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Failure Mode and Effects Analysis (FMEA) Template

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Failure Mode and Effects Analysis (FMEA) Template and Agreement

Company Name:    Contractor Name:

Recitals

WHEREAS, Company Name and Contractor Name (collectively the Parties) seek to identify, document and mitigate risks associated with the design, manufacture, assembly, or service processes described in this document; and

WHEREAS, the Parties desire to establish a formal Failure Mode and Effects Analysis (FMEA) framework to record potential failure modes, assess risk priority, assign corrective actions, and verify closure in accordance with accepted quality management practices; and

WHEREAS, the Parties agree that this document will serve as both an operational FMEA template and a binding agreement governing the conduct, deliverables, payment (if applicable), confidentiality and applicable law between the Parties for the activities set forth herein.

Scope of Work

This FMEA will apply to the following processes, systems, components or services:

Payment Terms

Term and Termination

Term Commencement Date:    Term Expiration Date:

Either Party may terminate this agreement for material breach by the other Party which remains uncured after days' written notice. Termination will not relieve either Party of obligations accrued prior to termination.

Confidentiality

Each Party shall keep confidential all non-public information disclosed in connection with this FMEA, not disclose such information to third parties except as required for performance, and use such information solely for the purposes of carrying out the FMEA. This obligation shall survive termination for a period of five (5) years.

Governing Law

This Agreement shall be governed by and construed in accordance with the laws of the state or jurisdiction specified by the Parties:

Entire Agreement

This document, together with any attachments, constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersedes all prior oral or written agreements, representations or understandings related to the FMEA work described herein.

FMEA Identification

Prepared By:

Department:

FMEA Reference / Revision:

Date Completed:

FMEA Table Entries

Use the rows below to list potential failure modes, causes, existing controls, and recommended actions. Severity (S), Occurrence (O) and Detection (D) are numeric ratings; RPN is S × O × D. Document ownership and target completion dates for corrective actions.

Item / Process Step:

Function:    Potential Failure Mode:

Potential Effects:

Severity (S):    Potential Causes:

Occurrence (O):    Current Controls:

Detection (D):    RPN:

Responsible:

Target Completion:

Status:

Item / Process Step:

Function:    Potential Failure Mode:

Potential Effects:

Severity (S):    Potential Causes:

Occurrence (O):    Current Controls:

Detection (D):    RPN:

Responsible:

Target Completion:

Status:

Item / Process Step:

Function:    Potential Failure Mode:

Potential Effects:

Severity (S):    Potential Causes:

Occurrence (O):    Current Controls:

Detection (D):    RPN:

Responsible:

Target Completion:

Status:

Item / Process Step:

Function:    Potential Failure Mode:

Potential Effects:

Severity (S):    Potential Causes:

Occurrence (O):    Current Controls:

Detection (D):    RPN:

Responsible:

Target Completion:

Status:

Item / Process Step:

Function:    Potential Failure Mode:

Potential Effects:

Severity (S):    Potential Causes:

Occurrence (O):    Current Controls:

Detection (D):    RPN:

Responsible:

Target Completion:

Status:

Item / Process Step:

Function:    Potential Failure Mode:

Potential Effects:

Severity (S):    Potential Causes:

Occurrence (O):    Current Controls:

Detection (D):    RPN:

Responsible:

Target Completion:

Status:

Risk Assessment Guidance

Severity Scale: 1 (negligible) to 10 (catastrophic). Occurrence Scale: 1 (remote) to 10 (frequent). Detection Scale: 1 (certain detection) to 10 (no detection). Use conservative professional judgment; where RPN exceeds acceptable thresholds, document immediate containment and corrective action.

Verification and Closure

Verifier Name:

Verification Date:

Approvals and Agreement Certification

By signing below, the Parties certify that the information recorded in this FMEA is accurate to the best of their knowledge, that recommended actions will be implemented according to the responsibilities and target dates listed, and that any confidential information contained herein will be handled pursuant to the Confidentiality clause above.

Company Authorized Representative:

Party A Printed Name:

By:

Date:

Contractor / Supplier Authorized Representative:

Party B Printed Name:

By:

Date:

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What this Failure Mode and Effects Analysis (FMEA) Template Is

A Failure Mode and Effects Analysis (FMEA) Template is a structured worksheet used to identify potential failure modes in products, processes, or systems, assess their effects, rank risks, and capture recommended mitigation actions. The template standardizes how teams record failure descriptions, causes, current controls, severity, occurrence and detection ratings, and resulting Risk Priority Numbers (RPNs). Organizations use the template during design reviews, process changes, and periodic quality audits to reduce safety incidents, improve reliability, and document decisions for traceability and regulatory review.

Why a Standardized FMEA Template Matters

Using a consistent FMEA Template improves clarity, repeatability, and accountability across teams; it ensures risk ranking is comparable, corrective actions are tracked, and management has a single source of truth for mitigation decisions.

Why a Standardized FMEA Template Matters

Who Typically Prepares and Reviews an FMEA Template

Cross-functional teams prepare FMEAs to capture technical, operational, and control perspectives before product launch or process changes.

  • Design Engineers — Document failure modes, causes, and design controls during product development.
  • Quality and Reliability Teams — Quantify risk metrics, verify controls, and drive corrective actions.
  • Operations and Maintenance — Provide real-world failure data and confirm detection mechanisms.

Final review usually involves a responsible manager who approves the RPN thresholds and assigns owners for corrective actions.

Core Sections to Include in a Professional FMEA Template

A usable FMEA Template groups information so teams can quickly capture the failure context, evaluate risk numerically, and show corrective action status for audits and continuous improvement.

Item / Process

Clear identification of part, assembly, subsystem, or process step that is the subject of the analysis, including revision number and reference documents.

Failure Mode

Concise description of how the item could fail to perform its intended function, written as an observable condition or deviation.

Effect & Severity

Statement of the consequence to the user or system and a severity rating that aligns with your organization’s numeric scale.

Cause & Occurrence

Root cause description and an occurrence rating based on historical data, test results, or engineering judgment.

Detection Controls

Existing controls that detect or prevent failure modes and a detection rating for their effectiveness.

Actions & Ownership

Recommended corrective actions, assigned owner, target completion date, and updated RPN after mitigation is implemented.

Essential Information and Fields to Include

Document Title: FMEA name and revision
Item Identifier: Part or process code
Ratings Scale: Severity/Occurrence/Detection
RPN Value: Calculated RPN
Action Owner: Responsible person
Target Date: Completion deadline

Risks and Consequences of an Incomplete or Incorrect FMEA

Unidentified Hazards: Safety incidents
Regulatory Noncompliance: Audit findings
Product Recalls: High recall costs
Warranty Exposure: Increased claims
Operational Downtime: Production delays
Liability Risk: Legal exposure

Common Preparation Mistakes to Avoid

  • Using vague failure descriptions that cannot be tested or measured, which prevents effective corrective action selection.
  • Assigning occurrence, severity, or detection ratings without data or consistent scoring rules, producing misleading RPNs.
  • Omitting owner or due date for corrective actions, which leaves mitigation work untracked and incomplete.
  • Failing to update the FMEA after design or process changes, making the document obsolete during audits or incidents.

Step-by-step: How to Complete the FMEA Template

Follow these sequential steps to ensure a complete, auditable FMEA that drives measurable risk reduction.

  • 01
    Identify item: Record part/process and revision details.
  • 02
    List failures: Document each possible failure mode.
  • 03
    Rate risk: Apply severity, occurrence, detection numbers.
  • 04
    Assign actions: Specify corrective tasks, owners, and dates.

Where to File and Who Receives the Completed FMEA

Define routing so the completed FMEA is discoverable for audits and actionable by stakeholders.

  • Quality Management: Primary repository for approved FMEAs and revision history.
  • Engineering Team: Receives draft and final copies for design updates.
  • Production/Operations: Gets actionable items and implementation instructions.
  • Regulatory/Audit: Holds retained copies for compliance reviews.

How to Configure an Online FMEA Workflow

Set up fields, approvals, and automated routing to keep FMEA reviews timely and auditable.

Field Configuration
Item ID Auto-populate from BOM or process list
RPN Calculation Auto-calc formula field
Approval Flow Sequential sign-off by owner and QA
Notifications Email/SMS reminders to owners

Digital Delivery, File Types, and Integrations

Choose a platform that supports PDF and DOCX templates, audit trails, and common integrations for traceability.

  • File Formats: PDF and Word DOCX supported
  • Integrations: Salesforce, NetSuite, Google Workspace
  • Audit Trail: Timestamped action history

Ensure the platform supports role-based access, conditional fields, and exportable audit reports for compliance.

Typical Timelines and Processing Expectations

Define expected turnaround and review cycles so owners and reviewers meet compliance and product launch schedules.

Initial Completion:

Within 2–4 weeks of design freeze

Corrective Action:

Assigned within 7 calendar days

Verification:

Validation within 30 days after action

Periodic Review:

Annually or after major change

Version Control:

Archive superseded revisions immediately

Comparing FMEA with Similar Risk Analysis Documents

Select the approach that matches your objective: preventive design validation, causal analysis, or safety hazard assessment.

Criteria FMEA Fault Tree
Primary goal preventive risk ranking root-cause analysis
Typical input process steps event/failure logic
Typical output actions & rpn cause probability tree
Use timing design/changes post-failure investigation

eSignature vendor pricing and capability snapshot for FMEA workflows

When digitizing FMEA approvals and corrective-action sign-offs, compare starting price, trial availability, bulk-send ability, audit trails, HIPAA support, and envelope limits to match volume and compliance needs.

signNow DocuSign Adobe Sign PandaDoc HelloSign
Starting Price $8/user/mo $15/user/mo $14/user/mo $19/user/mo $15/user/mo
Free Trial 7-day free trial Varies by vendor Varies by vendor Varies by vendor Varies by vendor
Bulk Send Yes Yes Yes Yes Varies
Audit Trail Yes Yes Yes Yes Yes
HIPAA Compliant Yes Yes Yes No No
Envelope Cap No cap 100 envelopes/user/year Varies Varies Varies

Frequently Asked Questions: Using the FMEA Template

Answers to common questions about completion, approval, digital signing, and retention for FMEA records.


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