ולידציה – Operation Qualification – OQ- part 1
Protocol Preparation Overview
The Operation Qualification (OQ) protocol is part of the validation documentation that covers the verification of the proper operation of the system under validation in the user's facility. This OQ protocol is generic, and the system may include a PC with Human/Machine Interface (HMI), a Programmable Logic Controller* (PLC), pressure, temperature and humidity transmitters, and other monitoring and control components designed to maintain the user's facility in proper environmental conditions (temperature, pressure and humidity)
This OQ protocol is intended to verify that the system under validation operates according to the acceptance criteria specified in the Schedule of System Operation (SSO), and also meets the vendor's requirements and the user's specifications. It must be reviewed and approved prior to the OQ performance
OQ Protocol Contents
The OQ protocol is structured in a relatively standard fashion, with predetermined chapters and sections, where the final contents are tailored according to the type and size of the system under validation
:The chapters and sections of an OQ protocol are
Documents Verification – procedure intended to verify that all the documents required for performing the OQ procedure are approved and available
OQ Test Procedures – this is the main part of the protocol, and provides the description of the test procedures and the result tables for filling and approving the test results
: Note
As the final contents of the OQ protocol are tailored according to the type and size of the system under validation, and this document is generic, it covers test procedures that may not be necessary in small or simple systems
Documents Verification
:This procedure is intended to verify that all the documents required for performing the OQ procedure are approved and available. These documents are
Functional Requirements Specification (FRS)
Installation Qualification (IQ) Protocol
Piping and Instrumentation Drawing – P&ID
Input/Output (I/O) List
Schedule of System Operation (SSO)
OQ Test Procedures
This chapter contains all the test procedures or verification required to verify the system under validation is properly installed and can be properly operated according to the supplier's requirements and user's specifications
:Each test procedure or verification must include the same contents
Purpose or Objective
Procedure or Method
Acceptance Criteria
Test Results
*Here are some examples of the PLCs used by smartlogic: 6XV1830-0EH10, 6ES7131-4BF00-0AA0,6ES7193-4CA40-0AA0,6ES7134-4GD00-0AB0,6ES7193-4CA40-0AA0, 6ES7138-4CA01-0AA0,6ES7193-4CC20-0AA0, 6ES7590-1AB60-0AA0, 6ES7511-1AK00-0AB0, 6ES7954-8LP01-0AA0,6ES7155-6AU00-0BN0