Business Use

Annexure 1

TITLE: FMECA to Modify Control Panel of Tumbler dryers

Residual

Detectability Ranking
Risk

Likelihood Ranking
Severity Ranking
Part Function / Use Potential Potential Effects Potential Is Risk Mitigation Evaluati Risk

SXLXD
/process/ Failure Mode of Failure Cause of risk Plan on Com
(Describ

RPN
component Failure acce munic

(D)
(L)
p e if new ation
ted risks are (Yes/
yes/ introduc No)
No ed
(Yes/
No)
Tumbler Dryer To Operate 1. Tumbler 1. No Sufficient 1. HMI 4 4 2 32 YES 1. After NO NO
Control Panel Tumbler Dryer dryer tumbler for failure Modification of
operation Drying of control panel
capsule after OPL will be
prepared, and
Encapsulation
training will be
provided to
Operators and
maintenance
team
2. Capsule drying
time will be
controlled
manually. QA
and Production
department
will ensure
from Batch
record or TD
Ref. No.: VV-QUAL-67143 Version No. 2.0 DOC ID: VV-QUAL-72729
Page 1 of 1
 Business Use

Annexure 1

TITLE: FMECA to Modify Control Panel of Tumbler dryers

Label or TD
History sheet
drying time of
capsules.

FMECA Done By:

Reviewed and Approved By:

Ref. No.: VV-QUAL-67143 Version No. 2.0 DOC ID: VV-QUAL-72729

Page 2 of 1