Operation Qualification

1.0        PURPOSE

To lay down the procedure for Operation and Facility Qualification of the Equipments / Instruments/Systems/ Facility.

2.0        SCOPE 

2.1    This procedure is applicable in All departments

3.0        RESPONSIBILITY

3.1    Validation – Coordinator

4.0        ACCOUNTABILITY

4.1    Manager-Quality Assurance

5.0        PROCEDURE

OPERATION QUALIFICATION :
5.1    The OQ protocol will be as detailed as possible to avoid later confusion over any aspect that was not previously documented. The records can be used as a basis for comparison for proposed changes.
5.2    The protocol consists of the following information in the respective cells of the format given in Annexure-I

5.3    The contents of the Protocols shall be as follows
 
5.3.1    TABLE OF CONTENTS 

5.3.1.1    Protocol Approval
5.3.1.1.1    Consists of the Name, Designation, Signature 
and date of the person(s) responsible for the Preparation, Checking and Approval of the Protocol. 

5.3.1.2    Objective
5.3.1.2.1    The objective of the protocol shall be 
discussed in this section.

5.3.1.3    Scope
5.3.1.3.1    The scope of the subjected equipment shall 
be discussed in this section 

5.3.1.4    Execution Team
 
5.3.1.4.1    Name, Designation and signatures of the 
Execution team responsible for the execution of the protocol 
 
5.3.1.5    Critical instrument Calibration 
5.3.1.5.1    The class “C” Instruments identified for 
calibration during Installation Qualification shall be calibrated and the observation and or the results shall be recorded in a separate data sheet or reference of the data sheet shall be provided in this section.
 
5.3.1.6    Key Functions 
5.3.1.6.1    The key functions will be classified but not 
limited to the specific headings listed here. Each function test shall be recorded in a separate test data sheet specifying each test function, action, expected output/result, actual output/result, remarks.

i.    Equipment /System Start up
ii.    Functional Checks     
iii.    Interlocks and alarms Check
iv.    Safety / Security checks
v.    Equipment /system shut down

Headings may be  combined on case to case basis: based on the respective procedure.

5.3.1.7    Simulation Cycle 
5.3.1.7.1    Three trials shall be carried out to check the 
operational accuracy 

5.3.1.8    Verification of Standard Operating Procedure 
5.3.1.8.1    Verification of the SOPs for Operation, 
Cleaning and Preventive Maintenance and Calibration.

5.3.1.9    Deficiencies and Corrective Action Report
a). Description of deficiency observed and date  
b). Person responsible for corrective action and date assigned 
c). Corrective actions taken /conducted with signature and date. 
 
5.3.1.10    Summary and Evaluation of Results
            a). Summary of document with relevant data
b). Analysis / Evaluation of data finished in the document.

5.3.1.11    Abbreviations
5.3.1.11.1    Expanded form of abbreviations used shall be defined.
5.3.1.12    Post approval
5.3.1.12.1    Consists of the Name, Designation, Signature 
and date of the person(s) responsible for the Preparation, Checking and Approval of the Protocol. 

5.4    Preparation execution of the OQ protocol as per Annexure-I
5.5    Facility shall be qualified as per facility qualification format (Annexure – II) and Area qualification format (Annexure – III)

                                                        END OF DOCUMENT