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TNT-F-0064 02/23/2018
Rev. 19
TNT-EDM
AS 9100 D
Quality Manual
www.tntedm.com
Document Identifier
TNT-Quality Manual
Date: 2/23/18
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Section 1: Welcome
TNT-EDM, Inc. has established a Quality Management System (QMS) and manages
processes in accordance with AS9100D (Note: Where AS9100 is read, it is to be
understood AS9100D). TNT-EDM, Inc. is located at 47689 Anchor Court, Plymouth, MI.
48170.
TNT-EDM, Inc. has always applied high quality standards to its processes and
operations and continues its dedication in maintaining high levels of quality and integrity
in communicating with people inside and outside of its business operation.
We invite you to review our quality system in action. To arrange a visit, contact us at:
TNT-EDM, Inc.
47689 Anchor Court
Plymouth, MI. 48170
(734) 459-1700 – Phone
(734) 459-1745 – Fax
Website: www.tntedm.com
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COMPANY PHILOSOPHY
At TNT-EDM, our people are our most important resource. The contribution of
each employee to the quality of our products and achieving total customer
satisfaction is the basis for our continuing growth and success. We will
constantly strive to maintain an atmosphere in which our employees can
exercise personal initiative, fully utilize individual talents and feel a sense of
pride and value.
QUALITY POLICY
TNT-EDM, Inc. will provide best in class products and services to meet or exceed
our customers’ cost, quality, reliability, and delivery requirements and their
future expectations. TNT-EDM, Inc. is dedicated to continuous improvement in all
facets of its business to enhance our customers’ and our continued long-term
profitable growth.
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These items that are not applicable do not affect the ability or responsibility of TNT-
EDM, Inc. to provide product that meets customer and applicable statutory and
regulatory requirements.
3.3 Definitions
Unless otherwise noted, TNT-EDM applies the definition of terms according to ISO 9000
and AS9100.
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Table of Contents
Page #
Title Page 1
Introduction to Organization 2
Quality Policy and Objectives 3
Terms and Definitions 4
Table of Contents 5
Interested Parties 6
TNT EDM Interaction of Processes 7
Responsibility and Authority, Org Chart 8
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Interested Parties
TNT-EDM has determined that the following are interested parties of the Quality
Management System:
• Customers
• Suppliers
• Regulatory or Statutory
• AS9100 Registrar
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TNT-EDM IOP’s
Management Processes
Core Processes
Support Processes
and support clauses in Quality Manual
Configuration Management
Control of Documents
Production Process Verification
Control of Records
Control of Production Process Changes
Responsibilities and Authorities
Control of Production Equip. and Tools
Resources
Validation of Processes for Production
Competence, Training & Awareness
Identification and Traceability
Infrastructure
Customer Property
Work Environment
Control of Monitoring & Measuring Equip.
Project Management
Monitoring & Measurement of Processes
Risk Management
Monitoring & Measuring of Product
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Organizational Chart
President /
CEO
CFO
Quality
System General Project Sys/CAD Sales
Manager Manger Managers Administrator
(Mgmt Rep)
Department
Leaders
Design Wire EDM Sinker EDM Electrodes Benching Machining / Inspection Office/HR ID - OD /
Shipping- SURFACE
Receiving / Grinding
Facility
Maint.
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We monitor and review information about these external and internal issues during our
Management Review meetings (see SWOT analysis).
TNT-EDM monitors and reviews information about these interested parties and their
relevant requirements. This review is performed as part of the Management Review
processes. A general description of the Interested Parties is listed on page 6 of this
Quality Manual.
We apply all the requirements of this International Standard as they are applicable
within the determined scope of our quality management system (see 3.1).
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TNT-EDM has determined the processes needed for the quality management system
and their application throughout the organization, and has:
a) determined the inputs required and the outputs expected from these
processes;
b) determined the sequence and interaction of these processes;
c) determined and apply the criteria and methods (including monitoring,
measurements and related performance indicators) needed to ensure the
effective operation and control of these processes;
d) determined the resources needed for these processes and ensure their
availability;
e) assigned the responsibilities and authorities for these processes;
f) addressed the risks and opportunities as determined in accordance with the
requirements of 6.1;
g) evaluated these processes and implemented any changes needed to ensure
that these processes achieve their intended results;
h) improve the processes and the quality management system.
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CLAUSE 5 LEADERSHIP
5.1 Leadership and commitment
5.1.1 General
Top management demonstrates leadership and commitment with respect to the quality
management system by:
a) taking accountability for the effectiveness of the quality management system;
b) ensuring that the quality policy and quality objectives are established for the
quality management system and are compatible with the context and strategic
direction of the organization;
c) ensuring the integration of the quality management system requirements into the
organization’s business processes;
d) promoting the use of the process approach and risk-based thinking;
e) ensuring that the resources needed for the quality management system are
available;
f) communicating the importance of effective quality management and of
conforming to the quality management system requirements
g) ensuring that the quality management system achieves its intended results;
h) engaging, directing and supporting persons to contribute to the effectiveness of
the quality management system;
i) promoting improvement;
j) supporting other relevant management roles to demonstrate their leadership as it
applies to their areas of responsibility.
5.2 Policy
5.2.1 Establishing the quality policy
Top management has established, implemented and maintains a quality policy that:
a) is appropriate to the purpose and context of TNT-EDM and supports its strategic
direction;
b) provides a framework for setting quality objectives;
c) includes a commitment to satisfy applicable requirements;
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CLAUSE 6 PLANNING
6.1 Actions to address risks and opportunities
6.1.1 When planning for the quality management system, we consider the issues
referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and
opportunities that need to be addressed to:
a) give assurance that the quality management system can achieve its intended
result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement.
Actions taken to address risks and opportunities are proportionate to the potential
impact on the conformity of products and services.
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TNT-EDM considers:
a) the purpose of the changes and their potential consequences;
b) the integrity of the quality management system;
c) the availability of resources;
d) the allocation or reallocation of responsibilities and authorities.
Management ensures the QMS is maintained when changes to the QMS are planned
and implemented. Subsequent major changes that may affect the performance, quality
or reliability of the product will be identified, reviewed and approved and the QMS
documentation will be updated.
The QMS documentation acts as the overall quality plan for TNT-EDM. As required,
specific quality processes may be developed for individual products; these plans include
the information given above. In such cases, the appropriate department manager (with
support from the Quality Manager) has overall responsibility for the development of
quality plans.
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CLAUSE 7 SUPPORT
7.1 Resources
7.1.1 General
TNT-EDM determines and provides the resources needed for the establishment,
implementation, maintenance and continual improvement of the quality management
system.
We consider:
a) the capabilities of, and constraints on, existing internal resources;
b) what needs to be obtained from external providers.
7.1.2 People
TNT-EDM determines and provide the persons necessary for the effective
implementation of its quality management system and for the operation and control of
its processes.
7.1.3 Infrastructure
We determine, provide and maintain the infrastructure necessary for the operation of its
processes and to achieve conformity of products and services.
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We have established, implemented and maintain a process for the recall of monitoring
and measurement equipment requiring calibration or verification.
When addressing changing needs and trends, we consider our current knowledge and
determine how to acquire or access any necessary additional knowledge and required
updates.
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7.2 Competence
Company:
a) determines the necessary competence of person(s) doing work under its control
that affects the performance and effectiveness of the quality management
system;
b) ensures that these persons are competent on the basis of appropriate education,
training, or experience;
c) where applicable, takes action to acquire the necessary competence, and
evaluate the effectiveness of the actions taken;
d) retains appropriate documented information as evidence of competence.
7.3 Awareness
We ensure that persons doing work under the organization’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 performance;
d) the implications of not conforming with the quality management system
requirements.
e) relevant quality management system documented information and changes
thereto
f) their contribution to product or service conformity
g) their contribution to product safety
h) the importance of ethical behavior
7.4 Communication
TNT-EDM determines 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.
7.5.1 General
Our quality management system includes:
a) documented information required by this International Standard;
b) documented information determined by us as being necessary for the
effectiveness of the quality management system.
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7.5.3.2 For the control of documented information, TNT-EDM addresses 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.
e) prevention of the unintended use of obsolete documented information by
removal or by application of suitable identification or controls if kept for any
purpose.
The controls for documents are defined in the TNT-P-0035 Control of Documents.
Records are controlled to provide evidence of conformity to requirements. Records that
are subject to control are maintained according to the TNT-P-0036 Control of Records
and TNT-EDM’s Purchase Order Terms and Conditions.
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CLAUSE 8 OPERATION
8.1 Operational planning and control
TNT-EDM plans, implements and controls the processes (see 4.4) needed to meet the
requirements for the provision of products and services, and to implement the actions
determined in Clause 6, by:
a) determining the requirements for the products and services;
b) establishing criteria for:
1) the processes;
2) the acceptance of products and services;
c) determining the resources needed to achieve conformity to the product and
service requirements;
d) implementing control of the processes in accordance with the criteria;
e) determining, maintaining and retaining documented information to the extent
necessary:
1) to have confidence that the processes have been carried out as
planned;
2) to demonstrate the conformity of products and services to their
requirements.
f) Determining the processes and controls needed to manage critical items,
including production process controls when key characteristics have been
identified;
g) Engaging representatives of affected organization functions for operational
planning and control;
h) Determining the process and services to be obtained from external providers;
i) Establishing the controls needed to prevent the delivery of nonconforming
products and services to the customer.
As appropriate to TNT-EDM, customer requirements and products and services, we
plan and manage product and service provision in a structured and controlled manner
including scheduled events performed in a planned sequence to meet requirements at
acceptable risk, within resource and schedule constraints.
The output of the planning is the E2 SYSTEM traveler, related drawings, inspection
packages, operator check sheets, and specifications that show dimensions,
characteristics, tolerances, and any key characteristic identified by TNT-EDM or the
customer. Likewise, these instructions define any processes, documents or resource
requirements specific to the product. Inspection, testing and other monitoring steps will
also be defined in the E2 SYSTEM traveler.
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We establish, implement and maintain a process to plan and control the temporary or
permanent transfer of work, to ensure the continuing conformity of the work to
requirements. The process ensures that work transfer impacts and risks are managed.
We plan, implement and control a process for managing operational risks to the
achievement of applicable requirements, which includes as appropriate to the
organization and the products and services:
Prior to acceptance of contract or purchase order, relevant risk criteria are assessed to
identify risk and determine feasibility. Criteria may include but are not limited to:
If any of the above criteria can not be resolved, or causes unease to trained personnel,
then the order is considered “high risk”.
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• Top management investigates, confirms, and documents any risk associated with
the order.
• Results of this assessment are logged on TNT-F-0058 Internal Feasibility
Review Form.
• If the decision to accept risk is made, the appropriate personnel will be notified
and the mitigation process will continue.
TNT-EDM plans, implements and controls the processes needed to assure product
safety during the entire life cycle, as appropriate to TNT-EDM and the product.
TNT-EDM plans, implements and controls a process appropriate to the product, for the
prevention of counterfeit or suspect part use and their inclusion in product(s) delivered
to the customer.
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TNT-EDM ensures that contract or order requirements differing from those previously
defined are resolved.
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We confirm the customer’s requirements before acceptance, when the customer does
not provide a documented statement of their requirements.
Order entry into E2 SYSTEM is a record of review. Records of actions arising from the
review shall become part of the work package.
Design and development is not performed by TNT-EDM and is therefore not applicable
per our quality scope.
We identify and manage the risks associated with the external provision of processes,
products, and services, as well as the selection and use of external providers.
We require that external providers apply appropriate controls to their direct and sub-tier
external providers, to ensure that requirements are met.
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TNT-EDM:
a) ensures that externally provided processes remain within the control of its quality
management system;
b) defines both the controls that it intends to apply to an external provider and those
it intends to apply to the resulting output;
c) takes into consideration:
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When externally provided product is released for production use, pending completion of
all required verification activities, it shall be identified and recorded to allow recall and
replacement if it is subsequently found that the product does not meet requirements.
When TNT-EDM delegates verification activities to the external provider, the scope and
requirements for delegation will be defined and a register of delegations is maintained.
We periodically monitor the external provider’s delegated verification activities.
Purchase orders include statements in our “terms & conditions” section concerning the
following items, when and where we require these items:
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When any of these items are required by TNT-EDM, the required items is clearly stated
on the first page of the Purchase Order. TNT-EDM ensures adequacy of specified
purchase requirements before communicating them to the supplier.
When external provider test reports are utilized to verify externally provided products,
TNT-EDM will implement a process to evaluate the data in the test reports to confirm
that the product meets requirements. When a customer or organization has identified
raw material as a significant operational risk (e.g. critical items), we will implement a
process to validate the accuracy of test reports. When applicable, TNT-EDM Quality will
review results.
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principles and appropriate for use (i.e matching the sampling plan to the
criticality of the product and to the process capability).
d) the use of suitable infrastructure and environment for the operation of processes;
e) the appointment of competent persons, including any required qualification;
f) the validation, and periodic revalidation, of the ability to achieve planned results
of the processes for production and service provision, where the resulting output
cannot be verified by subsequent monitoring or measurement;
g) the implementation of actions to prevent human error;
h) the implementation of release, delivery and post-delivery activities.
i) The establishment of criteria for workmanship (e.g. written standards,
representative samples, illustrations);
j) The accountability for all products during production (e.g. parts quantities, split
orders, non-conforming product);
k) The control and monitoring of identified critical items, including key
characteristics, in accordance with established processes;
l) The determination of methods to ensure variable data (e.g. tooling, on-machine
probing, inspection equipment);
m) The identification of in-process inspection/verification points when adequate
verification of conformity cannot be performed at later stages;
n) The availability of evidence that all production and inspection/verification
operations have been completed as planned, or as otherwise documented and
authorized;
o) The provision for the prevention, detection, and removal of foreign objects;
p) The control and monitoring of utilities and supplies (water, compressed air,
electricity, chemical products) to the extent they affect conformity to product
requirements;
q) The identification and recording of products released for subsequent production
use pending completion of all required measuring and monitoring activities. To
allow recall and replacement if it is later found that the product does not meet
requirements.
CEO, Program Manager, Production Manager, and Quality Manager have the authority
to approve changes to production processes.
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For processes where the resulting output cannot be verified by subsequent monitoring
or measurement, TNT-EDM will establish arrangements for these processes including,
as applicable:
We use a representative item from the first production run of a new part of assembly to
verify that the production process, production documentation, and tooling are able to
produce parts and assemblies that meet requirements. This activity will be repeated
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when changes occur that invalidate the original results (e.g. engineering changes,
production process changes, tooling changes).
We also maintain the identification of the configuration of the products and services in
order to identify any differences between the actual configuration and the required
configuration.
When acceptance authority media are used (e.g. stamps, electronic signatures,
passwords), the organization shall establish controls for the media.
We have controls for the unique identification of the outputs when traceability is a
requirement and retain the documented information necessary to enable traceability.
8.5.4 Preservation
TNT-EDM preserves the outputs during production and service provision, to the extent
necessary to ensure conformity to requirements.
a. Cleaning;
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We retain documented information describing the results of the review of changes, the
person(s) authorizing the change, and any necessary actions arising from the review.
The release of products and services to the customer will not proceed until the planned
arrangements have been satisfactorily completed, unless otherwise approved by a
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relevant authority and, as applicable, by the customer. (see E2 Travelers and inspection
records.)
We also ensure that all documented information required to accompany the products
and services
We take appropriate action based on the nature of the nonconformity and its effect on
the conformity of products and services. This also applies to nonconforming products
and services detected after delivery of products, during or after the provision of
services.
− defining the responsibility and authority for the review and disposition of
nonconforming outputs and the process for approving persons making these
decisions;
− taking actions necessary to contain the effect of the nonconformity on other
processes, products, or services;
− timely reporting of nonconformities affecting delivered products and services to the
customer and to relevant interested parties;
− defining corrective actions for nonconforming products and services detected after
delivery, as appropriate to their impacts.
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Counterfeit, or suspect counterfeit, parts will be controlled to prevent reentry into the
supply chain.
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TNT-EDM evaluates the performance and the effectiveness of the quality management
system.
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9.2.2 We:
a) plan, establish, implement and maintain an audit program(s) including the
frequency, methods, responsibilities, planning requirements and reporting, which
take into consideration the importance of the processes concerned, changes
affecting the organization, and the results of previous audits;
b) define the audit criteria and scope for each audit;
c) select auditors and conduct audits to ensure objectivity and the impartiality of the
audit process;
d) ensure that the results of the audits are reported to relevant management;
e) take appropriate correction and corrective actions without undue delay;
f) retain documented information as evidence of the implementation of the audit
program and the audit results.
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CLAUSE 10 IMPROVEMENT
10.1 General
TNT-EDM determines and selects opportunities for improvement and implement any
necessary actions to meet customer requirements and enhance customer satisfaction.
These include:
a) improving products and services to meet requirements as well as to address
future needs and expectations;
b) correcting, preventing or reducing undesired effects;
c) improving the performance and effectiveness of the quality management system.
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The controls for controlling nonconforming product are defined in TNT-P-0029 Control
of Nonconforming Product and TNT-P-0025 Corrective and Preventive Action
Process.
We consider the results of analysis and evaluation, and the outputs from management
review, to determine if there are needs or opportunities to be addressed as part of
continual improvement.
Revision History
Revision Description Page Section Rev. date Changed by Approved
of change changed
19 Initial issue; All - 02/23/18 T.LOCKHART T.LOCKHART
rewritten to
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