Addition of equipment/ instrument.

Preparation: User
URS Review: Engg
Addition of equipment in Approval: QA
Addition of new equipment in existing facility
new facility
Change Control process
Change control committee

Approval through SAP & Asset code Preparation: User

generation Review: Engg, MM
Document generated: Authorization: QA, User
Approved Change control
document.
Approved URS
Design Qualification Preparation: Vendor
DQ document
Review: User, Engg, Authorization:
PR, PO QA, User and Engg
FAT

PR & PO generation
User & MM, CC to WH

Material ordering
MM

FAT
Performed by: User, Engg & QA.

Material received at site

Inform MM and return

the material NO Physical checking of Performed by WH, QA & User
material for damage &
content?

YES
Installation of instrument/ equipment at site Performed by: Vendor in the presence of
user, Engineering and QA
Document generated:
Validation protocol
IQ, OQ & PQ Reports
Updation on equipment ID list in case of Equipment ID generation Requestor: User
new equipment Issuer: QA
Updated preventive maintenance schedule
by Engineering
Updation of Calibration planner by Commissioning of instrument/ equipment Performed by: Vendor in the presence of
Engineering user, Engineering and QA
Re-validation (why requalification )or
qualification , for new equipment (even
like to like) , it should be qualification
first, then requalification as per the Prepared by: User
Validation protocol Reviewed by: Engg and QA
planner
Closure of the change control Authorized by: QA
Installation Qualification

Prepared by: In-house (User &

Operational Qualification Engg) & Outsourced (vendor)

Performance Qualification

Instrument / equipment certification by user 1

Preventive Planned by: Engg Calibration Planned by: ENGG Validation

Performed by: User & Engg
Maintenance Performed by: Engg Performed by: CCL Authorized by: QA
Authorized by: User and QA Authorized by: User & QA

Disposal request is placed by User

1
Documentation

STOP Vetted by Engg

NO
YES

NO Disposal instruction received Disposal of Instrument /

Director approval from MM/ADM Equipment
YES
Sr No Items of process flow Mind Mapping (System in Place) Compliance (System function) – GAP(s)
1 Addition of equipment/instrument Yes No Gap

2 URS Yes No Gap

3 Change control Yes No Gap

4 Approval through SAP & Asset code generation Yes No Gap

5 Design qualification Yes No Gap

6 PR & PO generation Yes No Gap

7 Material ordering Yes No Gap

8 FAT Yes No Gap

9 Material received at site Yes No Gap

10 Physical checking of material for damage & content Yes No Gap

11 Installation of instrument/equipment at site Yes No Gap

12 Equipment ID generation Yes No Gap

13 Commissioning of instrument/equipment Yes No Gap

14 Validation protocol Yes No Gap

15 Installation qualification Yes No Gap

16 Operational qualification Yes No Gap

17 Performance qualification Yes It is not initiating by the user

18 Instrument/equipment certification by user Yes No Gap

19 Preventive maintenance of instrument/equipment Yes No Gap

20 Calibration of instrument/equipment Yes No Gap

21 Validation of instrument/equipment Yes It is not initiating by the Engg

22 Disposal request is placed by user Yes No Gap

23 Engg vetting process Yes No Gap

24 Director approval process Yes No Gap

25 Disposal instruction received Yes No Gap

26 Disposal of equipment/instrument Yes No Gap

27 Documentation of disposal process Yes No Gap