To lay down the procedure for Design Qualification of the Equipments / Instruments/Systems.
1.0 PURPOSE
To lay down the procedure for Design 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 Design Qualification (DQ) 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
|
Cell Number |
Information |
Font |
|
01 |
To write the equipment/System name |
Upper case |
|
02 |
To write the equipment number |
Upper case |
|
03 |
To write the protocol number |
Upper case |
|
04 |
To write the effective date of the protocol |
Numeric |
|
05 |
To write the name of the Block |
Upper case |
|
06 |
To write the name of the module |
Upper case |
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 mentioned in this section.
5.3.1.3 Scope
5.3.1.3.1 The scope of the subjected equipment shall be mentioned in this section
5.3.1.4 Responsibility
5.3.1.4.1 In this section various responsibilities of different department involved in the qualification activities shall be mentioned.
5.3.1.5 Equipment / System Description
5.3.1.5.1 Brief description of the Equipment/System shall be mentioned.
5.3.1.6 Basis of Equipment / System design
5.3.1.6.1 The equipment / system capacity with reference to user requirement specifications shall be mentioned.
5.3.1.7 Design data (detailed specification)
5.3.1.7.1 The reference of data sheet shall be mentioned. Specifications of identified major/ critical components shall mentioned along with documentation requirements.
5.3.1.8 References
5.3.1.8.1 Reference documents like, user requirement specification, data sheets and drawing shall be mentioned.
5.3.1.9 Post construction review and discussions
5.3.1.10 Deviations and corrective actions taken
5.3.1.11 Summary and conclusion
5.3.1.12 Design qualification 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 DQ protocol as per Annexure-I
END OF DOCUMENT
Design qualification, quality assurance
