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CDOIF
Chemical and Downstream Oil
Industries Forum
CDOIF is a collaborative venture formed to agree strategic areas for
joint industry / trade union / regulator action aimed at delivering
health, safety and environmental improvements with cross-sector
benefits.
Guideline – Demonstrating Prior Use v4
Page 11 of 30
2. The Quality Management System
1
for manufacture of a component similar to the
one in question has been independently verified by a third party certification body,
and would be supported by a third party certificate verifying compliance with
relevant standards such as ISO 9001. In addition, the equipment manufacturer
(or third party certification body) has performed a quality assurance gap analysis
between the component which is intended to form part of the SIF, and the version
which has been assessed to identify any differences which may impact a claim of
prior use.
3. Where there has been no third party or retrospective assessment of the
component, the following information should be available from the manufacturer
in order for the duty holder to make an accurate evaluation of the suitability of the
component:
•
The suitability of the quality management system
•
The length of time that the manufacturer has been trading
•
The quantity of components that have been manufactured (which may be
required where there is limited confidence in the manufacturers quality
management system or the component has been manufactured over a
limited period of time)
•
Whether the component is still in production
o
If it is still in production, a history of design modifications where
this is available
•
The process of revision control that is in place for modifications to the
component
•
Availability of operating and maintenance manuals for the component
•
The procedures in place for returns and equipment failure assessments
(note that this refers to the procedures in place to monitor returns of failed
equipment, and not to the sole use of this information as part of a prior
use demonstration)
•
Evidence of and procedures for dealing with component re-call’s or safety
modifications
•
Evidence of reliability data for the component where this is available
1
Most manufacturers will have a quality management system and be accredited to a
standard such as ISO 9001. Part of this management system should have a
modification process which evaluates the impact of reported failures and
modifications in order to improve the quality of the devices being manufactured.
Appropriate evidence of design and manufacture to an industry recognised standard
should also be provided where possible. For example, an isolation valve situated in a