Establish Protocol IQ / OQ / IOQ

Purpose

Installation Qualification

Installation Qualification or IQ is one of the 3 validation steps. Installation qualification is a documented process that verifies that all aspects of facilities, utilities and equipment that affect product quality meet the approved design specifications and that the device or instrument has been properly delivered with all technically documented specifications and properly installed.

 Operational Qualification

Operational Qualification or OQ is the 2 nd of the 3 validation steps. Operational qualification or OQ is an essential process in the development of equipment commonly used by food & pharmaceutical companies. OQ can be simply defined as a series of tests that ensure that equipment and its subsystems operate consistently and reliably within their specified limits. It is a collection of test cases used to verify the proper functioning of a system. The requirements for the operational qualification test are laid down in the specification of functional requirements. Operational qualification must be performed before the system is released for use. 

Target Audience

Employees of High Tech, Food and Pharmaceutical companies who work directly or indirectly with the commissioning of operational equipment and/or systems.

 Intent

This training consists of 1 half day (4 hours) and deals with the process of information collection, setting up protocol and method of control. During this training we will set up an IQ protocol and simulate an execution.

Program

Installation Qualification

· Why an IQ
· Which data should be collected
· Drawing up IQ Protocol
· Inspecting technical drawings for up-to-dateness
· Check supplied documents
· Check installation of architectural and functional components
· Check mechanical components
· Control Electrical components
· Control Computer Software & Hardware components
· Control Support local maintenance
· Check that all critical instruments are calibrated

Operational Qualification 

· Functionality of an OQ
· When to create an OQ
· Making use of the established requirements
· Draft, review and authorization process OQ Protocol
· Job description operator, validation executor and witness
· Perform qualification

· Dealing with deviation

Qty participants   8 - 12