RISK ASSESSMENT REPORT

Site Performing Risk Assessment:

1
Sanzyme (P) Ltd., Healthcare Unit – II.
Subject:
2
IBMS software up gradation
Risk Assessment Ref. No. & Date of Initiation:
3
QRA/19/010-00 & 25/10/19
4 Departments involved in Performing Risk Assessment:
Quality Assurance, Production, Engineering and Quality control.
Back Ground:
Presently IBMS software available with version number: GENESIS64 V 10.85 for monitoring
of Production cold room (PN/WIC-001); Dispensed material storage (PN/RFG-001);
Warehouse cold room -1 (WH/WIC-001); Warehouse cold room-2 (WH/WIC-002); Walk in
cooler (WH/WIC-003); Warehouse under test raw material (WH/RFG-001); Approved RM
Refrigerator (WH/RFG-002); Control sample room (QC/WIC-001); Micro Refrigerator
(MB/RFG-001); Walk-in stability chamber (QA/WSC-001).
5 It was proposed to upgrade the IBMS software to Version number: GENESIS64 V 10.95 for
monitoring of Production cold room (PN/WIC-001); Dispensed material storage (PN/RFG-
001); Ware house cold room -1(WH/WIC-001); Ware house cold room-2 (WH/WIC-002);
Walk in cooler (WH/WIC-003); Ware house under test raw material (WH/RFG-001);
Approved RM Refrigerator (WH/RFG-002); Reject & recall cold room (WH/WIC-004) ,
Control sample room (QC/WIC-001); Micro Refrigerator (MB/RFG-001); Walk in stability
chamber (QA/WSC-001) as per change control No. CRNEU19023 to get the better
performance of the system for monitoring of the cold rooms through IBMS.
6 Risk Assessment Tool :
FMEA (Failure Mode Effect Analysis)

Format No.: QA022-F05.02 Page 1 of 6

 RISK ASSESSMENT REPORT
RPN: Risk priority
SEV: Severity Score OCC: Occurrence Score DET: Detectability Score Score
Number
Very High 5 Very High 5 Very High 1 Low / Very Low /
1-7
High 4 High 4 High 2 None
Moderate / Medium 3 Moderate / Medium 3 Moderate / Medium 3 Moderate / Medium 8-25
Low 2 Low 2 Low 4
High / Very High >25
None 1 None 1 None 5

Occurrence

Occurrence
Serial Responsib

Detection

Detection
Severity

Severity
Item or Potential Potential “After”
No. of Potential Current Recommended ility and

RPN

RPN
Process Failure effect(s) of action
the Cause(s) Controls Action Target
Step mode failure taken
risk Date
1. Up Data may Actual 4 Calibration of 4 Recommende 2 32 The temperature EU,PN,W
gradatio not record condition of sensors not d to record the shall be H,QC,MI
n of the cold rooms performed. temperature of monitored by CRO,QA
Software under all cold rooms trained 25/10/19
monitoring Software may twice in a day personnel and
through not be chamber record the
system will validated. inbuilt sensors observed value
not be display on the manually till the
traceable sensor is IBMS wrong
during failure calibrated. under usage
period Qualification Software
Temperature chamber is validation shall
excursions if place be performed.
any during calibrated.
failure period
Format No. QA022-F05.02 Page 2 of 6
 RISK ASSESSMENT REPORT
RPN: Risk priority
SEV: Severity Score OCC: Occurrence Score DET: Detectability Score Score
Number
Very High 5 Very High 5 Very High 1 Low / Very Low /
1-7
High 4 High 4 High 2 None
Moderate / Medium 3 Moderate / Medium 3 Moderate / Medium 3 Moderate / Medium 8-25
Low 2 Low 2 Low 4
High / Very High >25
None 1 None 1 None 5

Occurrence

Occurrence
Serial Responsib

Detection

Detection
Severity

Severity
Item or Potential Potential “After”
No. of Potential Current Recommended ility and

RPN

RPN
Process Failure effect(s) of action
the Cause(s) Controls Action Target
Step mode failure taken
risk Date
may affect the
product
quality
2. Sensors Improper data 4 Sensors data 3 Only Manual Temperature to EN & QA .
incompati not Monitoring 1 9 be ensured with
bility with compared calibrated data
updated with loggers and
software calibrated should not vary
sensors data more than ± 0.5
ºc
Re Qualification
of protocol shall
be performed of
IBMS.

Format No. QA022-F05.02 Page 3 of 6

 RISK ASSESSMENT REPORT
RPN: Risk priority
SEV: Severity Score OCC: Occurrence Score DET: Detectability Score Score
Number
Very High 5 Very High 5 Very High 1 Low / Very Low /
1-7
High 4 High 4 High 2 None
Moderate / Medium 3 Moderate / Medium 3 Moderate / Medium 3 Moderate / Medium 8-25
Low 2 Low 2 Low 4
High / Very High >25
None 1 None 1 None 5

Occurrence

Occurrence
Serial Responsib

Detection

Detection
Severity

Severity
Item or Potential Potential “After”
No. of Potential Current Recommended ility and

RPN

RPN
Process Failure effect(s) of action
the Cause(s) Controls Action Target
Step mode failure taken
risk Date
Backup data After upgraded
may not of software all
SOP was
Accessing match to user data shall
User data may available
user data upgraded be verified if
not retrieved (QA/SOP-
at different patch which any discrepancy
3. which leads to 3 2 054) to 3 18 IT
user levels is unable absorbed user
existing user restore or
from access to creation request
login failure. modified the
backup user coded shall be given
user data.
from for software
backup. QA/SOP-054
4. Licensing The complete 4 Up gradation 3 No Current 4 48 Licensing data IT
upgraded with out controls are shall be reset for
software may licensing available upgraded
not accessible • upgraded patches and
due to lack of may not during
Format No. QA022-F05.02 Page 4 of 6
 RISK ASSESSMENT REPORT
RPN: Risk priority
SEV: Severity Score OCC: Occurrence Score DET: Detectability Score Score
Number
Very High 5 Very High 5 Very High 1 Low / Very Low /
1-7
High 4 High 4 High 2 None
Moderate / Medium 3 Moderate / Medium 3 Moderate / Medium 3 Moderate / Medium 8-25
Low 2 Low 2 Low 4
High / Very High >25
None 1 None 1 None 5

Occurrence

Occurrence
Serial Responsib

Detection

Detection
Severity

Severity
Item or Potential Potential “After”
No. of Potential Current Recommended ility and

RPN

RPN
Process Failure effect(s) of action
the Cause(s) Controls Action Target
Step mode failure taken
risk Date
qualification
licensing of
software shall be
configured verified for
licensing
existing activated
access rights
license data licensed
software details
is used duration
of license.

Format No. QA022-F05.02 Page 5 of 6

 RISK ASSESSMENT REPORT
Conclusion:
• Based on the above Assessment by adapting FMEA (Failure Mode Effects Analysis) tool, it is
concluded that proposed activity has direct impact on the Product manufactured as it having
maximum RPN 48. Hence it is considered as High. However mitigation actions are proposed for
High and medium risks.
• Risk assessment recommendation shall be executed to mitigate the risk identified.
• After completion of action items risk reports shall be prepared.

Approval

Name Designation & Department Sign / Date

Prepared By K. Suma Reddy Executive - EU

Ramu Chava Head - EU

Bipin Dalavi Head - PN

G. Ratna Prasad Manager - QC

Reviewed By K. Surreddy Dy. Manager - MB

G. Narsing Rao Asst. Manager - WH

Jagadish M Asst. Manager - QA

S. Bojjanna Dy. Manager - QA

Approved By M. Ali Abbas Sr. Manager- QA

Format No.: QA022-F05.02 Page 6 of 6