FMEA (Failure Mode and Effect Analysis) is not just a tool, it is a part of the automotive quality system. It is highly important because of FMEA linkages with all core tools and automotive foundational standards:
- ISO 9001:2015 – Risk-based quality management.
- IATF 16949:2016 – Automotive quality management standard.
- APQP (Advanced Product Quality Planning) – Structured product development framework.
- PPAP (Production Part Approval Process) – Customer submission package.
Understanding these FMEA linkages helps organizations to use FMEA as a live risk management tool.
1. FMEA and ISO 9001:2015 #
ISO 9001:2015 introduced the concept of risk-based thinking.
- Clause 6.1 – Actions to Address Risks and Opportunities requires organizations to identify and manage risks systematically.
- FMEA is one of the most practical tools to meet this requirement.
Example:
- ISO 9001 requires you to identify risks in processes.
- FMEA provides the structured method to do so (failure mode → cause → effect → preventive actions).
Thus, FMEA is an implementation tool for ISO 9001’s risk-based thinking.
2. FMEA and IATF 16949:2016 #
IATF 16949 is built on ISO 9001 but adds automotive-specific requirements.
- Clause 8.3.3.3 – Special Characteristics: FMEA identifies which functions or processes are safety/critical.
- Clause 9.1.1 – Monitoring and Measurement: FMEA feeds into control methods for monitoring high-risk areas.
- Customer-Specific Requirements (CSRs): Many OEMs mandate AIAG-VDA FMEA format in their supplier quality requirements.
Example:
- Ford and GM require FMEA as part of APQP and PPAP deliverables.
- VW and BMW require compliance with the AIAG-VDA handbook.
Without FMEA, suppliers cannot comply with IATF 16949.
3. FMEA and APQP (Advanced Product Quality Planning) #
APQP is a 5-phase framework for product development in automotive. It is a structure way of development steps and FMEA is one of important document in that:
- Phase 2 (Product Design & Development): DFMEA is applied to identify design risks.
- Phase 3 (Process Design & Development): PFMEA is applied to identify process risks.
- Phase 4 (Product & Process Validation): FMEA results link to Control Plans and validation tests.
Example:
- In an alternator project, DFMEA ensures design meets voltage/current requirements.
- PFMEA ensures assembly processes like winding or bolting are robust.
APQP without FMEA = incomplete risk analysis.
4. FMEA and PPAP (Production Part Approval Process) #
PPAP is the customer submission package required before mass production. FMEA is one of its core documents.
- DFMEA and PFMEA must be submitted to customers to demonstrate risk analysis and preventive actions.
- FMEA provides the basis for the Control Plan, which is another PPAP element.
PPAP Core Documents (linkages):
- Design FMEA – supports Design Records, Engineering Change Docs.
- Process FMEA – supports Control Plan, Dimensional Results, MSA, SPC.
FMEA is not only required by PPAP, it is the foundation for most PPAP documents.
Visual Flow – FMEA Linkages #
ISO 9001 → Risk-based Thinking
↓
IATF 16949 → Automotive QMS
↓
APQP Phase 2 → DFMEA
APQP Phase 3 → PFMEA
↓
Control Plan & Validation
↓
PPAP Submission Package
Why FMEA Linkages are Critical #
- Compliance: FMEA ensures adherence to ISO 9001, IATF 16949, and OEM requirements.
- Integration: FMEA feeds into APQP and PPAP deliverables, ensuring risk prevention across the lifecycle.
- Efficiency: A well-maintained FMEA reduces redundant documents by becoming the central risk management system.
- Customer Trust: Strong FMEA practices increase confidence during customer audits and PPAP approval.
Key Takeaways #
- ISO 9001: FMEA = tool for risk-based thinking.
- IATF 16949: FMEA = compliance with risk and special characteristic requirements.
- APQP: FMEA = core activity in Phases 2 & 3.
- PPAP: FMEA = mandatory deliverable, linked to Control Plans.
FMEA is the connecting bridge across all major quality tools and standards.
