FMEA in APQP & IATF 16949 Context

In the automotive industry, providing a product that is safe, reliable, and compliant is not optional, it is mandatory.

Therefore FMEA (Failure Mode and Effects Analysis) becomes important and it plays a key role in both below topics,

• APQP (Advanced Product Quality Planning)
• IATF 16949:2016 (Quality Management System Standard for Automotive Production)

FMEA is not just a documentation, it is a risk analysis strategy. Risk-based tool to ensure “do it right the first time” and achieve zero-defect manufacturing.

This article explains how FMEA fits into APQP phases and aligns with IATF 16949 requirements.

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What is APQP? #

Advanced Product Quality Planning (APQP) is a structured method used by the automotive industry to ensure product quality is built into the design and manufacturing process from concept to production.

It is divided into 5 key phases:

1. Planning and Definition
2. Product Design and Development
3. Process Design and Development
4. Product and Process Validation
5. Feedback, Assessment & Corrective Action

FMEA is one of the Core Tools used in multiple APQP phases.

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Role of FMEA in APQP #

FMEA is integrated throughout APQP. It is not just as a single activity, but as a continuous input-output loop across 5 stages of APQP.

Phase-wise FMEA Application:

APQP Phase	FMEA Activity
Phase 1 – Planning	Define scope, team, timeline for FMEA (5Ts)
Phase 2 – Product Design	Perform DFMEA to assess design risk
Phase 3 – Process Design	Develop PFMEA to address process risks
Phase 4 – Product and Process Validation	Confirm actions from DFMEA/PFMEA are implemented
Phase 5 – Feedback	Update FMEA based on lessons learned, field failures, etc.

Tip: APQP requires evidence of effective use of FMEA during customer audits and PPAP submissions.

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What is IATF 16949? #

IATF 16949:2016 is the global QMS standard created specially for the automotive industry.

It is based on ISO 9001:2015 but includes additional automotive-specific requirements, which including:

• Risk management
• Product safety
• Defect prevention
• Process capability
• Customer-specific requirements

IATF 16949 focuses on Risk-based thinking: FMEA is the primary method for risk analysis.

IATF mandatorily says that:

❝ Use of quality core tools including FMEA, Control Plan, MSA, SPC, and PPAP where applicable. ❞
(Ref: IATF 16949:2016, Section 8.3.5.1)

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Role of FMEA in IATF 16949 Compliance #

FMEA directly supports and contributed to several IATF clauses:

IATF Clause	FMEA Contribution
6.1 – Actions to Address Risks	FMEA identifies, evaluates, and prioritizes risks
8.3.5.1 – Design & Development Outputs	DFMEA ensures functional safety and robust design
8.5.1.1 – Control of Production Processes	PFMEA drives Control Plan creation
10.2.5 – Problem Solving	Lessons from FMEA feed into corrective actions
9.1.1.1 – Monitoring & Measurement	PFMEA defines critical characteristics for SPC

Not having FMEAs, or keeping them outdated, is a common major non-conformance in IATF audits.

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Example: DFMEA & PFMEA Use in Real Project using APQP and IATF framework #

Scenario: Launching a Seat Position Sensor Module

Stage	FMEA Used	Purpose
Design Development	DFMEA	Identify failure modes like signal drift, connector corrosion, housing crack
Process Design	PFMEA	Address risks like incorrect placement, soldering defect, incorrect calibration
Process Validation	FMEA Actions Verified	Confirm controls like vision system, torque tool poka-yoke, training effectiveness

Each FMEA output is connected to Control Plan, Work Instructions, and PPAP Submission.

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FMEA is a Living Document #

As per both APQP and IATF 16949:

• FMEA must be updated regularly
• Revisit after design changes, customer complaints, new failure data, or audit findings
• Must show evidence of risk reduction through recommended actions

FMEA acts as the bridge between design, process, and validation in the automotive quality journey.

Example – Linking FMEA to Standards #

Imagine a bolting process on an automotive assembly line:

• DFMEA Analyze the risk of product characteristics – Torque requirement.
• PFMEA identifies: Risk of under-torqued bolts – Effect = Component loosens in vehicle.
• Control Plan defines: Torque monitoring system + operator checks.
• PPAP submission shows: FMEA + Control Plan – proving risk prevention.
• IATF 16949 compliance: It all shows and demonstrate risk-based approach & customer requirement fulfillment.

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Summary Table: FMEA in APQP & IATF #

Feature	APQP	IATF 16949
Purpose	Plan quality from the start	Manage and reduce risk
FMEA Type	DFMEA, PFMEA	Both mandatory
Document Status	Active during all phases	Must be current during audits
Linked Tools	Control Plan, DVP&R, PPAP	MSA, SPC, CAPA

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