Does The Joint Commission require an FMEA?

It requires a proactive risk assessment. Under the National Performance Goals effective January 2026, accredited hospitals select at least one high-risk process every 18 months and conduct a proactive risk assessment. FMEA is the best-known method, but the standard doesn't mandate a particular tool.

Can we use HFMEA instead of traditional FMEA scoring?

Yes. Traditional FMEA multiplies severity, occurrence and detection into a risk priority number; the VA's Healthcare FMEA uses a hazard score and a decision tree. The ready-made template can follow the method your team uses.

How do mitigations get done before go-live?

Each mitigation becomes a plan step with an owner, a team and a due date, so open actions are visible to the project lead and the sponsor before the go-live decision.

How does an FMEA connect to our risk register?

Risks that remain significant after the assessment stay visible on your risk register with an owner, mitigation actions and a review date, alongside the safety events and audit findings that show whether a risk is turning real.

What's the difference between FMEA and root cause analysis?

FMEA looks forward, at how a process could fail before anyone is harmed. Root cause analysis looks back at an event that already happened. Use what an RCA finds to update the FMEA for the same process.

HIPAA compliance, a BAA and SSO are included in every package.

ImprovementFlow · Improvement Methods

Find how a process could fail before a patient finds out

Run FMEA or HFMEA on a high-risk process before it goes live: map the steps, score each failure mode, and turn the highest risks into actions with an owner, a due date and a measure. ImprovementFlow keeps the analysis on a project, tracks the mitigations to done and keeps the residual risk visible on your risk register.

Request a Demo See how an FMEA runs

Beside a new automated medication dispensing cabinet still partly wrapped in film, a pharmacist opens a drawer while a nurse walks through retrieving a medication, a pharmacy technician holds a tablet showing a grid of green, amber and coral rows and a nurse educator points at the coral row

Sound familiar?

What we hear from patient safety and risk leaders using standard approaches

Common frustrations with the usual tools and workarounds — the gaps ImprovementFlow is built to close.

We do our proactive risk assessment because the surveyor will ask for it. Then the spreadsheet goes in a folder.

An FMEA done to satisfy the standard rarely changes the process it was meant to protect.

The team agreed on twelve mitigations in the meeting. I don't know how many were done before go-live.

Actions written into a worksheet have no owner chasing them and no date anyone sees.

Nobody went back after go-live to check whether the failure modes we predicted actually showed up.

Without a look at event reports and measures after launch, the scores are never tested against reality.

How it works

From a high-risk process to mitigations that are done before go-live

Keep the FMEA or HFMEA method your team already uses. ImprovementFlow gives the analysis an owner, the actions a due date and the results a place to be checked.

1
Choose the process and the team
Start an FMEA project for the high-risk process from the ready-made FMEA template, set the scope, the steps and the scoring scale your team uses, and name the multidisciplinary team.
2
Map the steps and list what could fail
Map the process as it will actually run, then list the failure modes, causes and effects for each step, with process mapping and FMEA among the analysis tools on the project.
3
Score and choose what to act on
Score each failure mode with RPN or the HFMEA hazard score, and review high-severity failure modes on their own, not only by total score.
4
Turn each mitigation into tracked work
Each action becomes a plan step with an owner, a team and a due date, favoring changes that design the failure out, so everything agreed in the meeting is done before go-live.
5
Check it after go-live
Linked measures, follow-up reviews and safety event reports show whether the failure modes you predicted are appearing. Risks that remain significant stay on your risk register with an owner and a review date.

1
Choose the process and the team
Start an FMEA project for the high-risk process from the ready-made FMEA template, set the scope, the steps and the scoring scale your team uses, and name the multidisciplinary team.
2
Map the steps and list what could fail
Map the process as it will actually run, then list the failure modes, causes and effects for each step, with process mapping and FMEA among the analysis tools on the project.
3
Score and choose what to act on
Score each failure mode with RPN or the HFMEA hazard score, and review high-severity failure modes on their own, not only by total score.
4
Turn each mitigation into tracked work
Each action becomes a plan step with an owner, a team and a due date, favoring changes that design the failure out, so everything agreed in the meeting is done before go-live.
5
Check it after go-live
Linked measures, follow-up reviews and safety event reports show whether the failure modes you predicted are appearing. Risks that remain significant stay on your risk register with an owner and a review date.

In practice

An FMEA on new automated dispensing cabinets, before go-live

Scores rank the failure modes; they don't measure them. That's why a severity 9 failure mode is flagged even when its total score is low.

Automated dispensing cabinets on three inpatient units

Severity, occurrence and detection each scored 1 to 10, and RPN = S × O × D. Flagged rows have an RPN of 150 or more, or a severity of 9 or 10.

Process step	Failure mode	Effect	S	O	D	RPN	Planned action
Retrieve	Nurse selects the wrong patient profile	Wrong medication reaches a patient	9	4	6	216	Show only the nurse's assigned patients by defaultOwner: Pharmacy informatics
Restock	Medication loaded into the wrong pocket	Next nurse removes the wrong drug	8	3	7	168	Barcode scan every item at restockOwner: Pharmacy operations manager
Storage	Expired stock left in the cabinet	Expired dose given	6	5	5	150	Weekly expiration-date report for techniciansOwner: Pharmacy technician supervisor
Override	Drug removed on override without pharmacist review	Interaction or allergy missed	9	2	3	54	Limit the override list to emergency medicationsOwner: Pharmacy and therapeutics committee
Return	Returned dose placed in the wrong return bin	Delay in crediting and restocking	3	4	3	36	Monitor

Retrieve216
Nurse selects the wrong patient profile
Wrong medication reaches a patient
Severity 9, occurrence 4, detection 6
Show only the nurse's assigned patients by defaultOwner: Pharmacy informatics
Restock168
Medication loaded into the wrong pocket
Next nurse removes the wrong drug
Severity 8, occurrence 3, detection 7
Barcode scan every item at restockOwner: Pharmacy operations manager
Storage150
Expired stock left in the cabinet
Expired dose given
Severity 6, occurrence 5, detection 5
Weekly expiration-date report for techniciansOwner: Pharmacy technician supervisor
Override54
Drug removed on override without pharmacist review
Interaction or allergy missed
Severity 9, occurrence 2, detection 3
Limit the override list to emergency medicationsOwner: Pharmacy and therapeutics committee
Return36
Returned dose placed in the wrong return bin
Delay in crediting and restocking
Severity 3, occurrence 4, detection 3

Illustrative example with no patient information. Your team chooses its scoring scale, its action threshold and its actions.

Who it's for

Something useful for everyone involved

Patient safety and risk managers: Every proactive risk assessment with its scores, actions and owners in one place, ready when a surveyor asks.
FMEA teams: A structured project to map the process, score failure modes and agree actions, instead of a blank spreadsheet.
Action owners: Their mitigations with a due date and a definition of done, visible before go-live.
Pharmacy, nursing and clinical engineering leaders: Risks to their new process found and addressed before it reaches patients.
Executives and safety committees: Evidence that high-risk processes are assessed and the agreed actions were completed.

What changes

From working around the problem to working on it

Today

An FMEA spreadsheet filed for the survey
Mitigations with no owner or due date
Go-live before the actions are done
No check on whether predictions came true

With ImprovementFlow

Each assessment on a project with its team
Every mitigation owned, dated and tracked
Open actions visible before go-live
Measures, follow-up reviews and event reports checked after launch

Built for proactive risk work in healthcare

FMEA or HFMEA, your way: ImprovementFlow ships a ready-made FMEA template, and your team can customize it without IT, so the worksheet follows traditional FMEA scoring, the VA's HFMEA hazard scoring or the format you already use.
Connected to risk and safety: Assessments sit alongside your risk register and safety event reporting, so a predicted failure and a reported event are seen together.
Secure from day one: HIPAA compliance, a BAA and SSO are included in every package.

Getting started

Your first 90 days

Start with the next high-risk process you're about to change.

Weeks 1–2
Adapt the ready-made FMEA template and scoring scale with us, and choose the first process, its scope and its team.
Weeks 3–6
Map the process, score the failure modes and assign every agreed mitigation an owner and a due date.
Weeks 7–12
Track mitigations to done before go-live, set the measures and follow-up review dates, and add remaining risks to the register.

Guides

Guides for proactive risk assessment

Plain-language primers for the people who run and join FMEAs.

Frequently asked questions

Does The Joint Commission require an FMEA?: It requires a proactive risk assessment. Under the National Performance Goals effective January 2026, accredited hospitals select at least one high-risk process every 18 months and conduct a proactive risk assessment. FMEA is the best-known method, but the standard doesn't mandate a particular tool.
Can we use HFMEA instead of traditional FMEA scoring?: Yes. Traditional FMEA multiplies severity, occurrence and detection into a risk priority number; the VA's Healthcare FMEA uses a hazard score and a decision tree. The ready-made template can follow the method your team uses.
How do mitigations get done before go-live?: Each mitigation becomes a plan step with an owner, a team and a due date, so open actions are visible to the project lead and the sponsor before the go-live decision.
How does an FMEA connect to our risk register?: Risks that remain significant after the assessment stay visible on your risk register with an owner, mitigation actions and a review date, alongside the safety events and audit findings that show whether a risk is turning real.
What's the difference between FMEA and root cause analysis?: FMEA looks forward, at how a process could fail before anyone is harmed. Root cause analysis looks back at an event that already happened. Use what an RCA finds to update the FMEA for the same process.
What about security?: HIPAA compliance, a BAA and SSO are included in every package.

Bring us the process you're changing next. We'll show you where it could fail.

Tell us which high-risk process is coming up and how your team runs proactive risk assessments today. We'll walk through an FMEA from the first process map to mitigations done before go-live.

We typically respond within one business day.

Prefer email? info@communify.us

Explore a 90-day pilot →