PFMEA Course for Medical Device Manufacturing

Process Failure Mode and Effects Analysis (PFMEA) - English

Process FMEA is a systematic method for identifying potential failures in manufacturing, assessing their severity, occurrence, and detection difficulty, and then prioritizing corrective actions to prevent product defects and ensure quality.

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Process FMEA (PFMEA)

Process FMEA is a systematic, team-based method to identify and evaluate potential process failures, their effects, root causes, and current controls. It prioritizes risks using numerical analysis and recommends preventive actions to improve reliability and reduce manufacturing defects.

Explain foundational concepts of pFMEA along with a brief history and how it integrates with ISO 14971 and Process Validation requirements.
Apply systematic tools, such as, function analysis, process flow diagrams, to identify failure modes supported by data.
Develop risk-appropriate prevention and detection controls using the 6M framework to identify appropriate control types based on risk.
Evaluate failure mode risk using severity, occurrence, and detection to calculate RPN values and apply severity-weighted prioritization.
Translate pFMEA into comprehensive control plans that align control strategies with IQ/OQ/PQ validation stages.
Develop and sustain pFMEA as a living document that improves with production data and learning.

Course curriculum

1. Welcome to pFMEA!
2. Course learning objectives
1. Learning objectives
2. Standards referenced
3. FMEA Background (Part 1)
4. FMEA Background (Part 2)
5. FMEA Background (Part 3)
6. FMEA Background (Part 4)
7. FMEA Background (Part 5)
8. FMEA Background (Part 6)
9. FMEA Background (Part 7)
10. FMEA Background (Part 8)
11. FMEA Background (Part 9)
12. FMEA Background (Part 10)
13. FMEA Background (Part 11)
14. FMEA Background (Part 12)
15. FMEA Background (Part 13)
16. FMEA Background (Part 14)
17. FMEA Background (Part 15)
18. FMEA Background (Part 16)
19. FMEA Background (Part 17)
20. QUIZ
1. Learning objectives
2. FMEA Examples (Part 1)
3. FMEA Examples (Part 2)
4. FMEA Examples (Part 3)
5. FMEA Examples (Part 4)
6. FMEA Examples (Part 5)
7. FMEA Examples (Part 6)
8. FMEA Examples (Part 7)
9. FMEA Examples (Part 8)
10. FMEA Examples (Part 9)
11. FMEA Examples (Part 10)
12. QUIZ
13. SAMPLE DEVICE & PROCESS
1. Learning objectives
2. FMEA Tool Introduction (Part 1)
3. FMEA Tool Introduction (Part 2)
4. FMEA Tool Introduction (Part 3)
5. FMEA Tool Introduction (Part 4)
6. FMEA Tool Introduction (Part 5)
7. FMEA Tool Introduction (Part 6)
8. FMEA Tool Introduction (Part 7)
9. FMEA Tool Introduction (Part 8)
10. FMEA Tool Introduction (Part 9)
11. FMEA Tool Introduction (Part 10)
12. FMEA Tool Introduction (Part 11)
13. FMEA Tool Introduction (Part 12)
14. FMEA Tool Introduction (Part 13)
15. FMEA Tool Introduction (Part 14)
16. FMEA Tool Introduction (Part 15)
17. FMEA Tool Introduction (Part 16)
18. FMEA Tool Introduction (Part 17)
19. FMEA Tool Introduction (Part 18)
20. FMEA Tool Introduction (Part 19)
21. FMEA Tool Introduction (Part 20)
22. FMEA Tool Introduction (Part 21)
23. FMEA Tool Introduction (Part 22)
24. FMEA Tool Introduction (Part 23)
25. QUIZ
26. SAMPLE DEVICE & PROCESS
27. SAMPLE DEVICE & PROCESS - DQS ANSWERS
1. Learning objectives
2. pFMEA and Process Validation (PV) (Part 1)
3. pFMEA and Process Validation (PV) (Part 2)
4. pFMEA and Process Validation (PV) (Part 3)
5. pFMEA and Process Validation (PV) (Part 4)
6. pFMEA and Process Validation (PV) (Part 5)
7. pFMEA and Process Validation (PV) (Part 6)
8. pFMEA and Process Validation (PV) (Part 7)
9. pFMEA and Process Validation (PV) (Part 8)
10. pFMEA and Process Validation (PV) (Part 9)
11. pFMEA and Process Validation (PV) (Part 10)
12. pFMEA and Process Validation (PV) (Part 11)
13. pFMEA and Process Validation (PV) (Part 12)
14. pFMEA and Process Validation (PV) (Part 13)
15. QUIZ
1. Learning objectives
2. Failure Modes (Part 1)
3. Failure Modes (Part 2)
4. Failure Modes (Part 3)
5. Failure Modes (Part 4)
6. Failure Modes (Part 5)
7. Failure Modes (Part 6)
8. Failure Modes (Part 7)
9. Failure Modes (Part 8)
10. QUIZ
11. SAMPLE DEVICE & PROCESS
12. SAMPLE DEVICE & PROCESS - DQS ANSWERS
1. Learning objectives
2. Failure Effects (Part 1)
3. Failure Effects (Part 2)
4. Failure Effects (Part 3)
5. Failure Effects (Part 4)
6. QUIZ
7. SAMPLE DEVICE & PROCESS
8. SAMPLE DEVICE & PROCESS - DQS ANSWERS
1. Learning objectives
2. Failure Causes (Part 1)
3. Failure Causes (Part 2)
4. Failure Causes (Part 3)
5. Failure Causes (Part 4)
6. Failure Causes (Part 5)
7. QUIZ
8. SAMPLE DEVICE & PROCESS
9. SAMPLE DEVICE & PROCESS - DQS ANSWERS
1. Learning objectives
2. Failure Effect Severity (Part 1)
3. Failure Effect Severity (Part 2)
4. Failure Effect Severity (Part 3)
5. Failure Effect Severity (Part 4)
6. QUIZ
7. SAMPLE DEVICE & PROCESS
8. SAMPLE DEVICE & PROCESS - DQS ANSWERS
1. Learning objectives
2. Failure Cause Occurrence (Part 1)
3. Failure Cause Occurrence (Part 2)
4. Failure Cause Occurrence (Part 3)
5. Failure Cause Occurrence (Part 4)
6. Failure Cause Occurrence (Part 5)
7. Failure Cause Occurrence (Part 6)
8. Failure Cause Occurrence (Part 7)
9. Failure Cause Occurrence (Part 8)
10. Failure Cause Occurrence (Part 9)
11. QUIZ
12. SAMPLE DEVICE & PROCESS
13. SAMPLE DEVICE & PROCESS - DQS ANSWERS
1. Learning objectives
2. Failure Cause Detection (Part 1)
3. Failure Cause Detection (Part 2)
4. Failure Cause Detection (Part 3)
5. Failure Cause Detection (Part 4)
6. Failure Cause Detection (Part 5)
7. QUIZ
8. SAMPLE DEVICE & PROCESS
9. SAMPLE DEVICE & PROCESS - DQS ANSWERS
1. Learning objectives
2. Control Types (Part 1)
3. Control Types (Part 2)
4. Control Types (Part 3)
5. Control Types (Part 4)
6. Control Types (Part 5)
7. Control Types (Part 6)
8. Control Types (Part 7)
9. Control Types (Part 8)
10. Control Types (Part 9)
11. Control Types (Part 10)
12. Control Types (Part 11)
13. Control Types (Part 12)
14. Control Types (Part 13)
15. Control Types (Part 14)
16. Control Types (Part 15)
17. Control Types (Part 16)
18. Control Types (Part 17)
19. Control Types (Part 18)
20. Control Types (Part 19)
21. Control Types (Part 20)
22. Control Types (Part 21)
23. Control Types (Part 22)
24. Control Types (Part 23)
25. QUIZ
1. Lessons learned
2. FMEA Risk Priority Number (RPN) (Part 1)
3. FMEA Risk Priority Number (RPN) (Part 2)
4. FMEA Risk Priority Number (RPN) (Part 3)
5. FMEA Risk Priority Number (RPN) (Part 4)
6. FMEA Risk Priority Number (RPN) (Part 5)
7. FMEA Risk Priority Number (RPN) (Part 6)
8. FMEA Risk Priority Number (RPN) (Part 7)
9. FMEA Risk Priority Number (RPN) (Part 8)
10. FMEA Risk Priority Number (RPN) (Part 9)
11. FMEA Risk Priority Number (RPN) (Part 10)
12. QUIZ
13. SAMPLE DEVICE & PROCESS
14. SAMPLE DEVICE & PROCESS - DQS ANSWERS
1. Learning objectives
2. pFMEA Examples (Part 1)
3. pFMEA Examples (Part 2)
4. pFMEA Examples (Part 3)
5. pFMEA Examples (Part 4)
6. pFMEA Examples (Part 5)
7. pFMEA Examples (Part 6)
8. pFMEA Examples (Part 7)
9. pFMEA Examples (Part 8)
10. pFMEA Examples (Part 9)
11. pFMEA Examples (Part 10)
12. pFMEA Examples (Part 11)
13. pFMEA Examples (Part 12)
14. pFMEA Examples (Part 13)
15. pFMEA Examples (Part 14)
16. pFMEA Examples (Part 15)
17. pFMEA Examples (Part 16)
18. pFMEA Examples (Part 17)
19. pFMEA Examples (Part 18)
20. pFMEA Examples (Part 19)
21. pFMEA Examples (Part 20)
22. pFMEA Examples (Part 21)
23. pFMEA Examples (Part 22)
24. pFMEA Examples (Part 23)
25. pFMEA Examples (Part 24)
26. pFMEA Examples (Part 25)
27. pFMEA Examples (Part 26)
28. pFMEA Examples (Part 27)
29. pFMEA Examples (Part 28)
30. QUIZ
31. SAMPLE DEVICE & PROCESS
1. Learning objectives
2. pFMEA Best Practices (Part 1)
3. pFMEA Best Practices (Part 2)
4. pFMEA Best Practices (Part 3)
5. pFMEA Best Practices (Part 4)
6. pFMEA Best Practices (Part 5)
7. pFMEA Summary (Part 1)
8. pFMEA Summary (Part 2)
9. pFMEA Summary (Part 3)
10. pFMEA Summary (Part 4)
11. pFMEA Summary (Part 5)
12. pFMEA Summary (Part 6)
13. QUIZ
1. Thank you!
2. pFMEA Additional resources
3. FINAL EXAM
4. Medical Device Process FMEA Course Survey

$1,500.00
223 lessons
1.5 hours of video content
Downloadable content
Approximately 16-20 hours

Train with DQS

Medtech Business Review awarded DQS Top Medical Device Consulting 2026

"What we offer is capability-focused training. We understand the regulation, but we are also going to teach you how to implement it smartly." — Dr. John Salvato

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Course Flyer

We are proud of our course content, which has been forged over years of client engagements, countless interactions with regulatory agencies, and sharpened through product submissions. Click on the following link to see more. PFMEA_Course_Overview APR26 ENG.pdf

Process Failure Mode and Effects Analysis (PFMEA) - English

Process FMEA (PFMEA)

Course curriculum

Welcome to Process Failure Mode and Effects Analysis (pFMEA) for Medical Devices

Chapter 1 - FMEA Background

Chapter 2 - FMEA Examples

Chapter 3 - FMEA Tool introduction

Chapter 4 - pFMEA and Process Validation (PV)

Chapter 5 - Failure Modes

Chapter 6 - Failure Effects

Chapter 7 - Failure Causes

Chapter 8 - Failure Effect Severity

Chapter 9 - Failure Cause Occurrence

Chapter 10 - Failure Cause Detection

Chapter 11 – Control Types

Chapter 12 – Risk Priority Number (RPN)

Chapter 13 - pFMEA Examples

Chapter 14 - pFMEA Best Practices and Summary

Process Failure Mode and Effects Analysis (pFMEA) Conclusion

Train with DQS

Course Flyer