RISK ASSESSMENT IN PURIFIED

WATER SYSTEM (PWS) USING

FMEA AND FUZZY
PRIORITIZATION AT
PHARMACEUTICAL COMPANY
Broto Dhegdo Haris Pranoto
Mohammad Arif Rohman
Introduction
• Water is a major part of the pharmaceutical
industry and water is used to prepare sterile
and non-sterile product materials, wash
hands during production and before the
drug production process (Sandle, 2015).

• There have been some problems during the

existing operation of PWS consist of not
optimal flow process, filter blocking which
causes growth of microorganism, inaccurate
chemical adjustment during operation.
• The main source of water used in the
• Fuzzy FMEA is the development of the FMEA pharmaceutical industry to make
method which provides flexibility to medicines is water produced from the
accommodate uncertainty due to the vagueness purification process using the Purified
of the information possessed or subjective Water System (PWS)
preference elements used in the assessment of
the failure mode that occurs (Braglia et al. 2003).
The 3rd International Conference on Management of Technology, Innovation, and Project
 Literature review

PWS in PT XYZ
Quality Risk Management United States Pharmacopeia (USP)
process according to ICH and the Indonesia Food and Drug
Q9 Administration (BPOM)

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1 Methodology
Initiate Quality Risk Management
2.1
(QRM)
Identifying risks and fuzzy comparison matrixes for
occurrence, severity, and detection

2.2
Determining importance coefficients (weight
2 vectors) by fuzzy prioritization method
The stages of Failure Mode and Effect Analysis
(FMEA) 2.3
Converting the importance coefficients (weight
vectors) into FMEA degrees

2.4

Finding Risk Priority Number (RPN) values

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Result and Discussion
• As a result, 22 Risk identified for new
purified water system an RPN value which
are higher than 72.
• Risk reduction or control actions are
required. Risk control recommendations
for all high and medium risks must be
reviewed and approved by Decision
Makers.
• Proposed risk control actions and
individual or group responsibilities for
these actions must be documented. If a
high risk cannot be further reduced,
formal acceptance must be documented
and approved by Site Quality and
Operations Head.
• This process can be realized by
investments to be made on the equipment,
employees, and supplier.

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 Conclusion
o The total risks identified in the new purified water system at PT
XYZ are 23 risks, of which 22 have a Risk Priority Number
(RPN) value of more than 72.Therefore this requires mitigation
actions that need to be monitored through the risk register.
o Risk response in the form of risk mitigation, which is based on
data or experience during old purified water system operations
starting from mitigation in the form of administration
(procedure creation), procurement or storage of spare parts if
the main component is damaged, design (Valve, Reverse
Osmosis type), and the determination of the parameters of the
level indicator (chemicals, temperature and pressure).
o Risk communication has followed quality risk management
according to the International Conference on Harmonization
(ICH Q9), starting from initiation, assessment, control to risk
assessment from the new purified water system to decision
makers at PT XYZ, at every stage of the process.
Suggestion
o The results of the research can be used as input
and reference for PT XYZ in conducting risk
assessments of several critical processes or tools
that exist in similar industries.
o Risks identified in this study are not limited to other
studies to ascertain the potential risks during the
operation of the purified water system, because the
potential risks can differ according to the critical
processes and parameters that are used as
references during the operation process.

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 THANK YOU

brotodhegdo@gmail.com , arif@ce.its.ac.id