Problem Analysis of

Rahzi Dilemma’s Case

Decision Making and Negotiation

1. SG5 SLEMBA BPOM 1:

2. 1. Ely Rahmawati (NIM 29320072)
3. 2. Imam Luqman Hakim (NIM 29320073)
4. 3. Jazari Alfaridi (NIM 29320067)
5. 4. Kurniawan Norat (NIM 29320042)
6. 5. Rizka Ayu Kusuma Widjanarko (NIM 29320139)
7. 6. Shanty Sarah (NIM 29320212)
June 2021
 SITUATION APPRAISAL
Score*
Concerns Timing Trend Impact Process
(Priority)
1. The urge from SPC and Braxton’s leaders to use the H H H DA 9 (1)
‘frozen’ Epogex commercially instead of discard them
due to the claim of QA data study provided
2. Timeline for conducting clinical study of Epogex in H H H DA 9 (1)
Indonesia may not be fulfilled if the Epogex are not
ordered immediately
3. Temperature deviation during epogex storage (frozen M M H PA 7 (2)
epogex)
4. The QA study data of a “freeze-thaw” Epogex that M L H PA 6 (3)
Braxton had conducted in 2012 may be out of date &
irrelevant because it was not tested on the human
(patient), related to patient safety issue
5. As a new player in biosimilar market in Indonesia, any L L H PPA 5 (4)
issues regarding products safety and efficacy could
be jeopardize the reputation of SPC
6. The shelf life of Epogex only 18 months (limited), H M M DA 7 (2)
urgently required decision to be made
7. Potential financial loss if the frozen Epogex are L L M PPA 4 (5)
*score for each prioritiy: Low (L) = 1; Medium (M) = 2; High (H) = 3
discarded
 PROBLEM ANALYSIS
(Fishbone/Ishikawa Diagrams)

Machinery Manpower
Temperature 3PL does not 3PL does not carry
regulator was Not yet using understand the
technology for out the procedures
broken procedures
monitoring e.g., RFID There has been no
The temperature gauge
Equipment training for the
was not calibrated Lack of logistics
maintenance personnel involved
The logistics personnel/over workload
Cold storage was is not routine
not calibrated Refrigerant
officer misread Lack of experience of Supply Temperature
the procedures Chain Div. in logistics arrangement
leak
of cold supply chain
deviation
during epogex
storage
Temperature
Length of
shipment sensitive product Method has
Method does
not updated
(frozen
Uninformative
Sea wave
label packaging
been not epogex)
Transit validated Method is hard
time Do not have cold chain to understand
Method has not
monitoring equipment
been socialized No performance
on packaging
No adequate method in evaluation
handling temperature scoreboard
sensitive products

Environment Materials Methods

*methods including procedures, SOPs

 CONCLUSION
 Problem Analysis based on fishbone/ishikawa diagrams showed
possible causes from the aspect of methods, manpower,
materials, machinery and environment
 It is necessary to verify each possible causes as the basis for
Decision Analysis to examine the available options and the risks
of each alternative
 For the next process, Potential Problem Analysis can be done to
avoid possible negative consequences and turn situations to the
advantage
THANK YOU