Stage Two self-assessment for low hygiene risk

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BRC Global Standard for Packaging and Packaging Materials
Self-Assessment Tool for Stage Two of Enrolment Scheme
Welcome to the BRC Global Standards Self-Assessment tool
We hope that you will find this useful
This tool will be applicable for all BRC/IOP Global Standard for Packaging and Packaging Materials issue
4 low hygiene risk category enrolment visits or gap analyses.
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 towards the end of your enrolment phase.
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 your Understanding of the Requirements
for the BRC/IOP Global Standard for Packaging and Packaging Materials issue 4 and may be useful for
the personnel 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 Packaging and Packaging Materials Issue 4 please do not hesitate to contact the
BRC Global Standards team:
Email – enquiries@brcglobalstandards.com
Telephone – 020 7854 8939
P068 Low Hygiene Risk Self-Assessment Checklist – Stage Two
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Non-conformity Summary
No.
Req. ref
Rank
Details of non-conformity
1
2
3
4
5
6
7
8
9
Rank: Critical, Major or Minor
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Stage Two
Section One – Senior Management Commitment and Continual Improvement
1.3
Product safety and quality management policy
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.
Details
Section Three – 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 the working methods and practices or
references to where such information is documented.
3.1.2 The manual or relevant components shall be readily
available to key staff.
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.
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
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handled, e.g. the use of products or services where
assessment or approval has not been undertaken.
Assessment may take the form (on a batch or delivery
basis) of:
■ certificate of analysis
■ declaration of compliance.
3.6
Document 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.
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.
Details
Details
Section Four – Site Standards
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
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their activities.
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.
4.7
Maintenance
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 re-commencing
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.
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
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
4.4.5
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locker and changing rooms.
Facilities for visitors and contractors shall comply
with the company’s hygiene policy.
4.10
Waste and Waste Disposal
Details
Statement of Intent
Suitable facilities shall be provided 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.
4.12
Transport, Storage and Distribution
Details
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 Storage, including off-site storage, shall be
controlled to protect the product from
contamination.
4.12.6 Work in progress shall be suitably labelled and
covered to ensure proper identification and prevent
damage.
4.12.7 Material intended for recycling shall be
appropriately protected against contamination
hazards.
4.12.8 All vehicles used for deliveries shall be in a condition
to minimise the risk of product contamination.
4.12.9 All company-owned vehicles used for deliveries shall
be visually checked for cleanliness before loading.
4.8.4
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Unsatisfactory lorries shall not be loaded.
4.12.10 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.
Section Five – Product and Process Control
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.
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.
5.5
In-line Testing and Measuring Equipment
Statement of Intent
The company shall use hazard and risk analysis principles to
determine the need for in-line product testing equipment to
ensure the integrity and quality of products.
5.5.1
The accuracy of in-line equipment shall be specified
having due regard to the product parameter being
measured and controlled.
5.5.2
The company shall establish and implement
procedures for the operation, routine monitoring
and testing of equipment.
5.6
Calibration
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Statement of Intent
Where specialist measuring is required to assess compliance
with product safety and legality, the devices shall be
maintained and calibrated.
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.
Section Six – Personnel
6.1
Training and Competence
Details
FUNDAMENTAL
Statement of Intent
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
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 relevant training
as appropriate. Records of training shall be
maintained.
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