QUALIFICATION WORKBOOK CUSTOMIZED SYSTEMS IQ;OQ

The picture may be different from the article and can include supply, which is not in the standard scope.

 

Creation of a workbook as proof of qualification for custom systems.

The documents in the workbook form the basis for the system operator, for example, to be able to carry out system qualification independently. It also serves as a template for monitoring institutions such as the FDA (Food and Drug Administration).
The workbook contains the following sections: IQ OQ.

Installation Qualification (IQ)

Documented confirmation that the water treatment system, as installed or modified, complies with the approved design and manufacturer's recommendations (order specifications).

Installation Qualification (IQ) essentially includes:

Installation qualification (IQ) essentially includes:
- Acceptance reports from the manufacturer for trial operation (FAT)
- Creation of specifications for delivery and assembly
- Conformity of offer with delivery and execution
- On-site plant construction
- Establishment of media connections, e.g., water/wastewater/electricity/control cables
- If necessary, integration into the process environment and its connection to other systems
- Initial cleaning and, if necessary, initial disinfection as required and to the extent necessary
- Operating instructions with maintenance instructions and maintenance measures
- Flow charts
- Consumables lists
- Spare parts lists
- Acceptance and handover reports

Operational Qualification (OQ)

Documented confirmation that the quality-relevant functions of the water treatment plant are reproducibly triggered by the control system and that the plant operates within the planned working range.

Operational qualification (OQ) essentially includes:
- Creation of specifications for operational verification
- Verification of the functionality of system components, interlocks, alarms, and sensors
- Verification of the operating instructions for conformity
- Logging

A documentation folder containing all necessary documents for qualification and validation is provided to the user.