Process FMEA for medical devices · Self-paced

PFMEAs that keep defects out of production and the business running.

Understand the process, find real failure modes, develop actual causes, estimate ratings, and build Control Plans aligned with your Manufacturing Process Validation, practiced step-by-step on a sample device process.

Enroll for $1,500Try Chapter 1 free

Training a team or paying by purchase order? Email us

14 chapters · about 16–20 hours · tied to ISO 14971 and PV

Top Medical Device Consulting 2026 award badge from MedTech Business ReviewTop Medical Device Consulting 2026 MEDTECH Business Review"Best I've ever seen in the industry." Mike Z., Senior Management Consultant
One PFMEA line, pouch heat sealingIllustrative example
Typical entry
Failure mode
Bad seal
Cause
Operator error
Control
100% visual inspection
Ratings
S 5O ?D ?RPN debated
After this course
Failure mode
Seal strength below specification
Cause
Sealer temperature drifts below the validated range
Control
Temperature alarm and interlock, plus seal strength test per lot
Ratings
S 5O 3 · dataD 4 · testIn the Control Plan
Sample device process exercises walk you through every step, with DQS answers.
Sound familiar?

The PFMEA exists. It just isn't doing any good.

  • It was copied from the last product and never updated with production data.
  • Causes say "operator error," and the control is "retrain" or "100% visual inspection."
  • Occurrence ratings are guesses, because nobody tied them to yield or process data.
  • The PFMEA, the Control Plan and the IQ/OQ/PQ protocols don't agree with each other.

That isn't a lack of effort. It's the lack of a method that connects the process map, the risks, the controls and validation. This course teaches that method.

Check your PFMEA

How does your last PFMEA hold up?

Answer for the most recent PFMEA your team finished. Your answers stay on this page and aren't sent anywhere.

  1. Is your PFMEA built from a current Process Flow Diagram and updated with production data?
  2. Is each cause a specific process condition, not "operator error"?
  3. Are your Occurrence ratings based on yield, capability or other process data?
  4. Do your controls prevent or detect the cause, instead of relying on retraining or visual inspection?
  5. Do your PFMEA, Control Plan and IQ/OQ/PQ protocols agree with each other?
What changes

After the course, your team will be able to

Function analysis · Process Flow Diagrams

Find the failure modes that matter

Map every process step, then identify failure modes, effects and causes supported by data rather than memory.

Prevention · Detection · 6M framework

Choose controls that match the risk

Use the 6M framework to find root causes and select prevention and detection controls sized to the risk, not "retrain the operator."

Severity · Occurrence · Detection · RPN

Rate and prioritize with data

Assign S, O and D from evidence, calculate RPN, and apply severity-weighted prioritization so the highest risks get fixed first.

Control Plan · IQ/OQ/PQ · ISO 14971

Make the PFMEA run the line

Translate the PFMEA into a Control Plan aligned with Process Validation, and keep it a living document fed by production data.

Is this right for you?

Built for the people who build, control and validate the process

See who it's for, and who it isn't

This course is for you if

  • You are a manufacturing, process or quality engineer who builds or contributes to PFMEAs.
  • You write Control Plans or IQ/OQ/PQ protocols and want them to trace back to real risks.
  • You work at a contract manufacturer and need PFMEAs that satisfy several customers.
  • You review PFMEAs for audits and want to know what good looks like.
  • You are moving from automotive and want to see how PFMEA works under medical device regulations.

It is probably not for you if

  • You want a one-hour overview of FMEA vocabulary.
  • You are looking for a worksheet template without changing how your team controls the process.
How the course is built

Four stages, from process map to Control Plan

Each stage includes hands-on work on a sample device process, plus quizzes to confirm you have it before moving on.

Stage 1

Foundations

FMEA background, worked examples, the tool set, and how PFMEA connects to Process Validation.

Chapters 1–4
Stage 2

Building the analysis

Write failure modes, effects and causes for each process step, using function analysis and the 6M framework.

Chapters 5–7
Stage 3

Rating the risk

Severity, Occurrence and Detection, each rated from criteria and process evidence instead of opinion.

Chapters 8–10
Stage 4

Control and prioritize

Control types, RPN and severity-weighted prioritization, complete PFMEA examples, and best practices.

Chapters 11–14
  • 16–20 hrs of learning in 222 lessons
  • 14 quizzes plus a final exam
  • Sample device process exercises, with DQS answers
  • Downloadable course materials

Not sure yet? Start Chapter 1 free. You get access inside the course as a student, including the Chapter 1 quiz, before you decide.

Chapters marked "Your gap" match the answers you gave in the PFMEA check.

  1. FMEA BackgroundYour gap
  2. FMEA ExamplesYour gap
  3. FMEA Tool IntroductionYour gap
  4. PFMEA and Process ValidationYour gap
  5. Failure ModesYour gap
  6. Failure EffectsYour gap
  7. Failure CausesYour gap
  8. Failure Effect SeverityYour gap
  9. Failure Cause OccurrenceYour gap
  10. Failure Cause DetectionYour gap
  11. Control TypesYour gap
  12. Risk Priority Number (RPN)Your gap
  13. PFMEA ExamplesYour gap
  14. PFMEA Best Practices and SummaryYour gap
For managers and team leads

PFMEA is a team method. Train the team on one.

When manufacturing, quality and validation share the same approach, PFMEAs match across lines and sites, Control Plans trace to real risks, and audits go faster.

  • A shared vocabularyOne way to write failure modes, causes and controls across every line and site.
  • Pairs with the rest of the libraryDesign FMEA, Process Validation and Safety Risk Management courses build on the same foundation.
  • Impact your business positivelyInvestment in professional development is not a 'nice-to-have'. It has real, tangible benefits.Get the white paper
Dr. John Salvato, founder of Design Quality Services
Your instructor

Dr. John Salvato

Founder and President, Design Quality Services

John has spent more than 30 years in medical device and automotive quality and regulatory work. Since founding DQS in 2017 he has built FMEA, Process Validation and risk management methods for device makers and contract manufacturers around the world, and defended that work with agencies and regulatory bodies.

ISO 13485 Lead AuditorISO 14971FDA Design ControlsIEC 62304

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

Before you enroll

Questions people ask

Can I try it before I buy?
Yes. Start Chapter 1 free. You get access inside the course as a student and work through the full chapter, including the Chapter 1 quiz, before you decide.
How much time does it take?
Plan on about 16 to 20 hours. The course is self-paced across 14 chapters and 222 lessons, and much of that time goes into the sample device process exercises rather than video. You have 60 days of access, plus a live discussion with a DQS expert to make sure the concepts are clear.
How is this different from the Design FMEA course?
Design FMEA looks at how the design can fail. Process FMEA looks at how the manufacturing process can fail to produce that design. The two share the same foundations and work best together; this course focuses on process steps, process controls and Process Validation.
Does it cover Control Plans and IQ/OQ/PQ?
Yes. You learn to translate the PFMEA into a Control Plan whose control strategy aligns with the IQ, OQ and PQ stages of Process Validation, and to keep it current with production data.
How does PFMEA relate to ISO 14971?
PFMEA is one of the analysis tools that feeds your safety risk management process. The course shows how PFMEA integrates with ISO 14971 and Process Validation requirements. For full ISO 14971 coverage, see the DQS Safety Risk Management course.

Make your next PFMEA the one that runs the line.

Learn a method your team can defend on the production floor, in audits and in every validation.

$1,500 · self-paced · start today

Enroll nowTry Chapter 1 free

Training a team or paying by purchase order? Email us