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Trostel, Ltd.

Quality Manual Uncontrolled copy if printed


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Date of Issue: January 28 , 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.

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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.

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Quality Policy Manual Index


ISO/TS16949:2009 (E)
Section/Clause

TITLE

PAGE

N/A

Purpose of Quality Manual

5.3

Quality Policy/Vision Statement/


Scope and Exclusions

N/A

Quality Policy Manual Index

3-5

Quality Management System

4.1

General Requirements

4.2

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

6-8

Management Responsibility

5.1

Management Commitment

5.2

Customer Focus

5.3

Quality Policy

5.4

Planning
* 5.4.1 Quality Objectives
* 5.4.2 Quality Management System Planning

10

5.5

Responsibility, Authority and Communication


* 5.5.1 Responsibility and Authority
* 5.5.2 Management Representative
* 5.5.3 Internal Communication

10 - 11

5.6

Management Review
* 5.6.1 General
* 5.6.2 Review Input
* 5.6.3 Review Output

11-12

6
6.1

Resource Management
Provisions of Resources

13
13

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Quality Policy Manual Index


ISO/TS16949:2009 (E)
Section/Clause

TITLE

PAGE

6.2

Human Resources
* 6.2.1 General
* 6.2.2 Competence, Awareness and Training

13-14

6.3

Infrastructure

14-15

6.4

Work Environment

15

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
* 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

23 - 25

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* 7.5.5 Preservation of Product


Quality Policy Manual Index
ISO/TS16949:2009 (E)
Section/Clause

TITLE

7.6

Control of Monitoring and Measuring Devices

30 - 32

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
* 8.5.1 Continual Improvement
* 8.5.2 Corrective Action
* 8.5.3 Preventive Action

39 - 41

----

Appendixes
A. Documented Procedures
B. Organizational Charts-See file
C. Controlled Circulation
D. Continuous Improvement Cycle
E. Documentation Pyramid
F. Amendment Record
G. Process Road Map
H. Molding Process Interaction Map
I. Compounding Process Interaction Map

42 - 51
42
43
44
45
46
47 - 48
49
50
51

PAGE

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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 SOPs 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)
b)
c)
d)

Documented statements of a quality policy and quality objectives;


A quality manual;
Documented procedures that are required by ISO/TS 16949:2009, See Appendix A;
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.

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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
SOPs. 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)
b)
c)
d)
e)
f)

Approve documents for adequacy prior to their issue;


Review and update as necessary and to re-approve documents,
Ensure that changes and the current revision status of documents are identified,
Ensure that relevant versions of applicable documents are available at points of use,
Ensure that documents remain legible and are readily identifiable;
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

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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.

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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.

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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 SOPs 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.

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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)
b)
c)
d)

Special characteristics;
Setting quality objectives and related training;
Corrective and preventative actions;
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.

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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)
b)
c)
d)
e)
f)
g)
h)
i)

The results of audits;


Customer feedback;
Process performance and product conformity;
The status of preventive and corrective actions;
Follow-up actions from previous management reviews;
Planned changes that could affect the quality management system; and
Recommendations for improvement;
Input from other TROSTEL, LTD.. employees;
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.

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6 RESOURCE MANAGEMENT
6.1

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

6.2

a)

Increase efficiency;

b)

implement, maintain and improve the quality system;

c)

enhance customer satisfaction by meeting or exceeding customer


requirements.

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...

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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).

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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.

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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.

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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;

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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.

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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;
The responsibilities and authorities for design and/or development activities.

c)

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)
b)
c)
d)

Functional and performance requirements;


Applicable regulatory and legal requirements;
Applicable information derived from previous similar designs; and
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

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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
7.3.2.3

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.

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 customers special characteristic symbol or
the organizations 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)
b)
c)

Meets the design and/or development input requirements;


Provides appropriate information for production and service operations;
Contains or references product acceptance criteria;

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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)
b)

Evaluate the ability of the results to fulfill requirements;


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.

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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

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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 SOPs. 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

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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,

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part evaluation by a designated laboratory,

another method agreed with the customer.

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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.

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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;

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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.

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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.

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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.

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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.

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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.

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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:

7.6.3.2

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.

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.

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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:

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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. Followup 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.

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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

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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.

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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

8.3

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.

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.

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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;

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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:

8.5

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.

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

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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 customers 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.

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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.

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Appendix A - Documented Procedures


Procedure Name
Documentation Of Tactical Procedures
Doc, Data and Records Control
Non-Conforming Materials
Internal Quality Audits
Training
Documentation Control Policy
Corrective and Preventive Action
Process

Number
TPQA-001
TPQA-002
TPQA-003
TPQA-004
TPQA-005
TPQA-006
TPQA-007

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Appendix B Organization Charts

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

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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.

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Appendix D

Continual Improvement Cycle of


The Quality Management System at Trostel

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


(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)

Management
Responsibility

Measurement,
analysis and
improvement

Resource
management

Product
Realization

Product

Satisfaction
(PPM,
Customer Visits,
Customer
Surveys,
Corrective
Actions, Internal
Audits, etc)

Output

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

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Appendix E

Documentation Pyramid

Level 1
Quality Policy
Manual QPM
Environmental
Management
System EMS
Other Policies (i.e.
safety, travel, etc.)
Level 2
Tactical Procedures for Quality
Assurance TPQAs

Level 3
Standard Operating Procedures
Data Records
Process Flow
Forms, etc.

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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
A

11/15/1995
12/12/1996

7/23/1998

1/15/1999

02/22/2000

Initial Release
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.
Product Development and Launch Process (PDLP) was Advanced Product Quality
Planning (APQP).
Project Management was APQP.
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.
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.

03/20/2002

8/30/2003

10/20/03

Added Process Maps to Appendix

11/10/03

Made revisions per the Desk Audit report

06/21/04

Revised Process Flow diagram (pg 48) per surveillance audit finding June 21, 2004

05/20/05

5.5.2 Revised Management Representative due to Organizational change and


updated process Roadmap.

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
Completely restructured quality policy manual to reflect structure and requirements
of ISO/TS 16949:2002.

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04/24/06

Updated Process Road Map to include Engineering Design, Program, Process


Updated signature page for new Plant Manager (TMX)

09/29/06

5/15/07

Updated signature page for Plant Managers at MCD & TMX

8/28/07

2/3/09

10/23/09

Changed Trostel Vision to Trostel Mission on page 2 along with Bruce Betters as
President and CEO.
Updated process roadmap to reflect no production at Lake Geneva facility. Updated
org. chart for business units. Updated management representative & customer
representatives
Updated process road map to include LG lab testing. Remove Nate Salasis as Plant
Manager - TMX

12/4/09

04/16/2010

Updated for TS16949 (2009)(E) and ISO9001 (2008)


Updated Appendix G

9/20/11

Addition of Trostel Texas and Power Business Unit

9/24/12

12/20/12

Updated to reflect current organization. Management representative and Customer


representative updated.
Updated Process Road map, Quality Policy Statement and Mission Statement.

11/5/13

1/28/14

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.
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.

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High Level Process Map

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Appendix H

Molding Process Interaction Map

Business
Planning &
Objectives
Equipment &
tooling
maintenance

Facilities
Management

Management
Review
Control of
NonConforming
Products
TPQA-003

Finance

Policies & Directions

Personnel &
skills
TPQA-005

Approved by: Greg Vassmer


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Information
System

Internal
Audits
TPQA-004

Corrective &
Preventive
Actions
TPQA-007

Continuous
Improvement

Customer
Satisfaction

Customer complaints
Customer Surveys
Supplier Assessments
Product Return

Material

Finished Goods

Order
Entry

Purchase Order

Scheduling
Requirements

Manufacturing

Meterials

Inventory
Mgt.

Specifications,
Control Plans,
Instructions, etc.

Material Requests

RFQ

Quotes

Purchasing

Product Tests
& Results

Metrology

Receiving

Packaged
Finished Products

Shipping

Shipper

Billing

Invoices
Payments

Purchase
Order

APQP Process
APQP001

Supplier

Purchased Products

PPAP

Corporate Support Process

Site Process

Customer

Customer

Received Products

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Appendix I

Compounding Process Interaction Map

Business
Planning &
Objectives
Equipment &
tooling
maintenance

Facilities
Management

Control of
NonConforming
Products
TPQA-003

Management
Review

Finance

Policies & Directions

Personnel &
skills
TPQA-005

Approved by: Greg Vassmer


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Information
System

Corrective &
Preventive
Actions
TPQA-007

Continuous
Improvement

Internal
Audits
TPQA-004

Customer
Satisfaction

Customer complaints
Customer Surveys
Supplier Assessments
Product Return

Material

Quality Control

Order
Entry

Purchase Order

Scheduling
Requirements

Manufacturing

Material

Inventory
Mgt.

Material Requests

Purchasing

Specifications,
Control Plans,
Instructions, etc.

Receiving

RFQ

Quotes

Packaged
Finished Products

Shipping

Shipper

Billing

Invoices
Payments

Purchase
Order

L0025 (Custom Mix)

Supplier

Purchased Products

Trial

Corporate Support Process

Site Process

Customer

Customer

Received Products

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