Quality Manual - Stamped

TGL

QUALITY MANUAL

ISO/TS 16949: 2002

Current issue status 02 / 02.05.2008

Copy No.

Issued To

Copy 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

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ISO/TS 16949: 2002 Document No. QMSM/01 Issue No./Date 02/02.05.08

Rev. No./Date 00/02.05.08 QUALITY MANUAL

Content Sheet Page No. 1 of 1

Sl. No. Document No. Clause No. Document Description Rev. No.

Number of page(s)

1 QMSM/01 - Content Sheet 00 01

2 QMSM/02 - List of abbreviations 00 02

3 QMSM/03 - Company Profile 00 01

4 QMSM/04 4.2.2 Scope and exclusions for QMS 00 01

5 QMSM/05 5.3 Quality Policy 00 01

6 QMSM/06 5.4.1 Quality Objectives 00 03

7 QMSM/07 5.5.1 Organization Structure 00 01

8 QMSM/08 4.2.2 Sequence and Interaction between processes - Generic diagram

00 02

9 QMSM/09 4.0 Quality Management System - Requirement 00 03

10 QMSM/10 5.0 Management Responsibility 00 04

11 QMSM/11 6.0 Resource Management 00 02

12 QMSM/12 7.0 Product Realization 00 09

13 QMSM/13 8.0 Measurement, Analysis and Improvement 00 06

14 QMSM/14 - List Of Processes 00 02

15 QMSM/15 - Clause wise process mapping 00 07

02/00/02.05.2008 New release for ISO/TS 16949:2002

Issue / Rev. No/ Date Change Details Summary

Prepared by M.R. Reviewed & Approved by C.O.O.


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ISO/TS 16949: 2002 Document No. QMSM/02

Issue No./Date 02/02.05.08


List of abbreviations Page No. 1 of 2

Sl. No. Abbreviation Abbreviation description

1 APQP Advanced Product Quality Planning

2 B/D Break Down

3 CA Corrective action

4 CAR Corrective action report

5 CFT Cross Functional Team

6 CP Control Plan

7 FMEA Failure Mode and Effect analysis

8 HOD Head of department

9 HT Heat Treatment

10 I/C In-charge

11 IATF International Automotive Task Force

12 IQA Internal Quality Audit

13 M/C Machine

14 MGT Management

15 MMD Monitoring and Measuring Devices

16 MNT Maintenance

17 MOM Minutes of Meeting

18 MR Management Representative

19 MRM Management Review Meeting

20 MSA Measurement System Analysis

21 NABL National Accredited Board for Inspection and Calibration Laboratory

22 NC Non-Conformance

23 NCR Non-Conformance Report

24 OEE Overall Equipment Efficiency

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List of abbreviations Page No. 2 of 2

Sl. No. Abbreviation Abbreviation description

25 OEM Original Equipment Manufacturer

26 PA Preventive Action

27 PAR Preventive Action report

28 PDCA Plan-Do-Check-Act

29 PFD Process Flow Diagram

30 PM Preventive Maintenance

31 PO Purchase Order

32 PPAP Production Part Approval Process

33 PPM Parts Per Million

34 QA Quality Assurance

35 QMSM Quality Management System Manual

36 R & A Responsibilities & Authorities

37 R/M Raw Material

38 RPN Risk Priority Number

40 WI Work Instruction

41 TGL Turbo Gears India Private Limited





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Company Profile Page No. 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 sub-assemblies 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.





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Scope & Exclusions for Quality Management

System Page No. 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. Chapter Description

QMSM/09 Quality Management System - Requirements

QMSM/10 Management Responsibility

QMSM/11 Resource Management

QMSM/12 Product Realization

QMSM/13 Measurement, Analysis and Improvement

Exclusions: The following exclusions have been considered for TGL’s QMS.

Sr. Clause No. Clause Description Justification for exclusion.

1. 7.3.2.1 Product Design Input

2. 7.3.3.1 Product Design Output

All Design / Drawings are provided by the customer. TGL is designing only manufacturing processes and manufactures the products as per customer requirement.





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Quality Policy Page No. 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,

industrial and other applications, catering to customers

globally.

We will continually improve satisfaction of all stakeholders

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.

Shashank Jauhri

Chief Operating Officer Electronic Copy on Carraro Intranet is only updated

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Quality Objectives Page No. 1 of 3

Sr. Function Process Objective / Process measures U/M Target –

2008

Management review ----- ----- ----- 1 Top Management

Business planning Business Plan Achievement % 100%

Control of documents ----- ----- -----

Control of Records ----- ----- -----

Repetitive NC Nos. Zero Internal audit

Audit Plan Vs Actual % 100%

Control of NC product COPQ % -

Corrective action ----- ----- -----

Preventive action ----- ----- -----

2. MR

Continual improvement ----- ----- -----

Handling of enquiries Hit Ratio % 30%

Customer satisfaction & analysis

Customer satisfaction level (Survey) % 75%

3. Sales Monitoring of customer satisfaction based on objective data.

Customer satisfaction Index (Objective Data)

% 75%

Incoming Inspection Supplier Rejection PPM 3,000

Set up approval ----- ----- -----

Customer complaints (max.) / Month Nos. 5

Final inspection Customer Rejection (max.) / Month PPM 4,500

Handling of customer complaints Repetitive complaints Nos. Zero

Control of MMD (Calibration)

Calibration Plan Vs Actual % 100%

4. QA

Layout inspection Plan Vs Actual % 100%


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2008

Product audit Plan Vs Actual % 100%

Process audit Plan Vs Actual % 100% 4. QA

Supplier QMS Development Plan Vs Actual % 100%

Supplier planning & procurement Supplier Performance % 95%

Production Planning Inventory Turns 12 5 Logistics

Dispatch Sales Rs. As per

Business Plan

Utilization % 80% by Dec 08 6. Production Manufacturing

Internal Rejection PPM 15,000

Supplier evaluation, selection, purchasing & re-evaluation – Forging, Job work

First time right samples % 90%

7. Purchase Supplier evaluation, selection, purchasing & re-evaluation – consumables

----- ----- -----

Carburizing Hardening Internal Rejection PPM 1,500

Induction Hardening Internal Rejection PPM 1,500 8. Heat Treatment

Nitriding Internal Rejection PPM 1,500

Training Training Plan Vs Actual % 100%

9. HR Employee motivation scheme Plan vs. actual % 100%


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2008

MTBF Hrs 250 Breakdown maintenance

MTTR Hrs 1.25

BD % % 0.75% 10 Maintenance

Preventive maintenance PM Plan Vs Actual % 100%

New product development First time right samples % 95%

Control of external origins ----- ----- ----- 11 Manufacturing Engineering

Change Management ----- ----- -----

Tool Procurement ----- ----- -----

Tool Stores Control ----- ----- ----- 12 Tool Room

Tooling Maintenance Tooling Maintenance Plan vs. Actual % 100%

Approach for deployment of quality objectives

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.

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




TGLISO/TS 16949: 2002 Document No. QMSM/07



Organization Structure Page No. 1 of 1

COO

SLS & CR PUR HR MFG QA & MR

MFG. ENGG

MNT HT LOG / SOTRES

A/C & FINANCE





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Sequence & Interaction between processes

Page No. 1 of 2

Sequence & Interaction between processes generic diagram: - Refer Page 2 of 2 of this section.





TGLTooling

Procurement

Tool stores control

Change Implementation

Management Review

Continual Improvement

Inprocess inspection

Control of NC Products

Supplier QMS Devp

B/D Maint, Preventive

Maint.

Supplier Evaluation, Selection,

proceurement, re-evaluation

(Consumables)

Calibration

Final inspection

Despatch

Handling of customer

complaints

Process Audit

Corrective Action

Preventive Action

Internal Audit

Layout Inspection Customer

Satisfaction

Product Audit

PROCESS INTERACTION DIAGRAM Doc No.: QMSM / 08Issue No. : 02 / 02.05.2008

Rev. No. : 00 / 02.05.2008

Tooling Maint.

Mfg - Hard

Supplier Planning & Procurement

Stores control

Incoming inspection

Set up Approval

Mfg. - softSet up

ApprovalInprocess inspection

Heat Treatmment

Handling of new enquiries

NPD

Customer

Supplier Evaluation, Selection,

proceurement, re-evaluation (Forging /

Job work)

Prod planning

Business Planning

Control of documents

Control of external origins

Control of records

Training

Motivation

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Quality Management System - Requirements

Page No. 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. d) Ensured the availability of resources and information necessary to support the operations and

monitoring of these processes. e) Monitoring, measuring and analyzing these processes, as per section QMSM/13 f) Established process to implement actions necessary to achieve planned results and continual

improvement of these processes. 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. Documented statements of a quality policy as per section QMSM/05 b. Documented statement of Quality Objectives as per section QMSM/06 c. A quality management system manual d. 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,


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Page No. 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 TGL has established and maintained a quality manual that includes

a) The scope of the quality management system, including details of and justification for any exclusions (QMSM/04)

b) The documented procedures established for the quality management system. (QMSM/14)

c) A description of the interaction between the processes of the quality management system (QMSM/08).

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). Electronic Copy on Carraro Intranet is only updated

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Page No. 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.





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Management Responsibility

Page No. 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 To assure the effectiveness and efficiency, COO reviews the product realization processes and support processes. 5.2 Customer Focus COO ensures that customer requirements are determined through customer satisfaction surveys and customer specific requirements are met with the aim of enhancing customer satisfaction. 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.


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Page No. 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,

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

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.


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Page No. 3 of 4

5.5.3 Internal Communication: For the effectiveness of quality management system, following internal communication system has been established.

Sl. # Internal communication matter Mode of communication Resp. 1. Status of achievement of quality

objectives and process measures Display board, Review meetings, MRM All HOD

2. Quality Policy Display Board, Training All HOD 3. Quality Objectives. Departmental Manual, Quality Manual,

Display Board All HOD

4. Responsibilities & authorities Departmental Manual 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). 5.6.1.1 Quality Management system performance: Cost of Poor quality and trends of performance of QMS is discussed in MRM. 5.6.2 Review Input: The input to Management review includes

a) Follow-up actions from previous MRM b) Results of Audit c) Customer feed back/customer satisfaction d) Process performance and product conformity e) Status of corrective and preventive action f) Changes that could affect the quality management system g) Status of quality policy & objectives h) Status of cost of poor quality i) Recommendations for improvement. j) 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.


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Resource Management Page No. 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). Records of education, training, skills and experience are maintained 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).


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Resource Management Page No. 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 Work environment: TGL determines and is managing the work environment needed to achieve conformity to product requirements. 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.





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Product Realization Page No. 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 Acceptance criteria as “zero” defect is defined in sampling plan used for product acceptance. 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. Electronic Copy on Carraro Intranet is only updated

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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 If formal review is not possible, requirement of review is waived with prior permission of customer authorization. 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). Electronic Copy on Carraro Intranet is only updated

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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 This clause is not applicable – Refer QMSM/05. 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). Electronic Copy on Carraro Intranet is only updated

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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.


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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 Supplier quality management system development is carried out as per procedure of supplier QMS Development (QA/P/09). 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. Requirement for approval of product, procedures, processes and equipment. b. Requirement for qualification of personnel, and c. 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). Electronic Copy on Carraro Intranet is only updated

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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. Control Plans are reviewed and updated when any change occurs affecting product, manufacturing Process, measurement, logistics, supply sources or 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

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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. 7.5.1.8 Service agreement with customer 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

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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 In order to detect deterioration, the condition of the products in stock, is assessed at appropriate intervals. 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. 7.6 Control of monitoring and measuring devices 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). Electronic Copy on Carraro Intranet is only updated

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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.

7.6.3.2 External Laboratories 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.





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Measurement, Analysis & Improvement

Page No. 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 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). 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

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Page No. 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 Manufacturing process audit is conducted as per plan to determine its effectiveness as per procedure of process audit. (QA/P/07). 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. Electronic Copy on Carraro Intranet is only updated

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Page No. 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. Manufacturing process capability or performance as specified by customer part approval process requirements are maintained. Process Flow diagram and control plan are implemented including

Measurement techniques Sampling plans Acceptance criteria Reaction plan, when acceptance criteria are not met.

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). Electronic Copy on Carraro Intranet is only updated

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Page No. 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 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). 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.


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Page No. 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 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. 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.


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Page No. 6 of 6

8.5.2 Corrective action 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 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). 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).





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List of Processes Page No. 1 of 2

Sr. No.

Process Description Procedure No. Function

1 Management review MGT / P / 01 2 Business planning MGT / P / 02

Top Management

3 Control of documents MR / P / 01 4 Control of Records MR / P / 02 5 Internal audit MR / P / 03 6 Control of NC product MR / P / 04 7 Corrective action MR / P / 05 8 Preventive action MR / P / 06 9 Continual improvement MR / P / 07

MR

10 Handling of new enquiries SLS / P / 01 11 Customer satisfaction & analysis SLS / P / 02

12 Monitoring of customer satisfaction based on objective data SLS / P / 03

Sales

13 Incoming Inspection QA / P / 01 14 Set up approval & in-process inspection QA / P / 02 15 Final inspection QA / P / 03 16 Handling of customer complaints QA / P / 04 17 Control of MMD (Calibration) QA / P / 05 18 Layout inspection QA / P / 06 19 Process audit QA / P / 07 20 Product audit QA / P / 08 21 Supplier QMS Development QA / P / 09

QA

22 Supplier planning & procurement LOG / P / 01 23 Production Planning LOG / P / 02 24 Stores Control LOG / P / 03 25 Dispatch LOG / P / 04

Logistics

26 Manufacturing PRD / P / 01 Production

27 Supplier evaluation, selection, purchasing & re-evaluation – Forging, Job work PUR / P / 01

28 Supplier evaluation, selection, purchasing & re-evaluation – consumables PUR / P / 02

29 Purchasing Process PUR / P / 03

Purchase


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List of Processes Page No. 2 of 2

Sr. No.

Process Description Procedure No. Function

30 Carburizing Hardening HT / P / 01 31 Induction Hardening HT / P / 02 32 Nitriding HT / P / 03

Heat Treatment

33 Training HR / P / 01 34 Employee motivation HR / P / 02

HR

35 Breakdown maintenance MNT / P / 01 36 Preventive maintenance MNT / P / 02

Maintenance

37 New product development ME / P / 01 38 Control of external origins ME / P / 02 39 Change Management ME / P / 03

ME

40 Tool Procurement TR / P / 01 41 Tool Stores Control TR / P / 02 42 Jigs & Fixture Management TR / P / 03

Tool Room





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Clause-wise process mapping

Page No. 1 of 7

Clause

No. Requirement QM Ref. Process Ref. Any other Ref.

4.1 Establishment, Documentation, implementation and maintaining QMS QMSM/09 - -

4.1.1 Controls over outsourced processes QMSM/09 - - 4.2.1 Documentation requirement QMSM/09 - - 4.2.2 Quality Manual QMSM/09 - -

4.2.3 Procedure of control of documents. Controls over external origins QMSM/09 MR/P/01

ME/P/02 -

4.2.3.1

Process to assure timely review, distribution and implementation of engineering specifications. Maintaining records of implementation of engineering changes

QMSM/09 ME/P/03 -

4.2.4 Procedure of control of records QMSM/09 MR/P/02 -

4.2.4.1 Records shall satisfy regulatory and customer requirements for its retention

QMSM/09 MR/P/02 List of records

5.1 Evidences of management commitment QMSM/10 - -

5.1.1 Review of product realization process to assure their effectiveness QMSM/10 - -

5.2 Ensuring determination and implementation of customer requirements

QMSM/10 - -

5.3 Quality Policy QMSM/05, QMSM/10, - -

5.4.1 Defining measurable quality objectives at relevant function

QMSM/06 QMSM/10, - -

5.4.1.1 Defining quality objectives in business plan QMSM/10 MGT/P/02 Business Plan

5.4.2 QMS Planning QMSM/10 MR/P/01 -

5.5.1 Defining responsibilities and authorities QMSM/10 - Responsibilities /

Authorities 5.5.1.1 Responsibility for quality QMSM/10 - - 5.5.2 Management Representative QMSM/10 - MR/RA/01 5.5.2.1 Customer Representative QMSM/10 - SLS/RA/01 5.5.3 Internal communication process QMSM/10 - -

5.6.1

Planned interval of management review. Conducting management review and maintaining records of the same

QMSM/10 MGT/P/01 MRM Agenda, Minutes of MRM

5.6.1.1 Review of QMS performance QMSM/10 MGT/P/01 MRM Agenda 5.6.2 Management Review inputs QMSM/10 MGT/P/01 MRM Agenda


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Page No. 2 of 7

Clause


5.6.2.1

“Analysis of actual and potential field failures and their and impact on quality, safety and environment” as input to management review

QMSM/10 MGT/P/01 MRM Agenda

5.6.3 Management review output QMSM/10 MGT/P/01 MOM 6.1 Provision of resources QMSM/11 - -

6.2.1 Performing work affecting product quality by competent personnel QMSM/11 - Competence criteria

6.2.2

Determination of required competency, taking appropriate actions and maintaining records of education, experience, training and skills

QMSM/11 HR/P/01 HR/LOR

6.2.2.1 Competency to achieve product design / development skills QMSM/11 - -

6.2.2.2 Procedure on training QMSM/11 HR/P/01 -

6.2.2.3 On the job training for the personnel in any new or modified jobs including contract labor.

QMSM/11 HR/P/01 HR/LOR

6.2.2.4 Employee motivation and empowerment QMSM/11 HR/P/02 -

6.3 Determination, providing and maintaining infrastructure

QMSM/11 QMSM 12

MNT/P/01 MNT/P/02 -

6.3.1 Plant, Facility and equipment planning QMSM/12 - -

6.3.2 Contingency Plan QMSM/12 - Contingency plan

6.4 Determination and managing of work environment QMSM/12 - -

6.4.1 Employee risk assessment in design & development and manufacturing process.

QMSM/12 ME/P/01 Employee risk assessment

6.4.2 Maintaining cleanliness of premises QMSM/12 - - 7.1 Planning of product realization QMSM/12 ME/P/01 -

7.1.1 Addressing of customer requirement and its technical reference in Control plan or quality plan

QMSM/12 ME/P/01 -

7.1.2 Acceptance criteria QMSM/12 - - 7.1.3 Confidentiality QMSM/12 - -

7.1.4 Validation of changes before implementation. QMSM/12 ME/P/03 ECN

7.2.1 Determination of requirement related to product requirement QMSM/12 SLS/P/01

ME/F/01, SLS/F/03,

Customer PO Electronic Copy on Carraro Intranet is only updated

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Page No. 3 of 7

Clause No. Requirement QM Ref. Process Ref. Any other Ref.

7.2.1.1

Demonstration of conformity to customer requirements for designation, documentation and control of special characteristics

QMSM/12 ME/P/01 List of special characteristics

7.2.2 Review of requirements related to product and maintaining its records. QMSM/12 SLS/P/01 SLS/F/03

7.2.2.1 Customer authorization to waive to review the requirements related to the product

QMSM/12 SLS/P/01 -

7.2.2.2 Conducting feasibility including risk analysis QMSM/12 SLS/P/01 ME/F/01

7.2.3 Determination and implementation of communication processes as required to customer

QMSM/12 - -

7.2.3.1 Ability to communicate information to customer in their specified language and formats

QMSM/12 - -

7.3.1 Design and development planning QMSM/12 ME/P/01 - 7.3.1.1 Use of multidisciplinary approach QMSM/12 ME/P/01 -

7.3.2 Determination of design and development inputs and maintaining its record

QMSM/12 ME/P/01 Mfg. Process design input

7.3.2.1

Identification, documentation and review of product design inputs

QMSM/12, QMSM/11 - -

7.3.2.2 Identification, documentation and review of manufacturing design inputs

QMSM/12 ME/P/01 Mfg. Process design input

7.3.2.3 Defining special characteristics in FMEA, CP and use of symbols QMSM/12 ME/P/01

FMEA, Control Plan, List of Special Characteristics

7.3.3 Design and development outputs QMSM/12 ME/P/01 Quality Planning Sign off

7.3.1.1 Product Design outputs QMSM/14, QMSM/12 - -

7.3.3.2 Manufacturing process design output QMSM/12 ME/P/01 Quality Planning Sign off

7.3.4 Design and development review and its record QMSM/12 ME/P/01 MOM

7.3.4.1

Measurements at specified stages of design and development and reporting summary results to management review

QMSM/12 ME/P/01 MOM


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Page No. 4 of 7

Clause


7.3.5 Design and development verification in accordance with planed arrangement and its record

QMSM/12 ME/P/01 MOM

7.3.6 Design and development validation in accordance with planed arrangement and its record

QMSM/12 ME/P/01 MOM

7.3.6.1

Performing design and development validation in accordance with customer requirement and program timing.

QMSM/12 ME/P/01 -

7.3.6.2 Prototype programming as required to customer. QMSM/12 ME/P/01 -

7.3.6.3 Product approval processes QMSM/12 ME/P/01, PUR/P/03 PPAP

7.3.7 Identification of design and development changes and maintaining its record.

QMSM/12 ME/P/01 ECN

7.4.1 Selection and evaluation of suppliers. Maintaining records of evaluation. QMSM/12 PUR/P/01 PUR/F/01,

PUR/F/06, PUR/F/05

7.4.1.1 Conformity of regulatory requirement to all purchased products / material QMSM/12 PUR/P/03 Purchase Order

7.4.1.2 Supplier QMS development QMSM/12 QA/P/09 QMS Audit, Audit Plan

7.4.1.3 Use of customer approved sources, where specified by customer. QMSM/12 PUR/P/01 Purchase Orders

7.4.2 Providing purchasing information QMSM/12 PUR/P/03, 02 Purchase Orders

7.4.3 Establishment and implementation of process for verification of purchased product

QMSM/12 QA/P/01 QA/F/01

7.4.3.1 Methods to use for ensuring incoming product quality QMSM/12 QA/P/01 -

7.4.3.2 Monitoring of supplier performance QMSM/12 LOG/P/01 WI for monitoring

supplier performance

7.5.1 Planning and carrying out production in controlled condition. QMSM/12 PRD/P/01 Production plan,

production report 7.5.1.1 Control Plan and its review QMSM/12 ME/P/01, QA/P/04 - 7.5.1.2 Work Instruction QMSM/12 - -

7.5.1.3 Verification of job set-ups and last piece QMSM/12 PRD/P/01,

QA/P/02 QA/F/03

7.5.1.4 Preventive and predictive maintenance QMSM/12, 11 MNT/P/01,

MNT/P/02 PM Plan

7.5.1.8 Service agreement with customer QMSM/12 - -


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Page No. 5 of 7

Clause


7.5.1.5 Management of production tooling QMSM/12 TR/P/01, 02, 03 -

7.5.1.6 Production scheduling in customer order driven QMSM/12 LOG/P/02 Production plan

7.5.1.7 Feedback of information from service QMSM/12 - -

7.5.2 Validation of processes and its record QMSM/12 HT/P/01, 02, 03 -

7.5.2.1 Validation of all processes QMSM/12 - -

7.5.3 Appropriate identification and traceability to products and its record QMSM/12 - Tag

7.5.4 Taking care of customer property and maintaining its record QMSM/12 - Tag

7.5.5 Preserving the conformity of product during internal processing &delivery to the intended destiny.

QMSM/12 LOG/P/03 -

7.5.5.1 Assessment of material condition in stock and following FIFO. QMSM/12 LOG/P/03 -

7.6 Control of monitoring and measuring devices and maintaining its record QMSM/12 QA/P/05 QA/F/07

7.6.1 Conducting applicable statistical studies on measurement system QMSM/12 ME/P/01 MSA Results

7.6.2 Calibration results QMSM/12 QA/P/05 QA/F/07 7.6.3.1 Internal laboratory and its scope QMSM/12 - Lab Scope

7.6.3.2 NABL or ISO/IEC 17025 accredited external laboratories QMSM/12 - -

8.1 Planning and implementation of monitoring, measurement, analysis and improvement processes

QMSM/13 - -

8.1.1 Identification of statistical concepts QMSM/13 - -

8.2.1 Customer Satisfaction to understand their perception QMSM/13 SLS/P/02 SLS/F/04

8.2.1.1 Customer satisfaction based on objective data QMSM/13 SLS/P/03 -

8.2.2 Conducting internal audits at planned interval. Procedure of internal audit. Maintaining records of audit results

QMSM/13 MR/P/03 MR/F/04, 05, 06, 07

8.2.2.1

Conducting audits to verify compliance with this technical specification and any additional QMS requirement.

QMSM/13 - -

8.2.2.2 Conducting audit at each manufacturing process QMSM/13 QA/P/08 QA/F/30

8.2.3 Monitoring and measurement of processes QMSM/13 - -


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Clause


8.2.2.3 Conducting product audit at appropriate stages of product realization

QMSM/13 QA/P/07 QA/F/29

8.2.2.4 Conducting internal audits in all working shifts. QMSM/13 MR/P/03 MR/F/05

8.2.2.5 Internal auditors qualification QMSM/13 MR/P/03 List of auditors

8.2.3.1

Monitoring and measurement of manufacturing processes. Maintaining records of process changes

QMSM/13 ME/P/03 Process Change Record

8.2.4 Monitoring and measurement of products. Maintaining records of inspection results

QMSM/13 QA/P/01, 02, 03 QA/F/03, 04, 05, 25

8.2.4.1 Layout Inspection and functional testing QMSM/13 QA/P/04 QA/F/31

8.2.4.2 Appearance item QMSM/13 - -

8.3 Procedure of control of NC Products. Maintaining records of actions of NC products.

QMSM/13 MR/P/04 Rework inspection report

8.3.1 Classification of suspect product as NC products QMSM/13 MR/P/04 -

8.3.3 Information to customer in case of shipment of NC products to customer.

QMSM/13 MR/P/04 -

8.3.4 Customer waiver and its record QMSM/13 MR/P/04 - 8.4 Analysis of data QMSM/13 - -

8.4.1 Comparison of trends of data against target QMSM/13 - -

8.5.1 Continual improvements QMSM/13 MR/P/07 -

8.5.1.1 Defining process for continual improvement QMSM/13 MR/P/07 -

8.5.1.2 Manufacturing process improvement QMSM/13 MR/P/07 -

8.5.2 Procedure of corrective action. Records of corrective action. QMSM/13 MR/P/05 QA/F/06

8.5.2.1 Use of problem solving technique in corrective action process. QMSM/13 MR/P/05 QA/F/06

8.5.2.2 Use of error proofing methods in their corrective action process. QMSM/13 MR/P/05 QA/F/06

8.5.2.3 Analysis of customer rejected parts and maintaining its record QMSM/13 MR/P/05 QA/F/06

8.5.3 Procedure of preventive action. Records of preventive action QMSM/13 MR/P/06 FMEA


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Page No. 7 of 7





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