Beruflich Dokumente
Kultur Dokumente
th
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.
th
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.
th
TITLE
PAGE
N/A
5.3
N/A
3-5
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
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
th
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
7.2
7.3
7.4
Purchasing
* 7.4.1 Purchasing Process
* 7.4.2 Purchasing Information
* 7.4.3 Verification of Purchased Product
7.5
23 - 25
th
TITLE
7.6
30 - 32
33
8.1
General
33
8.2
8.3
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
th
th
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.
th
Records retention
th
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.
th
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
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
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.
Revision: X
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.
5.6.1.1
th
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)
5.6.2.1
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.
th
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)
c)
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.
b)
c)
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)
Revision: X
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)
b)
c)
th
Work Environment
TROSTEL, LTD. has determined and manages the work environment needed to fulfill
obligations and achieve conformity to product requirements.
Cleanliness of premises
TROSTEL, LTD. maintains its premises in a state of order, cleanliness and repair consistent
with the product and manufacturing process needs.
th
7 Product Realization
7.1
b)
c)
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.
th
Customer-Related Processes
b)
Requirements not specified by the customer but necessary for intended use;
c)
d)
b)
c)
th
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)
b)
Product information;
c)
d)
th
b)
c)
7.3.2
Revision: X
Special characteristics
Revision: X
d)
Defines the characteristics of the product that are essential to its safe and
proper use.
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.
th
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.
th
7.4
Purchasing
Revision: X
b)
c)
Revision: X
b)
c)
d)
e)
f)
a control plan for pre-launch and production that takes into account the design
FMEA and manufacturing process FMEA outputs.
Revision: X
Initiates the specified reaction plan when the process becomes unstable or
not statistically capable.
Revision: X
set-up;
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.
th
th
7.6
th
Revision: X
Revision: X
7.6.3.2
External laboratory
When a qualified laboratory is not available for a given piece of equipment, calibration may be
performed by the equipment manufacturer.
Revision: X
General
TROSTEL, LTD. has planned and implemented the measurement, monitoring,
analysis and improvement activities needed to:
a)
b)
c)
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
8.2.1.1
Revision: X
b)
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
8.2.2
th
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
8.2.2.4
Revision: X
measurement techniques,
sampling plans,
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.
Revision: X
8.3
b)
c)
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.
th
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;
Revision: X
b)
c)
d)
Suppliers.
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
th
b)
c)
Evaluating the need for actions to ensure that nonconformities do not recur;
d)
e)
f)
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
8.5.2.3
th
b)
c)
d)
e)
th
Number
TPQA-001
TPQA-002
TPQA-003
TPQA-004
TPQA-005
TPQA-006
TPQA-007
th
Organization Charts are maintained and kept by the Director of Human Resources.
th
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.
Revision: X
Appendix D
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).
th
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.
th
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.
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
11/10/03
06/21/04
Revised Process Flow diagram (pg 48) per surveillance audit finding June 21, 2004
05/20/05
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.
th
04/24/06
09/29/06
5/15/07
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
9/20/11
9/24/12
12/20/12
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.
Appendix G
th
Revision: X
Appendix H
Business
Planning &
Objectives
Equipment &
tooling
maintenance
Facilities
Management
Management
Review
Control of
NonConforming
Products
TPQA-003
Finance
Personnel &
skills
TPQA-005
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
Site Process
Customer
Customer
Received Products
Revision: X
Appendix I
Business
Planning &
Objectives
Equipment &
tooling
maintenance
Facilities
Management
Control of
NonConforming
Products
TPQA-003
Management
Review
Finance
Personnel &
skills
TPQA-005
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
Supplier
Purchased Products
Trial
Site Process
Customer
Customer
Received Products