What is Failure Mode and Effects Analysis (FMEA)?

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Failure Mode and Effects Analysis (FMEA)?

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More details on specific FDA expectations for Failure Mode and Effects Analysis (FMEA) can be found in the guidance document below.

Three (3) options to create an FMEA.

Option 1. You can create a great Failure Mode and Effects Analysis (FMEA), using a template.

You can download a free sample of a Failure Mode and Effects Analysis (FMEA) template in .pdf format. 

To see the complete list of the most popular templates, click here.

In addition, you can request a quotation to buy online a full Failure Mode and Effects Analysis (FMEA)template document in MS Word format that is completely editable, ready to fill, and adapt to your needs.

Option 2. We can bring you a formal training on how to create your own Failure Mode and Effects Analysis (FMEA) using our template(s).

This option is recommended if you want to learn more about how to build a robust Failure Mode and Effects Analysis (FMEA). One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build reliable risk management using a template. You can improve your corporate validation procedures and policies incorporating our template sections.  It includes the template, an exam, and a training certificate for each assistant.  Request a quote now.

Option 3. We can create a customized Failure Mode and Effects Analysis (FMEA) for your company.

One of our expert(s) will create and prepare for you a customized Failure Mode and Effects Analysis (FMEA) procedure with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.

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STATUTORY AND REGULATORY REQUIREMENTS

Companies are expected to establish the applicability of the Part 11 rules to their systems using a risk-based analysis to identify the most

critical electronic records.

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

ISO 31000:2018, Risk management

– Guidelines, provides principles, framework, and a process for managing risk.

httpss://www.iso.org/iso-31000-risk-management.html

ISO 14971:2019 Medical devices

— Application of risk management to medical devices

httpss://www.iso.org/standard/72704.html

Risk Evaluation and Mitigation Strategy (REMS)

A required risk management plan that uses risk mitigation strategies beyond FDA‐approved FDA professional labeling.

• FDA Amendments Act of 2007 authorized the FDA to require sponsors to develop and comply with REMS programs if determined necessary to ensure the benefits outweigh the risks. – FDA does not directly regulate healthcare professionals or patients who may be impacted by a REMS.
• Applies to NDAs, BLAs, and ANDAs. • REMS can be required pre‐ or post‐approval.
• Designed to achieve specific goals to mitigate risks associated with the use of a drug.
• FDA specifies the required elements of a REMS.
• Drug sponsors develop the REMS program based on the required elements. FDA reviews and approves the REMS.
• Each REMS has specific safety measures that are targeted to the serious risk(s) associated with the drug or class of drugs.
• All REMS include elements, communication, and/or educational materials to communicate risk information to various stakeholders.

More details on specific (FMEA) can be found in:

httpss://www.fda.gov/media/71543/download

httpss://www.fda.gov/food/cfsan-risk-safety-assessments/initiation-and-conduct-all-major-risk-assessments-within-risk-analysis-framework

httpss://www.fda.gov/food/buy-store-serve-safe-food/risk-assessment-what-it-and-what-does-it-have-do-my-food

httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/premarketing-risk-assessment

httpss://www.fda.gov/food/science-research-food/cfsan-risk-safety-assessments

httpss://www.fda.gov/media/81256/download

References

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

https://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

httpss://www.fda.gov/media/94074/download

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

httpss://ispe.org/publications/guidance-documents/gamp-5

https://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

httpss://www.fda.gov/media/94074/download

https://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

httpss://www.fda.gov/media/94074/download

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

httpss://ispe.org/publications/guidance-documents/gamp-5

For medical devices, the 21 CFR 820.65 – Traceability controls lay down requirements for product and quality data traceability

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.65

Related topics and resources:

Validation Plan, Installation Qualification, Operational Qualification, Performance Qualifications, Component Qualification, Traceability Matrix, Ppk, Control Charts, Cpk, User Requirements, Functional Requirement Specifications, GAMP5, risk assessment