QUALIFICATION WORKBOOK CUSTOMIZED SYSTEMS DQ;IQ;OQ;PQ

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.

The documents in the workbook form the basis for the work of, for example,the plant operator, enabling them to carry out plant 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:
DQ IQ OQ PQ.

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Design Qualification (DQ)

Design qualification combines the information from the requirements and specifications and evaluates it.
If no design qualification has been carried out, the order specificationsare used and a comparison is made with the system design of the supplier.

Design qualification (DQ) essentially includes:
- Creation of specifications for equipment, delivery, assembly, and operation
- Monitoring of functional suitability by the system control, in particular the interlocks, alarms, and sensors (with certificates if necessary)
- Calculations and logging
- Design programs
- Documentation requirements

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Installation Qualification (IQ)

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

Installation Qualification (IQ) essentially includes:
- Acceptance reports from the manufacturer on trial operation (FAT)
- Creation of specifications for delivery and installation
- 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 according to requirements and scope
- Operating instructions with maintenance instructions and maintenance measures
- Flow charts
- Consumables lists
- Spare parts lists
- Acceptance, handover reports

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Operational Qualification (OQ)

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

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

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Performance Qualification (PQ)

Documented confirmation that the water treatment plant supplies water in the required quality—purified water (aqua purificata/ultra pure water)—and that the required performance is achieved.

Performance qualification (PQ) essentially includes:
- Creation of specifications for process verification
- Verification of process performance under worst-case conditions
- Determination of regular requalification

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