575 West 800 South
Salt Lake City, UT. 84101

Quality Management Systems Manual

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 ISO 9001 (2000). 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 ISO 9001 - 2000. Each section begins with a policy statement expressing Prime Machine Inc. 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 ISO standard and the company’s best business practices. These business practices are dynamic and maintained in order to ensure customer satisfaction and continuous improvement.

President: Douglass J Murray 

 

Table of Contents

This document is not to be reproduced except in full, with written consent from Prime Machine, Inc.

Table of Contents:

Introduction

Quality Manual Distribution Policy:

Section 1: Scope

1.1 General

1.2 Application

Section 2: Normative Reference

2.0 Quality Management System References

Section 3: Definitions and Clarifications

3.0 Quality Management System Definitions

3.1 Customer Quality Requirement Categorical Index

Section 4: General Requirements

4.1 General requirements

4.2 Documentation Requirements

4.2.1 General

4.2.2 Quality manual

4.2.3 Control of documents

4.2.4 Control of quality records

Section 5: Management Responsibility

5.1 Management commitment

5.1.1 Management Responsibility Definitions:

5.2 Customer focus

5.3 Quality policy

5.4 Planning

5.4.1 Quality objectives

5.4.2 Quality management system planning

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

5.5.2 Management representative

5.5.3 Internal communication

5.6 Management review

5.6.1 General

5.6.2 Review input

5.6.3 Review output

Section 6: Resource Management

6.1 Provision of resources

6.2 Human resources

6.2.1 General

6.2.2 Competence, awareness and training

6.3 Infrastructure

6.4 Work Environment

Section 7: Product Realization

7.1 Planning of product realization

7.2 Customer-related processes

7.2.1 Determination of requirements related to the product

7.2.2 Review of requirements related to the product

7.2.3 Customer communication

7.3 Purchasing

7.3.1 Purchasing process

7.3.2 Purchasing information

7.3.3 Verification of purchased product

7.4 Production and Service Provision

7.4.1 Control of production and service provision

7.4.2 Validation of processes for production and service provision

7.4.3 Identification and traceablility

7.4.4 Customer property

7.4.5 Preservation of product

7.5 Control of monitoring and measuring devices

Section 8: Measurement, Analysis and Improvement

8.1 General

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

8.2.2 Internal Audit

8.2.3 Monitoring and measurement of processes

8.2.4 Monitoring and measurement of product

8.3 Control of Non-conforming Product

8.4 Analysis of Data

8.5 Improvement

8.5.1 Continual improvement

8.5.2 Corrective action

8.5.3 Preventive action

Addendum A: Industry Specifications Mapping

AA-1.0 Intent and Purpose

AA-2.0 AS9003 Specific mappings

Section 1: Scope

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 9001:2000 and to comply with market specific customer needs.

Prime Machine Inc. has determined that the following requirements are not applicable to the current operations at this site and are documented as exclusions:

ü Prime Machine Inc. does not design products for manufacture. The scope of their supply to the customer is to manufacture to customer furnished specifications and/or drawings. Based upon this defined scope of work, the requirements of section 7.3 of the ISO 9001:2000 standard, have been excluded from this Quality Management System.

ü 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 is a mutli-faceted service and production organization with a wide range of customers. To assure all customer needs are met Prime has a robust system for determining customer needs through the contract review activity PMF-102. This wide range of customers have often have dramatically different needs from the QMS. In support of these diverse needs, Prime machine maintains three 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.

Figure 1

 

Section 2:

The following documents were used as reference during the preparation of the Quality Management System:

ü U.S. Department of Defense Specification and standards Mil-Q-9858A

ü U.S. Department of Defense Specification and standards Mil-45208A

ü American National Standard ANSI/ISO/ASQ Q9000-2000, Quality               Management Systems - Vocabulary.

ü American National Standard ANSI/ISO/ASQ Q9001-2000, Quality Management Systems - Requirements

ü American National Standard ANSI/ISO/ASQ Q9004-2000, Quality Management Systems - Guidelines for performance Improvements.

ü SAE International Standards AS9100-2000 and AS9003.

ü Boeing BQMS appendix B - 2001. (D6-82479 rev B).

Section 3:

Definitions and Clarifications

ü Contract review / proposal - The response to a customers 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.

ü 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 )

ü 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 )

ü 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.

ü 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.

ü PMP- Prime Machine Inc. Procedure . These are also considered support documentation for this manual.

ü PMF-Prime Machine Inc. Flow Diagram. These are also considered support documentation for this manual.

ü PCP-Prime Machine Process Control Procedure. These are standard procedures that PMI had developed for recurring and/or specialized work. These PCP’s are referenced in the shop routers as required for additional process control.

ü Customer owned property - Any type of instrumentation, accessories, manuals, or shipping containers that belong to a customer.

ü Customer supplied product - Any type of service or material supplied to be utilized in the manufacture, modification or repair of customer-owned property.

ü Product - The end item result of meeting all contract terms and conditions. (e.g.: manufactured goods, merchandise, services etc.)

ü WIP - A `work in progress` status for the work scope operations performed on a project. This May include meetings and customer progress documentation requirements.

ü 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.

ü 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.

ü QFM or Qform-Prime Machine Inc. quality control Form.

ü 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.

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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.

ü 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 customers 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 area manager or shift supervisor.

ü Quality Level II- Applies to work that has some degree of complexity where quality planning is based upon best industry practices or Prime Machine workmanship standards and internal documentation. Specifications of quality and performance will be determined for each work package by the project manager, and Prime Machine reserves the right to perform all Material Review activities on Quality level II projects.

ü 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.

Section 4:

General Requirements

Document Control PMP-001

Control of Quality Records PMP-002

Process Control PMP-003

Prime Machine Inc. has established, documented and implemented a Quality Management System (QMS) to meet the intent of the requirements of ISO 9001:2000. 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.

To design and implement the QMS Prime Machine Inc. has:

ü Initiated contract review procedures to assure compliance to contractual or customer related requirements. This information is used in developing procedures/processes that will meet those requirements.

ü 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.

ü Determined the sequence and interaction of these processes, and illustrated them on the Business Process Diagram.

ü 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.

ü Ensured the continuing availability of materials personnel and documents necessary to achieve planned results and continual improvement of these processes.

ü Established systems to monitor, measure and analyze these processes.

ü Established processes to identify and implement actions necessary to achieve planned results and continual improvement of these processes.

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4.2.1 General

Figure 1 demonstrates the relation ship of the QMS documentation. The QMS documentation includes:

ü A documented Quality Policy

ü This Quality Manual

ü Documented Procedures

ü Documents identified as needed for the effective planning, operation and control of our processes, and

ü Quality Records

 

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 one 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.

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:

ü Approving documents for adequacy prior to issue

ü Reviewing and updating as necessary and re-approving documents

ü Ensuring that changes and current revision status of documents are identified

ü Ensuring that relevant versions of applicable documents are available at points of use

ü Ensuring that documents remain legible and readily identifiable

ü Ensuring that documents of external origin are identified and their distribution controlled, and

ü Preventing the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose

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.

Figure 3

Figure 4

Section 5:

Management Responsibility

Process Improvement PMF-105

Non-Conforming Material PMP-00

Process Control PMF-003

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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:

ü Communicate the importance of meeting customer, statutory, and regulatory requirements by direct communication with the staff.

ü Establish quality objectives.

ü Establish the quality policy.

ü Conduct Annual management reviews.

ü Ensure the availability of resources.

ü Define and delegate the established quality objectives responsibilities.

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

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.

Prime Machine 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:

ü People: Prime machine 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.

ü Technology: Prime machine 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.

ü Systems: Prime Machine develops and structures business systems to measure, report and continually improve our quality objectives.

At Prime Machine 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.

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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:

ü Efficiency factor expressed as: total sales(labor only)/total hours, to be within 10% of target value.

ü On time delivery to be greater than 90%.

ü Maintain revenue growth of 2% per year.

ü Maintain OSHA safety rating of: Zero lost work hours per year.

ü Create and implement a customer survey to evaluate PMI performance.

These Quality objectives are measurable, and are reviewed against performance goals at each management review meeting.

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 ISO 9001 standard. Quality planning takes place as changes that affect the quality system are planned and implemented.

5.5.1 Responsibility and authority

An organizational chart has been established to show the interrelation of personnel in the organization. Job functions and the organizational chart are reviewed and approved by top management for adequacy. This chart is available throughout the organization 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 managements representative, he/she has the following responsibilities and authority:

ü Ensure that processes needed for the quality management system are established and implemented.

ü Report to top management on the performance of the quality management system, and note needed improvements.

ü Promote awareness of customer requirements throughout the organization.

ü Act as a liaison with external parties such as customers or auditors on matters relating to the QMS.

ü Assist with training of new and revisions to existing procedures.

5.5.3 Internal communication

Processes are established for communication within the organization. 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.

5.6.1 General

Top management reviews the QMS mannual at management review meetings. This review assesses the continuing QMS suitability, adequacy and effectiveness, identifying opportunities for improvement and needed changes. 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:

ü Results of audits.

ü Customer feedback.

ü Scrap and rework cost.

ü On time delivery.

ü Status of preventive and corrective actions.

ü Follow-up actions from previous management reviews.

ü Planned changes that could affect the quality management system.

ü Recommendations for improvement.

5.6.3 Review output

During these review meetings, management will identify appropriate actions to be taken regarding the following issues:

ü Improvement of the effectiveness of the quality management system and its processes.

ü Improvement of product related to customer requirements.

ü Resource needs.

Responsibility 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.

Section 6:

Resource Management

Contract Review PMF-102

Process Control PMP-003

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Prime Machine Inc. has implemented a Quality Management System that complies with the ISO 9000 2000 standard. 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.

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.

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. All employees are trained on the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.

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 and supporting services. As new infrastructure requirements arise, they will be documented in the management review and or regular staff meetings. Existing infrastructure is maintained as required.

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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.

Section 7:

Product Realization

Process Control PMP-003

Purchasing PMP-004

Tool Management PMP-005

Receipt of product PMF-103

Order Completion PMF-104

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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 identify:

ü The quality objectives and requirements for the product,

ü Processes, documentation and resources required.

ü Verification, validation, monitoring, inspection and test requirements.

ü Criteria for product acceptance.

The output of quality planning is included in the completed Shop Router for the specific work to be performed.

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:

ü Requested by the customer.

ü Customer specifications or standards.

ü Required for delivery and post-delivery activities.

ü Not stated by the customer but necessary for specified use or known and intended use. (QC levels I & II)

ü Statutory and regulatory requirements related to the product.

ü Additional requirements determined by Prime Machine Inc. (QC levels I & II)

ü Customer requirements are determined according to the Contract Review PMF-102.

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:

ü Product requirements are defined.

ü Contract or order requirements differing from those previously expressed are resolved.

ü Prime Machine Inc. has the ability to meet the defined requirements.

ü 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.

ü Where a customer does not provide a documented statement of requirement, the customer requirements are confirmed before acceptance.

ü 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:

ü Product Information.

ü Enquiries, contracts and order handling, including amendments.

ü Customer Feedback, including customer complaints.

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7.3.1 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. 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.

7.3.2 Purchasing information

Purchasing information describes the product to be purchased, including where appropriate:

ü Requirements for approval of product, processes and equipment.

ü Requirements for qualification of personnel.

ü Quality management system requirements

The purchasing documents are reviewed to ensure the adequacy of requirements before orders are placed with the supplier.

7.3.3 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-104 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.

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7.4.1 Control of production and service provision

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:

ü The availability of information that describes the characteristics of the product.

ü The availability of work instructions.

ü The use of suitable equipment.

ü The availability and use of monitoring and measuring devices.

ü The implementation of monitoring and measurement.

ü The implementation of release, delivery and post-delivery activities.

7.4.2 Validation of processes for production and service provision

Prime Machine Inc. validates any 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 will be defined as required in the shop router (Ref PMP003 and PMP005). 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:

ü Informing the customer of facts and findings.

ü Defined criteria for review and approval of the processes.

ü Destructive and non-destructive testing of sample parts.

ü 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.

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).

ü Customer or specification approval of equipment, processes and qualifications of personnel. If required, this is inclusive of sub-contract level work as well.

ü Use of documented internal proprietary methods and procedures.

ü Requirements for records and documentation and control.

ü First article inspections if required.

ü Revalidation of non-conforming products.

7.4.3 Identification and traceablility

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 traceablility needs. Prime Machine Inc. controls and records the unique identification of the product where ever traceablility is a contract specified requirement. The specific method of identification will be determined on a case by case basis and will be defined in the Shop Router.

7.4.4 Customer property

Prime Machine Inc. exercises care with customer property while it is under the organization's control or being used. Control of Customer property is outlined in the following procedures and process flows; PMP-003Process Control, PMP -005 Tool Management, PMF-103 Receipt of product and PMP-007 Control of NCR. These processes outline the Identification, verification, protection and safeguarding of customer property provided for use. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this is reported to the customer and records maintained.

7.4.5 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 PMP003-1.10)

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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.

Where necessary to ensure valid results, measuring equipment is:

ü Calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards.

ü Adjusted or re-adjusted as necessary.

ü Identified to enable the calibration status to be determined.

ü Safeguarded from adjustments that would invalidate the measurement result.

ü Protected from damage and deterioration during handling, maintenance and storage.

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

Section 8:

Measurement, Analysis and Improvement

1.1 Process Improvements PMF-105

1.2 Internal Audits PMP-006

1.3 Control of Nonconforming Product PMP-007

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Prime Machine Inc. has planned and implements the monitoring, measurement, analysis and improvement processes as needed:

ü To demonstrate conformity of the product.

ü To ensure conformity of the quality management system.

ü To continually improve the effectiveness of the quality management system.

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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.

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Prime Machine Inc. determines, collects and analyses 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:

ü Customer satisfaction.

ü Conformance to product requirements.

ü Characteristics and trends of processes and products including opportunities for preventive action.

ü Supplier Performance. (Ref PMP-004 sec.6.0)

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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.

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, PMF-105 define requirements for:

ü Reviewing nonconformities (including customer complaints).

ü Determining the causes of nonconformities.

ü Evaluating the need for action to ensure that nonconformities do not recur.

ü Determining and implementing action needed.

ü Records of the results of action taken.

ü Reviewing corrective action taken.

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.

A documented procedures PMP-006 Internal audit, PMP-007 control of NCR, and PMF-105 process improvement define requirements for:

ü Determining potential nonconformities and their causes.

ü Evaluating the need for action to prevent occurrence of nonconformities.

ü Determining and implementing action needed.

ü Records of results of action taken.

ü Reviewing preventive action taken.

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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 quality system documentation. If they are more familiar with or are using a specific industry specification this will help to show Prime Machines compliance to the intent of the referenced industry standard.

AA-2.0 AS9003 Specific mappings

The following maps AS9003 and BQMS appendix B to the PMI documentation:

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	PMP005
4.1.2	QMS - 5.1.1		4.11.2	PMP005
4.2 Quality System			4.11.3	PMP005 - 4.3
4.2.1	QMS - 5.5.1		4.11.4	PMP005 - 4.0
4.2.2	PMP002 - 1.1		4.12 Inspection and Test Status
4.3 Contract Review	QMS - 7.1		4.12.1	PMP003 - 1.7
4.4 Design Control (Not Applicable)	-		4.12.2	PMP007 - 1.0
4.5 Document and Data Control	-		4.12.3	PMP003 - 1.7
4.5.1	PMP001 - 2.0		4.13 Control of Non-conforming Product	-
4.5.2	PMP001 - 4.0		4.13.1	PMP007
4.6 Purchasing			4.13.2	PMP007 - 2.0
4.6.1	QMS - 7.4.3		4.13.2.1	PMP007 - 3.0
4.6.2	PMP004 - 2.0		4.13.2.2&3	PMP007- 3.0
4.6.3	PMP004 - 4.0		4.13.3	PMP007 - 4.5
4.6.4	PMP003 - 1.8		4.13.4	PMP007 - 4.5
4.6.5	PMP004- 6.0		4.13.5	PMP007 - 5.0
4.6.6.	QMS - 7.4.2		4.14 Corrective and Preventative Action	-
4.6.7	PMP004 - 6.0		4.14.1	PMP007- 4.3
4.7 Control of Customer Supplier Product	PMP003 - 1.5		4.14.2	QFM 201
4.8 Product Identification and Traceablility	PMP003 - 1.5		4.15 Handling, storage, packaging, preservation, and delivery	-
4.9 Process Control	-		4.15	PMP003 - 1.10
4.9.1	PMP003 - 1.6		4.16 Control of Quality Records
4.9.2	PMP003 - 1.6.1		4.16.1	PMP002
4.9.3	PMP003 - 1.7		4.16.2	PMP002 - 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	PMP5		4.17	PMP006
4.10 Inspection and Testing	-		4.18 Training	-
4.10.1	PMP003 - 1.7		4.18	QMS - 6.2.1
4.10.2	PMP003 - 1.9		4.19 Servicing (Not Applicable)	-
4.10.3	PMP003 - 1.7		4.20 Statistical Techniques	-
4.10.4	PMP003 - 1.9		4.20.1	PMP003 - 1.7
4.10.5	PMP003 - 1.9		4.20.2	PMP003 - 1.7
			4.20.2.1	QMS - 3.1

Table of Contents

-- End of PMI QMS Manual --