Introduction - Prime Machine, Inc. · QFM or Qform- Prime Machine Quality Control Form Material Review- Material review is the activity performed by the material review board to determine

Prime Machine, Inc. Quality Systems Manual

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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 2011To Administration

President

Purchasing AccountingAerospace

Receiving

DriverPayroll,

A/RTool Rm / Inventory

Shipping

Production Manager

Machine Shop Mgr Mechanic

Shop MgrWeld Shop

MgrEngine

Shop Mgr

Maintenance Mgr

Programming/CAD

Machinist -Day

Machinist -Night

Mechanic Welders Mechanics JanitorOff ice, A/P

Night Machine

Shop Mgr

Sales/Project Manager

EnginePower/Oil/Gas

Inside Sales

Field Service

Quality Manager Safety DirectorEngineering Manager

Metrology


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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 buy-off 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 PMP-002

Shop Router Creation & Maintenance 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 (PMF-101) 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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Figure 1

Prime Machine Operations

Manual

PMP-006

Internal

Audit

PMP-001

Document

Control

Dwgs Spec

datasets

PMP-002

Control of

Records

Identification of

records &

retention policy

PMP-004

Purchasing

Supplier

management

PMP-007

Control of

Non-

Conforming

Materials

PMP-003

Process Control

Quality planning,Work

orders job execution

PMP-005

Tool Management

Calibration,numbering

and storage

PMF-101

Macro

Business

Flow

PMF-102

Contract

review

PMF-103

Receipt

of

Product

PMF-104

Order

Completion

Qform-2xx-3xx

Quality FormsJob Descriptions/

personell file

PCP-4QQ

Process Specific

Prcoess Control

Procedures

Contract review

notes

Completed job

folder

Tool Calibration

cert

Prime Machine Inc.Document Hierarchy

QMS Level 1 Documented Procedures & Process Flows

QMS Level 2 Process Flows

QMS Level 3 forms & records

Management

Review

Minutes

PMF-105

Process

Improvement

Preventative

Maintenance plan

Quality Management

SystemProcedures(QMS)Adminstrative policiesWork Place Safety

Process Qual

records; welding,

NDT...


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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 PMF-105

Nonconforming Material 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 PMP-005

Receipt of product 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. Configuration management planning b. Configuration identification c. Change control d. Configuration status accounting and e. 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 PMF-102 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



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7.3.3 Design and Development Outputs


7.3.4 Design and Development Review


7.3.5 Design and Development Verification


7.3.6 Design and Development Validation


7.3.6.1 Design Documentation, Verification, and Validation


7.3.6.2 Design Verification and Validation Testing


7.3.7 Control of Design and Development


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 re-evaluation 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, PPC-520) 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 PMF-105 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. PMI Spec. AS 9003 Spec. PMI Spec.

4.1 Management Responsibility - 4.11 Control of Inspection, Measurement

and Test Equipment -

4.1.1 QMS 5.1 4.11.1 PMP-005

4.1.2 QMS 5.1.1 4.11.2 PMP-005

4.2 Quality System 4.11.3 PMP-005 - 4.3

4.2.1 QMS 5.5.1 4.11.4 PMP-005 - 4.0

4.2.2 PMP-002 - 1.1 4.12 Inspection and Test Status

4.3 Contract Review QMS 7.1 4.12.1 PMP-003 - 1.7

4.4 Design Control - 4.12.2 QMS 7.3

4.5 Document and Data Control - 4.12.3 PMP-003 - 1.7

4.5.1 PMP-001 - 2.0 4.13 Control of Nonconforming Product -

4.5.2 PMP-001 - 4.0 4.13.1 PMP007

4.6 Purchasing 4.13.2 PMP-007 - 2.0

4.6.1 QMS - 7.5.3 4.13.2.1 PMP-007 - 3.0

4.6.2 PMP-004 - 2.0 4.13.2.2&3 PMP-007- 3.0

4.6.3 PMP-004 - 4.0 4.13.3 PMP-007 - 4.5

4.6.4 PMP-003 - 1.8 4.13.4 PMP-007 - 4.5

4.6.5 PMP-004 - 6.0 4.13.5 PMP-007 - 5.0

4.6.6. QMS – 7.5.2 4.14 Corrective and Preventative Action -

4.6.7 PMP-004 - 6.0 4.14.1 PMP-007- 4.3

4.7 Control of Customer Supplier

Product PMP-003 - 1.5 4.14.2 QFM-201

4.8 Product Identification and

Traceability PMP-003 - 1.5

4.15 Handling, storage, packaging,

preservation, and delivery -

4.9 Process Control - 4.15 PM-P003 - 1.10

4.9.1 PMP003 - 1.6 4.16 Control of Quality Records

4.9.2 PMP003 - 1.6.1 4.16.1 PMP-002

4.9.3 PMP003 - 1.7 4.16.2 PMP-002 - 1.0

4.9.4 PMF-103 4.16.3 QMS 1.1

4.9.5 PMP003 - 1.7 4.17 Internal Quality Assessment -

4.9.6 PMP-005 4.17 PMP-006

4.10 Inspection and Testing - 4.18 Training -

4.10.1 PMP-003 - 1.7 4.18 QMS - 6.2.1

4.10.2 PMP-003 - 1.9 4.19 Servicing (Not Applicable) -

4.10.3 PMP-003 - 1.7 4.20 Statistical Techniques -

4.10.4 PMP-003 - 1.9 4.20.1 PMP-003 - 1.7

4.10.5 PMP-003 - 1.9 4.20.2 PMP-003 - 1.7

4.20.2.1 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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J Update to AS9100C:2009 (Rev C) PJM 8/1/12 PM

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