Miele G 7836, G 7883 Installation Qualification IQ, Implementation, Operation Qualification OQ

Miele Service Pack: Qualification of cleaning systems

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).

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.

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.

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 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).

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.

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