RISK MANAGEMENT TOOLS - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 30

TABLE 2.4 Example Template for Conducting HAZOP Analysis
Node:
10

Process Stream:
Purified Water System

Drawings:
PFD 1
P&ID 2

Design Conditions/Parameters:
Supply water by batch to process vessel at one of several steps—initialization, quench, final purge, cleaning, makeup

Comments:
Evaluation conducted as part of Design Review.

Risk Matrix

Deviation Causes Consequences Safeguards S L RR Recommendations Responsibility Remarks

No flow Flow Valve
fails closed
when open is
required

Inability to supply
water when
needed

1. Valve position
indication
2. Flow indication
FI-YY on line
3. Operator
surveillance

2 4 8 No recommendations—

Safeguards deemed
adequate

N/A None

No flow Loss of
Pressure on
supply line

Inability to supply
water when
needed

1. Pressure
measurement
PI-XX
2. Operator
surveillance

2 3 6 No Recommendations—

Safeguards deemed
adequate

N/A None