Corporate Quality System Manual. Doc. No.: DOC Revision 5

Transcription

1 Corporate Quality System Manual Doc. No.: DOC Revision 5 Page 1 of 13

2 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 Page 2 of 13

3 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 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 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 technology enables dramatic improvements in harmonic results, linearity, power handling and overall RF performance which today remain unmatched by any other RF process technology. Page 3 of 13

4 Figure 1: Peregrine Global Manufacturing Locations Figure 2: Peregrine Design, Sales and Support Locations DOC Rev 5 Page 4 of 13

5 3 Management Responsibility 3.1 Top Management Organization 3.2 Management Responsibility 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 Customer Focus The business units will ensure that customer requirements are understood and communicated effectively throughout the organization and to the top Page 5 of 13

6 3.3 Quality Policy management team. Top management will ensure customer requirements are met in such a way as to improve customer satisfaction. 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 Page 6 of 13

7 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 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 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 Page 7 of 13

8 4.2 Peregrine QMS Process Map Resource Management Peregrine QMS System Map Resource Control Human Resources Facilities Management Executive Management Corrective & Preventive Action Information Technology Document Control Resource Requirements Business Plan Development Management Review Business Metrics Internal Audit Customer Satisfaction Quality Records Failure Analysis Training Environmental Mgmt Financial Statement Preparation Equipment/ Maintenance Resources Corporate Goals & Policies Metrics Continual Improvement Measurement System Analysis Product Change Control Control of Nonconforming Product Internal Process Development Internal & Subcontractors CUSTOMER REQUIREMENTS Product Marketing Sales Product Development Order Review & Acceptance Configuration Management Planning & Purchasing Manufacturing Customer Sales Order Shipping CUSTOMER SATISFACTION Application Support Page 8 of 13

9 4.3 AS9100C/ISO 9001:2008 QMS Documentation Matrix # AS9100C / ISO 9001:2008 Requirement Procedures 4 Quality Management System 4.1 General Requirements DOC Documentation Requirements General Requirements DOC Quality Manual DOC Control of Documents DOC Control of Records DOC Management Responsibility 5.1 Management Commitment DOC Customer Focus DOC-35306, DOC Quality Policy DOC Planning Quality Objectives (Quality Management System) DOC Quality Management System Planning DOC Responsibility, Authority and Communication Responsibility and Authority DOC Management Representative DOC Internal Communication DOC Management Review General DOC Review Input DOC Review Output DOC Resource Management 6.1 Provision of Resources DOC Human Resources General DOC Competence, Training and Awareness DOC Infrastructure (Process Control) DOC Work Environment DOC Product Realization 7.1 Planning of Product Realization DOC (DOC in PSE) 7.2 Customer-Related Processes Determination of Requirements Related to the Product DOC Review of Requirements Related to the Product (Contract Review/ Product Development Procedure) Customer Communication DOC Design and Development DOC-00442, DOC Design and Development Planning DOC (DOC in PSE) Page 9 of 13

10 # AS9100C / ISO 9001:2008 Requirement Procedures Design and Development Inputs DOC Design and Development Outputs DOC Design and Development Review DOC Design and Development Verification DOC Design and Development Validation DOC Design and Development Validation-Supplemental DOC Prototype Programme (Design and/or Development Verification & Validation Testing) DOC Control of Design and Development Changes DOC Purchasing Purchasing Process DOC (DOC in PSE) Purchasing Information DOC Verification of Purchased Product DOC Production and Service Provision Control of Production and Service Provision DOC-01251, DOC (DOC51154 in PSE) Control Plan (Production Documentation) DOC Work Instructions (Control of Production Process Changes) DOC Verification of job set-ups (Control of Production Equipment, Tools & Numerical Control (N.C.) Machine Programs) Preventive and Predictive Maintenance (Control of Work Transferred, on a Temporary Basis, Outside the Organization s Facilities) Management of production tooling (Control of Service Operations) DOC DOC (AS9100C: Not applicable to PSE) DOC Validation of Processes for Production and Service Provision Not Applicable to PSemi Identification and Traceability DOC Customer Property Not Applicable to PSemi Preservation of Product (Handling, Storage, Packaging, Preservation and Delivery) DOC Control of Monitoring and Measurement Devices DOC (DOC in PSE) 8 Measurement, Analysis and Improvement 8.1 General DOC Monitoring and Measurement Customer Satisfaction DOC Internal Audit DOC Monitoring and Measurement of Processes DOC Monitoring and Measurement of Product DOC Layout Inspection and Functional Testing (Inspection Documentation) DOC Appearance Items Not Applicable to PSemi 8.3 Control of Nonconforming Product DOC Analysis of Data DOC-01251; DOC Page 10 of 13

11 8.5 Improvement Continual Improvement DOC-00410, DOC Corrective Action DOC Preventive Action DOC Note: Not Applicable: Appearance Items, Customer Property & Customer-Owned Tooling 4.4 ISO/TS16949:2009 QMS Documentation Matrix (where applicable) Process Name Business Plan Development Procedure Management Review Process Development Flow Product Marketing Process Product Development Process Configuration Management Process Sales Procedure Order Review and Acceptance Procedure Planning and Purchasing Procedure Manufacturing Process Application Support Procedure Customer Sales Order Shipping Process Business Process Executive Management Document Number Customer Oriented Processes DOC DOC DOC DOC DOC DOC DOC DOC DOC-50253, DOC DOC DOC DOC Support Processes Resource Management and Resource Control Human Resources Process Facilities Management Information Technology Procedure Document Control Quality Records Equipment Maintenance Process Failure Analysis Procedure Training Environmental Management Procedure Finance Statement Preparation Corrective Action Procedure Internal Audits Procedure Customer Satisfaction (Application Support) Continual Improvement Procedure Measurement Systems Analysis Process Product Change Control Control of Nonconforming Product DOC DOC DOC DOC DOC DOC DOC DOC DOC DOC DOC DOC DOC DOC DOC DOC DOC Page 11 of 13

12 5 Revision History CO # Revision Date Originator Description of Change /05/ /10/17 B. Givens & J. Greenwood B. Givens & J. Greenwood /08/04 Gene Lyons /02/27 P. Nunnelley /08/22 Gene Lyons /11/ /04/10 L. Witsell L. King /09/18 P. Nunnelley First revision of PSA & PSC Quality System Manual merger. All document references on Pages updated. Building photo changed to new building. 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. Revise to current practices, update document references and corporate overview section. Minor revision to document number references Added Not Applicable to PSemi on page 23, sections & for clarification Peregrine spelled incorrectly 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, /1/23 G. Lyons Updated quality policy and photo for PSC /3/25 C. Villarreal 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 /11/26 P. Nunnelley /10/21 G. Lyons 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 12 of 13

13 CO # Revision Date Originator Description of Change /09/23 P. Nunnelley 1) Replace Org chart 3.1 & Senior Mgmt. with Top Mgmt. throughout document, 2) Replace QMS System Map, ) Updated Peregrine locations Fig 1. 4) Aligned sections 3.2 & 3.3 with TS ) Added TS16949 QMS Process List, page /10/06 P. Nunnelley Typo, formatting updates. Section fonts to be uniform within the document. CO /04/16 S. Im Agile Migration CO /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 /10/14 P. Nunnelley Updated Org chart in section 3.1. Removed the Research Process from section 4.2 and 4.4. CO /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 /10/05 G. Kong Quality System Manual- update document procedure numbers on pages Update Top Corporate Org chart. Page 13 of 13