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In the pharmaceutical, food-processing
and cosmetics industries, all cleaning
systems used in production, quality
assurance and R&D must be 'qualified'.
Qualification involves the following:
Design Qualification (DQ), Installation
Qualification (IQ), Operation Qualification
(OQ), Performance Qualification (PQ)
and, in some cases, process validation. In
all cases, responsibility for implementing
the necessary measures lies with the
equipment operator. Miele's in-house
after-sales service operation, though, can
provide support by assuming some of the
duties incumbent on the operator. Miele's
tailored service package covers Installation
and Operation Qualification (IQ/OQ).
Installation Qualification (IQ)
The objective of Installation Qualification
is to verify that the cleaning system and
its installation comply with the operator's
and manufacturer's requirements. During
the IQ inspection, Miele service engineers
document, check and assess the following:
Compliance of shipment with original order,
unit configuration and condition, installation
and connection to on-site utilities and the
calibration of certain measuring systems.
Miele Service Pack:
Qualification of cleaning systems
Training of service engineers
Miele's own service engineers are given
training covering all aspects of machine
technology (installation, programming,
repair and maintenance) in regular
refresher courses. This is complemented
by specialised training on the qualification
of Miele cleaning systems used in industrial
and laboratory operations. Theory and
practice are not confined to washer-
disinfectors either: they also cover all
peripheral units likely to be encountered in
industrial applications (for example Miele's
Aqua Purificator to produce demineralised
water, dispensing systems and accessories
such as mobile injector units and inserts).
Implementation
Before IQ/OQ can be performed by Miele's
in-house service engineers the necessary
documentation must be compiled, checked
and approved by the operator for use during
the inspection. Miele service technicians
will then perform qualification on the basis
of this documentation. All the necessary
calibrated and certified test apparatus is
provided by Miele.
Training of operatives and the
documentation of such measures is also
carried out during Operation Qualification.
This constitutes a comprehensive package
comprising IQ/OQ paperwork, the services
of highly skilled and qualified service
engineers and the use of calibrated,
certified test apparatus.
Operation Qualification (OQ)
The objective of Operation Qualification is
to furnish proof that the cleaning system
meets the requirements of the operator and
equipment manufacturer when installed
and connected. Operation Qualification
documentation, inspections and evaluation
cover functions with a relevance to safety
and operation, process-related messages
and warnings, and programme sequence.