IMC Quality Management System

Transcription

1 Contents IMC Quality System Handbook Revision 1.0, 30-Aug-2011 Public Legal Disclaimer: The information given in this document shall in no event be regarded as a guarantee of conditions or characteristics ("Beschaffenheitsgarantie"). With respect to any examples or hints given herein, any typical values stated herein and/or any information regarding the application of the device, Intel Mobile Communications hereby disclaims any and all warranties and liabilities of any kind, including without limitation warranties of no infringement of intellectual property rights of any third party. Edition 2011 Published by Intel Mobile Communications Neubiberg, Germany Intel Mobile Communications All Rights Reserved Rev. 1.0, 30-Aug-2011 Public 1

2 Contents Contents 1 Preamble IMC Company Profile IMC Mission Responsibilities and Release Regarding Quality System Handbook IMC s Quality Policy IMC Quality System General IMC Process and Framework Quality Documentation System Targets / KPIs and Analysis of Data Continuous Improvement and Problem Solving Responsibilities in the Quality Professional functions for Quality Quality Control Loops Processes Vision to Plan Process Market to Business Process Innovation Process Demand to Cash Process Finance & Accounting Human Resources Purchasing Information Technology QM Process Quality System Customer Related Processes Design and Development Production and Service Provision Measurement, Analysis and Improvement Terms Rev. 1.0, 30-Aug-2011 Public 2

3 Revision History Revision History Revision Number Description Revision Date 1.0 All pages, new defined based on existing documentation and alignment to Intel s Quality System handbook. 30-Aug-2011 Release Function / Role Name (Department) Date Signature Author Approver Owner/Releaser Bernd Buchwald Martin Wollschläger W.K. Tan Signed in System Distribution / Access List: Table of recipients or persons with access permission or ident of separate distribution list Name (Department) Name (Department) Name (Department) Intranet / Internet Rev. 1.0, 30-Aug-2011 Public 3

4 Preamble 1 Preamble 1.1 IMC Company Profile Intel Mobile Communications (IMC) develops, manufactures and markets innovative semiconductor products and solutions for wireless communications. IMC's goal is to enable the smooth transmission of voice and high-speed data to the end-user's equipment. IMC offers a mature portfolio of RF transceivers, cellular platforms, and connectivity solutions for mobile phones, smart phones, and mobile computing devices. Leveraging its unique advantages in the areas of RF and mixed-signal expertise, monolithic integration capabilities, and excellent knowhow in cellular software and systems, IMC provides superior customer solutions. The manufacturing of IMCs products is realized with external production partners. 1.2 IMC Mission Connect the world with leading-edge secure and seamless wireless solutions. 1.3 Responsibilities and Release Regarding Quality System Handbook Responsibilities for QM The roles of the Quality function include translation of Quality System (QMS) requirements into suitable processes, procedures & measures, support compliance and evaluation of their effectiveness for continuous improvement, as well as active promotion of our quality culture. Everybody s openness and engagement as part of IMC "Community of Quality" is the key to our joint and lasting success. Release Tan, Weng Kuan Senior Vice President & General Manager Intel Mobile Communications Martin Wollschläger Senior Director & QM Head Intel Mobile Communications Rev. 1.0, 30-Aug-2011 Public 4

5 IMC s Quality Policy 2 IMC s Quality Policy Vision All IMC employees act as quality managers in their areas of effectiveness. Policy Statement Our commitment to quality is an essential ingredient of our culture and values. We strive to maintain the highest standards to ship products that meet our stated goals and targets. If and when a problem arises, we will quickly respond by effective deviation management and keep our customer informed on the issue investigation and resolution. All employees feel responsible for quality. Strategy Promotion of IMC s Quality culture based on the zero failure mindset of well trained and highly educated people Risk management based on prevention and built-in to the business processes Definition of uniform tools and systems which are applied in the business processes Training and development of Personnel corresponding to their needs Requirement management, target setting as well as deviation management and assessments / compliance checks to evaluate the effectiveness and efficiency in the organizational units and processes by defined criteria Continuous improvement Best practices are regularly applied and used for business process and product improvement Requirements & Targets Deviation & Transparency Gate Keeping & Process Compliance Gate Keeper CONTINUOUS IMPROVEMENT 6Sigma/ 8D Owner of the QMS: IMC Quality Area of application: This Quality System Handbook is valid for: All sites and processes of Intel Mobile Communications worldwide Rev. 1.0, 30-Aug-2011 Public 5

6 IMC Quality System 3 IMC Quality System 3.1 General IMC s Quality System (QMS) ensures a win-win partnership with customers. The company works closely together with customer, listens to them and fulfills their requirements across the whole value chain. Stringent conformance, interoperability and field tests prepare mobile phone platforms for fast product qualification and integration into the customer solutions. Intel Mobile Communications - formerly the Wireless Solutions division of Infineon Technologies AG - was fully acquired by Intel early in At this time IMC still follows the system and regulations from Infineon. From this time onward, these regulations are being gradually replaced by either Intel or IMC s own regulations based on business needs. QMS Modification and Transfer Plan 02/ / / to 1 copy of IFX QMS to transfer ISO certification to IMC GmbH at February Preparation of Process & Tools for IMC Modification of QMS to pass external certification audit in Sep 2011 Target: IMC QMS & Processes are adequately aligned with Intel Process Framework Boundary Conditions New IMC certificate is issued ( spring 2011) New IMC contract with certification body existing since Feb 2011 Responsibility for QMS transfer project clearly defined within IMC QM Boundary Conditions IMC Process Framework is defined with respect to customer requirements and company goals defined activities, tools & responsibilities enables effective and efficient cooperation IMC headquarter and all major sites world wide are certified according ISO 9001 IMC regulations are seen as Intel Group Guidelines and will be replaced appropriately through Intel Specifications, Policy/Guidelines & Procedures until 09/2013 Planning & Controlling of all transfer & modification IMC QM QMS. Product Quality, Processes, Tools and Interfaces managed during all phases of modification and transfer. Rev. 1.0, 30-Aug-2011 Public 6

7 IMC Quality System IMC s QMS fulfils the requirements from different standards and is certified according ISO 9001:2008. Other standards and norms are considered and integrated into the Quality System. The QM-System is a translator between requirements and business processes. 3.2 IMC Process and Framework Mission of Process Describes the processes as they are lived in the day to day operational business and is an essential prerequisite for operational excellence Aligns all activities with respect to customer requirements and company goals Defines who makes what, how, with whom? And how is it measured and improved? Enables effective and efficient cooperation IMC Process Framework Quality is integrated into all core and enabler processes of IMC s Business Process Framework - from the upmost level 0 down to the lowest level of a described Business Process. Rev. 1.0, 30-Aug-2011 Public 7

8 Finance & Acconting Human Resouces Purchasing Inforemation Tech nology Quality Quality System IMC Quality System IMC Process Framework Level 0 Core Processes Vision to Plan Market to Business Innovation Demand to Cash Enabler Processes Tasks and Roles of Process Process embraces the following activities assigned to the roles in process management: & controlling by KPIs Leader User User User Owner Leader User User User Definition & implementation of process & business success Leader User User User Execution of process steps More details are defined on the Process homepage. Rev. 1.0, 30-Aug-2011 Public 8

9 IMC Quality System 3.3 Quality Documentation System The picture shows how IMC s document structure is linked to Intel document structure. Moving from the top of this structure downwards, documents become more specific in their purpose and scope, and contents becomes increasingly detailed. IMC QM Manual IMC Process Framework Corporate Business Principles IMC Quality Document Hierarchy Group Guidelines Governing Specifications IMC regulations are seen as Intel Group Guidelines and will be replaced appropriately through Intel Specifications, Policy/Guidelines & Procedures until 09/2013 Operational Policy/Guidelines Operational Procedures Intel Quality Document Hierarchy Details of processes for all phases of a document life cycle as well as documentation rules and templates are defined within the IMC process Document Control. Archiving regulations and archiving periods for technical documents are defined within the IMC regulation Storage periods for technical documents. 3.4 Targets / KPIs and Analysis of Data Measurements of processes and activities are defined and reviewed regularly by owner/leader and the respective management to demonstrate compliance to the requirements. When planned targets are not achieved, appropriate actions will be defined. Data received from customer satisfaction survey/ scorecard, product conformity assessment and trends of process indicators are used for continuous improvement of the processes and Quality System. Rev. 1.0, 30-Aug-2011 Public 9

10 IMC Quality System 3.5 Continuous Improvement and Problem Solving Strategy Continuous Improvement and Problem Solving is one of the IMC s cornerstones to enhance the performance of its business processes and products, improvements and cost savings, and to benefit its interested parties. IMC uses the 8D as well as the Six Sigma methodology. The 8 step discipline includes problem description, containment actions, root cause analysis and corrective and preventive actions. Five phases of harmonized CI process Overall Target Setting: Identify Project: Solve Nonconformity: Capitalize Success: Overall Target Achievement Overall targets defined which should be supported by projects decision based on situation analysis Solve the nonconformity as given in the task and control the project Recognize success, share best practices, multiply success and use lessons learned for further improvement Check target achievements and identify further improvements Rev. 1.0, 30-Aug-2011 Public 10

11 Responsibilities in the Quality 4 Responsibilities in the Quality IMC Staff Member of IMC Board in Charge of QM (Business responsibility) Responsibility for quality towards customers, suppliers and the society as part of the business responsibility Definition and review of the Quality Policy and release of the Quality System Organization of Quality Definition and implementation of the overall Process Framework Definition, agreement and controlling of Quality Objectives Evaluation of the performance of Quality ( Review) Internal and external communication of Quality issues / topics Establishment and maintenance of mutual beneficial relationship with key customers and ensuring that customer requirements are met and customer satisfaction is enhanced Encouraging employee participation in the continuous improvement program Ensuring the availability of necessary resources Head of Quality (Expertise and support) Definition and continuous improvement of the Quality Publish the Quality System in the Intranet Development / definition of common QM-processes and QM-Tools Periodic evaluation of QM performance and information of the Education and training measures regarding Quality Process (Definition, coordination and Process methods). Planning and maintenance of the Quality System to meet requirements and changes Rev. 1.0, 30-Aug-2011 Public 11

12 Professional functions for Quality 5 Professional functions for Quality The professional responsibilities for Quality are assigned to following functions: The quality management department The product & software/system quality management within the business lines and R&D The enabling technology and services department The supplier quality management within the supplier management The customer quality management within the regions Intel Mobile Communications Weng Kuan Tan Senior Vice President & General Manager, Intel Mobile Communications (IMC) Hermann Eul President, Intel Mobile Communications (IMC) Christin Eisenschmid Vice President Business Administration, Intel Mobile Communications (IMC) Armin Sarstedt Supplier Stefan Butz Entry Phone Stefan Wolff Smartphone & RF Christin Eisenschmid Finance Werner Luschnig Supply Chain Op Hussein Mecklai R&D Ingo Kohrmeyer Human Resources Nicole Lau Legal Martin Wollschlaeger Quality Alexander Straub Business Development Franz Neppl ETS IMC Fellows Zdravko Boos Fellow RF Dieter Stengl IT Helmut Vogler SMD Brigitte Mueller Communications Christian Mucke Fellow Systems & Software Regional Sales Heads Andrew Wang Greater China/ South Asia Sam Kim/Jim Kim Korea Osamu Sato Japan Michael Richter EMEA Thom Degnan Americas QM function Rev. 1.0, 30-Aug-2011 Public 12

13 Quality Control Loops 6 Quality Control Loops The top management reviews the IMC s quality management system at planned intervals to ensure suitability, adequacy and effectiveness. Improvements and needs for changes to the system will be initiated. Quality management system topics are covered during different reviews on a monthly, quarterly or yearly basis. The combination of all these reviews together is the management review in the sense of ISO Topics to be covered: Results of internal and external audits including process compliance level Customer feedback Process performance and product conformity Status of preventive and corrective actions Follow up actions from previous reviews Changes that could affect the QM system Areas for improvements Output of every review is documented decisions and actions to cover necessary improvements to the QM system and processes as well as to the fulfillment of customer requirements. Rev. 1.0, 30-Aug-2011 Public 13

14 Processes 7 Processes 7.1 Vision to Plan Process In correspondence with its title, Vision to Plan, the process describes the development and operationalization of IMC s strategy by means of defining measurable targets. The process is supported by several rolling forecasts and accompanied by continuous controlling. The IMC VtP process is closely connected to Intel planning and controlling activities. Level 1: Vision to Plan Target Setting & Target Breakdown Strategy Development Controlling & Review Forecasting 7.2 Market to Business Process Requirements from the customer including delivery and post-delivery, legal requirements and other requirements are gathered, checked and agreed with the customer. Before any commitment is given to the customer to supply a product, an intensive review is conducted to check the feasibility to fulfill product requirements, and contract and order requirements. Records of these reviews are available. Committed requirements will be agreed as internal targets within other business processes like innovation process. Clear interfaces are defined to ensure effective and efficient communication with the customer regarding e.g. product information, contracts, feedbacks like customer satisfaction and complaints. Rev. 1.0, 30-Aug-2011 Public 14

15 Processes The sub process Customer Relations covers various activities to establish and improve business relationships, and to develop prospective business. Five major sub-processes and their interaction build up the Market to Business Process, one of the 4 core processes at Intel Mobile Communications. Market to Business creates a clear picture of our markets. It systematically develops and attends to our customers. Furthermore MTB is responsible for a customer oriented and future shaping technology & product portfolio. Level 1: Market to Business Market Intelligence Marketing Strategy Product Lifecycle Sales Strategy Sales Process 7.3 Innovation Process Quality planning is part of the Innovation process and consists of quality objectives and requirements for the product. Reviews, verification, validation, monitoring, measurement, inspection and test activities specific to the product are defined and recorded during development of projects. Reviews and assessments are performed by cross functional teams, results contain clear action plans if necessary and covers also any changes and deviations as well as risks. Review of changes, deviations and risks always considers also the impact of already produced or delivered parts. Responsibilities are clearly defined within all steps and phases of the projects. Requirements agreed for the projects cover functional, performance and legal aspects. Whenever possible, information and learning s from previous projects is also used as input. The development output enables the verification against the inputs and the agreed requirements. Part of the output is also information for the purchasing and supply chain. The development process contains major engineering activities like technology, chip & package development. Level 1: Rev. 1.0, 30-Aug-2011 Public 15

16 Processes Innovation Roadmap Process Development Process Performance Ramp Down Process 7.4 Demand to Cash Process IMC ensures that products purchased from external production partners are conform to the specification and agreed requirements. Appropriate control is in place to ensure process and product quality as well as the verification against the requirements. If appropriate, requirements for qualification of process and personnel from the production partner are also defined. The control and the validation of processes for production and service provision is ensured by our external production partners. Clear defined interfaces enable IMC to ensure identification and traceability of the products at any time. Systematic supplier selection with defined criteria s for evaluation and re-evaluation is in place. All external production partners (SiFos and OSAT sites) are certified according ISO9001 and ISO During all phases of the supply chain IMC ensures product requirements through appropriate defined procedures and measures regarding handling, storage and protection. Level 1: Demand to Cash Plan Make / Source Deliver Basic Data Sample Order Rev. 1.0, 30-Aug-2011 Public 16

17 Processes 7.5 Finance & Accounting Some of the Finance & Accounting processes are covered by the Intel Corporate Finance organization. Financial Accounting (including external reporting) is done by Corporate as well as Tax and Treasury which are handled globally by the respective corporate departments (Treasury and Global Tax & Trade). IMC is covering through its own Finance organization the cost accounting (evaluation of production steps and product costing) and the corresponding inventory evaluation. IMC Finance is also performing the monthly closing activities (which support the Financial Accounting process) and the internal Reporting (based on the results of the Financial Accounting process) Level1: Finance & Accounting Financial Accounting Tax and Treasury Cost Accounting & Inventory Evaluation Monhtly Closing & Internal Reporting Rev. 1.0, 30-Aug-2011 Public 17

18 Processes 7.6 Human Resources HR services are defined to: focus on the employee life cycle aim to deliver and improve the employee experience ensure (legal and process) compliance Source Support Develop Mobilize Compensate Governance The HR business processes enables all employees to be competent to perform the work related to their job : Raise the motivation and awareness of the relevance and importance of the peoples activity for quality Compare knowledge and abilities of process owner, process leader and process user with the process requirements (e.g. process description) Plan, develop, maintain, qualify training modules adequate to close the identified gaps Train process owner, process leader and process user for missing knowledge Temporary workers are trained as well. Verify and document the success of training and education by the demonstrated performance of personnel Rev. 1.0, 30-Aug-2011 Public 18

19 Processes 7.7 Purchasing IMC Purchasing process ensures sourcing for IMC core business indirect material. Main supported business topics are e.g. R&D Business, IP Licensing or Test & Measurement. IMC ensures that purchased goods and services are conforming to the specification and agreed requirements. Appropriate procedures and measures are in place to ensure process and product quality as well as the verification against the requirements. Systematic supplier selection with defined criteria s for evaluation and re-evaluation is in place. 7.8 Information Technology Information technology processes support all kind of IMC processes and activities. The processes are closed linked to Intel s IT processes. For many activities processes and services are used from Intel. Level 1: Service Strategy Financial Portfolio Business Alignment Demand Enterprise Architecture Cross Functional Processes Service Design Service Level Service Catalog IT Security Supplier IT Service Continuity Software Asset & License Service Transition Project Execution Change (IT) Release & Deployment Asset & Configuration Knowledge Service Operation Incident Problem Request Fulfillment Access Intel Corp. IT IMC IT Shared * * limited to IMC service products Rev. 1.0, 30-Aug-2011 Public 19

20 Processes 7.9 QM Process The quality management processes support the other core and enabler processes to ensure effective measures are in place to guarantee high process and output quality. Level 1 and Level 2 processes are shown within this QM manual: Level 1: Quality Quality System Customer related Processes Design and Development Production and Service Provision Measurement, Analysis and Improvement Quality System Within the Quality System process different overall valid QM processes are described. Level 2: Quality System Document Control Allocation of Development Code Paper Archive Environmental Topics Rev. 1.0, 30-Aug-2011 Public 20

21 Processes Customer Related Processes Complaint / Service Quality IMC applies resources and tools to ensure the service quality over the lifetime of the products. Complaint : IMC performs analysis and problem solving on customer complaints where IMC s products were claimed to deviate from defined specifications. The customer will receive a report documenting the analysis plan, results and conclusion. As appropriate, a formal 8D report summarizing the detailed analysis results and actions taken will be published by IMC QM. Goals for response times are defined and used for standard complaints. In urgent cases the feedback time may be shortened to ensure the customer is timely informed of analysis findings and actions taken to minimize impact to customer in critical situations. In some cases, extensive analysis may require additional efforts and time and may surpass the response time target for completing the 8D analysis report, in such cases IMC will inform customer and provide intermediate updates as needed. IMC s Problem Solving Method is based on the 8D method. Details are defined within the respective business processes. Level 2: Customer related Processes Complaint Customer Audits Rev. 1.0, 30-Aug-2011 Public 21

22 Processes Design and Development For design and development support is given through two QM processes. Technical risk management is defined as QM process and built-in as proactive measure into the respective business processes. Technical risks are evaluated frequently throughout all phases of the development and documented in a Failure Mode and Effect Analysis (FMEA). Internal labs facilities have a clear defined scope, which includes capabilities to perform measurements. Necessary personal competences and procedures are defined. Appropriate ESD measures in place and regularly checked. Control of measuring equipment is clearly regulated in the process calibration. External Labs shall be accredited to ISO/IEC or national equivalent. Level 2: Design and Development FMEA Calibration Rev. 1.0, 30-Aug-2011 Public 22

23 Processes Production and Service Provision To support effective processes for production and service provision two processes are in place. These two effective business processes with our production partners ensure that products which do not conform to the requirements are identified, controlled and not delivered to the customer. Level 2: Production and Service Provision Change Excursion Rev. 1.0, 30-Aug-2011 Public 23

24 Terms Measurement, Analysis and Improvement Conformity of the product is shown through results from our production partners. The conformity of our Quality System is demonstrated through our internal assessment results which are regularly evaluated and used for the continuous improvement of the Quality System. Internal Audits and Assessments Internal auditing determines if requirements are met, evaluates processes and systems for effectiveness and efficiency, and identifies opportunities for continuous improvements. The IMC Internal Assessment Process is based on the ISO9001 requirements but also consider CMMI and ISO/EN IMC has qualified lead auditors responsible for the world wide internal audit program, audit plan, audit execution, result reporting and follow up. The results are used for the evaluation of the Quality System by the top management. Details defined within the respective business processes. Level 2: Measurement, Analysis and Improvement Internal Audits Continuous Improvement 8 Terms Terms are used according ISO 9001 and ISO 9000 (current editions). Rev. 1.0, 30-Aug-2011 Public 24