API Spec Q1

Inhouse Training
PT. Yokohama Industrial Products
Manufacturing Indonesia Awareness and
Implementation process
 API Spec Q1 Purpose

The specification has been developed to address Quality Management System for
organizations that manufacture products or provide manufacturing-related
services under the specification for use petroleum and natural gas industry
Spesifikasi yang dikembangkan membahas Sistem Manajemen Mutu untuk organisasi yang memproduksi
produk atau menyediakan produk manufakturing dengan spesifikasi untuk penggunaan industri minyak dan
gas bumi

The specification promotes the integration of process approach into the

application to developing, implementing and improving the effectiveness of
Quality Management System.
Spesifikasi yang menganjurkan proses pendekatan terintegrasi dalam penerapannya untuk
mengimplementasikan, pengembangan, dan meningkatkan efektivitas Sistem Manajemen Mutu.
 API Spec Q1 Goal
The goal of this specification is to provide the minimum requirements for the development of a
Quality Management System that provides for continual improvement, emphasized defect prevention
and strives to minimize variation and waste from manufacturing organizations

Tujuan dari spesifikasi ini adalah untuk menyediakan persyaratan minimum untuk pengembangan
Sistem Manajemen mutu yang menyediakan untuk perbaikan terus-menerus, mencegah cacat
produksi dan berusaha untuk meminimalkan variasi dan limbah dari organisasi manufaktur
 API Spec Q1 Terms
Shall : as used in a standard, “Should” denotes a minimum requirement in order to confirm to
the specification.

Compliance : Act or process of satisfying the legal and other applicable requirements to
regulation or regulatory body
Critical : That deemed by the organization, product specification, or customer as mandatory,
indispensable or essential needed for a stated purpose or task and requiring specific action.

Design Validation : That deemed by the organization, product specification, or customer as

mandatory, indispensable or essential needed for a stated purpose or task and requiring specific
action.
 API Spec Q1 Terms
Design Validation : Process of proving a design by testing to demonstrate the
conformity of the product to design requirements
a)Prototype Tests
b)Functional and/or Operational Test of production products.
c)Tests specified by industry standards and/or regulatory requirements
d)Field performance tests and reviews
Design Verification: Process examining the result of design and development output
to determine conformity with specified requirements.
a)Conforming the accuracy of design results through the performance of
alternative calculations
b)Review of design output documents independent of activities and development.
c)Comparing new designs to similar proven designs.
 API Spec Q1 Terms
First Article : Representative sample of product, componnet, or output from a process used to
verify that prescribed activities have satisfied the requirement as specified by the organization .

Outsource Activity :Function or process that is performed by an external

supplier on behalf of the organization.
API Spec Q1 Requirements

Clause 4 - Quality
Management
Documents / System
Requirement's
Record

Clause 6 - Quality
Management System Clause 5 -
Monitoring, Product
measurements , Analysis Realization
and Improvement
 API Spec Q1 Requirements VS Implementation

PRODUCT
IN COMING PROCESS DELIVERY PROCESS
REALIZATION
PROCESS
 API Spec Q1 Requirements VS Implementation
MANUFACTURING MANAGEMENT CONTROLLED

PRODUCT
IN COMING PROCESS REALIZATION DELIVERY PROCESS
PROCESS

QUALITY MANAGEMENT CONTROLLED

 API Spec Q1 Requirements VS Implementation
First Article Production Planning Contingency Plan
3.1.11 5.2, 5.7.2 ning
Contract Review 5.5
Purchasing
5.1, 5.1.2, 5.1.3 5.6
Risk Assessment Design and Development
5.3 5.4, 5.4.1, 5.4.2, 5.4.3
IN COMING PROCESS
QMS Planning Preventive Maintenance
4.1, 4 5.7.8, 5.8
Document requirements Organization Capability
4.4, 4.4.1, 4.4.2, 4.4.3, 4.3
4.4.4
 API Spec Q1 Requirements VS Implementation
In-process Inspection & Testing Organization Capability Product Realization Design and Development
5.7.7, 5.7.7.1, 5.7.7.2 4.3, 4.3.2, 4.3.2, 4.3.3 5.1.3 5.4.4, 5.4.5, 5.4.6, 5.4.7

Purchasing Control
PRODUCT 5.6.1.1, 5.6.1.2, 5.6.1.3,
IN COMING PROCESS REALIZATION 5.6.1.4, 5.6.1.5, 5.6.2
PROCESS
Product ion and Servicing Provisio
n
QMS Monitoring, Measurement, A 5.7, 5.7.1, 5.7.2, 5.7.4, 5.7.5, 5.7.6
nalysis Control of Non-conforming Product
6, 6.1, 6.2, 6.3 5.10. 5.10.1, 5.10.2, 5.10.3, 5.10.4, 5.10.5
Risk Assessment Management of Change
5.3 5.11. 5.11.1, 5.11.2, 5.11.3
 API Spec Q1 Requirements VS Implementation
Final Inspection & Testing Produc Release Risk Assessment
5.7.7.3 5.9 5.3

PRODUCT
REALIZATION DELIVERY PROCESS
PROCESS

Improvement Management Review

6.4, 6.4.1, 6.4.2, 6.4.3 6.5
THANK YOU
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ATTENTION

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