**Failure Modes and Effects Analysis (FMEA) for Auto Capsule Filling Machine Performance

Qualification:**

**1. Identify the CQAs (Critical Quality Attributes):**

- Capsule weight accuracy

- Blend homogeneity

- Fill weight consistency

**2. Select the Worst-Case Scenario:**

- Worst-case scenario: Significant deviation in capsule weight accuracy due to a malfunction in the
dosing system.

**3. Identify Failure Modes:**

- Failure Mode 1: Dosing system calibration drift

- Failure Mode 2: Auger malfunction leading to inconsistent powder flow

- Failure Mode 3: Sensor malfunction causing inaccurate weight measurement

**4. Assess Severity, Occurrence, and Detection for Each Failure Mode:**

| Failure Mode | Severity (S) | Occurrence (O) | Detection (D) |

|---------------------------------|--------------|----------------|---------------|

| 1. Dosing system calibration drift | High | Moderate | High |

| 2. Auger malfunction | High | Low | Moderate |

| 3. Sensor malfunction | High | Low | High |

**5. Calculate Risk Priority Number (RPN):**

- RPN = Severity × Occurrence × Detection

| Failure Mode | RPN |

 |---------------------------------|-----|

| 1. Dosing system calibration drift | 180 |

| 2. Auger malfunction | 120 |

| 3. Sensor malfunction | 120 |

**6. Prioritize Mitigation Strategies:**

- Prioritize addressing the dosing system calibration drift (RPN: 180) due to its highest risk.

**7. Implement Mitigation Measures:**

- Regular calibration checks and adjustments for the dosing system.

- Implement redundant sensors and alarms for immediate detection of calibration drift.

- Develop a preventive maintenance schedule for the auger system to minimize the risk of malfunction.

**8. Reassess RPN after Mitigation:**

- Conduct a post-mitigation FMEA to reassess the RPN for each failure mode.

**9. Document and Validate Mitigation Measures:**

- Document all implemented measures, calibration records, and maintenance activities.

- Validate the effectiveness of the mitigation measures through performance testing and data analysis.

**10. Continuous Improvement:**

- Periodically review and update the FMEA based on ongoing equipment performance, feedback, and
any new risks identified during routine operation.

By systematically applying FMEA, the auto capsule filling machine's worst-case scenario related to
capsule weight accuracy can be thoroughly addressed, ensuring the performance qualification meets the
desired quality standards.

**Failure Modes and Effects Analysis (FMEA) for Auto Capsule Filling Machine Performance
Qualification:**
**1. Identify the CQAs (Critical Quality Attributes):**

- Capsule weight accuracy

- Blend homogeneity

- Fill weight consistency

**2. Select the Worst-Case Scenario:**

- Worst-case scenario: Significant deviation in capsule weight accuracy due to a malfunction in the
dosing system.

**3. Identify Failure Modes:**

- Failure Mode 1: Dosing system calibration drift

- Failure Mode 2: Auger malfunction leading to inconsistent powder flow

- Failure Mode 3: Sensor malfunction causing inaccurate weight measurement

**4. Assess Severity, Occurrence, and Detection for Each Failure Mode:**

| Failure Mode | Severity (S) | Occurrence (O) | Detection (D) |

|---------------------------------|--------------|----------------|---------------|

| 1. Dosing system calibration drift | High | Moderate | High |

| 2. Auger malfunction | High | Low | Moderate |

| 3. Sensor malfunction | High | Low | High |

**5. Calculate Risk Priority Number (RPN):**

- RPN = Severity × Occurrence × Detection

| Failure Mode | RPN |

|---------------------------------|-----|

| 1. Dosing system calibration drift | 180 |

 | 2. Auger malfunction | 120 |

| 3. Sensor malfunction | 120 |

**6. Prioritize Mitigation Strategies:**

- Prioritize addressing the dosing system calibration drift (RPN: 180) due to its highest risk.

**7. Implement Mitigation Measures:**

- Regular calibration checks and adjustments for the dosing system.

- Implement redundant sensors and alarms for immediate detection of calibration drift.

- Develop a preventive maintenance schedule for the auger system to minimize the risk of malfunction.

**8. Reassess RPN after Mitigation:**

- Conduct a post-mitigation FMEA to reassess the RPN for each failure mode.

**9. Document and Validate Mitigation Measures:**

- Document all implemented measures, calibration records, and maintenance activities.

- Validate the effectiveness of the mitigation measures through performance testing and data analysis.

**10. Continuous Improvement:**

- Periodically review and update the FMEA based on ongoing equipment performance, feedback, and
any new risks identified during routine operation.

By systematically applying FMEA, the auto capsule filling machine's worst-case scenario related to
capsule weight accuracy can be thoroughly addressed, ensuring the performance qualification meets the
desired quality standards.

Certainly, let's perform a Failure Modes and Effects Analysis (FMEA) for a specific critical quality
attribute (CQA) in the performance qualification of a capsule filling machine. For this example, let's focus
on the CQA of "Capsule Weight Accuracy."
**1. Identify the CQAs:**

- Capsule Weight Accuracy

**2. Select the Worst-Case Scenario:**

- Worst-case scenario: Significant deviation in capsule weight accuracy due to a malfunction in the
dosing system.

**3. Identify Failure Modes:**

- Failure Mode 1: Dosing system calibration drift

- Failure Mode 2: Auger malfunction leading to inconsistent powder flow

- Failure Mode 3: Sensor malfunction causing inaccurate weight measurement

**4. Assess Severity, Occurrence, and Detection for Each Failure Mode:**

| Failure Mode | Severity (S) | Occurrence (O) | Detection (D) |

|---------------------------------|--------------|----------------|---------------|

| 1. Dosing system calibration drift | High | Moderate | High |

| 2. Auger malfunction | High | Low | Moderate |

| 3. Sensor malfunction | High | Low | High |

**5. Calculate Risk Priority Number (RPN):**

- RPN = Severity × Occurrence × Detection

| Failure Mode | RPN |

|---------------------------------|-----|

| 1. Dosing system calibration drift | 180 |

| 2. Auger malfunction | 120 |

| 3. Sensor malfunction | 120 |

**6. Prioritize Mitigation Strategies:**

- Prioritize addressing the dosing system calibration drift (RPN: 180) due to its highest risk.

**7. Implement Mitigation Measures:**

- Regular calibration checks and adjustments for the dosing system.

- Implement redundant sensors and alarms for immediate detection of calibration drift.

- Develop a preventive maintenance schedule for the auger system to minimize the risk of malfunction.

**8. Reassess RPN after Mitigation:**

- Conduct a post-mitigation FMEA to reassess the RPN for each failure mode.

**9. Document and Validate Mitigation Measures:**

- Document all implemented measures, calibration records, and maintenance activities.

- Validate the effectiveness of the mitigation measures through performance testing and data analysis.

**10. Continuous Improvement:**

- Periodically review and update the FMEA based on ongoing equipment performance, feedback, and
any new risks identified during routine operation.

By following this FMEA process, you can systematically address the worst-case scenario related to
capsule weight accuracy and ensure the performance qualification of the capsule filling machine aligns
with the desired quality standards.