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

Biomedical Engineering Reference

In-Depth Information

TABLE 7.6 Example of a 10-Point Quantitative FMEA Risk Analysis Calculation,

Where: Risk = Risk Priority Number = Sev × Occ × Det

• Severity (SEV): Classify the severity or importance of the effect.

• Very low to no impact 1

• Unimportant failure 2-3

• Failure of medium importance, may cause customer dissatisfaction 4-6

• Critical failure, may cause harm to patient 7-8

Extremely critical failure, will likely cause significant harm to patient 9-10

• Occurrence (OCC): Estimate the probability of occurrence of the failure.

• Very low probability 1

• Failure might happen, but very seldom 2-3

• Failure happens from time to time 4-6

• Failure happens frequently 7-8

High probability that failure will happen 9-10

• Detection (DET): Evaluate the probability of the failure detection.

• Failure detection is ensured 1

• High probability of failure detection 2-3

• Failure detection not certain 4-6

• Low probability of failure detection 7-8

Failure detection is highly improbable 9-10

TABLE 7.7 Examples of Risk Category Descriptions and Risk Priority Rankings

for a 10-Point Quantitative FMEA