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DOC-35187-5 Quality System · PDF fileQuality System Manual Doc. No.: ... • Design and...

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DOC35187 Rev 5 Page 1 of 13 Corporate Quality System Manual Doc. No.: DOC-35187 Revision 5
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Page 1: DOC-35187-5 Quality System  · PDF fileQuality System Manual Doc. No.: ... • Design and development project status ... DOC-35187-5_Quality_System_Manual

DOC-­‐35187  Rev  5                                                                                                                                                                                                                                                                                                                                                                                                  Page  1  of  13  

Corporate Quality System Manual

Doc. No.: DOC-35187 Revision 5

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DOC-­‐35187  Rev  5                                                                                                                                                                                                                                                                                                                                                                                                      Page  2  of  13  

Table of Contents

1 Introduction

1.1 Purpose

1.2 Scope

2 Corporate Overview

2.1 Scope of the QMS

2.2 Overview

3 Management Responsibility

3.1 Top Management Organization

3.2 Management Responsibility

3.3 Quality Policy

3.4 Management Review

3.5 Responsibility and Authority

4 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 (where applicable)

5 Revision History

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DOC-­‐35187  Rev  5                                                                                                                                                                                                                                                                                                                                                                                                      Page  3  of  13  

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 as applicable to relevant sites.

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 high-performance 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 silicon-on-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™ technology enables dramatic improvements in harmonic results, linearity, power handling and overall RF performance which today remain unmatched by any other RF process technology.

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DOC-­‐35187  Rev  5                                                                                                                                                                                                                                                                                                                                                                                                      Page  4  of  13  

Figure 1: Peregrine Global Manufacturing Locations

Figure 2: Peregrine Design, Sales and Support Locations

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DOC-­‐35187  Rev  5                                                                                                                                                                                                                                                                                                                                                                                                      Page  5  of  13  

3 Management Responsibility 3.1 Top Management Organization

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

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DOC-­‐35187  Rev  5                                                                                                                                                                                                                                                                                                                                                                                                      Page  6  of  13  

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: • 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

3.4 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:

• QMS Requirements & Performance Trends (KPIs)

• Monitoring of Quality Objectives

• Continual Improvement

• Achievement of Business Plan

• Results of audits

• Customer feedback

• 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

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DOC-­‐35187  Rev  5                                                                                                                                                                                                                                                                                                                                                                                                      Page  7  of  13  

• 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

• QMS Improvement Actions

• Customer Product Requirement Improvement Actions

• Resource Needs

3.5 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. Locations outside company headquarters may designate their own local management representative. 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 and/or the local management representative in conjunction with the Business Unit and Operations Vice Presidents are responsible for ensuring customer requirements are met throughout the product realization process.

4 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 3.

Level 1

Quality Manual

Level 2

Operating Procedures

Level 3

Work Instructions

Level 4

Forms & Checklists

Quality Policy & Overview of QMS

Top level description of critical process

flows

D etailed instructions of

proces s

Document used to record results

Figure 3: Peregrine Document Control System Pyramid

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DOC-­‐35187  Rev  5                                                                                                                                                                                                                                                                                                                                                                                                      Page  8  of  13  

4.2 Peregrine QMS Process Map

Peregrine QMS System Map

Executive Management

Business Plan DevelopmentManagement Review

Cor

pora

te G

oals

& P

olic

ies

Resource Management

Facilities Management

Quality Records

Human Resources

Document Control

ResourcesMetric

s

Resource Requirements Business Metrics

Environmental Mgmt

Financial Statement Preparation

Resource Control

Training

InformationTechnology

Failure Analysis

Corrective & Preventive Action

Internal Audit

Customer Satisfaction

Continual Improvement

Measurement System Analysis

Product Change Control

Control of Nonconforming

Product

Product Marketing

Sales

Product Development

Manufacturing

Order Review & Acceptance

Planning & Purchasing

Internal & Subcontractors

Internal

Process Development

Application Support

Configuration Management

CU

STO

MER

REQ

UIR

EMEN

TS

CU

STO

MER

SA

TISF

AC

TIO

N

Customer Sales Order

Shipping

Equipment/Maintenance

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DOC-­‐35187  Rev  5                                                                                                                                                                                                                                                                                                                                                                                                  Page  9  of  13  

4.3 AS9100C/ISO 9001:2008 QMS Documentation Matrix

# AS9100C / ISO 9001:2008 Requirement Procedures 4 Quality Management System 4.1 General Requirements DOC-35187 4.2 Documentation Requirements 4.2.1 General Requirements DOC-35187 4.2.2 Quality Manual DOC-35187 4.2.3 Control of Documents DOC-35294 4.2.4 Control of Records DOC-35296 5 Management Responsibility 5.1 Management Commitment DOC-00410 5.2 Customer Focus DOC-35306, DOC-35187 5.3 Quality Policy DOC-35187 5.4 Planning 5.4.1 Quality Objectives (Quality Management System) DOC-35187 5.4.2 Quality Management System Planning DOC-00410 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and Authority DOC-00410 5.5.2 Management Representative DOC-00410 5.5.3 Internal Communication DOC-00410 5.6 Management Review 5.6.1 General DOC-35179 5.6.2 Review Input DOC-35179 5.6.3 Review Output DOC-35179 6 Resource Management 6.1 Provision of Resources DOC-00410 6.2 Human Resources 6.2.1 General DOC-00410 6.2.2 Competence, Training and Awareness DOC-35300 6.3 Infrastructure (Process Control) DOC-01251 6.4 Work Environment DOC-01251 7 Product Realization 7.1 Planning of Product Realization DOC-50045 (DOC-50827 in

PSE) 7.2 Customer-Related Processes 7.2.1 Determination of Requirements Related to the Product DOC-50045 7.2.2 Review of Requirements Related to the Product

(Contract Review/ Product Development Procedure) DOC-00442, DOC-50045

7.2.3 Customer Communication DOC-01052 7.3 Design and Development 7.3.1 Design and Development Planning DOC-50045 (DOC-50827 in

PSE)

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DOC-­‐35187  Rev  5                                                                                                                                                                                                                                                                                                                                                                                                      Page  10  of  13  

# AS9100C / ISO 9001:2008 Requirement Procedures 7.3.2 Design and Development Inputs DOC-50045 7.3.3 Design and Development Outputs DOC-50045 7.3.4 Design and Development Review DOC-50045 7.3.5 Design and Development Verification DOC-50045 7.3.6 Design and Development Validation DOC-50045 7.3.6.1 Design and Development Validation-Supplemental DOC-50045 7.3.6.2 Prototype Programme (Design and/or Development Verification

& Validation Testing) DOC-50045 7.3.7 Control of Design and Development Changes DOC-50045 7.4 Purchasing 7.4.1 Purchasing Process DOC-35311 (DOC-50439 in

PSE) 7.4.2 Purchasing Information DOC-35311 7.4.3 Verification of Purchased Product DOC-01249 7.5 Production and Service Provision 7.5.1 Control of Production and Service Provision DOC-01251, DOC-01255

(DOC51154 in PSE) 7.5.1.1 Control Plan (Production Documentation) DOC-01251 7.5.1.2 Work Instructions (Control of Production Process Changes) DOC-01251 7.5.1.3 Verification of job set-ups (Control of Production Equipment,

Tools & Numerical Control (N.C.) Machine Programs) DOC-01251 7.5.1.4 Preventive and Predictive Maintenance (Control of Work

Transferred, on a Temporary Basis, Outside the Organization’s Facilities)

DOC-01251 (AS9100C: Not applicable to PSE)

7.5.1.5 Management of production tooling (Control of Service Operations) DOC-35306

7.5.2 Validation of Processes for Production and Service Provision Not Applicable to PSemi 7.5.3 Identification and Traceability DOC-01254 7.5.4 Customer Property Not Applicable to PSemi 7.5.5 Preservation of Product (Handling, Storage, Packaging,

Preservation and Delivery) DOC-01255

7.6 Control of Monitoring and Measurement Devices DOC-50634 (DOC-52957 in PSE)

8 Measurement, Analysis and Improvement 8.1 General DOC-35179 8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction DOC-35306 8.2.2 Internal Audit DOC-35305 8.2.3 Monitoring and Measurement of Processes DOC-35305 8.2.4 Monitoring and Measurement of Product DOC-01249 8.2.4.1 Layout Inspection and Functional Testing (Inspection

Documentation) DOC-01249 8.2.4.2 Appearance Items Not Applicable to PSemi 8.3 Control of Nonconforming Product DOC-35310 8.4 Analysis of Data DOC-01251; DOC-35179

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DOC-­‐35187  Rev  5                                                                                                                                                                                                                                                                                                                                                                                                      Page  11  of  13  

8.5 Improvement 8.5.1 Continual Improvement DOC-00410, DOC-35187 8.5.2 Corrective Action DOC-35304 8.5.3 Preventive Action DOC-35304

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

4.4 ISO/TS16949:2009 QMS Documentation Matrix (where applicable) Business Process – Executive Management

Process Name Document Number Business Plan Development Procedure DOC-35172 Management Review DOC-35179

Customer Oriented Processes Process Development Flow DOC-35202 Product Marketing Process DOC-35203 Product Development Process DOC-50045 Configuration Management Process DOC-35198 Sales Procedure DOC-35205 Order Review and Acceptance Procedure DOC-35200 Planning and Purchasing Procedure DOC-50253, DOC-35311 Manufacturing Process DOC-35199 Application Support Procedure DOC-00317 Customer Sales Order Shipping Process DOC-35186

Support Processes – Resource Management and Resource Control Human Resources Process DOC-35250 Facilities Management DOC-35251 Information Technology Procedure DOC-35292 Document Control DOC-35294 Quality Records DOC-35296 Equipment Maintenance Process DOC-35303 Failure Analysis Procedure DOC-35298 Training DOC-35300 Environmental Management Procedure DOC-35301 Finance Statement Preparation DOC-35302 Corrective Action Procedure DOC-35304 Internal Audits Procedure DOC-35305 Customer Satisfaction (Application Support) DOC-00317 Continual Improvement Procedure DOC-35307 Measurement Systems Analysis Process DOC-35309 Product Change Control DOC-35082 Control of Nonconforming Product DOC-35310

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DOC-­‐35187  Rev  5                                                                                                                                                                                                                                                                                                                                                                                                      Page  12  of  13  

5 Revision History

CO # Revision Date Originator Description of Change

03593 01 2004/05/21 B. Givens &

J. Greenwood First revision of PSA & PSC Quality System Manual merger.

03685 02 2004/10/17 B. Givens &

J. Greenwood

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

03977 03 2005/08/04 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

005039 06

2006/11/17

2007/04/10

L. Witsell

L. King

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

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 Remove business processes from manual.

006661 10 2008/11/26 P. Nunnelley

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

009629 11 2010/10/21 G. Lyons

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

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DOC-­‐35187  Rev  5                                                                                                                                                                                                                                                                                                                                                                                                      Page  13  of  13  

CO # 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.

CO-00434 1 2013/04/16 S. Im Agile Migration

CO-01564 2 2013/06/12 G. Lyons

Converted documents to Agile part numbering scheme throughout document, updated organization chart in section 3.1, added Management Review items in section 3.4

CO-03670 3 2013/10/14 P. Nunnelley

Updated Org chart in section 3.1. Removed the Research Process from section 4.2 and 4.4.

CO-04013 4 2013/11/18 T. Gainey

Updated to account for ISO9001 certification in PSE. Modified 3.5 to account for local management system representative and added various PSE document references to 4.3

CO-07201 5 2014/10/05 G. Kong

Quality System Manual- update document procedure numbers on pages 10-12. Update Top Corporate Org chart.


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