Installation Qualification

1.0     PURPOSE 
        To lay down the procedure for Installation Qualification of the Equipments / Instruments/Systems.

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

5.1    The IQ 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

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

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

5.3.1.3    Scope

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

5.3.1.4    Execution Team
 
Name, Designation and signatures of the Execution team responsible for the execution of the protocol 
 
5.3.1.5    Equipment / System Description   
          
        Brief description of the Equipment/System
 
5.3.1.6    Identification of major components / Accessories

    The major components of the subjected equipment shall be identified and recorded

5.3.1.7    Installation Check / Review 

5.3.1.8    Inspection Check / Review

Inspection of each part and the sub part of the installed equipment     in detail shall be recorded in the individual Data sheets.

5.3.1.9    Identification, Classification and Verification of Process Control Instruments 

The process control instruments shall be identified and classified into two categories 
•    Critical 
•    Monitor

5.3.1.10    Identification and verification of Material of      Construction

5.3.1.11    Identification and Verification of Supporting Utilities

5.3.1.12    List of the Supporting utilities shall be identified and recorded  

5.3.1.13    Identification of Standard Operating Procedure 

5.3.1.14    Identification of the SOPs for Operation, Cleaning and Preventive Maintenance and Calibration.

5.3.1.15    Identification and Verification of Documents

5.3.1.16    Each document provided with the equipment /system shall be identified with unique code number for traceability.

All the relevant drawing will be categorized and attached in this section 
a). Piping and Instrumentation diagram (P&ID)
b). General arrangement / Schematic line diagram
c). Utilities 
d). Isometric Diagrams (Using drawings might vary as per requirement  of individual protocol)

5.3.1.17    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. 
 
5.3.1.18    Summary and Evaluation of Results

        a). Summary of document with relevant data
        b). Analysis / Evaluation of data finished in the document.

5.3.1.19    Abbreviations
Expanded form of abbreviations used shall be defined.
5.3.1.20    Post approval
5.3.1.21    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 IQ protocol as per Appendix-I

END OF DOCUMENT

Installation qualification, quality assurance