✅ Steps in Risk Assessment (As per ICH Q9)

 

✅ Steps in Risk Assessment (As per ICH Q9)

1. Risk Identification

• What could go wrong?

• Identify potential hazards, failure points, or sources of variability

📌 Example: "There is a risk of cross-contamination during tablet coating."

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2. Risk Analysis

• Assess the severity, probability, and detectability of the identified risk.

Parameter	Description
Severity (S)	Impact on product quality/patient
Probability (P)	Likelihood of occurrence
Detectability (D)	Likelihood of detecting before release

📌 Tools often used: FMEA, Ishikawa (fishbone), 5 Whys, Hazard Analysis

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3. Risk Evaluation

• Combine scores to prioritize risks (e.g., using a Risk Priority Number – RPN):

$$\text{RPN} = \text{Severity} \times \text{Probability} \times \text{Detectability}$$

• Set thresholds:

  • High risk (e.g., RPN > 100) → needs immediate action

  • Medium risk → requires mitigation

  • Low risk → monitor or accept

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4. Risk Control

• Decide on actions to eliminate or reduce risk:

  • Corrective actions

  • Process redesign

  • Preventive maintenance

  • SOP changes

  • Additional controls or alarms

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5. Risk Review

• Monitor over time

• Reassess if:

  • A change occurs

  • A deviation or complaint arises

  • New data is available

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🧾 Output of Risk Assessment:

• Risk assessment report (RA form)

• Mitigation plan (if needed)

• Updated procedures or specifications

• Documentation in validation protocol, change control, or investigation

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📌 Example – Simple Risk Matrix

	Low Impact	Medium Impact	High Impact
Low Likelihood	Low Risk	Medium Risk	High Risk
Medium Likelihood	Medium Risk	High Risk	High Risk
High Likelihood	High Risk	High Risk	High Risk