Corporate Quality System Manual Document Revision 12

Corporate Quality System Manual Document 001-0001 Revision 12 001-0001 Rev 12 Page 1 of 12 Table of Contents 1 2 3 4 5 Introduction 1.1 Purp...
Author: James Ferguson
16 downloads 1 Views 1MB Size
Corporate Quality System Manual Document 001-0001 Revision 12

001-0001 Rev 12

Page 1 of 12

Table of Contents 1

2

3

4

5

Introduction 1.1

Purpose

1.2

Scope

Corporate Overview 2.1

Scope of the QMS

2.2

Overview

Management Responsibility 3.1

Top Management Organization

3.2

Management Responsibility

3.3

Quality Policy

3.4

Management Review

3.5

Responsibility and Authority

Peregrine Quality Management System (QMS) 4.1

QMS Overview

4.2

QMS Process Map

4.3

AS9100C/ISO9001:2008 QMS Documentation Matrix

4.4

TS16949:2009 QMS Documentation Matrix

Revision History

001-0001 Rev 12

Page 2 of 12

1

Introduction 1.1

Purpose The purpose of this quality manual is to define Peregrine Semiconductor’s quality management system and policies. This manual acts as the foundation of Peregrine’s quality management system which is based upon and complies with the international standard AS 9100C, ISO 9001:2008 and ISO/TS16949:2009.

1.2

Scope This quality manual applies to all Peregrine Semiconductor facilities and operations worldwide.

2

Corporate Overview 2.1

Scope of the QMS (Quality Management System) The scope of the QMS is the design, development, manufacture, and test of highperformance communications RFICs for the wireless infrastructure, mobile wireless; broadband communications and infrastructure; and high-reliability markets. These ICs are manufactured on the company’s proprietary UltraCMOS™ mixed-signal process technology.

2.2

Overview Peregrine Semiconductor Corporation products are uniquely poised to meet the needs of a global RF design community in high-growth applications such as LTE, HSDPA and WCDMA digital cellular and mobile TV; broadband communications such as DTV/PCTV/DVR; and in high-reliability applications such as telecom infrastructure, industrial, automotive, military and satellite systems. Peregrine UltraCMOS™ devices are manufactured under licensed foundry partnerships with CMOS semiconductor manufacturers located throughout the world. The Company, headquartered in San Diego, California, maintains global sales support operations and a worldwide technical distribution network. See Figure 1 for global design, manufacturing and sales support locations. Additional information is available on the web at www.psemi.com. UltraCMOS™ mixed-signal process technology is a patented advancement of siliconon-insulator (SOI) technology on a sapphire substrate providing high yields, competitive costs and a viable alternative to compound semiconductor technologies. UltraCMOS™ delivers significant performance advantages over competing processes such as GaAs, SiGe, BiCMOS and bulk silicon CMOS in applications where RF performance, low power and high levels of integration are paramount. These measurable power and size savings offer advantages for both manufacturers and consumers, including longer battery life, smaller batteries, lower power consumption and bills, less electronic waste…and a greener RF solution. Further, the company’s revolutionary HaRP™ and DuNE™ technologies further exploit the fundamental benefits of silicon-on-sapphire, enabling dramatic improvements in harmonic results, linearity, power handling and overall RF performance which today remain unmatched by any other RF process technology.

001-0001 Rev 12

Page 3 of 12

Figure 1: Peregrine global design, manufacturing and sales support locations 3 Management Responsibility 3.1

Top Management Organization

Chief Executive Officer Chief Executive Officer

Chief Technical Officer

Chief Marketing Officer

Chief Financial Officer

VP Operations

VP Quality

VP HPS Business Uiit

VP MWS Business Unit

VP RF Infrastructure

VP RF Technology Solutions

001-0001 Rev 12

Page 4 of 12

3.2

Management Responsibility 3.2.1 Management Commitment Top management has the overall responsibility for developing, implementing and maintaining a quality management system that meets the needs of our customers as well as any statutory or regulatory requirements. They are responsible for defining the quality policy and objectives of the company and ensuring these are communicated, implemented and monitored throughout the organization.

3.2.2 Customer Focus The business units will ensure that customer requirements are understood and communicated effectively throughout the organization and to the top management team. Top management will ensure customer requirements are met in such a way as to improve customer satisfaction.

3.3

Quality Policy Peregrine’s quality policy is defined below. The Vice President of Quality is responsible for reviewing the quality policy with Top Management at least yearly to ensure the quality policy is aligned with key business goals and objectives. Any changes to the quality policy are reviewed and approved by the Chief Executive Officer and Vice President of Quality.

Peregrine Semiconductors Quality Policy: Peregrine Semiconductor is committed to providing quality products and services that meet or exceed our customers’ requirements the first time, every time. Peregrine will achieve this by:

3.4



Fully understanding our customers’ requirements and expectations



Providing products utilizing proven designs and manufacturing processes



Developing a highly trained workforce that is motivated, empowered and fully accountable



Establishing strong relationships with world class suppliers



Continually improving the efficiency and effectiveness of our business processes and quality management system

Management Review The quality management system is reviewed by top management at planned intervals to ensure it is effective in achieving Peregrine’s quality objectives. During these reviews the top management team will review at a minimum the following criteria:

001-0001 Rev 12



Results of audits



Customer feedback

Page 5 of 12

3.5

4



Effectiveness of corrective and preventative action system



Field returns and field failure rates



Any changes or potential changes that could impact the quality management system



Process performance and process efficiency for manufacturing



Cost of poor quality



Design and development project status



The Quality Policy



Recommendations for changes to the quality policy or quality management system



Action items from prior management review

Responsibility and Authority 3.5.1

Management Representative: The Vice President of Quality is the top management team representative and ISO/TS16949 management representative responsible for establishment, implementation, and monitoring of the QMS and the quality policy as well as reviewing all decisions impacting and changes to the quality management system. The management representative is responsible for reporting the performance of the QMS to the top management and promoting awareness of customer requirements.

3.5.2

Customer Representative: The Vice President of Quality in conjunction with the Business Unit and Operations Vice Presidents are responsible for ensuring customer requirements are met throughout the product realization process.

Peregrine Quality Management System (QMS) 4.1

The quality manual defines the quality policy the quality management system Peregrine has implemented to ensure compliance to the AS9100C, ISO9001:2008 and ISO/TS16949:2009 international standards. The quality management system is further defined by a series of operating procedures, instructions, forms and checklists as defined in Figure 2.

Level 1 Quality Manual

Quality Policy & Overview of QMS

Level 2 Operating Procedures

Level 3 Work Instructions

Level 4 Forms & Checklists

Top level description of critical process flows Detailed instructions of process

Document used to record results

Figure 2: Peregrine Document Control System Pyramid

001-0001 Rev 12

Page 6 of 12

4.2

Peregrine QMS Process Map

Peregrine QMS System Map

Resource Management

Resource Control

Human Resources

Information Technology

Corrective Action

Executive Management

Facilities Management

Resource Requirements

Business Plan Development Management Review

Document Control

Customer Satisfaction

Corporate Goals & Policies

Quality Records Failure Analysis Training Environmental Mgmt Financial Statement Preparation

Internal Audit

Business Metrics

R

es o

ur ce s

Equipment Maintenance

Continual Improvement Measurement System Analysis Product Change Control

s ric et M

Control of Nonconforming Product

Internal

Process Development

Product Marketing

Product Development

Internal & Subcontractors

Configuration Mgmt Manufacturing

Sales

Order Review & Acceptance

Planning / Purchasing

Customer Sales Order Shipping

CUSTOMER SATISFACTION

CUSTOMER REQUIREMENTS

Research

Application Support

001-0001 Rev 12

Page 7 of 12

4.3

AS9100C/ISO 9001:2008 QMS Documentation Matrix

#

AS9100C / ISO 9001:2008 Requirement

4

Quality Management System

4.1

General Requirements

4.2

Documentation Requirements

4.2.1

General Requirements

001-0001

4.2.2

Quality Manual

001-0001

4.2.3

Control of Documents

002-0002

4.2.4

Control of Records

002-0013

4.3

Configuration Management

006-0005

5

Management Responsibility

5.1

Management Commitment

003-0001

5.2

Customer Focus/Satisfaction

007-0003, 001-0001

5.3

Quality Policy

001-0001

5.4

Planning

5.4.1

Quality Objectives

001-0001

5.4.2

QMS Planning

003-0001

5.5

Responsibility, Authority and Communication

5.5.1

Responsibility and Authority

003-0001

5.5.2

Management Representative

003-0001

5.5.3

Internal Communication

003-0001

5.6

Management Review

5.6.1

General

003-0002

5.6.2

Review Input

003-0002

5.6.3

Review Output

003-0002

6

Resource Management

6.1

Provision of Resources

6.2

Human Resources

6.2.1

General

003-0001

6.2.2

Competence, Awareness and Training

008-0001

6.3

Process Control

005-0001

6.4

Work Environment

005-0001

7

Product Realization

7.1

Planning of Product Realization

7.2

Customer-Related Processes

7.2.1

Determination of Requirements Related to the Product

004-0001

7.2.2

Review of Requirements Related to the Product

007-0001, 007-0002, 004-0001

7.2.3

Customer Communication

007-0001

7.3

Design and Development

7.3.1

Design and Development Planning

001-0001 Rev 12

Procedures 001-0001

003-0001

004-0001

004-0001

Page 8 of 12

#

AS9100C / ISO 9001:2008 Requirement

Procedures

7.3.2

Design and Development Inputs

004-0001

7.3.3

Design and Development Outputs

004-0001

7.3.4

Design and Development Review

004-0001

7.3.5

Design and Development Verification

004-0001

7.3.6

Design and Development Validation

004-0001

7.3.6.1

Documentation of Design and/or Dev. Verification & Validation

004-0001

7.3.6.2

Design and/or Development Verification & Validation Testing

004-0001

7.3.7

Control of Design & Development Changes

004-0001

7.4

Purchasing

7.4.1

Purchasing Process

006-0001

7.4.2

Purchasing Information

006-0001

7.4.3

Verification of Purchased Product

002-0003

7.5

Production and Service Provision

7.5.1

Control of Production and Service Provision

7.5.1.1

Production Documentation

005-0001

7.5.1.2

Control of Production Process Changes

005-0001

7.5.1.3

Control of Production Equipment, Tools & Numerical Control (N.C.) Machine Programs

005-0001

Control of Work Transferred, on a Temporary Basis, Outside the Organization’s Facilities

005-0001

7.5.1.5

Control of Service Operations

007-0003

7.5.2

Validation of Processes for Production and Service Provision

Not Applicable to PSemi

7.5.3

Identification and Traceability

006-0003

7.5.4

Customer Property

Not Applicable to PSemi

7.5.5

Preservation of Product

006-0004

7.6

Control of Monitoring and Measurement Devices

002-0011

8

Measurement, Analysis & Improvement

8.1

General

8.2

Monitoring and Measurement

8.2.1

Customer Satisfaction

007-0003

8.2.2

Internal Audit

002-0015

8.2.3

Monitoring and Measurement of Processes

002-0015

8.2.4

Monitoring and Measurement of Product

002-0003

8.2.4.1

Inspection Documentation

002-0003

8.2.4.2

First Article Inspection

Not Applicable to PSemi

8.3

Control of Nonconforming Product

002-0009

8.4

Analysis of Data

005-0001; 003-0002

8.5

Improvement

8.5.1

Continual Improvement

003-0001, 01-0001

8.5.2

Corrective Action

002-0010

8.5.3

Preventive Action

002-0010

7.5.1.4

005-0001, 006-0004

003-0002

Note: Not Applicable: Appearance Items, Customer Property & Customer-Owned Tooling

001-0001 Rev 12

Page 9 of 12

4.4

ISO/TS16949:2009 QMS Documentation Matrix Business Process – Executive Management Process Name Document Number

Peregrine Business Plan Development

003-0003

Management Review

003-0002

Customer Oriented Processes Research Procedure

004-0005

Process Development Flow

006-0024

Product Marketing Process

007-0010

Product Development Process

004-0001

Configuration Management Process

006-0022

Sales Procedure

007-0008

Order Review and Acceptance Procedure

007-0007

Planning and Purchasing Procedure

006-0023

Manufacturing Process

006-0020

Application Support Procedure

76-0004

Customer Sales Order Shipping Process

006-0021

Support Processes – Resource Management and Resource Control Human Resources Process

008-0002

Facilities Management

92-0008

Information Technology Procedure

94-0013

Document Control

002-0002

Quality Records

002-0013

Equipment Maintenance Process

10-0312

Failure Analysis Procedure

02-0001

Training

008-0001

Environmental Management Procedure

01-0105

Finance Statement Preparation

008-0003

Corrective Action Procedure

002-0010

Internal Audits Procedure

002-0015

Customer Satisfaction

007-0003

Continual Improvement Procedure

002-0008

Measurement Systems Analysis Process

002-0012

Product Change Control

002-0005

Control of Nonconforming Product

002-0009

001-0001 Rev 12

Page 10 of 12

5 Revision History DCN # 03593

03685

03977

Revision 01

02

03

Date

Originator

2004/05/21

B. Givens & J. Greenwood

First revision of PSA & PSC Quality System Manual merger.

2004/10/17

B. Givens & J. Greenwood

All document references on Pages 19-28 updated. Building photo changed to new building.

2005/08/04

Description of Change

Gene Lyons

Footer changed to show revision All new document references accepted, where still not resolved replaced with ‘TBA’. Removed product information. Quality organization and ISO registration information updated.

04197

04

2006/02/27

P. Nunnelley

Revise to current practices, update document references and corporate overview section.

04463

05

2006/08/22

Gene Lyons

Minor revision to document number references

2006/11/17

L. Witsell

2007/04/10

L. King

Added ‘Not Applicable to PSemi’ on page 23, sections 7.5.2 & 8.2.4.2 for clarification Peregrine spelled incorrectly

005039

06

005506

07

2007/09/18

P. Nunnelley

1) PSA Document numbers that were converted from Lotus Notes to Arena, Document System. 2) Update PSC Headquarters street address due to move and remove Test Faculity (Kenamar) address, now under PSC Headquarters. 3) Remove President from CEO title pg, 5

005970

08

2008/1/23

G. Lyons

Updated quality policy and photo for PSC

006248

09

2008/3/25

C. Villarreal

006661

10

2008/11/26

P. Nunnelley

009629

11

2010/10/21

G. Lyons

001-0001 Rev 12

Remove business processes from manual. 1) At the bottom of page 9, added the following note: Note: Exclusions: Appearance Items, Customer Property & Customer-Owned Tooling 2) Remove Peregrine Semiconductor Australia/Wafer Fab from Corporate reference, Add as manufacturer 3) Update page 4 Corporate Overview 4) Remove page 3 faculities map & Process Interrelationship map page 8 5 Remove Operations & Sales Offices 1)Updated introduction 2)Updated corporate profile 3) Added management responsibility 4) Added QMS process map 5) Update operational procedure table 6)Re-formatted document

Page 11 of 12

DCN #

Revision

Date

Originator

Description of Change

010910

12

2011/09/23

P. Nunnelley

1) Replace Org chart 3.1 & Senior Mgmt with Top Mgmt throughout document, 2) Replace QMS System Map, 4.2. 3) Updated Peregrine locations Fig 1. 4) Aligned sections 3.2 & 3.3 with TS16949 5) Added TS16949 QMS Process List, page 11

011212

12

2011/10/06

P. Nunnelley

Typo, formatting updates. Section fonts to be uniform within the document.

001-0001 Rev 12

Page 12 of 12

Suggest Documents