POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 157

Preliminary Risk Assessment - Where is the risk?

(HU)MAN MACHINES MEASUREMENT

SPC for CPPs

Training

Line speed

Set up

Lighting
measurement

Vision

Lighting
intensity

Speed
measurement

qualification

Safe & effective
meets customer's
expectations,
particulate free
vials corrugated

controls

Physical

Realign with
strategic goals

Particulates

Process Review and

Plan

Nozzle strikes

Provide
resources

Analytical

Glass shards

MATERIALS MANAGEMENT

METHODS

Figure 7.6 Ishikawa Fishbone analysis example. ( See insert for color representation of

the figure .)

7.3.9 Criticality Analysis

Another method of impact assessment might ask questions related to: How impor-
tant is the function of the equipment or system to the quality of the product? Let
us look at this from the perspective of the light example.

1. What is the impact on product quality if this process step—visual

inspection—fails?
2. How important is the system or component—lighting—to the success of
the process step?
3. How robust is the process? How much variance can the process take and
still be effective—what are the operating parameters?
4. How effective or reliable are the control systems in place to control varia-
tion and prevent failure?
5. How effective are the ways to detect a failure before it adversely affects
the quality of the product or patient safety?
6. What is the control strategy or risk mitigation/risk reduction strategy for
assuring that process results remain in specification?

For the purpose of this exercise—one could use a simple HIGH, MEDIUM,
and LOW rating system. HIGH means very important, severe, definitely could
happen. LOW means not very important, not of much concern, doubtful it would
happen; MEDIUM is everything in between. Question (6) requires a more exten-
sive answer.