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Eagle Machining, Inc.
Quality Management System
90012008
Document No.
EAGLE MACHINING, INC.
QUALITY MANAGEMENT SYSTEM
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10310 Antoine Drive Bldg D, Houston, Texas 77086
BUSINESS OPERATING MANUAL
(QUALITY MANUAL)
Revision Date: 08/01/2014
Approved By: Joseph Vu
Date: 08/01/2014
This manual is the property of Eagle Machining, Inc. (EMI). It must not be reproduced in whole or in part or otherwise
disclosed without prior written consent from Eagle Machining, Inc. and may be used interchangeably in this manual
or quality management system.
The official controlled copy of this manual is the signed PDF document on the Eagle Machining, Inc. server and
visible to all authorized users. All printed copies, and all electronic copies and versions except the ones described
above, are considered uncontrolled copies used for reference only.
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Complies with International Standard ANSI/ISO/ASQ Q9001:2008
Clause Number
Title
0
Table of Contents
TOC
1
1.1
1.2
2
2.1
3
3.1
4
4.1
4.2
4.2.1
4.2.2
4.2.3
4.2.4
4.3
5
5.1
5.2
5.3
5.4
5.4.1
5.4.2
5.5
5.5.1
5.5.2
5.5.3
5.6
5.6.1
5.6.2
5.6.3
Scope
General
Application
Normative References
Normative Reference
Terms and Definitions
Terms and Definitions
Quality Management System
General Requirements
Documentation Requirements
General
Quality Manual
Control of Documents
Control of Records
Document Structure
Management Responsibility
Management Commitment
Customer Focus
Quality Policy
Planning
Quality Objectives
QMS Planning
Responsibility, Authority and Communications
Responsibility and Authority
Management Representative
Internal Communication
Management Review
General
Input
Output
1.0
6
Resource Management
Provision of Resources
Human Resources
General
Competence, Training and Awareness
Infrastructure
Work Environment
6.1
6.2
6.2.1
6.2.2
6.3
6.4
2 of 28
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2.0
3.0
4.0
5.0
6.0
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Title
7
7.5.3
7.5.4
7.5.5
7.6
Product Realization
Planning of Product Realization
Customer-Related Processes
Determination of Requirements Related to Product
Review of Requirements Related to Product
Customer Communication
Design and Development (7.3)(Exclusion taken)
Purchasing
Purchasing Process
Purchasing Information
Verification of Purchased Product
Production and Service Provision
Control of Production and Service Provision
Validation of Production and Service
Provision)(Exclusion taken)
Identification and Traceability
Customer Property
Preservation of Product
Control of Monitoring and Measuring Devices
8.1
8.2
8.2.1
8.2.2
8.2.3
8.2.4
8.3
8.4
8.5
8.5.1
8.5.2
8.5.3
Measurement, Analysis and Improvement
General
Monitoring and Measurement
Customer Satisfaction
Internal Audit
Monitoring & Measurement of Processes
Monitoring and Measurement of Product
Control of Nonconforming Product
Analysis of Data
Improvement
Continual Improvement
Corrective Action
Preventive Action
8
Page (s)
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Clause Number
7.1
7.2
7.2.1
7.2.2
7.2.3
7.3
7.4
7.4.1
7.4.2
7.4.3
7.5
7.5.1
7.5.2
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7.0
8.0
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1. SCOPE
1.1
General
This Quality Management System (QMS) manual establishes the basis of the Eagle Machining, Inc.
Quality Management System.
This Quality Manual demonstrates and documents Eagle Machining, Inc. commitment to maintaining
a high-level of quality and strong customer service within an environment that has safety as a first
priority.
Since the philosophy of Eagle Machining, Inc. is that quality is an integral part of the entire business
operation. This Quality Manual may be referred to as the Business Operating Manual and can be
used interchangeably throughout the QMS.
It is focused on customer satisfaction and establishes the requirements for management of the
processes that are essential to the implementation and continual improvement of the QMS.
Our QMS complies with all applicable requirements contained in ISO 9001:2008 and encompasses
all operations at this facility.
This Business Operating Manual specifies requirements by which the Quality Management System
demonstrates ability to:
 Consistently provide product that meets customer and applicable regulatory requirements,
 Enhance customer satisfaction through the effective application of the Quality Management System,
including processes for continual improvement of the system and the assurance of conformity to
customer and applicable regulatory requirements.
1.2 Application

This Scope applies to the Eagle Machining, Inc. facility located at 10310 Antoine Dr, Bldg D, Houston,
TX 77086.
 Eagle Machining, Inc. provides precision machining for machined parts.
This Business Operating Manual is intended to demonstrate conformance to:
ANSI/ISO/ASQ Q9001-2008 American National Standard: Quality Management System
requirements. This standard is the United States legal equivalent of the ISO 9001:2008 international
standard. These two reference numbers may be used interchangeably in this manual and the quality
management system. The reference to the year is not used. Reference to this conformance standard
also implies reference to all guidance standards contained therein.
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1.3 Other Relevant Standards
ANSI/ISO/ASQ Q9000-2005 Quality Management Systems—Fundamentals & Vocabulary
ANSI/ISO/ASQ Q9004-2009 Managing for the sustained success of an organization—A quality
management approach
In addition to the conformance and compliance standards, may from time to time use other
standards documents as guidance in its operations and Quality Management System.



These may include but are not limited to current editions of the following:
ANSI/NCSL Z540.3 American National Standard — Requirements for the calibration of measuring
and testing equipment
ISO 10012 Measurement management systems — Requirements for measurement processes and
measuring equipment
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
1.3.1
Abbreviations, Acronyms and Definitions
ANSI
ASQ
FAA
IEC
ISO
Metrology
NCSLI
PDF
QMS
American National Standards Institute
American Society for Quality
Federal Aviation Administration (the USA regulatory agency for aviation and
aerospace operations.)
International Electrotechnical Commission
International Organization for Standardization
The science and practice of precision measurement, specifically the various
disciplines of calibration required by customers
National Conference of Standards LaboratoriesInternational
Portable Document Format, a file system extension used to designate a document
that conforms to the requirements of international standard ISO32000-1, Document
management – Portable document format – Part 1: PDF 1.7
Quality Management System.
1.4 Services offered
 The product of Eagle Machining, Inc. is the service of providing Precision Machining for machined
parts.
The Company’s vision is to become the leading Precision Machiningfacility in the worldwide
industrial & commercial markets and provide strong support toward continually building a superior
Machine Shop team.
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1.5 Purpose of This Manual
Eagle Machining, Inc.’s overall commitment to quality in work practice and customer service is defined
through its Core and Support Business Processes. Through each of these business processes, the
Business Management System is aligned with the goals and strategic direction of the organization.
The Business Management system as described in this Business Operating Manual defines the
company’s commitment:
 by demonstrating its ability to consistently provide quality service that meets customer and
applicable regulatory requirements,
 by addressing customer satisfaction through the effective application of the system,
including the processes for continual improvement and the prevention of nonconformity,
 through employee empowerment, especially for innovative action to improve the company’s
performance, and
 through orderly change management that will maintain a high level of service in technologically
complex and fast-paced environments, both to accommodate technological change and for
continual improvement of technical skill and capability.
1.5.1 Business Operating Manual
This Level 1 Business Operating Manual and its subsidiary documents describe the
Quality Management System of EMI Machining Inc. It provides an overview of the quality
policies and key requirements for the company. It is the source of reference for all matters
dealing with quality. It is available for inspection by our customers, potential customers, third
party quality auditors, and regulatory agencies.
1.5.2 Subsidiary Level 2 Documents
There are several Level 2 quality documents that include information on:
 Organizational structure
 Responsibilities and authorities, including Management Representativeappointment
 business processes including core and support processes
 Core Business Processes define the departments’ sequence of processes and subprocesses required to achieve contracted requirements and address applicable
requirements of clause 7 of ISO 9001, and regulatory requirements.
 Support Business Processes address infrastructure requirements such as those described
by clauses 5, 6 and 8 of ISO 9001, and regulatory requirements.
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1.5.3 Computer Network
The computer network is an important piece of the QMS. This network contains the
documents and applications that define the management controls by which the department
demonstrates conformance to its QMS. It also demonstrates the effectiveness of the QMS
towards attainment of the company’s management objectives.
This network contains at least the following documents and records:
 The Business Operating Manual, Required Procedures, and other instructions and forms
that implement the policies in the Business Operating Manual.
 Internal Auditing Information: including audit schedule, audit checklists that detail the
department management controls, plus conformance criteria; conformance responsibility; and
objective evidence criteria for each control. These controls are further described in the
corresponding level 2 quality procedures.
 Audit findings that assess compliance and effectiveness and needs for improvement
 Corrective and preventive activities for continual improvement
 Summaries of Management Review meetings, including action items and their current status
of accomplishments.
 Other support documents as needed to supplement this information.
1.5.4 Permissible Exclusions and Mitigation
Eagle Machining, Inc. does not provide design or development activity for customers.
Therefore, clause 7.3 of the ISO 9001 standard is not applicable and is excluded.
Eagle Machining, Inc. does not perform servicing or produce products that that readily lend
themselves to any type of servicing by the manufacturer. Therefore, Clause 7.5.2 service
provision is excluded.
These exclusions shall not affect Eagle Machining, Inc.’s ability or responsibility to provide
products that meet all customer requirements, including any statutory and regulatory
requirements.
1.5.5 Distribution, Review and Revision
The Business Operating Manual is maintained on the network as a read-only document and is
available to all Department employees and to other interested and authorized parties. All
copies printed from the network are not valid 24 hours after printing as stated in the Footer of
each page and are uncontrolled. Electronic copies, other than the one visible on the company
internal network, are uncontrolled.
The Business Operating Manual will be reviewed by management and revised as required.
After management review, the Business Operating Manual is updated (if needed) by
incorporating all approved changes. The Management Representative may approve minor
changes and updates to the Business Management System. (Minor changes include, for
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example, spelling corrections, punctuation corrections where the sense of the sentence is not
changed, or maintaining hyperlinks and references to other documents on the network.) The
revision date is updated, and the document is re-approved and released as a new issue in its
entirety. The revision data on the cover refers to the entire document. Procedures for quality
policies and procedures documents within the QMS are covered in section 4.2.3 Control of
Documents, and implemented by QP 423.
Eagle Machining, Inc. has established, documented and implemented an effective QMS as a
means of ensuring that its machining activities conform to specified requirements, to foster an
environment of continual improvement with an eventual goal of achieving its position as the
leading ISO 9001 precision machiningorganization in the community.
2. NORMATIVE REFERENCES
REFERENCE DOCUMENTS




2.1
ISO 9001:2008 Clause 1
ANSI/ISO/ASQ Q9001-2008
ANSI/ISO/ASQ Q9000-2005
ANSI/ISO/ASQ Q9004-2009
management approach
Quality Management System Requirements
Quality Management Systems—Fundamentals & Vocabulary
Managing for the sustained success of an organization—A quality
Normative Reference
This establishes the Eagle Machining, Inc. Quality Management System (QMS) as the Normative
Reference. Eagle Machining, Inc. Quality Policy Manual contains the requirements and supporting
documentation, which demonstrates conformance to the ISO 9001:2008 QMS.
The Business Operating Manual is a controlled document and acts as a normative document for the
rest of the system.
3.0
TERMS AND DEFINITIONS
3.1
Glossary, definitions of terms.
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QUALITY MANAGEMENT SYSTEM
REFERENCE DOCUMENTS







4.1
ISO 9001:2008 Clause 4
Quality Procedure QP423, Control of Documents
Quality Procedure QP424, Control of Records
Quality System Manual Clause 5.3,
Quality System Manual Clause 5.4.1,
Quality System Manual Clause 6.1,
Quality System Manual Clause 7
Quality Management System-General
Eagle Machining, Inc. has established, documented and implemented a Quality Management
System as a means of ensuring that products conform to specified requirements. The outline
structure of the documentation covering the Quality Management System requirements is defined in
this Quality System Manual. This Quality System Manual includes or references the documented
procedures that form the quality system and provides direction to continually improve its
effectiveness in accordance with the requirements of ISO 9001:2008.
The Quality Management System is maintained by:
a) identifying the processes needed for its QMS and their application throughout the
organization,
b) determining the sequence and interaction of these processes,
c) determiningthe criteria and methods needed to ensure that both the operation and control of
these processes are effective, as contained in Quality Procedures and Work Instructions.
d) ensuringthe availability of resources and information necessary to support the operation and
monitoring of these processes per QMS Clause 6.
e) monitoring, measuring and analyzing these processes, and
f)
implementing actions necessary to achieve planned results and continual improvement of
these processes.
The QMS processes are managed in accordance with the requirements of ISO 9001:2008.
Processes that are outsourced, which affect product conformity with these requirements, are
identified and management ensures control over such processes through the approval of suppliers,
supplier qualification, supplier audits, source and incoming inspection.
4.2
Documentation Requirements
4.2.1. General
The Quality Management System documentation includes;
a) documented statements of a quality policy and quality objectives, per Quality System Manual
Clause 5.3 and 5.4.1,
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b) this Quality System Manual (see 4.2.2 below),
c) the documented procedures and work instructions referenced within each Clause of this Manual,
where required by the ISO 9001:2008,
d) documents needed to ensure the effectiveness of;
e) planning, operation and control of the processes, and
f)
records required by the ISO 9001:2008 (see 4.2.4 below).
4.2.2. Quality System Manual
The Quality System Manual provides an overall description of the scope of the Quality Management
System, the general quality system, quality objectives and documented procedures (referenced by
this manual), and a description of the interaction between the processes of the Quality Management
System. It is the source of reference for all matters dealing with quality. It is available for inspection
by our customers, potential customers, third party quality auditors and regulatory agencies.
The Quality System Manual is maintained on the network as a read-only document and is available
to all employees and to other interested and authorized parties. All copies printed from the network
are reference copies and are uncontrolled. Electronic copies other than the one visible on the
internal network are uncontrolled.
This established and maintained Quality System Manual includes;
a) the scope of the QMS as defined in Clause 1 as it applies to Eagle Machining, Inc.,
b) This Eagle Machining, Inc. facility does not perform design and development, therefore
exclusion is taken to Clause 7.3, Design and Development.
Eagle Machining, Inc. does not perform servicing or produce products that that readily lend
themselves to any type of servicing by the manufacturer. Therefore, Clause 7.5 service provision
is excluded.
c) the requirements of the QMS as it applies to products
d) inclusion or reference to the documented procedures and work instructions established for the
QMS , and
e) a description of the interactions between the processes of the Quality Management System
(below).
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Continual Improvement of the
Quality Management System
Management
Responsibility
Resource
Management
Measurement
Analysis &
Improvement
Product
Realization
Input
11 of
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Product
Output
The Process-Based Quality
Management System
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PROCESS INTERACTION FOR Eagle Machining, Inc.
TOP
MANAGEMENT
HUMAN RESOURCES /
TRAINING
QUALITY CONTROL
MANUFACTURING /
PRODUCTION
SALES /
MARKETING /
CUSTOMER
SERVICE
MATERIALS
MACHINING
FINAL INSPECTION
REWORK /
REPAIR
Receiving,
Inventory,Shipping,
Delivery
PURCHASING
SUPPLIERS*
CUSTOMER*
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Control of Documents
Documents required by the QMS are prepared, reviewed, approved, distributed and controlled by
appropriate functions within the organization, which are defined in Quality Procedure QP423 Control
of Documents.
Records are a special type of document and are controlled IAW Procedure QP424 Control of
Records.
This procedure defines the controls needed;
a) for approval of documents for adequacy prior to issue,
b) for review and update as necessary and re-approval of documents,
c) for ensuring changes and the current revision status of documents are identified,
d) for ensuring that relevant versions of applicable documents are available at points of use,
e) for ensuring that documents remain legible and readily identifiable,
f)
for ensuring that documents of external origin are identified and their distribution is controlled,
and
g) for preventing the unintended use of obsolete documents and to apply suitable identification to
them if they are retained for any purpose.
Internal quality audits ensure that quality documentation remains compatible with processes in use,
and remains compliant with applicable requirements.
4.2.4
Control of Records
Records have been established and are maintained to provide evidence of conformity to
requirements and of the effective operation of the QMS. Records are maintained legible, readily
identifiable and retrievable. Procedure QP424, Control of Records, defines the controls needed for
the identification, storage, protection, retrieval, retention time and disposition of records.
Records may be in the form of any type of media, such as hard copy or electronic media.
Records are made available for evaluation by the customer or his representative for an agreed
period, where agreed contractually.
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Documentation Structure
The diagram below outlines the structure of the Eagle Machining, Inc. Quality Management System:
Q u a lity M a n a g e m e n t S y ste m
(Q M S )
Q u a lity
P o lic y
M anual
D e p a rt m e n t
S p e c ific
P ro c e d u re s
S y ste m s
O p e r a tio n s
P r o c e s se s
W o r k In st ru c tio n s
L ev el 1
L ev el 2
L ev el 3
R e q u ir e d R e c o r d s
L ev el 4
Level 1 – Quality Policy Manual – A description of the Eagle Machining, Inc. Quality Management System
method of establishing, implementing, and maintaining a QMS that meets the requirements of the
ISO 9001:2008 Standard.
Level 2 – Quality Procedures – Department Specific Operating Procedures stating the requirements
Level 3 – Department specific work instructions that provide detailed instructions for work in support of the
Department Procedures.
Level 4 – Records required by the Quality Management System or Operating Procedures or Work
Instructions.
RESPONSIBILITIES
Top management is responsible for ensuring that issues of appropriate documents are available for use and
are periodically reviewed for removal of all obsolete issues.
The establishment of the Quality Management System is the responsibility of top management.
Top Management is responsible for the Quality System Manual and for the overall control of documents.
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MANAGEMENT RESPONSIBILITY
REFERENCE DOCUMENTS

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

5.1
ISO 9001:2008 Clause 5
Quality System Manual Clause 6
Quality System Manual Clause 7.2.1,
Quality System Manual Clause 8.2.1,
Quality System Manual Clause 7.1,
Quality System Manual Clause 4.1,
Quality System Manual Clause 4.2.4,
Quality Procedure, Internal Quality System Audits, QP822
Quality Procedure, Corrective Action System, QP852
Quality Procedure, Preventive Action System, QP853
Management Commitment
Management provides evidence of its commitment to the development and implementation of the
Quality Management System and to continually improving its effectiveness by;
a) communicating to all employees the importance of meeting customer as well as statutory
and regulatory requirements,
b) establishing the quality policy (see 5.3 below), and ensuring that this policy is understood by
all employees,
c) ensuring that the quality objectives (see 5.4.1 below) are established and reviewed for
continuing suitability and adequacy and, when necessary, the need for change,
d) conducting management reviews (see 5.6 below), and
e) ensuring the availability of resources, per QSM Clause 6.
5.2
Customer Focus
Management ensures that customer requirements are determined, per QSM Clause 7.2.1. These
requirements are met with the aim of enhancing the satisfaction of our customer, per QSM Clause
8.2.1.
5.3
Quality Policy
Eagle Machining, Inc. is committed to providing products and services that meet customer
requirements. We monitor our process performance and review our quality objectives for
continual improvement of our quality management system.
Management ensures that the Quality Policy
a) is communicated and understood within the organization, and
b) is reviewed for continuing suitability.
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Our Quality Policy means that we will provide our customers with products and services that meet
their requirements while continually improving the Quality Management System to enhance
customer satisfaction.
5.4
Planning
5.4.1
Quality Objectives
It is the responsibility of Top Management to ensure that quality objectives, including those needed
to meet product requirements (see 7.1 a) are established at relevant functions and levels within the
organization. These objectives are measurable and consistent with the quality policy.
The overall quality objectives are as follows:
a) to comply with customer contract requirements ,
b) to establish, monitor and measure internally set quality goals,
c) continual Improvement of the Quality Management System, based on our internal and external
customer feedback and other internal management system mechanisms,
5.4.2
QMS Planning
Eagle Machining, Inc. management ensures that:
a) the planning of the Quality Management System is carried out in order to meet the requirements
given per 4.1 as well as the quality objectives,
b) the integrity of the QMS is maintained when changes to the QMS are planned and implemented.
5.5
Responsibility, Authority and Communications
5.5.1
Responsibility and Authority
The responsibilities and authorities of all employees within the organization are defined and
communicated by top management. Our management with responsibility and authority for corrective
action is promptly informed of products or processes that do not conform to requirements.
5.5.2
Management Representative
The Quality Manager is the Management Representative who, irrespective of other responsibilities,
has responsibility and authority that includes:
a) ensuring that processes needed for the QMS are established, implemented, and maintained,
b) reporting on the performance of the QMS, including any need for improvement, and
c) ensuring the promotion and awareness of customer requirements throughout the organization.
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Internal Communication
Management has established communication processes within the facility that ensure
communication takes place regarding the effectiveness of the QMS.
5.6
Management Review
5.6.1
General
Eagle Machining, Inc. top management conducts reviews as needed, or as a minimum, annual reviews
of the quality management system to ensure its continuing suitability, adequacy and effectiveness.
This review includes assessing opportunities for improvement and the need for changes to the quality
management system, including the quality policy and objectives. In addition, the quality management
system is reviewed for its effectiveness in ensuring that the structure of the quality management
system and the resources provided are adequate to meet requirements. The results of each review are
maintained per QP424 Control of Records. Follow-up actions are communicated to employees by top
management.
5.6.2
Management Review Input
Inputs to the management review include information on
a) Results of audits QP822,
b) Customer feedback,
c) Process performance and product conformity to requirements,
d) Status of corrective action QP852 and preventive actions QP853,
e) Follow-up actions from previous management reviews,
f) planned changes that could affect the QMS,
g) Recommendations for improvement.
5.6.3
Management Review Output
The outputs from the review include all decisions and actions related to
a) Improvement of the effectiveness of the QMS and its processes
b) Improvement of product related to customer requirements, and
c) Resource needs
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RESOURCE MANAGEMENT
REFERENCE DOCUMENTS
6.1

ISO 9001:2008 Clause 6

Quality Policy Manual Clause 4.3,

Quality Policy Manual Clause 7.1,

Quality Policy Manual Clause 6.2.2 Competence, Training and Awareness.
Provision of Resources
Top management determines and provides the resources needed to implement and maintain the
QMS and continually improve its effectiveness and to enhance customer satisfaction by meeting
customer requirements.
The manager of each department identifies the requirements and provides adequate resources for
the efficient and effective accomplishment of all tasks and responsibilities assigned within that
organization. This includes trained personnel and qualified personnel for the performance of work
and verification activities.
6.2
Human Resources
6.2.1
Human Resources Department has processes for identifying the training needs and
provides for the training of all personnel performing activities affecting quality.
Personnel performing work affecting product quality are determined to be competent on the
basis of appropriate education, training, skills and experience and are provided access to
relevant work instructions.
6.2.2
Competence, Training and Awareness
In order to ensure continual improvement and customer satisfaction, the Eagle Machining, Inc.
management:
a) determines the necessary competence for personnel performing work affecting product quality,
including verification of experience, education, and training,
b) provides training or takes other actions to satisfy these needs,
c) evaluates the effectiveness of the actions taken,
d) ensures that its personnel are aware of the relevance and importance of their activities and how
they contribute to the achievement of the quality objectives,
e) maintains appropriate records of education, training, skills and experience.
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Infrastructure
Management determines, provides and maintains the infrastructure needed to achieve product
conformance to product requirements. The infrastructure includes, as applicable,
a) buildings, workspace and associated utilities,
b) process equipment (hardware and software),
c) supporting services (such as transport or communication),
6.4
Work Environment
Management determines and manages the work environment needed to achieve conformity to
product requirements.
7.
PRODUCT REALIZATION
REFERENCE DOCUMENTS






ISO 9001:2008, Clause 7
Quality System Manual Clause 4.1,
Quality System Manual Clause 4.3,
Quality Procedure, Control of Records, QP424
Quality Procedure, Purchasing, QP 74
Form 72,EMI COP
7.1
Planning of Product Realization
The processes needed for product realization are planned and developed and are consistent with
the requirements of the other processes of the Quality Management System as defined in QSM
Clause 4.1, in planning product realization management determines the following:
a) Product requirements and quality objectives,
b) the need to establish processes, documents, and provide resources specific to the product,
c) required verification, validation, monitoring, inspection and test activities specific to the product
and the criteria for product acceptance,
d) records needed to provide evidence that the realization processes and resulting product meet
the requirements QSM Clause 4.2.4.
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Customer-Related Processes
7.2.1
Determination of requirements related to the product
Eagle Machining, Inc. determines the requirements specified by the customer, including the
requirements for delivery and post-delivery activities. Requirements not stated by the customer but
necessary for specified use or intended use are reviewed and resolved prior to the delivery of the
product. Any statutory or regulatory requirements are determined and acted upon by BestMachine
Shopas well as any company-specific requirements.
Before acceptance, the Sales Department reviews contracts, at a minimum, for pricing, quantities,
and ship-dates. Appropriate departments are consulted as necessary during the Contract
Review.(Ref. Form 72 EMI COP)
7.2.2
Review of requirements related to the product
The requirements related to the product are reviewed prior to the commitment to supply the product
to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of
changes to contracts or orders) and ensure that;
a) product requirements are defined,
b) contract or order requirements differing from those previously expressed are resolved, and
c) Eagle Machining, Inc. has the ability to meet the defined requirements.
Records of the results of the review and actions arising from the review are maintained as part of the
Contract File per Clause 4.2.4.
Where the customer provides no documented statement of requirement, the customer requirements
are confirmed before acceptance.
Where product requirements are changed, relevant documents are modified and relevant personnel
are made aware of the changed requirements.
7.2.3
Customer Communication
Eagle Machining, Inc. determines and implements effective arrangements for communicating with
customers in relation to product information, inquiries, contracts or order handling, including
amendments, customer feedback, including customer complaints.
Eagle Machining, Inc. accomplishes customer product communications through assignment of
personnel as the customer contact. Additional customer contact may be from feedback that relates
to product issues after acceptance by the customer.
7.4.1
Purchasing Process(QP74)
The purchasing process ensures that purchased product conforms to specified purchase
requirements. The type and extent of control applied to the supplier and the purchased product is
dependent upon the effect of the purchased product on subsequent product realization or the final
product. Suppliers are evaluated and selected based on their ability to supply product in accordance
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with our requirements. Eagle Machining, Inc. has a documented procedure to ensure that purchased
products conform to specified requirements. Criteria for selection, evaluation and re-evaluation of
suppliers are established.
Records of the results of evaluations and any necessary actions arising from the evaluation are
maintained in accordance with QPM Clause 4.2.4, Control of Records.
7.4.2
Purchasing Information
Purchasing information describes the product to be purchased including requirements for approval of
product, procedures, processes, and equipment as appropriate.
The adequacy of specified purchase requirements is ensured through verification prior to their
communication to the supplier.
Purchasing documents contain information clearly describing the product ordered, including, where
applicable:
a) the type, class, style, grade, or other precise identification
b) the title or other positive identification, and applicable issue of specifications, drawings, process
requirements, inspection instructions, and other relevant data, including requirements for
approval or qualification of product, procedures, process equipment and personnel.
c) the title, number, and issue of the quality system standard to be applied.
7.4.3
Verification of Purchased Product (7.4.3)
Inspection or other activities necessary for ensuring that purchased product meets specified
purchase requirements are established and implemented. When Eagle Machining, Inc., our
Customers or the Customer's representative, intends to perform verification at the supplier’s
premises the right to verify shall be afforded by the supplier.
Where Eagle Machining, Inc. verifies purchased product at the supplier’s premises, Eagle
Machining, Inc. specifies verification arrangements and the method of product release in the
purchasing documents.
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Production and Service Provision
7.5.1
Control of Production and Service Provision
Production and service provision are planned and carried out under controlled conditions which
include;
a) the availability of information that describes the characteristics of the product,
b) the availability of work instructions, as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring devices,
e) the implementation of monitoring and measurement, and
f)
the implementation of release, delivery and post-delivery activities.
7.5.2 Eagle Machining, Inc. does not perform servicing or produce products that that readily lend
themselves to any type of servicing by the manufacturer. Therefore, Clause 7.5.2 service
provision is excluded.
7.5.3
Identification and Traceability
Product is identified by suitable means throughout product realization where appropriate. This
includes identification of product status with respect to monitoring and measurement requirements.
Where traceability is a requirement, controls and records of the unique identification of the product
are maintained.
7.5.4
Customer Property
Care is exercised with customer property while it is under the control of, or being used by Eagle
Machining, Inc. Processes are in place to identify, verify, protect and safeguard customer property
provided for use or incorporation into the product. If any customer property is lost, damaged or
otherwise found to be unsuitable for use, this situation is reported to the customer and records
maintained.
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Preservation of Product
The conformity of product is preserved during internal processing and delivery to the intended
destination. This preservation includes identification, handling, packaging, storage and protection of
all tangible aspects of our product. Preservation also applies to the constituent parts of the product.
The customer specifies the requirements for handling, packaging, storage, preservation and
delivery.
7.6
Control of Monitoring and Measuring Equipment
The monitoring and measurement to be undertaken and the monitoring and measuring equipment
needed to provide evidence of conformity of product to determined requirements have been
determined. Procedures have been established to ensure that monitoring and measurement can be
carried out and are carried out in a manner that is consistent with the monitoring and measurement
requirements.
Where necessary to ensure valid results, measuring equipment is;
a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement
standards traceable to international or national measurement standards. Where no such
standards exist, the basis used for calibration or verification is recorded,
b) adjusted or re-adjusted as necessary,
c) identified to enable the calibration status to be determined,
d) safeguarded from adjustments that would invalidate the measurement result,
e) protected from damage and deterioration during handling, maintenance and storage.
In addition, the validity of the previous measuring results are assessed and recorded when the
equipment is found not to conform to requirements, and appropriate action is taken on the
equipment and any product affected.
Records of the results of calibration and verification are maintained IAW Clause 4.2.4.
When used in the monitoring and measurement of specified requirements, the ability of computer
software to satisfy the intended application is confirmed prior to initial use and reconfirmed as
necessary.
8. MEASUREMENT, ANALYSIS AND IMPROVEMENT
REFERENCE DOCUMENTS







ISO 9001:2008 Clause 8.0
Quality Policy Manual Clause 7.1,
Quality Policy Manual Clause 4.2.4,
Quality Procedure, Control of Nonconforming Product, QP83
Quality Procedure, Corrective Action, QP852
Quality Procedure, Internal Audit, QP822
Quality Procedure, Preventive Action,QP853
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8.1 General
The monitoring, measurement, analysis and improvement processes needed to demonstrate conformity of the
product and to ensure conformity of the Quality Management System are planned and implemented.
8.2 Monitoring and Measurement
Ensuring conformity of the product to requirements is demonstrated by:
a) Nonconformance analysis related to the Control of Nonconforming Product QP83,
b) Product audits,
c) Applying “Lessons Learned”,
d) Warranty analysis,
e) Inspection,
Internal and external audits, nonconformance, corrective and preventive actions and customer feedback
results are used to continually improve the effectiveness of the Quality Management System.
This includes the determination of applicable methods, including statistical techniques, and the extent of their
use.
8.2.1
Customer Satisfaction
As one of the measurements of the performance of the Quality Management System, information relating to
customer perception as to whether the organization has met customer requirements is monitored. The
methods for obtaining this information have been determined and include:
a) Customer Complaints,
b) Acceptance by the Customer Representative prior to shipment,
c) Direct customer contact via meetings, telephone and e-mail,
d) Spare parts speed of delivery information,
e) Warranty issues,
Customer feedback may result in changes to the specifications or configuration as contracted with the
customer.
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Internal Audit
Internal audits are conducted at planned intervals to determine whether the Quality Management System
a) Conforms to the planned arrangements per QPM Clause 7.1 to the QMS requirements established
within this Manual, and
b) is effectively implemented and maintained.
Internal quality audits are planned and scheduled on the basis of the status and importance of the processes
and areas, including the results of previous audits. Auditors do not audit their own work.
The audit criteria, scope, frequency and methods are defined in documented procedures, per QP822,
including their planning and implementation. Selection of auditors and the conduct of audits ensure
objectivity and impartiality of the audit process.
The results of the audits are recorded and brought to the attention of the personnel having responsibility in
the area audited. The management personnel responsible for the area make timely corrective actions on the
deficiencies found during the audits. Follow-up activities include the verification of the actions taken and the
reporting of verification results.
Records are maintained in accordance with QPM 4.2.4
8.2.3
Monitoring and Measurement of Processes
Suitable methods for monitoring and, where applicable, measurement of the QMS processes are applied
within the operations to demonstrate the ability of the processes to achieve planned results. When planned
results are not achieved, correction and corrective action is taken, as appropriate, to ensure conformity of the
product.
8.2.4
Monitoring and Measurement of Product
The characteristics of the product are monitored and measured 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, per QPM Clause 7.1. The required inspection and testing, and the records to be
established, are documented in the quality procedures.
Evidence of conformity with the acceptance criteria is maintained. These records indicate the person(s)
authorizing release of product.
Product release and delivery do not proceed until all the planned arrangements have been satisfactorily
completed, per QPM Clause 7.1 unless otherwise approved by a relevant authority, and where applicable, by
the customer.
8.3
Control of Nonconforming Product
Product, which does not conform to product requirements, is identified and controlled to prevent its
unintended use or delivery. The controls and related responsibilities and authorities for dealing with
nonconforming product are defined in QP83.
a) by taking action to eliminate the detected nonconformity (reworked to meet specified requirements),
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b) by authorizing its use, release or acceptance under concession by a relevant authority and, where
applicable, by the customer;
c) by taking action to preclude its original intended use or application (isolated, scrapped or returned to
vendor).
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 nonconforming product is detected after delivery or use
has started, action is taken which is appropriate to the effects, or potential effects, of the nonconformity.
8.4
Analysis of Data
Appropriate data is determined, collected and analyzed to demonstrate the suitability and effectiveness of
the Quality Management System and to evaluate where continual improvement of that effectiveness can be
made. Data generated as a result of monitoring and measurement or from other relevant sources aids the
fulfillment of the analysis requirements through the trending of the data. The types of data include, but are
not limited to:
a) customer satisfaction,
b) conformance to product requirements,
c) characteristics and trends of processes and products including opportunities for preventive action, and
d) suppliers.
8.5
Improvement
8.5.1
Continual Improvement
The effectiveness of its Quality Management System is continually improved through the use of the quality
policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management
review.
8.5.2
Corrective Action
Action, which is appropriate to the magnitude of the problem and commensurate with the risks encountered,
is taken to eliminate the cause of nonconformities in order to prevent recurrence. The root cause of the
problem is identified and an action plan is developed to correct the problem and eliminate any recurrence
The Corrective Action and Preventive Action procedures are separate Quality System Procedures that make
a clear distinction between corrective action and preventive action and their inter-relationship.
Procedure QP852 defines requirements for:
a) reviewing nonconformities (including customer complaints),
b) determining the causes of non-conformities,
c) evaluating the need for action to ensure that nonconformities do not recur,
d) determining and implementing action needed,
e) records of the results of action taken, and
f)
reviewing corrective action taken.
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Any changes to the documented procedures resulting from corrective action is implemented and recorded,
following the Corrective Action Procedure QP852.
8.5.3
Preventive Action
Action, which is appropriate to the effects of the potential problem, is taken to eliminate the causes of
potential nonconformities in order to prevent their occurrence. Preventive actions are appropriate to the
effects of the potential problems.
The specifics are outlined by procedure QP853 which defines requirements for:
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)
Records of results of action taken, per QPM Clause 7.1 and,
e)
Reviewing preventive action taken.
RESPONSIBILITIES
Any employee, supplier or customer may initiate a preventive action request.
The Quality Manager is responsible for ensuring that causes of problems and adverse trends are thoroughly
investigated and that effective preventive actions are taken and reporting on the timeliness of the actions.
Eagle Machining, Inc. maintains records, which provide objective evidence that the product has been
inspected and/or tested. These records show clearly whether the product has passed or failed the
inspections and/or tests according to defined acceptance criteria.
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