NPD (New Product Development) Process

The New Product Development (NPD) process is a structured approach used by organizations to bring a
new product from concept to market. It typically includes stages from idea generation to post-launch
review. The process ensures alignment with customer needs, business goals, and manufacturing capabilities.

Typical NPD Process Stages

1. Idea Generation

• Purpose: Identify new product opportunities.

• Sources:
o Customer feedback
o Market research
o Internal brainstorming
o Competitor analysis
o Technology trends
• Tools: VOC (Voice of Customer), QFD, benchmarking

Note: VOC (Voice of the Customer)

VOC refers to the collection and analysis of customer needs, expectations, preferences, and
feedback. It helps product developers understand what customers truly want and prioritize features
that deliver value. VOC is typically gathered through surveys, interviews, complaints, market research,
and focus groups.

QFD (Quality Function Deployment)

QFD is a structured method for translating customer requirements (VOC) into engineering
characteristics and design specifications. It uses tools like the House of Quality to ensure the final
product meets customer needs. QFD aligns design, manufacturing, and quality functions with
customer expectations.

Benchmarking
Benchmarking involves comparing a product, process, or performance standard against industry
leaders or competitors. It helps identify best practices, performance gaps, and improvement
opportunities. Benchmarking can be internal (within the company), competitive (vs. other
companies), or functional (across industries).

2. Idea Screening

• Purpose: Filter ideas based on feasibility and alignment with business goals.
• Activities:
o Preliminary technical and commercial assessment
o SWOT analysis
o Risk and ROI estimation

Note:

Preliminary Technical and Commercial Assessment

This is an initial feasibility review conducted before significant investment is made in a new product,
service, or project. It evaluates both the technical viability and commercial potential of the concept.

Key Components:

• Technical Feasibility:
o Can the product be manufactured using current technologies or processes?
o Are the required materials and resources available?
o Does the company have the expertise or will new capabilities be needed?
• Commercial Viability:
o Is there a clear market demand?
o Who are the target customers?
o What is the estimated price point, and how does it compare to competitors?
o Does the idea align with the company’s business strategy?

This assessment helps determine whether to move the idea forward into more detailed development
stages (e.g., concept design, prototyping).

SWOT Analysis (Strengths, Weaknesses, Opportunities, Threats)

SWOT is a strategic planning tool used to understand internal and external factors that can impact the
success of a new product or project.

Components:

Category Description
Strengths Internal capabilities that give an advantage (e.g., strong brand, skilled team, proprietary
technology)
Weaknesses Internal limitations that could hinder success (e.g., limited resources, skill gaps, supply chain issues)
Opportunities External trends or market gaps the company can exploit (e.g., emerging markets, unmet customer
needs)
Threats External risks that could negatively affect the project (e.g., new regulations, competitive actions,
economic shifts)

SWOT helps identify strategic priorities and supports risk-aware decision-making.

Risk and ROI Estimation

This is a structured evaluation of the potential risks involved in the project and the expected
return on investment (ROI) if it succeeds.

Risk Assessment:

• Technical Risks: Will the product work as intended? Are there design or production
challenges?
• Market Risks: Will customers buy the product? Is demand uncertain?
• Financial Risks: Will costs exceed projections? Is funding secured?
• Regulatory Risks: Are there legal or compliance barriers?
• Risks are typically rated by likelihood and impact, and may be managed using mitigation
plans.

ROI Estimation:
 • ROI = (Projected Profit – Investment Cost) ÷ Investment Cost
• Consider:
o Development and production costs
o Marketing and distribution expenses
o Estimated revenue over product life cycle
o Payback period and breakeven point

This analysis supports go/no-go decisions and helps prioritize high-potential projects.

3. Concept Development & Evaluation

• Purpose: Flesh out product concepts and evaluate customer appeal.

• Outputs:
o Product definition/specification
o Target market, value proposition
o Cost, price, and margin estimates
• Tools: Concept testing, Pugh matrix, Kano model

Concept Testing

Concept testing is the process of evaluating a new product idea by presenting it to potential
customers to gather feedback. The goal is to assess customer interest, perceived value, and usability
before investing in development. It helps identify which concepts are most likely to succeed in the
market.

Pugh Matrix

Also known as a decision matrix, the Pugh Matrix is used to compare multiple options (such as
product concepts or design alternatives) against a set of weighted criteria. Each option is rated relative
to a baseline, helping teams make objective, data-driven decisions.

Kano Model

The Kano Model is a tool for prioritizing product features based on customer satisfaction. It
classifies features into:

• Basic Needs (must-haves),

• Performance Needs (more is better),
• Excitement Needs (unexpected but delightful).

It helps in aligning product development with customer expectations and value creation.

4. Business Analysis

• Purpose: Assess financial viability and strategic fit.

• Includes:
o Forecasting costs, revenue, break-even
o Resource planning
o Risk analysis
 Note:

Forecasting Costs, Revenue, Break-Even

This involves estimating:

• Costs: Development, production, marketing, and operations

• Revenue: Expected sales volume × price
• Break-Even Point: When total revenue equals total costs
These forecasts help determine financial viability, pricing strategy, and funding needs.

Resource Planning

Resource planning identifies the people, equipment, materials, and time required to complete a
project. It ensures the right resources are available at the right time, avoiding delays, bottlenecks,
or cost overruns.

Risk Analysis

Risk analysis involves identifying potential issues that could impact the project, assessing their
likelihood and impact, and developing mitigation strategies. It helps improve project stability,
preparedness, and decision-making.

5. Product Design & Development

• Purpose: Develop detailed product design, including:

o CAD models, BOM (Bill of Materials)
o DFMEA (Design Failure Mode and Effects Analysis)
o Prototyping and simulation
• Cross-functional involvement: R&D, Engineering, Quality, Procurement

6. Process Design & Development

• Purpose: Prepare for manufacturing.

• Activities:
o Process Flow Diagram
o PFMEA (Process Failure Mode and Effects Analysis)
o Control Plan
o Tooling and equipment design
o Supplier selection and PPAP preparation

7. Prototype Testing & Validation

• Purpose: Validate functionality, performance, and manufacturability.

• Includes:
o Design validation
o Pre-production builds
o Lab, environmental, and regulatory testing
o Pilot production
8. Production Ramp-Up (Launch Preparation)

• Purpose: Transition from development to full-scale production.

• Includes:
o Operator training
o Line validation
o Capability studies (Cp, Cpk)
o Final PPAP submission and approval

9. Product Launch

• Purpose: Deliver the product to the market.

• Activities:
o Marketing and sales launch
o Logistics and distribution
o Customer service planning
o Change management controls

10. Post-Launch Review & Continuous Improvement

• Purpose: Learn from performance data and customer feedback.

• Metrics Tracked:
o Sales performance vs. forecast
o Customer complaints or returns
o Internal issues (scrap, rework)
• Tools: 8D, CAPA, Lean/Six Sigma reviews

Supporting Documents Throughout NPD

Stage Key Documents

Idea & Concept Business Case, Customer Requirements
Design DFMEA, CAD Drawings, Specification Sheet
Development PFMEA, Control Plan, Work Instructions
Validation Test Reports, PPAP, MSA
Launch SOPs, Quality Plan, Training Records

Common Frameworks Used in NPD

1. APQP (Advanced Product Quality Planning) – used in automotive
2. Stage-Gate Process – used across industries
3. Design for Six Sigma (DFSS) – quality by design approach
4. Lean Product Development – minimizes waste and speeds up development
In Details:
1. APQP – Advanced Product Quality Planning
Used primarily in the automotive industry.

What is it?

APQP is a structured approach to product and process design that ensures a product meets customer
expectations from development through production.

Key Features:

• Originated from the AIAG (Automotive Industry Action Group).

• Heavy focus on quality, risk prevention, and cross-functional collaboration.
• Aligns with the PPAP submission process.

Phases of APQP:

Phase Description
1. Plan & Define Program Understand customer needs and expectations (e.g. VOC, QFD).
2. Product Design & Development Create DFMEAs, DVP&Rs, design reviews, and specifications.
3. Process Design & Development Develop PFMEA, Control Plans, Process Flow Charts, and work
instructions.
4. Product & Process Validation Perform capability studies, pilot runs, measurement system
analysis (MSA), and PPAP.
5. Feedback, Assessment & Launch product and use feedback for continuous improvement.
Corrective Action

Used For:

• Complex products with strict quality requirements.

• Automotive suppliers, aerospace, and high-risk industries.

2. Stage-Gate Process
Used across industries for managing NPD projects.

What is it?

The Stage-Gate (or Phase-Gate) process is a project management model where a product goes through
sequential stages separated by "gates" (decision points). Developed by Dr. Robert Cooper.

Key Features:

• Each Stage involves cross-functional work (e.g. R&D, marketing, ops).

• Each Gate is a review meeting where leadership decides: Go / Kill / Hold / Rework.
• Helps manage risk, resources, and investment systematically.

Example Stages:
 Stage Purpose
Stage 0 Discovery / Ideation
Stage 1 Scoping – market and technical evaluation
Stage 2 Business Case Development
Stage 3 Product Development
Stage 4 Testing & Validation
Stage 5 Launch

Used For:

• Consumer goods, electronics, pharmaceuticals, and industrial sectors.

• Ensures discipline, visibility, and strategic alignment in NPD.

3. DFSS – Design for Six Sigma

A quality engineering approach that ensures a product is designed right the first time.

What is it?

DFSS focuses on preventing defects by designing products and processes that meet Six Sigma performance
levels (i.e., 3.4 defects per million opportunities).

Key Features:

• Emphasizes data-driven design and customer-centric requirements.

• Uses statistical tools and predictive modeling during design.
• Often follows one of two roadmaps:
o DMADV – Define, Measure, Analyze, Design, Verify
o IDOV – Identify, Design, Optimize, Verify

Tools Used:

• VOC (Voice of the Customer)

• CTQs (Critical to Quality)
• QFD (Quality Function Deployment)
• TRIZ (Theory of Inventive Problem Solving)
• Monte Carlo simulations

Used For:

• High-complexity designs, regulated industries, and situations where redesign or defect costs are high.

4. Lean Product Development (LPD)

A methodology to eliminate waste and improve speed in product development.

🔍 What is it?

Derived from Lean Manufacturing, LPD applies Lean principles to product development—reducing delays,
overengineering, rework, and non-value-added activities.
Key Principles:

1. Eliminate Waste – avoid over-design, excess features, or unnecessary approvals.

2. Decide Late (with data) – keep options open until the last responsible moment.
3. Deliver Fast – develop a minimum viable product (MVP) and iterate quickly.
4. Build Knowledge – learn through quick experiments and feedback loops.
5. Team Empowerment – cross-functional, collocated, and empowered teams.
6. Visual Management – Kanban boards, daily standups, etc.

Common Tools:

• A3 problem solving
• Value Stream Mapping
• Set-Based Design
• Pull Planning and Kanban

Summary
Framework Focus Industry Strength
APQP Product & process quality Automotive, aerospace Risk prevention, compliance
Stage-Gate Project management Cross-industry Milestone-based control
DFSS Design for quality Healthcare, aerospace, electronics Data-driven design
Lean PD Speed & efficiency Manufacturing, software Eliminating waste, agility

What is the difference between NPD vs. ECR/ECO

Topic NPD ECR/ECO
Scope New product or major redesign Minor product change
Complexity High Medium to Low
PPAP Required Yes Often Yes
Project Timeline Weeks to months Days to weeks
Component Development (CD)
Process

Responsibility: CD, Procurement

Component Development (CD) Process
1. RFQ Stage (Request for Quotation)
Input: BOM (Bill of Materials) from RFQ team

Key Activities:

• RFQ Release: Share BOM with Long-Term Suppliers (LTS) for both parts and tooling requirements.
• Quotation Collection: Receive quotes for both component parts and tooling from multiple suppliers.
• Cost Comparison:
o Analyze received quotations on parameters like cost, lead time, and technical capability.
o Benchmark quotes and prepare a comparative analysis sheet.
• Internal Review:
o Submit comparison and recommendation to HOD and SCM team for validation.
o Ensure proper documentation and follow standard costing templates.
• Feasibility Check:
o Conduct preliminary discussions with suppliers to understand their manufacturing feasibility
and any red flags.
o Present findings to R&D for design/DFM feedback.
• Supplier Finalization:
o Lock the technically and commercially suitable supplier.
o Submit final cost to RFQ team for quoting to the customer.

2. Supplier Identification & Feasibility Review

Input: Approved drawing and project requirements

Key Activities:

• Mass Production Feasibility:

o Resend updated RFQ to shortlisted suppliers with mass production intent.
o Request production feasibility confirmation including equipment list, manpower plan, and
infrastructure readiness.
• Capacity Review:
o Assess supplier’s monthly production capacity vs. customer forecast.
o Analyze impact of NPD volume on existing load.
• Supplier Evaluation Criteria:
o Technical capability (machines, gauges, process control)
o Historical quality (PPM, rejections)
o Delivery performance
o Cost competitiveness
• Documentation:
o Compile feasibility data, capacity charts, and evaluation checklist.
o Submit findings to HOD and SCM.
o Finalize the supplier with SCM’s commercial confirmation.

3. Tooling and Part Development

Input: Capex Approval & Finalized Supplier
Key Activities:

• Capex & PR Processing:

o Prepare Capital Expenditure (Capex) Sheet for tooling.
o After internal approval, raise Purchase Requisition (PR).
o Submit technical and commercial details to SCM for PO issuance.
• Design for Manufacturing (DFM) Finalization:
o Align with R&D and supplier on DFM agreement.
o Ensure all part-specific features, tolerances, and material specs are clarified.
• Tool Development Tracking:
o Share time plan with supplier and start weekly tracking.
o Visit tool room frequently for:
▪ Tool design approval
▪ Progress monitoring
▪ Early risk detection
• Tool Trials & Sample Development:
o Conduct initial trial (T0/T1/T2) for the tool.
o Generate Sample Inspection Reports (SIR) and submit to R&D.
o Conduct physical fitment trial if required.
• Plant QA Engagement:
o Submit samples to Plant QA for full layout and dimensional inspection.
o Coordinate closure of deviations in consultation with R&D and QA.
• Tool GRN (Goods Receipt Note):
o After tool approval, facilitate GRN at the plant.
o Coordinate with Finance for tool vendor payment post-quality signoff.

4. PPAP (Production Part Approval Process) & SOP Handover

Input: Dimensional Clearance & Sample Approval

Key Activities:

• PPAP Execution at Supplier End:

o Collaborate with NPD Quality to conduct on-site PPAP at supplier.
o Verify documents: Process Flow, FMEA, Control Plan, MSA, SPC, Layouts, and Functional
Test Reports.
• Pre-PPAP Readiness Audit:
o Audit for:
▪ Availability and calibration of jigs, fixtures, gauges.
▪ Operator training
▪ Machine readiness and SOP documentation
• PPAP Audit Closure:
o Ensure closure of all audit findings.
o Final approval of parts for regular production.
• PSW (Part Submission Warrant) Sign-Off:
o Obtain PSW from NPD Quality post-approval of all PPAP documents.
• Purchase Order for Production:
o Raise PO with SCM for SOP (Start of Production) quantities.
• Initial Production Monitoring:
o Ensure at least 3 months of stable supply from supplier.
o Meet PPM (Parts Per Million) target and review supplier performance.
• QA Issue Handling:
 o Track initial quality issues.
o Coordinate containment and corrective actions with supplier and internal teams.

5. Prototype Development
Input: R&D Requirement for Prototype

Key Activities:

• Proto Supplier Identification:

o Select capable supplier based on lead time and low-volume expertise.
• Cost Settlement:
o Finalize prototype batch costing and get R&D concurrence.
• PR Release & PO Generation:
o Initiate PR with all commercial details.
o Coordinate with SCM for prompt PO release.
• Prototype Delivery:
o Monitor part development and trial runs.
o Ensure timely delivery and feedback for design validation.

Cross-Functional Collaboration Required:

Function Involvement
R&D Design clarification, DFM, fitment trial, deviation approval
SCM PR, PO release, supplier finalization, cost negotiations
Quality (NPD + Plant QA) Dimensional approval, PPAP, layout, PSW
Finance Capex approval, tool payment release
Supplier Quotation, feasibility, tooling, part delivery

Tools & Documentation Involved:

• BOM, Drawing, Capex Sheet, PR/PO, RFQ Comparison Sheet
• Feasibility Study Report
• DFM/DFMEA/Control Plan
• SIR (Sample Inspection Report), Layout Reports
• PPAP Documents (Level 3)
• PSW Sign-off Sheet
• Supplier Evaluation Checklist
• Tool Tracker and Development Milestones

Key Success Criteria:

• On-time tooling and part readiness
• Cost competitiveness with approved supplier
• 100% PPAP and PSW approval before SOP
• Minimal deviation and smooth handover to plant
• Achieving PPM targets and stable ramp-up
Capex Items for Tooling in New Component Development
When developing a new component, specific tooling investments are required to enable consistent, accurate,
and cost-effective production. These tooling investments fall under Capital Expenditures (Capex) because
they are essential for launching and sustaining long-term production.

Key Capex Tooling Items for New Component Development

Tooling Item Purpose in New Component Development

Prototype Tools Temporary or soft tools used to produce parts for early testing, validation, and
trials
Production Tools (e.g., Molds, Final tools used for full-scale production (e.g., injection molds, stamping dies,
Dies) casting dies)
Jigs and Fixtures Custom tools to hold, position, or support the component during manufacturing
or assembly
Checking Fixtures / Gauges Used to inspect and validate component dimensions and tolerances during
production
Assembly Aids Tools or fixtures to assist in joining or assembling the new component with other
parts
Tooling for End-of-Line Testing Equipment required for functional testing of the component before shipment
Tooling Modifications Required changes to existing tools to accommodate design updates or
improvements
Spare Tooling Backup tools to reduce downtime during maintenance or failure of the primary
tooling

Why These Are Capital Investments

• They have a high upfront cost and long useful life

• Used repeatedly for producing the same component
• Help ensure product quality, efficiency, and consistency
• Typically depreciated over several years according to accounting standards

Capex Planning in NPD (New Product Development)

During the early phases of component development (e.g., APQP), Capex tooling needs should be:

• Estimated and approved during project planning

• Tracked against budget during tool design, fabrication, and tryouts
• Documented with tooling ownership, supplier details, and expected life

Examples for a New Component (e.g., Plastic Housing)

Tooling Item Description

Injection Mold For final plastic part production
Prototype Mold Soft tooling for design validation
CMM Fixture Holds part in place during dimensional inspection
Assembly Fixture Ensures correct positioning in final assembly
Go/No-Go Gauge Quick in-line check for key part features
Trim Tool Trims excess material post-molding
What is an LOI (Letter of Intent)?
A Letter of Intent (LOI) is a formal document that indicates the intention of a company to place an order
with a supplier, prior to the issuance of a formal Purchase Order (PO). It is often used during the early
stages of procurement when some approvals are still pending, but the company wants to reserve supplier
bandwidth or initiate urgent activities like tooling or part development.

Purpose of LOI in Supplier Orders:

Purpose Description
Advance Assures the supplier that they will receive a formal order soon.
Confirmation
Start Initial Allows supplier to begin critical tasks like tool design, raw material
Activities procurement, or proto development without waiting for final PO.
Avoid Delays Used to avoid lead-time loss during internal approval or PR/PO processing.
Commercial Confirms commercial terms (tentatively or conditionally) until final PO is issued.
Commitment
Project Planning Helps in planning resources and timelines for NPD or urgent development.

Typical Contents of an LOI:

• Reference to RFQ or quotation
• Description of part/tooling
• Tentative quantity and cost
• Scope of work and delivery timeline
• Conditions for formal PO issuance
• Payment terms (if agreed)
• Non-binding clause (optional or legal binding based on company policy)
• Signature from authorized signatory

Important Notes:
• An LOI is not a legally binding PO, but it may have legal implications if worded as a commitment.
• Usually issued after supplier finalization but before PR approval or PO release.
• Used in critical projects like New Product Development (NPD) or urgent tool kick-off.

Example Use Case in Your NPD Process:

During Tool Development (Stage 3):

Once the supplier is finalized and technical discussions (DFM, feasibility) are cleared, but Capex/PR approval
is still under process, you can issue an LOI to the tool supplier to start tool design or material ordering —
helping to save 2–4 weeks of lead time.
 PPAP
(Production Part Approval Process)

18 standard PPAP (Production Part Approval Process) elements, as specified by AIAG and widely used
industry-wide:

1. Design Records – the part drawings/specifications.

2. Authorized Engineering Change Documents – approved change notices not reflected in the
drawing.
3. Customer Engineering Approval – written confirmation that the customer’s engineering group has
approved the design or trials.
4. Design Failure Mode and Effects Analysis (DFMEA) – design-level risk assessment.
5. Process Flow Diagram (PFD) – visual workflow from raw material to finished part.
6. Process Failure Mode and Effects Analysis (PFMEA) – process-level risk analysis.
7. Control Plan – quality control steps throughout production.
8. Measurement System Analysis (MSA) – gauge R&R and calibration evidence.
9. Dimensional Results – measurement data for ballooned drawing characteristics.
10. Records of Material / Performance Test Results – material certifications and test reports (e.g.
DVP&R).
11. Initial Process Studies – SPC charts demonstrating process capability.
12. Qualified Laboratory Documentation – certificates from accredited labs.
13. Appearance Approval Report (AAR) – customer approval of appearance attributes, if applicable.
14. Sample Production Parts – actual parts from early production runs.
15. Master Sample – benchmark part signed off by supplier and customer.
16. Checking Aids – fixtures, templates, gauges, plus calibration records.
17. Customer-Specific Requirements – any extra documentation requested by the client.
18. Part Submission Warrant (PSW) – summary form certifying the completeness of the PPAP
 PPAP In Details

1st PPAP Document: Design Record

The Design Record is the foundation of the PPAP submission. It consists of the complete engineering
documentation that defines the part or assembly — including organization- and customer-owned drawings,
specifications, dimensions, and any customer-specific requirements.

The submitted design record must meet the latest approved drawing and include all necessary technical
details to manufacture and inspect the part accurately.

What to Include:

• Final Released Drawings (ballooned if needed)

• Characteristics Library: Identifies critical and significant features
• Dimensions, Tolerances, Attributes clearly listed
• Specifications: Material, performance, finish, and any other technical standards
• Special Characteristics identified and labeled (e.g., safety or regulatory features)
• Control of Revisions: Clear evidence the latest revision is being used
• Access Reference: Note stating access to controlled drawings via internal systems like REDI,
Workflow, EPIX, etc.

Note: What is a Ballooned Drawing?

A ballooned drawing (also called a bubble drawing) is a copy of the engineering drawing where:

• Each dimension, tolerance, feature, or specification is circled and assigned a unique number.
• These numbers (balloons) are then linked to an inspection or dimensional results sheet, such as a First Article Inspection Report (FAIR) or PPAP
Dimensional Results form.

Evaluation Questions ?:

1. Is a copy of the drawing included that supports the part or assembly – both Organization and supplier drawing?

• Yes: Ensure the drawings include the organization’s master drawing and, if applicable, supplier-
provided detail/component drawings.
• Purpose: Confirms alignment between both parties and full visibility of what's being manufactured.

2. Is a list of specifications supporting the production of this part provided?

• Yes: This includes industry standards (e.g., ASTM, ISO), material specs, plating/coating, performance
expectations, etc.
• Tip: Use a specification matrix for easy reference.

3. Is change level verification assured or available that the supplier has the latest revisions of specifications?

• Yes: Evidence such as a revision history or a signed document from engineering indicating the current
revision was used.
• Note: Traceability is essential to avoid manufacturing to outdated requirements.
4. Is the form of dimension throughout the PPAP identical in all documentation (metric/English)?

• Yes: Consistent units (either metric or imperial) must be maintained across all documents, FMEAs,
Control Plans, Inspection Reports, etc.
• Tip: A conversion error here could cause major quality issues.

5. Is the form of reporting dimensions throughout the PPAP per Organization drawing?

• Yes: Reporting units, decimal places, tolerances, and presentation format must match the
organization’s standard or drawing expectations.
• Important: This ensures dimension readings are comparable to customer-defined expectations.

6. Have dimensions that affect fit, function, and durability been identified?

• Yes: These are often marked as Special Characteristics (SC, CC, or KPC) and must be called out
clearly.
• Impact: Affects product safety, reliability, and customer satisfaction.

7. Are reference dimensions identified to minimize inspection layout time?

• Yes: Reference dimensions (typically enclosed in parentheses) should be used strategically to guide
layout or inspection efficiency.
• Goal: Reduce time spent during quality checks and focus on critical dimensions.

8. Are sufficient control points and datum surfaces identified to design functional gages?

• Yes: Datum features must be defined so gages and fixtures can be accurately designed for consistent
part inspection.
• Essential for: Repeatable and accurate quality control during production.

9. Are tolerances compatible with accepted manufacturing standards?

• Yes: Tolerances should be feasible for production based on manufacturing capability studies and
industry standards.
• Avoid: Overly tight or unrealistic tolerances that drive up cost or scrap.

10. Are there any requirements specified that can’t be evaluated using known inspection techniques?

• Yes/No (Explain): If requirements (e.g., internal geometry, residual stress) require special tools or
destructive testing, those methods should be documented and justified.
• Flag anything that needs alternative inspection methods or cannot be verified.

Summary:

The Design Record must present a clear, consistent, and complete picture of the part definition,
including:

• Who owns the design

• What is expected (dimensions/specs)
• How it will be controlled and measured
• That the version being used is current and validated
2nd PPAP Document: Authorized Engineering
Change Documents
This section refers to any official changes to the design or product configuration that have been approved
by engineering but are not yet reflected in the official Design Record (drawing or specification). These
documents ensure that any deviation from the released design is fully traceable, approved, and documented.

Such changes may involve:

• Temporary or permanent design alterations

• Changes in materials, dimensions, processes, or suppliers
• Modifications to tooling or inspection methods

What Are Authorized Engineering Change Documents?

These can include:

• Engineering Change Notices (ECNs) or Engineering Change Requests (ECRs)

• Deviation Authorizations or Waivers
• Temporary Change Authorizations (TCAs)
• Pre-PPAP Engineering Approvals

They must be approved by the customer and internal engineering before the part is submitted.

Why This Is Important:

• Prevents unauthorized or undocumented changes

• Ensures the customer is aware of and approves all differences from the design record
• Supports traceability and quality compliance
• Critical for design validation and audit purposes

Key Elements That Must Be Verified:

1. If applicable, is the approved deviation attached?

• What to check: If a part or process differs from the current drawing, an approved deviation form
must be included.
• Why: This proves that customer and engineering are aware of the change and have signed off.
• Best Practice: Attach both the approved deviation document and the related engineering change
form if available.

2. Is the deviation completely filled out?

• What to check:
o Description of the deviation
o Reason for deviation (e.g., supplier issue, design update pending)
o Parts affected (including serial numbers or lot codes if applicable)
o Impact analysis (fit, form, function, safety)
• Why: Incomplete documents can cause delays or rejection of the PPAP submission.
 • Tip: Use standard deviation forms with all required fields to ensure completeness.

3. Are proper approvals in place?

• What to check:
o Required signatures from internal engineering, quality, and customer engineering (if
applicable)
o Date and validity period of the deviation
• Why: PPAP submissions without proper signatures are not considered valid. This ensures
accountability and authorization.
• Note: Some customers (e.g., GM, Ford, Stellantis) require approval through their specific portals or
systems.

4. Does the deviation clearly identify number of pieces, time limit, change forthcoming, etc.?

• What to check:
o Total quantity of parts covered under the deviation
o Time frame (e.g., "valid for 60 days" or "until tooling repair is complete")
o Description of the permanent corrective action or engineering change forthcoming
o Final disposition of affected parts (e.g., "will be used for pilot build only")
• Why: Helps the customer determine the scope and risk of accepting the deviation.
• Best Practice: Include references to future ECNs/ECRs or drawings in progress.

Example Scenario:

Situation: A supplier runs out of specified material temporarily and uses an alternative grade that meets
performance but differs slightly.

• Deviation Form is submitted to both internal engineering and customer.

• It includes a description: "Using 1018 steel instead of 1020 steel for 500 pieces due to supplier
shortage."
• Indicates affected serial numbers or lot numbers.
• States that material will revert to 1020 after August 15.
• Approved by both internal quality and customer engineering.

This deviation would need to be attached to the PPAP package with full traceability.

Summary Checklist:

Requirement Status
Approved deviation included (if applicable) ✅
Form completely filled out ✅
Customer and internal approvals documented ✅
Quantity/timeframe/scope clearly stated ✅
Link to upcoming permanent change or ECN ✅
3rd PPAP Document: Customer Engineering Approval
What It Means:

Customer Engineering Approval is the formal confirmation from the customer’s engineering
department that the part, assembly, or system meets the design intent and performance expectations. It
applies whether the organization owns the design or is building to customer-provided specifications.

It ensures:

• The customer agrees to the design or deviation submitted.

• There is traceable evidence of approval for production.
• Any exceptions (waivers or deviations) are formally documented and approved.

This requirement is non-negotiable unless a documented engineering waiver is in place.

When is it Required?

• For design-responsible suppliers submitting new or revised designs

• When there are changes to fit, form, function, material, or manufacturing process
• In case of deviations from the original drawing/specification
• For parts requiring functional or application validation

What to Include
1. Formal Controlled Document for Customer Engineering Approval

This is an official approval document issued by the customer (OEM or Tier 1), confirming that the part or
design has been evaluated and accepted.

It may include:

• Signed application checklist

• Test and validation reports signed by customer engineering
• Email or portal-based approval from OEM (e.g., GM eTRACS, Ford eAPQP, Stellantis
TeamCenter)
• Functional specification agreement
• A formal Engineering Approval Form signed by the customer's product or systems engineer

Format: Controlled document, with revision number, date, part number, customer name, and contact
info.

2. Formal Controlled Document of Engineering Waiver (If Approval Is Not Yet Received)

If formal customer approval is not yet obtained, but production must proceed, a temporary engineering
waiver is required.

The Engineering Waiver should:

• Clearly state the reason for the waiver

• Reference the affected part number and revision
 • Include the quantity of parts or time period covered
• Be signed by customer engineering
• Be traceable to a deviation record or temporary change notice

This does not replace full engineering approval — it temporarily permits production under specified
conditions until full approval is received.

Supporting Internal Documents

Even if customer engineering approval is received, you must also show how internal teams interpret and
apply the design throughout the process. Include:

• Application checklists: Ensures the organization has evaluated fit, function, and interface conditions.
• Process Instruction Sheets: Internal work instructions that detail how design features (e.g., critical
dimensions or tolerances) are applied on the production floor.
• Functional specifications: Confirm the part meets intended performance in its actual use environment
(form, fit, and function).
• Design interpretation documents: Used when customer drawings require clarification for
manufacturability or inspection.

Note: These must match the Control Plan and be kept under formal document control. Discrepancies may
lead to PPAP rejection.

Evaluation Checklist for Customer Engineering Approval:

Question What to Look For
1. Is a formal, controlled document for Signed approval from the customer’s engineering team, often
Customer Engineering Approval via OEM system or email with traceable ID.
included?
2. Is a formal, controlled document of If approval is pending, a waiver with time/volume limits and
engineering waiver included (if needed)? proper signatures is attached.
3. Do internal documents reflect the Process Instructions, Control Plans, and Operator Instructions
Design Record clearly? accurately reflect critical and special characteristics from the
design.
4. Are all documents under revision Check for document control numbers, revision dates, and
control? traceability back to the PPAP part number.

Example Scenario:
A supplier submits a new steering component. The customer hasn't yet finalized approval, but production
must begin to meet launch deadlines. The supplier:

• Submits a Customer Engineering Waiver approved for 2,000 pilot build units
• Includes an application checklist confirming fit and function in the vehicle
• Shares internal Process Instruction Sheets showing critical torque specs and inspection points
• Includes a note: "Full approval expected via Ford eAPQP by August 5"

This submission meets PPAP expectations with traceable and controlled documentation.

Note: Customer Engineering Approval ensures formal, traceable acknowledgment that the design or
any variation from the design is acceptable to the customer. Without it, a PPAP cannot be fully approved.
4th PPAP Document: Design FMEA
Design FMEA (DFMEA) is a proactive risk assessment tool used by design-responsible organizations to
systematically identify, analyze, and mitigate potential failure modes in a product before it is released for
manufacturing and customer use.

It ensures that design weaknesses are discovered early and addressed to prevent:

• Performance issues
• Safety failures
• Warranty claims
• Customer dissatisfaction

Key DFMEA Principles:

• Focuses on the product design, not the process.

• Evaluates how each component or system might fail to meet its intended function.
• Prioritizes failure modes by Risk Priority Number (RPN) or Action Priority (AP).
• Promotes design improvements to reduce or eliminate failure risks.
• Must be owned and maintained by the design-responsible party (supplier or internal).

What’s Required?
1. Design FMEA of Saleable Part and Components

• The supplier must attach a current DFMEA that covers the saleable part number (customer part)
and its internal components.
• Should reflect the latest design revision.
• Must cover all product functions, including:
o Structural
o Mechanical
o Electrical
o Environmental
o Safety

Purpose: Ensures that the primary component sold to the customer has been thoroughly evaluated for design
risks.

2. Cascading DFMEAs to Lower Design Levels

The DFMEA should be cascaded through the product hierarchy to ensure complete coverage:

Level Description
a. Product / Vehicle High-level FMEA that considers the product in the context of the full vehicle or
Level system (e.g., impact on crash safety, emissions, etc.)
b. System / Group FMEA covering the sub-system, like the braking system or HVAC system
Level
c. Assembly Level FMEA of specific assemblies, like brake caliper or compressor subassembly
d. Component FMEA of individual components such as seals, valves, connectors, etc.
Level
Purpose: Captures failure interactions across levels and ensures complete risk analysis of the full design.

3. Does the DFMEA Drive Design Improvements?

• The main goal of DFMEA is not documentation, but design enhancement.

• FMEAs must include:
o Executed design actions (e.g., tolerance change, material upgrade)
o Revised RPN or Action Priority after mitigation
• Signs of a good FMEA:
o Actions are closed
o Risk levels are reduced
o The document is living (actively updated)

Purpose: Confirms that the DFMEA is being used as a tool for continuous improvement, not just compliance.

4. Proprietary Information Handling

• If the DFMEA contains proprietary design information (e.g., trade secrets), a formal statement
must be attached to the PPAP that:
o States the DFMEA exists and is maintained
o Will be made available to the customer upon request or during an audit
• Some companies provide a DFMEA summary sheet instead

Purpose: Maintains confidentiality while still ensuring compliance.

5. Does DFMEA Address All High-Risk Failure Modes with Action Plans?

• High-Risk = Based on:

o High severity (impact to safety, compliance, performance)
o Or high Action Priority (AP) as per AIAG/VDA
• There must be:
o Defined actions
o Responsible persons
o Target and actual completion dates
o Status updates
• Simply noting the issue is not sufficient — action must be evidence-based.

Purpose: Ensures critical issues are not just identified but actively resolved.

6. Are DFMEA Failure Modes Considered in A/D/V and DVP&R?

• DFMEA should directly inform:

o Analysis activities (e.g., FEA, thermal simulation)
o Design Verification Plan and Report (DVP&R)
o Validation testing (e.g., vibration, thermal cycling, durability)
• Every high-risk failure mode should map to a test or analysis that verifies it's been addressed.

Purpose: Ensures that risk mitigation is validated with data, not just assumptions.
Summary Checklist
Requirement Criteria
DFMEA attached for the saleable part ✅ Yes
DFMEA cascaded through system levels ✅ Yes
DFMEA used to drive design improvements ✅ Yes
Proprietary info statement included (if needed) ✅ Yes
High-risk failure modes have action plans ✅ Yes
DVP&R and validation consider DFMEA failure modes ✅ Yes

Example Scenario:
A supplier designs a new plastic fuel connector.

• DFMEA identifies a potential leak due to stress cracking under high temperature.
• Severity = 9, Occurrence = 4, Detection = 5 → RPN = 180
• Design team changes resin grade and adds reinforcing ribs.
• DVP&R includes pressure tests and heat aging tests to validate the change.
• RPN drops to 72 after action.
• A proprietary DFMEA declaration is attached to PPAP, since material data is confidential.

This submission shows that risk was not only identified but managed and validated.

More Details:
DFMEA Template (AIAG/VDA Hybrid Format)
Proprietary Design FMEA Declaration

Part Number(s): [Insert Part Numbers]

Part Description: [Insert Description]
Revision Level: [Insert Rev]
Customer: [Insert Customer Name]

Supplier Name: [Insert Supplier Name]

Contact Name: [Insert Contact Person]
Title: [Insert Title]
Email: [Insert Email]
Phone: [Insert Phone Number]

Authorized Signature: _________________________

Date: [Insert Date]
Ite Functi Failu Effec S Cause O Prevent Detect D AP Recomme Respons Target Stat Revis Revis Revis Fin
m on re t of (Severi of (Occurre ion ion (Detecti (Actio nded ible Date us ed S ed O ed D al
Mode Failu ty) Failure nce) Control Contr on) n Actions AP
re s ols Priori
ty)
1 Maint Leaka Fuel 9 Material 5 Use of Visual 6 H Change to Design 08/15/2 Ope 9 2 4 M
ain ge loss, degrada high- inspect heat- Eng. 025 n
fluid fire tion temp ion resistant
seal risk polymer material
Notes:

• Use S, O, D scales from AIAG/VDA (1–10)

• Use the AP Decision Table below for Action Priority
• Add more rows as needed

Action Priority (AP) Calculator Guide

AP Lookup Logic (AIAG/VDA Table Snapshot)

Severity Occurrence Detection AP Level

≥9 ≥4 ≥5 High
≥7 ≥4 ≥6 High
≥5 ≥4 ≥7 Medium
<5 Any Any Low

Key Points to be checked in DFMEA:

1. Single DFMEA for Family of Parts

• A single DFMEA may cover a family of similar parts or materials, provided all design characteristics
are thoroughly addressed.
• This promotes consistency and efficiency while ensuring comprehensive risk coverage across similar
components.

2. Attachment of DFMEA Documents

• The supplier must attach the current DFMEA for the saleable part number and all relevant
components.
• To fully capture risk across product hierarchy, DFMEAs should be attached for:
a. Product/Vehicle Level – High-level system integration risks.
b. System/Group Level – Intermediate assemblies or systems.
c. Assembly Level – Specific sub-assemblies.
d. Component Level – Individual parts and materials.
• This cascade ensures all levels of the product structure are evaluated for potential design risks.

3. Design Improvements Driven by DFMEA

• The primary objective of DFMEA is to identify failure modes that require design improvements.
• Executable action plans should be created to eliminate or mitigate risks, leading to robust, reliable
products.

4. Proprietary DFMEA Declaration

• If the DFMEA contains proprietary or confidential information, a formal statement must be included
stating that the DFMEA is available for customer review upon request.
• This protects intellectual property while ensuring transparency and customer trust.
5. Addressing High-Risk Failure Modes with Actions

• DFMEA must identify all high-risk failure modes (based on severity, occurrence, detection, or Action
Priority).
• Clear, executable corrective or preventive action plans should be documented and tracked for these
risks.

6. Consideration in Validation and Verification Plans

• The Analysis/Development/Validation (A/D/V) phase and Design Verification Plan & Report
(DVP&R) should incorporate failure modes identified in the DFMEA.
• This confirms that identified risks are tested and verified before product launch.

7. Integration and Interface Failure Modes

• DFMEA scope should include potential failure modes related to integration and interfaces between
systems or components, verified through block diagrams and functional analyses.
• This prevents failures arising from system interactions, not just individual part functions.

8. Incorporation of Lessons Learned

• Historical data from warranty claims, field failures, and campaign records should inform failure mode
identification.
• Leveraging this “lessons learned” approach improves risk prediction accuracy.

9. Identification of Special Characteristics Candidates

• DFMEA outputs should help identify candidate Special Characteristics (SCs), which are critical design
or quality parameters requiring special attention.

10. Consideration of Similar Part DFMEAs

• Review of DFMEAs for similar or previous parts is essential to avoid reinventing the wheel and to
benefit from prior risk assessments.

11. Cross-Functional Team Involvement

• Effective DFMEA development involves personnel from all relevant support groups including design
engineering, quality, manufacturing, and suppliers to ensure all perspectives are considered.

12. Use of Customer Reliability/Warranty Data

• Customer feedback, reliability, and warranty data should be incorporated into DFMEA inputs to
capture real-world issues.

13. Living Document Status

• The DFMEA should be regularly updated to reflect design changes, new failure modes, and closed-
loop actions — ensuring it remains a current risk management tool.
14. Inclusion of Customer Product Problems and Countermeasures

• Past customer product issues and their countermeasures must be documented within the DFMEA.

15. Countermeasures for High-Risk Items

• For high-risk failure modes, appropriate countermeasures must be planned or implemented and tracked
to closure.

16. Continuous Quality Improvement Usage

• DFMEA data should feed into ongoing quality improvement initiatives (e.g., 8D reports, Kaizen
events).

17. Assignment of Responsible Individuals

• Persons responsible for corrective actions and improvements should be clearly identified within the
DFMEA process.

18. Use of Customer Plant Problems

• Problems encountered at customer facilities should be used to inform and update the DFMEA.

19. Cause Descriptions Are Controllable

• Causes should be described clearly in terms of design elements or process factors that can be
controlled or modified.

20. Criteria for Special Characteristics Documented

• The rationale and criteria used to select Special Characteristics should be well documented.

21. Involvement of Relevant Personnel in SC Determination

• Cross-functional participation in identifying Special Characteristics ensures accuracy and

completeness.

22. Consideration of Dimensional Tolerances and Material Properties

• All relevant tolerances and material specs must be incorporated into the DFMEA risk evaluation.

23. Use of DFMEA to Determine Special Characteristics

• DFMEA outputs are a key input for defining Special Characteristics.

24. Identification of SC for All Products

• All applicable products and parts should have identified Special Characteristics.

25. Inclusion of Warranty and Reliability Data for SC Determination

• Field data should support the selection and validation of Special Characteristics.
26. Evidence That All Known SCs Are Included

• Verification that every Special Characteristic identified in product requirements or regulations is

represented.

27. Inclusion of Attribute Characteristics

• Attributes (non-measurable characteristics like color or surface finish) should be included in risk
assessments.

28. NPI and ECN Considerations in SC Identification

• New Product Introductions (NPI) and Engineering Change Notices (ECN) should be reflected in SC
updates.

29. Clear Linkage to PFMEA and Other APQP Documents

• DFMEA should be linked to Process FMEA (PFMEA), control plans, and other Advanced Product
Quality Planning (APQP) documentation for seamless risk management.

30. Inclusion of Design Review Action Lists

• Actions arising from design reviews should be captured in the DFMEA or linked documentation.

31. Attachment of Similar/Historical DFMEAs

• Including previous DFMEAs supports traceability and understanding of design evolution.

32. Historical Campaign and Warranty Data Included

• Past recalls, campaigns, and warranty data should inform current DFMEA.

33. VOC (Voice of Customer) Cascaded Through QFD: Customer requirements and feedback
should be embedded throughout Quality Function Deployment (QFD) and reflected in DFMEA inputs.

List of Special Characteristics from Supplier Design Responsible: All Special

Characteristics (SC) identified during design must be documented and communicated clearly. Suppliers must
list all SCs and ensure that their design adheres to the agreed criteria.

Supplier Responsibilities for Special Characteristics:

Question Explanation
1 Are all Special Required Characteristics (SRCs) These are mandatory customer or regulatory
identified and listed? SCs.
2 Are all Special Design Characteristics (SDCs) identified SCs critical to design function, safety, or
and listed? compliance.
3 Are all Special Process Characteristics (SPCs) identified Process-related SCs impacting quality or
and listed? reliability.
4 Was supplier design carried out considering the above Design must incorporate and respect all
criteria? identified SCs.
5th PPAP Document: Process Flow Diagram
(PFD)Assessment
What is a Process Flow Diagram?

A Process Flow Diagram (PFD) is a visual map of the complete manufacturing process for a part or
assembly, from receiving raw materials to delivering finished goods. It ensures transparency, traceability, and
alignment across design, manufacturing, quality, logistics, and customer expectations.

The PFD should:

• Show all operations (value-added & non-value-added)

• Include material flow, inspections, rework, packaging
• Be synchronized with PFMEA and Control Plan
• Account for alternate or back-up processes and suppliers

Detailed Assessment Criteria

1. PFD Must Identify All Key Operations

• Covers manufacturing, handling, inspection, packaging, shipping, rework, and scrap.

• Subcontracted processes must also be clearly identified.
• Alternate or backup processes should not be omitted.

Example: If a plating step is done externally, the PFD should include "Send to External Plating Vendor" and
identify quality checks upon return.

2. Rework and Scrap Handling

• The diagram should visibly illustrate how rejected material or non-conforming parts are handled.
• Should show paths to rework stations or scrap disposition points, including any decision points or
inspections.

Tip: Label these routes clearly using dotted lines or different colors to distinguish from the main production
flow.

3. Logical Process Layout

• Operations must be sequenced correctly based on actual production.

• Flow should reflect plant layout and material movement efficiently (U-shape, straight line, etc.).
Evaluate: Are steps physically possible in the sequence shown? Are bottlenecks or backtracking
present?

4. Complete and Accurate Production Sequence

• The PFD must start with purchased/raw materials and proceed through:
o In-house and subcontracted manufacturing
o Inspection steps
o Cleaning and packaging
o Final shipment
 o Consumption by customer

5. Inclusion of Pull System / Optimization Concepts

• Lean practices like kanban, FIFO lanes, supermarkets, etc., should be shown if applicable.
• Look for signals like “kanban trigger point” or “pull from finished goods.”

6. Controlled and Reviewed PFD

• Must include:
o Revision control
o Review history
o Sign-offs from responsible parties
• Must match PFMEA, Control Plan, and actual shop floor practices.

7. Assembly and Packaging Steps Included

• Every final assembly operation, packaging detail (e.g., in trays, bags, cartons), and labeling or
inspection prior to shipment should be on the chart.

8. Operation/Sequence Numbering

• Every step should be numbered consistently, as these numbers are used in PFMEA and Control Plan.

E.g.: Operation 10 = "Laser Cutting", Operation 20 = "Deburring", etc.

9. Use of FMEA to Build PFD

• FMEA is a key input when constructing a PFD.

• Verify that high-risk or special process steps identified in PFMEA are represented.

10. Inspection, Attribute Checks, and QA Steps

• Clearly indicate:
o Inline inspections (e.g., torque check)
o Attribute checks (visual, go/no-go)
o Measurement or functional tests
o Data logging points

11. Rework and Scrap Flow Illustrated

• Separate flow paths for:

o Reinspection
o Repair or Rework
o Scrap bin or quarantine area

12. Material Handling and Quality Risks

• Ensure:
o Each material movement is illustrated (manual, forklift, conveyor, etc.)
o Handling-related risks (damage, contamination) are acknowledged
o Subcontracted steps are reviewed for control plans and traceability
13. Final Shipment and Consumption

• The last steps must include:

o Finished Goods Inventory
o Shipping Inspection
o Transport (e.g., truck, courier)
o Delivery to Customer or Warehouse

14. Physical Movement Identified

• Indicate how parts move:

o Manual, tray, roller conveyor, robotic arm, tubs, etc.

Tip: This helps link to ergonomic, safety, and efficiency evaluations.

15. Storage and Staging Points

• Clearly identify where WIP (Work in Process) or FG (Finished Goods) may be stored or staged.

Look for terms like: “Hold Area,” “WIP Rack,” “Curing Zone”

16. Special Handling Requirements

• Steps like pre-heating, cooling, post-processing, or assembly setups must be shown.

17. Alternate / Backup Processes and Sources

• Identify:
o In-house alternate equipment or lines
o Backup subcontractors
o Emergency outsourcing routes

These must also be validated and included in PFMEA/Control Plan.

18. Alternate / Backup Processes and Sources

• Identify:
o In-house alternate equipment or lines
o Backup subcontractors
o Emergency outsourcing routes

These must also be validated and included in PFMEA/Control Plan.

19. Validation of Alternates or Backups

• Alternate processes or subcontract sources must be:

o Qualified
o Approved
o Included in PPAP if used

20. Creation of Special Characteristics

 • The PFD must highlight operations where Special Characteristics (SCs) originate.
• These operations will require enhanced controls in Control Plan and PFMEA.

Example: If a heat-treatment process controls a critical hardness spec, label this operation accordingly.

Best Practices for PFD Implementation

Aspect Best Practice
Format Use standard symbols for operations, inspections, decisions, flow arrows
Alignment Ensure PFD operation numbers match PFMEA and Control Plan
Software Use Excel, Visio, Lucidchart, or AIAG templates
Review Cross-functional review (Engineering, Quality, Production, Supplier)
Control Version/revision control with signature block

6th PPAP Document: Process Failure Mode and

Effects Analysis (PFMEA)
Overview:

PFMEA is a systematic, structured approach used to identify and evaluate potential failure modes in a
manufacturing or assembly process. The purpose is to reduce risk by implementing corrective actions
before defects occur. PFMEA is a live document and must be used proactively in conjunction with the
Process Flow Diagram and Control Plan.

It identifies:

• Where and how the process might fail

• Effects and causes of failures
• Risk levels (via Severity, Occurrence, Detection)
• Actions to reduce or eliminate risk

Key Requirements :
1. Supplier Shall Attach Approved PFMEA(s)

• The latest version of PFMEA must be approved, documented, and included in the PPAP package.
• Should have revision history, sign-off, and match current engineering level.

2. Cascade with Other DFMEAs

PFMEA must align with upstream design documentation:

• Product Vehicle – System-level failures impacting manufacturing

• System/Group Level – Interfaces and interactions across modules
• Assembly Level – Failures during final part assembly
• Component Level – Risk in manufacturing of individual parts
3. Inclusion of Tier-2 or Lower PFMEAs

• PFMEAs from sub-suppliers must be included where they manufacture critical or high-risk
components.
• These should be reviewed for alignment with your PFMEA, especially if risks are shared.

4. Proprietary DFMEA Declaration

• If DFMEA is proprietary but PFMEA depends on it, include a formal declaration stating it is
available at the supplier’s site for audit/review.

5. List of Recommended Actions Attached

• Corrective actions identified in PFMEA must be listed, tracked, and monitored.

• Include due dates, responsibilities, and status for transparency.

6–8. Confirmed Special Characteristics Lists

• Three separate lists must be submitted:

o ✅ Special Required Characteristics (SRC)
o ✅ Special Design Characteristics (SDC)
o ✅ Special Process Characteristics (SPC)

These must be clearly traceable to PFMEA, Control Plan, and prints.

9. Correct Identification of Part Number & Engineering Change Level

• PFMEA must reflect the correct part number, revision, and engineering change level, ensuring that
the document corresponds to the actual product.

10–11. Top Severity, Occurrence, RPN or AP Addressed

• Top risks should be prioritized using:

o Traditional RPN (Risk Priority Number): Severity × Occurrence × Detection
o Or Action Priority (AP) per AIAG-VDA: A ranking system of High/Medium/Low
• Corrective actions for high-severity or high-priority items must be evident.

12. All Special Characteristics Identified

• Each SC must be:

o Clearly marked in PFMEA
o Linked to detection/prevention controls
o Escalated into Control Plan

13. PFMEA in English (or Translated)

• Must be understandable by the customer, especially in global supply chains.

• Attach both native language and English versions if needed.

14. Inclusion of All Product and Process Requirements

• All:
 o Print dimensions
o Specification limits
o Customer requirements
o Attribute/functional characteristics
Must be included and analyzed.

15–16. Adequate & Special Controls

• PFMEA must describe detection and prevention controls for each failure mode.
• Special Characteristics require more stringent controls (e.g., 100% inspection, mistake-proofing).

17. Emphasis on Error-Proofing (Poka-Yoke)

• Mistake-proofing should be a primary improvement goal.

• FMEA must show action items like sensors, automated checks, or control fixtures to prevent errors.

18. Addressing High-Risk Failure Modes

• All failure modes identified as “high-risk” by the team (due to severity or AP) must have documented
mitigation plans.

19. All Other Failure Modes Considered

• Even low-risk items must be addressed to ensure completeness.

20. Failure Modes Carried to Control Plan

• There should be traceability between:

o PFMEA failure modes
o Corresponding control measures in the Control Plan
o Process steps in the Process Flow Diagram

21. Full APQP Integration

• PFMEA must align and be consistent with:

o Process Flow Diagram
o Control Plan
o DFMEA
o Work Instructions
o Process Capability & Gage R&R

22. Timely Completion (“Window of Opportunity”)

• PFMEA must be done early in the planning stage, ideally before tooling or production investment,
when it's easiest and cheapest to implement changes.

23. Trained, Cross-Functional FMEA Team

• The team must include trained representatives from:

o Design
o Manufacturing
o Quality
 o Maintenance
o Suppliers (if applicable)

Each participant should have documented FMEA training.

24. FMEA Fully Completed and Updated

• Must include:
o Initial risk ratings
o Actions taken
o Updated risk ratings (post-mitigation)
o Evidence that actions are closed

25. Required Actions Implemented

• Actions labeled “Required” must have:

o Verified closure
o Actual impact on reducing Severity, Occurrence, or Detection

26–27. SC Criteria and Personnel

• The criteria for selecting Special Characteristics must be documented.

• The selection process must include appropriate personnel (Design, Quality, Customer Engineering).

28. Dimensional and Material Property Coverage

• All tolerances and specs related to dimensions, materials, and processes must be analyzed for
potential failure modes.

29. Linkage to Design FMEA

• PFMEA should reflect risks identified in DFMEA where manufacturing can influence or exacerbate
those design failures.
• Use DFMEA to inform what special controls are required in process.

Summary of Best Practices:

Key Element Best Practice
Format AIAG 4th Ed or AIAG-VDA Hybrid
Risk Priority Use Action Priority (High/Med/Low)
Integration Match step numbers with Flow Diagram & Control Plan
Controls Show both detection and prevention
Status Must show “action taken” and updated risk ratings
Training Document FMEA training for team members
Special Characteristics Clearly flagged and supported with control strategy
7th PPAP Document: Control Plan
The Process Control Plan is a living document that outlines the necessary controls in manufacturing to
ensure product quality, process consistency, and conformance to customer requirements. It directly
supports APQP Phase 4 – Product and Process Validation and ensures linkage with the Process Flow
Diagram, PFMEA, and work instructions.

Control Plan Detailed Requirements

1. Full Scope of Operations

• A control plan must cover every operation related to:

o Purchasing
o Manufacturing
o Assembly
o Packaging
o Shipping
o Inspection & testing (in-process and final)

2. Stakeholder Review & Evidence of Use

• Must be reviewed with the customer or internal organization team.

• Evidence of use in New Product Introduction (NPI) projects must exist.

3. Nonconformance & Corrective Action

• Must document:
o How nonconforming products are identified, segregated, and dispositioned.
o Actions taken to correct root causes.
o Procedures to prevent recurrence.

4. Requirement Traceability

• All drawing dimensions, specifications, PO clauses, and attribute checks must be traceable on the
plan.

5. Format Compliance

• Must follow AIAG Control Plan Manual format with columns like:
o Process Step
o Product/Process Characteristics
o Control Method
o Reaction Plan
o Special Characteristics

6. Cross-Functional Team Involvement

• Document must include participation by:

o Engineering
o Quality
o Manufacturing
 o Maintenance
o Logistics
o Operators

7. Document Identification

• Part number, current engineering revision, and control plan version must be stated.
• The document must be revision-controlled.

8. Integration with APQP Documents

• Control Plan must be keyed to:

o PFMEA (failure modes)
o Process Flow Diagram (operation numbers)
o Work instructions (reference IDs)

9. Inspection Coverage

• Must include:
o Receiving Inspection
o In-Process Inspection
o Final Product Verification

10. Special Characteristics & Testing

• All Special Characteristics from DFMEA and PFMEA must be marked.

• Performance tests and frequencies should be listed explicitly.

11. Equipment and Measurement Systems

• Identify equipment such as:

o Press type, machine ID, fixture type
• List gages and test methods:
o Attribute, variable, SPC
o Are gages traceable to national standards?

12. Reaction Plans

• For each failure mode or out-of-control condition, include:

o Who acts
o What action to take
o Escalation path
o Containment methods

13. Language Accessibility

• Available in English or translated for customer use.

12. Special Characteristics Selection

• Show that:
o Customer feedback is considered.
 o DFMEA, PFMEA, SFMEA were referenced during creation.

15. Material, Packaging, and Design Change Coverage

• Include:
o Material requirements (e.g., coating, hardness)
o Packaging and labeling controls
o Change control process linkage for new parts or engineering changes

16. Reference to Supporting Documents

• If you mention work instructions, SOPs, or visual aids, they must be attached or accessible.

17. Coverage Completeness

• Cover:
o All non-print attributes (like cleanliness, noise)
o All organization part numbers
o Each manufacturing operation, even if outsourced

18. Development Methodology & Sampling

• Show methodology:
o Based on PFMEA
o Statistical data (initial capability, Cpk)
• Include sample size and test frequency guidelines.

19. Identification & Control of Content

• Each process step should include:

o Step number
o Operation name
o Responsibility
o Measurement technique
o Control frequency
o Revision date

20. Machine and Process Details

• Include:
o Machine make/model
o Fixture or gage numbers
o Setup instructions
o Control documents like inspection criteria, changeover instructions

21. Alternate & Backup Process Plans

• Control Plans must exist for:

o Backup equipment
o Alternate processes
o All attribute characteristics
22. Assembly, Packaging, and Supplier Processes

• Detail packaging steps and controls.

• Create or obtain control plans from subcontractors or suppliers.

23. Communication & NC Handling

• Suppliers must be informed of requirements and their plans reviewed.

• Must include:
o Handling of nonconforming materials
o Escalation procedures
o Feedback loop from quality failures

24. Change Management & Effectiveness

• Show that the plan is updated with:

o Process changes
o Equipment upgrades
o Corrective actions
• Should have a revision log.

25. Feedback from Customer Rejections

• Include lessons from:

o Warranty returns
o Customer complaints
o Design changes

26. Gage Compatibility & Performance Requirements

• Ensure all:
o Engineering test specs (durability, functional)
o Measurement systems are traceable and validated

8th PPAP Document: Measurement Systems

Analysis
MSA is conducted to evaluate the accuracy, repeatability, reproducibility, and stability of the measurement
systems used in quality-critical processes. The goal is to ensure measurement systems provide reliable,
repeatable, and consistent data that can be trusted for decision-making.

Key Requirements & Evaluation Criteria:

1. MSA Coverage for All Gages (Variable & Attribute)

• All measurement devices and systems listed in the Control Plan must have supporting MSA studies.
o Variable gages → Gage R&R Studies
o Attribute gages → Attribute Agreement Analysis (AAA)
 • Includes manual, automated, destructive, and non-contact systems.
• Includes in-process and final inspection gages.

Common Tools that Require MSA:

• Calipers, micrometers, torque wrenches, coordinate measuring machines (CMMs), pin gages, attribute
templates, vision systems.

2. Correct Gage-to-Part Mapping

• Each MSA report should:

o Reference the correct part number, feature, and gage ID.
o Be traceable to the gage family (where applicable).
o Match the characteristics on the Control Plan and PFMEA.
• Ensure gage calibration ID, revision level, and measurement range are clearly identified.

3. MSA Acceptability per AIAG Guidelines

Acceptability Ranges (Variable Gages – Gage R&R)

Gage R&R (%) Interpretation
≤ 10% Acceptable
10–30% Marginal – may be acceptable depending on: importance of feature, cost, criticality
> 30% Not acceptable – must improve the measurement system

Gage R&R Studies Should Include:

• Repeatability – variation from the same operator using the same gage multiple times
• Reproducibility – variation across different operators using the same gage
• Total Gage R&R as % of process variation

Attribute Studies Must Show:

• Appraiser Agreement ≥ 90%

• Part Agreement ≥ 90%
• Correctness to Reference ≥ 90%
• Acceptable Kappa values if statistically evaluated

4. Correlation Concerns

• For correlated gages (e.g. cross-functional gages, inline vs offline comparison), correlation studies
must be conducted.
o Correlation coefficient (R) should be ≥ 0.90
o Use paired sample t-test or linear regression for comparison
• If CMM or vision systems are used, correlation to hand tools or functional gages must be validated.

5. Customer Review and Approval

• MSA studies for Special Characteristics or Customer-Controlled Characteristics may require:

o Formal customer approval or waiver
o Submission during PPAP, Run@Rate, or Capability studies
• Review should include:
o AIAG-compliant summary of studies
o Evidence of actions taken for unacceptable gages
 o Confirmation that studies are within the effective date window

Additional Best Practices

Requirement Best Practice
Frequency of MSA Conduct MSA on all gages annually or with major process changes
Sample Size Minimum: 10 parts × 3 operators × 2 trials
Gage Calibration All gages used in MSA must be calibrated and traceable
Documentation Maintain clear MSA logs with version, revision date, method used
Software Tools Use Minitab, Q-DAS, InfinityQS, or Excel with validated templates
Training MSA studies must be performed by trained quality personnel

9th PPAP Document: Dimensional Results

Dimensional Results is the part of the PPAP submission that provides actual measured values of part
features compared against the specifications on the ballooned drawing. It is used to verify that the part
conforms to all required dimensions and tolerances defined by the engineering drawing or CAD model.

Purpose

To demonstrate that:

• The part meets all dimensional requirements.

• The manufacturing process can consistently produce parts within the specified tolerances.
• Any critical or key characteristics are verified and controlled.

What This Document Includes

A standard Dimensional Results sheet typically includes:

Field Description
Balloon/Bubble Number A unique ID that corresponds to a number on the ballooned drawing.
Drawing Dimension / The nominal value and tolerance as given in the engineering drawing (e.g.,
Specification Ø10.00 ± 0.10 mm).
Measured Value(s) The actual measured value(s) of the part feature. Usually 3 to 5 samples are
taken per characteristic.
Pass/Fail Indicates whether the measured result falls within tolerance (PASS or
FAIL).
Instrument Used The tool or equipment used for measurement (e.g., Vernier caliper, CMM,
height gauge).
Sample Size Typically 3, 5, or more samples from the production run. May be more if
required by the control plan or customer.

Ballooned Drawing

A ballooned (or bubbled) drawing is a copy of the engineering drawing where:

• Each dimensional feature is numbered or "ballooned".

• Each balloon corresponds to a row in the Dimensional Results sheet.
 • Helps trace the measurement results back to the original drawing.

Ballooning ensures traceability and reduces confusion in complex parts with many features.

Example

Drawing Feature: Hole diameter Ø5.00 ± 0.05 mm

Balloon Number: 12

Balloon # Drawing Spec Measured Values (mm) Pass/Fail Instrument

12 Ø5.00 ± 0.05 mm 4.98, 4.99, 5.01 PASS CMM

When Does It Fail?

Fails when:

• Any one measurement is outside the allowed tolerance.

• Results show inconsistent manufacturing, even if values are within spec.
• Key or critical characteristics are not measured or recorded correctly.

Best Practices

• Use calibrated instruments and document their ID or calibration status.

• Align measurements with sampling plan defined in your Control Plan.
• Double-check measurements for features with tight tolerances or safety relevance.
• Clearly distinguish actuals vs. nominal in the result sheet.
• Include date, operator name, and part number/revision on the results sheet.

Supporting Documents

Often submitted with:

• Ballooned Drawing (linked to Dimensional Report)

• Gage R&R (MSA) results showing the measurement system is reliable
• Control Plan (shows how often and how features are measured in production)

10th PPAP Document: Records of Material /

Performance Test Results
The primary goal is to demonstrate that:

• The material composition and properties conform to design specifications.

• The product performs as intended under defined operating and environmental conditions.
• All applicable customer, safety, and regulatory requirements are met.
What to Include
This section includes two key components:

1. Material Certification Records

These documents verify that the raw materials used in the product meet the required standards. Typical
materials include metals, plastics, coatings, or adhesives.

Common examples:

• Material Test Reports (MTRs)

• Chemical composition reports (e.g., steel alloy contents)
• Mechanical property reports (e.g., tensile strength, hardness)
• Plating or coating certifications (e.g., zinc thickness, corrosion resistance)
• Compliance statements for REACH, RoHS, or other regulations

Each certification should be clearly traceable to a specific material batch and supplier.

2. Performance Test Results

These demonstrate that the product functions reliably under expected use conditions. This includes both in-
house and third-party test reports.

Common examples:

• Design Validation Plan and Report (DVP&R)

• Environmental testing (e.g., salt spray, temperature cycling, humidity)
• Mechanical or structural testing (e.g., load, fatigue, vibration)
• Functional testing (e.g., sealing performance, conductivity)
• Industry standard testing (e.g., ASTM, ISO, UL)

About the DVP&R

The Design Verification Plan and Report (DVP&R) is a structured document that outlines the planned
performance tests and their results.

Typical fields in a DVP&R include:

Field Description
Test Item The characteristic or feature being tested
Test Method The procedure or standard used (e.g., ASTM D412)
Specification The required limit or performance target
Results Actual measured values
Pass/Fail Status Indicates compliance with specification
Comments Notes or corrective actions if results are out of spec

Example:

Test Method Spec Result Status

Salt Spray ASTM B117 96 hrs, no rust 120 hrs PASS
Pull-Out Force Internal Spec ≥ 400 N 420 N PASS
Best Practices
• Ensure test results are traceable to specific part numbers, lot numbers, and suppliers.
• Use accredited testing laboratories when required (ISO/IEC 17025 certification is preferred).
• Confirm all equipment used for testing is calibrated and documented under Measurement System
Analysis (MSA).
• Document any deviations and corrective actions clearly.

Documents Commonly Included

Document Type Description
Material Certification Chemical/mechanical properties of raw material
Plating or Coating Certification Thickness, adhesion, corrosion resistance
Third-party Lab Reports Performance or regulatory test results
DVP&R Design validation testing plan and results
SDS (Safety Data Sheets) Required for hazardous materials
Regulatory Declarations REACH, RoHS, Conflict Minerals, as applicable

Summary

Topic Summary
Purpose Confirms material and performance compliance
Responsible Parties Supplier quality engineers, test labs, material vendors
Timing Required during PPAP, product validation, or changes
Required Documentation DVP&R, test reports, certifications, compliance records

11th PPAP Document: Statistical Process Control

(SPC) Charts Demonstrating Process Capability
Initial Process Studies are conducted to statistically evaluate the stability and capability of the manufacturing
process. This element provides objective, data-driven evidence that the process can consistently produce parts
that meet design specifications.

It is a critical part of the PPAP process, especially for key or critical product characteristics, and is
typically documented through SPC charts and capability indices.

Purpose

The purpose of initial process studies is to:

• Verify that the production process is stable and in statistical control.

• Confirm that the process is capable of producing parts within specified tolerance limits over time.
• Identify any variation or instability early, before full production is launched.
• Provide a foundation for ongoing process control and continuous improvement.
Key Concepts and Terms
1. Process Capability

Process capability refers to the natural variability of a process compared to its tolerance limits. It is
typically measured using statistical indices such as:

Index Description

Cp Measures the potential capability of a process, assuming it is centered within the tolerance range.

Cpk Measures the actual capability, taking into account both the process variation and how well it is centered.

Typical minimum target values:

• Cp ≥ 1.33
• Cpk ≥ 1.33
These values may be higher for safety-critical features or based on customer requirements.

2. Control Charts (SPC Charts)

SPC charts are used to monitor the stability of a process over time. They display measured values in sequence
and help identify trends, shifts, or special causes of variation.

Common types:

• X̄ and R Charts: Used for variables data (e.g., dimensions, force).

• P-Charts: Used for attribute data (e.g., percent defective).
• Individual (I-MR) Charts: Used for individual measurements when sample sizes are small.

What to Include in the PPAP Submission

The documentation in this section should include:

Item Description
Characteristic Studied The specific feature measured (e.g., hole diameter, wall thickness).
Specification Nominal value and upper/lower tolerance limits.
Measurement The tool or method used to obtain the data (e.g., CMM, caliper).
Method
Sample Size Typically 100 consecutive parts or a sample size large enough to establish statistical
validity.
SPC Charts Control charts that demonstrate the variation and stability of the process.
Cp and Cpk Values Calculated from the data collected.
Conclusion/Action Interpretation of results and any corrective actions if required.

Example Table Format

Characteristic Spec (mm) X̄ Cp Cpk Control Chart Attached Status

Diameter 10.00 ±0.05 10.01 1.45 1.38 Yes PASS
Flatness ≤ 0.1 mm 0.07 1.60 1.55 Yes PASS
When and Where Initial Studies Apply

• Required for all key product or process characteristics identified by the customer, FMEA, or design
documents.
• Should be completed using parts from the production trial run (not prototypes).
• Results must reflect the actual production conditions, including operator, machine, material, and
tooling.

Interpreting Results

• If Cp and Cpk ≥ 1.33: Process is generally considered capable.

• If Cp or Cpk < 1.33: Investigation and improvement are required.
o Implement corrective actions such as tooling adjustments, process changes, or operator
training.
o Re-study the process after improvements are made.
• If the process cannot meet requirements even after improvements, the customer may allow alternative
controls (e.g., 100% inspection or error-proofing).

Best Practices
• Use calibrated measuring instruments and verified data collection methods.
• Ensure the sampling method is representative of normal production variation.
• Involve cross-functional teams (quality, engineering, production) in the analysis.
• Keep SPC studies updated throughout the life of the product, especially after changes.

Summary
Aspect Summary
Purpose To confirm the process is stable and capable before full production
Primary Metrics Cp, Cpk, control chart behavior
Data Requirement At least 100 consecutive parts or sufficient for valid statistical study
Required When For all key/critical characteristics
Outcome Determines if corrective action or special controls are needed

12th PPAP Document: Qualified Laboratory

Documentation
This PPAP element ensures that any testing, measurement, or validation used to support the PPAP
submission—especially for material, performance, or durability—is conducted by a qualified and accredited
laboratory. It provides assurance to the customer that the data presented is credible, traceable, and
compliant with international standards.

Purpose

The purpose of this element is to:

• Verify that testing used in the PPAP was performed by competent, independent, and qualified
laboratories.
• Confirm that lab certifications are current and traceable.
• Ensure integrity and validity of results reported in other PPAP elements, such as:
 o Element 10 (Material / Performance Test Results)
o Element 11 (Initial Process Studies)
o Any other element involving lab-based measurements or analysis

What to Include in the PPAP Submission

For each external or internal laboratory used during testing, the following documentation should be included:

Item Description
Laboratory Name and Address Identifies the facility where the testing was performed.
Scope of Accreditation Lists the specific types of tests or measurements the lab is certified to perform.
Accreditation Certificate Issued by a recognized accrediting body (e.g., ISO/IEC 17025 certificate).
Validity Period Certification must be valid at the time of testing.
Reference to Test Reports Link or reference to where test results appear (e.g., in Element 10).

Internal vs. External Laboratories

External Labs

• Must be accredited by a recognized body, such as:

o ISO/IEC 17025 (the international standard for testing/calibration labs)
o National bodies (e.g., A2LA, NVLAP, NABL, CNAS, UKAS)
• Typically used for:
o Material testing
o Environmental or durability tests
o Third-party performance validation

Internal Labs

• If the supplier has in-house labs, those labs must:

o Be certified or approved by the customer.
o Demonstrate competence, traceability, and calibration control.
o Follow documented procedures.
o Maintain measurement equipment under a calibrated system (aligned with ISO 10012 or
ISO/IEC 17025 standards).

Note: If using an internal lab, documentation should include:

• A lab capability declaration

• List of test methods used
• Evidence of internal audit or quality control systems

Examples of Common Tests Requiring Lab Documentation

Test Type Example

Chemical analysis Elemental composition of steel, plastic, or rubber
Mechanical tests Tensile strength, hardness, yield
Environmental tests Salt spray, thermal cycling, humidity
Electrical tests Conductivity, insulation resistance
Coating/plating Thickness, adhesion, corrosion resistance
EMC testing For electronics with RF or electromagnetic performance requirements
Best Practices
• Always verify that the lab’s scope of accreditation covers the specific tests being conducted.
• Keep a record of the certificate expiration date and certifying authority.
• For recurring testing, maintain a lab approval matrix for traceability.
• Ensure lab equipment is calibrated and traceable to national or international standards.

Common Nonconformities
• Using labs without valid accreditation
• Using test methods outside of the lab’s accredited scope
• Missing or expired lab certificates in the PPAP package
• Failure to document traceability between test results and the laboratory

Summary Table
Topic Details
Purpose Confirm tests in the PPAP were conducted by qualified, accredited labs
Applies To Both internal and external labs
Required Documentation Accreditation certificates, lab name, scope, and validity dates
Common Standard ISO/IEC 17025
Connection To Material testing, performance testing, DVP&R, SPC
Risk If Missing PPAP rejection, loss of credibility, re-testing required

13th PPAP Document: Appearance Approval

Report (AAR)
The Appearance Approval Report (AAR) is a formal document used to confirm that the appearance-
related attributes of a part or product meet all agreed-upon customer requirements. This applies only to
parts where visual and cosmetic characteristics are critical to function, brand identity, or customer
satisfaction.

It is required only when specified by the customer or when appearance is an important product feature.

Purpose

The purpose of the AAR is to:

• Provide evidence that the part's visual aspects have been inspected and approved by the customer.
• Ensure that the part meets aesthetic expectations, such as color, texture, gloss, surface finish, and
labeling.
• Document any appearance-related testing or evaluation performed.
• Ensure consistency of appearance across mass production.

When the AAR is Required

The AAR is typically required when:
 • The part is customer-facing or visible to the end user (e.g., interior automotive trim, cosmetic covers,
appliances).
• The product has appearance specifications such as color, gloss, surface texture, paint finish, coating,
or pattern.
• The part includes decorative elements such as labels, logos, or printing.
• The customer design record or control plan references appearance approval.
• The product is part of a regulated industry (e.g., automotive, medical devices) with specific visual
standards.

If there are no applicable appearance characteristics, the AAR may be omitted or marked "Not Applicable"
with customer agreement.

What the AAR Includes

Section Description
Part Information Part number, name, revision level, program, supplier name
Customer Information Customer name, representative, plant/location
Description of Appearance Items List of appearance-related features being evaluated (e.g., color, gloss, texture)
Specification Reference Appearance standard or visual specification used for evaluation
Submission Level Level of PPAP submission (Level 1-5)
Approval Section Signatures from both supplier and customer confirming appearance approval
Sample Reference Master sample or retained sample submitted for approval

Common Appearance Characteristics Evaluated

• Color (visual match to master sample or color standard)

• Surface finish (texture, grain, matte vs. gloss)
• Paint/coating consistency
• Material uniformity (no streaks, flow lines, or defects)
• Etching or marking (e.g., date code, serial number, logos)
• Dimensional appearance (e.g., symmetry, fit within an assembly)
• Defects such as scratches, pits, dents, orange peel, or foreign particles

Approval Process
1. Preparation of Sample Parts
Supplier prepares parts that are representative of full production using the final manufacturing process.
2. Visual Evaluation
The parts are reviewed under standard lighting and environmental conditions, using any reference
standards (e.g., color chips, surface templates).
3. Submission to Customer
The AAR and associated appearance samples are submitted to the customer for inspection.
4. Customer Review and Approval
The customer inspects the sample and signs the AAR if acceptable. If not acceptable, feedback is
provided, and resubmission may be required.
5. Retention of Master Sample
A signed and approved sample is kept as a Master Appearance Sample at both the supplier and
customer locations for future reference.

Best Practices
• Evaluate samples under controlled lighting conditions (e.g., D65 daylight).
 • Use objective visual aids such as gloss meters, colorimeters, or texture comparators.
• Reference official appearance standards (e.g., GM 4465M, ISO 2813, or ASTM D523 for gloss).
• Retain a signed master sample with the same material, process, and appearance as production parts.
• Record any appearance deviations or waivers in the PPAP documentation.

Summary
Topic Description
Purpose Confirms customer acceptance of visual and aesthetic features
Applicability Required for customer-facing or visually important components
Key Document Appearance Approval Report (AAR), with customer signature
Linked Documents Master Sample, Control Plan, Appearance Standards
Outcome Approval to proceed with production based on appearance conformity

14th PPAP Document:. Sample Production Parts

Sample Production Parts are actual components produced during the initial production run, using final
manufacturing conditions. These parts are physically submitted to the customer as tangible evidence that the
manufacturing process can consistently produce parts that meet all specifications.

They represent the final, approved configuration of the product and are used by the customer for visual,
dimensional, and functional evaluation.

Purpose

The purpose of submitting sample production parts is to:

• Demonstrate that the supplier can produce conforming parts under full production conditions.
• Provide a reference sample for the customer to verify that all engineering, quality, and appearance
requirements have been met.
• Serve as a benchmark for comparison during ongoing production, inspections, and dispute
resolution.
• Validate the effectiveness of the manufacturing process and supporting documentation (e.g., control
plan, FMEAs).

Requirements and Guidelines

1. Produced Under Normal Conditions

Sample parts must be made using:

• Final production tooling, equipment, and processes

• Approved materials from approved suppliers
• Standard production rates
• Qualified operators
• In the intended production environment (factory, line, and shift)

2. Quantity of Parts

The typical quantity of sample parts is:

 • 1 to 5 parts per customer request, unless otherwise specified
• May include additional parts for testing, validation, or appearance review
• Must be traceable to the specific lot, batch, and production run documented in the PPAP

3. Identification

Each sample part should be:

• Clearly labeled or tagged as a PPAP submission sample

• Marked with relevant information such as:
o Part number
o Revision level
o Date of manufacture
o Tool cavity (if applicable)
• Accompanied by a Sample Part Submission Label (per customer format or AIAG guidelines)

4. Associated Documentation

Sample production parts must be linked to:

• Ballooned drawings (referenced in Element 9)

• Dimensional results and inspection reports
• Appearance approval (if applicable)
• The Design Record, including engineering changes
• Process flow and control plans used during production

Use of Sample Production Parts

Customers may use the submitted parts for:

• Visual inspections
• Dimensional verification
• Assembly fit checks
• Appearance comparison
• Benchmarking during product audits or future PPAPs

Approved sample parts often become the Master Samples (refer to Element 15).

Best Practices
• Produce and submit parts representative of typical process variation, not hand-finished or specially
prepared.
• Maintain full traceability of sample parts to the specific production run and documentation.
• Store one or more retained samples internally for future quality comparisons.
• Label parts clearly to avoid mix-ups during customer evaluations.

Summary
Topic Description
Purpose Provide physical proof that production can consistently meet specifications
Requirements Parts made using final tools, equipment, materials, and processes
Quantity As required by the customer (typically 1 to 5 pieces)
 Labeling Identification tag or Sample Part Submission Label
Linked PPAP Elements Dimensional Results, Appearance Approval, Control Plan
Outcome Customer confirms part acceptability before approving mass production

15th PPAP Document: Master Sample

A Master Sample is a physical example of a production part that has been verified and approved by both
the supplier and the customer. It serves as the benchmark against which future production parts are visually
and dimensionally compared to ensure consistency and conformity throughout the product lifecycle.

The Master Sample represents the agreed-upon standard for appearance, fit, function, and specification
compliance.

Purpose

The purpose of the Master Sample is to:

• Establish a visual and dimensional reference for acceptable parts.

• Ensure that all involved parties—supplier, customer, and production teams—have a common
understanding of what constitutes an acceptable part.
• Support ongoing quality assurance by enabling comparisons during routine inspections, audits, and
problem-solving.
• Serve as a reference in cases of discrepancy or disputes regarding part compliance.

Requirements for a Master Sample

1. Produced Under Normal Production Conditions

The Master Sample must be made:

• Using final production tooling and processes

• During the trial production run associated with the PPAP submission
• From approved materials and using qualified methods

2. Fully Approved

The sample must:

• Be inspected and verified by the supplier for dimensional and appearance compliance
• Be reviewed and approved by the customer, either through physical inspection or acceptance of the
Appearance Approval Report (if applicable)
• Be clearly labeled as a Master Sample and signed by representatives from both the supplier and the
customer

Information Required on Master Sample Label

Each Master Sample must be clearly identified with a durable tag or label containing the following
information:

Field Description
Part Number Complete customer part number
 Part Name As listed in the design record
Revision Level Current drawing or design revision
Date of Manufacture When the part was produced
Tool Cavity Number If applicable (multi-cavity tools)
Signature – Supplier Approval Name and signature of responsible supplier official
Signature – Customer Approval Name and signature of customer representative
Reason for Master Sample e.g., PPAP approval, Appearance Approval, etc.

Storage and Retention

• Supplier Retention: At least one Master Sample must be kept by the supplier in a controlled and
protected location, accessible for comparison purposes.
• Customer Retention: The customer may also retain a Master Sample, particularly for visually critical
components or high-risk applications.
• Duration: Master Samples are typically retained for the life of the part plus any additional service
period defined by the customer or industry standards.
• If a design change occurs, a new Master Sample must be submitted and approved.

Applications of the Master Sample

• Used by production inspectors to verify appearance and minor attributes.
• Serves as the reference point during audits, re-validations, or problem investigations.
• Acts as a training aid for quality and assembly personnel.
• Used to confirm part integrity after tooling changes, supplier changes, or process adjustments.

Best Practices
• Store Master Samples in a clean, clearly labeled, and secured area.
• Avoid damage or exposure to conditions that could alter appearance or dimensions.
• Maintain a Master Sample log with identification numbers and storage locations.
• Update Master Samples any time there is a design, process, or tooling change that affects the
product.

Summary
Topic Description
Purpose Establishes an approved physical reference for ongoing quality assurance
Requirements Approved by both supplier and customer; made under production conditions
Labeling Must include part information and signatures of both parties
Retention Kept for life of the part; updated when design or process changes occur
Application Used for visual inspection, audits, and training

16th PPAP Document: Checking Aids

Checking Aids are any tools, devices, or equipment used by the supplier to measure, inspect, or verify that a
product meets its dimensional and functional specifications during production or quality checks. This includes
fixtures, templates, jigs, gauges, measurement tools, and custom inspection devices developed specifically
for the part.

In the context of PPAP, the supplier must provide evidence that these checking aids are properly designed,
controlled, and calibrated, and that they are capable of producing accurate and repeatable results.

Purpose

The purpose of this element is to:

• Ensure that inspection and measurement tools used during production are suitable for verifying the
product’s critical and key characteristics.
• Provide traceable calibration records to confirm measurement accuracy.
• Demonstrate that inspection and test equipment conforms to customer and industry standards.
• Prevent measurement errors, which can lead to product nonconformance.

What to Include in the PPAP Submission

The supplier must submit documentation covering the following aspects:

Component Description
List of Checking Aids Description of all inspection tools used to measure product
characteristics
Design Records or Drawings Drawings or CAD models showing the design of custom checking
fixtures
Calibration Records Certificates showing that all checking aids are calibrated and
traceable
Gage Repeatability & Reproducibility (Gage MSA results showing consistency and reliability of measurement
R&R) system
Usage Instructions Procedures for how the checking aid is used on the production floor
Control and Storage Plan Documentation of how checking aids are stored, maintained, and
controlled

Examples of Checking Aids

Type of Checking Aid Example

Fixtures Welding fixtures, holding jigs for measuring complex geometry
Templates Cutouts or overlays used to check outlines or contours
Custom Gauges Go/No-Go gauges, plug gauges, thread gauges
Attribute Gauges Visual indicators for presence/absence or shape conformity
Functional Test Rigs Devices simulating real-world usage to verify product function
Inspection Software/Devices CMM programs, laser scanners, camera-based systems

Calibration Requirements

• All checking aids must be calibrated to a recognized standard (national or international).

• Calibration intervals must be clearly defined and adhered to.
• Calibration records should include:
o Date of last calibration
o Calibration method or standard used
o Results and adjustment actions (if any)
o Next calibration due date
 • Calibration must be traceable to certified reference standards, such as NIST (National Institute of
Standards and Technology) or equivalent.

Gage Repeatability and Reproducibility (Gage R&R)

For checking aids used to measure critical characteristics, a Measurement System Analysis (MSA) must
be conducted to assess:

Aspect Description

Repeatability Variation when the same operator measures the same part multiple times

Reproducibility Variation between different operators measuring the same part

Acceptable Limits Generally, % Gage R&R should be less than 10% of total process variation

Control and Maintenance

• Checking aids must be tagged or labeled with identification numbers.

• A control plan must be in place to define:
o Who is responsible for maintenance and calibration
o Where the checking aids are stored
o How damaged or worn tools are taken out of service
• Records of repair, modification, or re-qualification must be maintained.

Summary
Topic Description
Purpose Verifies that measurement tools are accurate, reliable, and properly maintained
What to Include List of checking aids, calibration records, usage procedures, MSA results
Types of Aids Fixtures, gauges, templates, jigs, inspection software
Calibration Required with traceable standards and defined intervals
MSA Requirement Gage R&R for tools used on key characteristics
Control Must be labeled, stored, and tracked per internal procedures

17th PPAP Document: Customer-Specific

Requirements
Customer-Specific Requirements (CSRs) are any additional documents, standards, procedures, or
conditions that a particular customer mandates in addition to the standard PPAP requirements defined by
AIAG or industry norms. These requirements vary by customer and must be fulfilled for the PPAP submission
to be considered complete and acceptable.

CSRs ensure that the supplier aligns fully with the individual expectations, policies, and quality systems of
the customer.

Purpose
The purpose of this element is to:

• Ensure full compliance with customer-specific quality and documentation standards.

• Address any special contractual or operational requirements that may not be covered in the
standard PPAP process.
• Integrate the supplier’s quality system with the customer’s operating procedures.
• Prevent delays or rejections in the PPAP approval process by meeting all outlined customer
expectations.

What to Include in the PPAP Submission

This section should include all documents or references required by the customer under their Customer-
Specific Requirements manual, supplier quality manual, or engineering agreements.

Required Item Description

Customer PPAP Guidelines Reference to any customer-specific PPAP checklists or submission formats
Additional Testing Requirements Special performance or durability tests requested by the customer
Packaging or Labeling Standards Customer-defined packaging instructions or barcode label requirements
Approved Supplier Deviation Any documented deviations from standard specifications approved by the
customer
Special Approval Forms Forms required by the customer (e.g., Supplier Change Request, Run at Rate)
Regional or Regulatory Certifications for local regulations (e.g., IMDS, REACH, RoHS, etc.)
Compliance
Language or Format Submissions in a specific language or file format (e.g., PDF, Excel, XML)
Requirements

Sources of Customer-Specific Requirements

These may come from:

• Customer Supplier Quality Manuals

• Customer Engineering Specifications
• Program Agreements or Contracts
• OEM Websites or Portals (e.g., GM SupplyPower, Ford Q1, Stellantis Covisint)
• Direct Communication from customer quality representatives

Each automotive OEM (e.g., GM, Ford, BMW, Honda, Toyota) and Tier 1 customer may have different sets
of CSRs, even for the same PPAP level.

Examples of Customer-Specific Requirements

Customer Possible CSR Examples

General Motors GM 1927 Launch Readiness Checklist, GM Specific Control Plan Format
Ford Motor Company Ford STA Appearance Approval Format, Run at Rate Confirmation
Stellantis (FCA) PSO Checklist (Product/Process Sign-Off), Chrysler-Specific Gage R&R format
BMW VDA 6.3 Process Audit, BMW-specific FMEA formats
Toyota Toyota Business Practice Requirements, Packaging Compliance Specifications

Best Practices

• Always review customer-specific manuals and guidelines at the start of each new project or PPAP
submission.
 • Work closely with the customer's quality or purchasing contact to clarify CSR expectations.
• Maintain a CSR checklist for each customer or program to track required documents and approvals.
• Keep records of any email approvals or exceptions granted by the customer.
• Integrate CSR elements into your Control Plan, FMEA, and inspection documentation.

Summary
Topic Description
Purpose Address unique customer requirements beyond standard PPAP elements
Source Customer quality manuals, engineering agreements, or supplier portals
Typical Inclusions Extra forms, testing, packaging specs, language or format requirements
Risk If Ignored PPAP rejection, delays in product launch, or supplier non-compliance
Best Practice Maintain CSR checklists and confirm compliance during APQP and PPAP stages

18th PPAP Document: Part Submission Warrant

(PSW)
The Part Submission Warrant (PSW) is the summary document that certifies a complete and accurate
PPAP submission. It is the final and most critical element of the PPAP package. The PSW confirms that the
supplier has reviewed all PPAP requirements and that the submitted parts meet all applicable design records
and customer specifications.

The PSW must be signed by an authorized supplier representative and submitted to the customer for
review and approval.

Purpose

The purpose of the PSW is to:

• Provide an official certification that all PPAP elements have been reviewed, completed, and verified
by the supplier.
• Confirm that the parts submitted are representative of normal production conditions.
• Formally document the customer’s disposition (e.g., approved, interim approval, or rejected).
• Ensure all design changes, test results, and process validations have been addressed.

What the PSW Includes

Field Description
Part Number and Name As defined on the design record
Supplier Information Supplier name, code, and address
Customer Information Customer plant, contact person, or receiving location
Engineering Change Level Latest change level incorporated into the part
Reason for Submission Initial submission, design change, tooling change, etc.
Submission Level One of five PPAP levels (Level 1 to Level 5)
Declaration Formal statement certifying part conformance and PPAP completion
Material Reporting Info IMDS number or reference (if applicable to material compliance)
 Supplier Authorized Signature Name, title, and signature of the responsible quality representative
Customer Approval Status Approved, Interim Approval, or Rejected, signed by the customer

Reasons for Submission

The PSW form includes a section where the supplier identifies the reason for submission, such as:

• Initial production submission

• Engineering design change
• Tooling or equipment transfer, replacement, or refurbishment
• Material change
• Supplier or manufacturing location change
• Correction of a discrepancy

Submission Levels (as shown on PSW)

Level Description
1 PSW only
2 PSW with limited supporting data
3 PSW with full PPAP documentation
4 PSW and other requirements defined by the customer
5 PSW with complete documentation and on-site review at the supplier's location

Customer Disposition

The PSW is completed by the supplier and then submitted to the customer. After review, the customer selects
one of the following:

Status Meaning
Approved Full approval. Parts can be used for production and shipment.
Interim Approval Temporary approval. Limited quantity may be shipped under defined conditions.
Rejected Submission not approved. Supplier must correct issues and resubmit.

Best Practices
• Ensure all other PPAP elements (1–17) are completed and validated before submitting the PSW.
• Use the AIAG standard PSW form, or a customer-specific version if required.
• Include accurate and complete information, especially regarding material declarations and
submission reasons.
• Keep a signed copy of the PSW in internal quality records for traceability.
• Only submit the PSW with parts that match the submission documentation.

Summary
Topic Description
Purpose Certifies that the PPAP package is complete and the part meets all requirements
Submitted By Supplier (authorized quality representative)
Reviewed By Customer (quality or engineering representative)
Key Contents Part info, change level, submission level, material data, signature
Approval Options Approved, Interim Approval, or Rejected
Importance Required for formal PPAP approval and production release
New Product Development (NPD) Responsibilities
NPD is a cross-functional process that requires collaboration across multiple departments. Each team
member or function has defined responsibilities to ensure the product is developed efficiently, meets customer
needs, and launches successfully.

Key Roles and Their Responsibilities

Role/Function Responsibilities
Project Manager - Overall project planning, coordination, and progress tracking
- Managing timelines, budgets, and resources
- Communicating with stakeholders and resolving issues
Product Design / Engineering - Designing product to meet specifications and customer requirements
- Creating CAD models, drawings, and prototypes
- Conducting design reviews and validation
Manufacturing / Process Engineering - Developing manufacturing processes and tooling requirements
- Planning production methods and capacity
- Ensuring process capability and efficiency
Quality Assurance / Control - Defining quality standards and inspection criteria
- Performing testing, audits, and validation
- Managing PPAP and customer quality submissions
Purchasing / Supply Chain - Sourcing materials, components, and tooling
- Managing supplier relationships and logistics
- Ensuring on-time delivery of parts and materials
Marketing / Sales - Providing customer insights and market requirements
- Developing go-to-market strategies and product positioning
- Gathering customer feedback during development
Finance - Budgeting and cost control
- Performing financial analysis such as ROI and break-even
- Approving capital expenditures and investments
Regulatory / Compliance - Ensuring product meets all legal and industry standards
- Managing certifications and environmental requirements

General NPD Responsibility Highlights

• Cross-Functional Collaboration: All teams must work closely to align design, production, quality,
and market needs.
• Stage Gate Reviews: Each phase requires sign-off from responsible owners before progressing.
• Risk Management: Identifying and mitigating technical, financial, and market risks.
• Documentation: Maintaining thorough records of design, testing, approvals, and changes.
• Customer Focus: Ensuring the product satisfies customer expectations and regulatory requirements.