Section
5 Quality Assurance Scheme for Machinery
5.1 General
5.1.1 This certification scheme is applicable to both individual and series
produced items manufactured under closely controlled conditions and will be
restricted to works where the employment of quality control procedures is well
established. LR will have to be satisfied that the practices employed will ensure
that the quality of finished products is to standards which would be demanded when
using traditional survey techniques.
5.1.2 The Classification Committee will consider proposed designs for
compliance with LR’s Rules or other appropriate requirements and the extent to which
the manufacturing processes and control procedure ensure conformity of the product
to the design. A comprehensive survey will be made by the Surveyors of the actual
operation of the quality control programme and of the adequacy and competence of the
staff to implement it.
5.1.3 The procedures and practices of manufacturers which have been granted
approval will be kept under review.
5.1.4 Approval by another organisation will not be accepted as sufficient
evidence that a manufacturer’s arrangements comply with LR’s requirements.
5.2 Requirements for approval
5.2.1
Facilities. The manufacturer is required to have adequate equipment and
facilities for those operations appropriate to the level of design, development and
manufacture being undertaken.
5.2.2
Experience. The manufacturer is to demonstrate that the firm has experience
consistent with technology and complexity of the product type for which approval is
sought and that the firm’s products have been of a consistently high standard.
5.2.3
Quality policy. The manufacturer is to define management policies and
objectives or quality and ensure that these policies and objectives are implemented
and maintained throughout all phases of the work.
5.2.4
Quality system documentation. The manufacturer is to establish and maintain a
documented quality system capable of ensuring that material or services conform to
the specified requirements, including the requirements of this Section.
5.2.5
Management representative. The manufacturer is to appoint a management
representative, preferably independent of other functions, who is to have defined
authority and responsibilities for the implementation and maintenance of the quality
system.
5.2.6
Responsibility and authority. The responsibilities and authorities of senior
personnel within the quality system are to be clearly documented.
5.2.7
Internal audit. The manufacturer is to conduct internal audits to ensure
continued adherence to the system. An audit programme is to be established with
audit frequencies scheduled on the basis of the status and importance of the
activity and adjusted on the basis of previous results.
5.2.8
Management review. The quality system established in accordance with the
requirements of this Section is to be systematically reviewed at appropriate
intervals by the manufacturer to ensure its continued effectiveness. Records of such
management reviews are to be maintained and be made available to the Surveyors.
5.2.9
Contract review. The manufacturer is to establish and implement procedures
for conducting a contract review prior to and after acceptance to ensure that:
- the requirements of the contract are adequately defined and
documented;
- any requirements differing from those specified in the original
enquiry/tender are resolved; and
- the manufacturer has the capability to meet and verify
compliance to the specified requirements.
5.2.10
Work instruction. The manufacturer is to establish and maintain clear and
complete written work instructions that prescribe the communication of specified
requirements and the performance of work in design, development and manufacture
which would be adversely affected by lack of such instructions.
5.2.11
Documentation and change control. The manufacturer is to establish and
maintain control of all documentation that relates to the requirements of this
scheme. This control is to ensure that:
- documents are reviewed and approved for adequacy by authorised
personnel prior to use, are uniquely identified and include indication of
approval and revision status;
- all changes to documentation are in writing and are processed in
a manner that will ensure their availability at the appropriate location and
preclude the use of nonapplicable documents;
- provision is made for the prompt removal of obsolete
documentation from all points of issue or use; and
- documents are to be re-issued after a practical number of
changes have been issued.
5.2.12
Records. The manufacturer is to develop and maintain a system for collection,
use and storage of quality records. The period of retention of such records is to be
established in writing and is to be subject to agreement by the Classification
Committee.
5.2.13
Design. The manufacturer is to establish and maintain a design control system
appropriate to the level of design being undertaken. Documented design procedures
are to be established which:
- identify the design practices of the manufacturer’s
organisation including departmental instructions to ensure the orderly and
controlled preparation of design and subsequent verification;
- make provision for the identification, documentation and
appropriate approval of all design change and modifications;
- prescribe methods for resolving incomplete, ambiguous or
conflicting requirements; and
- identify design inputs such as sources of data, preferred
standard parts or materials and design information and provide procedures
for their selection and review by the manufacturer for adequacy.
5.2.14
Purchasing. The manufacturer is to ensure that purchased material and
services conform to specified requirements.
5.2.15
Selection and approval of sub-contractors and suppliers. The manufacturer is
to establish and maintain records of acceptable suppliers and sub-contractors. The
selection of such sources, and the type and extent of control exercised, are to be
appropriate to the type of product or service and the suppliers’ or sub-contractors’
previously demonstrated capability and performance. Documented procedures for
approval of new suppliers are to be established and records of vendor assessments
(where carried out) are to be maintained and made available to the Surveyors upon
request.
5.2.16
Purchasing data. Each purchasing document should contain a clear description
of the material or service ordered, including, as applicable, the following:
- The type, class, grade, or other precise identification;
- The title or other positive identification and applicable issue
of specifications, drawings, process requirements, inspection instructions
and other relevant data.
5.2.17
Verification of purchased material and services. The manufacturer is to
ensure that the Surveyors are afforded the right to verify at source or upon receipt
that purchased material and services conform to specified requirements. Verification
by the Surveyors shall not relieve the manufacturer of his responsibility to provide
acceptable material nor is it to preclude subsequent rejection.
5.2.18
Product identification. The manufacturer is to establish and maintain a
system for identification of the product to relevant drawings, specifications or
other documents during all stages of production, delivery and installation.
5.2.19
Manufacturing control. The manufacturer is to ensure that those operations
which directly affect quality are carried out under controlled conditions. These are
to include the following:
- Written work instructions wherever the absence of such
instructions could adversely affect compliance with specified requirements.
These should define the method of monitoring and control of product
characteristics.
- Established criteria for workmanship through written standards
or representative samples.
5.2.20
Special processes. Those processes where effectiveness cannot be verified by
subsequent inspection and test of the product are to be subjected to continuous
monitoring in accordance with documented procedures, in addition to the requirements
specified in Pt 5, Ch 1, 6.2 Guidance for spare parts.
5.2.21
Receiving inspection. The manufacturer is to ensure that all incoming
material is not to be used or processed until it has been inspected or otherwise
verified as conforming to specified requirements. In establishing the amount and
nature of receiving inspection, consideration is to be given to the control
exercised by the supplier and documented evidence of quality conformance supplied.
5.2.22
In-process inspection. The manufacturer is to:
- perform inspection during manufacture on all characteristics
that cannot be inspected at a later stage;
- inspect, test and identify products in accordance with specified
requirements;
- establish product conformance to specified requirements by use
of process monitoring and control methods where appropriate;
- hold products until the required inspections and tests are
completed and verified; and
- clearly identify non-conforming products to prevent
unauthorised use, shipment, or mixing with conforming material.
5.2.23
Final inspection. The manufacturer is to perform all inspections and tests on
the finished product necessary to complete the evidence of conformance to the
specified requirements. The procedures for final inspection and test are to ensure
that:
- all activities defined in the specification, quality plan or
other documented procedure have been completed;
- all inspections and tests that should have been conducted at
earlier stages have been completed and that the data is acceptable; and
- no product is to be dispatched until all the activities defined
in the specifications, quality plan or other documented procedure have been
completed, unless products have been released with the permission of the
Surveyors.
5.2.25
Inspection and test status. The manufacturer is to establish and maintain a
system for the identification of inspection status of all material, components and
assemblies by suitable means which distinguish between conforming, non-conforming
and uninspected items. The relevant inspection and test procedures and records are
to identify the authority responsible for the release of conforming products.
5.2.26
Control of non-conforming material.
- The manufacturer is to establish and maintain procedures to
ensure that material that does not conform to the specified requirements is
controlled to prevent inadvertent use, mixing or shipment. Repair, rework or
concessions on non-conforming material and re-inspection are to be in
accordance with documented procedures.
- Records clearly identifying the material, the nature and extent
of non-conformance and the disposition are to be maintained.
5.2.27
Sampling procedures. Where sampling techniques are used by the manufacturer
to verify the acceptability of groups of products, the procedures adopted are to be
in accordance with the specified requirements or are to be subject to agreement by
the Surveyors.
5.2.28
Corrective action. The manufacturer is to establish and maintain documented
procedures for the review of non-conformances and their disposition. These should
provide for:
- monitoring of process and work operations and analysis of
records to detect and eliminate potential causes of non-conforming
material;
- continuing analysis of concessions granted and material scrapped
or reworked to determine causes and the corrective action required;
- an analysis of customer complaints;
- the initiation of appropriate action with suppliers or
subcontractors with regard to receipt of non-conforming material; and
- an assurance that corrective actions are effective.
5.2.29
Purchaser supplied material. The manufacturer is to establish and maintain
documented procedures for the control of purchaser supplied material.
5.2.30
Handling, storage, and delivery:
- The manufacturer is to establish and maintain a system for the
identification preservation, segregation and handling of all material from
the time of receipt through the entire production process. The system is to
include methods of handling that prevent abuse, misuse, damage or
deterioration.
- Secure storage areas or rooms are to be provided to isolate and
protect material pending use. To detect deterioration at an early stage, the
condition of material is to be periodically assessed.
- The manufacturer is to arrange for the protection of the quality
of his product during transit. The manufacturer is to ensure, in so far as
it is practicable, the safe arrival and ready identification of the product
at destination.
5.2.31
Training. The manufacturer is to follow a policy for recruitment and training
which provides an adequate labour force with such skills as are required for each
type of work operation. Appropriate records are to be maintained to demonstrate that
all personnel performing process control, special processes inspection and test or
quality system maintenance activities have appropriate experience or training.
5.3 Arrangements for acceptance and
certification of purchased material
5.3.1 The manufacturer is to establish and maintain procedures and controls to
ensure compliance with LR’s requirements for certification of materials and
components at the supplier’s plant. The manufacturer’s system for control of such
purchased material may be based on one of the following alternatives, subject to the
approval of LR:
- Product certification by LR’s Surveyors at the supplier’s works in
accordance with the requirements of the Rules for Materials.
- Agreed Inspection Procedures at the
manufacturer’s plant combined with documentary evidence of vendor assessments,
vendor rating records and annual surveillance visits to the suppliers.
- Recognition of quality agreements between the
manufacturer and his suppliers which are to provide for initial vendor
assessments and regular surveillance visits (a minimum of four per year). The
quality agreement must identify the individual in the supplier’s plant who is
charged with the responsibility for release of materials or components and the
procedures to be adopted.
5.3.3 Where the manufacturer’s system for control of purchased material is
based upon Pt 6, Ch 1, 3 Ergonomics of control stations, the Surveyors shall also make
surveillance visits to the supplier’s works at the minimum specified intervals. The
manufacturer is also to make available to the Surveyors documentary evidence of the
operation of quality agreements or Agreed Inspection Procedures where applicable.
5.4 Information required for approval
5.4.1 Manufacturers applying for approval under this scheme are to submit the
following information:
- A description of the products for which certification is
required including, where applicable, model or type number.
- Applicable plans and details of material used.
- An outline description of all important manufacturing plant and
equipment.
- A summary of equipment used for measuring and testing during
manufacture and completion.
- The Quality Manual.
- A typical production flow chart and quality plan covering all
stages from ordering of materials to delivery of the finished product.
- The system used for the identification of raw materials,
semi-finished and finished products.
- The number and qualifications of all staff engaged in testing,
inspection and quality control duties.
- A list of suppliers of components and manufacturers, proposed
procedures to ensure compliance with LR’s requirements for certification of
materials and components at the supplier’s plant.
5.5 Assessment of works
5.5.1 After receipt and appraisal of the information requested in Pt 5, Ch 1, 5.4 Information required for approval, an inspection of the works is to be carried
out by the Surveyors to examine in detail all aspects of production, and in
particular the arrangements for quality control.
5.5.2 The Surveyors will not specify in detail acceptable quality control
procedures, but will consider the arrangements proposed by the works in relation to
the manufacturing processes and products.
5.5.3 In the event of procedures being considered inadequate, the Surveyors
will advise the manufacturer how such procedures are to be revised in order to be
acceptable to LR.
5.5.4 Gauging, measuring and testing devices are to be made available to the
Surveyors, and where appropriate, personnel for the operation of such devices.
5.6 Approval of works
5.6.1 If the initial assessment of the works confirms that the manufacturing
and quality control procedures are satisfactory, the Classification Committee will
issue to the manufacturer a Quality Assurance Approval Certificate which will
include details of the products for which approval has been given. This Certificate
will be valid for three years with renewal subject to satisfactory performance and
to a satisfactory triennial reassessment.
5.6.2 An extension of approval in respect of product type may be given at the
discretion of the Classification Committee without any additional survey of the
works.
5.6.3 LR will publish a list of manufacturers whose works have been
approved.
5.7 Maintenance of approval
5.7.1 The arrangements authorised at each works are to be kept under review by
the Surveyors in order to ensure that the approved procedures for manufacture and
quality control are being maintained in a satisfactory manner. This is to be carried
out by:
- regular and systematic surveillance;
- intermediate audits at intervals of six months;
- triennial reassessment of the entire quality system.
5.7.2 For the purpose of regular and systematic surveillance, the Surveyors
are to visit the works at intervals determined by the type of product and the rate
of production. The Surveyors are to advise a senior member of the quality control
department in regard to any matter with which they are not satisfied.
5.7.3 When minor deficiencies in the approved procedures are disclosed during
the systematic surveillance the Surveyors may, at their discretion, apply more
intensive supervision, including the direct inspection of products.
5.7.4 Any noteworthy departures from the approved plans of specifications are
to be reported to the Surveyors and their written approval obtained prior to
despatch of the item.
5.7.5 Minor alterations in the approved procedures may be permitted provided
that the Surveyors are advised and their prior concurrence obtained.
5.7.6 In addition to the regular visits by the Surveyors, an intermediate audit
is to be carried out every six months. This will normally be carried out by
Surveyors other than those regularly in attendance at the works. This audit is to
consist of an examination of part of the manufacturer’s quality system. An audit
plan will be established indicating those areas of the quality system which will be
examined during every intermediate audit and the frequency of examination of other
areas such that all areas are subject to audit before reassessment is due.
5.7.7 The manufacturer’s entire quality system is to be subject to
reassessment at three-yearly intervals. This is to be conducted by Surveyors
nominated by LR.
5.8 Suspension or withdrawal of
approval
5.8.1 When the Surveyors have drawn attention to significant faults or
deficiencies in the manufacturing or quality control procedures and these have not
been rectified, approval of the works will be suspended. In these circumstances, the
manufacturer will be notified in writing of the Classification Committee’s reasons
for the suspension of approval.
5.8.2 When approval has been suspended and the manufacturer does not effect
corrective measures within a reasonable time, the Classification Committee will
withdraw the Quality Assurance Approval Certificate.
5.9 Identification of products
5.9.1 In addition to the normal marking by the manufacturer, all certified
products are to be hard stamped on a principal component with a suitable
identification, LR’s brand and the number of the approved works.
5.9.2 After issue of the Quality Assurance Approval Certificate, products may
be dispatched with certificates signed on behalf of the manufacturer by an
authorised senior member of the quality control department or by an authorised
deputy. These certificates are to be countersigned by the Surveyor to certify that
the approved arrangements are being kept under review by regular and systematic
auditing of the manufacturer’s quality system.
5.9.3 The following declarations are to be included on each certificate:
- ‘This is to certify that the items described above have been
constructed and tested with satisfactory results in accordance with the
Rules of LIoyd’s Register.
Signed...................................................... Manager of QC
Department.’
- ‘This certificate is issued by the manufacturer in accordance
with the arrangements authorised by Lloyd’s Register in Quality Assurance
Approval Certificate No. QA.M................................... I certify
that these arrangements are being kept under review by regular and
systematic auditing of the approved manufacturing and quality control
procedures. Signed.......................................................
Surveyor to Lloyd’s Register’.
5.9.4 In the event of noteworthy departures from the approved plan or
specification being accepted, a standard ‘Concession’ form is to be completed and
signed by the following authorised persons: the design Manager, the Quality Control
Manager or their deputies. In all cases, where strength or functioning may be
affected, the form is to be submitted to the Surveyors for approval and
endorsement.
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