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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), Perfor-
mance Qualification (PQ) and, in some
cases, process validation. In all cases, re-
sponsibility for implementing the necessary
measures lies with the equipment operator.
Miele’s in-house after-sales service opera-
tion, though, can provide support by
assuming some of the duties incumbent on
the operator. Miele’s tailored service pack-
age covers Installation and Operation
Qualification (IQ/OQ).
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 service engineers
Miele’s own service engineers are given
training covering all aspects of machine
technology (installation, programming, re-
pair and maintenance) in regular refresher
courses. This is complemented by spe-
cialised training on the qualification of
Miele cleaning systems used in industrial
and laboratory operations. Theory and
practice are not confined to washer-disin-
fectors 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).
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 docu-
ment, check and assess the following:
Compliance of shipment with original
order, unit configuration and condition, in-
stallation and connection to on-site utilities
and the calibration of certain measuring
systems.
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 in-
stalled and connected. Operation Qualifi-
cation documentation, inspections and
evaluation cover functions with a relevance
to safety and operation, process-related
messages and warnings, and programme
sequence.
Training of operatives and the documenta-
tion of such measures is also carried out
during Operation Qualification. This consti-
tutes a comprehensive package compris-
ing IQ/OQ paperwork, the services of high-
ly skilled and qualified service engineers
and the use of calibrated, certified test
apparatus.
Miele Service Pack:
Qualification of cleaning systems