EQUIPMENTDESIGN & QUALIFICATIONS

Equipment QualificationEquipment Qualification (EQ) is the overall process of ensuring that an instrument is appropriate for its intended use.

Qualification StagesDesign Qualification

Installation Qualification

Operational Qualification

Performance Qualification

Qualification PurposesDesign qualification (DQ) for setting functional and performance specifications (operational specifications). Installation qualification (IQ) for performing and documenting the installation in the selected user environment.

Qualification PurposesOperational qualification (OQ) for testing the equipment in the selected user environment to ensure that it meets the previously defined functional and operational specifications. Performance qualification (PQ) for testing that the system consistently performs as intended for the selected application.

Design QualificationDescription of the process Selection of the process technique Description of the intended use of the equipment Description of the intended environment Preliminary selection of the functional and performance specifications (technical, environmental, safety) Preliminary selection of the supplier Instrument tests (if the technique is new) Final selection of the equipment Final selection of the supplier and equipment Development and documentation of final functional and operational specifications

Equipment DesignAppropriate design & specificationsShould be based on process requirementAdequate sizeSuitably locatedTo facilitate operationsTo facilitate proper cleaning

Equipment DesignConstructed material should beNon- reactiveNon- additiveNon-absorptiveTo prevent product contact with equipment lubricants and coolantsMaintenance

Installation QualificationThe process of checking/verifying the installation to ensure that the critical components meet the approved specifications and that they are installed correctly in accordance with design documentationTo establish that the critical components are installed correctly and in accordance with design documentation requirements (ie purchase orders, contracts etc), that supporting documentation is in place and of suitable quality.

IQ MethodologyVerification of utilities and building servicesCompare equipment, as received, with purchase order (including software, accessories, spare parts) Check documentation for completeness (operating manuals, maintenance instructions, standard operating procedures for testing, safety and validation certificates) Check equipment for any damage

IQ MethodologyInstall hardware (computer, equipment, fittings and tubing for fluid connections, power cables, data flow and instrument control cables) Materials in product contact verificationSwitch on the instruments and ensure that all modules power up and perform an electronic self-test Verify correct software installation, e.g., are all files loaded. Utilities to do this should be included in the software itself.

IQ MethodologyIdentify and make a list with a description of all hardware, include drawings where appropriate. Instrumentation (Critical /Non-critical) List equipment manuals and SOPs Instrument features (Model no.,Capacity, Identification no.,)Prepare an installation report

OQ MethodologyApplication SOPsUtilization listProcess descriptionTest instruments utilized and calibrationCritical functional parametersTest reports functions (Challenge tests)Traceable standards establishmentTraining

PQ Methodology"Performance Qualification (PQ) is the process of demonstrating that an equipment consistently performs according to a specification appropriate for its routine use " Important here is the word consistently. The test frequency is much higher than for OQ. Another difference is that PQ should always be performed under conditions that are similar to routine process requirements.

PQ MethodologyPlacebo trails (If applicable)Define the performance criteria and operating conditions. Select critical parameters with some allowance to drift out of predefined specifications. Define corrective actions on what to do if the system does not meet the criteria, in other words if the system is out of specification

Basic IQ,OQ & PQCommissioning and QualificationProject Phases Qualification PhasesTechnology Transfer Collecting data Conceptual Design Basic Design Preliminary VMP Detailed Design Detailed VMP Procurement Detailed planning,DQ Construction IQ Pre commissioning Commissioning OQ