IATF Quality Management System Manual (Telamon)
IATF Quality Management System Manual (Telamon)
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Telamon Corporation
Dayton, OH
Fresnillo, MX
Skopje, MK
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TABLE OF CONTENT
Foreword………….…………………………………………………..…………………….…………3
1.0 - Scope………………………………………………………………………………………….….3
2.0 – Normative References..…………………………………………………………………...….3
3.0 – Fundamentals…….…………………………………………………………….………..…4-5
4.0 – Context of Organization…….….…………………………………………….…….…………6
4.1 Understanding of the organization and its context
4.2 Needs and expectations of interested parties
4.3 Scope of the QMS
4.4 QMS and its processes
5.0 – Leadership.……………………………………………………………..………………..……..8
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities and authorities
6.0 – Planning…..………………………..………………………..………….…….……………..…..12
6.1 Actions to address risks and opportunity
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7.0 – Support……………………………..…………..………….……………….………………..…...14
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8.0 – Operation…….…………………………..………………………………..………………..…….21
8.6 Release of products and services
8.7 Control of nonconforming outputs
9.0 – Performance evaluation………………………………………………………………………..38
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
10.0 – Improvement…………………………………………………………………………………….43
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
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Foreword
The purpose of this manual is to describe the policies and company-wide control structure of the Quality
Program that is used to achieve our corporate mission.
The Telamon Corporation's Quality Program is based on the requirements of the International
Organization for Standardization as defined in the ISO 9001:2015 standard and IATF16949:2016.
Telamon Corporation in this Quality Manual includes the Telamon Industrial Solutions division located in:
• Carmel, IN,
Telamon Industrial Solutions Corporation is referred to in the balance of this manual as "Telamon", and its
Quality Program as Telamon Quality Program. Where applicable, reference may be made to a specific
location exclusively, as outlined above.
B. The methodology known as “Plan-Do-Check-Act” as shown in the ISO 9001:2015 standard, and below, can
be applied to Telamon’s processes.
• Plan: Context of organization; Leadership; Planning; Support
• Do: Operation
• Check: Perform evaluation
• Act: Improvement
2. Normative References-The following documents, in whole or in part, are normatively referenced in this
document and are indispensable for its application. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
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To meet the requirements of ISO 9001:2015 the following applicable elements have been implemented and maintained in
this Quality Manual:
4.0 – Context of the Organization
4.1 Understanding of the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
5.0 - Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities and authorities
6.0 – Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7.0 – Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8.0 – Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products and services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of non-conforming process outputs
9.0 Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
Certification/Registration
Telamon demonstrates conformance to the ISO requirements by successfully completing third-party registration audits by
an accredited ISO registrar. For each three-year interval, 100% of Telamon’s entire scope that is registered and all
applicable requirements and measurements are assessed, unless an alternative method is implemented. Telamon
demonstrates conformance to the ISO9001:2015 requirements by successfully completing third-party registration audits
by an accredited ISO9001:2015 registrar.
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Internal
Issue Requirement Carmel Dayton Fresnillo Skopje
Contracts with Customers’ and Ensure contracts X X
Suppliers are complied with.
Customer Satisfaction Meet Customer X X X X
goals
Organizational Structure Structure to meet X X
requirement/goals
Organizational Culture Lean Culture X X X
Organizational Values H2S2 X
External
Issue Carmel Dayton Fresnillo Skopje
Governmental Regulations Labor Laws X X X X
Governmental
Safety
Market Conditions/ Economic Shifts Resource X X X X
Adjustments
Changes in Technologies Benchmarking X X
Competition Benchmarking X X
Telamon monitors and reviews the information about these external and internal issues. Issues include positive and
negative factors or conditions for consideration. Understanding the external context is facilitated by considering issues
arising from legal, technological, competitive, market, cultural, social, and economic environments, whether international,
national, regional or local. Understanding the internal context is facilitated by considering issues related to values, culture,
knowledge and performance of the organization. This formal review is performed, at a minimum; annually to ensure
relevance for these factors. Records of this review are documented as an addendum to T-05-F02.A Management
Review Action Register.
Telamon has
a) identified the processes needed for the quality management system and their application throughout Telamon. The
high level processes are shown in the flow and tables following clause 10.3 at the end of this manual.
b) determined the sequence and interaction of these processes (see table)
c) determined the criteria and methods needed to ensure that both the operation and control of these processes are
effective according to the following Process Map on the next page.
d) ensured the availability of resources and information necessary to support the operation and monitoring of these
processes according to Planning: Actions to Address Risks and Opportunities (TIS-P000010A.RA )
e) monitored, measured and analyzed these processes according to Management Review
f) implemented actions necessary to achieve planned results and continual improvement of these processes
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b) the requirements of these interested parties that are relevant to the quality management system as seen, for
example, in contracts and master agreements and defined operational/financial goals.
Telamon monitors and reviews the information about these interested parties and their relevant requirements. This may
be done by individual departments or at the executive level, and in joint meetings with the parties. For example, Quarterly
Business Reviews may be held with clients to review Telamon’s performance to expectations. Interested parties matrix
form TIS-F0219 for Fresnillo plant will be found in a separated document.
The scope of this manual applies to the operations of Telamon Industrial Solutions Group (ISG) at 600 N. Irwin Street,
Dayton, OH 45403, including the manufacture and service of our products. Products included in the scope of
registration include:
Telamon ISG – Dayton provides support to Telamon ISG – Fresnillo, MX & Telamon ISG – Skopje in the following areas:
Sales, Engineering/Process Design, APQP, Purchasing, Management Review, Policy Making, QMS Management.
Telamon Corporate (Carmel, IN) provides support to the Dayton facility in the areas of Internal Auditing and Management
Review.
The Quality Management System implemented at Telamon ISG, upholds the entirety of the IATF 16949 Standard with the
exclusion of product design. As a contract manufacturing organization, Telamon builds product to our customers
designed drawings and specifications with no input on product design.
The scope of this manual also applies to the operations of Telamon ISG-Fresnillo, at Circuito Plan De Fresnillo, #3 Parque
Industrial Fresnillo, Fresnillo, Zacatecas MX 99059 & Telamon ISG-Skopje, at Str. 8 Indjikovo No. 24, Skopje, MK,
including the manufacture of our products. Products included in the scope of registration include
• Wire Harnesses
The QMS implemented at Telamon ISG-Fresnillo & Telamon ISG-Skopje, upholds the entirety of the IATF 16949
Standard, with the exclusion of Product Design. Telamon ISG-Fresnillo & Telamon ISG-Skopje receive support from
Telamon ISG – Dayton in the following areas: Sales, Engineering/Process Design, APQP, Purchasing, Management
Review, Policy Making, QMS Management. Further support is received from Telamon Corporate (Carmel, IN) in the
areas of Internal Auditing and Management Review.
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4.3.1
Supporting functions:
Telamon Corporate Quality provides support for Internal Auditing and compliance.
Telamon Core Management provides support for Management Review, including resource management and
Business Planning.
4.4.1
Telamon has established, implemented, maintains and continually improves its Quality Management System, including
the processes needed and their interactions. (see the flow and tables following clause 10.3 at the end of this manual)
Telamon has determined the processes needed for the QMS and their application throughout Telamon’s organization and
has determined:
a) Inputs required and the outputs expected from these processes
b) The sequence and interactions of these processes;
c) The criteria, methods, including monitoring, measurements and related performance indicators needed to
ensure the effective operation, and control of these processes;
d) The resources needed for these processes and to ensure their availability;
e) The assignment of the responsibilities and authorities for these processes;
f) The risks and opportunities in accordance with the requirements of 6.1, and plan and implement the
appropriate actions to address them;
g) The methods for monitoring, measuring, as appropriate, and evaluation of processes and, if needed, the
changes to processes to ensure that they achieve intended results;
h) Opportunities for improvement of the processes and the quality management system.
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4.4.2
Telamon maintains documented information to the extent necessary to support the operation of processes and retain
documented information to the extent necessary to have confidence that the processes are being carried out as planned.
See Documented Information TIS-D000001A, for the definition of the controls needed for the identification, storage,
protection, retrieval, retention time and disposition of records.
5. Leadership
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h) Ensuring that the quality management system achieves its intended results;
i) Engaging, directing and supporting persons to contribute to the effectiveness of the quality management
system;
j) Promoting continual improvement;
k) Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of
responsibility.
Monthly Business unit meetings are held and actions documented to facilitate improvement and track the operational
performance to goals.
NOTE: Reference to business can be interpreted broadly to mean those activities that are core to the purpose of the
organization’s existence, weather the organization is public, private, for profit or not-for-profit.
This is done at Executive Committee Meetings and regularly scheduled reviews with the Business Unit Leaders
and Corporate Staff Leaders. Reviews may include discussions on financial status, customer feedback,
processes, risks, personnel and resource needs
5.2 Policy
Telamon's Quality management system which is described in this manual, has been developed and implemented
and is fully supported by Management, and is understood throughout Telamon.
Telamon Confidential and Proprietary Information
Hard Copies Authorized ONLY for Revisions or Redlines
H2S2 – Honesty, Harmony, Simplicity, Stewardship
Quality Management System Manual
IATF TIS Dayton/Fresnillo/Skopje 21-DEC-18
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Telamon’s Vision
Because the quality of our products and services is and will continue to be the key to Telamon's
competitiveness, it is increasingly vital for all of us at Telamon to understand and use our quality management
system to do the best job, the first time and every time.
Telamon Corporate Values
We practice:
Honesty--We build long-term customer relationships based on integrity and trust.
Harmony--We work with internal teams, suppliers, and customers with the common goal
of meeting our customers’ needs.
Simplicity --We use the latest technology, tools, and training to streamline
processes in order to improve our service.
Stewardship --We deliver for those we untrusted us.
H2S2
Honesty Harmony Simplicity Stewardship
Telamon’s goals are to reduce our facility’s carbon footprint, to use environmentally responsible vendors and
products, to reduce landfill disposal, and to increase recycling. Our efforts also include reducing the amount of
documentation that is printed by our company, investing in enterprise project management systems and
workflow capabilities, and reducing our use of electricity.
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a) Ensuring that the quality management system conforms to the requirements of the ISO Standard;
b) Ensuring that the processes are delivering their intended outputs;
c) Reporting on the performance of the quality management system, on opportunities for improvement, in
particular to top management;
d) Ensuring the promotion of customer focus throughout the organization;
e) Ensuring that the integrity of the quality management system is maintained when changes to the quality
management system are planned and implemented
The high level Organization Chart is established by the Executive Management Committee and published through
a Companywide email. The individual Business Units identify their director reports and employees, and
communicate that to their teams. This may be done in an organization chart or a job description. Changes in the
high level organization’s structure will be shown in this manual, on the following page.
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5.3.2 Responsibility and authority for product requirements and corrective actions
Top management has ensured that:
a) All Personnel are responsible for conformity to product requirements and have the authority to stop shipment and
stop production to correct quality problems;
NOTE: due to the process design in some industries, it might not always be possible to stop production
immediately. In this case, the affected batch must be contained and shipment to the customer prevented.
b) The V.P. of Quality, with authority and responsibility for corrective action is promptly informed of product or
processes that do not conform and that all potential nonconforming product is identified and contained;
c) Production operations across all shifts are staffed with personnel in charge of, or delegated responsibility for,
ensuring conformity to product requirements.
6. Planning
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Telamon established a process to lessen the impact of negative effects of risk including the following:
a) Determining potential nonconformities and their causes;
b) Evaluating the need for action to prevent occurrence of nonconformities;
c) Determining and implementing action needed;
d) Documented information of action taken;
e) Reviewing the effectiveness of the preventive action taken;
f) Utilizing lessons learned to prevent recurrence in similar processes (reference ISO9001, section 7.1.6)
See Guidelines for PFMEA
The contingency plan includes provision to validate that the manufactured product continues to meet customer
specifications after the re-start of production following an emergency in which production was stopped and if the
Regular shutdown processes were not followed.
See Shut down Audit results
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6.2.2
When planning how to achieve its quality objectives, Telamon has determined:
a) What will be done
b) What resources will be required
c) Who will be responsible
d) When it will be completed
e) How the results will be evaluated
The results of Telamon’s review regarding interested parties and their relevant requirements are considered when
Telamon established its annual (at a minimum) quality objectives and related performance targets (internal and external)
7. Support
7.1 Resources
7.1.1 General
Telamon has determined and provided the resources needed for the establishment, implementation, maintenance and
continual improvement of the quality management system.
Telamon has considered:
a) the capabilities of, and constraints on, existing internal resources;
b) what needs to be obtained from external providers
7.1.2 People
Telamon has determined and provides the persons necessary for the effective implementation of our quality management
system and for the operation and control of our processes.
7.1.3 Infrastructure
Telamon has determined, provides and maintains the infrastructure necessary for the operation of our processes and to
achieve conformity of products and services
NOTE: Infrastructure can include:
a) buildings and associated utilities:
b) equipment including hardware and software
c) transportation resources- for supplies only
d) information and communication technology
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product, and
b) facilitates synchronous material flow, as applicable.
Methods are developed and implemented to evaluate manufacturing feasibility for new product or new operations.
Manufacturing feasibility assessments include capacity planning. These methods are applicable for evaluating proposed
changes to existing operations.
Telamon maintains process effectiveness, including periodic re-evaluation relative to risk, to incorporate any changes
made during process approval, control plan maintenance (refer to section 8.5.1.1), and verification of job set-ups (section
8.5.1.3)
Assessments of manufacturing feasibility and evaluation of capacity planning are inputs to management reviews (section
9.3)
NOTE 1 – includes application of lean manufacturing principles
NOTE 2 – apply to on-site supplier activities, as applicable
NOTE A suitable environment for the operation of processes can be a combination of physical factors, such as:
a) social (e.g. non-discriminatory, calm, non-confrontational);
b) psychological (e.g. stress-reducing, burn-out prevention, emotionally protective);
c) physical (temperature, humidity, light, airflow, hygiene, noise)
These factors can differ substantially depending on the products and services provided.
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Telamon ensures that the calibration/ verification activities and records include:
• revisions following engineering changes that impact measurement systems,
• any out-of-specification readings as received for calibration/verification,
• an assessment of the risk of the intended use of the product caused by the out-of-specification condition,
• when a piece of inspection measurement and test equipment is found to be out of calibration or defective
during its planned verification or calibration or during use, documented information on the validity of the
previous measurement results obtained with this piece of inspection measurement and test equipment is
retained, including the associated standard’s last calibration date and the next due date on the calibration
report;
• notification to the customer if suspect product or material has been shipped;
• equipment identification, including the measurement standard against which the equipment is calibrated,
• statements of conformity to specification after calibration/verification;
• verification that the software used for production and process control is as specified;
• records of the calibration and maintenance activities for all gauging (including employee-owned equipment,
customer-owned equipment, or on-site supplier-owned equipment);
• production related software verification used for product and process control (including software installed on
employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipment).
The following equipment is available in the laboratory to perform the tests, evaluations, and calibrations identified above:
• Profilometers - Surface Finish
• Optical Vision System - Dimensional Measurement
• Coordinate Measuring Machines (CMM) - Dimensional measurement, Gage Calibrations, and Gage R&R
• Standard Measuring Instruments ( calipers, micrometers, etc…) - Dimensional Measurement.
• Granite Surface Plates - Dimensional Measurement
• Height Stands w/ Indicators - Dimensional Measurement
• Gage Blocks - Dimensional Measurements and Calibration
• Mic Master - Calibration
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The following is the list of standards that are followed in performing the tests, evaluations, and calibrations identified
above (latest revision are assumed where applicable):
The inspections and calibrations listed above have been verified capable to be performed in the laboratory of Telamon as
a result of the following:
• The instruments used for inspections and calibrations are either standard equipment that does not require special
instruction, or specialized instruction and training has been provided
• The individuals specifying the inspection, tests, and calibrations have used specialized training, past work
experience and knowledge in defining those methods
• The individuals performing the inspections, tests, and calibrations have had either specialized training or have
had sufficient work experience in performing them
• The methods used in performing the inspections, tests and calibrations have proven effective in maintaining an
acceptable level of quality on all outgoing products. No history exists of quality issues arising due to incorrect
inspection, tests, or calibration methods being used
When a qualified laboratory is not available for a given piece of equipment, calibration services may be performed by the
equipment manufacturer. In such cases, Telamon ensures that the requirements listed in 7.15.3.1 have been met.
Use of calibration services, other than by qualified (or customer accepted) laboratories, may be subject to government
regulatory confirmation, if required.
Note 1 Organizational knowledge is knowledge specific to Telamon. It is generally gained by experience. It is information
that is used and shared to achieve Telamon’s objectives.
Note 2 Telamon’s organizational knowledge can be based on:
a) internal sources (e.g. learning from failures and successful projects, capturing undocumented knowledge and
experience; the results of improvements in processes, products and services)
b) external sources (e.g. standards, academia, conferences, gathering knowledge from customers or external
providers)
Telamon Confidential and Proprietary Information
Hard Copies Authorized ONLY for Revisions or Redlines
H2S2 – Honesty, Harmony, Simplicity, Stewardship
Quality Management System Manual
IATF TIS Dayton/Fresnillo/Skopje 21-DEC-18
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7.2 Competence
Telamon has:
a) determined the necessary competence of personnel performing work under its control that affects its
performance and the effectiveness of the quality Management System;
c) ensured that these persons are competent on the basis of appropriate education, training, or experience.
where applicable, taken actions to acquire the necessary competence, and evaluated the effectiveness of
the actions taken;
d) retained appropriate documented information as evidence of competence
NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the re-
assignment of currently employed persons; or the hiring or contracting of competent persons
Quality management System auditors, manufacturing process auditors, and product auditors are all able to demonstrate
the following minimum competencies:
a) understanding of the automotive process approach for auditing, including risk-based training;
b) understanding of applicable customer-specific requirements;
c) understanding of applicable ISO9001 and IATF 16949 requirements related to the scope of the audit;
d) understanding of applicable core tool requirements related to the scope of the audit;
e) understanding how to plan, conduct, report, and close our audit findings.
Additionally, manufacturing process auditors are able to demonstrate technical understanding of the relevant
manufacturing process(es) to be audited, including process risk analysis (such as PFMEA) and control plan. Product
auditors are able to demonstrate competence in understanding product requirements and use of relevant measuring and
test equipment to verify product conformity.
Where training is provided to achieve competency, documented information is retained to demonstrate the trainer’s
competency with the above requirements.
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met customer specific requirements for auditor qualification and demonstrate the minimum following core competencies,
including understanding of:
a) the automotive process approach to auditing, including risk based thinking;
b) applicable customer and organization specific requirements;
c) applicable ISO9001 and IATF 16949 requirements related to the scope of the audit;
d) applicable manufacturing process(es) to be audited, including PFMEA and control plan;
e) applicable core tool requirements related to the scope of the audit;
f) how to plan, conduct, prepare audit reports, and close out audit findings.
7. 3 Awareness
Persons doing work under Telamon’s control are aware of:
a) the quality policy
b) relevant quality objectives
c) their contribution to the effectiveness of the quality management system, including the benefits of improved quality
performance
d) the implications of not conforming with the quality management system requirements
Telamon has 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 industrial manufacturing organization. Employees are made aware of quality and delivery status
through a variety of meeting forums and informal communications. Production status, productivity & quality are tracked in
each work center. The work centers also have charts where suggestions can be recorded and implementation can be
tracked.
Telamon has 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. Quality measurements are posted in the
industrial manufacturing area to show production output, quality alerts, OTD, safety and PPM at minimum. Employees
also may share in a monetary incentive program.
7.4 Communication
Telamon has determined the internal and external communications relevant to the quality management system including:
a) on what it will communicate
b) when to communicate
c) with whom to communicate
d) how to communicate
e) who communicates
7.5 Documented Information: information required to be controlled and maintained by Telamon and the medium on
which it is contained
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7.5.1 General
Telamon’s quality management system includes
a) documented information required by the ISO9001:2015 standard
b) documented information determined by Telamon as being necessary for the effectiveness of the quality
management system
7.5.3.2 For the control of documented information, Telamon has addressed the following activities, as applicable:
a) distribution, access, retrieval and use
b) storage and preservation, including preservation of legibility
c) control of changes (e.g. version control)
d) retention and disposition
Documented information of external origin determined by Telamon to be necessary for the planning and operation of the
quality management system is identified as appropriate, and controlled.
NOTE Access can imply a decision regarding the permission to view the documented information only, or the permission
and authority to view and change the documented information
When an engineering standard/ specification change results in a product design change, see 8.3.6. When an engineering
standard/ specification change results in a product realization process change, refer to section 8.5.6.1. Telamon retains a
record of the date on which each change is implemented in production. Implementation includes updated documents.
Review is completed within 10 working days of receipt of notification of engineering standards/ specifications changes.
NOTE A change in these standards/ specifications may require an updated record of customer production part approval
when these specifications are referenced on the design record or if they affect documents of the production part approval
process, such as control plan, risk analysis (such as FMEAs), etc.
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8 Operation
Where the customer provides no documented statement of requirement, the customer requirements are confirmed by the
organization before acceptance by Telamon’s point of contact for that customer -
Telamon controls planned changes and reviews the consequences of unintended changes, taking action to mitigate any
adverse effects, as necessary. For example: Where product requirements are changed, Telamon ensures that relevant
documented information is amended (such as BOMs, WIs, WOs,) and that relevant personnel are made aware of the
changed requirements.
8.1.2 Confidentiality
Telamon ensures the confidentiality of customer-contracted products and projects under development, including related
product information. Non Disclosure Agreements are in place for each customer, as evidence.
8.1.C.4 NOTE Examples of tools to be managed include design and development, testing, configuration management,
documentation, scripts, customizations, dies, stamps, fixtures, and diagnostic tools, as well as software used to build and
test product.
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c) obtaining customer feedback relating to products and services, including customer complaints
d) the handling or treatment of customer property.
e) establishing specific requirements for contingency actions, when relevant. See Emergency Disaster Plan
This review is conducted prior to Telamon’s commitment to supply products and services to the customer and ensures
contract or order requirements differing from those previously defined are resolved. (See TIS-P000008S Order/Contract
Review)
Where the customer does not provide a documented statement of their requirements, the customer requirements are
confirmed by Telamon before acceptance.
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Telamon validates through production runs, benchmarking studies, or other appropriate methods, our ability to make
product to specifications at the required rate.
8.2.3.2 –
Telamon retains documented information, as applicable:
a) on the results of the review
b) b) on any new requirements for the products and services
8.3 Design and development of products and services – Telamon does not design
8.3.1 General
Where the detailed requirements of Telamon’s products and services are not already established or not defined by the
customer or by other interested parties, such that they are adequate for subsequent production or service provision,
Telamon establishes implements and maintains a design and development process (as it applies to the delivery of our
product/ service). The Single Point of Contact at Telamon (may be the Engineer) works directly with the customer contact
to establish the processes that are required for Telamon to deliver to the customer.
NOTE 1 Telamon can also apply the requirements given in 8.5 to the development of processes for production and
services provision
NOTE 2 For services, design and development planning can address the whole service delivery process. Telamon may
therefore choose to consider the requirements of clauses 8.3 and 8.5 together.
8.3.2 Design and development planning – Telamon does not design product.
In determining the stages and controls for design and development of production, Telamon considers:
a) the nature, duration and complexity of the design and development activities;
b) requirements that specify particular process stages, including applicable design and development reviews;
c) the required design and development verification and validation
d) the responsibilities and authorities involved in the design and development process
e) the internal and external resource needs for the design and development of products and services;
f) the need to control interfaces between individuals and parties involved in the design and development process;
g) the need for involvement of customer and user groups in the design and development process;
h) the requirements for subsequent provision of product and services;
i) the level of control expected for the design and development process by customers and other relevant interested
parties
j) the documented information needed to demonstrate that design and development requirements have been met.
Telamon Confidential and Proprietary Information
Hard Copies Authorized ONLY for Revisions or Redlines
H2S2 – Honesty, Harmony, Simplicity, Stewardship
Quality Management System Manual
IATF TIS Dayton/Fresnillo/Skopje 21-DEC-18
Page 26 of 51
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NOTE One approach for considering design alternatives is the use of trade-off curves.
8.3.4.1 Monitoring
Measurements at specified stages during the design and development of products and processes are defined, analysed,
and reported with summary results as an input to management review (see section 9.3.2.1)
When required by the customer, measurements of the product and process development activity are reported to the
customer at stages specified, or agreed to, by Telamon’s customer.
NOTE When appropriate, these measurements may include quality risks, costs; lead times, critical paths, and other
measurements.
Where contractually agreed with the customer, this would include evaluation of the interaction of Telamon’s product,
including embedded software, within the system of the final customer’s product.
Telamon Confidential and Proprietary Information
Hard Copies Authorized ONLY for Revisions or Redlines
H2S2 – Honesty, Harmony, Simplicity, Stewardship
Quality Management System Manual
IATF TIS Dayton/Fresnillo/Skopje 21-DEC-18
Page 28 of 51
All performance-testing activities are monitored for timely completion and conformity to requirements.
When services are outsourced, Telamon includes the type and extent of control in the scope of its quality management
system to ensure that outsourced services conform to requirements (see ISO9001, section 8.4)
Telamon obtains documented product approval prior to shipment, if required by Telamon’s customers. Records of such
approval is retained.
NOTE Product approval should be subsequent to the verification of the manufacturing process.
8.3.5.1 Design and Development Outputs – Supplemental – (customer owns the design)
The product design output is expressed in terms that can be verified and validated against design input requirements. The
product design output includes but is not limited to the following, as applicable:
a) Design risk analysis (FMEA);
b) Reliability study results;
c) Product special characteristics
d) Results of product design error-proofing, such as DFSS, DFMA, and FTA.
e) Product definition including 3D models, technical data packages, product manufacturing information, and
geometric dimensioning & tolerancing (GD&T);
f) Product design review results;
g) Service diagnostic guidelines and repair and serviceability instructions;
h) Service part requirements;
i) Packaging and labeling requirements for shipping.
NOTE Interim design outputs should include any engineering problems being resolved through a trade-off process.
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e) Manufacturing process flow charts/layout, including linkage of product, process, and tooling;
f) Capacity analysis;
g) Manufacturing process FMEA;
h) Maintenance plans and instructions;
i) Control plan (see annex A)
j) Standard work and work instructions;
k) Process approval acceptance criteria;
l) Data for quality, reliability, maintainability, and measurability;
m) Results of error-proofing identification and verification, as appropriate;
n) Methods of rapid detection, feedback, and correction of product/ manufacturing process nonconformities.
Manufacturing process improvement continually focuses upon control and reduction of variation in product characteristics
and manufacturing process parameters.
Controlled characteristic internally, are documented in the control plan
Continual improvement is implemented once manufacturing processes are capable and stable, or product characteristics
are predictable and meet customer requirements.
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8.4.1.2 Supplier Selection Process – See Supplier Selection & Assessment (TIS-P000017P)
Telamon has a documented supplier selection process. The selection process includes:
a) An assessment of the selected supplier’s risk to product conformity and uninterrupted supply of Telamon’ s
product to their customer
b) Relevant quality and delivery performance
c) An evaluation of the supplier’s quality management system;
d) Multidisciplinary decision making; and
e) An assessment of software development capabilities, if applicable.
Other supplier selection criteria that is considered includes the following:
a) Volume of automotive business (absolute and as a percentage of total business);
b) Financial stability;
c) Purchased product, material, or service complexity;
d) Required technology (product or process);
e) Adequacy of available resources (e.g., people, infrastructure);
f) Design ana development capabilities (including project management);
g) Manufacturing feasibility;
h) Change management process;
i) Business continuity planning (e.g., disaster preparedness, contingency planning);
j) Logistics process;
k) Customer service.
All requirements of section 8.4 (except requirements in IATF 16949, section 8.4.1.2) are applicable to Telamon’s control of
customer-directed sources unless specific agreements are otherwise defined by the contract between Telamon and its
customers.
8.4.2 Type and Extent of Control - Supplier Selection & Assessment (TIS-P000017P)
Telamon has ensured that externally provided processes, products and services do not adversely affect Telamon’s ability
to consistently deliver conforming products and services to our customers.
Telamon has:
a) Ensured that externally provided processes remain within the control of our quality management
b) Defined both the controls that we intend to apply to an external provider and those we intend to apply to the
resulting input;
c) Telamon has taken into consideration:
i. The potential impact of the externally provided processes, products and services on Telamon’s
ability to consistently meet customer and applicable statutory and regulatory requirements;
ii. The effectiveness of the controls applied by the external provider;
d) Determined the verification, or other activities, necessary to ensure that the externally provided processes,
products and services meet requirements.
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If the customer defines special controls for certain products with statutory and regulatory requirements, Telamon ensures
they are implemented and maintained as defined, including at the suppliers.
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8.4.3 Information for External Providers See Supplier Selection & Assessment (TIS-P000017P)
Telamon ensures the adequacy of requirements prior to our communication to the external provider, and then
communicates our requirements for the following:
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NOTE Suitable infrastructure includes appropriate manufacturing equipment required to ensure product compliance.
Monitoring and measuring resources include appropriate monitoring and measuring equipment required to ensure
effective control of manufacturing processes.
Telamon has developed a control plan for pre-launch and production that shows linkage and incorporates information
from the design risk analysis (if provided by customer), process flow diagram, and manufacturing process risk analysis
outputs (such as FMEA).
Telamon provides measurement and conformity data collected during execution of either the pre-launch or production
control plans (if required by the customer).
The control plan includes:
a) controls used for the manufacturing process control, including verification of job set-ups;
b) first-off/ last-off part validation, as applicable;
c) methods for monitoring of control exercised over special characteristics (see annex A) defined by both the
customer and Telamon,
d) customer-required information, if any, and
e) specified reaction plan (see annex A) when nonconforming product is detected, the process becomes
statistically unstable or not statistically capable.
Control plans are reviewed and updated as required for any of the following:
f) Telamon determines that it has shipped nonconforming product to the customer;
g) when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources
production volume changes, or risk analysis (FMEA) (see Annex A).
Customer approval may be required after review of the control plan.
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P000013M)
At a minimum, the system includes:
a) Identification of process equipment necessary to product conforming product at the required volume;
b) Availability of replacement parts for the equipment identified in item a);
c) Provision of resource for machine, equipment, and facility maintenance;
d) Packaging and preservation of equipment, tooling, and gauging;
e) Applicable customer-specific requirements;
f) Documented maintenance objectives, for example: OEE (Overall Equipment Effectiveness), MTBF (Mean Time
Between Failure), and MTTR (Mean Time To Repair), and Preventive maintenance compliance metrics.
Performance to the maintenance objectives shall form an input into management review (see ISO9001, section
9.3);
g) Regular review of maintenance plan and objectives and a documented action plan to address corrective actions
where objectives are not achieved;
h) Use of preventive maintenance methods;
i) Use of predictive maintenance methods, as applicable;
j) Periodic overhaul.
8.5.1.5 Management of Production Tooling and Manufacturing, Test, Inspection Tooling and Equipment
Telamon provides resources for tool and gauge design, fabrication, and verification activities for production and service
materials and for bulk materials, as applicable.
Telamon has established and implemented a system for production tooling management, whether owned by Telamon or
the customer, including:
a) Maintenance and repair facilities and personnel;
b) Storage and recovery;
c) Set-up;
d) Tool-change programs for perishable tools;
e) Tool design modification documentation, including engineering change level of the product;
f) Tool modification and revision to documentation;
g) Tool identification, such as serial or asset number; the status, such as production repair or disposal; ownership;
and location.
Telamon verifies that customer-owned tools, manufacturing equipment, and test/inspection equipment are permanently
marked in a visible location so that the ownership and application of each item can be determined.
Telamon implements a system to monitor these activities if any work is outsourced.
Telamon includes relevant planning information during production scheduling, e.g., customer orders, supplier on-time
delivery performance, capacity, shared loading (multi-part station), lead time, inventory level, preventive maintenance, and
calibration.
8.5.2 Note: Inspection and test is not indicated by the location of product in the production flow unless inherently obvious,
such as material in an automated production transfer process. Alternatives are permitted if the status is clearly identified,
documented, and achieves the designated purpose.
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Telamon conducts an analysis of internal, customer, and regulatory traceability requirements for all automotive products,
including developing and documenting traceability plans, based on the levels of risk or failure severity for employees,
customers, and consumers. These plans define the appropriate traceability systems, processes, and methods by product,
process, and manufacturing location that:
a) Enable Telamon to identify nonconforming and/or suspect product;
b) Enable Telamon to segregate nonconforming and/or suspect product;
c) Ensure the ability to meet the customer and/or regulatory response time requirements;
d) Ensure documented information is retained in the format (electronic, hardcopy, archive) that enables Telamon to
meet the response time requirements;
e) Ensure serialized identification of individual products, if specified by the customer or regulatory standards;
f) Ensure the identification and traceability requirements are extended to externally provided products with
safety/regulatory characteristics.
NOTE – Customer property can include material, components, tools and equipment, customer premises, intellectual
property and personal data.
8.5.4 Preservation –
Telamon ensures the preservation of outputs during production and service provision, to the extent necessary to maintain
conformity to requirements.
Preservation applies to material and components from external and/or internal providers from receipt through processing,
including shipment and until delivery to/acceptance by the customer.
In order to detect deterioration, Telamon assesses at appropriate planned intervals the condition of product in stock, the
place/type of storage container, and the storage environment.
Telamon uses an inventory management system to optimize inventory turns over time and ensure stock rotation, such as
first-in-first-out (FIFO).
Telamon ensures that obsolete product is controlled in a manner similar to that of nonconforming product.
Telamon complies with preservation, packaging, shipping, and labeling requirements as provided by our customers.
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a) the potential undesired consequences associated with our products and services;
b) the nature, use and intended lifetime of the products and services;
c) customer feedback;
d) customer requirements;
e) statutory and regulatory requirements.
NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance
services, and supplementary services such as recycling or final disposal.
NOT E1 This ensures that Telamon has an open line of communication with its customers and is aware of nonconforming
products and material that may be identified at the customer location or in the field.
NOTE 2: “Service concerns” include the results of field failure test analysis (see section 10.2.6) where applicable.
Telamon reviews and controls changes for production or service provision to the extent necessary to ensure continuing
conformity with requirements.
Telamon retains documented information describing the results of the review of changes, the personnel authorizing the
change, and any necessary actions arising from the review.
Telamon has documented the process that manages the use of alternate control methods. Included in the process, based
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on risk analysis (such as FMEA), severity, and the internal approvals to be obtained prior to production implementation of
the alternate control method.
Before shipping product that was inspected or tested using the alternate method, if required, Telamon obtains approval
from our customer. Telamon maintains and periodically reviews a list of approved alternate process control methods that
are referenced in the control plan.
Standard work instructions are available for each alternate process control method. Telamon reviews the operation of
alternate process controls on a daily basis, at a minimum, to verify implementation of standard work with the goal to return
to the standard process as defined by the control plan as soon as possible. Example methods include but are not limited
to:
a) daily quality focused audits (e.g., layered process audits, as applicable);
b) daily leadership meetings.
Restart verification is documented for a defined period based on severity and confirmation that all features of the error-
proofing device or process are effectively reinstated.
Telamon implements traceability of all product produced while any alternate process control devices or processes are
being used (e.g., verification and retention of first piece and last piece from every shift).
Telamon ensures that the planned arrangements for initial release of products and services encompass product or service
approval.
Telamon ensures that product or service approval is accomplished after changes following initial release, according to
ISO9001, Section 8.5.6.
NOTE 1 Layout inspection is the complete measurement of all product dimensions shown on the design record(s).
NOTE 2 The frequency of layout inspection is determined by the customer.
8.6.4 Verification and Acceptance of Conformity of Externally provided Products and Service
Telamon’s Receiving Inspection & Testing (TIS-P000020Q) outlines the process to assure the quality of purchased
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Telamon takes appropriate corrective action based on the nature of the nonconformity and its impact on the conformity of
products and services. This applies also to nonconforming products and services detected after delivery of the products or
during the provision of services.
As applicable, Telamon deals with nonconforming process outputs, products and services in one or more of the following
ways:
a) correction;
b) segregation, containment, return or suspension of provision of products and services;
c) informing the customer;
d) obtaining authorization for:
a. use ‘”as-is”
b. release, continuation or re-provision of the products and services;
c. acceptance under concession.
When there is a nonconforming process output, products and services are corrected, conformity to the requirements are
verified.
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Telamon retains documented information on the disposition of reworked product including quantity, disposition date, and
applicable traceability information.
Telamon obtains documented customer authorization for concession for the product to be repaired.
Telamon retains documented information on the disposition of reworked product including quantity, disposition date, and
applicable traceability information.
Telamon has a documented process for disposition of nonconforming product not subject to rework or repair. For product
not meeting requirements, Telamon verifies that the product to be scrapped is rendered unusable prior to disposal.
Telamon does not divert nonconforming product to service or use without prior customer approval. (TIS-P000036Q)
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9 Performance Evaluation
NOTE – For some manufacturing processes, it may not be possible to demonstrate product compliance through process
capability. For those processes, alternate methods such as batch conformance to specification may be used.
Telamon maintains manufacturing process capability or performance results as specified by the customer’s part approval
process requirements. Telamon verifies that the process flow diagram, PFMEA, and control plan are implemented,
including adherence to the following:
a) measurement techniques,
b) sampling plans,
c) acceptance criteria,
d) records of actual measurement values and/or test results for variable data;
e) reaction plans and escalation process when acceptance criteria are not met.
Significant process events, such as tool change or machine repair is recorded and retained as documented information.
Telamon initiates a reaction plan from the control plan and evaluated for impact on compliance to specifications for
characteristics that are either not statistically capable or are unstable. These reaction plans shall include containment of
product and 100% inspection as appropriate. A corrective action plan is then completed by the Telamon, indicating
specific timing and assigned responsibilities to assure that the process becomes stable and statistically capable. The
plans are reviewed with and approved by the customer when so required.
Telamon maintains records of effective dates of process change.
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perceptions of the degree to which customer requirements have been met. Some of the methods for obtaining and using
this information have been determined and are:
• Compilation and Analysis of Telamon delivery performance to the Customer
• Defect Free Measurement
• Trending of CARs due to customer complaints
• Direct communication between the Customer and the PM, QM, or VP of Quality
• Report Cards from the Customer on Telamon’s performance
• Kudos from the customer
Repeat business and opportunities to bid on future work with existing customers can confirm their perception of Telamon.
NOTE Information related to customer views can include customer satisfaction or opinions surveys, customer data on
delivered products or services quality, market-share analysis, compliments, warranty claims and dealer reports.
9.1.3.1 Prioritization
Trends in quality and operational performance are compared with progress toward objectives and lead to action to support
prioritization of action for improving customer satisfaction.
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9.2.2
Telamon’s Internal Audits follow the process-audit approach, with conformances and non-conformances documented on
the appropriate Telamon Internal Audit Checklist summary.
a) An audit program has been planned, established, implemented and maintained taking into consideration the
frequency, methods, responsibilities, planning requirements and reporting, status and importance of the
processes concerned, customer feedback, changes impacting the organization, areas to be audited, as well as
the results of previous audits.
b) Telamon defines the audit criteria and scope for each audit;
c) Telamon selects auditors and conducts audits to ensure objectivity and the impartiality of the audit process.
d) Telamon ensures that the results of the audits are reported to relevant management;
e) Telamon takes necessary correction and corrective actions without undue delay;
f) Telamon retains documented information as evidence of the implementation of the audit program and the audit
results.
NOTE ISO19011 may be used for guidance.
The manager responsible for the area being audited ensures that actions are taken without undue delay to eliminate
detected nonconformities and their causes. Target time for closures is:
Major Non-conformances should be closed as soon as possible, in less than 30 days.
Minor Non-conformances should be closed in less than 60 days
Follow-up activities include the verification of the actions taken and the reporting of verification results by a representative
of the Quality Department. The Due Date is a target date for the team and may be extended by the V.P of Quality as
appropriate.
The audit program is prioritized based upon risk, internal and external performance trends, and criticality of the
process(es).
Where Telamon is responsible for software development, Telamon includes software development capability
assessments in the internal audit program.
The frequency of audits is reviewed and, where appropriate, adjusted based on occurrence of process changes, internal
and external nonconformities, and/or customer complaints. The effectiveness of the audit program is reviewed as a part of
management review.
Within each individual audit plan, each manufacturing process is audited on all shifts, where it occurs, including the
appropriate sampling of the shift handover.
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This manufacturing process audit includes an audit of the effective implementation of the process risk analysis (such as
PFMEA), control plan, and associated documents.
The Quality Manager or Designate will provide information about the quality program and take the necessary closed loop
actions to ensure continuous compliance to ISO 9000:2015 and IATF 16949 Quality System Standards. Records of the
quality system reviews and any resulting corrective actions or verifications of implementation will be documented and
retained for at least 3 years.
Management review is conducted at least annually. The frequency of management review(s) is increased based on
risk to compliance with customer requirements resulting from internal or external changes impacting the quality
management system and performance-related issues.
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Records of the management reviews are maintained by the V.P. of Quality for a period no less than (1) year.
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Manufacturing Man.
P = Primary responsibility
Document Control
Engineering Man.
IATF
Eng. Associates
Mfg. Associates
Material Control
Mfg. Supervisor
Materials Man.
QA Inspectors
Executive VP
Clause C = Contributing responsibility
QA Manager
QA Auditors
Purchasing
VP Quality
Engineers
President
VP Sales
Shipping
4.0 Context of Organization
5.2 Policy P P P P
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Manufacturing Man.
P = Primary responsibility
Document Control
Engineering Man.
IATF
Eng. Associates
Mfg. Associates
Material Control
Mfg. Supervisor
Materials Man.
QA Inspectors
Executive VP
Clause C = Contributing responsibility
QA Manager
QA Auditors
Purchasing
VP Quality
Engineers
President
VP Sales
Shipping
7.0 Support
7.1 Resources P P C C C C
7.2 Competence C P C C C C
7.3 Awareness C P C C C C C C C C C C C C C C C
7.4 Communication C P C C C C C C
7.5 Documented information C C C C C C P
8.0 Operation
10.1 General C C P C C C C C C C C C C C C C C C
10 Improvement
10.1 General
Telamon determines and selects opportunities for improvement and implements necessary actions to meet customer
requirements and enhance customer satisfaction.
This includes, as appropriate:
a) improving processes to prevent nonconformities;
b) improving products and services to meet known and predicted requirements;
c) improving quality management system results
NOTE Improvement can be effected reactively (e.g. corrective action), incrementally (e.g. continual improvement), by
step change (e.g. breakthrough), creatively (e.g. innovation) or by re-organization (e.g. transformation).
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b) evaluates the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur
elsewhere, by:
1) reviewing the nonconformity;
2) determining the causes of the nonconformity;
3) determining if similar nonconformities exist, or could potentially occur;
c) implement any action needed;
d) review the effectiveness of any corrective action taken;
e) make changes to the quality management system, if necessary.
Corrective actions are appropriate to the effects of the nonconformities encountered.
NOTE 1 In some instances, it can be impossible to eliminate the cause of a nonconformity.
NOTE 2 Corrective action can reduce the likelihood of recurrence to an acceptable level.
If a customer has specific processed, tools, or systems for problem solving, Telamon uses those unless otherwise
approved by the customer.
10.2.4 Error-proofing
Telamon uses error-proofing methods in their corrective action process, as stated in TIS-P000037Q. The details of the
methods used is documented in the process risk analysis (such as the PFMEA) and test frequencies documented in the
control plan.
The process includes the testing of error-proofing devices for failure or simulated failure. Records of the testing are
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maintained. Challenge parts, when used, are identified, controlled, verified, and calibrated where feasible. Error-proofing
device failures have a reaction plan.
Where requested by the customer, this includes analysis of the interaction of embedded software of Telamon’s product
within the system of the final customer’s product.
Telamon communicated the results of testing/ analysis to the customer and also within Telamon.
Telamon considers the outputs of analysis and evaluation, and the outputs from management review, to confirm if there
are areas of underperformance or opportunities that shall be addressed as part of continual improvement.
Where applicable, Telamon selects and utilizes applicable tools and methodologies for investigation of the causes of
underperformance and for supporting continual improvement.
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Process Interaction
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The Following Matrix Identifies the associated System Procedures that Support this Manual
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Executive Approval
Controlled
Document invalid if stamp is black