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Introduction
Prime Machine, Inc. developed and implemented a Quality Management System in order to
document and continually improve the company’s best business practices, better understand
and satisfy the requirements and expectations of its customers and improve the overall
performance of the company.
The Quality Management System of Prime Machine, Inc. complies with the intent of the
international standard SAE AS-9100 Rev C. This system addresses the development,
production, and servicing of the company’s products.
The manual is divided into eight sections that correlate to the Quality Management System
sections of SAE AS-9100 – Rev C. Each section begins with a policy statement expressing
Prime Machine, Inc.’s obligation to implement the basic requirements of the referenced Quality
Management System section. Each policy statement is followed by specific information
pertaining to the procedures that describe the methods used to implement the necessary
requirements.
This manual describes the Quality Management System, delineates authorities, inter
relationships and responsibilities of the personnel responsible for performing within the system.
The manual also provides procedures or references for activities comprising the Quality
Management System to ensure compliance to the necessary requirements of the standard.
This manual is used internally to guide the company’s employees through the various
requirements of the SAE AS-9100 Rev C. standard and the company’s best business practices.
These business practices are dynamic and maintained in order to ensure customer satisfaction
and continuous improvement.
This manual is also used externally, to introduce our Quality Management System to our
customers and other external organizations or individuals. The manual is used to familiarize
them with the controls that have been implemented and to assure them that the integrity of the
Quality Management System is maintained and focused on customer satisfaction and
continuous improvement.
President:
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Quality Manual Distribution Policy:
The QMS documentation, Quality Manual, procedures, process flows and many of the forms are
on-line documents. The most current revision of each document is the on-line version. With the
exception of some hard copy forms in use, all paper copies of the QMS documents are
considered “reference only” and their current revision level verified before use. Training on how
to access the QMS documentation will be provided to all employees as part of their employee
orientation. Employee training records are kept on all permanent employees of Prime Machine,
Inc.
Access to this manual is provided to the customer and/or regulatory agencies upon request or
where appropriate to satisfy contractual obligation with Prime Machine, Inc. or compliance to the
customers internal quality systems.
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Section 1: Scope
1.1 General
This standard includes ISO 9001:2008 quality management system requirements and
specifies additional requirements for a quality management system for the aerospace
industry.
It is emphasized that the quality management system requirements specified in this
standard are complementary (not alternative) to contractual and applicable law and
regulatory requirements.
The quality manual outlines the policies, procedures and requirements of the Quality
Management System. The system is structured to meet the intent of the conditions set
forth in the International Standard ISO 9001:2008 and AS9100 Rev C to comply with
market specific customer needs.
1.2 Application
Prime Machine, Inc. has determined that the following requirements are not applicable to
the current operations at this site and are documented as exclusions:
 Prime Machine, Inc. is primarily a manufacturing facility. The main scope of their
supply to the customer is to manufacture from customer furnished specifications,
CAD data, and/or drawings. Design, service and industrial processes are
specifically excluded.
 Prime Machine, Inc. is not a mass quantity producer of products. The facility is
capable of supporting such contracts, but is not currently engaged in sustaining
such ventures. This means that there is not a current need for Statistical process
controls, statistical data analysis, or related processes applicable to this type of
manufacturing. These processes can be readily implemented to comply with any
customer or contractual requirements.
Additionally, Prime Machine, Inc. is a multi-faceted service and production organization
with a wide range of customers. To assure all customer needs are met Prime Machine,
Inc. has a robust system for determining customer needs through the contract review
activity PMF-102. This wide range of customers has often dramatically different needs
from the QMS. In support of these diverse needs, Prime Machine, Inc. maintains three
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distinct different levels of performance and documentation within the QMS. These levels
are identified during contract review and are communicated to the customer.
The three distinct levels are defined in this manual under Section 3.1, Customer Quality
Requirement Categorical Index.
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Prime Machine, Inc
Organizational Structure
January 2011
To Administration
President
Sales/Project
Manager
Quality Manager
Engine
Inside
Sales
Field
Service
Production
Manager
Engineering
Manager
Aerospace
Power/
Oil/Gas
Safety Director
Metrology
Machine
Shop Mgr
Night
Machine
Shop Mgr
Purchasing
Mechanic
Shop Mgr
Weld Shop
Mgr
Engine
Shop Mgr
Shipping
Programming
/CAD
Machinist Day
Mechanic
Welders
Mechanics
Receiving
Janitor
Tool Rm /
Inventory
Machinist Night
Accounting
Maintenance
Mgr
Driver
Payroll,
A/R
Office, A/P
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Section 2: Normative Reference
2.0 Quality Management System References
The following documents were used as reference during the preparation of the Quality
Management System:
 U.S. Department of Defense Specification and standards Mil-Q-9858A
 U.S. Department of Defense Specification and standards Mil-45208A
 American National Standard ANSI/ISO/ASQ Q9000-2008, Quality Management
Systems - Vocabulary
 American National Standard ANSI/ISO/ASQ Q9001-2008, Quality Management
Systems – Requirements
 American National Standard ANSI/ISO/ASQ Q9004-2008, Quality Management
Systems – Guidelines for performance Improvements
 ISO 9000:2005 Quality Management Systems – fundamentals and vocabulary
 SAE International Aerospace Standards AS9100 and AS9003
 Boeing BQMS appendix B - 2001. (D6-82479 rev B)
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Section 3: Definitions and Clarifications
3.0 Quality Management System Definitions
This section is for definitions unique to Prime Machine, Inc.:
 Contract Review / Proposal – The response to a customer’s work scope
requests. This is where intent to meet specific customer requirements is initiated
and documented. It becomes the basis for all downstream shop/work order
routers and associated paperwork.
 Shop Router- The documentation that describes the methodology for production
and records pertinent data for a given component or assembly. This document
may be for individual components, a lot of components or a static document tied
to a production line of products. (REF. PMP-003)
 Work Order Router- This is a computer generated sequence of operations that
defines the complete scope of work to be performed against a specific job
number. The electronic version of the work order router is considered the sole
authority data for work in process and it is maintained within Global Solutions
with the most current sequence of operations. The work order router is the initial
planning step in the execution of a work package and as changes are made to
work in process the Work Order Router is updated. (REF. PMP-003)
 Traveler- The traveler is the printed document package that defines the
sequence of operations to be performed in the execution of a specific work order
including inspection points. This package also contains the appropriate,
inspection forms, material certs and other data gathered as the part progressing
thru processing. This document package is enclosed in a clear envelope which
also contains other pertinent in-process documentation that travels with the parts
on the shop floor.
 Job Folder- The job folder is the final collection point for all paperwork
associated with a specific job that serves as the historical documentation for the
work performed. All pertinent documents will be contained in the folder; drawings,
work order routers, material certifications, inspection sheets... The job folder is
considered the historical record of note for each job.
 PMP- Prime Machine Procedure. These are also considered support
documentation for this manual.
 PMF-Prime Machine Flow Diagram. These are also considered support
documentation for this manual.
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 PPC-Prime Machine Process Control Procedure. These are standard procedures
that PMI had developed for recurring and/or specialized work. These PPC’s are
referenced in the shop routers as required for additional process control.
 Customer Owned Property - Any type of instrumentation, accessories,
manuals, or shipping containers that belong to a customer
 Customer Supplied Product - Any type of service or material supplied to be
utilized in the manufacture, modification or repair of customer-owned property
 Product – The end item result of meeting all contract terms and conditions (e.g.:
manufactured goods, merchandise, services etc.)
 WIP – A `work in progress` status for the work scope operations performed on a
project (This May include meetings and customer progress documentation
requirements.)
 Source Inspection- An agreement made with the customer, government or their
designee, to verify conformance of a product at Prime Machine, Inc. or at Prime
Machine, Inc. supplier’s premises
 Quality Records – Documentation of those activities wherein records of said
activities must be maintained will be specified in the procedure or work
instruction level documents, as applicable
 QFM or Qform- Prime Machine Quality Control Form
 Material Review- Material review is the activity performed by the material review
board to determine the disposition of products that do not meet specification.
This activity is performed by shop management and Quality personnel and may
rework repair scrap or Use as is any component under their review. Refer to
PMP-007 Control of Non conforming materials.
3.0.1 Customer Quality Requirement Categorical Index:
This section defines the work scope quality categories for all work performed at Prime
Machine, Inc. These classifications were implemented to more closely and accurately
control the level of quality and efficiency on all operations performed:
 Quality Level I- Applies to work that is simplistic in nature and has minimal
quality, inspection and documentation requirements. This work is initiated at the
customer’s discretion and communication of requirements and results can be
verbal. Approval of quality and release of finished product or related activities
can be made by the Prime Machine, Inc. area manager or shift supervisor.
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
Quality Level II- Applies to work that has some degree of complexity where
quality planning is based upon best industry practices or Prime Machine, Inc.
workmanship standards and internal documentation. Specifications of quality and
performance will be determined for each work package by the project manager,
and Prime Machine, Inc. reserves the right to perform all Material Review
activities on Quality level II projects.
 Quality Level III- Applies to work where the customer provides and/or specifies
in writing or by contract, all specifications, drawings and applicable inspection
plans and quality requirements. This information shall be provided before any
related process is started, and will constitute the current specification in force on
the individual project. The customer will be closely involved in all stages of
planning, production, assembly, and inspection. The customer will provide buyoff criteria and procedures or provide for source inspection of the work
performed, and shall reserve the right to conduct the material review activity on
these programs. All work done under AS9100 Rev C is, by definition, Quality
Level III.
3.1 Risk
Risk is defined as an undesirable situation or circumstance that has both a
likelihood of occurring and a potentially negative consequence.
3.2 Special Requirements
Those requirements identified by the customer, or determined by Prime Machine,
which have high risks to being achieved, thus requiring their inclusion in the risk
management process. Factors used in the determination of special requirements
include product or process complexity, past experience and product or process maturity.
Examples of special requirements include performance requirements imposed by the
customer that are at the limit of Prime Machine’s capacity, or requirements determined
by Prime Machine to be at the limit of its technical or process capabilities.
3.3 Critical Items
Those items (e.g., functions, parts, software, characteristics, processes) having
significant effect on the product realization and use of the product; including safety,
performance, form, fit, function, producibility, service life, etc.; that require specific
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actions to ensure they are adequately managed. Examples of critical items include
safety critical items, fracture critical items, mission critical items, key characteristics, etc.
3.4 Key Characteristic
A key characteristic is an attribute or feature whose variation has a significant
effect on product fit, form, function, performance, service life or producibility that requires
specific actions for the purpose of controlling variation. NOTE: Special requirements
and critical items are new terms and, along with key characteristics, are interrelated.
Special requirements are identified when determining and reviewing requirements
related to the product (see 7.2.1 and 7.2.2). Special requirements can require the
identification of critical items. Design output, 7.3.3 (which is excluded by Prime Machine,
see 1.2) can include identification of critical items that require specific actions to ensure
they are adequately managed. Some critical items will be further classified as key
characteristics because their variation needs to be controlled.
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Section 4:
Related Documents
Document Control
PMP-001
Control of Quality Records
Shop Router Creation & Maintenance
PMP-002
PMP-003
Process Realization
PMP-009
4.1 General Requirements
Prime Machine Inc. has established, documented and implemented a Quality
Management System (QMS) to meet the intent of the requirements of SAE AS-9100 Rev
C. Prime Machine manages these processes in accordance with the International
Standard. The system is maintained and continually improved through the use of the
quality policy, quality objectives, audit results, analysis of data, corrective and preventive
action and management review. Prime Machine’s QMS will also adhere to all customer
and applicable statutory and regulatory quality management system requirements.
To design and implement the QMS Prime Machine Inc. has:
 Initiated contract review procedures (PMF-102) to assure compliance to
contractual or customer related requirements. This information is used in
developing procedures/processes that will meet those requirements.
 Identified the processes needed for the QMS and their application throughout the
organization. They are documented on the Business Process Diagram (PMF101) at the end of this section of the Quality Manual.
 Determined the sequence and interaction of these processes, and illustrated
them on the Business Process Diagram.
 Determined criteria and methods needed to ensure that the operation and control
of the processes are effective. They are documented in the Shop Router, the
floor work instructions, and the performance metrics table.
 Ensured the continuing availability of materials personnel and documents
necessary to achieve planned results and continual improvement of these
processes.
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 Established systems to monitor, measure and analyze these processes.
 Established processes to identify and implement actions necessary to achieve
planned results and continual improvement of these processes.
When Prime Machine outsources any process that affects product conformity to
requirements, Prime Machine will ensure control over such processes. The type and
extent of control to be applied to these outsourced processes is defined within this
manual, buy the main control will be through QMF-218, Sub-Process Materials Tracking
Form. NOTE: Processes needed for this quality management system include
processes for management activities, provision of resources, product realization,
measurement, analysis and improvement. NOTE 2: an “outsourced process” is a
process that Prime Machine needs for its quality management system and which Prime
Machine chooses to have performed by an external party. NOTE 3: Ensuring control
over outsourced processes does not absolve Prime Machine of the responsibility of
conformity to all customer, statutory and regulatory requirements. The type and extent
of control be applied to the outsourced processes can be influenced by factory such as:
a.
The potential impact of the outsourced process on Prime Machine’s
capability to provide product that conforms to requirements
b. The degree to which the control for the process is shared
c. The capability of achieving the necessary control through the application of
7.4
4.2 Documentation Requirements
4.2.1 General
Figure 1 demonstrates the relationship of the QMS documentation. The QMS
documentation includes:
 A documented Quality Policy
 This quality manual
 Documented procedures
 Documents identified as needed for the effective planning, operation and control
of our processes
 Quality records
 Quality system requirements imposed by the applicable regulatory authorities
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Prime Machine, Inc. will ensure that personnel have access to quality management
system documentation and are aware of relevant procedures. Customer and/or
regulatory authorities’ representatives shall have access to quality management system
documentation. NOTE: where the term “documented procedure” appears within this
manual, this means that the procedure is established, documented, implemented and
maintained. A single document may address the requirements for one or more
procedures. A requirement for documented procedure may be covered by more than
one document.
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Prime Machine Inc.Document Hierarchy
Prime Machine Operations
Manual
Quality Management
SystemProcedures(QMS)
Work Place Safety
Adminstrative policies
QMS Level 1 Documented Procedures & Process Flows
PMP-001
Document
Control
Dwgs Spec
datasets
PMP-002
Control of
Records
Identification of
records &
retention policy
PMP-003
Process Control
Quality planning,Work
orders job execution
PMP-004
Purchasing
Supplier
management
PMP-005
Tool Management
Calibration,numbering
and storage
PMP-006
Internal
Audit
QMS Level 2 Process Flows
PMF-101
Macro
Business
Flow
PMF-103
Receipt
of
Product
PMF-102
Contract
review
PMF-104
Order
Completion
PMF-105
Process
Improvement
QMS Level 3 forms & records
Qform-2xx-3xx
Quality Forms
PCP-4QQ
Process Specific
Prcoess Control
Procedures
Management
Review
Minutes
Process Qual
records; welding,
NDT...
Preventative
Maintenance plan
Job Descriptions/
personell file
Contract review
notes
Figure 1
Tool Calibration
cert
Completed job
folder
PMP-007
Control of
NonConforming
Materials
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This page not used at this time
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4.2.2 Quality Manual
This Quality Manual has been prepared to describe Prime Machine, Inc. QMS. The
scope and permissible exclusions of the QMS are described in Section 1 of this manual.
Each section of the manual references documented QMS procedures relating to the
requirements outlined in that section. The Business Process Diagram at the end of
Section 4 provides a description of the interaction between the processes of the QMS
system. Design, service and industrial processes are specifically excluded from the
scope.
4.2.3 Control of Documents
All of the QMS documents are controlled according to the Document Control Procedure
(PMP-001). This procedure defines the process for:
 Approving documents for adequacy prior to issue
 Reviewing and updating as necessary and re-approving documents
 Ensuring that changes and current revision status of documents are identified
 Ensuring that relevant versions of applicable documents are available at points of
use
 Ensuring that documents remain legible and readily identifiable
 Ensuring that documents of external origin are identified and their distribution
controlled
 Preventing the unintended use of obsolete documents and to apply suitable
identification to them if they are retained for any purpose
Prime Machine, Inc. coordinates document changes with customers and/or regulatory
authorities in accordance with contract or regulatory requirements.
4.2.4 Control of Quality Records
Quality records are maintained to provide evidence of conformity to requirements and of
the effective operation of the QMS. The records are maintained according to the Control
of Quality Records Procedure (PMP-002). This procedure requires that quality records
remain legible, readily identifiable and retrievable. The procedure defines the controls
needed for identification, storage, protection, retrieval, retention time and disposition of
quality records.
The documented procedure defines the method of controlling records that are created by
and/or retained by suppliers. Records are available for review by customers and
regulatory authorities in accordance with contract or regulatory requirements.
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Section 5: Management Responsibility
Related Documents:
Process Improvement
Nonconforming Material
PMF-105
PMP-007
Process Control
PMF-003
5.1 Management Commitment
Prime Machine, Inc. is managed with a very hands-on approach by the president of the
company. The president and his management staff have been actively involved in
implementing the quality management system (QMS). The Team has provided the vision
and strategic direction for the growth of the QMS, and established quality objectives and
the quality policy.
5.1.1 Management Responsibility Definitions
To continue to provide leadership and show commitment to the improvement of the
QMS, management will do the following:
 Communicate the importance of meeting customer, statutory, and regulatory
requirements by direct communication with the staff
 Establish quality objectives (5.4.1)
 Establish the quality policy (5.3)
 Conduct annual management reviews
 Ensure the availability of resources
 Define and delegate the established quality objectives responsibilities
5.2 Customer Focus
Prime Machine, Inc. strives to identify current and future customer needs, to meet
customer requirements and exceed customer expectations. This is accomplished
through direct customer interface and discussion of current and future projects
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Top management ensures that customer requirements are understood and met, by
requiring strong customer interface throughout the proposal and initial contract stage of
all projects. Customer requirements are determined and confirmed, converted into
internal requirements, and communicated to the appropriate staff in our organization in
accordance with PMF-102 Contract Review. Top management of Prime Machine shall
ensure that product conformity and on-time delivery performance are measured and that
appropriate action is taken if planned results are not, or will not be, achieved.
5.3 Quality Policy
Prime Machine, Inc. strives to be first in business excellence, quality and value. Our
objective is to brand the name Prime as “first in business excellence, quality and value in
the eyes of our customers”.
To meet this objective we are continually improving our people, technology and systems
in the following manner:
 People: Prime Machine, Inc. provides a secure and safe work environment. We
encourage personal growth by providing opportunities for learning and
improvement. We foster stewardship in our employees by requiring reporting and
accountability.
 Technology: Prime Machine, Inc. continually researches, procures and applies
the latest technology and tooling that enhances our productivity, capability and
scope of the services that we provide to our customers.
 Systems: Prime Machine, Inc. develops and structures business systems to
measure, report and continually improve our quality objectives.
At Prime Machine, Inc. we are always stepping in the right direction to enhance our
quality, shorten our delivery times and add real value to improve our business success.
Top management ensures that the quality policy:
a.
Is appropriate to the purpose of Prime Machine
b. Includes a commitment to comply with requirements and continually improve
the effectiveness of the quality management system
c. Provides a framework for establishing and reviewing quality objectives
d. Is communicated and understood within the organization and
e. Is reviewed for continuing suitability (see quality management meeting notes)
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5.4 Planning
5.4.1 Quality Objectives
Quality objectives are established to support our organization’s efforts in achieving our
quality policy and reviewed annually for suitability. Objectives have been established for
the following:
 Track number of new customers, or customers that have not done business in
over one year, that give us new business, per quarter.
 Track number of new skills per employee, per quarter, via the skill matrix.
 Track number days without a lost time injury.
 Track percentage of on-time deliveries, based on information on the router.
 Track new equipment purchased, per quarter.
These Quality objectives are measurable, and are reviewed against performance goals
at each management review meeting. (see 7.1.a)
5.4.2 Quality Management System Planning
The quality system has been planned and implemented to meet our quality objectives
and the requirements of 4.1 of the SAE AS-9100 Rev C. standard. Quality planning
takes place as changes that affect the quality system are planned and implemented,
maintaining the integrity of the quality management system.
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority
An organizational chart has been established to show the interrelation of personnel at
Prime Machine, Inc. Job functions and the organizational chart are reviewed and
approved by top management for adequacy. This chart is available throughout Prime
Machine, Inc. to help employees understand responsibilities and authorities. An
organizational chart is located on page 4 of this manual.
5.5.2 Management Representative
The Quality Assurance manager has been appointed by the president as the
management representative. As management’s representative, he/she has the following
responsibilities and authority:
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 Ensure that processes needed for the quality management system are
established and implemented
 Report to top management on the performance of the quality management
system, and note needed improvements
 Promote awareness of customer requirements throughout Prime Machine, Inc.
 Act as a liaison with external parties such as customers or auditors on matters
relating to the QMS
 Assist with training of new and revisions to existing procedures
 Resolve matters pertaining to quality, and
 Has the organizational freedom and unrestricted access to top management to
resolve quality management issues.
5.5.3 Internal Communication
Processes are established for communication within Prime Machine, Inc. Methods of
communicating the effectiveness of the QMS are performed and include regular staff
meetings and the annual management review. This communication may take the form of
review of the quality objectives, results of both internal and customer audits and new
business opportunities.
5.6 Management Review
5.6.1 General
Top management reviews the QMS manual at management review meetings. This
review assesses the continuing QMS suitability, adequacy and effectiveness, identifying
opportunities for improvement and needed changes, including the quality policy and
quality objectives. Records are maintained for each management review meeting.
5.6.2 Review Input
Assessment of the QMS is based on a review of information inputs to management
review. These inputs include the following:
 Results of audits
 Customer feedback
 Process performance and product conformity
 Scrap and rework cost
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 On time delivery
 Status of preventive and corrective actions
 Follow-up actions from previous management reviews
 Planned changes that could affect the quality management system
 Recommendations for improvement
5.6.3 Review Output
During these review meetings, management will identify appropriate actions to be taken
regarding the following issues:
 Improvement of the effectiveness of the quality management system and its
processes
 Improvement of product related to customer requirements
 Resource needs
Responsibilities for required actions are assigned to members of the staff in attendance.
Any decisions made during the meeting, assigned actions, and their due dates are
recorded in the minutes of management review.
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Section 6: Resource Management
Related Documents
Contract Review
PMF-102
Process Control
PMP-003
6.1 Provision of Resources
Prime Machine, Inc. has implemented a Quality Management System that complies with
the AS 9100 Rev C and ISO 9001:2008 standards. This implementation was achieved
with management commitment and with sufficient resources for the implementation. To
effectively maintain and continually improve the system, management determines and
provides necessary resources. It is Prime Machine’s goal to enhance customer
satisfaction by meeting their requirements.
6.2 Human Resources
6.2.1 General
To ensure competence of our personnel new employees are hired depending upon their
qualifications in the manufacturing industry. New employees are given an orientation by
a senior employee, which includes a copy of the QMS documentation. A senior
employee then provides on the job training to the new employee, evaluating the new
employee’s performance at each task to determine their competence. NOTE:
Conformity to product requirements can be affected directly or indirectly by personnel
performing any task within the quality management system.
6.2.2 Competence, Awareness and Training
Employee qualifications are reviewed before hire, when an employee changes positions,
or when the requirements for a position change. If any differences between the
employee’s qualifications and the requirements for the job are found, training or other
action is taken to provide the employee with the necessary competence for the job. An
evaluation of the training and its effectiveness will be done before the employee is
deemed competent to perform work affecting conformity to product requirements. All
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employees are trained on the relevance and importance of their activities and how they
contribute to the achievement of the quality objectives. Appropriate records of
education, training, skills and experience will be maintained (see 4.2.4)
6.3 Infrastructure
To meet quality objectives and product requirements Prime Machine, Inc. has
determined the infrastructure needed. The infrastructure has been provided, and
includes buildings, workspace, utilities, process equipment (both hardware and software)
and supporting services (such as transport, communication or information systems). As
new infrastructure requirements arise, they will be documented in the management
review and or regular staff meetings. Existing infrastructure is maintained as required.
6.4 Work Environment
A work environment suitable for achieving product conformance is maintained.
Requirements are determined during the Contract Review PMF-102 and Process
Control PMP-003 as required. The work environment is managed for continuing
suitability. Data from the quality system is evaluated to determine if the work
environment is sufficient for achieving product conformance, or if preventive or corrective
action related to the work environment is required. Work environment factors include:
temperature, humidity, lighting, cleanliness, protection from electrostatic discharge, etc.
NOTE: The term “work environment” relates to those conditions under which work is
performed including physical, environmental and other factors (such as noise,
temperature, humidity, lighting or weather).
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Section 7: Product Realization
Related Documents
Process Control
PMP-003
Purchasing
PMP-004
Tool Management
Receipt of product
PMP-005
PMF-103
Order Completion
PMF-104
7.1 Planning of Product Realization
Quality planning is required before new products or processes are implemented. The
quality planning takes place as the Shop Router is created per PMP-003. During this
planning, management or assigned personnel determine the following:
 Quality objectives and requirements for the product
o
NOTE: Quality objectives and requirements for the product include
consideration of aspects such as:

Product and personal safety

Reliability, availability and maintainability

Producibility and inspectability

Suitability of parts and material used in the product

Selection and development of embedded software, and

Recycling of final disposal of the product at the end of its life
 The need to establish processes, documents, and resources specific to the
product
 Required verification, validation, monitoring, inspection and test requirements
 Criteria for product acceptance
 Configuration management appropriate to the product;
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 The identification of resources to support operation and maintenance of the
product
Planning output shall be in conformance with PMP-001, PMP-002, and PMP-003.
Planning documents specifying processes and/or quality management systems, and the
resources to be applied to a specific product, project or contract, can be referred to as a
quality plan. This output of quality planning is to be included in the completed Shop
Router for the specific work to be performed.
7.1.1 Project Management
As appropriate to Prime Machine and the product, Prime Machine shall plan and
manage product realization in a structured and controlled manner to meet requirements at
acceptable risk, within resource and schedule constraints.
7.1.2 Risk Management
Prime Machine shall establish, implement and maintain a process for managing risk to
the achievement of applicable requirements that includes as appropriate to Prime Machine and
the product.
a. Assignment of responsibilities for risk management
b. Definition of risk criteria (e.g., likelihood, consequences, risk acceptance)
c. Identification, assessment and communication of risks throughout product
realization,
d. Identification, implementation and management of actions to mitigate risks that
exceed the defined risk acceptance criteria and
e. Acceptance of risks remaining after implementation of mitigating actions.
7.1.3 Configuration Management
Prime Machine will establish, implement and maintain a configuration management
process that includes, as appropriate to the product:
a.
b.
c.
d.
e.
Configuration management planning
Configuration identification
Change control
Configuration status accounting and
Configuration audit. NOTE: See ISO 10007 for guidance
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7.1.4 Control of Work Transfers
Prime Machine will establish, implement and maintain a process to plan and control the
temporary or permanent transfer of work (e.g., from one organization facility to another, from the
organization to a supplier, from one supplier to another supplier) and to verify the conformity of
the work to requirements. (QFM-218, Sub-Process Materials Tracking)
7.2 Customer-Related Processes
7.2.1 Determination of Requirements Related to the Product
Prime Machine, Inc. determines customer requirements before acceptance of an order.
Customer requirements include those:
 Requested by the customer
 Customer specifications or standards
 Required for delivery and post-delivery activities
 Not stated by the customer but necessary for specified use or known and
intended use (QC levels I & II)
 Statutory and regulatory requirements related to the product
 Additional requirements determined by Prime Machine, Inc (QC levels I & II)
 Customer requirements are determined according to the Contract Review PMF102 NOTE: Requirements related to the product can include special
requirements.
7.2.2 Review of Requirements Related to the Product
Prime Machine, Inc. has a process in place for the review of requirements related to the
product Contract Review PMF-102.
The review is conducted before the order is accepted. The process ensures that:
 Product requirements are defined.
 Contract or order requirements differing from those previously expressed are
resolved.
 Prime Machine, Inc. has the ability to meet the defined requirements.
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 Special requirements of the product are determined, and
 Risks (e.g., new technology, short delivery time frame) have been identified (see
7.1.2)
 Known risks have been adequately identified and planned for along with
assessment of other risks such as new technology implementations or process
and/or schedule changes.
 Records are maintained showing the results of the review and any actions arising
from the review. These records are letters and notes generated in accordance
with PMF-102 Contract Review. These records are integral to the Global Shop
Solutions software database. Where a customer does not provide a documented
statement of requirement, the customer requirements are confirmed before
acceptance.
 When product requirements are changed, Prime Machine, Inc. communicates
changes to relevant personnel and amends relevant documents.
7.2.3 Customer Communication
Prime Machine, Inc. is always in close contact with their customers. As an order
progresses thru the manufacturing cycle the customer is kept up to date on progress and
problems. Regular communication with the customer is maintained in the following
areas:
 Product information
 Enquiries, contracts and order handling, including amendments
 Customer feedback, including customer complaints
7.3 Design and Development
7.3.1 Design and Development Planning
This section not used.
7.3.2 Design and Development Inputs
This section not used.
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7.3.3 Design and Development Outputs
This section not used.
7.3.4 Design and Development Review
This section not used.
7.3.5 Design and Development Verification
This section not used.
7.3.6 Design and Development Validation
This section not used.
7.3.6.1 Design Documentation, Verification, and Validation
This section not used.
7.3.6.2 Design Verification and Validation Testing
This section not used.
7.3.7 Control of Design and Development
This section not used.
7.4 Purchasing
7.4.1 Purchasing Process
A documented procedure control of purchasing PMP-004 is followed to ensure that
purchased product conforms to the specified purchase requirements. The procedure
outlines the extent of control required for suppliers and the purchased product, which is
dependent upon the effect of the purchased product on subsequent product realization
or the final product. Prime Machine, Inc. is responsible for the quality of all products
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purchased from suppliers, including customer-designated sources. Suppliers are
evaluated and selected based on their ability to supply product in accordance with
requirements as outlined in the procedure. Criteria for selection, evaluation and reevaluation are documented in the procedure. Records of the evaluation and any
necessary actions are maintained as quality records. Prime Machine, Inc.:
 Maintains a register of approved suppliers that includes the scope of the approval
 Periodically reviews supplier performance; records of these reviews are used as
a basis for establishing the level of controls implemented (QFM-225 Vendor
Audit)
 Defines the necessary actions to take when dealing with suppliers that do not
meet requirements (PMP-007)
 Ensures where required that both Prime Machine, Inc. and all suppliers use
customer-approved special process sources
 Defines the process, responsibilities and authority for the approval status
decision, changes of the approval status and conditions for a controlled used of
suppliers depending on the supplier’s approval status (PMP-004)
 Determines and manages the risk when selecting and using suppliers (see 7.1.2)
 Prime Machine is responsible for the conformity of all products purchased from
suppliers, including product from sources defined by the customer.
 NOTE: One factor that can be used during supplier selection and evaluation is
supplier quality date from objective and reliable external sources, as evaluated
by Prime Machine. (E.g. information from accredited quality management system
or process certification bodies, organization approvals from government
authorities). Use of such data would be only one component of Prime Machine’s
supplier control process and Prime Machine remains responsible for verifying
that purchased product meets specified purchase requirements.
7.4.2 Purchasing Information
Purchasing information describes the product to be purchased, including where
appropriate:
 Requirements for approval of product, processes and equipment
 Requirements for qualification of personnel
 Quality management system requirements
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 The name or other positive identification, and applicable issues of specifications,
drawings, process requirements, inspection instructions and other relevant
technical data
 Requirements for design, test, inspection, verification (including production
process verification), use of statistical techniques for product acceptance, and
related instructions for acceptance by Prime Machine, and as applicable critical
items including any key characteristics
 Requirements for test specimens (e.g., production method, number, storage
conditions) for design approval, inspection, investigation or auditing
 Requirements for the need to notify Prime Machine of nonconforming product,
obtain Prime Machine approval for nonconforming product, notify Prime Machine
of changes in product and/or process, changes of suppliers, changes of
manufacturing facility location and, where required, obtain Prime Machine
approval and, flow down to the supply chain the applicable requirements
including customer requirements.
 Requirements for the supplier to notify Prime Machine of changes in product
and/or process definition and, where required, obtain organization approval
 Right of access by Prime Machine, Inc., its customer, and regulatory authorities
to all facilities involved in the order and to all applicable records
 Requirements for the supplier to flow down to sub-tier suppliers and applicable
requirements in the purchasing documents, including key characteristics where
required
 Record retention requirements.
The purchasing documents are reviewed to ensure the adequacy of requirements before
orders are placed with the supplier.
7.4.3 Verification of Purchased Product
The Purchasing Procedure PMP-004 describes the process used to verify that
purchased product meets specified purchase requirements and process flow PMF-103
Receipt of Product defines the actions upon receipt of the product. If Prime Machine, Inc.
or the customer will perform Source Inspection at the supplier’s premises, the verification
arrangements and method of product release are documented in the purchasing
information. Verification can include:
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 Obtaining objective evidence of the quality of the product from suppliers (e.g.,
accompanying documentation, certificate of conformity, test reports, statistical
records, process control)
 Inspection and audit at supplier’s premises
 Review of the required documentation
 Inspection of products upon receipt
 Delegation of verification to the supplier, or supplier certification.
 Customer verification activities performed at any level of the supply chain will not
be used by Prime Machine or the supplier as evidence of effective control of
quality and does not absolve Prime Machine of its responsibility to provide
acceptable product and comply with all requirements.
 Where purchased 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.
Purchased product is not used or processed until it has been verified as conforming to
specified requirements unless it is released under positive recall procedure.
When Prime Machine, Inc. utilizes test reports to verify purchased product, the data in
those reports are acceptable per applicable specification. Prime Machine, Inc.
periodically validates test reports for raw material.
When Prime Machine, Inc. delegates verification activities to the supplier, the
requirements for delegation are defined and a register of delegations maintained.
When Prime Machine, Inc. or its customers perform verification at the supplier’s
premises, Prime Machine, Inc. states the intended verification arrangements and method
of product release in the purchasing information.
When specified in the contract, the customer or the customer’s representative affords
the right to verify at the supplier’s premises and Prime Machine, Inc.’s premises that
subcontracted product conform to specified requirements.
Verification by the customer is not used by Prime Machine, Inc. as evidence of effective
control of quality by the supplier and does not absolve Prime Machine, Inc. of the
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responsibility to provide acceptable product, nor precludes subsequent rejection by the
customer.
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
Planning considers, as applicable:
 Establishing, implementing and maintaining appropriate processes to manage
critical items, including process controls where key characteristics have been
identified,
 The identification of in-process verification points when adequate verification of
conformance cannot be performed at a later stage of realization (QFM-218)
 The design manufacture and use of tooling so that variable data measurements
can be taken, particularly for key characteristics
 Special processes (see 7.5.2)
Prime Machine, Inc. plans and carries out production and service provision under
controlled conditions according to the developed Shop Router per PMP-003. Controlled
conditions include, as applicable:
 The availability of information that describes the characteristics of the product.
This information can include drawings, parts lists, materials and process
specifications.
 The availability of work instructions. Work instructions can include process flow
charts, production documents (e.g. manufacturing plans, travelers, routers, work
orders, process cards) and inspection documents.
 The use of suitable equipment. Suitable equipment can include product specific
tools (e.g. jigs, fixtures, molds) and software programs.
 The availability and use of monitoring and measuring devices
 The implementation of monitoring and measurement
 The implementation of product release, delivery and post-delivery activities
 Accountability for all product during manufacture (e.g., parts quantities, split
orders, nonconforming product)
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 Evidence that all manufacturing and inspection operations have been completed
as planned, or as otherwise documented and authorized (QFM-203)
 Provision for the prevention, detection, and removal of foreign objects (PPC-522)
 Monitoring and control of utilities and supplies such as water, compressed air,
electricity and chemical products to the extent they affect conformity to product
requirements and,
 Criteria for workmanship, which shall be stipulated in the clearest practical
manner (e.g., written standards, representative samples or illustrations)
7.5.1.1 Production Process Verification
Prime Machine will use a representative item from the first production run of a new part
or assembly to verify that the production processes, production documentation and tooling are
capable of producing parts and assemblies that meet requirements. This process shall be
repeated when changes occur that invalidate the original results (e.g., engineering changes,
manufacturing process changes, tooling changes). This activity is often referred to as first
article inspection.
7.5.1.2 Control of Production Process Changes
Persons authorized to approve changes to production are identified. Prime Machine, Inc.
identifies and obtains acceptance of changes that require customer and/or regulatory
authority approval in accordance with contract or regulatory requirements. Changes
affecting processes, production equipment, tools and programs are documented.
Procedures are available to control their implementation. The results of changes to
production processes are accessed to confirm that the desired effect has been achieved
without adverse effects to product conformity.
7.5.1.3 Control of Product Equipment, Tools and Numerical Control (NC) Machine
Programs (software)
Production equipment, tools and software programs used to automate and
control/monitor product realization processes are validated prior to release and are
maintained and inspected periodically according to documented procedures. Validation
prior to production use includes verification of the first article produced to the design
data/specification. Storage requirements, including periodic preservation/condition
checks, are defined for production equipment or tooling in storage.
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7.5.1.4 Post-Delivery Support
Post-Delivery support is provided, as applicable, for the
 Collection and analysis of in-service data
 Actions to be taken where problems are identified after delivery, including
investigation, reporting activities, and actions on service information consistent
with contractual and/or regulatory requirements
 The control and updating of technical documentation
 The approval, control, and use of repair schemes
 The controls required for off-site work (e.g., Prime Machine, Inc.’s work
undertaken at the customer’s facilities)
7.5.2 Validation of Processes for Production and Service Provision
Prime Machine, Inc. validates any processes (frequently referred to as special
processes) for production and service provision where the resulting output will not be
verified by subsequent monitoring or measurement. Validation demonstrates the ability
of these processes to achieve planned results. These validation requirements are
defined as required in the shop router (Ref PMP-003 and PMP-005). This also includes
any processes that are performed at a sub-contract level or where deficiencies may
become apparent only after the product is in use.
Process validation may include the following:
 Informing the customer of facts and findings
 Defined criteria for review and approval of the processes
 Use of specific methods and procedures,
 Destructive and non-destructive testing of sample parts
 Compliance to all customer required standards of manufacturing quality or
process control. This may include but is not limited to:
1. U.S. Department of Defense Specification and standards Mil-Q-9858A.
2. U.S. Department of Defense Specification and standards Mil-45208A.
3. American National Standard ANSI/ISO/ASQ Q9000-2000, Quality
.Management Systems - Vocabulary.
4. American National Standard ANSI/ISO/ASQ Q9001-2000, Quality
Management Systems – Requirements.
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5. American National Standard ANSI/ISO/ASQ Q9004-2000, Quality
Management Systems – Guidelines for performance Improvements.
6. SAE International Standard AS9003.
7. SAE International Standard AS9100 and AS9102.
8. Boeing BQMS appendix B - 2001. (D6-82479 rev B).
 Customer or specification approval of equipment, processes and qualifications of
personnel. If required, this is inclusive of sub-contract level work as well
 Use of documented internal proprietary methods and procedures
 Control of the significant operations and parameters of special processes in
accordance with documented process specifications and changes thereto
 Requirements for records and documentation and control (see 4.2.4)
 First article inspections if required
 Revalidation of nonconforming products
7.5.3 Identification and Traceability
Prime Machine, Inc. identifies the product throughout product realization in accordance
with the PMP-003 Process Control document. The Shop Router is the primary document
for identifying all identification requirements and capturing all traceability needs. Prime
Machine, Inc. maintains the identification of the configuration of the product in order to
identify any differences between the actual configuration and the agreed configuration.
Prime Machine, Inc. identifies the product status with respect to monitoring and
measurement requirements throughout product realization. Prime Machine, Inc. controls
and records the unique identification of the product wherever traceability is a contract
specified requirement (see 4.2.4). The specific method of identification will be
determined on a case-by-case basis and will be defined in the Shop Router. When
acceptance authority media are used (e.g., stamps, electronic signatures, passwords)
Prime Machine establishes appropriate controls for the media.
According to the level of traceability required by contract, regulatory or other established
requirement, Prime Machine, Inc.’s system provides for:
 Identification to be maintained throughout the product life
 All the products manufactured from the same batch of raw material or from the
same manufacturing batch to be traced, as well as the destination (delivery,
scrap) of all products of the same batch
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 For an assembly, the identity of its components and those of the next higher
assembly to be traced
 For a given product, a sequential record of its production (manufacture,
assembly, inspection) to be retrieved (QFM-220)
NOTE: In some industry sectors, configuration management is a means by which
identification and traceability are maintained (see 7.1.3)
7.5.4 Customer Property
Prime Machine, Inc. exercises care with customer property while it is under Prime
Machine, Inc.'s control or being used. Control of Customer property is outlined in the
following procedures and process flows: PMP-003 Process Control, PMP -005 Tool
Management, PMF-103 Receipt of Product and PMP-007 Control of NCR. If any
customer property is lost, damaged or otherwise found to be unsuitable for use, this is
reported to the customer and records maintained. (See 4.2.4)
NOTE: Customer property can include intellectual property, including customer furnished
data used for design, production and/or inspection and personal data.
7.5.5 Preservation of Product
Prime Machine, Inc. preserves the conformity of product during internal processing and
delivery to the intended destination per process flow PMF-103 Receipt of Product and
PMF-104 Order Completion. This preservation includes identification, handling,
packaging, storage and protection. Preservation also applies to the constituent parts of a
product. Customer requirements shall be provided for in full. (Ref PMP-003-1.10)
Preservation of product includes, where applicable in accordance with product
specifications and/or applicable regulations, provisions for:
 Cleaning
 Prevention, detection and removal of foreign objects (PPC-522)
 Special handling for sensitive products
 Marking and labeling including safety warnings
 Shelf life control and stock rotation
 Special handling for hazardous materials
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Prime Machine, Inc. ensures that documents required by the contract/order to
accompany the product are present at delivery and are protected against loss and
deterioration.
7.6 Control of Monitoring and Measuring Devices
Prime Machine, Inc. has determined the monitoring and measurement to be undertaken
during the manufacture of each component as specified in the component Shop Router
(PMP-003). The monitoring and measuring devices needed to provide evidence of
product conformity have also been identified and are contained on the calibration tool
list. Calibration is performed in accordance with PMP-005 Tool Management.
Prime Machine, Inc. maintains a register of these monitoring and measuring devices and
has defined the process employed for their calibration including details of equipment
type, unique identification, location, frequency of checks, check method and acceptance
criteria.
NOTE: Monitoring and measuring devices include, but are not limited to: test hardware,
test software, automated test equipment (ATE) and plotters used to produce inspection
data. It also includes personally owned and customer supplied equipment used to
provide evidence of product conformity.
Prime Machine, Inc. has established processes (PPC-517, PPC-518, PPC-519, PPC520) 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.
Prime Machine, Inc. ensures that environmental conditions are suitable for the
calibrations, inspections, measurements and tests being carried out. Where necessary
to ensure valid results, measuring equipment is:
 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 shall be recorded (see 4.2.4).
 Adjusted or re-adjusted as necessary
 Identified to enable the calibration status to be determined (QFM-221)
 Safeguarded from adjustments that would invalidate the measurement result
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 Protected from damage and deterioration during handling, maintenance and
storage
 Prime Machine has established, implemented and maintained a process for the
recall of monitoring and measuring equipment requiring calibration or verification.
In addition, during each calibration interval, if a tool is found to be out of calibration,
Prime Machine, Inc. takes appropriate action on the equipment and any product
affected. Records of the results of calibration and verification are maintained.
When used in the monitoring and measurement of specified requirements, the ability of
computer software to satisfy the intended application is confirmed. This is undertaken
prior to initial use and reconfirmed as necessary. Confirmation of the ability of computer
software to satisfy the intended application would typically include it verification and
configuration management to maintain its suitability for use.
Section 8: Measurement, Analysis
and Improvement
Related Documents
Process Improvements
PMF-105
Internal Audits
PMP-006
Control of Nonconforming Product
PMP-007
8.1 General
Prime Machine, Inc. has planned and implements the monitoring, measurement,
analysis and improvement processes as needed:
 To demonstrate conformity of the product
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 To ensure conformity of the quality management system
 To continually improve the effectiveness of the quality management system
This includes determination of applicable methods, including statistical techniques, and
the extent of their use.
NOTE: According to the nature of the product and depending on the specified
requirements, statistical techniques are used to support: design verification (e.g.,
reliability, maintainability, safety); process control;( selection and inspection of key
characteristics; process capability measurements; statistical process control; design of
experiment); inspection – matching sampling rate to the criticality of the product and to
the process capability; and failure mode and effect analysis.
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
As one of the measurements of the performance of the quality management system,
Prime Machine, Inc. monitors information relating to customer perception as to whether
Prime Machine, Inc. has fulfilled customer requirements. This measurement is in the
form of a customer survey that is either mailed out to the customer, or the customer is
called to complete the survey. Information that is monitored and used for the evaluation
of customer satisfaction includes, but is not limited to, product conformity, on-time
delivery performance, customer complaints and corrective action requests. Prime
Machine has developed and implemented a plan for customer satisfaction improvement
that addresses deficiencies identified by these evaluations and assesses the
effectiveness of the results. Monitoring customer perception can include obtaining input
from sources such as customer satisfaction surveys, customer data on delivered product
quality, user opinion surveys, lost business analysis, compliments, warranty claims and
dealer reports.
8.2.2 Internal Audit
Prime Machine, Inc. conducts internal audits at planned intervals to determine whether
the quality management system:
 Conforms to the planned arrangements (see 7.1), to the requirements of this
International Standard (AS9100C) and to the quality management system
requirements established by the organization. Note: Planned arrangements
include customer contractual requirements.
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 Is effectively implemented and maintained
An audit program has been designed and implemented and identifies an audit schedule
based on the importance of the areas to be audited, as well as the results of previous
audits. The audit criteria, scope, frequency, methods, responsibilities and requirements
for planning and conducting audits, and for reporting and maintaining results, are defined
and documented in the Internal Audit procedure PMP-006. Auditors shall not audit their
own work. Records of the audits and their results are maintained (see 4.2.4)
The management responsible for the area being audited ensures that actions are taken
without undue delay to eliminate detected nonconformities and their causes. Follow-up
activities include the verification of the actions taken and the reporting of verification
results (see 8.5.2).
Detailed tools and techniques have been developed, such as check sheets, process
flowcharts, and any similar method to support audit of the quality management system
requirements. The acceptability of the selected tools is measured against the
effectiveness of the internal audit process and overall performance of Prime Machine,
Inc.
Internal audits meet contract and/or regulatory requirements.
8.2.3 Monitoring and Measurement of Processes
Prime Machine, Inc. applies suitable methods for monitoring and, where applicable,
measurement of the quality management system processes. These elements are
previously defined in Section 5.4 above. When targets are not met, correction and
corrective action is taken .When considering suitable methods, Prime Machine takes into
account the type and extent of monitoring or measurement appropriate to each o fit
process in relation to their impact on the conformity to product requirements and on the
effectiveness of the quality management system. In the event of process nonconformity,
Prime Machine, Inc.:
 Takes appropriate action to correct the nonconforming process
 Evaluates whether the process nonconformity has resulted in product
nonconformity
 Determines if the process nonconformity is limited to a specific case or whether it
could have affected other process or products and
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 Identifies and controls the nonconforming product (see 8.3)
8.2.4 Monitoring and Measurement of Product
Prime Machine, Inc. monitors and measures the characteristics of the product to verify
that product requirements are fulfilled. This is carried out at appropriate stages of the
product realization process identified in the component Shop Router and as required per
PMF-103 Receipt of Product and PMF-104 Order Completion.
When key characteristics are identified, they are monitored and controlled in accordance
with the established processes.. When Prime Machine, Inc. uses sampling inspection as
a means of product acceptance, the plan is statistically valid and appropriate for use (i.e.
it matches the sampling plan to the criticality of the product and to the process
capability). The plan precludes the acceptance of lots whose samples have known
nonconformities. When required the plan is submitted for customer approval.
Where product is released for production use pending completion of all required
measurement and monitoring activities, it shall be identified and recorded to allow recall
and replacement if is is subsequently found that the product does not meet
requirements.
Evidence of conformity with the acceptance criteria is maintained. Records indicate the
person authorizing release of product to the customer (see 4.2.4). Product release does
not occur until all the process defined by PMF-104 Order Completion has been
completed, unless otherwise approved by a management authority, and where
applicable by the customer. Product will not be released until all documents required to
accompany the product are present at delivery.
Measurements requirements for product acceptance shall be documented and shall
include:
a. Criteria for acceptance and/or rejection
b. Where in the sequence measurement and testing operations are to be
performed
c. Required records of the measurement results (at a minimum,
indication of acceptance or rejection), and
d. Any specific measurement instruments required and any specific
instructions associated with their use.
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8.3 Control of Nonconforming Product
Prime Machine, Inc. ensures that 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 the Control of Nonconforming Product Procedure PMP-107.
NOTE: The term “nonconforming product” includes nonconforming product returned from
a customer.
Prime Machine, Inc.’s documented procedure defines the responsibility for review and
authority for the disposition of nonconforming product and the process for approving
personnel making these decisions.
Prime Machine, Inc. deals with nonconforming product in one or more of the following
ways:
 By taking action to eliminate the detected nonconformity
 By authorizing its use, release or acceptance under concession by a relevant
authority and, where applicable, by the customer
 By taking action to preclude its original intended use or application
 By taking action appropriate to the effects, or potential effects, of the
nonconformity when nonconforming product is detected after delivery or use has
started
 Prime Machine’s nonconforming product control process provides for timely
reporting of delivered non conforming product: Note: Parties requiring
notification of nonconforming product can include suppliers, internal
organizations, customers, distributors and regulatory agencies.
 By taking actions necessary to contain the effect of the nonconformity on other
processes or products.
Prime Machine, Inc. does not use dispositions of use-as-is or repair unless it is approved
by an authorized representative of the organization responsible for the design. Note:
Authorized representative includes personnel having delegated authority from the design
organization.
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Prime Machine does not use dispositions of use-as-is or repair unless specifically
authorized by the customer, if the nonconformity results in a departure from the contract
requirements.
Product dispositioned for scrap is conspicuously and permanently marked, or positively
controlled, until physically rendered unusable.
Records of the nature of nonconformities and any subsequent action taken, including
concessions obtained, are maintained (4.2.4).
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, Prime
Machine, Inc. takes action appropriate to the effects, or potential effects, of the
nonconformity.
8.4 Analysis of Data
Prime Machine, Inc. determines, collects and analyzes performance data to continually
evaluate the quality management system to look for improvement opportunities. The
data (as noted in 5.4 above) is collected and reviewed in accordance with PMF-105
Process Improvements. This data may also include information generated as a result of
monitoring and measurement and from other relevant sources.
The analysis of data provides information relating to:
 Customer satisfaction (see 8.2.1)
 Conformance to product requirements (8.2.4)
 Characteristics and trends of processes and products including opportunities for
preventive action (see 8.2.3 and 8.2.4)
 Supplier performance (Ref PMP-004 sec.6.0) (see also 7.4)
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8.5 Improvement
8.5.1 Continual Improvement
Prime Machine, Inc. continually improves the effectiveness of the quality management
system through the use of the quality policy, quality objectives, audit results, analysis of
data, corrective and preventive actions and management review.
Prime Machine monitors the implementation of improvement activities and evaluates the
effectiveness of the results. NOTE: continual improvement opportunities can result from
lessons learned, problem resolutions and the benchmarking of best practices.
8.5.2 Corrective Action
Prime Machine, Inc. takes action to eliminate the cause of nonconformities in order to
prevent recurrence. Corrective actions are appropriate to the effects of the
nonconformities encountered.
Documented procedures PMP-003, PMP-007, and PMF-105 define requirements for:
 Reviewing nonconformities (including customer complaints)
 Determining the causes of nonconformities
 Evaluating the need for action to ensure that nonconformities do not recur
 Determining and implementing action needed
 Records of the results of action taken (see 4.2.4)
 Reviewing corrective action taken
 Flow down of the corrective action requirement to a supplier, when it is
determined that the supplier is responsible for the nonconformity,
 Specific actions where timely and/or effective corrective actions are not achieved
 Determining if additional nonconforming product exists based on the causes of
the nonconformities and taking further action when required.
8.5.3 Preventive Action
Prime Machine, Inc. determines action to eliminate the causes of potential
nonconformities in order to prevent their occurrence. Preventive actions are appropriate
to the effects of the potential problems.
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Documented procedures PMP-006 Internal Audit, PMP-007 Control of NCR, and PMF105 Process Improvement define requirements for:
 Determining potential nonconformities and their causes
 Evaluating the need for action to prevent occurrence of nonconformities
 Determining and implementing action needed
 Records of results of action taken (see 4.2.4)
 Reviewing preventive action taken NOTE: examples of preventative action
opportunities include risk management, error proofing, failure mode and effect
analysis (FMEA), and information on product problems reported by external
sources.
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Addendum A: Industry Specifications
Mapping
AA-1.0 Intent and Purpose
Mapping of individual industry specifications requirements is implemented here to help
guide employees and customers thru the Prime Machine, Inc. quality system
documentation. If they are more familiar with or are using a specific industry specification
this will help to show Prime Machine, Inc.’s compliance to the intent of the referenced
industry standard.
AA-2.0 AS9003 Specific Mappings
The following page maps AS9003 and BQMS appendix B to the PMI documentation:
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AS 9003 Spec.
4.1 Management Responsibility
-
4.1.1
4.1.2
4.2 Quality System
4.2.1
4.2.2
4.3 Contract Review
4.4 Design Control
4.5 Document and Data Control
QMS 5.1
QMS 5.1.1
QMS 5.5.1
PMP-002 - 1.1
QMS 7.1
-
AS 9003 Spec.
4.11 Control of Inspection, Measurement
and Test Equipment
4.11.1
4.11.2
4.11.3
4.11.4
4.12 Inspection and Test Status
4.12.1
4.12.2
4.12.3
4.5.1
PMP-001 - 2.0
4.13 Control of Nonconforming Product
4.5.2
4.6 Purchasing
4.6.1
4.6.2
4.6.3
4.6.4
4.6.5
PMP-001 - 4.0
4.13.1
4.13.2
4.13.2.1
4.13.2.2&3
4.13.3
4.13.4
4.13.5
4.6.6.
4.6.7
4.7 Control of Customer Supplier
Product
4.8 Product Identification and
Traceability
4.9 Process Control
4.9.1
4.9.2
4.9.3
4.9.4
4.9.5
4.9.6
4.10 Inspection and Testing
4.10.1
4.10.2
4.10.3
4.10.4
4.10.5
PMI Spec.
QMS - 7.5.3
PMP-004 - 2.0
PMP-004 - 4.0
PMP-003 - 1.8
PMP-004 - 6.0
QMS – 7.5.2
4.14 Corrective and Preventative Action
PMI Spec.
PMP-005
PMP-005
PMP-005 - 4.3
PMP-005 - 4.0
PMP-003 - 1.7
QMS 7.3
PMP-003 - 1.7
PMP007
PMP-007 - 2.0
PMP-007 - 3.0
PMP-007- 3.0
PMP-007 - 4.5
PMP-007 - 4.5
PMP-007 - 5.0
-
PMP-004 - 6.0
4.14.1
PMP-007- 4.3
PMP-003 - 1.5
4.14.2
QFM-201
PMP-003 - 1.5
PMP003 - 1.6
PMP003 - 1.6.1
PMP003 - 1.7
PMF-103
PMP003 - 1.7
PMP-005
PMP-003 - 1.7
PMP-003 - 1.9
PMP-003 - 1.7
PMP-003 - 1.9
PMP-003 - 1.9
4.15 Handling, storage, packaging,
preservation, and delivery
4.15
4.16 Control of Quality Records
4.16.1
4.16.2
4.16.3
4.17 Internal Quality Assessment
4.17
4.18 Training
4.18
4.19 Servicing (Not Applicable)
4.20 Statistical Techniques
4.20.1
4.20.2
4.20.2.1
PM-P003 - 1.10
PMP-002
PMP-002 - 1.0
QMS 1.1
PMP-006
QMS - 6.2.1
PMP-003 - 1.7
PMP-003 - 1.7
QMS - 3.1
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Addendum B : Supporting Documents Index
AB 1.0 General
This is the list of support documents that are referenced throughout the QMS manual.
These documents are more item specific and detail oriented in their content than are the
QMS manual sections and appropriate sub categories. These documents are considered
part of the QMS manual, but are also stand alone entities in the areas that they were
written to document.
AB 2.0 Prime Machine Procedure (PMP) Descriptions and Purpose
The PMP or Prime Machine Procedure is written to explain Prime Machine, Inc.’s
implementation strategies of the standards that are laid out in the QMS manual. Some of
these are written to show direct compliance to an industry specific standard, or to show
how a procedure has been created or modified to meet or exceed the specific
requirements that exist at Prime Machine, Inc.
AB 2.1 PMP-001 Document Control
This document is intended to define the procedure to control the following documents
used in the course of business at Prime Machine, Inc. These documents include; internal
procedures, NCR Reports, Customer Purchase orders, Customer drawings, Customer
Data sets and job files. All internal documents will be maintained as electronic files. All
printed copies of internal documents are considered reference only and the revision
status must be verified prior to use.
AB 2.2 PMP-002 Records Control
This document is to define the procedure for record retention. This procedure shall
define what documents are considered records, the method of storage, indexing,
access, and the retention period.
AB 2.3 PMP-003 Work Order Router
This document is intended to define the requirements for the creation of a Shop Router,
revisions to a Shop Router and maintenance of the Shop Router. This procedure will
define the methods for identification of the router and the required information to be
contained in the router.
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AB 2.4 PMP-004 Purchasing
This document is intended to define the methods for purchasing of deliverable products
and general management of the supplier base.
AB 2.5 PMP-005 Tool Management
This document defines the Tool Management policy for all tooling, measurement and
test equipment used at Prime Machine, Inc.
AB 2.6 PMP-006 Internal Audit
This document is intended to define the requirements of the internal audit program at
Prime Machine, Inc. The elements of the program that will be discussed are: the basis or
audit criteria, audit schedule, frequency of audits, qualifications of personnel performing
the audits, the format for reporting the results, and corrective action policy.
AB 2.7 PMP-007 Nonconformance
This document is intended to define the processes Prime Machine, Inc. utilizes to
ensures that product which do not conform to product requirements are identified and
controlled to prevent their unintended use or delivery. This procedure only applies to
Q.A. Levels II & III.
AB 2.8 PMP-008 Inspection Reporting
This document is intended to define the procedure to control the inspection report
documents used in the course of business at Prime Machine, Inc. for level II and III
quality control requirements.
AS/EN 9110 Quality Management Systems – Requirements for Aviation
Maintenance Organizations.
AS/EN 9120 Quality Management Systems – Requirements for Aviation, Space and
Defense Distributors
ISO 9000 Quality Management Systems – Fundamentals and vocabulary
ISO 9001 Quality Managements Systems - Requirements
ISO 9004 Managing for the sustained success of an organization – a quality
management approach (to be published)(revision of ISO 9004:2000)
ISO 10007 Quality Managements Systems – Guidelines for Configuration
Management
ISO 19001 Guidelines for quality and/or environmental management systems
auditing
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This page not used at this time.
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Table of Contents
Introduction ................................................................................................................................ 1
Section 1: Scope ........................................................................................................................ 3
1.1 General............................................................................................................................. 3
1.2 Application ........................................................................................................................ 3
Section 2: Normative Reference ............................................................................................... 6
2.0 Quality Management System References ......................................................................... 6
Section 3: Definitions and Clarifications .................................................................................... 7
3.0 Quality Management System Definitions .......................................................................... 7
3.1 Customer Quality Requirement Categorical Index: ........................................................... 8
Section 4: ..................................................................................................................................11
4.1 General Requirements.....................................................................................................11
4.2 Documentation Requirements .........................................................................................12
4.2.1 General .....................................................................................................................12
4.2.2 Quality Manual ..........................................................................................................16
4.2.3 Control of Documents ...............................................................................................16
4.2.4 Control of Quality Records ........................................................................................16
Section 5: Management Responsibility ....................................................................................22
5.1 Management Commitment...............................................................................................22
5.1.1 Management Responsibility Definitions .....................................................................22
5.2 Customer Focus ..............................................................................................................22
5.3 Quality Policy ...................................................................................................................23
5.4 Planning ..........................................................................................................................24
5.4.1 Quality Objectives .....................................................................................................24
5.4.2 Quality Management System Planning .....................................................................24
5.5 Responsibility, Authority and Communication ..................................................................24
5.5.1 Responsibility and Authority ......................................................................................24
5.5.2 Management Representative ....................................................................................24
5.5.3 Internal Communication ............................................................................................25
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5.6 Management Review .......................................................................................................25
5.6.1 General .....................................................................................................................25
5.6.2 Review Input .............................................................................................................25
5.6.3 Review Output ..........................................................................................................26
Section 6: Resource Management ...........................................................................................27
6.1 Provision of Resources ....................................................................................................27
6.2 Human Resources ...........................................................................................................27
6.2.1 General .....................................................................................................................27
6.2.2 Competence, Awareness and Training .....................................................................27
6.3 Infrastructure ...................................................................................................................28
6.4 Work Environment ...........................................................................................................28
Section 7: Product Realization .................................................................................................29
7.1 Planning of Product Realization .......................................................................................29
7.2 Customer-Related Processes ..........................................................................................30
7.2.1 Determination of Requirements Related to the Product .............................................31
7.2.2 Review of Requirements Related to the Product .......................................................31
7.2.3 Customer Communication .........................................................................................32
7.3 Design and Development ................................................................................................32
7.3.1 Design and Development Planning ...........................................................................32
7.3.2 Design and Development Inputs ...............................................................................32
7.3.3 Design and Development Outputs.............................................................................33
7.3.4 Design and Development Review .............................................................................33
7.3.5 Design and Development Verification .......................................................................33
7.3.6 Design and Development Validation .........................................................................33
7.3.6.1 Design Documentation, Verification, and Validation ...............................................33
7.3.6.2 Design Verification and Validation Testing .............................................................33
7.3.7 Control of Design and Development ..........................................................................33
7.4 Purchasing ......................................................................................................................33
7.4.1 Purchasing Process ..................................................................................................33
7.4.2 Purchasing Information .............................................................................................34
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7.4.3 Verification of Purchased Product .............................................................................35
7.5 Production and Service Provision ....................................................................................37
7.5.1 Control of Production and Service Provision .............................................................37
7.5.1.1 Production Documentation .........................................................................................38
7.5.1.2 Control of Production Process Changes.................................................................38
7.5.1.3 Control of Product Equipment, Tools and Numerical Control (NC) Machine
Programs ...........................................................................................................................38
7.5.1.5 Control of Service Operations ................................................................................39
7.5.2 Validation of Processes for Production and Service Provision ...................................39
7.5.3 Identification and Traceability ....................................................................................40
7.5.4 Customer Property ....................................................................................................41
7.5.5 Preservation of Product .............................................................................................41
7.6 Control of Monitoring and Measuring Devices..................................................................42
Section 8: Measurement, Analysis and Improvement ...............................................................43
8.1 General............................................................................................................................43
8.2 Monitoring and Measurement ..........................................................................................44
8.2.1 Customer Satisfaction ...............................................................................................44
8.2.2 Internal Audit .............................................................................................................44
8.2.3 Monitoring and Measurement of Processes ..............................................................45
8.2.4 Monitoring and Measurement of Product...................................................................46
8.3 Control of Nonconforming Product ...............................................................................47
8.4 Analysis of Data...............................................................................................................48
8.5 Improvement....................................................................................................................49
8.5.1 Continual Improvement .............................................................................................49
8.5.2 Corrective Action.......................................................................................................49
8.5.3 Preventive Action ......................................................................................................49
Addendum A: Industry Specifications Mapping .........................................................................51
AA-1.0 Intent and Purpose .................................................................................................51
AA-2.0 AS9003 Specific Mappings ....................................................................................51
Addendum B : Supporting Documents Index.............................................................................53
AB 1.0 General ..................................................................................................................53
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AB 2.0 Prime Machine Procedure (PMP) Descriptions and Purpose..................................53
AB 2.1 PMP-001 Document Control...................................................................................53
AB 2.2 PMP-002 Records Control......................................................................................53
AB 2.3 PMP-003 Work Order Router .................................................................................53
AB 2.4 PMP-004 Purchasing .............................................................................................54
AB 2.5 PMP-005 Tool Management ...................................................................................54
AB 2.6 PMP-006 Internal Audit ..........................................................................................54
AB 2.7 PMP-007 Nonconformance ....................................................................................54
AB 2.8 PMP-008 Inspection Reporting ...............................................................................54