RISK MANAGEMENT TOOLS - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 37

Initiate
quality risk management
process

Risk ranking and filtering

Risk assessment

Identify risk factors (hazards)

Hazard identification

Risk analysis U

n
a
c
c
e
p
t
a
b
l
e

Group risk factor into categories

Risk evaluation

Assign risk scores

Risk control

Risk reduction

Rank and filter

Risk acceptance

Output/report and
implementation

Risk review

Risk event

Figure 2.10 Risk ranking and filtering.

very useful for identifying all potential hazards that may not have been identified
from a PHA or HAZOP.

2.4.7.3 Checklist Analysis A checklist analysis is a systematic evaluation
against preestablished criteria in the form of a checklist. The process generates
qualitative lists of conformance and nonconformance determinations, with
recommendations for correcting nonconformance. The best use of checklists is
when there is an existing process or standard. For example, there is a design
review for a product, and there is an ASTM (American Society for Testing and
Materials) standard for certain characteristics that the product needs to meet. A
checklist would be created so that at the end of the risk assessment the checklist
would be used for conformance to the standard.