QUALITY MANUAL. Chipcon AS

Transcription

1 QUALITY MANUAL Chipcon AS ISO 9001:2000 Chipcon Quality Management System (CQMS)

2 Revision Records Revision Number Effective Date Change Description Author Reviewed Approved by QA Manager New org. chart, updated Department descriptions Introduction changed (chapter 1). Procedures for customer satisfaction survey changed (section 8.2.1). Fig. 1 & 5 updated. Jan-Bjørnar Lund Arne Kjensmo Svein Anders Tunheim Svein Anders Tunheim Minor adjustments after review. Arne Kjensmo Svein Anders Tunheim Update after internal CQMS review and Management review Arne Kjensmo Editorial changes. Svein Anders Tunheim Updated after Chipcon internal Svein Anders audit, Chipcon management Tunheim review and external audit First official release. Svein Anders Tunheim Updated document. Complete. Svein Anders For internal review New document, Preliminary Status, not complete. Tunheim Svein Anders Tunheim Svein Anders Tunheim Geir Førre Geir Førre Geir Førre (Geir Førre) (Geir Førre) Jan-Bjørnar Lund Arne Kjensmo Chipcon AS Quality Manual Revision 1.15 Page 2 of 36

3 Table of contents 1 INTRODUCTION GENERAL COMPANY INFORMATION AND QUALITY POLICY QUALITY SYSTEM SCOPE AND PURPOSE OVERVIEW OF CHIPCON S ORGANIZATION AND CORE PROCESSES GENERAL COMPANY ORGANIZATION Sales Engineering Operations Business Development Research and Product Planning Figure 8 Wireless Chipcon Technology Advisory Board (TAB) CORE PROCESSES OUTSOURCED PROCESSES QUALITY MANAGEMENT SYSTEM DOCUMENTATION DOCUMENTATION STRUCTURE DOCUMENT CONTROL QUALITY RECORDS MANAGEMENT RESPONSIBILITY MANAGEMENT COMMITMENT CUSTOMER FOCUS QUALITY POLICY PLANNING Quality Objectives Quality management system planning RESPONSIBILITY, AUTHORITY AND COMMUNICATION Responsibility and authority Management representative Internal communication MANAGEMENT REVIEW RESOURCE MANAGEMENT PROVISION OF RESOURCES HUMAN RESOURCES INFRASTRUCTURE AND WORK ENVIRONMENT PRODUCT REALIZATION PLANNING OF PRODUCT REALIZATION Integrated Circuits (ASSPs and ASICs) Development Kits General CUSTOMER-RELATED PROCESSES Determination of requirements related to the product Review of requirements related to the product Customer communication DESIGN AND DEVELOPMENT Design and development planning...26 Chipcon AS Quality Manual Revision 1.15 Page 3 of 36

4 7.3.2 Design and development inputs Design and development outputs Design and development review Design and development verification Design and development validation Control of design and development changes PURCHASING Purchasing process Purchasing information Verification of purchased product PRODUCTION AND SERVICE PROVISION Control of production and service provision Validation of processes for production and service provision Identification and traceability Customer property Preservation of product INSTRUMENT CALIBRATION MEASUREMENT, ANALYSIS AND IMPROVEMENT GENERAL MONITORING AND MEASUREMENT Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of product CONTROL OF NONCONFORMING PRODUCT ANALYSIS OF DATA IMPROVEMENT OVERVIEW OF CHIPCON QUALITY SYSTEM DOCUMENTS REFERENCES...36 Chipcon AS Quality Manual Revision 1.15 Page 4 of 36

5 1 INTRODUCTION 1.1 General Company Information and Quality Policy Chipcon is a leading international fables semiconductor company designing, producing and marketing high-performance standard radio frequency integrated circuits (RF-ICs) for use in a variety of short-range wireless applications. With our world-leading standard products, we offer low cost, one- and two-way high performance radio solutions that can be used in a large variety of wireless applications. Our standard products are sold worldwide and our goal is always to deliver qualified, reliable and tested products directly and timely to the customer. Chipcon is a highly customer focused organization and is committed to supply products and services that conform to the requirements of our customers in terms of price, delivery, and quality. To achieve this a quality consciousness is established throughout the organization and it is recognized that the work of every Chipcon employee affect the quality of our products and services. We always focus on customer interest and our task is to fulfil and preferably surpass customer expectations. All our preventive measures and continuous improvements are based on facts, and through everyone s commitment we continuously develop and improve the quality in our work. Chipcon s Quality Policy Statement: We are dedicated to providing integrated circuit products and services that meet our customers requirements and expectations. We will achieve these results due to everyone s commitment and due to the continuous improvements of all aspects of our business. We are committed to: Quality being the responsibility of each and every Chipcon employee. Quality and Reliability by design. Customer support and timely delivery. Measures of Quality that are numeric, exact and critical. Management support for, and involvement in, continuous improvement of our quality management system to achieve zero product defects. Chipcon AS Quality Manual Revision 1.15 Page 5 of 36

6 2 QUALITY SYSTEM SCOPE AND PURPOSE Chipcon s quality management system documentation is written, implemented and maintained to meet the requirements of ISO 9001:2000 with a scope of registration for: DEVELOPMENT, CHARACTERIZATION, MANUFACTURING THROUGH SUBCONTRACTORS, MARKETING AND SALES OF HIGH PERFORMANCE RADIO FREQUENCY (RF), ANALOG, DIGITAL AND MIXED-SIGNAL INTEGRATED CIRCUITS. The purpose of this manual and the associated procedures is to describe the manner in which Chipcon successfully operates with a reputation of quality and reliability. In this manual we identify the processes that are necessary for our quality management system. The sequence, interaction and management of these processes are described in this manual together with its supporting procedures. We strive to continually improve our core processes as well as the quality system as a whole. Defining the quality objectives and using the quality management system to meet those objectives achieve our improvements. Through process monitoring (and measurement where appropriate), and the analysis of data collected during such monitoring, the degree to which the quality objectives are met is determined. We continuously analyse and set quality objectives to improve our products, using formal processes in our quest to achieve customer satisfaction, using methods and techniques that foster continuous improvement and good business practices. This Quality Manual describes the quality management system within Chipcon and is a controlling document in the organization in order to reach high quality in everything we do. The Quality Manual also serves as a tool: To establish a common basis for the detailed Quality Management System procedures and routines used within Chipcon To inform Chipcon Employees, Customers, Suppliers and relevant Authorities of the Chipcon Quality Management System To identify roles, responsibility and authority for quality. This Quality Manual follows the structure of the requirements of the ISO 9001:2000 standard. Management responsibility, Resource management, Product realization and Measurement, analysis and improvement are described in sections 5, 6, 7 and 8 respectively. Chapter 3 gives an overview of Chipcon s core processes, while chapter 4 describes the documentation of Chipcon s quality management system. Chipcon AS Quality Manual Revision 1.15 Page 6 of 36

7 3 OVERVIEW OF CHIPCON S ORGANIZATION AND CORE PROCESSES 3.1 General Chipcon s Management is highly committed to ensuring and improving quality at all levels of work within the organization. The main responsible for the Quality System at Chipcon is the Quality Assurance Manager (see 5.5.2). The Quality Assurance Manager reports to the Management Representative. At regular intervals the Chipcon Management performs internal reviews of the Quality System (see 5.6). 3.2 Company Organization The organization of Chipcon consists of six departments as shown in Figure 1 (please see next page): 1) Sales, 2) Engineering, 3) Operations, 4) Business Development, 5) Research and Product Planning and 6) Figure 8 Wireless. In addition there are administrative, Marketing Communication, IT and financial functions reporting to CFO. Chipcon AS Quality Manual Revision 1.15 Page 7 of 36

8 President & CEO Geir Førre CFO Barry Rudolph CTO Svein A. Tunheim VP Engineering Eivind Fremstad VP Worldwide Sales John H. Fjellheim VP Business Development Sverre D. Moen VP Operations Arne Kjensmo President Figure 8 Wireless Barry Rudolph Finance Administration Research and Product Planning IC Design Software & Tools Sales Europe Business Development ZigBee RF Design Sales US Logistics CTO Software Marketing Communication Quality Management Jan-Bjørnar Lund Dataconvertes & Analog filtering Signal Processing Reference Design & Test Sales Asia Business Development Consumer Support Tools ZigBee Support IT SoC Technical Support Product Management Figure 1. Chipcon Organisation

9 3.2.1 Sales The Sales Department at Chipcon is responsible for sales and technical customer support of components (integrated circuits). This includes sales of ASSPs (Application Specific Standard Products) and ASICs (Application Specific Integrated Circuits, i.e. customized chips). The sales department is organised as a matrix sales unit were the VP Component Sales is responsible for the geographical worldwide sales of standard components whereas the VP Strategic Sales is responsible for key-account sales in well-defined market segments as well as sales of strategic development projects Engineering The Engineering Department is responsible for all development projects at Chipcon. A development project starts with a project handover from the Research and Product Planning Department after TAB approval of phase 0. The project ends when a product has been transferred to volume production and the responsibility is taken over by the Operations Department Operations The Operations Department is responsible for volume production of all Chipcon products and all services related to order processing and product delivery to customers Business Development The Business Development Department is responsible for sales of strategic development projects and key account management Research and Product Planning The Research and Product Planning Department is responsible for strategic product planning (ASSPs) as well as general technology evaluation. This Department works closely both with the Sales and Engineering Departments Figure 8 Wireless Figure 8 Wireless provides software and networking solutions for Zigbee wireless networks. Figure 8's solutions are used as building blocks and development tools to allow companies to quickly create smart wireless networks. Chipcon AS Quality Manual Revision 1.15 Page 9 of 36

10 3.2.7 Chipcon Technology Advisory Board (TAB) Chipcon TAB is a group of people from Chipcon who is responsible for planning and maintaining Chipcon s product roadmap and to give advise to the Chipcon Management Team and Chipcon Board regarding strategic directions for new product developments. For ongoing Chipcon ASSP developments Chipcon TAB has the role as the customer of the product, and shall review requirement specifications, general project progress as well as design descriptions and datasheets. Members of Chipcon TAB are: VP Research and Product Planning (leader), VP Engineering, VP Sales, Director Technical Support and the company President. 3.3 Core Processes The core processes of Chipcon are: Sales, including Technical Support (see section 3.2.1) Engineering (see section 3.2.2) Operations (see section 3.2.3) Business Development (see section 3.2.4) Research and Product Planning (see section 3.2.5) Figure 8 Wireless (see section 3.2.6) More detailed description of these processes is done in chapter 7 and 8. Management responsibility, resource management and measurement, analysis and continual improvement comprise the overall framework in which these core processes are performed. Figure 1 shows how these processes are inter-linked in Chipcon s quality management system. Chipcon AS Quality Manual Revision 1.15 Page 10 of 36

11 Continual improvement of the quality management system Customers Management responsibility Customers Resource management Measurement, analysis and improvement Satisfaction Product Realization Requirements Business Development Requirements Input Project decision TAB Prestudy Research and product planning Project decision TAB Specification, design and test Engineering Transfer to production Operation Product Output Requirements Sales Key : Value-adding activities Information flow Figure 1. Visualization of Chipcon s quality management system. Chipcon AS Quality Manual Revision 1.15 Page 11 of 36

12 3.4 Outsourced processes Chipcon is a fabless semiconductor company and there are a number of processes that are outsourced. The most important ones are: Manufacturing of silicon wafers with integrated circuits Production test of wafers (if applicable) Assembly (bonding, packaging and marking) Production test of packaged chips ESD- and latch up tests (as part of reliability testing) ASSP development kit production The control of these processes is done according to the Procedure for control of outsourced processes. All subcontractors used by Chipcon for the ASSP/ASIC supply to customers are world-leading within their businesses, and all have certified quality systems according to ISO 9001 / ISO 9001:2000 and QS When introducing new subcontractors in Chipcon s fabless semiconductor model, careful evaluation is performed. The characterisation testing of Chipcon s standard product chips is not outsourced, and is always performed by Chipcon. The qualification testing (including ESD, LU and Reliability) is partly outsourced to subcontractors. Figure 2. Chipcon s fabless semiconductor model Chipcon AS Quality Manual Revision 1.15 Page 12 of 36

13 4 QUALITY MANAGEMENT SYSTEM DOCUMENTATION 4.1 Documentation Structure Chipcon s quality management system documentation ensures effective operation and control of our business processes. Our quality management system documentation is designed to meet the requirements of ISO 9001:2000. Four levels of documentation are defined in the quality management system: LEVEL 1 : LEVEL 2 : LEVEL 3: LEVEL 4: Quality Manual Quality procedures describe how quality management system processes are conducted in compliance with the ISO 9001:2000 requirements. Work Instructions, detailed project checklists, quality plans, routines, etc. describe in detail how activities affecting quality and customer satisfaction are performed. Quality Records Figure 3 shows a simplified structure of the documentation. Low Quality Manual Cross-referencing Quality Procedures and detailed Process Descriptions Level of detail Work Instructions, detailed project checklists, routines, etc. Quality Records High Figure 3. Document structure of Chipcon s Quality Management System The approval, issue and control of this Quality Manual, the Quality Procedures, the Quality Policy and all Chipcon quality system documentation is described in the Procedure for Control of Documents. The Quality Manual is classified as an open document and can be accessed through Chipcon s external web pages. Chipcon AS Quality Manual Revision 1.15 Page 13 of 36

14 For Chipcon internal use the complete Quality Management System is available for all employees at the following directory: G:\08-Rutiner & kvalitetssikring\083-cqms. The Quality Manual is located at the directory: G:\08-Rutiner & kvalitetssikring\083-cqms\cqms_1 Quality Manual Quality control procedures are located at the directory: G:\08-Rutiner & kvalitetssikring\083-cqms\cqms_2 Quality Control Procedures. Subdirectories include the various procedures. The latest revision is indicated by the highest revision number. The document CQMS_1_2 Overview of Chipcon Quality documents includes a complete overview of all quality procedures, as well as hyperlinks to their latest revisions (Chipcon internal information). Figure 4 shows the catalogue structure of Chipcon s Quality Management System. Figure 4. Catalogue structure of Chipcon s Quality Management System Chipcon AS Quality Manual Revision 1.15 Page 14 of 36

15 4.2 Document Control Chipcon s quality management system and all important information sources and documents affecting quality, are controlled by the Procedure for Control of Documents, which ensures that outdated or inaccurate information is not used and that appropriate information is available where it is needed. All documentation is reviewed and approved prior to use and changes to documentation are also reviewed, approved and controlled. Revision control is defined and used. Such documents are maintained in such a manner as to ensure that they remain legible, readily identifiable and retrievable. Any such documents that become obsolete are disposed of or marked to prevent unintended use. In order to maintain control of the electronic version of the quality system documents and data that are maintained on Chipcon s intranet, regular back-ups with internal and external backupstorage are performed and anti-virus software is in use. 4.3 Quality records Chipcon maintains quality records in order to provide evidence of conformance to ISO 9001:2000 quality management system requirements and to provide evidence of the effective operation of the quality management system. The Procedure for Control of Quality Records specifies the control of quality records with emphasis on the following: It describes which records that are established and maintained within Chipcon s Quality Management System. Storage of records Person responsible for maintaining the records. Retention period 5 MANAGEMENT RESPONSIBILITY 5.1 Management commitment The management at Chipcon is highly committed to ensuring and improving quality at all levels of work. This is reflected in sections 5.1 to 5.6 in this Quality Manual and specifically in the company s quality policy (see chapter 1). 5.2 Customer Focus Chipcon is a highly customer-oriented company, and customer focus is stated by the Management Team as the most important factor for success within our business area. Customer focus is emphasized at all levels within the organization. Special focus is set on determining and understanding the customer s requirements. We aim at meeting these requirements and also to learn from customer feedback and continuously improve our quality system. Chipcon AS Quality Manual Revision 1.15 Page 15 of 36

16 5.3 Quality Policy Chipcon s quality policy is stated in chapter 1. The management team continuously works on ensuring that this quality policy is reflected in the quality management system and communicated, understood and followed in the organization as a whole. 5.4 Planning Quality Objectives Quality objectives have been established that are derived from (or included in) Chipcon s Quality Policy. Quality objectives have been established to continually improve the quality management system as a whole as well as each management process, extending to processes involved with meeting product requirements. Quality objectives are defined through a set of Key Performance Indicators (KPIs) that are measurable, so that they can be analysed to determine the degree to which they are met. A number of indicators are defined and reflect the requirements from our customers and other interested parties, including policies and strategies. Most important are those indicators that show quality, effectiveness, and financial results. The goals and improvement work is established from those indicators. In general, Chipcon s quality plans are consistent with our normal methods of operation covered by existing procedures. These plans ensure that quality objectives set forth in our quality policy and those identified during Management Review Meetings are met. Chipcon s Quality Objectives based on the defined Key Performance Indicators are defined in the document Chipcon_Quality_Objectives Quality management system planning As part of the regular maintenance of our quality system, proposed modifications to processes and procedures are reviewed during Management Review Meetings to ensure that the requirements of the quality system have been addressed prior to the implementation of any modifications. This review ensures that no new process is implemented without first considering the actions that must be taken to ensure that Chipcon remains in compliance with the system as it is documented. Items evaluated and planned actions are documented in the Management Review Meeting minutes (see 5.6.) Chipcon AS Quality Manual Revision 1.15 Page 16 of 36

17 5.5 Responsibility, authority and communication Responsibility and authority The organization and its functions, responsibilities and authorities are documented. Every manager is responsible for the quality of his/her operation and the results of the operation. This implies among other things responsibility for: Setting goals, controlling, following up and improving the department s operations. Ensuring that the results correspond to requirements and goals. Continuous improvement of employees personal development, competence and professional skills. Making sure that the quality policy and customer requirements are known, understood and applied by everyone in daily work. Ensuring that the unit follows existing quality system and that changes or improvements become known and implemented. The documentation related to this is specific responsibility descriptions of a number of the positions within the company. In addition there are specific work instructions for e.g. development project leaders and development team members. A document is established which states the authority related to all different Chipcon positions Management representative Chipcon Management has appointed a member of the Management Team who, irrespective of other responsibilities has the main responsibility and authority to establish, implement and maintain Chipcon s Quality Management System to ensure that it continues to be compliant with the requirements of ISO 9001:2000. The Management Representative is responsible for evaluating the effectiveness of the quality system and reporting to the Management Team and other attendees at scheduled Management Review Meetings, and for making suggestions to improve the system. The Management Representative also ensures that employees are aware of the importance of meeting customer requirements and how those requirements relate to their work activities. Detailed implementation as well as the daily maintenance and follow-up of Chipcon s Quality Management System is the responsibility to the Quality Manager. The Quality Manager reports to the Management Representative. The Management Representative and the Quality Manager can be the same person Internal communication Although informal communication is an effective method of transmitting information relating to products and processes, formal mechanisms are in place to document and facilitate such communication. The Management Team meets on a regular basis, and the different Departments have their own regular meetings. Chipcon AS Quality Manual Revision 1.15 Page 17 of 36

18 The effectiveness of internal communications and any further formalization of such communication are considered during Management Review Meetings. The effectiveness of the quality management system processes are communicated to the various levels and functions of Chipcon through use of quality system documentation, training, Internal Audits (and subsequent reporting), the Document Control and Corrective and Preventive Action systems and Management Review Meetings. 5.6 Management review Management Review Meetings are held to assess and evaluate the quality system to ensure its continued effectiveness and suitability in satisfying the requirements of ISO 9001:2000 and our stated quality policy and objectives. Reviews are carried out as frequently as necessary, but at least annually. Topics discussed during the meeting and resulting action plans are recorded in Management Review Agenda and Minutes, which are maintained as quality records in accordance with the Procedure for Control of Quality Records. During Management Review Meetings, the Management Team reviews current performance and improvement opportunities arising from the results of internal audits, customer feedback, process performance/trends and product conformance, the status of corrective and preventive actions, and follow-up actions from previous meetings. Other inputs to the meeting include customer satisfaction data (see the Management Review procedure). The Key Performance Indicators (KPIs) are measured against the Quality Objectives. (This is done once per month or once per quarter.) The quality policy and quality objectives are also reviewed for their continuing suitability. Data gathered through measurement and monitoring activities are analysed to determine the effectiveness of the quality management system. (Such data may be summarized in reports that are submitted to attendees of the meeting.) Analysis is also applied to data relating to customer satisfaction, conformance to customer requirements, suppliers and any other relevant sources. Also, communications methodology (both internal and external) is reviewed. Chipcon will continually improve the quality management system. This improvement is facilitated not only by management review, but by establishing and reviewing the quality policy and quality objectives, internal audit results, the analysis of data and corrective and preventive actions. All such processes are managed to achieve improvement. Management Review also includes quality system planning to ensure that changes in our processes are evaluated and that quality system requirements are addressed prior to their implementation. In addition, the Management Review Meetings serve as a forum where Chipcon may evaluate potential problems and take actions to prevent their occurrences. Outputs from Management Review Meetings (which are recorded in the minutes), include action items regarding the improvement of the quality management system, improvement of products in relation to customer requirements, and the identification of any needed resources to ensure the continuing satisfaction of our customers. Findings during the audit shall be documented by standard Finding Reports according to the Corrective and Preventive Actions Procedure. Chipcon AS Quality Manual Revision 1.15 Page 18 of 36

19 6 RESOURCE MANAGEMENT 6.1 Provision of resources The Chipcon Management Team will provide the resources needed to implement and maintain the quality management system and to meet customer requirements, thus enhancing customer satisfaction. 6.2 Human resources As Chipcon is a highly customer focused organization the Chipcon Management Team recognizes that the work of every Chipcon employee affect the quality of our products and services. All Chipcon employees are qualified to perform specific tasks on the basis of the appropriate education, training, skill and experience as evidenced by their Chipcon_Employee_CV. These records are controlled in accordance with the Procedure for Control of Quality Records. All personnel receive appropriate training to ensure that they are aware of their duties, responsibilities, and level of authority, and to ensure that the working practices specified in quality system documentation are implemented and followed. Chipcon s commitment to and policy for quality is communicated to all employees. This also includes the importance of meeting customer requirements, the importance of their respective positions, and how they contribute to the achievement of the quality objectives. As a part of the annual individual performance review needs for training are identified by the line manager and the employee. The provision of such training is also recorded on the employee s Chipcon_Employee_CV after the provided training has been evaluated and determined to be effective. The Management Team ensures that staffing and skill levels within the organization are appropriate to ensure the optimal efficiency and effectiveness of our operations. As part of quality planning, attendees of Management Review Meetings identify company-wide training needs in light of any new business developments or new technologies to be incorporated. As part of annual individual performance reviews each Chipcon employee shall update his or her Chipcon employee CV. Each employee s training is reviewed by his/her supervisor or manager in order to ensure the accuracy of his/her Chipcon employee CV and to ensure the continuing effectiveness of any training provided. 6.3 Infrastructure and Work Environment Management ensures that the Chipcon facilities are maintained appropriately to achieve conformity of the product, including workspaces, equipment and any supporting services related to facilities maintenance. Chipcon Management ensures that the appropriate human and physical factors of the work environment are considered and provided. Consideration of such factors includes health and safety conditions, work methods, handling methods, and ambient working conditions. Such considerations are assessed during Management Review Meetings. Chipcon AS Quality Manual Revision 1.15 Page 19 of 36

20 For the purpose of minimizing the risk of interruptions in operations, e.g. computer breaks, breakdowns of different media etc, there are responsible in-house resources and written routines for prevention of this. 7 PRODUCT REALIZATION 7.1 Planning of product realization Integrated Circuits (ASSPs and ASICs) For development of new Integrated Circuits the governing procedure is the Engineering Process document. This describes in detail how Chipcon carries out development projects. Sections 7.2 and 7.3 explain more about this Development Kits Development of software and hardware for development kits are coordinated with the project plan for the ASSP. The procedure for development kits is described in Development Tools Procedure. This procedure describes the phases in the development kit project. The development kit project is performed by the Software and Tools department and involves the project manager of the ASSP chip, the internal reviewer, director of technical support and the SW&Tools group manager General The processes related to product realization are planned and evaluated continuously through daily operations, and specifically during the Management Review. Chipcon AS Quality Manual Revision 1.15 Page 20 of 36

21 7.2 Customer-related processes The first interaction point between the customers and Chipcon typically occurs through Chipcon Sales activities. Other interaction points are e.g. customer support on Chipcon ASSPs, communication with customers and development partners throughout an IC development project, marketing activities. Chipcon has four main customer related processes related to Sales : 1. Sales of ASSP components (integrated circuits) This is done according to the Sales Department Procedure/Checklist: Control Procedure Sales / Quotation_Routine_Sales and the Operations Department Procedure : Procedure_for_Order_Processing. 2. Sales of ASIC components (integrated circuits) This is done according to the Sales Department Procedure/Checklist: Control Procedure Sales / Quotation_Routine_Sales and the Operations Department Procedure : Procedure_for_Order_Processing. 3. Sales of development projects (ASICs and/or ASSPs) This is done according to the Sales Department Procedure/Checklist: Control Procedure Sales / Checklist_ASIC_Quotation_and_Contract. 4. Sales of feasibility studies (ASICs and/or ASSPs) This is done according to the Sales Department Procedure/Checklist: Control Procedure Sales / Checklist_ASIC_feasibility_study_quotation Determination of requirements related to the product All IC developments shall be based on a requirement specification document. Chipcon ASSPs (Application Specific Standard Products) For a Chipcon ASSP the requirement specifications are determined by Chipcon (often together with a development partner). The basis for determining the specifications are general market input, regulatory requirements (e.g. frequency regulations) and specific customer input. Chipcon AS Quality Manual Revision 1.15 Page 21 of 36

22 The Chipcon Technology Advisory Board (TAB) is responsible for planning and maintaining Chipcon s product roadmap and to give advise to the Chipcon Management Team and Chipcon Board regarding strategic directions for new product developments. For ongoing Chipcon ASSP developments Chipcon TAB is the internal customer of the product, and shall review requirement specifications as well as design descriptions and datasheets. ASICs (Application Specific Integrated Circuit) The requirement specifications for an ASIC can either be provided by the customer, or it can be developed by Chipcon (often together with the customer) and then finally reviewed and approved by the customer. Feasibility Study Many projects require a feasibility study to be performed before one can decide the requirement specifications. Then Chipcon performs such a study in close cooperation with the customer (for internal ASSP developments this is Chipcon TAB). The end-result is a feasibility study report. This report can then be used as the basis for determining the final requirement specifications. In addition to addressing issues agreed upon with the customers such feasibility studies are also controlled against a Chipcon specific feasibility study checklist. The main focus during the feasibility study is on securing that the IC development is feasible with acceptable cost and risk, as well as on estimating the final performance of the product Review of requirements related to the product Before a formal quotation of a development project is sent to a customer, Chipcon shall carry out review of the product requirement specifications. This is done as part of the general Sales process for ASICs: Checklist_ASIC_Quotation_and_Contract. Records from the requirement specifications review are controlled according to the procedure Procedure for Control of Quality Records, and when a new project starts a copy of these records and all other technical information regarding the project shall be handed over to the ASIC project leader at the Project Startup handover meeting (ref. the Engineering Process) Customer communication Chipcon is a highly customer oriented organization, and every service provided by Chipcon shall be carried out according to the customer s expectations and needs. Chipcon focuses highly on active communications with our customers, as this is necessary to make sure that the customer and Chipcon get a common understanding of the service/product requirements. Chipcon AS Quality Manual Revision 1.15 Page 22 of 36

23 7.3 Design and development The design and development of integrated circuits (ICs) from project start to volume production is denoted the Engineering Process and is one of Chipcon s core processes. The Chipcon Engineering Process document describes in detail the development phase as well as the transfer to production (i.e. prototype characterisation tests, reliability tests and setting up production test of wafers and packaged chips). The Engineering Process refers to a set of very detailed checklists (hierarchical organized) that are followed through all phases of the development project until the product has gone through transfer-to-production. There are detailed checklists for e.g. project planning, design/verification/layout of analog/rf modules, design/verification/layout of digital blocks, top level verification (simulation and layout) and gdsii tape-out. When the product goes into volume production, the Operations department takes over the product responsibility. The Engineering process is linked to the other departments as shown in Figure 5. These processes are related to Chipcon s quality management system as shown in Figure 1. The development of ASSP Support Tools, most notably the ASSP Development Kits, is controlled according to the Development Tools Procedure. Requirements Business Development Customer Requirements Project decision TAB Prestudy Research and product planning Project decision TAB Specification, design and test Engineering Transfer to production Operation Product Requirements Sales Figure 5. Links between Chipcon s core processes Figure 6 shows the basic Chipcon development/manufacturing process flow for new ASSP/ASIC developments. The Chipcon Engineering Process document covers all the steps shown. Chipcon AS Quality Manual Revision 1.15 Page 23 of 36

24 PRODUCT PLANNING PHASE, by CHIPCON Product Definition Specification Development PRODUCT DEVELOPMENT, by CHIPCON Electrical Design and Simulation Device Layout Development of Plans/ Specifications for Prototype Test and Characterization, Reliability Tests and Production Tests WAFER PROCESSING OF PROTOTYPES by SUBCONTRACTOR PROTOTYPE ASSEMBLY by SUBCONTRACTOR (bonding, packaging and marking) PROTOTYPE CHARACTERIZATION, by CHIPCON No Results from Prototype Characterization OK? Yes Product Released QUALIFICATION TESTING (Including ESD, LU and Reliability) / REVIEW IMPLEMENTATION OF PRODUCTION TEST by SUBCONTRACTOR (Test at wafer level and final test, according to Chipcon's test specifications) No Results from Production Test and Reliability OK? Yes Transfer to production finalised. Figure 6. Simplified Development/Manufacturing process flow for new product developments Chipcon AS Quality Manual Revision 1.15 Page 24 of 36

25 The responsibilities of the Project Manager, project team members and the Chipcon internal reviewer (a Chipcon internal reviewer is always appointed for an IC development project) are given below. Project Manager's responsibilities: 1) Perform his/her work according to the Project Manager s work instructions document. 2) Overall responsibility for organisation of the project, i.e.: planning, allocate manpower to the different development tasks, monitor the project economy (person hours used), interface to customer, report status of project, project progress with respect to deadlines, QA plan. 3) Overall technical solutions (should develop and maintain the design specification). 4) Run the project according to Chipcon's Quality Management system 5) Responsible for project meetings and design reviews. 6) The Project Manager might/will also be involved in design/layout of modules. 7) Review work done by the other members of the project team. 8) The Project Manager will be involved in the final procedures at top-level (schematics/simulations and layout) before tape-out. Team members' (IC designers ) responsibilities: 1) Perform his/her work according to the ASIC designer s work instructions document. 2) Design/layout and technical considerations on module level as well as top level. 3) Follow project plans with respect to deliverables and deadlines. 4) Follow Chipcon's Quality system, i.e. focus on quality and efficiency in the design process. Chipcon Internal Reviewer's responsibilities: 1) Assure that ASIC/ASSP project leader follows Chipcon's QA system. 2) Play an active role during the project with respect to general QA aspects. 3) Review work done by the project leader. 4) Play an active role during design reviews. Chipcon AS Quality Manual Revision 1.15 Page 25 of 36

26 7.3.1 Design and development planning The assigned Project Manager does the detailed planning of development projects during the initial phase of the Engineering process. Specific detailed checklists are used during this phase in order to ensure a solid plan for realizing the product timely, with high quality and after the customer s requirements. During the planning phase the Project Manager and the internal project reviewer also perform an additional review of the product requirements, ref. the Engineering process. If incomplete, ambiguous or conflicting requirements are found they are discussed with the customer and resolved at an early stage. The customer and Chipcon must approve any changes in writing. For each project a specific Quality Plan is established during the start-up phase of the project, and delivered to the customer. The quality plan includes relevant references to the Engineering Process and explains at a general level the important issues related to quality assurance for the project. The detailed project schedule with design reviews is included in the plan, as well as reporting routines to the customer Design and development inputs Ref. the Engineering Process. The main inputs to the Engineering phase are: Requirement specifications Records from review of requirement specifications. Feasibility study report (if performed) Considerations and specifications review from the Sales department Contract documents Customer contact information Design and development outputs Ref. the Engineering Process. The main outputs from the Engineering phase are: Finished design at schematic / VHDL level. Finished top level chip layout (GDSII format) for production Assembly specifications (package selection and bonding diagram) Non-tested engineering samples (after the first prototype run). Characterisation report Reliability report Production test specifications (and their implementation at the test house) Tested samples (after the production test has been implemented; this is a part of the transfer-to-production phase). Chipcon does the characterisation of ASSPs in-house. Chipcon AS Quality Manual Revision 1.15 Page 26 of 36

27 For some ASIC developments the ASIC characterisation and reliability testing is performed by the customer; if so this is agreed upon in the development contract. Then Chipcon can assist at the customer s premises if required - the customer closely in the set-up of characterisation tests as well as the detailed testing itself Design and development review Ref. the Engineering Process. Design reviews are held at pre-defined stages throughout the development phase (as defined in the project specific Quality Plan). Records of the results of the design reviews and any necessary actions are maintained and controlled according to the Procedure for Control of Quality Records Design and development verification Chipcon has established detailed and very thorough routines for IC design and development verification. This is performed according to the Engineering Process Design and development validation Chipcon has established detailed and very thorough routines for design and development validation. For ASSPs/ASICs the main activities related to this are Prototype Characterisation and Qualification tests (including Reliability testing). This is performed according to the Engineering Process Control of design and development changes Control of design and development changes of ASSPs are done according to the Design change procedure for the Engineering Department. What is essential here is that any design changes are thoroughly reviewed and verified (through simulations), as appropriate before implementation. The review includes detailed evaluation of the effect of the changes on the product. Chipcon always performs First Article Inspection (FAI) after any design changes. After ASSP design changes, the datasheet is updated and the design changes are clearly documented in an Errata Sheet if necessary. If, for some reason, design changes have to be introduced which could have effects on backwards compatibility, Chipcon informs all affected customers about this. Such design changes are handled according to the Procedure for Customer Notification. Records from design and development changes are controlled by the Procedure for Control of Quality Records. Chipcon AS Quality Manual Revision 1.15 Page 27 of 36

28 7.4 Purchasing Purchasing process Figure 7 shows the manufacturing process for products that are already released. Where subcontractors are used this is indicated. The purchasing related to this process is done according to the procedure ASSP and ASIC Purchase Control. The control of outsourced processes is done according to the Procedure for control of outsourced processes. Chipcon AS Quality Manual Revision 1.15 Page 28 of 36

29 PURCHASING ORDERS by CHIPCON WAFER PROCESSING by SUBCONTRACTOR WAFERSORT (optional) by SUBCONTRACTOR (production test of each produced chip at wafer level according to Chipcon's production test specifications) ASSEMBLY by SUBCONTRACTOR (bonding, packaging and marking) FINAL TEST by SUBCONTRACTOR Production test of each produced chip, according to Chipcon's production test specifications TAPE & REEL (if required), by SUBCONTRACTOR PRODUCT DELIVERY TO CUSTOMER by CHIPCON Figure 7. Simplified Manufacturing process flow for released products Purchasing information The purchasing information describes the product to be purchased. This is done according to the procedure ASSP ASIC Purchase Control. Chipcon AS Quality Manual Revision 1.15 Page 29 of 36

30 7.4.3 Verification of purchased product Purchased products are verified through thorough production process control. All wafers produced must pass PCM (process control monitor) test at the silicon foundry. Full functional tests are performed at packaged level. This is done according to the Procedure for Monitoring of PCM data, Yield and Sampling Control. Chipcon always performs First Article Inspection (FAI) after any design changes. 7.5 Production and service provision Control of production and service provision The core processes within Chipcon are the Engineering Process, the Sales Process and the Operations Process. The quality procedures defined for the Engineering, Sales and Operations departments ensure that production and service provision are carried out under controlled conditions. For development projects VP Engineering has an overall responsibility for coordinating all projects run by Chipcon and providing the necessary resources (personnel and equipment). The responsibilities of the Project Manager, Project Team Member and Internal Project Reviewer are defined in section Validation of processes for production and service provision At the Management Reviews evaluation of the processes for production and service provision is done, to check if they comply with Chipcon s Quality Objectives. Continuous improvement of the processes is encouraged throughout the organization. E.g. for the Engineering process a specific work instruction exists which ensures that new relevant quality aspects found are fed back to the person responsible for the document. All Engineering checklists include a learning checkpoint about this. Special emphasis is also put on this during project debriefing meetings which are held after projects have been finalized Identification and traceability All finished products are marked according to instructions received from customer or internally documented instructions. In this way each product is traceable to the documentation valid at the time of manufacturing. Control of design and development changes of ASSPs are done according to the Design change procedure for the Engineering Department, see section After ASSP design changes, the datasheet is updated and the design changes are clearly documented in an Errata Sheet if necessary. Chipcon AS Quality Manual Revision 1.15 Page 30 of 36

31 If products should become obsolete, this situation is handled through Procedure for Obsolete products. Chipcon will inform all affected customers in due time and special options for Last Time Buy will be given Customer property Chipcon exercises care with customer property while it is under Chipcon s control or is being used by Chipcon. Typically the customer property might be intellectual property, e.g. module layout (GDSII file) or software code (C program, or VHDL/Verilog code). The regulation of this is normally done either through the development contract or through a specific Non-Disclosure-Agreement Preservation of product To preserve the conformity from reception to the delivery to the intended destination, products are identified, handled, packaged, stored and protected according to established routines. 7.6 Instrument Calibration Control of monitoring and measuring devices at Chipcon, that is instrument calibration of laboratory equipment, is done according to Procedure for Instrument Calibration. This procedure ensures that: All instruments are registered with unique identification labels All instruments that are subject to calibration are marked with last calibration date, and calibration expiry date Instruments are calibrated within the documented intervals against traceable measurement standards Instruments are protected from damage by use of ESD protection Instrument calibration is established, administered, and utilized to maintain CQMS improvement. Records of the results of the instrument calibration are maintained according to Procedure for Control of Quality Records. Chipcon AS Quality Manual Revision 1.15 Page 31 of 36