AS9100:2016 Quality Manual
AS9100:2016 Quality Manual
AS9100:2016 Quality Manual
AS9100:2016
Quality Manual
Revision: A
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Table of Contents
1. REVISION HISTORY 3
2. INTRODUCTION 4
5. LEADERSHIP 7
5.1. Leadership and commitment 7
5.1.1. General 7
5.1.2. Customer focus 8
5.2. Policy 8
5.2.1. Establishing the Quality Policy 8
5.2.2. Communicating the Quality Policy 9
5.3. Organizational roles, responsibilities and authorities 9
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8.1.4. Prevention of Counterfeit Parts 19
8.2. Requirements for products and services 19
8.2.1. Customer communication 19
8.2.2. Determining the requirements for products and services 19
8.2.3. Review of the requirements for products and services 20
8.2.4. Changes to requirements for products and services 20
8.3. Design and development of products and services 20
8.4. Control of externally provided processes, products and services 21
8.4.1. General 21
8.4.2. Type and extent of control 22
8.4.3. Information for external providers 22
8.5. Production and service provision 23
8.5.1. Control of production and service provision 23
8.5.2. Identification and traceability 26
8.5.3. Property belonging to customers or external providers 26
8.5.4. Preservation 26
8.5.5. Post-delivery activities 27
8.5.6. Control of changes 27
8.6. Release of products and services 27
8.7. Control of nonconforming outputs 28
8.7.1. Unintended use 28
8.7.2. Retention of Documentation 29
1. Revision History
Revision Date Description Approved By
Issue 10/9/17 Issued for AS9100 Rev. D Upgrade
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2. Introduction
Our organization has developed a Quality Management System to better satisfy the needs of its
customers and to continually improve the overall management of the company.
The purpose of this manual is to document the organization’s Quality Management System, define
the Quality Policy and Objectives, instruct and guide employees, and define the controls
implemented to assure product quality and customer satisfaction.
The quality system conforms to the requirements of the International Standard AS9100:2016. It
describes the major processes associated with our business as identified in Appendix C [Process
Flow Map].
This Flow Map also shows the interaction of these processes, identifies procedures that detail how
activities are performed, and identifies measuring methods for all processes so management can
assure the system is functioning as intended.
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4. Context of the organization
4.1. Understanding the organization and its context
Our organization determines external and internal issues that are relevant to our purpose
and our strategic direction and that affect our ability to achieve the intended result of our
quality management system.
Our organization monitors and reviews information about these external and internal issues
as described in SOP 56-01 [Management Review].
Customers: The people who use our services directly affect our ability to satisfy their needs.
We strive to understand the needs, expectations, and requirements of these people,
because how they use our service determines how new and existing services need to be
improved and created. These are considered to be one of our most important interested
parties.
Governments & non-government organizations: There are many industry specific and legal
requirements that our services need to meet, and there can be a great cost to not meeting
these. In addition, it’s important to understand the expectations of other organizations,
such as industry watchdog groups, which might identify what levels of performance and
durability which are expected by our customers and ultimately the end user or prime
customer which our customer is providing products to.
Owners & Employees: Even though Owners of Braddock Metallurgical and its employees are
not purchasers of our services, everyone working at Braddock wants to work in an
environment that performs quality services that will meet the needs and exceed the
expectations of our customers. It is always our goal to become a valued supplier to our
customers by, delivering conforming product, with consistent results, at an affordable price
on a regular basis.
Our organization applies all the requirements of the AS9100:2016 International Standard if
they are applicable within the determined scope of our quality management system.
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Our organization has determined that the following elements are not applicable:
Our organization does not design any product, and therefore Section
8.3 is not applicable.
Our organization does not perform any Field Service activities, and
therefore Section 8.5.5 f, g, and h are not applicable.
The scope of our organization’s quality management system (as stated above) shall be
available and be maintained. It states the types of products and a service covered and
provides justification for any requirement of this International Standard that our
organization determines is not applicable to the scope of our quality management system.
Conformity to this International Standard may only be claimed if the requirements
determined as not being applicable do not affect our organization’s ability or responsibility
to ensure the conformity of its products and services and the enhancement of customer
satisfaction.
Our organization has determined the processes needed for our quality
management system and their application throughout our organization, and:
a) defines the inputs required and the outputs expected from these processes in
Appendix C [Process Flow Map];
c) defines and applies the criteria and methods needed to ensure the effective
operation and control of these processes as described in Appendix C [Process Flow
Map] and in specific procedures related to each Core Process;
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h) improves the processes and the quality management system.
b) retains documented information to have confidence that the processes are being
carried out as planned as described in SOP 42-03 [Control of Quality Records].
Our organization has established and maintains documented information that
includes:
- a general description of relevant interested parties in 4.2.
- a description of the processes needed for the quality management system and
their application throughout the organization in Appendix C [Process Flow Map]
5. Leadership
5.1. Leadership and commitment
5.1.1. General
Top management shall demonstrate leadership and commitment with respect to
our quality management system by:
b) ensuring that our Quality Policy and Quality Objectives [Appendix A] are
established for our quality management system and are compatible with the
context and strategic direction of our organization;
e) ensuring that the resources needed for our quality management system are
available;
g) ensuring that the quality management system achieves its intended results;
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h) engaging, directing and supporting persons to contribute to the effectiveness of
our quality management system;
i) promoting improvement;
b) the risks and opportunities that can affect conformity of products and services
and the ability to enhance customer satisfaction are determined and addressed as
described in SOP 72-02 [Customer Purchase Order / Contract Review];
d) product and service conformity and on-time delivery performance are measured
as described in Appendix A [Quality Objectives] and appropriate action is taken if
planned results are not, or will not be, achieved.
5.2. Policy
5.2.1. Establishing the Quality Policy
QUALITY POLICY/MISSION STATEMENT
We are dedicated to providing our customers with an exceptional level of
heat treating quality and customer service utilizing value added
continuous improvement.
We accomplish this by having the proper FOCUS on our
customers and PRIDE among our employees.
Facilitating partnerships with customers and employees
Optimizing technology
Continually improving
Understanding customer’s needs
Sustaining organizational excellence
And
Personal
Responsibility
In
Developing
Excellence
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Top management has established, implemented and maintains Quality Policy that:
a) is appropriate to the purpose and context of the organization and supports its
strategic direction;
a) ensuring that our quality management system conforms to the requirements of this
International Standard;
b) ensuring that the processes are delivering their intended outputs;
c) reporting on the performance of our quality management system and on opportunities for
improvement (see 10.1), in particular to top management;
e) ensuring that the integrity of our quality management system is maintained when
changes to the quality management system are planned and implemented.
All departments and functions in the company are responsible for implementing,
maintaining, and improving the quality system, and providing training where
needed.
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Top Management
Formulates the quality policy and objectives
Provides resources necessary to maintain and improve the quality system
Conducts management reviews of the quality system
Production Control
Schedules production
Established production work orders
Production
Plans production facilities, equipment, and processes
Develops production processes
Develops process operator and set-up instructions
Controls and monitors processes
Conducts in-process inspections
Applies and maintains in-process product identification
Maintains production equipment
Carries out contract and order reviews
Process Owners
By Process Specifications
Internal Process Specifications
Individual Work Instructions
Individual Training
Receiving
Receives purchased products
Performs first-stage receiving inspection
Applies or verifies product identification for purchased products
Operates the material stockroom
Shipping
Packages products (secondary packaging)
Ships products to customers
Operates the finished product stockroom
Marketing and Sales
Conducts market research to anticipate customer expectations
Determines customer satisfaction
Establishes specifications for new products (product briefs)
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Advertises and promotes company's products
Monitors the quality performance of competitors
Plant Human Resources and Plant General Managers
Defines personnel qualification requirements
Implements measures to motivate personnel
Quality Assurance and Quality Control
Establishes and maintains the quality management system
Audits implementation and effectiveness of the quality system
Identifies opportunities for improvement of the quality system
Develops quality plans and control plans
Initiates corrective and preventive actions
Maintains and may calibrate measuring and test equipment
Carries out subcontractor quality surveys and audits
Performs inspections and testing
Selects qualified suppliers and subcontractors
Prepares and approves purchasing documents
Monitors and evaluates supplier performance
Identifies the need for the use of statistical techniques
Handles nonconforming products
Coordinates document control activities
Carries out contract and order reviews
Maintains, or coordinates the maintenance of quality records
Coordinates collection of quality performance data
P r o v i d e s , delegates, and ensures required training for its personnel.
Management Representative
Braddock Metallurgical has appointed the Corporate Director of Quality as the Senior Quality
Management Representative and has the authority and responsibility to:
Ensure that the quality management system is implemented, maintained and continually
improved;
Promote awareness of customer requirements throughout the organization;
Report to the top management on the performance of the quality system, including needs for
improvement;
Has the organizational freedom to resolve all matters pertaining to Quality; and
Coordinate communication with external parties on matters relating to the quality system, AS
9100 and ISO 9001 registration.
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Has the organizational freedom and unrestricted access to top management to resolve quality
management issues and can liaison with external parties on matters relating to the quality
management system.
Note: Each site Quality Manager has been designated as Deputy Management Representative for
their site by the Corporate Director of Quality.
The management representative shall have the organizational freedom and unrestricted
access to top management to resolve quality management issues.
6. Planning
6.1. Actions to address risks and opportunities
6.1.1. Consideration and Determination of Risk
When planning for our quality management system, our organization considers the
issues referred to in 4.1 and the requirements referred to in 4.2 and sets forth SOP
72-02 [Customer Purchase Order / Contract Review] in order to determine the
risks and opportunities that need to be addressed to:
a) give assurance that our quality management system can achieve its intended
result(s);
d) achieve improvement.
Risk Planning
Our organization sets forth SP 72-02 [Customer Purchase Order / Contract Review]
in order to plan:
b) how to:
1) integrate and implement the actions into its quality management system
processes (see 4.4);
b) be measurable;
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c) take into account applicable requirements;
e) be monitored;
f) be communicated;
g) be updated as appropriate.
7. Support
7.1. Resources
7.1.1. General
Our organization determines and provides the resources needed for the
establishment, implementation, maintenance and continual improvement of our
quality management system.
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b) what needs to be obtained from external providers.
7.1.2. People
Our organization determines 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
Our organization determines, provides and maintains the infrastructure necessary
for the operation of its processes and to achieve conformity of products and
services.
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This knowledge shall be maintained and be made available to the extent necessary.
When addressing changing needs and trends, our organization considers its current
knowledge and determines how to acquire or access any necessary additional
knowledge and required updates.
7.2. Competence
As described in SOP 62-01 [Competence, Training & Awareness], our organization:
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 actions to acquire the necessary competence, and evaluates the
effectiveness of the actions taken;
7.3. Awareness
Our organization ensures that persons doing work under our organization’s control are
aware of:
c) their contribution to the effectiveness of our quality management system, including the
benefits of improved performance;
d) the implications of not conforming with our quality management system requirements.
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7.4. Communication
Our organization determines the internal and external communications relevant to our
quality management system, including:
b) when to communicate;
d) how to communicate;
e) who communicates.
b) format (e.g. language, software version, graphics) and media (e.g. paper,
electronic);
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7.5.3.2. Distribution
As described in SOP 42-02 [Control of Documents] and SOP 42-03
[Control of Quality Records], for the control of documented information,
our organization addresses the following activities, as applicable:
8. Operation
8.1. Operational planning and control
As described in SOP 75-01 [Traveler], our organization 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:
c) determining the resources needed to achieve conformity to the product and service
requirements and to meet on-time delivery of products and services;
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e) determining, maintaining and retaining documented information to the extent necessary:
1) to have confidence that the processes have been carried out as planned;
f) determining the processes and controls needed to manage critical items, including
production process controls when key characteristics have been identified;
h) determining the process and resources to support the use and maintenance of the
products and services;
j) establishing the controls needed to prevent the delivery of nonconforming products and
services to the customer.
As appropriate to our organization, customer requirements, and products and services, our
organization plans and manages 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 as described in SOP 72-02
[Customer Purchase Order / Contract Review] and SOP 75-01 [Traveler].
The output of this planning shall be suitable for our organization’s operations.
The organization controls planned changes and reviews the consequences of unintended
changes, taking action to mitigate any adverse effects, as necessary.
Our organization ensures that outsourced processes are controlled (see 8.4) as described in
SOP 74-01 [Supplier Evaluation], SOP 74-02 [Purchasing] and SOP 74-03 [Verification /
Validation or Purchased Products / Services].
Our organization has established, implemented, and maintains a process to plan and control
the temporary or permanent transfer of work, to ensure the continuing conformity of the
work to requirements as described in SOP-BCP [Braddock Contingency Plan]. The process
ensures that work transfer impacts and risks are managed.
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8.1.2. Configuration Management
Our organization planned, implemented, and controls a process for configuration
management as appropriate to the organization and its products and services in
order to ensure the identification and control of physical and functional attributes
throughout the product lifecycle as described in SOP 75-04 [Product Identification
and Traceability] and SOP 82-05 [Product Inspection and Status].
These processes:
a) the requirements for the products and services are defined, including:
1) any applicable statutory and regulatory requirements;
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b) the organization can meet the claims for the products and services it offers
d) operational risks (e.g., new technology, ability and capacity to provide, short
delivery time frame) have been identified.
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Our organization identifies and manages the risks associated with the external
provision of processes, products, and services, as well as the selection and use of
external providers as described in SOP 74-01 [Supplier Evaluation].
Our organization requires that external providers apply appropriate controls to their
direct and sub-tier external providers, to ensure that requirements are met as
described in SOP 74-01 [Supplier Evaluation].
a) products and services from external providers are intended for incorporation into
our organization’s own products and services;
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d) defines the necessary actions to take when dealing with external
providers that do not meet requirements;
a) ensure that externally provided processes remain within the control of its quality
management system;
b) define both the controls that it intends to apply to an external provider and
those it intends to apply to the resulting output;
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j) the use of statistical techniques for product acceptance and related instructions
for acceptance by the organization;
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a) the availability of documented information that defines:
1) the characteristics of the products to be produced, the services to be
provided, or the activities to be performed;
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;
j) the accountability for all products during production (e.g., parts quantities, split
orders, nonconforming product);
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o) the provision for the prevention, detection, and removal of foreign objects;
p) the control and monitoring of utilities and supplies (e.g., water, compressed air,
electricity, chemical products) to the extent they affect conformity to product
requirements (see 7.1.3);
d) qualification of persons;
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when changes occur that invalidate the original results (e.g., engineering
changes, production process changes, tooling changes).
Our organization identifies the status of outputs with respect to monitoring and
measurement requirements throughout production and service provision.
When acceptance authority media are used (e.g., stamps, electronic signatures,
passwords), our organization establishes controls for the media.
Our organization controls the unique identification of the outputs when traceability
is a requirement and shall retain the documented information necessary to enable
traceability as described in SOP 75-04 [Product Identification and Traceability].
8.5.4. Preservation
Our organization preserves the outputs during production and service provision, to
the extent necessary to ensure conformity to requirements.
a) cleaning;
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e) shelf life control and stock rotation;
b) the potential undesired consequences associated with its products and services;
c) the nature, use and intended lifetime of its products and services;
d) customer requirements;
e) customer feedback;
When problems are detected after delivery, our organization shall take appropriate
action including investigation and reporting.
Our organization retains documented information describing the results of the review of
changes, the person(s) authorizing the change, and any necessary actions arising from the
review as described in SOP 72-02 Customer Purchase Order / Contract Review.
The release of products and services to the customer shall not proceed until the planned
arrangements have been satisfactorily completed, unless otherwise approved by a relevant
authority and, as applicable, by the customer.
Our organization retains documented information on the release of products and services.
The documented information shall include:
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a) evidence of conformity with the acceptance criteria;
When required to demonstrate product qualification, our organization ensures that retained
documented information provides evidence that the products and services meet the defined
requirements as described in SOP 42-03 [Control of Quality Records].
Our organization ensures that all documented information required to accompany the
products and services are present at delivery.
Our organization shall take appropriate action based on the nature of the
nonconformity and its effect on the conformity of products and services. This shall
also apply 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;
Our organization deals with nonconforming outputs in one or more of the following
ways:
a) correction;
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- after approval by an authorized representative of the organization
responsible for design or by persons having delegated authority from the
design organization;
9. Performance evaluation
9.1. Monitoring, measurement, analysis and evaluation
9.1.1. General
As described in Appendix A [Quality Objectives], our organization determines:
d) when the results from monitoring and measurement shall be analyzed and
evaluated.
Our organization shall evaluate the performance and the effectiveness of the
quality management system as described in SOP 56-01 [Management Review].
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a) conforms to:
1) our organization’s own requirements for its quality management system;
a) plans, establishes, implements and maintains an audit program including the frequency,
methods, responsibilities, planning requirements and reporting, which shall take into
consideration the importance of the processes concerned, changes affecting the
organization, and the results of previous audits;
c) selects auditors and conduct audits to ensure objectivity and the impartiality of the audit
process;
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d) ensures that the results of the audits are reported to relevant management;
b) changes in external and internal issues that are relevant to the quality management
system;
6) audit results;
e) the effectiveness of actions taken to address risks and opportunities (see 6.1);
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c) resource needs;
d) risks identified.
10. Improvement
10.1. General
Our organization determines and selects opportunities for improvement and implements any
necessary actions needed to meet customer requirements and enhance customer
satisfaction.
a) improving products and services to meet requirements as well as to address future needs
and expectations;
b) evaluate 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 and analyzing the nonconformity;
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h) take specific actions when timely and effective corrective actions are not
achieved.
Our organization considers the results of analysis and evaluation and the outputs from
management review, in order to determine if there are needs or opportunities that shall be
addressed as part of continual improvement.
Our organization monitors the implementation of improvement activities and evaluates the
effectiveness of the results as described in SOP 56-01 [Management Review].
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Document Appendix -A
Revision A
Braddock Metallurgical, Inc. Pages 1 of 1
Customer Product Conformity for all Plants shall be > 95%. This is based on number of
Customer Returns, Divided by the number of Lots Shipped.
Revision Issue
Braddock Metallurgical, Inc. Pages 1 of 1
President
Information
General / Plant Accounting
Technology
Manager JAX
Production
General / Plant
Manager for each
Manager NC
Facility
General / Plant
Manager DB
General / Plant
Manager BB
General / Plant
Sales & Marketing
Manager NJ
Document Appendix -C
Revision Issue
Braddock Metallurgical, Inc. Pages 1 of 1