The document outlines a comprehensive process for managing product realization, including stages from order confirmation to design development and quality control. It emphasizes continual improvement through quality management system audits, competency training, and contingency planning. Key sections highlight objectives, risk assessment, resource management, and customer communication within the framework.

1. Outsource
Process
Management
Responsibility
Resource
Management
Measuremen
t, Analysis
and
Improvement
Continual
Improvement
Product
Realization
Sales Department
1) Input Product Info.,
2) Quotation
3) Confirmation of Orders
Planning – Process Order
1) Production Needs
2) Purchasing Needs
3) QC Needs
Design & Development
1) Planning
2) Input – Output Review
3) Verification and Final Review
4) Validation and Approval
5) Design Changes
Planning – Process Order
1) Quality of Product Risk Assessment,
QCP, ITP, WI, PP, WPS and etc
2) Control of MOC (If any)
3) Contingency Planning
Personal Competency
1) Product Training (In House/External – Customer/School
Training)
2) Skill Training (If any)
Loading of Confirmation
1) PR Issue for (Raw/Sub-con/Services)
2) Job Traveller
3) Inspection (FA, In process & Final)
4) Control of Testing , Measuring, Monitoring
Equipment
Product Release
1) Control of NCR, CAR, PAR & Concession
2) Handling & Preservation
3) Storage of Product Release
Improvement
1) QMS Audit (IQA or Customer Audit)
2) Management Reporting (MR Meeting)
3) Analysis of Data
Customer
Communication
Control
Activities
Control of
Competency

2. Policy 4.1
Planning
Objectives 4.1
Quality
Management
System 4.1, 4.2,
4.3, 4.4, 4.5
Management
Review 6.5, 5.11
General
Requirement
(QMS) 6.1
Improvement
CAR, PAR 6.4
Control of NCR
5.10
Monitoring,
Measuring and
Improving 6.2
Analysis of Data
for
Improvement
6.3
Contingency
Planning 5.5
Risk
Assessment
and
Management 5.3
General
Requirement
5.1, 5.2
Customer
Related Process
5.2
Design &
Development
5.4
Monogrammer
Product (API
11D1 & 14L)
Production and
Service
Provisioning 5.7
Control of Testing,
Measuring &
Monitoring
Equipment 5.8
Product
Release 5.9
General
Requirement
(Information) 4.1
Human
Resources 4.3
Management of
Change 5.11
Work
Environment 4.3
General
Requirement 4.1
General
Requirement 5.1
Section 4: Organization
Section 6: QMS Monitoring, Measurement, Analysis, & Improvement
Section 5: Product and / or Service Realization
Section 4: Resource Management