What is the difference between a Design FMEA and a Process FMEA?

A Design FMEA (DFMEA) analyses the product design to identify potential failure modes in the design itself, considering how design weaknesses could lead to product failures in the field. A Process FMEA (PFMEA) analyses the manufacturing or assembly process to identify potential failure modes in the process steps, considering how process variations, equipment failures, human errors and material issues could produce defective products. Both types follow the same worksheet format and rating methodology, but the scope, failure modes and controls are different. Most products require both a DFMEA and a PFMEA.

How is the risk priority number (RPN) calculated and used?

The RPN is calculated by multiplying three ratings: severity (S) x occurrence (O) x detection (D), each rated on a 1 to 10 scale. The resulting RPN ranges from 1 (lowest risk) to 1,000 (highest risk). Failure modes with high RPNs are prioritised for corrective action. However, the RPN should not be the only criterion. Any failure mode with a severity rating of 9 or 10 (safety or regulatory impact) must be addressed regardless of the RPN value. After implementing corrective actions, the RPN is recalculated to verify that the risk has been reduced to an acceptable level.

Is FMEA required by industry standards?

FMEA is explicitly required by several industry standards. IATF 16949:2016 (automotive quality management) requires both Design FMEA and Process FMEA as part of the product development process. AS 9100 (aerospace quality management) requires FMEA or equivalent risk analysis. ISO 14971 (medical device risk management) references FMEA as a risk analysis technique. While ISO 9001:2015 does not specifically require FMEA, it requires risk-based thinking and the identification of actions to address risks and opportunities, for which FMEA is a widely accepted methodology.

How often should an FMEA be reviewed and updated?

An FMEA is a living document that should be updated whenever there is a design change, process change, new failure mode discovery, field failure, customer complaint or change in production conditions. At a minimum, the FMEA should be formally reviewed annually by the cross-functional team. Many organisations review FMEAs quarterly or align reviews with control plan revisions and management review meetings. After any significant quality escape, warranty claim or safety incident, the relevant FMEA should be reviewed immediately and updated to reflect the new information.

Is this FMEA worksheet template free?

Yes. Download and use this FMEA worksheet template at no cost. Open the file in your browser and use Print then Save as PDF for a paper copy. No MapTrack account is required. If you want digital FMEA management on mobile with RPN tracking, corrective action workflows, version control and risk trend dashboards, MapTrack can do that. Book a demo to see how it works.

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Free FMEA worksheet template (PDF-ready). Covers AIAG FMEA 4th Edition format with severity, occurrence, detection ratings and RPN calculation. Download free.

Jarrod Milford

Commercial Director

Updated 3 May 2026

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What is a fmea worksheet template?

A failure mode and effects analysis (FMEA) worksheet template is a structured document used to systematically identify potential failure modes in a product, process or system, assess the severity of their effects, estimate the likelihood of occurrence, evaluate the ability of current controls to detect the failure and calculate a risk priority number (RPN) that prioritises which failure modes require action. The template follows the format established by the Automotive Industry Action Group (AIAG) FMEA 4th Edition, which is the most widely adopted FMEA methodology across manufacturing, aerospace, medical device, mining and general industry sectors worldwide.

FMEA is a proactive risk management tool that identifies potential failures before they occur, rather than reacting to failures after the fact. Each row of the worksheet documents a specific function or process step, the potential failure mode, the potential effects of that failure, the potential causes, the current prevention controls, the current detection controls and the three risk ratings: severity (S), occurrence (O) and detection (D). These three ratings are multiplied to produce the risk priority number (RPN = S x O x D), which ranges from 1 to 1,000. High-RPN failure modes are prioritised for corrective action, and the worksheet is updated after actions are implemented to show the reduced RPN. Without a structured FMEA process, organisations lack a systematic method for identifying, prioritising and mitigating risks before they result in product failures, safety incidents, regulatory non-compliance or customer dissatisfaction.

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Benefits of using this fmea worksheet template

Proactive risk management: FMEA identifies potential failures before they occur, enabling organisations to implement prevention and detection controls before problems reach production or the customer.
Systematic prioritisation: the RPN calculation provides an objective, numerical basis for prioritising which failure modes require immediate action and which represent acceptable residual risk.
Regulatory compliance: FMEA is required or strongly recommended by numerous industry standards including IATF 16949 (automotive), AS 9100 (aerospace), ISO 14971 (medical devices) and ISO 31000 (risk management).
Design and process improvement: the structured analysis of functions, failure modes, effects, causes and controls reveals design weaknesses and process gaps that can be addressed before production begins.
Knowledge capture: a completed FMEA worksheet captures the collective knowledge of the cross-functional team about potential failures, their causes and effective controls, creating a reference document for future products and processes.
Continuous improvement: re-scoring the RPN after implementing corrective actions demonstrates measurable risk reduction and provides evidence of continuous improvement for management reviews and audits.

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What to include in a fmea worksheet template

This fmea worksheet template covers 8 key areas:

FMEA header: FMEA type (Design FMEA or Process FMEA), part or process name, FMEA number, revision level, prepared by, date, cross-functional team members and FMEA scope.
Function or process step: the intended function of the component or the specific step in the manufacturing process being analysed.
Potential failure mode: the way in which the function or process step could potentially fail to meet its intended purpose (e.g., cracks, deforms, fails to engage, incorrect dimension, missing operation).
Potential effects of failure: the consequences of the failure mode on the next operation, the final product, the customer, safety and regulatory compliance, described from the end user perspective.
Severity rating (S): a 1 to 10 rating of the seriousness of the failure effect, where 1 is negligible and 10 is a safety or regulatory hazard without warning.
Potential causes and occurrence rating (O): the root cause or mechanism of the failure mode and a 1 to 10 rating of the likelihood of occurrence, where 1 is extremely unlikely and 10 is almost certain.
Current controls and detection rating (D): the existing prevention and detection controls and a 1 to 10 rating of the ability of current controls to detect the failure before it reaches the customer, where 1 is almost certain detection and 10 is no detection capability.
RPN calculation and recommended actions: risk priority number (S x O x D), recommended actions for high-RPN items, responsible person, target date, actions taken and recalculated RPN after implementation.

How to use this fmea worksheet template

Assemble a cross-functional team, define the FMEA scope and type (Design or Process), and gather all relevant drawings, specifications and process documentation.: FMEA is a team exercise that requires input from design engineering, process engineering, quality, manufacturing, maintenance, reliability and customer-facing functions. Define whether this is a Design FMEA (analysing the product design) or a Process FMEA (analysing the manufacturing or assembly process). Gather all relevant documents including engineering drawings, specifications, process flow diagrams, control plans, historical warranty data, field failure reports and previous FMEA worksheets for similar products or processes.
List every function or process step, then identify all potential failure modes for each function, considering how the function could fail to meet its intended purpose.: Break the product or process down into its individual functions or process steps. For each function, brainstorm all the ways it could potentially fail. Consider complete loss of function, partial loss of function, intermittent function, degraded function, unintended function and overshoot of function. Reference historical failure data, warranty claims, customer complaints, similar product failures and industry failure mode databases. Every credible failure mode should be documented, regardless of perceived likelihood.
For each failure mode, describe the potential effects, identify potential causes, rate severity, occurrence and detection, and calculate the RPN.: Describe the effect of each failure mode from the end user perspective, including any safety or regulatory implications. Identify the potential root causes or mechanisms that could produce the failure mode. Assign severity (S), occurrence (O) and detection (D) ratings using the standard 1 to 10 scales from the AIAG FMEA 4th Edition rating tables. Calculate the RPN by multiplying S x O x D. Also evaluate whether any failure mode has a severity of 9 or 10 (safety or regulatory), which requires action regardless of the RPN value.
Prioritise high-RPN failure modes and any failure modes with high severity ratings, then develop recommended actions that reduce occurrence or improve detection.: Rank failure modes by RPN to identify those requiring priority action. Any failure mode with a severity rating of 9 or 10 must be addressed regardless of the RPN. Recommended actions should focus on reducing occurrence (eliminating or controlling the root cause through design changes, process improvements, error-proofing or enhanced prevention controls) or improving detection (adding inspections, tests, sensors or automated checks that catch the failure before it reaches the customer). Assign a responsible person and target date for each recommended action.
Implement the recommended actions, update the FMEA worksheet with the actions taken and recalculate the RPN to verify risk reduction.: After implementing each recommended action, update the FMEA worksheet with a description of the actions taken, the implementation date and any changes to prevention or detection controls. Re-rate severity, occurrence and detection to calculate the new RPN. Severity rarely changes unless the design is fundamentally altered, but occurrence and detection should improve as a result of the actions taken. Compare the original and revised RPNs to quantify the risk reduction achieved. The FMEA is a living document and should be updated whenever the design, process or controls change.

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How often should you complete this report?

An FMEA should be initiated during the design or process planning phase, before the product or process enters production. The initial FMEA is typically completed as part of the advanced product quality planning (APQP) process. Once established, the FMEA is a living document that must be updated whenever there is a design change, process change, new failure mode discovery, field failure, customer complaint, control plan revision or significant change in production volume or conditions.

At a minimum, the FMEA should be formally reviewed annually by the cross-functional team to verify that the risk ratings remain current, controls are still in place and effective, and no new failure modes have emerged. Many organisations align FMEA reviews with management review meetings, product audits or control plan revisions. After any significant quality escape, warranty claim or safety incident, the relevant FMEA should be reviewed and updated to reflect the new information and any additional controls implemented.

Frequently asked questions

What is the difference between a Design FMEA and a Process FMEA?: A Design FMEA (DFMEA) analyses the product design to identify potential failure modes in the design itself, considering how design weaknesses could lead to product failures in the field. A Process FMEA (PFMEA) analyses the manufacturing or assembly process to identify potential failure modes in the process steps, considering how process variations, equipment failures, human errors and material issues could produce defective products. Both types follow the same worksheet format and rating methodology, but the scope, failure modes and controls are different. Most products require both a DFMEA and a PFMEA.
How is the risk priority number (RPN) calculated and used?: The RPN is calculated by multiplying three ratings: severity (S) x occurrence (O) x detection (D), each rated on a 1 to 10 scale. The resulting RPN ranges from 1 (lowest risk) to 1,000 (highest risk). Failure modes with high RPNs are prioritised for corrective action. However, the RPN should not be the only criterion. Any failure mode with a severity rating of 9 or 10 (safety or regulatory impact) must be addressed regardless of the RPN value. After implementing corrective actions, the RPN is recalculated to verify that the risk has been reduced to an acceptable level.
Is FMEA required by industry standards?: FMEA is explicitly required by several industry standards. IATF 16949:2016 (automotive quality management) requires both Design FMEA and Process FMEA as part of the product development process. AS 9100 (aerospace quality management) requires FMEA or equivalent risk analysis. ISO 14971 (medical device risk management) references FMEA as a risk analysis technique. While ISO 9001:2015 does not specifically require FMEA, it requires risk-based thinking and the identification of actions to address risks and opportunities, for which FMEA is a widely accepted methodology.
How often should an FMEA be reviewed and updated?: An FMEA is a living document that should be updated whenever there is a design change, process change, new failure mode discovery, field failure, customer complaint or change in production conditions. At a minimum, the FMEA should be formally reviewed annually by the cross-functional team. Many organisations review FMEAs quarterly or align reviews with control plan revisions and management review meetings. After any significant quality escape, warranty claim or safety incident, the relevant FMEA should be reviewed immediately and updated to reflect the new information.
Is this FMEA worksheet template free?: Yes. Download and use this FMEA worksheet template at no cost. Open the file in your browser and use Print then Save as PDF for a paper copy. No MapTrack account is required. If you want digital FMEA management on mobile with RPN tracking, corrective action workflows, version control and risk trend dashboards, MapTrack can do that. Book a demo to see how it works.

Applicable regulatory standards

This template aligns with the following regulations and standards:

AIAG FMEA Manual, 4th Edition (Failure Mode and Effects Analysis)
IATF 16949:2016 Section 8.3.5.1 (Design and development outputs - supplemental)
ISO 31000:2018 (Risk management - Guidelines)
SAE J1739 (Potential Failure Mode and Effects Analysis)

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