
a site plan showing the location of pest control devices.
In the event of infestation, immediate action shall be taken to eliminate the
hazard. Action shall be taken to evaluate the potential for contamination or
damage to packaging and checks instigated before release.
Comments/Actions
4.12
Transport, storage and distribution
Statement of
Intent
The risk of contamination of raw materials and finished products shall be
minimised whilst in transport, storage or distribution.
4.12.1
All finished products and materials transferred between premises shall be
fully identified and protected during transit and storage.
4.12.2
Receipt documents and/or product identification shall facilitate correct
stock rotation of goods in storage.
4.12.3
Deliveries of incoming goods shall be visually checked for packaging
integrity and potential foreign body contamination.
4.12.4
All pallets shall be checked. Damaged, contaminated or unacceptable
pallets shall be discarded. Wooden pallets, if used, shall be sound, dry,
clean and free from damage and contamination.
4.12.5
Work in progress shall be suitably labelled and covered to ensure proper
identification and prevent damage.
4.12.6
Material intended for recycling shall be appropriately protected against
contamination hazards.
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4.12.7
All vehicles used for deliveries shall be in a condition to minimise the risk
of product contamination.
4.12.8
All company-owned vehicles used for deliveries shall be visually checked
for cleanliness before loading. Unsatisfactory lorries shall not be loaded.
4.12.9
Where the company employs third-party contractors there shall be a
contract or agreed terms and conditions. Where this is not possible, with
general carriers, the packaging shall be adequate to protect the product
against damage, contamination hazards, taint and odour.
4.12.10
Storage, including off-site storage, shall be controlled to protect the
product from contamination.
Comments/Actions
5. Product and Process control
5.1
Product design and development
Statement
of Intent
Product design and development processes shall be in place to ensure
the production of safe and legal products to defined quality parameters.
5.1.1
Customer requirements shall be defined and agreed prior to undertaking
development, where possible, taking into consideration process
requirements and end use.
5.1.2
A product specification shall be prepared and, where possible, agreed
with the customer or brand owner before the production process begins.
5.1.3
A process shall be in place to ensure final product concepts and artwork
are formally accepted by the specifier, where possible.
5.1.4
Production trials, where appropriate, shall be carried out and testing shall
validate that manufacturing processes are capable of producing a safe
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and legal product and that agreed product quality/print standards can be
consistently achieved.
5.1.5
The company shall ensure that the product design processes, procedures
and records of design together result in the development of specifications
for each manufacturing process step to ensure the production of safe and
legal products of the prescribed quality.
Comments/Actions
5.2
Packaging print control
Statement
of Intent
Processes shall be in place to ensure that print quality meets agreed
specifications and critical print content such as allergen/safety/legal
information is fully legible and correctly printed.
5.2.1
An assessment shall be carried out of the print process and handling of
printed packaging (product) to identify:


risks of loss of essential information
mixing of printed product.
Controls shall be established and implemented to reduce the risks
identified.
5.2.2
Printing plates, other print equipment and reproduction media shall be fully
traceable to the customer’s approved origination material.
5.2.3
Printing plates shall be appropriately stored.
5.2.4
Each print run shall be approved against the agreed standard (or master
sample). This shall be recorded.
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5.2.5
A system shall be in place to detect and identify printing errors during the
run, and to sort these errors from the acceptable printed material.
5.2.6
Where composite print is used (where a mixture of different designs are
printed together), a process shall be in place to ensure effective
segregation of differing print variants.
5.2.7
Samples of printed packaging shall be retained together with production
records for a period of time to be agreed with the customer/specifier/brand
owner.
5.2.8
Any unused printed product shall be accounted for and either disposed of
or identified and appropriately stored.
5.2.9
Personnel carrying out print quality control shall be appropriately trained,
aware of the importance of consumer safety information and adequately
supervised.
5.2.10
Lighting in print inspection cabinets and other means of print/colour
checking shall be agreed with the customer or be to accepted industry
standards.
Comments/Actions
5.3
Process control
FUNDAMENTAL
The production process shall be controlled through effective quality assurance
of operations to ensure packaging materials can be consistently produced to the quality
specified by customers.
Statement of
Intent
5.3.1
The company shall undertake a review of the manufacturing and, where
applicable, printing process to identify critical manufacturing process
control points that could affect the quality of the products produced.
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5.3.2
For each critical manufacturing process control point, machine settings or
process limits shall be established and documented – the process
specification.
5.3.3
Documented process checks shall be undertaken at start up, following
adjustments to equipment, and periodically during production, to ensure
products are consistently produced to the agreed quality specification.
5.3.4
A clearance procedure shall be in place to ensure that at start up, the line
is clear of all previous work and production documents.
5.3.5
In the event of changes to product composition, processing methods or
equipment, the company shall, where appropriate, re-establish process
characteristics and validate product data to ensure product safety, legality
and quality are achieved.
Comments/Actions
5.4
Product inspection and analysis
Statement
of Intent
The company shall use appropriate procedures and facilities when
undertaking or subcontracting inspection and analyses critical to product
safety, legality and quality.
5.4.1
Quality checks shall be carried out at appropriate stages in production to
demonstrate that raw materials, work in progress and the finished product
are within the tolerances laid down in the agreed product specification.
5.4.2
Personnel undertaking quality checks and analyses shall be suitably
trained and shall be competent to carry out the work.
5.4.3
Procedures shall be in place to ensure the reliability of test results.
5.4.4
Frequency of checks shall be in accordance with industry-accepted
practice or customer requirements and based on risk analysis.
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5.4.5
Where the company undertakes or subcontracts analyses 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 17025 (General Requirements for
the Competence of Testing and Calibration Laboratories). Documented
justification shall be available where accredited methods are not
undertaken.
Comments/Actions
5.5
In-line testing and measuring equipment
Statement
of Intent
In-line measuring or product testing equipment, where used, shall be
tested and maintained to ensure it is effective in ensuring product safety
integrity and quality.
5.5.1
The accuracy of in-line equipment shall be specified having due regard to
the product parameter being measured and controlled.
5.5.2
The company shall establish and implement procedures for the operation,
routine monitoring and testing of equipment.
Comments/Actions
5.6
Calibration
Statement
of Intent
Where specialist measuring is required to assess compliance with product
safety and legality, the devices shall be maintained and calibrated.
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5.6.1
Measuring equipment used to monitor critical manufacturing process
points and the product’s compliance with relevant legal requirements and
specifications shall be identified and calibrated.
5.6.2
Calibration shall be traceable to a recognised national standard. Where
such a traceable calibration is not possible, the company shall
demonstrate the basis by which standardisation is carried out.
Comments/Actions
5.7
Control of non-conforming product
Statement
of Intent
The company shall ensure that out-of-specification product is clearly
identified, labelled and quarantined.
5.7.1
Clear procedures for the control of out-of-specification or non-conforming
materials shall be in place and understood by all authorised personnel.
This shall include the effective labelling or quarantining of materials before
a decision has been made on their final disposition.
5.7.2
Non-conforming materials shall be assessed and a decision taken to
reject, accept by concession or authorise to be reworked or for an
alternative use. The decision and reasons shall be documented.
5.7.3
Corrective actions shall be implemented to avoid recurrence of the nonconformance Actions taken shall be documented.
Comments/Actions
5.8
Foreign body contamination control
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Statement
of Intent
The company shall be able to demonstrate that effective controls are in
place to ensure product is protected from contamination during production
and storage.
5.8.1
Foreign body control
5.8.1.1
Based on risk assessment, the company shall identify, control and
manage potential risks from physical contamination.
5.8.1.2
Based on the likelihood and risk of glass contamination, all bulbs and strip
lights, including those on flying insect control devices, shall be protected.
5.8.1.3
Where glass breakage occurs a responsible person shall be placed in
charge of the clean-up operation and shall ensure that no other area is
allowed to become contaminated due to the breakage. Any product that
has become contaminated shall be segregated and disposed of.
All breakages shall be recorded in an incident report.
Comments/Actions
5.8.2
Sharps control
5.8.2.1
There shall be a documented policy for the control of the use of sharps.
5.8.2.2
Sharp blades, equipment and tools shall not be left in a position that
allows them to contaminate the product.
5.8.2.3
Snap-off blade knives shall not be used.
Comments/Actions
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5.8.3
Chemical control
Statement
of Intent
Controls shall be in place to prevent contamination from chemical
hazards.
5.8.3.1
Chemicals including cleaning materials, lubricants and adhesives shall be
of the appropriate grade and be suitably controlled to prevent
contamination of the product.
Comments/Actions
6. Personnel
Raw materials handling, preparation, processing, packing and storage areas
6.1
Training and competence
FUNDAMENTAL
The company shall ensure that all employees are adequately trained,
instructed and supervised commensurate with their activity and are
competent to undertake their job role.
Statement of
Intent
6.1.1
All personnel, including temporary personnel, shall be appropriately
trained prior to commencing work and adequately supervised throughout
the working period.
6.1.2
The company shall routinely review the competencies of staff and provide
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relevant training as appropriate. Records of training shall be maintained.
Comments/Actions
6.2
Access and movement of personnel
Statement
of Intent
The company shall ensure that access and movement of personnel,
visitors and contractors shall not compromise product safety and quality.
6.2.1
There shall be a plan of the site, which defines access points for
personnel, travel routes and staff facilities.
6.2.2
If it is necessary to allow access through production areas, designated
walkways shall be provided that ensure there is adequate segregation
from materials.
Comments/Actions
6.3
Personal Hygiene
Statement
of Intent
The company’s personal hygiene standards shall be documented and
adopted by all personnel, including visitors to the production facility. These
standards shall be developed with due regard for risk of product
contamination.
6.3.1
The company shall have a documented jewellery policy.
6.3.2
Personal items and belongings including personal mobile phones shall not
be taken into production areas without the permission of the management.
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6.3.3
Eating (including the eating of confectionery and chewing of gum or
tobacco), drinking and smoking shall not be allowed in production or
storage areas.
6.3.4
Drinking of water from purpose-made dispensers and/or by using
disposable conical cups or spill-proof containers may be allowed, provided
it is confined to a designated area away from equipment.
Comments/Actions
6.4
Protective Clothing
Statement
of Intent
The risk of product contamination from clothing, hair or personal items
shall be minimised.
6.4.1
Appropriate clean protective clothing that cannot contaminate the product
shall be worn.
Where no need for protective clothing has been established by risk
assessment, it shall be fully justified and guidance provided to staff on any
limitations to personal clothing to prevent a contamination risk to the
product.
6.4.2
Where protective clothing is used it shall be kept adequately clean.
Changes of clothing shall be available as required.
6.4.3
Where protective clothing is used, clean and dirty clothing shall be
segregated and controlled to prevent cross contamination
6.4.4
Disposable protective clothing, if used, shall be subject to adequate
control to avoid product contamination.
Comments/Actions
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