The document outlines the processes and requirements for product design and development, emphasizing customer communication, safety, regulatory compliance, and multidisciplinary approaches throughout various phases of production. It details the steps from identifying customer requirements to manufacturing process design, including risk analysis and performance evaluations, while highlighting the importance of leadership commitment and planning. Additionally, it describes the mass production phase, focusing on quality objectives, monitoring, and corrective actions to ensure customer satisfaction.

1. Customer
Requirements
* Determining the requirements
for products and services
(8.2.2.1)
* Customer Specific
Requirements (4.3.2)
* Customer Communication
(8.2.1)
* Cost/Price Requirements
* Confidentiality (8.1.2)
Mass Production
* Customer Communication
(8.2.1)
* Logistic Requirements
* P.O. Requirements
* Volume Requirements
Review of the
requirements for
products and
services (8.2.3)
* Organization
manufacturing feasibility
(8.2.3.1.3)
* Multidisciplinary approach
(8.2.3.1.3)
*Leadership commitment
(5.1)
*Management review (9.3)
Project
Accept?
?ed
Accept
ed
Inform Customer
Design and Development of
products and services (8.3)
* Multidisciplinary Approach
(8.2.3.1.3)
* Product Safety (4.4.1.2)
* Statutory & Regulatory
Requirements (4.4.1.1, 8.4.2.2)
* Software, GD&T, tolerance
calculation (8.3.5.1)
* DFMEA/Risk analysis (6.1.2)
* Design Team Competency
(7.2.1)
* Identification of statistical tools
(9.1.1.2)
* Application of Statistical
Concepts (9.1.1.3)
* Complete and
accurate product
drawings and
specifications
* SC List (4.4.12)
Product Design Review
(8.3.5.1)
* Multidisciplinary Approach (8.2.3.1.3)
* Product Safety (4.4.1.2)
* Statutory & Regulatory
Requirements (4.4.1.1, 8.4.2.2)
* Software, GD&T, tolerance calculation
(8.3.5.1)
* DFMEA/Risk analysis (6.1.2)
* Design Team Competency (7.2.1)
* Identification of statistical tools
(9.1.1.2) *
Application of Statistical
Concepts (9.1.1.3)
Design
Review
passed?
New Product/Process
Development Phase
* Leadership Commitment (5.1)
* Preventive Action (6.1.2.2)
* Plant, facility, and equipment planning (7.1.3.1)
* Competence (7.2.1)
* Project Management and Planning (8.1.1)
* Confidentiality (8.1.2)
* Customer Communication (8.2.1.1)
* Control of change (8.5.6.1)
* Monitoring, measurement, analysis and
evaluation (9.1)
* Management Review (9.3)
Packaging Design
- In-process
- Product - Shipment
Packaging Qualification
*List of Product
Inspection & Test
Equipment
*Calibration (7.1.5.2)
Raw Material &
Components Design
* Multidisciplinary Approach
(8.2.3.1.3)
* Product Safety (4.4.1.2)
* Statutory & Regulatory
Requirements (4.4.1.1,
8.4.2.2)
* Software, GD&T, tolerance
calculation (8.3.5.1)
* DFMEA/Risk analysis
(6.1.2)
* Design Team Competency
(7.2.1)
* Identification of statistical
tools (9.1.1.2)
* Application of Statistical
Concepts (9.1.1.3)
Mfg. Process Design
- Multidisciplinary
Approach (8.2.3.1.3)
- Competency (7.2.1)
- PFMEA (6.1.2.1)
- Lay out Design
- Mfg. Process Flow
Design
- Line Balancing
Mfg. Process
Design Review
* Multidisciplinary
Approach (8.2.3.1.3)
* Leadership Commitment (5.1)
* Management review (9.3)
Mfg design output
(8.3.5.2) (15 items)
- Process
Specifications
- Floor Layout
- SC list of Mfg
Process
- Multidisciplinary
Approach
(8.2.3.1.3)
-…
-…
-…
- WI, MI, II, etc.
- Mfg. Process
Flow Chart
Complete and accurate
Raw Material &
Components drawing and
specifications
* SC List
Supplier Sourcing
- Raw Mat’l / Component
Inspection & Test Equipment
List – Calibration (7.1.5.2)
Build Raw
Mat’l/Components
- Prototype/Small Lot
Build Product
Prototype /
Small Lot
- Competency (7.2.1)
- Requirement rate
Build Mfg.
Process
* Investment
* Leadership
Commitment (5.1)
* Competency
Prototype / Product
Small Lot
- MSA (7.1.5.1.1)
- Master Sample
- Process Capability
Study
(15 items)
(PPAP-17 items)
End
Mfg Process (Mass
Production Phase)
* Competency
* Production
Control Plan
*WI, MI, II
* Rework
* Change Control
* Process Control
* SPC
* Cleanliness
* TPM



Support Function : HR, Logistic, F/A, Process, QA/QC,
Procurement, Planning, Maintenance, Test, Production, EHS,
Security, GA, etc….
Mass Production Phase
* Contingency Plans (6.1.2.3), * Quality Objectives and Planning
(6.2.2.1), * Resources (7.1), * Monitoring (9.1), * Calibration (7.1.5.2),
* Laboratory Requirements (7.1.5.3), * Competency (7.2.1),
* Internal Audit (7.2.3), * Management Review (7.2.4),
* Employee Motivation and Empowerment (7.3.2),
* Documented Information (7.5), * Supplier Control (8.4.1.2, 8.4.2.3,
8.4.2.4.1), * Control of Changes (8.5.6.1), * Control of Reworked
Products (8.7.1.4), * Application of Statistical Concept (9.1.1.3),
* Customer Satisfaction (9.1.2.1), * Internal Audit (9.2), * Continual
Improvement (10.3), * Error Proofing (10.2.4),
* Customer Complaints and Field Failure Test Analysis (10.2.6),
+
Customer
Feedback
- Warranty
Management
Systems
(10.2.5) --
Control of
Repair
Products
(8.7.1.5)
- Customer
Complaints
and Field
Failure
Analysis
(10.2.6)Feed Back
& Complaint
Handling
* Corrective
Action (5.3.2)
* Risk Analysis
(6.1.2.1)
+
ORGANIZATION BOUNDARY and SCOPE
[4.0 CONTEXT OF ORGANIZATION]
[4.1, 4.2, 4.3, 4.3.1, 4.3.2, 4.4, 4.4.1.1]
[Organization Roles, Responsibilities, Authorities, Process Owners (5.1.1.3)]
Mass
Production
Phase
NPPD Phase
Phase
NO YES
NO YES
YESNO
IATF16949:2016
QualityManagementSystemFlowchart
@อ.ปรีชาลีลานุกรม(PrichaLeelanukrom)
NO
YES
*PRODUCT
T
*SUPPORT
*SERVICE
Passed
Design
Review?
Product Approval
Process / Customer
Qualification Approval