QUALITY MANUAL ISO/TS 16949: 2002 TG Copy No. Issued To Copy Status Current issue status Turbo Gears India Pvt. Limited B2/3, MIDC, Ranjangaon, Pune District – 412210, India. Phone: +91 2138 – 661600 Fax: +91 2138 – 661631 Website: www.gear-world.com Electronic Copy on Carraro Intranet is only updated Page 1 of 46 L 02 / 02.05.2008 ISO/TS 16949: 2002 QUALITY MANUAL Sl. No. 1 2 3 4 5 6 7 8 9 10 11 12 13 Document No. QMSM/01 QMSM/02 QMSM/03 QMSM/04 QMSM/05 QMSM/06 QMSM/07 QMSM/08 QMSM/09 QMSM/10 QMSM/11 QMSM/12 QMSM/13 Document No. Issue No./Date QMSM/01 02/02.05.08 00/02.05.08 1 of 1 Content Sheet Rev. No./Date Page No. Clause No. 4.2.2 5.3 5.4.1 5.5.1 4.2.2 4.0 5.0 6.0 7.0 8.0 - Document Description Content Sheet List of abbreviations Company Profile Scope and exclusions for QMS Quality Policy Quality Objectives Organization Structure Rev. No. 00 00 00 00 00 00 00 00 00 Number of page(s) 01 02 01 01 01 03 01 02 03 04 02 09 06 02 07 TG QMSM/14 QMSM/15 Prepared by M.R. 14 15 02/00/02.05.2008 New release for ISO/TS 16949:2002 Change Details Summary Issue / Rev. No/ Date Electronic Copy on Carraro Intranet is only updated Page 2 of 46 L Sequence and Interaction between processes - Generic diagram Quality Management System Requirement Management Responsibility Resource Management Product Realization Measurement, Analysis and Improvement List Of Processes Clause wise process mapping 00 00 00 00 00 00 Reviewed & Approved by C.O.O. ISO/TS 16949: 2002 QUALITY MANUAL Sl. No. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Abbreviation APQP B/D CA CAR CFT CP FMEA HOD HT I/C IATF Document No. Issue No./Date QMSM/02 02/02.05.08 00/02.05.08 1 of 2 List of abbreviations Rev. No./Date Page No. Abbreviation description Advanced Product Quality Planning Break Down Corrective action Corrective action report Cross Functional Team Control Plan Failure Mode and Effect analysis Head of department Heat Treatment In-charge TG IQA Internal Quality Audit M/C Machine MGT Management MMD MNT Maintenance MOM MR Minutes of Meeting Management Representative MRM Management Review Meeting MSA Measurement System Analysis NABL NC NCR OEE Non-Conformance Non-Conformance Report Overall Equipment Efficiency International Automotive Task Force Monitoring and Measuring Devices National Accredited Board for Inspection and Calibration Laboratory Electronic Copy on Carraro Intranet is only updated Page 3 of 46 L ISO/TS 16949: 2002 QUALITY MANUAL Sl. No. 25 26 27 28 29 30 31 32 33 34 35 36 37 38 40 41 Abbreviation OEM PA PAR PDCA PFD PM PO PPAP PPM QA QMSM R&A R/M Document No. Issue No./Date QMSM/02 02/02.05.08 00/02.05.08 2 of 2 List of abbreviations Rev. No./Date Page No. Abbreviation description Original Equipment Manufacturer Preventive Action Preventive Action report Plan-Do-Check-Act Process Flow Diagram Preventive Maintenance Purchase Order Production Part Approval Process Parts Per Million Quality Assurance 02/00/02.05.2008 Issue / Rev. No/ Date TG Responsibilities & Authorities Raw Material RPN WI Risk Priority Number Work Instruction TGL Turbo Gears India Private Limited Prepared by M.R. Quality Management System Manual New release for ISO/TS 16949:2002 Change Details Summary Electronic Copy on Carraro Intranet is only updated Page 4 of 46 L Reviewed & Approved by C.O.O. ISO/TS 16949: 2002 QUALITY MANUAL Company Profile Document No. Issue No./Date Rev. No./Date Page No. QMSM/03 02/02.05.08 00/02.05.08 1 of 1 Turbo Gears is a part of the Italian multinational group – Carraro, headquartered in Italy. All the plants specializing in manufacturing gear components and subassemblies have been merged into a new vertical called GearWorld. GearWorld has plants in Italy, North America, South America, China and India. Turbo Gears India Pvt. Ltd. specializes in the production of high technology gears and subassemblies and was started in Dec 2005. Besides supplying to the Carraro group plants, it also caters to the component requirements of major OEMs worldwide. The products go to customers in Agricultural, Construction equipment, Automotive, Industrial equipment and other specialized sectors. Some of the key customers are: Force Man Trucks, Cummins, Caterpillar, Turner, Waukesha Engines Dresser, Transform, Ingersoll Rand, JKM Daerim and Dynamatics Technology. Since inception of the plant, focus has been on introduction of new processes and technologies for gear manufacturing. Starting with conventional gear processes, the company soon established gear-grinding technology as a key growth driver for superior quality gears. The company has also invested into new technologies like gas-Nitriding, heavy duty broaching and Hobbing used in high-end applications. The plant is ISO 9000-2001 certified and has applied for the ISO-TS 16949 in 2008. Total Quality Management is the driving force behind implementation of these initiatives. Gears for wind energy sector is a new growth initiative. The plant has a total investment of 150 crores. With strength of approx. 350 employees in 2008, the plant is expected to achieve a turnover around Rs. 130 crores. 02/00/02.05.2008 Issue / Rev. No/ Date TG Prepared by M.R. New release for ISO/TS 16949:2002 Change Details Summary Electronic Copy on Carraro Intranet is only updated Page 5 of 46 L Reviewed & Approved by C.O.O. ISO/TS 16949: 2002 QUALITY MANUAL Scope & Exclusions for Quality Management System Document No. Issue No./Date Rev. No./Date Page No. QMSM/04 02/02.05.08 00/02.05.08 1 of 1 Scope: Manufacturing and Supply of Transmission Gears & Shafts. Scope of the elements / clauses of ISO / TS 16949: 2002 to Manufacture and Supply of Transmission Gears & Shafts have been defined in following chapters of this quality management system. Chapter No. QMSM/09 QMSM/10 QMSM/11 QMSM/12 QMSM/13 Chapter Description Quality Management System - Requirements Management Responsibility Resource Management Product Realization Measurement, Analysis and Improvement Exclusions: The following exclusions have been considered for TGL’s QMS. Sr. 1. 2. Clause No. 7.3.2.1 7.3.3.1 Clause Description Product Design Input 02/00/02.05.2008 Issue / Rev. No/ Date TG Product Design Output Prepared by M.R. New release for ISO/TS 16949:2002 Change Details Summary Electronic Copy on Carraro Intranet is only updated Page 6 of 46 L Reviewed & Approved by C.O.O. Justification for exclusion. All Design / Drawings are provided by the customer. TGL is designing only manufacturing processes and manufactures the products as per customer requirement. ISO/TS 16949: 2002 QUALITY MANUAL Quality Policy Document No. Issue No./Date Rev. No./Date Page No. QMSM/05 02/02.05.08 00/02.05.08 1 of 1 Quality is the backbone of all product & services offered by TGL in line with Carraro Group philosophy. We will strive to achieve market leadership in our field of manufacturing & supply of premium quality gear components, & subassemblies for off highway, automotive, globally. through development of robust processes of manufacturing, introduction of advanced technologies and implementation of effective Quality Management System leading to profitable growth of the company. We will build a strong capable team with emphasis on continual knowledge assimilation & skill enhancement. TG We will continually improve satisfaction of all stakeholders Electronic Copy on Carraro Intranet is only updated Page 7 of 46 L industrial and other applications, catering to customers Shashank Jauhri Chief Operating Officer ISO/TS 16949: 2002 QUALITY MANUAL Sr. Function Document No. Issue No./Date QMSM/06 02/02.05.08 00/02.05.08 1 of 3 Quality Objectives Rev. No./Date Page No. Process Management review Objective / Process measures ----Business Plan Achievement --------Repetitive NC Audit Plan Vs Actual COPQ U/M ----% --------Nos. % % Target – 2008 ----100% --------Zero 100% ------------30% 75% 75% 3,000 ----5 4,500 Zero 100% 100% 1 Top Management Business planning Control of documents Control of Records Internal audit Control of NC product Corrective action Preventive action TG Handling of enquiries Sales Customer satisfaction & analysis Monitoring of customer satisfaction based on objective data. Incoming Inspection Set up approval Final inspection QA Handling of customer complaints Control of MMD (Calibration) Layout inspection Continual improvement L ------------Hit Ratio Customer satisfaction level (Survey) Customer satisfaction Index (Objective Data) Supplier Rejection ----Customer complaints (max.) / Month Customer Rejection (max.) / Month Repetitive complaints Calibration Plan Vs Actual Plan Vs Actual 2. MR ------------% % % 3. PPM ----Nos. PPM Nos. % % 4. Electronic Copy on Carraro Intranet is only updated Page 8 of 46 ISO/TS 16949: 2002 QUALITY MANUAL Sr. Function Document No. Issue No./Date QMSM/06 02/02.05.08 00/02.05.08 2 of 3 Quality Objectives Rev. No./Date Page No. Process Product audit Objective / Process measures Plan Vs Actual Plan Vs Actual Plan Vs Actual Supplier Performance Inventory Sales U/M % % % % Turns Rs. Target – 2008 100% 100% 100% 95% 12 As per Business Plan 80% by Dec 08 15,000 90% 4. QA Process audit Supplier QMS Development Supplier planning & procurement 5 Logistics Production Planning Dispatch L Utilization Internal Rejection First time right samples ----Internal Rejection Internal Rejection Internal Rejection Training Plan Vs Actual Plan vs. actual 6. Production Manufacturing % PPM % 7. TG Purchase Supplier evaluation, selection, purchasing & reevaluation – Forging, Job work Supplier evaluation, selection, purchasing & reevaluation – consumables Carburizing Hardening Induction Hardening Nitriding Heat Treatment Training HR Employee motivation scheme ----PPM PPM PPM % % ----1,500 1,500 1,500 100% 100% 8. 9. Electronic Copy on Carraro Intranet is only updated Page 9 of 46 ISO/TS 16949: 2002 QUALITY MANUAL Sr. Function Document No. Issue No./Date QMSM/06 02/02.05.08 00/02.05.08 3 of 3 Quality Objectives Rev. No./Date Page No. Process Breakdown maintenance Objective / Process measures MTBF MTTR BD % PM Plan Vs Actual First time right samples --------- U/M Hrs Hrs % % % ----------------% Target – 2008 250 1.25 0.75% 100% 95% ----------------100% 10 Maintenance Preventive maintenance New product development 11 Manufacturing Engineering Control of external origins Change Management Tool Procurement 12 Tool Room Tool Stores Control Approach for deployment of quality objectives Status of achievement of quality objectives is reviewed in every management review meeting. 02/00/02.05.2008 New release for ISO/TS 16949:2002 Change Details Summary Issue / Rev. No/ Date TG Prepared by M.R. Tooling Maintenance 1. Targets at each function are decided based on business plan. 2. Management representative ensures that targets are documented. 3. Management Representative ensures that personnel concerned are aware of how they are contributing to achieve quality objectives. 4. Where targets are not defined, data will be monitored and targets will be set in the year 2009. Electronic Copy on Carraro Intranet is only updated Page 10 of 46 L --------Tooling Maintenance Plan vs. Actual Reviewed & Approved by C.O.O. ISO/TS 16949: 2002 QUALITY MANUAL Organization Structure Document No. Issue No./Date Rev. No./Date Page No. QMSM/07 02/02.05.08 00/02.05.08 1 of 1 COO SLS & CR PUR HR MFG QA & MR L MFG. ENGG MNT HT Change Details Summary Reviewed & Approved by C.O.O. LOG / SOTRES A/C & FINANCE 02/00/02.05.2008 Issue / Rev. No/ Date Prepared by M.R. TG New release for ISO/TS 16949:2002 Electronic Copy on Carraro Intranet is only updated Page 11 of 46 ISO/TS 16949: 2002 QUALITY MANUAL Sequence & Interaction between processes Document No. Issue No./Date Rev. No./Date Page No. QMSM/08 02/02.05.08 00/02.05.08 1 of 2 Sequence & Interaction between processes generic diagram: - Refer Page 2 of 2 of this section. 02/00/02.05.2008 Issue / Rev. No/ Date TG Prepared by M.R. New release for ISO/TS 16949:2002 Change Details Summary Electronic Copy on Carraro Intranet is only updated Page 12 of 46 L Reviewed & Approved by C.O.O. Issue No. : 02 / 02.05.2008 PROCESS INTERACTION DIAGRAM Doc No.: QMSM / 08 Rev. No. : 00 / 02.05.2008 Customer Handling of new enquiries Change Implementation NPD Business Planning Control of documents Control of external origins Control of records Training Motivation Continual Improvement Management Review Prod planning Tooling Procurement Tool stores control Tooling Maint. Supplier Evaluation, Selection, proceurement, reevaluation (Consumables) Calibration TG Stores control Incoming inspection Inprocess inspection B/D Maint, Preventive Maint. Inprocess inspection Final inspection Despatch Supplier Evaluation, Selection, proceurement, reevaluation (Forging / Job work) L Supplier QMS Devp Layout Inspection Control of NC Products Supplier Planning & Procurement Corrective Action Preventive Action Process Audit Product Audit Internal Audit Mfg. - soft Heat Treatmment Mfg - Hard Set up Approval Customer Satisfaction Handling of customer complaints Set up Approval Electronic Copy on Carraro Intranet is only updated Page 13 of 46 Page 2 of 2 ISO/TS 16949: 2002 QUALITY MANUAL Quality Management System - Requirements Document No. Issue No./Date Rev. No./Date Page No. QMSM/09 02/02.05.08 00/02.05.08 1 of 3 4.1 General Requirements: TGL has established, documented, implemented and maintained a quality management system and are continually improving its effectiveness in accordance with the requirements of ISO/TS 16949 International Standard. TGL has: a) Identified the processes needed for the quality management system and their application throughout the organization b) Determined the sequence and interaction of these processes as per section QMSM/08 of this manual. c) Established Criteria and methods needed to ensure that both the operations and controls of these processes are effective and are described under each section. e) Monitoring, measuring and analyzing these processes, as per section QMSM/13 These processes are managed by the TGL in accordance with the requirements of this International Standard. Outsourced processes: TGL is ensuring controls over processes (which are outsourced & which affect product conformity with respect to requirements) as per the list of approved suppliers (refer list of suppliers). 4.2 Documentation Requirements 4.2.1 General Quality management system documentation includes: a. b. c. d. TG f) Established process to implement actions necessary to achieve planned results and continual improvement of these processes. Documented statements of a quality policy as per section QMSM/05 Documented statement of Quality Objectives as per section QMSM/06 A quality management system manual Documented procedures required by ISO/TS 16949:2002 International Standard. (Refer Departmental Procedure Manual MR) e. Documents needed by the organization to ensure the effective planning, operation and control of its processes, such as, Electronic Copy on Carraro Intranet is only updated Page 14 of 46 L d) Ensured the availability of resources and information necessary to support the operations and monitoring of these processes. ISO/TS 16949: 2002 QUALITY MANUAL Quality Management System - Requirements Document No. Issue No./Date Rev. No./Date Page No. QMSM/09 02/02.05.08 00/02.05.08 2 of 3 Departmental Manual covers, Departmental Organization chart Responsibilities and authorities of all positions as per Organization Chart Procedures for the identified processes List of records with retention period Process Flow diagrams Control plans, Work Instructions, Drawings & lists Formats, Records, Customer required documents f. Records required by ISO / TS 16949:2002 International Standard. • Refer List of records documented in each departmental manual. 4.2.2 Quality Manual a) b) c) 4.2.3 Control of Documents Documents required by the quality management system are controlled as per procedure of control of documents (MR/P/01) and procedure of control of external origins (ME/P/02). 4.2.3.1 Engineering Specifications Process is established for timely review of the engineering specifications, distribution and implementation of all customer engineering standards / specifications and changes based on customer-required schedule. It is ensured that review is done within two working weeks. The records of the date on which each change is implemented in production, including updated documents are maintained in Production. Refer Procedure of change management (ME/P/03). 4.2.4 Control of Records Records are established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system as per procedure of control of records (MR/P/02). TG The scope of the quality management system, including details of and justification for any exclusions (QMSM/04) The documented procedures established for the quality management system. (QMSM/14) A description of the interaction between the processes of the quality management system (QMSM/08). Electronic Copy on Carraro Intranet is only updated Page 15 of 46 L TGL has established and maintained a quality manual that includes ISO/TS 16949: 2002 QUALITY MANUAL Quality Management System - Requirements Document No. Issue No./Date Rev. No./Date Page No. QMSM/09 02/02.05.08 00/02.05.08 3 of 3 4.2.4.1 Records Retention It is ensured that records satisfy regulatory and customer requirements. Refer list of quality records documented in each departmental manual. 02/00/02.05.2008 Issue / Rev. No/ Date TG Change Details Summary Prepared by M.R. New release for ISO/TS 16949:2002 Electronic Copy on Carraro Intranet is only updated Page 16 of 46 L Reviewed & Approved by C.O.O. ISO/TS 16949: 2002 QUALITY MANUAL Management Responsibility Document No. Issue No./Date Rev. No./Date Page No. QMSM/10 02/02.05.08 00/02.05.08 1 of 4 5.0 Management Responsibility 5.1 Management Commitment Management of TGL is committed for the development and implementation of the quality management system and also continually improving its effectiveness by a) Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements. b) Establishing the quality policy (QMSM/05) c) Ensuring that quality objectives are established, (QMSM/06) d) Conducting management reviews (MGT/P/01) e) Ensuring the availability of resources. 5.1.1 Process Efficiency 5.2 Customer Focus 5.3 Quality Policy COO ensures that the quality policy: a) Is appropriate to the purpose of the organization, b) Includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, c) Provides a framework for establishing and reviewing quality objectives, d) Is communicated and understood within the organization, and e) Is reviewed for continuing suitability. Refer QMSM/05 5.4 Planning 5.4.1 Quality Objectives COO ensures that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the organization. The quality objectives are measurable and are in consistent with the quality policy. Quality objectives are documented in QMSM/06. TG COO ensures that customer requirements are determined through customer satisfaction surveys and customer specific requirements are met with the aim of enhancing customer satisfaction. Electronic Copy on Carraro Intranet is only updated Page 17 of 46 L To assure the effectiveness and efficiency, COO reviews the product realization processes and support processes. ISO/TS 16949: 2002 QUALITY MANUAL Management Responsibility Document No. Issue No./Date Rev. No./Date Page No. QMSM/10 02/02.05.08 00/02.05.08 2 of 4 5.4.1.1 Quality Objectives and measurements are defined and included in business plan by COO. The Quality Objectives and measurements are used to deploy the quality policy. Refer Procedure of Business planning (MGT/P/02). 5.4.2 Quality Management System Planning COO ensures that a) The planning of the quality management system is carried out in order to meet the requirements given in QMSM/09 as well as the quality objectives, and b) Whenever changes to the quality management system are planned and implemented, the integrity of the quality management system is maintained. 5.5 Responsibility, authority and communication 5.5.1 Responsibility, Authority: Responsibilities and authorities are defined in respective departmental manual and are communicated within the organization. 5.5.1.1 Responsibility for quality: Products or processes, which do not conform to requirements, are promptly informed to the management with responsibility and authority for corrective action. Refer procedure of control of non-conforming products. (MR/P/04). Personnel responsible for product quality have authority to stop the production to correct quality problems and it is defined and documented in respective departmental manual. Production operations across all shifts are staffed with personnel in charge of, or delegated responsibility ensuring product quality. 5.5.2 Management Representative: Mr. Sanjay Kumar has been appointed as MR by COO, who has responsibility and authority for: a) Ensuring that processes needed for the quality management system are established, implemented and maintained, 5.5.2.1 Customer Representative: COO appoints customer representatives for selecting special characteristics, setting quality objectives and related trainings, informing corrective and preventive actions to customer and developing products. TG b) Reporting to COO on the performance of the quality management system and any need for improvement, c) Ensuring the promotion of awareness of customer requirements throughout the organization, and d) Liaison with external parties on matters relating to the quality management system Electronic Copy on Carraro Intranet is only updated Page 18 of 46 L ISO/TS 16949: 2002 QUALITY MANUAL Management Responsibility Document No. Issue No./Date Rev. No./Date Page No. QMSM/10 02/02.05.08 00/02.05.08 3 of 4 5.5.3 Internal Communication: For the effectiveness of quality management system, following internal communication system has been established. Sl. # 1. 2. 3. 4. Internal communication matter Status of achievement of quality objectives and process measures Quality Policy Quality Objectives. Responsibilities & authorities Mode of communication Display board, Review meetings, MRM Display Board, Training Departmental Manual, Quality Manual, Display Board Departmental Manual Resp. All HOD All HOD All HOD All HOD 5.6 Management Review 5.6.1 General: Management Review Committee reviews the quality management system once in 6 months as per procedure of management review meeting to ensure its continuing suitability, adequacy and effectiveness. This review includes assessing opportunities for improvement and need for changes to the quality management system, including the quality policy and quality objectives. Record of MRM is maintained by MR. Refer to procedure on management review (MGT/P/01). 5.6.2 Review Input: The input to Management review includes a) b) c) d) e) f) g) h) i) j) Follow-up actions from previous MRM Results of Audit Customer feed back/customer satisfaction Process performance and product conformity Status of corrective and preventive action Changes that could affect the quality management system Status of quality policy & objectives Status of cost of poor quality Recommendations for improvement. Analysis of actual and potential field failure and their impact on quality, safety or the environment. 5.6.3 Review Output: The output of Management review includes Any decisions and actions related to a) Improvement of the effectiveness of the QMS and its processes b) Improvement of product related to customer requirements and c) Resource needs. TG 5.6.1.1 Quality Management system performance: Cost of Poor quality and trends of performance of QMS is discussed in MRM. Electronic Copy on Carraro Intranet is only updated Page 19 of 46 L ISO/TS 16949: 2002 QUALITY MANUAL Management Responsibility Document No. Issue No./Date Rev. No./Date Page No. QMSM/10 02/02.05.08 00/02.05.08 4 of 4 02/00/02.05.2008 Issue / Rev. No/ Date Prepared by M.R. TG Change Details Summary New release for ISO/TS 16949:2002 Reviewed & Approved by C.O.O. Electronic Copy on Carraro Intranet is only updated Page 20 of 46 L ISO/TS 16949: 2002 QUALITY MANUAL Resource Management Document No. Issue No./Date Rev. No./Date Page No. QMSM/11 02/02.05.08 00/02.05.08 1 of 2 6.0 Resource Management 6.1 Provision of resources: HOD determines resources and discusses the same in budget review meeting. Management of TGL provides the resources needed: a) To implement and maintain the quality management systems and continually improve its effectiveness, and b) To enhance customer satisfaction by meeting customer requirements. 6.2 Human Resources 6.2.1 General: Personnel performing work affecting product quality are competent on the basis of appropriate education, training, skills and experience. Competence criteria are defined for each designation in Annexure C in HR Department. 6.2.2 Competence, awareness and training: The necessary competence for personnel performing work affecting product quality is determined through training need identification. Appropriate actions are taken to satisfy these needs as per procedure on training (HR/P/01). 6.2.2.1 Product Design Skills: Personnel with product design responsibility are competent to achieve design requirements and skilled applicable tools and techniques. Applicable tools and techniques are identified. 6.2.2.2 Training: Documented procedure is established and maintained for identifying training needs and achieving competence of all personnel performing activities affecting product quality. Refer procedure on training. (HR/P/01). Personnel performing assigned task are qualified, as required, with particular attention to the satisfaction of customer requirements. 6.2.2.3 Training on the job: On-the-job training for personnel in any new or modified job affecting product quality including contract or agency personnel is provided. Personnel whose work can affect quality are informed about the consequences to the customer of non-conformity to quality requirements. Refer procedure of training. (HR/P/01). 6.2.2.4 Employee motivation and empowerment: A process is established to motivate employees to achieve quality objectives, to make continual improvement and to create an environment to promote innovation. The process includes the promotion of quality and technological awareness throughout the whole organization. Refer procedure of employee motivation (HR/P/02). TG Records of education, training, skills and experience are maintained as per procedure on training. (HR/P/01). Electronic Copy on Carraro Intranet is only updated Page 21 of 46 L ISO/TS 16949: 2002 QUALITY MANUAL Resource Management Document No. Issue No./Date Rev. No./Date Page No. QMSM/11 02/02.05.08 00/02.05.08 2 of 2 The measurement of employee awareness of the relevance and importance of their activities and how they contribute to the achievement of quality objectives is being carried out in internal audit. 6.3 Infrastructure: TGL determines infrastructure needed to achieve conformity to product requirements at the time of new product development. If any new facility is required, it is discussed with management and management provides the facility to achieve the conformity of product requirement. All concerned departments maintain the facility provided by the management to achieve the conformity of product requirement. Maintenance of the machines is carried out as per point No. 7.5.1.4 of QMSM/12 of this manual. 6.3.1 Plant Facility and equipment Planning: Management of TGL has used a multidisciplinary approach for developing plant, facility and equipment plans. A plant layout has been made with optimized material travel; handling and value added use of floors space and has facilitated synchronous material flow. Methods are developed and implemented to evaluate and monitor the effectiveness of existing operations. 6.3.2 Contingency Plan: Company-wide contingency plans are prepared to satisfy customer requirements in the events of an emergency such as utility interruptions, labor shortages and key equipments failures and field returns. 6.4.1 Personnel safety to achieve product quality: Employee risk assessment is carried out at the time of new product development and monitoring is done in manufacturing processes. 6.4.2 Cleanliness of the premises: Premises are maintained in a state of order, cleanliness and repaired consistent in the product and manufacturing process needs. 02/00/02.05.2008 Issue / Rev. No/ Date Prepared by M.R. TG Change Details Summary 6.4 Work environment: TGL determines and is managing the work environment needed to achieve conformity to product requirements. New release for ISO/TS 16949:2002 Reviewed & Approved by C.O.O. Electronic Copy on Carraro Intranet is only updated Page 22 of 46 L ISO/TS 16949: 2002 QUALITY MANUAL Product Realization Document No. Issue No./Date Rev. No./Date Page No. QMSM/12 02/02.05.08 00/02.05.08 1 of 9 7.1 Planning of product realization TGL plans and develops the processes needed for product realization. It is ensured that planning of product realization is consistent with the other processes of quality management system. At the time of new product development planning, TGL determines, • Quality objectives and requirements for the product. • The need to establish processes, documents and provide resources specific to the product • Required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance. • Records needed to provide evidence that realization processes and resulting product meet requirements. 7.1.1 Planning of product realization Customer requirements and reference to its technical specification are included in the planning of product realization as a component of the quality plan / control plan. 7.1.2 Acceptance criteria 7.1.3 Confidentiality Confidentiality of customer contracted products and projects under developments and related products information is maintained across the organization. 7.1.4 Change Control Change Management Process is established to control and react to changes that impact product realization. The effects of any change, including those changes caused by any suppliers, are assessed and verification and validation activities are defined in APQP timing chart to ensure compliance with customer requirements. Changes are validated before implementation. Refer Procedure of Change management (ME/P/03). Impact on forms, fit and functions (including performance and /or durability) are reviewed with the customer for proprietary design, if required, so that all effects can be properly evaluated. When required by the customer, additional verification / identification requirements, such as those required for new product introduction are met. TG Acceptance criteria as “zero” defect is defined in sampling plan used for product acceptance. Electronic Copy on Carraro Intranet is only updated Page 23 of 46 L ISO/TS 16949: 2002 QUALITY MANUAL Product Realization Document No. Issue No./Date Rev. No./Date Page No. QMSM/12 02/02.05.08 00/02.05.08 2 of 9 7.2 Customer related processes 7.2.1 Determination of requirements related to the product Requirements related to the product are determined as per procedure of handling of enquiries. (SLS/P/01). 7.2.1.1 Customer designated special characteristics TGL documents special characteristics identified on customer drawings in TGL Drawing, FMEA, and Control Plan with symbols and control is exercised as per control plan. 7.2.2 Review of requirements related to the product Requirements related to the product is reviewed prior to the commitment to supply of a product to the customer as per procedure of new enquiry handling and procedure of handling of existing order. (SLS/P/01). 7.2.2.1 Review of requirements related to the product 7.2.2.2 Organization manufacturing feasibility The manufacturing feasibility of the proposed product is investigated, confirmed and documented in contract review process including risk analysis as per procedure of handling of new enquiry. (SLS/P/01). 7.2.3 Customer Communication TGL has determined and implemented effective arrangements, such as e.g. email, website, Fax / Phone etc.) for communicating with customers in relation to, a) Product information, b) Enquiries, contracts or order handling, including amendments, and c) Customer feedback, including customer complaints. At the time of new enquiry with new customer, TGL determines customer communication facility requirements and implements the same. 7.2.3.1 Customer communication TGL has the ability to communicate necessary information including data, in a customer-specified language and format. (e.g. computer aided design data, electronic data exchange). TG If formal review is not possible, requirement of review is waived with prior permission of customer authorization. Electronic Copy on Carraro Intranet is only updated Page 24 of 46 L ISO/TS 16949: 2002 QUALITY MANUAL Product Realization Document No. Issue No./Date Rev. No./Date Page No. QMSM/12 02/02.05.08 00/02.05.08 3 of 9 7.3 Design and development 7.3.1 Design and Development Planning TGL plans and controls the development of product as per procedure of new product development. (ME/P/01). 7.3.1.1 Multidisciplinary Approach Multidisciplinary approach is used for • Development / finalization and monitoring of special characteristics. • Development and review of FMEA, including actions to reduce potential risks • Development and review of control plans. 7.3.2 Design and Development Input CFT determines and maintains the inputs relating to product requirements as per procedure of new product development. (ME/P/01). 7.3.2.1 Product Design Input 7.3.2.2 Manufacturing process design input CFT identifies, documents and reviews the manufacturing inputs and records are maintained as per procedure of new product development. (ME/P/01). 7.3.2.3 Special Characteristics CFT identifies the special characteristics and includes in all control plans. Symbols are used in the control plan and FMEA, Drawings, Operator instructions. 7.3.3 Design and Development output Development output is verified against development input and approved prior to release. Refer procedure of new product development (ME/P/01). 7.3.3.1 Product Design output This clause is not applicable – Refer QMSM/05. 7.3.3.2 Manufacturing process design output Manufacturing design output is verified against manufacturing design input requirements as per procedure of new product development. (ME/P/01). TG This clause is not applicable – Refer QMSM/05. Electronic Copy on Carraro Intranet is only updated Page 25 of 46 L ISO/TS 16949: 2002 QUALITY MANUAL Product Realization Document No. Issue No./Date Rev. No./Date Page No. QMSM/12 02/02.05.08 00/02.05.08 4 of 9 7.3.4 Design Development Review At suitable stages, systematic review is performed in accordance with planed arrangements and records of review is maintained. 7.3.4.1 Monitoring Measurements, at specified stages of development, are carried out as per APQP Time Line Chart. Summary results are reported in MRM. 7.3.5 Design and Development verification Development verification is carried out to ensure that the development outputs have met the development input requirements. Records are maintained. 7.3.6 & 7.3.6.1 Design and Development validation Development validation is performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, when known. Wherever applicable, validation is completed prior to the delivery or implementation of the product. Records are maintained. Development validation is performed in accordance with customer requirements. 7.3.6.2 Prototype program As per customer request proto type programme is carried out. 7.3.6.3 Product Approval Process Product Approval procedure is followed as required by customer. PPAP manual is referred for Part Approval Processes. Product Approval process is applied to all suppliers. 7.4 Purchasing Head Purchase ensures that purchased product conforms to specified purchase requirements during development and before handling over to Logistics. Head Logistics ensures that purchased product conforms to specified purchase requirements for regular supplies. The type and extent of control applied to the supplier and the purchased product is dependent upon the effect of the purchased product on subsequent product realization or the final product. TG Electronic Copy on Carraro Intranet is only updated Page 26 of 46 L ISO/TS 16949: 2002 QUALITY MANUAL Product Realization Document No. Issue No./Date Rev. No./Date Page No. QMSM/12 02/02.05.08 00/02.05.08 5 of 9 Suppliers are evaluated and selected based on their ability to supply product in accordance with the TGL’s requirements. Criteria for selection, evaluation and re-evaluation are established in procedure of Supplier Evaluation, Selection and Re-evaluation. Records of the results of evaluations and any necessary actions arising from the evaluation are maintained as per Procedure of Supplier evaluation, selection, purchasing & re-evaluation – Forging, Job work (PUR/P/01), Procedure of Supplier evaluation, selection, purchasing & re-evaluation – consumable (PUR/P/02). 7.4.1.1 Regulatory Requirements It is ensured that all purchased products or material used in product is conform to applicable regulatory requirements. 7.4.1.2 Supplier Quality Management System Development 7.4.1.3 Customer Approved Sources Where specified by contract, customer approved suppliers are used for procurement. 7.4.2 Purchasing information Purchase orders / Works orders are released for the products to be purchased. Purchasing information includes as applicable – a. b. c. Requirement for approval of product, procedures, processes and equipment. Requirement for qualification of personnel, and Quality management system requirements. Head Purchase / Head Logistics, ensures adequacy of specified requirements prior to their communication to the supplier. Refer Procedure of Supplier evaluation, selection, purchasing & re-evaluation – Forging, Job work (PUR/P/01), Refer Procedure of Supplier evaluation, selection, purchasing & re-evaluation – consumable (PUR/P/02) Refer Procedure of Supplier planning & procurement (LOG/P/01). 7.4.3 Verification of purchased product Inspection and testing process is established and implemented for ensuring that purchased product meets specified purchase requirement. Refer procedure of incoming inspection. (QA/P/01). TG Electronic Copy on Carraro Intranet is only updated Page 27 of 46 L Supplier quality management system development is carried out as per procedure of supplier QMS Development (QA/P/09). ISO/TS 16949: 2002 QUALITY MANUAL Product Realization Document No. Issue No./Date Rev. No./Date Page No. QMSM/12 02/02.05.08 00/02.05.08 6 of 9 7.4.3.1 Incoming Product Quality Receipt inspection and / testing such as sampling based on performance is used to assure the quality of purchased product. 7.4.3.2 Supplier Monitoring Supplier performance is monitored as per work instruction of monitoring of supplier performance (LOG / WI / 01). 7.5 Production and service provision Production is planned and carried out in controlled conditions as per procedure of Production Planning (LOG/P/02), Manufacturing (PRD/P/01), Carburizing Hardening (HT/P/01), Induction Hardening (HT/P/02), Nitriding (HT/P/03). 7.5.1.1 Control Plan Control Plans are developed at the Pre-launch and Production stage that takes into account manufacturing Process FMEA. Customer approval is obtained after review or the updating of the control plan, if specified by the customer. 7.5.1.2 Work Instructions Documented work instructions are prepared for all employees having responsibilities for the operation of processes that impact product quality. These instructions are accessible for use at the workstations. These instructions are derived from the sources such as control plan, quality plan and product realization process. 7.5.1.3 Verification of Job Set ups Job set up is verified during initial run of a job, material change over or job change. Refer procedure of Set up approval (QA/P/02), Procedure of manufacturing (PRD/P/01). Work instructions are prepared and made available for set up personnel. Statistical methods of verification are used, where applicable. 7.5.1.4 Preventive and Predictive Maintenance Key Process equipments are identified and resources are provided for machines/equipments maintenance. Total Preventive Maintenance system including predictive maintenance is developed. Refer Procedure of breakdown maintenance (MNT/P/01), Procedure on preventive maintenance (MNT/P/02). Electronic Copy on Carraro Intranet is only updated Page 28 of 46 TG Control Plans are reviewed and updated when any change occurs affecting product, manufacturing Process, measurement, logistics, supply sources or FMEA. L ISO/TS 16949: 2002 QUALITY MANUAL Product Realization Document No. Issue No./Date Rev. No./Date Page No. QMSM/12 02/02.05.08 00/02.05.08 7 of 9 7.5.1.5 Management of Production Tooling Resources for Tool / gauge Design, fabrication and verification activities are provided. A System for Production tooling management is established and implemented. If any work is outsourced, related all activities are monitored. Refer Procedure of Tooling maintenance (TR/P/03)). 7.5.1.6 Production Scheduling Production is scheduled in order to meet customer requirements, such as just in time supported by information system that permits access to production information at key stages of the process and is order driven. Refer procedure of planning. (LOG/P/02). 7.5.1.7 Feedback of information from service Customer communication process is established and maintained regarding information on service concerns to manufacturing, engineering and design activities. When there is a service agreement with the customer, effectiveness of • Any organization service centers, • Any special purpose tools or measurement equipment and • The training of service personnel is verified. 7.5.2 & 7.5.2.1 Validation of Processes All manufacturing processes are validated to demonstrate the ability to achieve planned results. 7.5.3 Identification and traceability Products are identified by Bins, tags etc throughout product realization. The organization is identifying the product status with respect to monitoring and measurement requirements through bins, tags, segregation etc. 7.5.4 Customer property Enough care is taken with customer property while it is under the TGL’s control or being used by TGL. Customer property is identified, verified, protected and safeguarded where it is provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this is reported to the customer and records maintained in Logistics department. Electronic Copy on Carraro Intranet is only updated Page 29 of 46 TG 7.5.1.8 Service agreement with customer L ISO/TS 16949: 2002 QUALITY MANUAL Product Realization Document No. Issue No./Date Rev. No./Date Page No. QMSM/12 02/02.05.08 00/02.05.08 8 of 9 7.5.4.1 Customer –owned production tooling Customer –owned tools, manufacturing, test, inspection tooling and equipments are permanently marked so that the ownership of each item is visible, and can be determined. 7.5.5 Preservation of Product The conformity of product is preserved during internal processing and delivered to the intended destination. This preservation includes identification, handling, packaging, storage and protection. Preservation is also applied to the constituent parts of product. Refer procedure of stores control (LOG/P/03). 7.5.5.1 Storage and inventory Inventory management system is used to optimize inventory turns over time and assured stock rotation, such as first in first out (FIFO). Obsolete products are controlled in a similar manner to non-conforming products. TGL has determined the monitoring and measurement to be undertaken and the monitoring & measuring devices to provide evidence of conformity of product to determine requirements. TGL has established processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. Details are defined in control of monitoring and measuring devices. (QA/P/05). 7.6.1 Measurement system analysis Statistical studies are conducted to analyze the variation present in the results of each type of measuring and test equipment system. This requirement is applied to Measurement systems referenced in the control plan. The analytical methods and acceptance criteria are used, if approved by the customer. WI for MSA is referred. 7.6.2 Calibration / Verification Records Records of the calibration / verification activities for all gauges, measuring and test equipments, needed to provide evidence of conformity of product to determine requirements including employee and customer owned equipments are maintained. Refer procedure of control of monitoring and measuring devices. (QA/P/05). TG 7.6 Control of monitoring and measuring devices Electronic Copy on Carraro Intranet is only updated Page 30 of 46 L In order to detect deterioration, the condition of the products in stock, is assessed at appropriate intervals. ISO/TS 16949: 2002 QUALITY MANUAL Product Realization Document No. Issue No./Date Rev. No./Date Page No. QMSM/12 02/02.05.08 00/02.05.08 9 of 9 7.6.3 Laboratory Requirements 7.6.3.1 Internal Laboratory Scope of laboratory including its capability to perform the required inspection, test or calibration services is defined. Laboratory scope is included in the QMS documentation. Following requirements are specified and implemented • Adequacy of the laboratory procedures. • Competency of the laboratory personnel. • Testing of the products. • Capability to perform these services correctly, traceable to the relevant process standards and • Review of the related records. 02/00/02.05.2008 Issue / Rev. No/ Date Prepared by M.R. TG Change Details Summary External laboratory facilities used for inspection, test or calibration services by TGL is ensured to have a defined laboratory scope including the capability to perform the required inspection, test or calibration and either • There is evidence that the external laboratory is acceptable to the customer. • The laboratory is accredited to ISO/IEC – 17025 or national equivalent. New release for ISO/TS 16949:2002 Reviewed & Approved by C.O.O. Electronic Copy on Carraro Intranet is only updated Page 31 of 46 L 7.6.3.2 External Laboratories ISO/TS 16949: 2002 QUALITY MANUAL Measurement, Analysis & Improvement Document No. Issue No./Date Rev. No./Date Page No. QMSM/13 02/02.05.08 00/02.05.08 1 of 6 8.1 General: TGL has planned and implemented the monitoring, measurement, analysis and improvement processes needed: To demonstrate conformity of the product, To ensure conformity of the quality management system, and To continually improve the effectiveness of the quality management system. This includes the determination of applicable methods, including statistical techniques, and extent of their use. 8.1.1 Identification of Statistical tools: Appropriate statistical tools for each process are determined during Advanced Product Quality Planning and included in control plans. 8.1.2 Knowledge of basic statistical concepts: Basic statistical concepts, such as, variation, control (stability), process capability, over adjustment is understood and utilized throughout the organization. 8.2 Monitoring and measurement 8.2.1 Customer Satisfaction 8.2.1.1 Customer Satisfaction Customer satisfaction is monitored through continual evaluation of performance of the realization process. Performance indicators are based on objective data and includes but are not limited to Delivered part quality performance Customer disruption including field returns Delivery schedule performance (including incidence of premium freight), and Customer notification related to quality or delivery issues The performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and efficiency of the process is monitored. Refer Procedure of monitoring of customer satisfaction based on objective data (SLS/P/03). 8.2.2 Internal Audit Internal audits are conducted six monthly to determine whether the quality management system Conforms to the planned arrangements, to the requirements of this international standard and to the quality management system requirements established by the organization, and Is effectively implemented and maintained. Electronic Copy on Carraro Intranet is only updated Page 32 of 46 TG As one of the measurements of the performance of the quality management system, TGL is monitoring information relating to customer perception as to whether TGL has met customer requirements. The methods for obtaining and using this information have been determined as per procedure of customer satisfaction and its analysis (SLS/P/02). L ISO/TS 16949: 2002 QUALITY MANUAL Measurement, Analysis & Improvement Document No. Issue No./Date Rev. No./Date Page No. QMSM/13 02/02.05.08 00/02.05.08 2 of 6 An audit program is planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits, The audit criteria, scope, frequency and methods are defined in Annual Audit Plan. Selection of auditors and conduct of audits ensures objectivity and impartiality of the audit process. It is ensured that auditors are not auditing their own work. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records has been defined in a documented procedure of internal audit (MR/P/03). The management responsible for the area being audited ensures that actions are taken without undue delay to eliminate detected non-conformities and their causes. Follow-up activities include the verification of the actions taken and the reporting of verification results. 8.2.2.1 QMS Audit QMS is audited to verify the compliance with this Technical specification and any additional QMS requirements. 8.2.2.2 Manufacturing Process Audit 8.2.2.3 Product Audit Products are audited at all stages of production and delivery to verify conformity to all specified requirements such as product dimensions, functionality, packaging and labeling as per plan as per procedure of product audit. (QA/P/08). 8.2.2.4 Internal Audit Plans Internal quality audit is scheduled according to an annual plan and covers all QMS processes, activities. Internal quality audit is carried out in all working shifts. When internal / external nonconformities or customer complaints occurs, the audit frequency is appropriately increased. Refer procedure of internal audit. (MR/P/03). 8.2.2.5 Internal Auditor Qualification Internal Auditor training has been given to all auditors. Qualified auditors carry out internal quality audit. TG Manufacturing process audit is conducted as per plan to determine its effectiveness as per procedure of process audit. (QA/P/07). Electronic Copy on Carraro Intranet is only updated Page 33 of 46 L ISO/TS 16949: 2002 QUALITY MANUAL Measurement, Analysis & Improvement Document No. Issue No./Date Rev. No./Date Page No. QMSM/13 02/02.05.08 00/02.05.08 3 of 6 8.2.3 Monitoring and measurement of processes Management system processes are monitored and measured. These methods demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action are taken, as appropriate, to ensure conformity of the product. 8.2.3.1 Monitoring and measurement of manufacturing processes Process studies are performed on all new manufacturing (including assembly or sequencing) processes to verify process capability and to provide additional input for process control. The results of process studies are documented with specification, where applicable, for means of production, measurement and test and maintenance and instructions. These documents include objectives for manufacturing process capabilities, reliability, maintainability and availability, as well as acceptance criteria. Significant process events, such as tool change or machine repair are recorded on control charts. Reaction plan is initiated from the control plan for characteristics that are either not statistically capable or are unstable. These reaction plans include containment of product and 100 % inspection as appropriate. A corrective action plan is then completed indicating specific timing and assigned responsibilities to assure that the process become stable and capable. The plans are reviewed with and approved by customer, when so required. Records of effective date of process changes are maintained by production. Refer Procedure of change management (ME/P/03). 8.2.4 Monitoring and measurement of product TGL is monitoring and measuring the characteristics of the product to verify that product requirements have been met. This is carried out at appropriate stages of the product realization process in accordance with the planned arrangements as per procedure on incoming inspection (QA / P / 01), Manufacturing (PRD/P/01) & Final Inspection (QA / P / 03). TG Measurement techniques Sampling plans Acceptance criteria Reaction plan, when acceptance criteria are not met. Electronic Copy on Carraro Intranet is only updated Page 34 of 46 L Manufacturing process capability or performance as specified by customer part approval process requirements are maintained. Process Flow diagram and control plan are implemented including ISO/TS 16949: 2002 QUALITY MANUAL Measurement, Analysis & Improvement Document No. Issue No./Date Rev. No./Date Page No. QMSM/13 02/02.05.08 00/02.05.08 4 of 6 8.2.4.1 Layout inspection and function testing Layout inspection and functional verification are carried out to applicable customer engineering material and performance standards for each product as specified in the control plan/ design record. Results are made available for customer review. Refer procedure of layout inspection. (QA/P/06). 8.2.4.2 Appearance items Manufacturing parts, designated by the customer as “Appearance Items”, the provision is made for Appropriate resources including lighting for evaluation Masters for color, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), as appropriate Maintenance and control of appearance masters and evaluation equipments & Verification that personnel making appearance evaluations are competent and qualified to do so. 8.3 Control of Nonconforming Product 8.3.1 Control of Nonconforming Products Product with unidentified or suspect status is classified as non-conforming product. 8.3.2 Control of Reworked product Work instructions are prepared for rework including re-inspection requirements. These are accessible and are utilized by the appropriate personnel as procedure of control of NC products. (MR/P/04). 8.3.3 Customer Information Customers are informed promptly in the events that nonconforming product is shipped (delivered) and recorded in customer communication register. 8.3.4 Customer Waiver Customer concession or deviation permits are obtained prior to further processing whenever the product or manufacturing process is different from that which is currently approved. TG Product, which does not conform to product requirements, is identified and controlled to prevent its unintended use or delivery. The control and related responsibilities and authorities for dealing with nonconforming product are being defined in a documented procedure of control of NC products. (MR/P/04). Electronic Copy on Carraro Intranet is only updated Page 35 of 46 L ISO/TS 16949: 2002 QUALITY MANUAL Measurement, Analysis & Improvement Document No. Issue No./Date Rev. No./Date Page No. QMSM/13 02/02.05.08 00/02.05.08 5 of 6 Records of quantity authorization and expiration of authorization are maintained by QA department. Sales department ensures compliance with the original or superseding specifications requirements when the authorization expires. Material shipped / delivered on an authorization is promptly identified on each shipping container. 8.4 Analysis of data TGL determines, collects and analyses appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This includes the data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data provides information relating to a) Customer satisfaction b) Conformity to product requirements c) Characteristics and trends of processes and product including opportunities of preventive action, and suppliers 8.4.1 Analysis and use of data 8.5.1 Continual Improvement TGL is continually improving the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. Continual improvement projects are identified and monitored. Refer procedure of continual improvement (MR/P/07). 8.5.1.2 Manufacturing Process improvement Manufacturing process improvements are continually focused upon control and reduction of variation in product characteristics and manufacturing process parameters. TG Trends in quality and operational performance are compared with progress towards objects and lead to action to support the following Development of priorities for prompt solutions to customer related problems Determination of key customers – related trends and correlation for status review, decision-making and longer term planning. An information system for the timely reporting of the product information arising from usage. Electronic Copy on Carraro Intranet is only updated Page 36 of 46 L ISO/TS 16949: 2002 QUALITY MANUAL 8.5.2 Corrective action Document No. Issue No./Date Rev. No./Date Page No. QMSM/13 02/02.05.08 00/02.05.08 6 of 6 Measurement, Analysis & Improvement Corrective actions are taken to eliminate the causes of detected non-conformities as per procedure of corrective action. (MR/P/05). 8.5.2.1 Problem Solving Problem solving process (8D) is established to find out the root cause identification and elimination of causes. Refer procedure of corrective action. (MR/P/05). 8.5.2.2 Error proofing Wherever possible, error-proofing methods are used in corrective action process. 8.5.2.3 Corrective action impact Corrective action and controls are implemented to eliminate the cause of a nonconformity and the same is applied to similar process and/or products. 8.5.2.4 Rejected product test / analysis 8.5.3 Preventive action Preventive actions are taken to eliminate the cases of all possible potential non-conformities as per procedure of preventive action. (MR/P/06). 02/00/02.05.2008 Issue / Rev. No/ Date Prepared by M.R. TG Change Details Summary Parts rejected by the customer’s manufacturing plants, engineering facilities and dealerships are analyzed. The cycle time of this process are minimized. Records of these analyses are kept and made available upon request. Corrective actions are analyzed and initiated to prevent recurrence as per procedure of corrective action. (MR/P/05). New release for ISO/TS 16949:2002 Reviewed & Approved by C.O.O. Electronic Copy on Carraro Intranet is only updated Page 37 of 46 L ISO/TS 16949: 2002 QUALITY MANUAL Sr. No. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 17 19 21 16 18 20 22 23 24 Document No. Issue No./Date QMSM/14 02/02.05.08 00/02.05.08 1 of 2 List of Processes Rev. No./Date Page No. Process Description Management review Business planning Control of documents Control of Records Internal audit Control of NC product Corrective action Preventive action Continual improvement Handling of new enquiries Customer satisfaction & analysis Monitoring of customer satisfaction based on objective data Incoming Inspection Set up approval & in-process inspection Final inspection Handling of customer complaints Procedure No. MGT / P / 01 MGT / P / 02 MR / P / 01 MR / P / 02 MR / P / 03 MR / P / 04 MR / P / 05 MR / P / 06 MR / P / 07 SLS / P / 01 Function Top Management MR L SLS / P / 02 SLS / P / 03 QA / P / 01 QA / P / 02 QA / P / 03 QA / P / 04 QA / P / 05 QA / P / 06 QA / P / 07 QA / P / 08 QA / P / 09 LOG / P / 01 LOG / P / 02 LOG / P / 03 LOG / P / 04 PRD / P / 01 PUR / P / 01 PUR / P / 02 PUR / P / 03 Sales TG Control of MMD (Calibration) Layout inspection Process audit Product audit Supplier QMS Development Production Planning Stores Control Dispatch Supplier planning & procurement Manufacturing Supplier evaluation, selection, purchasing & reevaluation – Forging, Job work Supplier evaluation, selection, purchasing & reevaluation – consumables Purchasing Process QA Logistics 25 27 28 26 Production Purchase 29 Electronic Copy on Carraro Intranet is only updated Page 38 of 46 ISO/TS 16949: 2002 QUALITY MANUAL Sr. No. 30 31 32 33 34 35 36 37 38 39 40 41 42 Document No. Issue No./Date QMSM/14 02/02.05.08 00/02.05.08 2 of 2 List of Processes Rev. No./Date Page No. Process Description Carburizing Hardening Induction Hardening Nitriding Training Employee motivation Breakdown maintenance Preventive maintenance New product development Control of external origins Change Management Tool Procurement Tool Stores Control Jigs & Fixture Management Procedure No. HT / P / 01 HT / P / 02 HT / P / 03 HR / P / 01 HR / P / 02 MNT / P / 01 MNT / P / 02 ME / P / 01 ME / P / 02 Function Heat Treatment HR Maintenance ME L TR / P / 01 TR / P / 03 TR / P / 02 ME / P / 03 Tool Room 02/00/02.05.2008 Issue / Rev. No/ Date Prepared by M.R. TG Change Details Summary New release for ISO/TS 16949:2002 Reviewed & Approved by C.O.O. Electronic Copy on Carraro Intranet is only updated Page 39 of 46 ISO/TS 16949: 2002 QUALITY MANUAL Clause No. 4.1 4.1.1 4.2.1 4.2.2 4.2.3 Document No. Issue No./Date Rev. No./Date Page No. QMSM/15 02/02.05.08 00/02.05.08 1 of 7 Clause-wise process mapping Requirement QM Ref. QMSM/09 QMSM/09 QMSM/09 QMSM/09 QMSM/09 Process Ref. MR/P/01 ME/P/02 Any other Ref. - 4.2.3.1 4.2.4 4.2.4.1 5.1 5.1.1 5.2 5.3 TG QMSM/10 QMSM/10 Quality Policy Defining measurable quality objectives at relevant function Defining quality objectives in business plan QMS Planning Defining responsibilities and authorities Responsibility for quality Management Representative Customer Representative Internal communication process Planned interval of management review. Conducting management review and maintaining records of the same Review of QMS performance Management Review inputs QMSM/05, QMSM/10, QMSM/06 QMSM/10, QMSM/10 QMSM/10 QMSM/10 QMSM/10 QMSM/10 QMSM/10 QMSM/10 QMSM/10 QMSM/10 QMSM/10 Establishment, Documentation, implementation and maintaining QMS Controls over outsourced processes Documentation requirement Quality Manual Procedure of control of documents. Controls over external origins Process to assure timely review, distribution and implementation of engineering specifications. Maintaining records of implementation of engineering changes Procedure of control of records Records shall satisfy regulatory and customer requirements for its retention Evidences of management commitment Review of product realization process to assure their effectiveness Ensuring determination and implementation of customer requirements QMSM/09 ME/P/03 - L QMSM/09 MR/P/02 QMSM/09 QMSM/10 MR/P/02 MGT/P/02 MR/P/01 MGT/P/01 MGT/P/01 MGT/P/01 List of records Business Plan Responsibilities / Authorities MR/RA/01 SLS/RA/01 MRM Agenda, Minutes of MRM MRM Agenda MRM Agenda 5.4.1 5.4.1.1 5.4.2 5.5.1 5.5.1.1 5.5.2 5.5.2.1 5.5.3 5.6.1 5.6.1.1 5.6.2 Electronic Copy on Carraro Intranet is only updated Page 40 of 46 ISO/TS 16949: 2002 QUALITY MANUAL Clause No. 5.6.2.1 5.6.3 6.1 6.2.1 Document No. Issue No./Date Rev. No./Date Page No. QMSM/15 02/02.05.08 00/02.05.08 2 of 7 Clause-wise process mapping Requirement QM Ref. QMSM/10 QMSM/10 QMSM/11 QMSM/11 Process Ref. MGT/P/01 MGT/P/01 - Any other Ref. MRM Agenda MOM Competence criteria 6.2.2 6.2.2.1 6.2.2.2 6.2.2.3 6.2.2.4 6.3 6.3.1 6.3.2 6.4 6.4.1 6.4.2 7.1 7.1.1 7.1.2 7.1.3 7.1.4 7.2.1 “Analysis of actual and potential field failures and their and impact on quality, safety and environment” as input to management review Management review output Provision of resources Performing work affecting product quality by competent personnel Determination of required competency, taking appropriate actions and maintaining records of education, experience, training and skills Competency to achieve product design / development skills Procedure on training On the job training for the personnel in any new or modified jobs including contract labor. Employee motivation and empowerment Determination, providing and maintaining infrastructure Plant, Facility and equipment planning Contingency Plan Determination and managing of work environment Employee risk assessment in design & development and manufacturing process. Maintaining cleanliness of premises Planning of product realization Addressing of customer requirement and its technical reference in Control plan or quality plan Acceptance criteria Confidentiality Validation of changes before implementation. Determination of requirement related to product requirement QMSM/11 HR/P/01 HR/LOR L QMSM/11 QMSM/11 HR/P/01 QMSM/11 QMSM/11 QMSM/11 QMSM 12 HR/P/01 HR/P/02 MNT/P/01 MNT/P/02 ME/P/01 ME/P/01 ME/P/01 ME/P/03 SLS/P/01 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 HR/LOR - TG Contingency plan Employee risk assessment ECN ME/F/01, SLS/F/03, Customer PO Electronic Copy on Carraro Intranet is only updated Page 41 of 46 ISO/TS 16949: 2002 QUALITY MANUAL Clause No. 7.2.1.1 7.2.2 7.2.2.1 7.2.2.2 7.2.3 7.2.3.1 7.3.1 7.3.1.1 7.3.2 Document No. Issue No./Date Rev. No./Date Page No. QMSM/15 02/02.05.08 00/02.05.08 3 of 7 Clause-wise process mapping Requirement Demonstration of conformity to customer requirements for designation, documentation and control of special characteristics Review of requirements related to product and maintaining its records. Customer authorization to waive to review the requirements related to the product Conducting feasibility including risk analysis Determination and implementation of communication processes as required to customer Ability to communicate information to customer in their specified language and formats Design and development planning Use of multidisciplinary approach Determination of design and development inputs and maintaining its record Identification, documentation and review of product design inputs Identification, documentation and review of manufacturing design inputs Defining special characteristics in FMEA, CP and use of symbols QM Ref. QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 Process Ref. ME/P/01 SLS/P/01 SLS/P/01 SLS/P/01 - Any other Ref. List of special characteristics SLS/F/03 ME/F/01 - TG QMSM/12 QMSM/12, QMSM/11 QMSM/12 QMSM/12 Design and development outputs QMSM/12 Product Design outputs QMSM/14, QMSM/12 QMSM/12 QMSM/12 QMSM/12 Manufacturing process design output Design and development review and its record Measurements at specified stages of design and development and reporting summary results to management review L QMSM/12 QMSM/12 ME/P/01 ME/P/01 ME/P/01 ME/P/01 ME/P/01 ME/P/01 ME/P/01 ME/P/01 ME/P/01 Mfg. Process design input Mfg. Process design input FMEA, Control Plan, List of Special Characteristics Quality Planning Sign off Quality Planning Sign off MOM MOM 7.3.2.1 7.3.2.2 7.3.2.3 7.3.3 7.3.1.1 7.3.3.2 7.3.4 7.3.4.1 Electronic Copy on Carraro Intranet is only updated Page 42 of 46 ISO/TS 16949: 2002 QUALITY MANUAL Clause No. 7.3.5 7.3.6 Document No. Issue No./Date Rev. No./Date Page No. QMSM/15 02/02.05.08 00/02.05.08 4 of 7 Clause-wise process mapping Requirement QM Ref. QMSM/12 QMSM/12 Process Ref. ME/P/01 ME/P/01 Any other Ref. MOM MOM 7.3.6.1 7.3.6.2 7.3.6.3 7.3.7 7.4.1 7.4.1.1 7.4.1.2 Design and development verification in accordance with planed arrangement and its record Design and development validation in accordance with planed arrangement and its record Performing design and development validation in accordance with customer requirement and program timing. Prototype programming as required to customer. Product approval processes Identification of design and development changes and maintaining its record. Selection and evaluation of suppliers. Maintaining records of evaluation. Conformity of regulatory requirement to all purchased products / material QMSM/12 QMSM/12 QMSM/12 ME/P/01 ME/P/01 ME/P/01, PUR/P/03 ME/P/01 PPAP ECN L QMSM/12 QMSM/12 PUR/P/01 QMSM/12 PUR/P/03 QA/P/09 PUR/P/01 PUR/P/03, 02 QA/P/01 QA/P/01 LOG/P/01 PRD/P/01 ME/P/01, QA/P/04 PRD/P/01, QA/P/02 MNT/P/01, MNT/P/02 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12, 11 QMSM/12 PUR/F/01, PUR/F/06, PUR/F/05 Purchase Order QMS Audit, Audit Plan Purchase Orders Purchase Orders QA/F/01 WI for monitoring supplier performance Production plan, production report QA/F/03 PM Plan - 7.4.1.3 7.4.2 7.4.3 7.4.3.1 7.4.3.2 7.5.1 7.5.1.1 7.5.1.2 7.5.1.3 7.5.1.4 7.5.1.8 TG Supplier QMS development Use of customer approved sources, where specified by customer. Providing purchasing information Establishment and implementation of process for verification of purchased product Methods to use for ensuring incoming product quality Monitoring of supplier performance Planning and carrying out production in controlled condition. Control Plan and its review Work Instruction Verification of job set-ups and last piece Preventive and predictive maintenance Service agreement with customer Electronic Copy on Carraro Intranet is only updated Page 43 of 46 ISO/TS 16949: 2002 QUALITY MANUAL Clause No. 7.5.1.5 7.5.1.6 7.5.1.7 7.5.2 7.5.2.1 7.5.3 7.5.4 7.5.5 7.5.5.1 7.6 7.6.1 Document No. Issue No./Date Rev. No./Date Page No. QMSM/15 02/02.05.08 00/02.05.08 5 of 7 Clause-wise process mapping Requirement QM Ref. QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 QMSM/12 Process Ref. TR/P/01, 02, 03 LOG/P/02 HT/P/01, 02, 03 LOG/P/03 LOG/P/03 QA/P/05 Any other Ref. Production plan Tag Tag QA/F/07 MSA Results QA/F/07 Lab Scope SLS/F/04 MR/F/04, 05, 06, 07 7.6.2 7.6.3.1 7.6.3.2 8.1 8.1.1 8.2.1 8.2.1.1 8.2.2 8.2.2.1 8.2.2.2 8.2.3 Management of production tooling Production scheduling in customer order driven Feedback of information from service Validation of processes and its record Validation of all processes Appropriate identification and traceability to products and its record Taking care of customer property and maintaining its record Preserving the conformity of product during internal processing &delivery to the intended destiny. Assessment of material condition in stock and following FIFO. Control of monitoring and measuring devices and maintaining its record Conducting applicable statistical studies on measurement system Calibration results Internal laboratory and its scope NABL or ISO/IEC 17025 accredited external laboratories Planning and implementation of monitoring, measurement, analysis and improvement processes Identification of statistical concepts Customer Satisfaction to understand their perception Customer satisfaction based on objective data Conducting internal audits at planned interval. Procedure of internal audit. Maintaining records of audit results Conducting audits to verify compliance with this technical specification and any additional QMS requirement. Conducting audit at each manufacturing process Monitoring and measurement of processes TG QMSM/12 QMSM/12 QMSM/12 QMSM/13 QMSM/13 QMSM/13 QMSM/13 QMSM/13 QMSM/13 QMSM/13 QMSM/13 L QMSM/12 QMSM/12 ME/P/01 QA/P/05 SLS/P/02 SLS/P/03 MR/P/03 QA/P/08 - QA/F/30 - Electronic Copy on Carraro Intranet is only updated Page 44 of 46 ISO/TS 16949: 2002 QUALITY MANUAL Clause No. 8.2.2.3 8.2.2.4 8.2.2.5 8.2.3.1 Document No. Issue No./Date Rev. No./Date Page No. QMSM/15 02/02.05.08 00/02.05.08 6 of 7 Clause-wise process mapping Requirement QM Ref. QMSM/13 QMSM/13 QMSM/13 QMSM/13 Process Ref. QA/P/07 MR/P/03 MR/P/03 ME/P/03 Any other Ref. QA/F/29 MR/F/05 List of auditors Process Change Record QA/F/03, 04, 05, 25 QA/F/31 - 8.2.4 8.2.4.1 8.2.4.2 8.3 8.3.1 8.3.3 8.3.4 8.4 8.4.1 8.5.1 8.5.1.1 8.5.1.2 8.5.2 8.5.2.1 8.5.2.2 8.5.2.3 8.5.3 Conducting product audit at appropriate stages of product realization Conducting internal audits in all working shifts. Internal auditors qualification Monitoring and measurement of manufacturing processes. Maintaining records of process changes Monitoring and measurement of products. Maintaining records of inspection results Layout Inspection and functional testing Appearance item Procedure of control of NC Products. Maintaining records of actions of NC products. Classification of suspect product as NC products Information to customer in case of shipment of NC products to customer. Customer waiver and its record Analysis of data Comparison of trends of data against target Continual improvements Defining process for continual improvement Manufacturing process improvement Procedure of corrective action. Records of corrective action. Use of problem solving technique in corrective action process. Use of error proofing methods in their corrective action process. Analysis of customer rejected parts and maintaining its record Procedure of preventive action. Records of preventive action QMSM/13 QMSM/13 QA/P/01, 02, 03 QA/P/04 - TG QMSM/13 QMSM/13 QMSM/13 QMSM/13 QMSM/13 QMSM/13 QMSM/13 QMSM/13 QMSM/13 QMSM/13 QMSM/13 QMSM/13 QMSM/13 L QMSM/13 QMSM/13 MR/P/04 MR/P/04 MR/P/04 MR/P/04 MR/P/07 MR/P/07 MR/P/07 MR/P/05 MR/P/05 MR/P/05 MR/P/05 MR/P/06 Rework inspection report QA/F/06 QA/F/06 QA/F/06 QA/F/06 FMEA Electronic Copy on Carraro Intranet is only updated Page 45 of 46 ISO/TS 16949: 2002 QUALITY MANUAL Clause-wise process mapping Document No. Issue No./Date Rev. No./Date Page No. QMSM/15 02/02.05.08 00/02.05.08 7 of 7 02/00/02.05.2008 Issue / Rev. No/ Date Prepared by M.R. TG Change Details Summary New release for ISO/TS 16949:2002 Reviewed & Approved by C.O.O. Electronic Copy on Carraro Intranet is only updated Page 46 of 46 L