Quality Manual Trostel

Trostel, Ltd. Quality Manual Uncontrolled copy if printed of 51 Revision: X Date of Issue: January 28

th, 2014 Approved by: Greg Vassmer

Management Representative

PURPOSE OF THE QUALITY POLICY MANUAL

This manual is issued to describe the Quality Assurance System to be employed by Trostel, Ltd. This manual and the systems and processes it describes will serve to ensure:

Implementation of Trostel, Ltd. Quality Policy at all manufacturing sites

Conformance to our customers requirements

Conformance to ISO/TS16949:2009(E)

As the Top Level Manager at my facility, I am ultimately responsible for the implementation and support of this Quality Policy Manual. My signature is proof of my commitment to the Policies stated in this manual.

____________________________________ Steve Dyer

President and CEO Trostel, LTD.

____________________________________ Greg Vassmer

Chief Technology and Quality Officer Trostel, LTD.




TROSTEL QUALITY POLICY

“TROSTEL IS COMMITTED TO BUILD A CULTURE OF CONTINUOUS

IMPROVEMENT THAT ENABLES US TO BE WORLD-CLASS IN ALL FACETS OF

OUR BUSINESS, AND MOST IMPORTANTLY TO EXCEED CUSTOMER

EXPECTATIONS.”

TROSTEL MISSION

“INCREASE SHAREHOLDER VALUE BY PROVIDING CUSTOMERS WITH HIGH

QUALITY ELASTOMERIC SOLUTIONS, WHILE PROMOTING EMPLOYEE

GROWTH AND ENSURING CORPORATE RESPONSIBILITY.”

SCOPE AND EXCLUSIONS

The scope of this Quality Policy Manual applies to all the Trostel locations Worldwide.

- The manufacture of rubber seals, precision moldings, assemblies, compression, injection and transfer moldings at Trostel Mexico S. de R.L. de C.V. located AV. Fomento Industrial Lote 8 Manzana 3, Parque Industrial del Norte, Reynosa, Tamps, 88736, Mexico,

- The manufacture of custom rubber compounds at Trostel Whitewater located 736 Executive Drive, Whitewater, Wisconsin, 53190-5545, United States,

- The cleaning and prepping of metals at Trostel Texas located at 3701 W Ursula

Ave, McAllen, TX 78503, - The design and engineering of molded products, material development lab, sales, finance,

MIS, quality management system, purchasing at Trostel Lake Geneva located 901 Maxwell Street, Lake Geneva, WI 53147.

Exclusions:

- The Trostel Quality Management System excludes the Design and Development requirements of ISO/TS 16949:2009, section 7.3, from its Trostel Whitewater facility. The justification for exclusion is that automotive customers provide their own recipes, thus removing design responsibilities from Trostel.




Quality Policy Manual Index ISO/TS16949:2009 (E) Section/Clause TITLE PAGE N/A Purpose of Quality Manual 1 5.3 Quality Policy/Vision Statement/ 2 Scope and Exclusions N/A Quality Policy Manual Index 3-5 4 Quality Management System 6 4.1 General Requirements 6 4.2 Documentation Requirements 6 - 8

* 4.2.1 General * 4.2.2 Quality Manual * 4.2.3 Control of Documents * 4.2.4 Control of Records

5 Management Responsibility 9 5.1 Management Commitment 9 5.2 Customer Focus 9 5.3 Quality Policy 9 5.4 Planning 10 * 5.4.1 Quality Objectives * 5.4.2 Quality Management System Planning 5.5 Responsibility, Authority and Communication 10 - 11 * 5.5.1 Responsibility and Authority * 5.5.2 Management Representative * 5.5.3 Internal Communication 5.6 Management Review 11-12 * 5.6.1 General * 5.6.2 Review Input * 5.6.3 Review Output 6 Resource Management 13 6.1 Provisions of Resources 13




Quality Policy Manual Index ISO/TS16949:2009 (E) Section/Clause TITLE PAGE 6.2 Human Resources 13-14 * 6.2.1 General * 6.2.2 Competence, Awareness and Training

6.3 Infrastructure 14-15

6.4 Work Environment 15

7 Product Realization 16

7.1 Planning of Product Realization 16 - 17 * 7.1.1 Planning of Product Realization-Supplemental * 7.1.2 Acceptance Criteria * 7.1.3 Confidentiality * 7.1.4 Change Control

7.2 Customer – related Processes 17 - 18 * 7.2.1 Determination of Requirements Related to the Product * 7.2.2 Review of Requirements Related to the Product * 7.2.3 Customer Communication

7.3 Design and Development 19 - 23 * 7.3.1 Design and Development Planning * 7.3.2 Design and Development Inputs * 7.3.3 Design and Development Outputs * 7.3.4 Design and Development Review * 7.3.5 Design and Development Verification * 7.3.6 Design and Development Validation *7.3.7 Control of Design and Development Changes

7.4 Purchasing 23 - 25 * 7.4.1 Purchasing Process * 7.4.2 Purchasing Information * 7.4.3 Verification of Purchased Product

7.5 Production and Service Provision 25 - 29 * 7.5.1 Control of Production and Service Provision * 7.5.2 Validation of Processes for Production and Service Provision * 7.5.3 Identification and Traceability * 7.5.4 Customer Property




* 7.5.5 Preservation of Product

Quality Policy Manual Index ISO/TS16949:2009 (E) Section/Clause TITLE PAGE 7.6 Control of Monitoring and Measuring Devices 30 - 32 8 Measurement, analysis and improvement 33 8.1 General 33 8.2 Monitoring and Measurement 33 - 37 * 8.2.1 Customer Satisfaction * 8.2.2 Internal Audit * 8.2.3 Monitoring and Measurement of Processes * 8.2.4 Monitoring and Measurement of Product 8.3 Control of Nonconforming Product 37 -38 8.4 Analysis of Data 38 - 39 8.5 Improvement 39 - 41 * 8.5.1 Continual Improvement * 8.5.2 Corrective Action * 8.5.3 Preventive Action ---- Appendixes 42 - 51 A. Documented Procedures 42 B. Organizational Charts-See file 43 C. Controlled Circulation 44 D. Continuous Improvement Cycle 45 E. Documentation Pyramid 46 F. Amendment Record 47 - 48 G. Process Road Map 49 H. Molding Process Interaction Map 50 I. Compounding Process Interaction Map 51




4 QUALITY MANAGEMENT SYSTEM 4.1 General requirements TROSTEL, LTD. has established, documented, implemented and maintains a quality management system. We continually improve its effectiveness in accordance with the requirements of ISO/TS 16949:2009(E) TROSTEL, LTD. has:

a) identified the processes needed for the quality management system and their application throughout TROSTEL, LTD..;

b) determined the sequence and the interaction of these processes, which is defined through the procedures;

c) determined the criteria and the methods needed to ensure that both the operation and the control of these processes are effective;

d) ensures the availability of resources and information that is necessary to support the operation and monitoring of these processes;

e) monitors, measures, and analyses these processes, and; f) implements actions that are necessary to achieve planned results and to continually

improve the processes The processes are managed by TROSTEL, LTD. in accordance with the requirements of ISO/TS 16949(E). When TROSTEL, LTD. chooses to outsource any process that affects customer product conformity with requirements, TROSTEL, LTD. ensures control over such processes. Control of these outsourced processes is identified within the quality management system. The method to ensure this control is documented in the SOP’s for purchasing. 4.1.1 Ensuring control over outsourced processes does not absolve TROSTEL, LTD. of the responsibility of conformity to all customer requirements. 4.2 Documentation requirements 4.2.1 General The quality management system documentation includes:

a) Documented statements of a quality policy and quality objectives; b) A quality manual; c) Documented procedures that are required by ISO/TS 16949:2009, See Appendix A; d) Documents needed by TROSTEL, LTD. to ensure the effective planning, operation

and control of our processes; e) Quality records that are required by ISO/TS 16949:2009 and are listed on the Quality

Document Matrix.




4.2.2 Quality manual TROSTEL, LTD. has established and maintains a quality manual that includes:

a) The scope of the quality management system, including details and justification for any exclusion. See Scope and Exclusions on page 2.

b) Documented Tactical procedures established for the quality management system are referenced in Appendix A of this manual

c) A description of the interaction between the processes of the quality management system that is accomplished through following the documented procedures and SOP’s. See Appendix G.

4.2.3 Control of documents Documents that are required by the quality management system are controlled. Quality records are controlled as specified in 4.2.4 A documented procedure (See Appendix A) is established to define the controls needed to:

a) Approve documents for adequacy prior to their issue; b) Review and update as necessary and to re-approve documents, c) Ensure that changes and the current revision status of documents are identified, d) Ensure that relevant versions of applicable documents are available at points of use, e) Ensure that documents remain legible and are readily identifiable; f) Ensure that documents of external origin are identified and that their distribution is

controlled; g) Prevent the unintended use of obsolete documents, and to apply suitable

identification to them if they are retained for any purpose. 4.2.3.1 Engineering specifications TROSTEL, LTD. has a process to assure the timely review, distribution and implementation of all customer engineering standards / specifications and changes based on our customer required schedule. The timely review is as soon and possible and does not exceed two working weeks. TROSTEL, LTD. maintains records of the date on which each change is implemented in production. Implementation includes updating pertinent documentation. 4.2.4 Control of quality records




Quality records are established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Quality records are legible, readily identifiable and are retrievable. A documented procedure is established that defines the controls needed for the identification, storage, protection, retrieval, retention time and disposition of quality records. See Appendix A 4.2.4.1 Records retention The control of records satisfies regulatory and customer requirements.




5 MANAGEMENT RESPONSIBILITY 5.1 Management commitment The Top Management of TROSTEL, LTD. provides evidence of its commitment to the development and implementation of the quality management system and to continually improving its effectiveness. This is done by:

a) Communicating throughout the organization the importance of meeting customer as well as statutory and regulatory requirements at TROSTEL, LTD. meetings and also living the quality system on a daily basis;

b) Establishing and living the quality policy; c) Ensuring quality objectives are established and that the objectives are used to drive

improvement to the system; d) Conducting management review on a minimal of a semi annual basis; and e) Ensuring the availability of needed resources.

5.1.1 Process efficiency Top Management reviews the product realization processes and the support processes to ensure their effectiveness and efficiency. 5.2 Customer focus The Top Management group ensures the customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction. Customer satisfaction is ensured by increasing customer confidence in TROSTEL, LTD. 5.3 Quality policy The Top Management ensures the quality policy

a) Is appropriate to the purpose of TROSTEL, LTD.; b) Includes a commitment to comply with requirements and continually improves 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) That it is reviewed for continuing suitability.




5.4 Planning 5.4.1 Quality objectives Top Management ensures the quality objectives, including those needed to meet requirements for product is established at relevant functions and levels within the organization. The quality objectives are measurable and consistent with the quality policy. These objectives are described in the Strategic Road Map. See Appendix C 5.4.1.1 Quality objectives – Supplemental Top management ensures that quality objectives and measurements are included in the business plan and used to deploy the quality policy. 5.4.2 Quality management system planning Top Management ensures that:

a) The planning of the quality management system is carried out in order to meet the requirements given in 4.1 as well as the quality objectives; and

b) The integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority Top Management ensures that the responsibility, authorities and their interrelation are defined and communicated appropriately within TROSTEL, LTD. Our organizational chart indicates the level of authority of each position and the job descriptions, Tactical procedures and SOP’s clearly define each functions responsibility. See Organizational Chart 5.5.1.1 Responsibility for quality Managers with responsibility and authority for corrective action are promptly informed of products or processes that do not conform to requirements. Personnel responsible for product quality have the authority to stop production to correct quality problems. Production operations across all shifts are staffed with personnel in charge of, or delegated responsibility for, ensuring product quality.




5.5.2 Management representative The President & CEO has appointed the Chief Technology and Quality Officer as the Management Representative who, in addition to other responsibilities, has the responsibility and authority that includes:

a) Ensuring the processes needed for the quality management system are established, implemented and maintained;

b) Reporting to top management on the performance of the quality management system and any need for improvement; and

c) Ensuring that awareness of customer requirements throughout the organization is promoted;

d) Directing TROSTEL, LTD. employees to meet the requirements and to implement the quality management system.

5.5.2.1 Customer representative The President & CEO has appointed the Vice President of Sales and Marketing with responsibility and authority to ensure that customer requirements are addressed. This includes:

a) Special characteristics; b) Setting quality objectives and related training; c) Corrective and preventative actions; d) Product design and development.

5.5.3 Internal communication Top management ensures the appropriate communication processes are established within TROSTEL, LTD. and that communication takes place regarding the effectiveness of the quality management system. This is done in two ways; by ensuring that procedures define which functions communicate information that is transferred internally and externally and a variety of regularly scheduled meetings. 5.6 Management review 5.6.1 General Top management reviews the TROSTEL, LTD.'s quality management system, on a minimal of an annual basis, to ensure it is suitable, adequate and effective. This review includes assessing opportunities for improvement and the need for changes to the existing quality management system, including the quality policy and quality objectives. Records of management review are maintained.




5.6.1.1 Quality management system performance These reviews include all requirements of the quality management system and its performance trends as an essential part of the continual improvement process. Part of the management review is the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality. These results are recorded to provide, as a minimum, evidence of the achievement of

- the quality objectives specifies in the business plan, and - customer satisfaction with product supplied

5.6.2 Review input The input to management review includes, as a minimum, information on:

a) The results of audits; b) Customer feedback; c) Process performance and product conformity; d) The status of preventive and corrective actions; e) Follow-up actions from previous management reviews; f) Planned changes that could affect the quality management system; and g) Recommendations for improvement; h) Input from other TROSTEL, LTD.. employees; i) Measuring progress against established objectives.

5.6.2.1 Review input – Supplemental Input to management review includes an analysis of actual and potential field-failures and their impact on quality, safety or the environment. 5.6.3 Review output The output from the management review includes any decisions and actions that are related to:

a) Improvement of the effectiveness of the quality management system and its processes;

b) Improvement of product related to customer requirements; c) Resource needs; d) Improvement to product related to increase in improvement and efficiencies; and e) Any actions as a result of review of each input item.




6 RESOURCE MANAGEMENT 6.1 Provision of Resources

The organization determines and provides, in a timely manner, the resources needed to:

a) Increase efficiency;

b) implement, maintain and improve the quality system;

c) enhance customer satisfaction by meeting or exceeding customer requirements.

6.2 Human Resources

6.2.1 General

Personnel affecting quality are competent on the basis of applicable education, training, skills and experience. The applicable education, training, skills and experience for each position are defined in the position specifications.

6.2.2 Competence, Awareness and Training

TROSTEL, LTD..:

a) Identifies competency needs for personnel performing activities affecting quality;

b) Provides training or other actions to satisfy these needs;

c) Evaluates the effectiveness of the training/actions taken;

d) Ensures that its employees are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives;

e) Maintains appropriate records of education, training, skills and experience.

6.2.2.1 Product design skills

TROSTEL, LTD. ensures that personnel with product design responsibility and competent to achieve design requirements and are skilled in applicable tools and techniques.

Applicable tools and techniques are identified by TROSTEL, LTD...




6.2.2.2 Training

TROSTEL, LTD. has established and maintains a documented procedure for identifying training needs and achieving competence of all personnel performing activities affecting product quality. Personnel performing specific assigned tasks are qualified, as required, with particular attention to the satisfaction of customer requirements. See Appendix F

6.2.2.3 Training on the job

TROSTEL, LTD. provides on-the-job training for personnel in any new or modified job affecting product quality, including contract or agency personnel. Personnel whose work can affect quality are informed about the consequences to the customer of nonconformity to quality requirements.

6.2.2.4 Employee motivation and empowerment

TROSTEL, LTD. has implemented a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process includes the promotion of quality and technological awareness throughout the whole organization.

TROSTEL, LTD. has implemented a process to measure the extent to which its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.

6.3 Infrastructure

TROSTEL, LTD. determines, provides and maintains the infrastructure required to achieve the conformity to product requirements. This infrastructure includes as applicable:

a) Buildings, workspace and associated utilities;

b) Process equipment, both hardware and software;

c) Supporting services (such as transport and communication).




6.3.1 Plant, facility and equipment planning

TROSTEL, LTD. uses a multidisciplinary approach for developing plant, facility, and equipment plans. Plant layouts shall optimize material travel, handling and value-added use of floor space, and facilitates synchronous material flow. Methods are developed and implemented to evaluate and monitor the effectiveness of existing operations. Lean Manufacturing is an integral part of this process.

6.3.2 Contingency plans

TROSTEL, LTD. utilizes contingency plans to satisfy customer requirements in the event of an emergency such as utility interruptions, labor shortages, key equipment failure and field returns.

6.4 Work Environment

TROSTEL, LTD. has determined and manages the work environment needed to fulfill obligations and achieve conformity to product requirements.

6.4.1 Personnel safety to achieve product quality Product safety and means to minimize potential risks to employees are addressed by TROSTEL, LTD. especially in the design and development process and in manufacturing process activities. 6.4.2 Cleanliness of premises TROSTEL, LTD. maintains its premises in a state of order, cleanliness and repair consistent with the product and manufacturing process needs.




7 Product Realization

7.1 Planning of Realization Processes

TROSTEL, LTD. plans and develops processes needed for product realization. Planning of product realization is consistent with the requirements of the other processes within the quality management system.

In planning the processes for product realization, TROSTEL, LTD. has determined the following, as appropriate:

a) Quality objectives and requirements for the product;

b) The need to establish processes and documentation and provide resources specific to the product;

c) Required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;

d) The records to provide evidence that the realization processes and resulting product meet requirements.

The output of planning is in a form that is suitable for TROSTEL, LTD.'s method of operation.

7.1.1 Planning of product realization – Supplemental

Customer requirements and references to its technical specifications are included in the planning of product realization as a component of the quality plan.

7.1.2 Acceptance criteria

Acceptance criteria is defined by TROSTEL, LTD. and, where required, approved by the customer.

For attribute data sampling, the acceptance level shall be zero defects.

7.1.3 Confidentiality

TROSTEL, LTD. ensures the confidentiality of customer-contracted products and projects under development, and related product information.




7.1.4 Change control

TROSTEL, LTD. utilizes a process to control and react to changes that impact product realization. The effects of any change, including those changes caused by any supplier, are assessed, and verification and validation activities are defined, to ensure compliance with customer requirements. Changes are validated before implementation.

For proprietary designs, impact on form, fit and function (including performance and/or durability) are reviewed with the customer 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

7.2 Customer-Related Processes

7.2.1 Determination of Requirements Related to the Product

TROSTEL, LTD. determines:

a) Requirements specified by the customer, including the requirements for delivery and post delivery activities;

b) Requirements not specified by the customer but necessary for intended use;

c) Statutory and regulatory requirements; including all applicable government, safety and environmental regulations, applied to acquisition, storage, handling, recycling, elimination or disposal of materials.

d) Additional requirements identified by TROSTEL, LTD...

7.2.1.1 Customer-designated special characteristics

TROSTEL, LTD. demonstrates conformity to customer requirements for designation, documentation and control of special characteristics.

7.2.2 Review of Requirements related to the product

TROSTEL, LTD. reviews the requirements related to the product. The review is conducted before TROSTEL, LTD. commits to supply the product to the customer and ensures that:

a) Product requirements are defined;

b) Contract or order requirements differing from those previously expressed are resolved;




c) TROSTEL, LTD. has the ability to meet the defined requirements.

The results of the review and subsequent follow-up actions are recorded and maintained.

When the customer does not provide a documented statement of requirement, TROSTEL, LTD. confirms these requirements before acceptance.

Where product requirements are changed, TROSTEL, LTD. ensures that relevant documentation is amended and that relevant personnel are made aware of the changed requirements.

7.2.2.1 Review of requirements related to the product – Supplemental

Waiving the requirement stated in 7.2.2 for a formal review requires customer authorization.

7.2.2.2 Organization manufacturing feasibility

TROSTEL, LTD. investigates, confirms, and documents the manufacturing feasibility of the proposed products in the contract review process, including risk analysis.

7.2.3 Customer Communication

TROSTEL, LTD. has determined and implemented arrangements for communication with customers relating to:

a) Customer expectations and corporate philosophy;

b) Product information;

c) Enquiries, contracts or order handling, including amendments;

d) Customer feedback, including customer complaints.

7.2.3.1 Customer communication – Supplemental

TROSTEL, LTD. has the ability to communicate necessary information, including data, in a customer-specified language and format.




7.3 Designs and/or Development

7.3.1 Design and /or development planning

TROSTEL, LTD. plans and controls design and/or development of the product. The planning includes and determines:

a) The stages of design and/or development processes; b) The review, verification and validation activities appropriate to each design

and/or development stage including prototypes; c) The responsibilities and authorities for design and/or development activities.

The interfaces between different groups involved in design and/or development is managed to ensure effective communication and clarity of responsibilities. Planning output is updated, as appropriate, as the design and development progresses.

7.3.1.1 Multidisciplinary approach TROSTEL, LTD. utilizes a multidisciplinary approach to prepare for product realization, including:

- development/finalization and monitoring of special characteristics, - development and review of FMEAs, including actions to reduce potential risks,

and - development and review of control plans.

7.3.2 Design and/or development inputs Inputs to the product requirements are determined and records are maintained. These inputs include: a) Functional and performance requirements; b) Applicable regulatory and legal requirements; c) Applicable information derived from previous similar designs; and d) Any other requirements essential for design and/or development. The inputs are reviewed for adequacy. Incomplete, ambiguous or conflicting requirements shall be resolved.

7.3.2.1 Product design input TROSTEL, LTD. Identifies, documents and reviews the product design input




requirements, including the following

- Customer requirements (contract review) such as special characteristics identification, traceability and packaging;

- Use of information: TROSTEL, LTD.. has a process to deploy information gained from previous design projects, competitor analysis, supplier feedback, internal input, field data, and other relevant sources, for current and future projects of a similar nature;

- Targets for product quality, life, reliability, durability, maintainability, timing and cost.

7.3.2.2 Manufacturing process design input TROSTEL, LTD. identifies, documents and reviews the manufacturing process design input requirements, including

- product design output data, - targets for productivity, process capability and cost, - customers requirements, if any, and - experience from previous developments. - Includes the use of error-proofing methods to a degree appropriate.

7.3.2.3 Special characteristics TROSTEL, LTD. identifies special characteristics and

- Includes all special characteristics in the control plan, - Complies with customer-specified definitions and symbols, and - Identifies process control documents including drawings, FMEAs, control plans,

and operator instructions with the customer’s special characteristic symbol or the organization’s equivalent symbol or notation to include those process steps that affect special characteristics.

7.3.3 Design and/or development outputs The outputs of the design and/or development process are documented in a manner that enables verification against the design and/or development inputs and are approved prior to release. The design and/or development output: a) Meets the design and/or development input requirements; b) Provides appropriate information for production and service operations; c) Contains or references product acceptance criteria;




d) Defines the characteristics of the product that are essential to its safe and proper use. Design and/or development output documents are approved prior to release.

7.3.3.1 Product design outputs – Supplemental The product design output is expressed in terms that can be verified and validated against product design input requirements. The product design output includes

- design FMEA, reliability, - product special characteristics and specifications, - product error-proofing, as appropriate, - product definition including drawings or mathematically based data, - product design reviews results, and - diagnostic guidelines where applicable.

7.3.3.2 Manufacturing process design output The manufacturing process design output is expressed in terms that can be verified against manufacturing process design input requirements and validated. The manufacturing process design output includes

- specifications and drawings, - manufacturing process flow chart/layout, - manufacturing process FMEAs, - control plan, - work instructions, - process approval acceptance criteria, - data for quality, reliability, maintainability and measurability, - results of error-proofing activities, as appropriate, and - methods of rapid detection and feedback of product/manufacturing process

nonconformities.

7.3.4 Design and/or development review At suitable stages, systematic reviews of design and/or development are conducted in accordance with planned arrangements to: a) Evaluate the ability of the results to fulfill requirements; b) Identify problems and propose necessary actions. The participants at each review include representatives from the functions concerned with the design and/or development stage that is being reviewed. The results of the design review and the follow-up actions that are needed are recorded.




7.3.4.1 Monitoring Measurements at specified stages of design and development are defined, analyzed and reported with summary results as an input to management review. 7.3.5 Design and/or development verification

Verification is performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions are maintained.

7.3.6 Design and/or development validation Design and or development validation is performed in accordance with planned arrangements to confirm that the product is capable of meeting the requirements for the intended use. When applicable, validation is completed prior to the delivery or implementation of the product. When it is not practical to perform full validation before delivery or implementation, partial validation is performed to the extent it is applicable. The results of validation and any required follow-up activities are recorded.

7.3.6.1 Design and development validation - Supplemental Design and development validation is performed in accordance with customer requirements including program timing.

7.3.6.2 Prototype program When required by the customer, TROSTEL, LTD. has a prototype program and control plan. TROSTEL, LTD. uses, wherever possible, the same suppliers, tooling and manufacturing processes as will be used in production. All performance-testing activities are monitored for timely completion and conformity to requirements. While services may be outsourced, TROSTEL, LTD. is responsible for the outsourced services, including technical leadership.

7.3.6.3 Product approval process TROSTEL, LTD. conforms to a product and manufacturing process approval procedure recognized by the customer. This approval process also applies to suppliers




7.3.7 Control of design and/or development changes

Design and development changes are identified and records are maintained. The changes are reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes includes evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions are maintained.

7.4 Purchasing

7.4.1 Purchasing Process

TROSTEL, LTD. controls the purchasing processes to ensure that purchased product conforms to requirements. The type and extent of our control is based upon the effect the product has on the product realization or the final product.

TROSTEL, LTD. has a process in place to evaluate and select suppliers based on their ability to supply product or service in accordance with our requirements. Criteria for selection and periodic evaluation are defined in SOP’s. The results of evaluations and follow-up actions are recorded per these procedures.

7.4.1.1 Regulatory conformity

All purchased products or materials used in product conform to applicable regulatory requirements.

7.4.1.2 Supplier quality management system development

TROSTEL, LTD. performs supplier quality management system development with the goal of supplier conformity with this Technical Specification. Conformity with ISO 9001-2008 is the first step in achieving this goal.

Unless otherwise specified by the customer, suppliers to TROSTEL, LTD... Are third party registered to ISO9001:2008 by an accredited third-party certification body.

7.4.1.3 Customer-approved sources




Where specified by the contract (e.g. customer engineering drawing, specification), TROSTEL, LTD. purchases products, materials or services from approved sources.

The use of customer-designated sources, including tool/gauge suppliers, does not relieve TROSTEL, LTD. of the responsibility for ensuring the quality of purchased products.

7.4.2 Purchasing Information

Purchasing documents describe the product to be purchased, including where appropriate:

a) Requirements for approval of product, procedures, processes and equipment;

b) Requirements for personnel qualifications; and

c) Quality management system requirements.

TROSTEL, LTD. ensures the adequacy of specified requirements contained in the purchasing documents prior to their communication to the supplier.

7.4.3 Verification of Purchased Product

TROSTEL, LTD. has established and implemented the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

When TROSTEL, LTD. or its customer intends to perform verification at the supplier's premises, TROSTEL, LTD. states the intended verification arrangement and method of product release in the purchasing information.

7.4.3.1 Incoming product quality

TROSTEL, LTD. has a process to assure the quality of purchased product utilizing one or more of the following methods:

- receipt of, and evaluation or, statistical data by TROSTEL, LTD..,

- receiving inspection and/or testing such as sampling based on performance,

- second- or third-party assessments or audits of supplier sites, when coupled with records of acceptable delivered product quality,




- part evaluation by a designated laboratory,

- another method agreed with the customer.

7.4.3.2 Supplier monitoring

Supplier performance is monitored through the following indicators:

- delivered product quality,

- customer disruptions including field returns,

- delivery schedule performance (including incidents of premium freight),

- special status customer notifications related to quality or delivery issues.

TROSTEL, LTD. promotes supplier monitoring of the performance of their manufacturing processes.

7.5 Productions and Service Provision

7.5.1 Control of Production and Service Provision

TROSTEL, LTD. controls manufacturing operations through the following controlled conditions, as applicable:

a) The availability of information that specifies the characteristics of the product;

b) Where necessary, the availability of work instructions;

c) The use and maintenance of suitable equipment;

d) The availability and use of monitoring devices;

e) The implementation of monitoring and measurement devices;

f) The implementation of release, delivery and post-delivery activities.

7.5.1.1 Control plan

TROSTEL, LTD. has

- developed control plans at the system, subsystem, component and/or material level for the product supplied, including those for processes producing bulk materials as well as parts, and,

- a control plan for pre-launch and production that takes into account the design FMEA and manufacturing process FMEA outputs.




The control plan

- lists the controls used for the manufacturing process control,

- includes methods for monitoring of control exercised over special characteristics defined by both the customer and the organization.

- Includes the customer-required information, if any, and

- Initiates the specified reaction plan when the process becomes unstable or not statistically capable.

7.5.1.2 Work instructions

TROSTEL, LTD. has prepared documented work instructions for all employees having responsibilities for the operation of processes that impact product quality. These instructions are accessible for use at the workstation.

These instructions are derived from sources such as the quality plan, the control plan and the product realization process.

7.5.1.3 Verification of job set-ups

Job set-ups are verified whenever performed, such as an initial run of a job, a material change over or a job change.

Work instructions are available for set-up personnel. TROSTEL, LTD. uses statistical methods of verification where applicable.

7.5.1.4 Preventive and predictive maintenance

TROSTEL, LTD. identifies key process equipment and provides resources for machine/equipment maintenance and develops an effective planned total preventive maintenance system. This system includes the following:

- planned maintenance activities;

- packaging and preservation of equipment, tooling and gauging;

- availability of replacement parts for key manufacturing equipment;




- documenting, evaluating and improving maintenance objectives.

TROSTEL, LTD. utilizes predictive maintenance methods to continually improve the effectiveness and efficiency of production equipment.

7.5.1.5 Management of production tooling

TROSTEL, LTD. provides resources for tool and gauge design, fabrication and verification activities.

TROSTEL, LTD. has established and implemented a system for production tooling management which includes:

- maintenance and repair facilities and personnel;

- storage and recovery;

- set-up;

- tool-change programs for perishable tools;

- tool-design modification documentation, including engineering change level;

- tool modification and revision to documentation;

- tool identification, defining the status, such as production, repair or disposal.

TROSTEL, LTD. has implemented a system to monitor these activities if any work is outsourced.

7.5.1.6 Production scheduling

Production is scheduled in order to meet customer requirements, such as just-in-time supported by an information system that permits access to production information at key stages of the process and is order driven.

7.5.1.7 Feedback of information from service

A process for the communication of information on service concerns to manufacturing, engineering and design activities is established and maintained.




7.5.1.8 Service agreement with customer

Currently Trostel, Ltd. does have any contractual agreements with the customer to provide service. When there is a service agreement with the customer, TROSTEL, LTD. will develop the system needed to meet the requirements of the standard.

7.5.2 Validation of Processes for Production and Service Provision

TROSTEL, LTD. validates any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.

Validation demonstrates the ability of these processes to achieve planned results.

TROSTEL, LTD. has established arrangements for these processes including, as applicable:

a) Defined criteria for review and approval of the processes;

b) Approval of equipment and qualification of personnel;

c) Use of specific methods and procedures;

d) Requirements for records; and

e) Revalidation.

7.5.2.1 Validation of processes for production and service provision - Supplemental

The requirements of 7.5.2 are applied to all processes for production and service provision.

7.5.3 Identification and Traceability

TROSTEL, LTD. identifies the product by suitable means throughout the product realization.

TROSTEL, LTD. identifies the status of the product with regard to monitoring and measurement requirements.

Where traceability is a requirement, TROSTEL, LTD.. controls and records the unique identification of the product.

7.5.3.1 Identification and traceability - Supplemental

The words “Where appropriate” in 7.5.3 of the TS16949 2009(E) standard do not apply and have been removed from our statement.




7.5.4 Customer Property

TROSTEL, LTD. exercises care with customer property while it is under the organization's control or is being used by TROSTEL, LTD... TROSTEL, LTD. identifies, verifies, protects and safeguards customer property provided for use and/or incorporation into the product. If any customer property is lost, damaged, or is otherwise found to be unsuitable for use, it is reported to the customer and records of this are maintained.

7.5.4.1 Customer- owned production tooling

Customer-owned tools, manufacturing, test, inspection tooling and equipment is permanently marked so that the ownership of each item is visible, and can be determined.

7.5.5 Preservation of Product

TROSTEL, LTD. preserves the conformity of the product to requirements while under TROSTEL, LTD. control and during delivery to the intended destination. This preservation includes identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.

7.5.5.1 Storage and inventory

In order to detect deterioration, the condition of product in stock is assessed at appropriate planned intervals.

TROSTEL, LTD. uses an inventory management system to optimize inventory turns over time and assure stock rotation, such as “first-in-first-out” (FIFO). Obsolete product is controlled in a similar manner to nonconforming product.




7.6 Control of Measuring and Monitoring Devices

TROSTEL, LTD. has determined the measuring and monitoring to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements.

Processes are established to ensure that monitoring and measurement can be carried out and is carried out in a manner that is consistent with the monitoring and measurement requirements.

Measurements to be made and the measuring and monitoring devices required are identified. This is to assure conformity of product to defined requirements. The measuring and monitoring devices are used and controlled to ensure that measurement capability is consistent with the measurement requirements. Where necessary to ensure valid results, measuring equipment is:

a) Calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification is recorded;

b) Adjusted or re-adjusted as necessary; c) Identified to enable the calibration status to be determined; d) Safeguarded from adjustments that would invalidate the measurement result; e) Protected from damage and deterioration during handling, maintenance and

storage.

In addition, TROSTEL, LTD. assesses and records the validity of previous measuring results when the equipment is found not to conform to requirements. TROSTEL, LTD. takes appropriate action on the equipment and also on any product affected. Records of the results of calibration and verification are maintained. When used in monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed. This is undertaken before the initial use and is reconfirmed as necessary.

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 used conforms to those in customer reference manuals on measurement systems analysis. Other analytical methods and acceptance criteria may be used if approved by the customer.




7.6.2 Calibration/verification records Records of the calibration/verification activity for all gauges, measuring and test equipment, needed to provide evidence of conformity of product to determined requirements, including employee- and customer-owned equipment, include

- equipment identification, including the measurement standard against which the equipment is calibrated,

- revisions following engineering changes, - any out-of-specification readings as received for calibration-verification, - an assessment of the impact of out-of-specification condition, - statements of conformity to specification after calibration/verification, and - notification to the customer if suspect product of material has been shipped.




7.6.3 Laboratory requirements

7.6.3.1 Internal laboratory

TROSTEL, LTD.’s internal laboratory facility has a defined scope that includes its capability to perform the required inspection, test, or calibration services. This laboratory scope is included in the quality management system documentation. The laboratory specifies and implements, as a minimum, technical requirements for:

- adequacy of the laboratory procedures,

- competency of the laboratory personnel,

- testing of the product,

- capability to perform these services correctly, traceable to the relevant process standard, and

- review of the related records.

7.6.3.2 External laboratory

External/commercial/independent laboratory facilities used for inspection, test or calibration services by TROSTEL, LTD. have a defined laboratory scope that includes the capability to perform the required inspection, test, or calibration, and either

- there is evidence that the external laboratory is acceptable to the customer, or

- the laboratory is accredited to ISO/IEC 17025 or national equivalent.

When a qualified laboratory is not available for a given piece of equipment, calibration may be performed by the equipment manufacturer.




8 Measurement, Analysis and Improvement

8.1 General

TROSTEL, LTD. has planned and implemented the measurement, monitoring, analysis and improvement activities needed to:

a) Demonstrate conformity of the product;

b) Ensure conformity of quality management system; and

c) Continually improve the effectiveness of the quality management system.

This includes determining the applicable methods that include statistical techniques and the extent of their use.

8.1.1 Identification of statistical tools

Appropriate statistical tools for each process are determined during advance quality planning and are included in the control plan.

8.1.2 Knowledge of basic statistical concepts

Basic statistical concepts, such as variation, control, process capability and over-adjustment are understood and utilized by TROSTEL, LTD...

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

TROSTEL, LTD. monitors customer satisfaction and/or dissatisfaction considering the customer's perception of satisfaction and/or dissatisfaction as one of the measurements of performance of the quality management system. The methodologies for obtaining and using this information are determined and defined.

8.2.1.1 Customer satisfaction – Supplemental

Customer satisfaction with TROSTEL, LTD. is monitored through continual evaluation of performance of the realization processes. Performance indicators are based on objective data and include, but are not limited to:




- delivered part quality performance,

- customer disruptions including field returns,

- delivery schedule performance (including incidents of premium freight), and

- customer notifications related to quality or delivery issues.

TROSTEL, LTD. monitors the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and efficiency of the process.

8.2.2 Internal Audit

TROSTEL, LTD. conducts planned internal audits to determine whether the quality management system:

a) Conforms to planned arrangements and the requirements of ISO/TS 16949:2009(E) and the requirements of the TROSTEL, LTD. quality system; and

b) Has been effectively implemented and maintained.

TROSTEL, LTD. plans the audit program 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. Selection of auditors and the conduct of audits ensure objectivity and impartiality of the audit process. Auditors do not audit their own work.

A procedure is documented that includes the responsibilities and requirements for planning and conducting audits, as well as reporting results and maintaining records. See Appendix F

Management responsible for the area being audited ensures that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up actions include the verification of the implementation of corrective action, and the reporting of verification results.

8.2.2.1 Quality management system audit

TROSTEL, LTD. audits its quality management system to verify compliance with this Technical Specification and any additional quality management system requirements.




8.2.2 Manufacturing process audit

TROSTEL, LTD. audits each manufacturing process to determine its effectiveness.

8.2.2.2 Product audit

TROSTEL, LTD. audits products at appropriate stages of production and delivery to verify conformity to all specified requirements, such as product dimensions, functionality, packaging and labeling, at a defined frequency.

8.2.2.3 Internal audit plans

Internal audits cover all quality management related processes, activities and shifts, and are scheduled according to an annual plan.

When internal/external nonconformities or customer complaints occur, the audit frequency appropriately increases.

8.2.2.4 Internal auditor qualification

TROSTEL, LTD. has internal auditors who are qualified to audit the requirements of this Technical Specification.

8.2.3 Monitoring and Measurement of Processes

TROSTEL, LTD. applies suitable methods for monitoring and where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action are taken appropriately to ensure conformity of the product to requirements.

8.2.3.1 Monitoring and measurement of manufacturing processes




TROSTEL, LTD. performs process studies 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 specifications, where applicable, for means of production, measurement and test, and maintenance instructions. These documents include objectives for manufacturing process capability, reliability, maintainability and availability, as well as acceptance criteria.

TROSTEL, LTD. maintains manufacturing process capability or performance as specified by the customer part approval process requirements. TROSTEL, LTD. ensures that the control plan and process flow diagram are implemented, including adherence to the specified

- measurement techniques,

- sampling plans,

- acceptance criteria, and

- reaction plans when acceptance criteria are not met.

Significant process events, such as tool change or machine repair, are recorded.

TROSTEL, LTD. initiates a reaction plan 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 by TROSTEL, LTD. to indicate specific timing and assigned responsibilities to assure that the process becomes stable and capable. The plans are reviewed and approved by the customer when so required.

TROSTEL, LTD. maintains records of effective dates of process changes.

8.2.4 Monitoring and Measurement of Product

TROSTEL, LTD. monitors and measures 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.

Evidence of conformity with the acceptance criteria is maintained. Records indicate the person(s) authorizing release of product.

Product release and service delivery does not proceed until specified activities have been satisfactorily completed, unless otherwise approved by the relative authority and/or the customer where applicable.




8.2.4.1 Layout inspection and functional testing

A layout inspection and a functional verification to applicable customer engineering material and performance standards are performed for each product as specified in the control plans. Results are available for customer review.

8.2.4.2 Appearance items

For TROSTEL, LTD.’s manufacturing parts designated by the customer as “appearance items”, TROSTEL, LTD. provide

- appropriate resources including lighting for evaluation,

- masters for color, grain, gloss, metallic brilliance, texture, distinctness of image, as appropriate,

- maintenance and control of appearance masters and evaluation equipment, and

- verification that personnel making appearance evaluations are competent and qualified to do so.

8.3 Control of Nonconforming Product

TROSTEL, LTD. ensures product that does not conform to requirements are identified and controlled to prevent unintended use or delivery. The activities, responsibilities and authorities for handling nonconforming product are defined in procedures. See Appendix A

Nonconformances are dealt with using one of the following methods

a) Taking action to eliminate the nonconformity;

b) Authorizing product use, release or acceptance under concession by relevant authority or customer, as applicable;

c) Taking action to preclude original intended use or application.

Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, are maintained.

When nonconforming product is corrected it is subject to re-verification to demonstrate conformity to the requirements.

When nonconformities are detected after delivery or product use, TROSTEL, LTD. takes action appropriate to the effects, or potential effects, of the nonconformity.




8.3.1 Control of nonconforming product – Supplemental

Product with unidentified or suspect status is classified as nonconforming product.

8.3.2 Control of reworked product

Instructions for rework, including re-inspection requirements, are accessible to and utilized by the appropriate personnel.

8.3.3 Customer information

Customers are informed promptly in the event that nonconforming product has been shipped.

8.3.4 Customer waiver

TROSTEL, LTD. obtains a customer concession or deviation permit prior to further processing whenever the product or manufacturing process is different from that which is currently approved.

TROSTEL, LTD. maintains a record of the expiration date or quantity authorized. TROSTEL, LTD. also ensures compliance with the original or superseding specifications and requirements when the authorization expires. Material shipped on an authorization is properly identified on each shipping container.

This applies equally to purchased product. TROSTEL, LTD. agrees with any requests from suppliers before submission to the customer.

8.4 Analysis of Data

TROSTEL, LTD. determines, collects and analyzes appropriate data to demonstrate the suitability and effectiveness of the quality management system and to identify improvements that can be made. This includes data generated by measuring and monitoring activities and other relevant sources.

Analysis of this data provides information on:

a) Customer satisfaction;




b) Conformance to product requirements;

c) Characteristics of processes, product and opportunities for preventive action;

d) Suppliers.

8.4.1 Analysis and use of data

Trends in quality and operational performance are compared with progress toward objectives and lead to action to support the following:

- development of priorities for prompt solutions to customer-related problems;

- determination of key customer-related trends and correlation for status review, decision-making and longer term planning;

- an information system for the timely reporting of product information arising from usage.

8.5 Improvement

8.5.1 Continual Improvement

TROSTEL, LTD. continually improves the effectiveness of the quality management system through the use of the quality policy, objectives, audit results, analysis of data, corrective and preventive action and management review.

8.5.1.1 Continual improvement of the organization

TROSTEL, LTD. shall define a process for continual improvement.

8.5.1.2 Manufacturing process improvement

Manufacturing process improvement continually focuses upon control and reduction of variation in product characteristics and manufacturing process parameters.

8.5.2 Corrective Action




TROSTEL, LTD. takes corrective action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective action is appropriate to the impact of the problems encountered.

The documented procedure for corrective action (See Appendix A) defines requirements for:

a) Reviewing nonconformities (including customer complaints);

b) Determining the causes of nonconformity;

c) Evaluating the need for actions to ensure that nonconformities do not recur;

d) Determining and implementing the corrective action needed;

e) Recording results of action taken;

f) Reviewing of corrective action taken.

8.5.2.1 Problem solving

TROSTEL, LTD. has a defined process for problem solving leading to root cause identification and elimination.

If a customer-prescribed problem-solving format exists, TROSTEL, LTD. uses the prescribed format.

8.5.2.1 Error-proofing

TROSTEL, LTD. uses error-proofing methods in their corrective action process.

8.5.2.2 Corrective action impact

TROSTEL, LTD. applies to other similar processes and products the corrective action, and controls implemented, to eliminate the cause of nonconformity.

8.5.2.3 Rejected product test/analysis

TROSTEL, LTD. analyzes parts rejected by the customer’s manufacturing plants, engineering facilities and dealerships. TROSTEL, LTD. minimizes the cycle time of this process. Records of these analyses are kept and made available upon request. TROSTEL, LTD. performs analysis and initiates corrective action to prevent recurrence.




8.5.3 Preventive Action

TROSTEL, LTD. identifies preventive action to eliminate the causes of potential nonconformities to prevent occurrence. Preventive actions taken are appropriate to the effects of the potential problems.

The documented procedure for preventive action (See Appendix A) defines requirements for:

a) Determining where potential problems may occur and their causes;

b) Evaluating whether or not action is needed to prevent occurrence of the nonconformity to other processes;

c) Determining and implementing action needed;

d) Recording results of action taken;

e) Reviewing preventive action taken.




Appendix A - Documented Procedures

Procedure Name Number

Documentation Of Tactical Procedures TPQA-001

Doc, Data and Records Control TPQA-002

Non-Conforming Materials TPQA-003

Internal Quality Audits TPQA-004

Training TPQA-005

Documentation Control Policy TPQA-006

Corrective and Preventive Action Process

TPQA-007




Appendix B – Organization Charts Organization Charts are maintained and kept by the Director of Human Resources.




Appendix C

CONTROLLED CIRCULATION

The Master Copy of the Quality Policy Manual is stored in “Autodesk Vault” . It shall be the final authority as to the amendment status for all sections in the manual. The access is read only to the manual and any printed copies are for reference only and may not be considered at the correct revision.

The Management Representative or designee is responsible for the maintenance of all controlled access to the Quality Policy Manual.




Appendix D

Continual Improvement Cycle of

The Quality Management System at Trostel

(A model of our process-based quality management system.)

Key Value-adding activities Information flow NOTE Statements in parentheses do not apply to ISO9001(2008).

(1. Trostel, Ltd. Top

Management 2. Corporate Quality 3. Divisional General Manager & Quality

Manager)

(People Training

Equipment)

Customers Requirements

(Approved Suppliers, APQP

process, Blueprints Customer

Specifications Packing

Requirements, PPAP, etc)

Customers (and other interested parties)

Satisfaction (PPM,

Customer Visits, Customer Surveys,

Corrective Actions, Internal

Audits, etc)

Output

Management Responsibility

Resource

management

Measurement,

analysis and

improvement

Product Realization

Product




Appendix E

Documentation Pyramid

Level 2 Tactical Procedures for Quality

Assurance – TPQA’s

Level 3 Standard Operating Procedures

Data Records Process Flow Forms, etc.

Level 1 Quality Policy

Manual – QPM Environmental Management

System – EMS Other Policies (i.e. safety, travel, etc.)




Appendix F AMENDMENT RECORD

This manual may contain only the pages issued and approved by the Management Representative. The Management Representative or designee will process all authorized changes. The Master Copy of the Quality Policy Manual is stored in “Autodesk Vault”.

The effective date of the latest revised section or element is the Issue date of the Policy Manual. Amendment Record List

Revision Effective Date

Description of Change(s)

REL 11/15/1995 Initial Release

A 12/12/1996 APQP was “Technical Marketing”. Engineering was “Product Engineering”. Process Validation was “Mold, Die, Equipment and Process Validation”. Purchasing was “Materials Management”. Restricted, Toxic or Hazardous Material Approval was numbered 7.0-70. Manufacturing and Material Control was “Materials Management”. Supplier Sample Submission was “DRAAPP”. Engineering was “Tool Engineering”.

B 7/23/1998 Product Development and Launch Process (PDLP) was Advanced Product Quality Planning (APQP). Project Management was APQP.

C 1/15/1999 Added QSA in Section 2.0 “QS-9000”. Y2K Compliance – 3.0c Added Y2K compliance statement to the introduction. 4.21 Production Part Approval Process deleted and moved into Element 4.2. 4.22 Continuous Improvement deleted and moved into Element 4.2. 4.23 Manufacturing Capabilities deleted and moved into Element 4.2. Added glossary.

D 02/22/2000 Updated to reflect organization change transferring tool management to the individual plants and updating Advanced Engineering to the Methods Team. Section 2.0 Added QS-9000 3rd Edition, PPAP 3rd Edition, QSA 2nd Edition. Section 3.0 Updated to state fully Y2K compliant. Section 4.2 Updated to include reference to 4.0-3 Custom Mixed Compound (PDLP). Change Advanced Engineering to Methods Team, Tool Engineering to Plant Engineering.

E 03/20/2002 Section 1.0 Removed Trostel Mission Statement paragraph and rewrote the Vision and Goal paragraphs. Section 4.1 changed title of procedure 9.0-05 and added procedure 9.0-30 and 10.0-20. Section 4.4 changed title of procedure 4.0-30. Section 4.5 changed title of procedure 4.0-30. Section 4.8 changed title of procedure 8.0-20. Section 4.10 Added reference of mixed compound in Section 4.10.6.3 and ISO

F

G

H I J

8/30/2003

10/20/03

11/10/03

06/21/04

05/20/05

Completely restructured quality policy manual to reflect structure and requirements of ISO/TS 16949:2002. Added Process Maps to Appendix Made revisions per the Desk Audit report Revised Process Flow diagram (pg 48) per surveillance audit finding June 21, 2004 5.5.2 Revised Management Representative due to Organizational change and updated process Roadmap.




K 04/24/06 Updated Process Road Map to include Engineering Design, Program, Process

L 09/29/06 Updated signature page for new Plant Manager (TMX)

M 5/15/07 Updated signature page for Plant Managers at MCD & TMX

N 8/28/07 Changed “Trostel Vision” to “Trostel Mission” on page 2 along with Bruce Betters as President and CEO.

P 2/3/09 Updated process roadmap to reflect no production at Lake Geneva facility. Updated org. chart for business units. Updated management representative & customer representatives

Q 10/23/09 Updated process road map to include LG lab testing. Remove Nate Salasis as Plant Manager - TMX

R 12/4/09 Updated for TS16949 (2009)(E) and ISO9001 (2008)

S 04/16/2010 Updated Appendix G

T 9/20/11 Addition of Trostel Texas and Power Business Unit

U 9/24/12 Updated to reflect current organization. Management representative and Customer representative updated.

V 12/20/12 Updated Process Road map, Quality Policy Statement and Mission Statement.

W 11/5/13 Updated the High Level Process Map, Updated signature page with Steve Dyer as President and CEO, Updated the Trostel Quality Policy and Mission statement, added TPQP-006 and 007.

X 1/28/14 Updated documentation pyramid, Appendix E. Updated the customer representative section 5.5.2.1., updated scope and exclusions p.2, updated page 5 to remove division wording and details of organization charts, added Appendix H and I,

molding and compounding process interaction maps.




Appendix G High Level Process Map




Appendix H Molding Process Interaction Map

Material

Business Planning & Objectives

Management Review

Cu

sto

mer

Custom

er

OrderEntry

Purchase Order

Supplier

PurchasingMaterial Requests

Purchase Order

InventoryMgt.

Shipping

Receiving

Purchased Products

APQP ProcessAPQP001

RFQ

Customer Satisfaction

Customer complaintsCustomer Surveys

Supplier AssessmentsProduct Return

InternalAudits

TPQA-004Corrective & Preventive

ActionsTPQA-007

Control of Non-

Conforming Products

TPQA-003

Continuous Improvement

Personnel & skills

TPQA-005

Facilities Management

Equipment & tooling

maintenance

Information System

Po

licie

s &

Dir

ect

ion

s

Quotes

Finance

Manufacturing

Spe

cifi

cati

on

s,

Co

ntr

ol P

lan

s,

Inst

ruct

ion

s, e

tc.

SchedulingRequirements

Received Products

Meterials

Finished Goods

Packaged Finished Products

MetrologyProduct Tests

& ResultsBilling Invoices

Payments

Shipper

PPAP

Corporate Support Process Site Process




Appendix I Compounding Process Interaction Map

Material

Business Planning & Objectives

Management Review

Cu

sto

mer

Custom

er

OrderEntry

Purchase Order

Supplier

PurchasingMaterial Requests

Purchase Order

InventoryMgt.

Shipping

Receiving

Purchased Products

L0025 (Custom Mix)RFQ

Customer Satisfaction

Customer complaintsCustomer Surveys

Supplier AssessmentsProduct Return

InternalAudits

TPQA-004Corrective & Preventive

ActionsTPQA-007

Control of Non-

Conforming Products

TPQA-003

Continuous Improvement

Personnel & skills

TPQA-005

Facilities Management

Equipment & tooling

maintenance

Information System

Po

licie

s &

Dir

ect

ion

s

Quotes

Finance

Manufacturing

Spe

cifi

cati

on

s,

Co

ntr

ol P

lan

s,

Inst

ruct

ion

s, e

tc.

SchedulingRequirements

Received Products

Material

Packaged Finished Products

Billing Invoices

Payments

Shipper

Trial

Quality Control

Corporate Support Process Site Process

Quality Manual Trostel

Documents

Transcript of Quality Manual Trostel