Precision Hermetic Quality Manual

AS9100

QUALITY MANUAL

PHT-M0001 Date: Page:

Rev. H 11/30/10 1 of 47 Approved by: Ventura Mejia Quality Manager

Confidential

Serial # _______________

PHT Quality Manual

1940 West Park Avenue Redlands

California 92373 Ph. (909) 381-6011 Fax. (909) 748-6014

The information contained in this document is the property of PHT and may not be copied, disclosed, reproduced or used except with specific permission of an authorized representative of

the company.

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Table of Contents

1.0 GENERAL: ..................................................................................................................................................... 5 1.1. QUALITY MANUAL APPROVAL ...................................................................................................................... 5 1.2. REVISION HISTORY ........................................................................................................................................ 6 1.3. AMENDMENT PROCEDURE ............................................................................................................................ 7 1.4. DISTRIBUTION LIST ....................................................................................................................................... 7

2.0 QUALITY VISION: ....................................................................................................................................... 8 2.1. CORPORATE VISION STATEMENT ................................................................................................................. 8 2.2. QUALITY SYSTEM PROCEDURES ................................................................................................................... 8 2.3. SCOPE ............................................................................................................................................................. 9 2.4. EXCLUSIONS ................................................................................................................................................... 9

3.0 INTRODUCTION TO COMPANY OPERATIOINS: ............................................................................. 10 3.1. PHT BACKGROUND AND HISTORY ............................................................................................................ 10 3.2. CONTINUAL IMPROVEMENT PHILOSOPHY ................................................................................................ 11 3.3. COMPANY STRUCTURE ............................................................................................................................... 11

4.0 QUALITY MANAGEMENT SYSTEM: .................................................................................................... 12 4.1. GENERAL REQUIREMENTS .......................................................................................................................... 12 4.2. DOCUMENTATION REQUIREMENTS ........................................................................................................... 12 4.2.1. GENERAL ....................................................................................................................................................................... 12 4.2.2. QUALITY MANUAL ....................................................................................................................................................... 13 4.2.3. CONTROL OF DOCUMENTS ......................................................................................................................................... 13 4.2.4. CONTROL OF RECORDS ............................................................................................................................................... 13 4.3. CONFIGURATION MANAGEMENT ................................................................................................................ 13

5.0 MANAGEMENT RESPONSIBILITY: ..................................................................................................... 15 5.1. MANAGEMENT RESPONSIBILITY ................................................................................................................ 15 5.2. CUSTOMER FOCUS ....................................................................................................................................... 15 5.3. QUALITY POLICY ......................................................................................................................................... 15 5.4. PLANNING .................................................................................................................................................... 16 5.4.1. QUALITY OBJECTIVES .................................................................................................................................................. 16 5.4.2. QUALITY MANAGEMENT SYSTEM PLANNING .......................................................................................................... 16 5.5. RESPONSIBILITY, AUTHORITY AND COMMUNICATION ............................................................................. 17 5.5.1. RESPONSIBILITY AND AUTHORITY ........................................................................................................................... 17 5.5.2. MANAGEMENT REPRESENTATIVE ............................................................................................................................. 18 5.5.3. INTERNAL COMMUNICATION ..................................................................................................................................... 18 5.6. MANAGEMENT REVIEW .............................................................................................................................. 18 5.6.1. GENERAL ....................................................................................................................................................................... 18 5.6.2. REVIEW INPUT ............................................................................................................................................................. 18 5.6.3. REVIEW OUTPUT .......................................................................................................................................................... 19

6.0 RESOURCE MANAGEMENT: ................................................................................................................. 20

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6.1. PROVISIONS OF RESOURCES ....................................................................................................................... 20 6.2. HUMAN RESOURCES .................................................................................................................................... 20 6.2.1. GENERAL ....................................................................................................................................................................... 20 6.2.2. COMPETENCE, AWARENESS AND TRAINING ........................................................................................................... 20 6.3. INFRASTRUCTURE ....................................................................................................................................... 20 6.4. WORK ENVIRONMENT ................................................................................................................................ 21

7.0 PRODUCT REALIZATION: ..................................................................................................................... 22 7.1. PLANNING OF PRODUCT REALIZATION ...................................................................................................... 22 7.2. CUSTOMER-RELATED PROCESSES .............................................................................................................. 22 7.2.1. DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT .................................................................... 22 7.2.2. REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT ..................................................................................... 22 7.2.3. CUSTOMER COMMUNICATION .................................................................................................................................... 23 7.3. DESIGN AND DEVELOPMENT ...................................................................................................................... 24 7.4. PURCHASING ............................................................................................................................................... 24 7.4.1. PURCHASING PROCESS ................................................................................................................................................ 24 7.4.2. PURCHASING INFORMATION ...................................................................................................................................... 24 7.4.3. VERIFICATION OF PURCHASED PRODUCT ................................................................................................................ 25 7.4.4. APPROVED MATERIALS FOR ONGOING PRODUCTION ........................................................................................... 25 7.4.5. EVALUATION OF SUBCONTRACTORS ........................................................................................................................ 25 7.4.6. SUBCONTRACTOR DEVELOPMENT ............................................................................................................................ 26 7.4.7. SCHEDULING SUBCONTRACTORS .............................................................................................................................. 26 7.4.8. GOVERNMENTAL SAFETY AND ENVIRONMENTAL REGULATIONS ...................................................................... 26 7.5. PRODUCTION ............................................................................................................................................... 26 7.5.1. CONTROL OF PRODUCTION ......................................................................................................................................... 26 7.5.2. VALIDATION OF PROCESSES FOR PRODUCTION ...................................................................................................... 30 7.5.3. IDENTIFICATION AND TRACEABILITY ...................................................................................................................... 31 7.5.4. CUSTOMER PROPERTY ................................................................................................................................................ 31 7.5.5. PRESERVATION OF PRODUCT .................................................................................................................................... 32 7.6. CONTROL OF MONITORING AND MEASURING DEVICES ............................................................................ 32

8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT: ....................................................................... 33 8.1. GENERAL ..................................................................................................................................................... 33 8.2. MONITORING AND MEASUREMENT ............................................................................................................ 33 8.2.1. CUSTOMER SATISFACTION ......................................................................................................................................... 33 8.2.2. INTERNAL AUDIT ......................................................................................................................................................... 33 8.2.3. MONITORING AND MEASUREMENT OF PROCESSES ............................................................................................... 34 8.2.4. MONITORING AND MEASUREMENT OF PRODUCT ................................................................................................. 35 8.3. CONTROL OF NONCONFORMING PRODUCT ............................................................................................... 40 8.3.1. GENERAL ....................................................................................................................................................................... 40 8.3.2. SUSPECT MATERIAL OR PRODUCT ........................................................................................................................... 40 8.3.3. VISUAL IDENTIFICATION ............................................................................................................................................ 40 8.3.4. REVIEW AND DISPOSITION OF NONCONFORMING PRODUCT .............................................................................. 40 8.3.5. PRIORITIZED REDUCTION PLANS ............................................................................................................................. 41 8.3.6. CONTROL OF REWORKED PRODUCT ........................................................................................................................ 41 8.3.7. ENGINEERING APPROVED PRODUCT AUTHORIZATION ........................................................................................ 41

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8.4. ANALYSIS OF DATA ..................................................................................................................................... 41 8.5. IMPROVEMENT ............................................................................................................................................ 42 8.5.1. CONTINUAL IMPROVEMENT ....................................................................................................................................... 42 8.5.2. CORRECTIVE ACTIONS ................................................................................................................................................ 42 8.5.3. PREVENTIVE ACTIONS ................................................................................................................................................ 43

9.0 HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY: ................................. 44 9.1. GENERAL ..................................................................................................................................................... 44 9.2. HANDLING ................................................................................................................................................... 44 9.3. STORAGE ..................................................................................................................................................... 44 9.4. INVENTORY ................................................................................................................................................. 44 9.5. PACKAGING ................................................................................................................................................. 44 9.6. CUSTOMER PACKAGING STANDARDS ........................................................................................................ 44 9.7. LABELING .................................................................................................................................................... 45 9.8. PRESERVATION ........................................................................................................................................... 45 9.9. DELIVERY .................................................................................................................................................... 45 9.10. SUPPLIER DELIVERY PERFORMANCE MONITORING ............................................................................... 45 9.11. PRODUCTION SCHEDULING ...................................................................................................................... 45

10.0 CONTROL OF QUALITY RECORDS: .................................................................................................. 46 10.1. RECORD RETENTION ................................................................................................................................ 46

11.0 TRAINING: .............................................................................................................................................. 47 11.1. TRAINING EFFECTIVENESS ....................................................................................................................... 47 Addendum to Quality Manual, titled AS9100 PHT Cross Reference Matrix is located in SimpleTrak

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1.0 GENERAL:

The purpose of this manual is to document the companys quality system, to instruct and guide employees whose actions affect product quality, and to inform the companys customers of controls that are implemented to assure product quality, and fulfillment of the Quality Policy. Precision Hermetic Technology, Inc. (PHT) has developed a quality management system to improve the operations and management of the company and satisfy the needs of its customers. The quality system is designed to operate within the requirements of ISO-9001:2008 and AS9100 Revision B, all subsequent references to ISO-9001, and or AS9100 refer to these revisions.

The quality manual is structured to address each element of the AS9100 quality system requirements. The activities undertaken to manufacture our products are described in general detail within each paragraph of section 7 AS9100 Quality System clauses, of this manual. The specific requirements associated with PHT processes and procedures are described in level II Operating Procedures and level III Work Instructions. This manual provides appropriate reference to these documents.

1.1. Quality Manual Approval

The Quality Manager is responsible for the maintenance of the Quality Manual. Document Control is responsible for the distribution of the Quality Manual. A copy of the Quality Manual is accessible to all employees. Document Control holds the master copy of the manual. Reference copies may be distributed to outside organizations or persons as needed. The PHT Quality Manual is issued under the authority of the President and Senior Staff of PHT, Inc. The purpose of this manual is to define the PHT quality system and to outline the structure of the documentation used in its implementation. The requirements contained within this document apply to all activities and processes within the company. We the undersigned acknowledge and accept the duties and responsibilities set forth in this Quality Manual.

________________________ ________________________ ________________________ President Chief Operating Officer Vice President of

Sales & Marketing

________________________ ________________________ ________________________ Operations Manager Finance / HR Manager New Development Mgr

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1.2. Revision History

Revised Section

Revised Page Reason for Revision

Rev. Level Date

Initial Release A 1/11/95

All All Reformatted the document, and corrected typographical errors.

B 10/30/08

All All Complete reformat and rewrite to AS9100 C 11/3/08

3.2 11 Organization Chart Update D 3/4/10

All All Update referenced procedure numbers E 4/15/10

2.3, 2.4, 7.3, 7.5.1

8, 24 Exclusion of Design and Service sections F 10/1/10

2.4, 4.2.4 5, 9, 13, & 14

Update per AS9100 Rev B Stage I Audit Findings G 11/5/10

1.0, 2.4, 4.2.2, 8.3.4, 10.1

4, 5, 6 9,13, 14,

41, 47

Update per AS9100 Rev B Stage II Audit H 11/30/10

This issue of the PHT Quality Manual is authorized by the undersigned. All previous issues are invalid. The PHT Management Representative in accordance with Paragraph 1.3 Amendment Procedure, of this manual shall approve revisions to this manual.

Ventura Mejia

Quality Manager Management Representative

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1.3. Amendment Procedure

The PHT Management Representative is responsible for ensuring that this manual accurately reflects our documented quality system, outlines the structure of our documentation and addresses the requirements of ISO-9001 and AS9100. The appointed Management Representative is authorized to approve revisions and amendments to this manual. A general description of each revision shall be recorded on the revision history page. When this manual is revised, a copy of the revised manual shall be distributed to all personnel on the distribution list shown below. It is the responsibility of all holders of the Quality Manual to discard old manuals upon receipt of revised copies. The current revision level of the Quality Manual shall be reflected on the Master List of controlled documents.

1.4. Distribution List

President Chief Operating Officer New Development Manager (Engineering) PC&L / Mfg Engineering Manager Vice-President of Sales & Marketing Operations Manager Finance / Human Resources Manager Customer Service Manager QA Manager

This manual may be released to a PHT employee not on the list above, or external organizations upon approval, on a need to know basis. Each manual released to a PHT employee, or external organization not marked with a serial number shall be considered an UNCONTROLLED COPY.

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2.0 QUALITY VISION:

2.1. Corporate Vision Statement

PHT is dedicated to a continuous improvement philosophy founded upon the principles of Knowledge Based Management. We will move forward with the clear understanding that quality improvement in our products comes through the systematic reduction of process variation. PHT is dedicated to instilling in our work force a clear understanding of the theory of variation and to provide them with the tools necessary to reduce it. Our objective is to clearly define the requirements of our customers and then to provide them with goods and services that exceed their expectations. PHT will become a world-class provider of goods and services. We will focus on our customers needs and strive for recognition in our industry as a distinctive and successful company. We will employ processes kind to the environment and supportive of our employees & communities.

2.2. Quality System Procedures

The quality system is based on the requirements of this manual. The structure of the documentation system is shown below. Quality system procedures reference the supporting documentation that indirectly form a part of the quality system.

Level 0 Requirements

Level 1 Why

Level 2 Who, What, When, Where

Level 3 How

Level 4 Evidence

Quality Policy

Quality Manual

AS9100 Quality Requirements

Procedures Referenced by the

quality manual or other level 2 procedures

Work Instructions

Records Forms

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The quality system procedures used at PHT are structured to address the requirements of ISO-9001 and AS9100. Documented procedures or work instructions have been prepared for all activities to the level where lack of these procedures could adversely affect quality. These instructions have been developed in a manner that provides a basis to evaluate system effectiveness and the accomplishment of our quality policy. Four levels of documentation define the PHT quality system.

Level 1 - This Quality Manual, defines our policies, organization, and responsibilities. Level 2 - The Company Procedures, which define in detail the operational methods, used to

accomplish the requirements of each element of AS9100. Level 3 - Work Instructions, which define individual work instructions, associated with specific

activities or tasks. Work Instructions may include documents of external origin. Level 4 - The forms used and the quality records produced by our defined system.

2.3. Scope

The requirements contained in this manual are applicable to all PHT employees. Our employees are an essential element of the PHT Quality Management System. This revision supersedes all previous releases and PHT reserves the right to revise this manual at any time without prior notification. The AS9100 registration covers the Quality Management System for the manufacture and assembly of components and assemblies for the aerospace, medical, military and other markets.

2.4. Exclusions

Paragraph 7.3 Design and Development PHT does not design or develop any products. Although PHT does provide design assistance to our Customers, the qualification and or validation is the Customers responsibility.

Paragraph 7.5.1.5 Service Provisions PHT does not provide aftermarket / warranty services for their products.

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3.0 INTRODUCTION TO COMPANY OPERATIOINS:

3.1. PHT Background and History

Precision Hermetic Technology was founded in 1989 as a manufacturer of glass to metal seals primarily for military and aerospace applications. At that time, PHTs customer base was located in California, and the company started its operations in San Bernardino in an 8,000 sq. ft. warehouse building. Co-founder Daniel B. Schachtel, originally from New York and a graduate of the University of Rochester, moved to California to help run the company in 1989. PHT initially began as an assembly plant with almost all components being purchased from subcontractors, and although PHT experienced solid growth, Schachtel believed that the companys potential was limited by its lack of vertical integration.

In 1994, Schachtel became president after buying out his remaining business partners. He quickly focused on aggressively attracting long-term industry professionals and providing them with the best possible tools for the job. As a result, the companys capabilities greatly expanded over the next 10 years, growing from a handful of manual machines to more than a dozen CNC machines in almost double the manufacturing space. In December of 2004, PHT moved to its current 25,000 sq. ft. headquarters in Redlands, CA, and currently operating two shifts with several dozen advanced CNC machine tools as well as a variety of process equipment. We now manufacture virtually all of our component requirements internally, and still continue to remain focused on developing new and better tools, continuous process improvement, and expanding our capabilities.

We still have a significant focus on Military and Aerospace applications, yet serve a variety of customers with an extremely diverse array of applications including spacecraft, military and commercial aircraft, missile and defense systems, ship borne systems, semiconductors, industrial process equipment, oil and gas industries, high reliability batteries, communications, cryogenics, and medical, to name a few. We will continue to expand our capabilities in order to support new and existing customers with an expanding range of products and solutions.

Our parts range in size from the size of a match head for a sensor application, to a two-foot diameter bulkhead for use on the International Space Station. The one thing that all our products share in common is that they are used in mission-critical applications. We recognize that peoples lives often depend on the performance of our products, and it is a responsibility that we accept with great pride.

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3.2. Continual Improvement Philosophy

The basis of our quality system is a continuous improvement philosophy. We define continuous improvement as the systematic elimination of process variation until we have obtained an output, which minimizes loss and optimizes value. Our manufacturing system begins with the qualification of processes through output analysis followed by reduction of variation, which may use Six Sigma Lean Principles. We employ a corrective and preventive action system that provides feedback on both administrative and manufacturing processes. Feedback is used as input to our continuous improvement efforts.

3.3. Company Structure

Top Management Level

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4.0 QUALITY MANAGEMENT SYSTEM:

4.1. General Requirements

PHT Inc. has established, documented and implemented a Quality Management System (QMS) in accordance with the requirements of AS9100. 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 PHT Inc. has:

Identified the processes needed for the QMS and their application throughout the organization and documented them on the Process Flow Diagram at the end of this section of the Quality Manual;

Determined the sequence and interaction of these processes, and illustrated them on the Process Flow Diagram;

Determined criteria and methods needed to ensure that the operation and control of the processes are effective, and documented them in quality plans, and work instructions;

Ensured the continuing availability of resources and information necessary to achieve planned results and continual improvement of these processes;

Established systems to monitor, measure and analyze these processes, and;

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

4.2. Documentation Requirements

4.2.1. General The QMS documentation includes:

A documented Quality Policy

This Quality Manual

Documented Procedures

Work Instructions

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

Quality Records

Records required by regulatory authorities.

PHT ensures that personnel have access to quality management system documentation and are aware of relevant procedures. We also provide customer or regulatory authorities access to quality management system documentation.

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4.2.2. Quality Manual This Quality Manual has been prepared to describe PHTs 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 Process Flow Chart at the end of section 4 provides a description of the interaction between the processes of the QMS system. The relationship between the AS9100 standard and documented procedure has been indicated by use of a numbering system that correlates to the AS9100 standard. An addendum has been included into SimpleTrak (AS9100 PHT Cross Reference Matrix) as a cross reference between the AS9100 clauses and the associated section of the corresponding PHT procedures.

4.2.3. Control of Documents All of the QMS documents are controlled according to the Document and Data Control Procedure (PHT-P0002). 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 and

Obtaining customer / regulatory agency approvals when required by contract or regulatory requirements

Coordinating document changes with customers or regulatory authorities in accordance with contract or regulatory requirements.

4.2.4. Control of Records Quality records are maintained to provide evidence of conformity to requirements and of the effective operation of the QMS. The records, including those created by or maintained by suppliers, are maintained according to the Control of Quality Records Procedure (PHT-P0001). This procedure requires that quality records remain legible, readily identifiable and retrievable. Records are available for review by customers and regulatory authorities in accordance with contract or regulatory requirements. The procedure defines the controls needed for identification, storage, protection, retrieval, retention time and disposition of quality records. Records are made available to customers and regulatory agencies when required by contract or regulatory requirements.

4.3. Configuration Management

The organization has established, documented and maintains a Part Number & Configuration Management process (PHT-P0026) that is appropriate to the product.

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Sales PHT-P0023

Request for Quote Customer Communication Customer Drawing Review PHT-F0045

Customer Service PHT-P0007 & 8

7.1 Planning of Product Realization 7.2.1 Determination of Requirements 7.2.3 Customer Communication

PC&L PHT-P0009

Receiving PHT-P0025

Manufacturing PHT-P0016

Quality PHT-P0001 & 2

Continual Improvement PHT-P0003, 4, 5 & 6

7.2.2 Review of Requirements

Customer PO Contract Review PHT-F0001 Feasibility/Risk PHT-F0004 Sales Order PHT-F0009 Order Acknowledgement PHT-F0056

7.4 Purchasing 7.4.5 Evaluation of Sub-Contractors

Material to Make/Buy PHT-F0010 Supplier Approval SimpleTrak Xtuple ERP System Supplier Quality Manual PHT-M0003

7.4.3 Verification of Purchased Prod. 7.5.3 Identification & Traceability 7.5.4 Customer Property 7.5.5 Preservation of Product

7.5.2 Validation Processes for Prod. 8.2 Monitoring & Measurement 9.0 Handling, Storage & Packaging

7.6 Control of Monitoring Devices 10.0 Control of Quality Records

5.0 Management Responsibility 7.2.3 Customer Communication 8.0 Measurement Analysis & Improvement 8.4 Analysis of Data 11.0 Training

8.2.2 Internal Audit 8.3 Control of Non-Conforming Product 8.5.1 Continual Improvement 8.5.2 Corrective Actions 8.5.3 Preventive Actions

Inspection Report PHT-F0038 Customer Property SimpleTrak

First Piece Inspection PHT-F0018 BOM Xtuple Traveler PHT-F0008 Control Plan PHT-F0040

Calibration SimpleTrak Document Control SimpleTrak ECN PHT-F0063

Requirements Evidence

Process Flow Chart

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5.0 Management Responsibility:

5.1. Management Responsibility PHT operates a quality system that meets the requirements of the International Quality Standards ISO-9001 and the Aerospace Standard AS9100. PHTs top management has been actively involved in implementing the quality management system (QMS). It has provided the vision and strategic direction for the growth of the QMS, and established quality objectives and the quality policy. The Management Responsibilities are documented in (PHT-P0011).

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.

Establish quality objectives

Establish the quality policy.

Conduct management reviews.

Ensure the availability of resources.

5.2. Customer Focus

PHT strives to identify current and future customer needs to meet customer requirements and exceed customer expectations.

Top Management ensures that customer requirements are understood and met, by requiring compliance with documented Customer Contract Review procedures (PHT-P0007). Customer requirements are determined, converted into internal requirements, and communicated to the appropriate people in our organization.

5.3. Quality Policy

Management has defined its policy for quality, including objectives for quality, and its commitment to quality. The quality policy is relevant to PHT, Inc. organizational goals, and the expectations and needs of our customers. The PHT quality policy is stated below: Top Management ensures that the quality policy is communicated to all employees. It is included in new employee training and training on the QMS to maintain high standards within our organization.

Management reviews the quality policy from time to time to determine the policys continuing suitability for our organization.

We shall, through continuous improvement, fully satisfy our customers requirements and our internal standards and do it on time in accordance with our delivery commitments.

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5.4. Planning

Quality planning is carried out on new product launches and major changes to production parts. This process involves Engineering, Sales & Marketing, Manufacturing and Quality organizations. Control Plans are developed for each part and work instructions prepared for manufacturing processes. Items to be addressed in quality plans are:

a. PHT uses Quality Planning (PHT-P0027) where necessary to introduce new technologies, new designs, and to control subcontractors. Quality plans state the requirements for introduction of a product or technology for release to the specified customer.

b. Documentation necessary to release the project to the customer may include, but is not limited to, control plans, certifications, design documentation, FMEAs, production flows, and procedures. The methods used for verification of the product or technology including inspection methods and equipment are also defined and specified. Control systems, process equipment and skills that may be required to execute new projects, currently not available, are acquired in sufficient time to meet planned release dates.

c. PHT reviews the compatibility of designs, for our production processes, and our inspection and test processes with applicable documentation.

d. The updating, as necessary, of the quality control, inspection, and testing techniques to accommodate the output of a new technology, or the development of new techniques or instrumentation.

e. The identification of any measurement capability requirement that exceeds PHTs current standard, in sufficient time for the needed capability to be developed or acquired. (The cost to develop or acquire this needed capability should be established at the outset, and considered a cost associated with the new technology).

f. The identification of suitable verification data at appropriate stages in the development of new product or processes.

g. The clarification of standards of acceptability for all features and requirements, including those, which contain a subjective element.

h. The identification and preparation of quality records.

5.4.1. Quality Objectives 1. To obtain and retain certification to the AS9100 Revision C Specification. 2. To define measures of effectiveness for all clauses of our quality system and gather data to

effectively manage and improve these activities. 3. To satisfy all customer requirements and exceed their expectations whenever possible.

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 AS 9100 standard. Quality planning takes place as changes that affect the quality system are planned and implemented.

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5.5. Responsibility, Authority and Communication

5.5.1. Responsibility and Authority An organizational chart for all departments within the company is maintained and controlled by the Human Resource department and is available to all managers. The Human Resource Manager is responsible for initial AS9100 orientation and Quality Manual introduction to new employees. Organizational charts have been established to show the interrelation of personnel in the organization. Job descriptions define the responsibilities and authorities of the positions in the Company, and are reviewed and approved by top management for adequacy, the Department Supervisor/Manager is responsible for establishing and revising job descriptions. These documents are available throughout the organization to help employees understand the responsibilities and authorities. A top management organizational chart is located on page 8 of this manual

Department managers are responsible to assure that their employees are adequately trained in the policies, procedures, and work instructions pertaining to the employee's function. It is the responsibility of all employees of PHT, Inc. to work within the established Quality System and to comply with operating procedures and work instructions.

a. Authority has been given to PHT manufacturing and quality personnel to stop production and to initiate action to prevent the occurrences of any nonconformity.

b. All supervisory personnel along with quality inspectors and internal auditors have been given the authority and responsibility for the identification and recording of any problems relating to the product, process or quality system.

c. Quality Assurance personnel and management personnel at all levels have been given the authority to initiate, recommend or provide solutions through designated channels.

d. Quality Assurance personnel along with internal auditors verify the implementation of solutions.

e. All personnel, whose work affects quality, are responsible to control further processing, assembly, production or delivery of non-conforming product until the deficiency or unsatisfactory condition has been corrected.

f. There are numerous positions throughout PHT where people have the responsibility to represent the needs of our customers. These positions include Sales Personnel, Design Team Personnel, Quality Assurance Personnel, Contract Review Personnel, Production Control Personnel and Management Personnel at all levels. Employees with such responsibilities must be honest and faithful in carrying out these activities. The selection of PHT Special Characteristics, Quality Objectives, Training Activities, Corrective & Preventive Actions, and Product and Tool Designs are undertaken with the best interests of the Customer always the primary consideration. All personnel who represent the customers needs are responsible to report to the management chain whenever the execution of processes may be contrary to the needs and expectations of customers.

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5.5.2. Management representative The Quality Assurance Manager has been appointed by Executive Management as the companys management representative. As management representative, he has the following responsibility and authority:

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

Report to Executive Management on the performance of the quality management system, and note-needed improvements.

Promote awareness of customer requirements throughout the organization.

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

Resolve matters pertaining to quality issues

Organizational freedom to resolve matters pertaining to quality.

5.5.3. Internal communication Processes are established for communication within the organization. Methods of communicating the effectiveness of the QMS include department and management meetings, management review, minutes of management review meetings in SharePoint, internal audit closing meetings, and other routine business communication.

5.6. Management Review

5.6.1. General PHT conducts formal management reviews of the QMS. These reviews are conducted on an annual basis, but may be held more frequently as required by executive management. The PHT management review is conducted by a cross-functional team charged with the responsibility to present data to executive management on the continuing suitability and effectiveness of the quality system. Data is presented on organizational goals and the effectiveness of operations in meeting customer requirements.

5.6.1.1.Management Review (supplemental) Management reviews all clauses of the quality system. The purpose of these reviews is to assess the effectiveness and continuing suitability of the quality system as well as the success of the system in meeting company policies & objectives.

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

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Process performance and product conformity Company level quality data 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

Responsibility for required actions is assigned to members of the management review team. Any decisions made during the meeting, assigned actions, and their due dates are recorded in the minutes of management review.

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6.0 RESOURCE MANAGEMENT:

6.1. Provisions of Resources

PHT, Inc. identifies resource requirements as part of the normal routine of managing, and provides adequate resources, including the assignment of trained personnel. The organizational structure includes a Quality Assurance Manager. All manufacturing requirements and associated verification activities are identified and assigned by plant management in support of customer needs. Documented procedures are provided where the lack of such procedures could adversely affect quality. Workmanship standards are provided in the clearest practical manner. Appropriate tools and equipment are provided to support operations. Internal quality system auditors are provided with training and charged with the responsibility to evaluate conformance to documented procedures and to assess the effectiveness of established processes.

6.2. Human resources

6.2.1. General To ensure competence of our personnel, job descriptions have been prepared identifying the qualifications required for each position that affects product quality. Qualifications include requirements for education, skills and experience. Appropriate qualifications, along with required training, provide the competence required for each position.

6.2.2. Competence, Awareness and Training Qualifications are reviewed upon hire, when an employee changes positions or the requirements for a position change. Department Managers maintain records of employee qualifications. If any differences between the employees 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. The results are then evaluated to determine if they were effective. Training and evaluation are conducted according to the Training Procedure (PHT-P0035). All employees are trained on the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.

6.3. Infrastructure

To meet quality objectives and product requirements PHT 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 quality plans. Existing infrastructure is maintained to ensure product conformity.

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6.4. Work Environment

A work environment suitable for achieving product conformance is maintained. Requirements are determined during quality planning and documented in the quality plan. 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.

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7.0 PRODUCT REALIZATION:

7.1. Planning of product realization

Quality planning is required before new products or processes are implemented. The quality planning may take place as a design project, or according to the Planning of Product Realization procedure (PHT-P0023). During this planning, management or assigned personnel identify:

The quality objectives and requirements for the product, Processes, documentation and resources required Verification, validation, monitoring, inspection and test requirements, and Criteria for product acceptance Resources to support operation and maintenance of the product.

The output of quality planning includes documented quality plans, processes, procedures and design outputs.

7.2. Customer-related processes

7.2.1. Determination of requirements related to the product PHT determines customer requirements before acceptance of an order. Customer requirements include those:

Requested by the customer Required for delivery and post-delivery activities Not stated by the customer but necessary for specified use or known and intended use Statutory and regulatory requirements related to the product Additional requirements determined by PHT

Customer requirements are determined according to the Customer Related Processes Procedure. (PHT-P0010)

7.2.2. Review of requirements related to the product PHT has a process in place for the review of requirements related to the product, Order Processing Procedure (PHT-P0008). 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 PHT has the ability to meet the defined requirements

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Records are maintained showing the results of the review and any actions arising from the review

When product requirements are changed, PHT communicates changes to relevant personnel and amends relevant documents

Feasibility/Risks (e.g., new technology, short delivery time scale) have been evaluated utilizing form (PHT-F0004).

7.2.2.1.Contract Review

7.2.2.2.General All contracts and orders are reviewed to assure customer requirements are adequately defined and understood, and to establish if PHT, Inc. has the ability to meet the contract requirements. Contract Review activities are carried out in accordance with the processes defined in (PHT-P0007).

7.2.2.3.Review Customer orders are reviewed by Sales to assure that the requirements are adequately defined and documented. Engineering will review customer specifications, drawings and technical requirements, and assure that they are adequately documented. Orders are also reviewed to identify any differences between the order and the agreed quotation or commitment, and to determine PHT's ability to meet the specified requirements. (Feasibility/Risk reviews are used on proposed products using the Feasibility/Risk form (PHT-F0004) as outlined in the Advanced Product Quality Planning and Control Plan work instruction PHT-P0030).

7.2.2.4.Amendment to a Contract Amendments to contracts are documented and reviewed to assure continued ability to comply with the changes. The impacts of changes are promptly and correctly communicated to the functions concerned.

7.2.2.5.Records Records of contract reviews are maintained by Sales. Specification and feasibility reviews are recorded and maintained in Document Control.

7.2.3. Customer communication PHT has a dedicated department to communicate with Customers in relation to:

Product Information Enquiries, contracts and order handling, including amendments Customer Feedback, including customer complaints Return Material Authorization (RMA) and warranty.

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7.3. Design and Development

Not Applicable

7.4. Purchasing

7.4.1. Purchasing process The Purchasing Department of PHT is responsible to insure that purchased products and services meet specified requirements. All materials used in production are purchased in accordance with (PHT-P0009) Purchasing procedure. Engineering is responsible for assuring that the material specification adequately defines the material requirements. Where the customer mandates specific subcontractors, this information is part of the engineering documentation. Subcontractors such as tool maintenance providers, calibration providers, transportation providers or other outside service providers are furnished with detailed instructions. Terms and Conditions of purchasing agreements are communicated to subcontractors via written agreement or via the purchase order (PO) itself. Special instructions are added to the purchase order when appropriate. 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. The organization is responsible for the quality of all products purchased from suppliers, including customer-designated sources.

7.4.2. Purchasing information The purchase order clearly describes material requirements. Review and approval of purchase orders, for adequacy of specified requirements, are undertaken prior to release. Purchase agreements shall contain the following information as appropriate:

Complete description of what is ordered including part number, model number, and all appropriate specifications and requirements, as applicable.

Quantity required. Date of order and date required. Account number, project number, asset number, etc. Appropriate Ship To location address. Price, method of shipment, contact person and other appropriate supporting information. Applicable quality system standards that apply. Special instructions and regulatory requirements when appropriate Requirements for approval of product, processes and equipment Requirements for qualification of personnel Quality management system requirements outlined in the Purchasing Procedure (PHT-P0009).

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7.4.3. Verification of purchased product All purchased products shall be verified as conforming to the requirements specified within purchase orders, contracts, or through referenced documentation. This verification shall be accomplished in accordance with documented procedures. PHT reserves the right to verify material at source, as specified in the individual purchase order. Purchased product is not used or processed until it has been verified as conforming to specified requirements. If test reports are used to verify purchased product, the data must meet applicable specifications. Test reports for raw material are periodically validated.

When verification activities are delegated to the supplier the requirements are defined, and a register of delegations is maintained.

If PHT or the customer will perform verification at the suppliers premises, the verification arrangements and method of product release are documented in the purchasing information. Where specified in the contract, the customer or the customers representative is given the right to verify at the suppliers premises and organizations premises that product conforms to specified requirements.

7.4.3.1.Supplier Verification at Subcontractors Premises When PHT intends to verify product quality at the suppliers premises, the purchase order shall clearly specify the verification requirements, acceptance criteria, and release methods. Quality records of source inspection shall be determined by the Quality Department and maintained in accordance with appropriate procedures.

7.4.3.2.Customer Verification of Subcontracted Product When customers of PHT have specified, in approved contracts, a right to inspect their product at our facilities or those of our suppliers, any such verification that products are conforming, shall not be used as the basis to determine our product quality. Such verification does not absolve PHT or our suppliers of the responsibility to provide acceptable product or services. When customers have indicated a requirement to inspect their products at the subcontractors premises, PHT shall notify the supplier, and shall accompany the customer during the inspection.

7.4.4. Approved Materials for Ongoing Production When our customers require that material or components be purchased from their approved subcontractors, these subcontractors are added to our Approved Supplier Listing (ASL) and are not changed without approval from the customer. Purchased materials are obtained from suppliers on the ASL. Additional suppliers are only used after they have met the established supplier approval process as outlined in the Supplier Quality Manual (PHT-M0003).

7.4.5. Evaluation of Subcontractors The assessment and selection of a supplier is made based upon their capability to furnish continuous delivery of quality products, materials or services to agreed upon requirements in a cost effective manner. Terms and conditions for doing business with PHT are provided to all subcontractors prior to completing purchasing agreements.

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7.4.6. Subcontractor Development The PHT goal is to develop suppliers, to follow the intent of AS9100, as their fundamental quality system requirement, as applicable, depending upon the level of supplies. The specifics associated with supplier development are outlined in the Supplier Quality Manual (PHT-M0003).

7.4.7. Scheduling Subcontractors All suppliers are expected to achieve and maintain 100% on-time delivery performance, PHT will provide adequate planning information, and purchase commitments to ensure this requirement is attainable. PHT monitors the delivery performance of suppliers. Corrective actions are initiated as appropriate and records of premium freight charges are retained.

7.4.8. Governmental Safety and Environmental Regulations PHT complies with all applicable government safety and environmental regulations. Purchased material which may be hazardous to human health requires that subcontractors provide Current Material Safety Data Sheets (MSDS) and properly label this material. MSDSs are maintained and made available to all personnel to clearly define the handling, storage, and application requirements and limitations associated with hazardous materials. Material Safety Data Sheets are controlled by the Document and Data Control Department. All materials used in manufacture satisfy all governmental and safety constraints on restricted toxic and hazardous materials, as well as, environmental, electrical and electromagnetic considerations applicable to the United States.

7.5. Production

PHT utilizes documented Procedures and Work Instructions for the planning and control of processes. Work instructions are provided for each manufacturing step where required. These instructions are provided to employees to insure an understanding of the specific requirements for completion of the activity involved. PHT defines special characteristics and documentation requirements to insure compliance with customer specifications and to establish baseline metrics for initiation of continuous improvement efforts. Appropriate skills training in Statistical Process Control (SPC) and over-adjustment (tampering) is provided to employees engaged in the operation of manufacturing equipment. Process control is undertaken in accordance with the procedures defined in Process Control (PHT-P0016). Processes and equipment are defined based on the needs of the customer. Processes and equipment are qualified and approved as appropriate to the complexity of the job, and the requirements of the associated control plan. Appropriate procedures, work instructions, and visual aids define appropriate workmanship criteria for all processes affecting the quality of our product.

7.5.1. Control of production PHT plans and carries out production under controlled conditions according to documented procedure (PHT-P0016). Service provisions are not applicable. Planning considers, as applicable:

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The establishment of process controls and development of control plans 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,

The design, manufacture, and use of tooling so that variable measurements can be taken, particularly for key characteristics, and

Special processes (see 7.5.2). Controlled conditions include, as applicable:

The availability of information that describes the characteristics of the product The availability of work instructions The use of suitable equipment The availability and use of monitoring and measuring devices The implementation of monitoring and measurement The implementation of release, delivery and post-delivery activities Accountability for all product during manufacture (e.g., parts quantities, split orders,

nonconforming product), part accountability to ensure nonconforming parts have been destroyed

Evidence that all manufacturing and inspection operations have been completed as planned, or as otherwise documented and authorized,

Provision for the prevention, detection, and removal of foreign objects, Monitoring and control of utilities and supplies such as water, compressed air,

electricity and chemical products to the extent they affect product quality, 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 Documentation All documentation used to control the quality of products during design, development, purchasing, manufacturing, test and inspection, storage and subsequent shipment, are controlled in accordance with Document Control Procedure (PHT-P0002). Document Control maintains a master list of released documentation, including external documentation. Categories of controlled documents and data include:

PHT Quality Manual Tooling Drawings Operating Procedure Customer Drawings and Specifications Work Instructions CAM Database Documents of External Origin CAD Database Material Safety Data sheets Part Submittal and Approval Documentation

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Control Plans Set-Up Sheets/Item Instructions Software for Process, Test and/or Inspection Inspection/Test Procedures Supplier Quality Manual Production operations are carried out in accordance with approved data. This data contains as necessary:

Drawings, parts lists, process flow charts including inspection operations, production documents and inspection documents

A list of specific or non-specific tools and numerical control (NC) machine programs required and specific instructions associated with their use.

7.5.1.2.Control of Production Process Changes The issuance and revision of all documentation that affects product quality or the quality system is authorized and controlled through appropriate procedures. These procedures ensure current information is available, as required, throughout PHT, Inc., and that obsolete information is withdrawn from use. Documents and data are reviewed and approved for adequacy by authorized personnel prior to use. PHT maintains a master list of controlled documents to preclude the inadvertent use of invalid or obsolete documents.

7.5.1.2.1. Engineering Specifications Changes to customer engineering standards or specifications are reviewed using the CDR/EWR Work Instruction (PHT-W0005) by the appropriate staff in a timely manner. Changes to engineering design requirements are processed in accordance with the PHT Engineering Change Notice (ECN) process. Approved changes are implemented promptly and the associated documentation is revised. When changes to customer referenced engineering standards or specifications impact the material form, fit, or function of manufactured parts, appropriate customer approvals are obtained prior to implementing these changes. Appropriate records of engineering changes and their effective production cut-in dates are maintained.

7.5.1.2.2. Document and Data Changes Changes to controlled documents developed by PHT are reviewed and approved by the original approval authority, unless specifically designated otherwise. Document and data changes, are identified by redline copies or appropriate attachments. Any employee at PHT may initiate a routine document or data change in accordance with the requirements defined by Document Control Procedure (PHT-P0002). It is the responsibility of personnel using revision-controlled documentation to assure that the revision is current, and that obsolete revisions are removed from use. Controlled documents requiring a change are subject to formal change procedures.

7.5.1.3.Control of Production Equipment, Tools and Numerical Control (N.C.) Machine Programs

Production equipment, tools and programs are validated prior to use and 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

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requirements, including periodic preservation/condition checks, have been be established for production equipment or tooling in storage.

7.5.1.4.Control of Work Transferred, on a Temporary Basis, Outside the Organizations Facilities

When planning to temporarily transfer work to a location outside the organizations facilities, the organization defines the process to control and validate the quality of the work.

7.5.1.5.Control of Service Operations

Not Applicable

7.5.1.6.Cleanliness of Premises PHT employs a clean-as-you-go philosophy supported by facility janitorial staff. In addition, general housekeeping and the work environment are evaluated, as a part of every internal audit to insure it is suitable for the activity being undertaken.

7.5.1.7.Contingency Plans Management has prepared appropriate contingency plans to address such things as utility interruptions, labor shortages, and key equipment failures. These plans are designed to protect the customers supply of product in the event of emergency. Contingency planning does not include disruptions caused by natural disasters and acts of God. These plans are reviewed and approved by appropriate personnel.

7.5.1.8.Designation of Special Characteristics All Special Characteristics, as specified by our customers, are clearly identified on process or assembly instructions, Control Plans, FMEAs, and related engineering documentation. The use of Special Characteristic symbols is intended to focus attention on controlling the variation of the labeled characteristic and to highlight the heightened concern for this feature. Customer designated special characteristics that affect a product or process are identified, documented, and controlled.

7.5.1.9.Preventive Maintenance PHT maintains a preventive maintenance system that addresses the maintenance requirements for plant and manufacturing equipment as well as the packaging/preservation of equipment, tooling and gauging. The system includes schedules for maintenance, maintenance procedures where necessary, predictive maintenance methods and the availability of replacement parts for key manufacturing equipment.

7.5.1.10. Process Monitoring and Operator Instructions Shop travelers, and work instructions are accessible within the work area for operators, who have the responsibility for operation of processes. Process monitoring is conducted and recorded by the accomplishment of first article, and in-process inspection, as defined in the control plan.

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7.5.1.11. Maintaining Process Control Preliminary process capability studies are conducted for customer designated special characteristics associated with products or processes. The requirements contained on the appropriate control plan shall be met or exceeded. This is accomplished through adherence to the specified:

Measurement Techniques Sampling Plans Acceptance Criteria Execution of Reaction plans when the acceptance criteria is not met

7.5.1.12. Modified Process Control Requirements When established default requirements for process capability (customer specific) are changed by the customer to represent higher or lower limits, the control plan shall be clearly annotated to reflect these requirements.

7.5.1.13. Verification of Job Set-Ups Detailed set-up instructions are documented and issued as a part of the set-up process. Qualified personnel perform set-ups. First articles, and/or set up check sheets, in accordance with applicable work instructions, are utilized to verify conformance to specified requirements

7.5.1.14. Process Changes Records of process change effective dates are maintained. Process changes to reduce variation are reviewed by authorized PHT personnel; coordinated with the customer, as required, and implemented when these changes do not adversely impact customer requirements. Records of process changes, and effective dates are maintained.

7.5.2. Validation of processes for production PHT validates any processes for production where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or has been delivered. Validation demonstrates the ability of these processes to achieve planned results. Service provisions are not applicable.

PHT has documented the process for validation including: Defined criteria for review and approval of the processes, qualification and approval

of special processes prior to use

Approval of equipment and qualification of personnel Use of specific 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

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Revalidation

7.5.3. Identification and Traceability PHT establishes and maintains a documented procedure for identifying product by suitable means from receipt and during all stages of production through the delivery process. A tracking system for components and sub-assemblies is effectively maintained to identify components to their next operation and by their work order number. Production materials and products are identified and stocked by a unique part number. The processes used are defined in Product Identification & Traceability (PHT-P0018). Final assemblies are suitably identified with a unique part number, revision, lot code for traceability, and additional customer-defined requirements as specified in the contract.

PHT maintains the identification of the configuration of the product in order to identify any differences between the actual configuration and the agreed configuration.

Product is identified with respect to monitoring and measurement requirements. PHT establishes and documents controls for acceptance authority media such as

stamps, electronic signatures or passwords. According to the level of traceability required by contract, regulatory, or other

established requirement, PHT system provides for: o Identification to be maintained throughout the product life; o 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;

o For an assembly, the identity of its components and those of the next higher assembly to be traced;

o For a given product, a sequential record of its production (manufacture, assembly, inspection) to be retrieved.

7.5.4. Customer Property

7.5.4.1.Control Of Customer Supplied Product Customer-supplied product is handled and dispositioned in accordance with (PHT-P0019). Customer-supplied product (including packaging) is examined upon receipt for condition, quantity, and conformance. Records are maintained, and the customer is notified of any lost, damaged or unsuitable material. Verification by PHT does not absolve the customer of the responsibility to provide acceptable product.

7.5.4.2.Customer Owned Tooling All customer-supplied tooling and equipment is permanently marked so that the ownership of each item is visually apparent. Customer-owned tooling is identified as specified in the contract.

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PHT exercises care with customer property while it is under the organization's control or being used. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this is reported to the customer and records maintained.

7.5.5. Preservation of Product PHT preserves the conformity of product during internal processing and delivery to the intended destination per procedure (PHT-P0020). This preservation includes identification, handling, packaging, storage and protection. Preservation also applies to the constituent parts of a product.

The organization ensures that documents required by the contract or order to accompany the product is present at delivery and is protected against loss and deterioration.

7.6. Control of Monitoring and Measuring Devices

PHT has determined the Inspection and Testing to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements. A documented procedure (PHT-P0022) outlines the process used to ensure that monitoring and measurement to be carried out are carried out in a manner that is consistent with the monitoring and measurement requirements.

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

Adjusted or re-adjusted as necessary Identified to enable the calibration status to be determined Safeguarded from adjustments that would invalidate the measurement result Protected from damage and deterioration during handling, maintenance and storage Be recalled according to a defined method when requiring calibration

In addition, Quality Assurance assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements. PHT takes appropriate action on the equipment and any product affected. Records of the results of calibration and verification are maintained PHT maintains a register of these monitoring and measuring devices.

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. PHT ensures that environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out.

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8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT: 8.1. General

PHT plans and implements the monitoring, measurement, analysis and improvement processes as needed.

To demonstrate conformity of the product, To ensure conformity of the quality management system, and To continually improve the effectiveness of the quality management system.

These processes are identified in documented procedures (PHT-P0024) and include determination of applicable methods, including statistical techniques, and the extent of their use for the inspection and testing of its products to assure that materials and products meet the specified requirements. Nonconforming lots are segregated whenever size permits, and dispositioned in accordance with Nonconforming Material Procedure (PHT-P0004). Incoming material is not used unless inspected, or otherwise approved as indicated by the ship to stock listing.

8.2. Monitoring and Measurement

8.2.1. Customer Satisfaction As one of the measurements of the performance of the quality management system, PHT monitors information relating to customer perception as to whether the organization has fulfilled customer requirements. The method for obtaining and using this information is identified in the Management Responsibility procedures (PHT-P0011).

8.2.2. Internal Audit It is the policy of PHT to insure that products throughout our plant conform to the quality standards and specifications required by our customers. Daily activities and processes must conform to documented procedures and meet the requirements of the International Standards Organization (ISO) series 9001 quality model and the AS9100 Aerospace Standard requirements. Internal quality audits are utilized to monitor and assess compliance and effectiveness. Internal auditors are selected and trained on applicable audit methods and operate independently of those who have direct responsibility of the area being audited. Audit activities are carried out in accordance with the Internal Audit Procedure (PHT-P0005).

Internal audits results are reviewed as a part of the management review process. The quality Manager maintains records of internal audits.

Audit results are recorded and communicated to the managers having responsibility for the area; it is their responsibility to correct deficiencies found during the audit. Audit summaries are forwarded to Management via Management Review. Follow-up audits verify the implementation and effectiveness of corrective actions.

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Detailed tools and techniques such as check sheets, process flowcharts, or any similar method to support audit of the quality management system requirements are developed, maintained and used according to the Internal Audit Procedure (PHT-P0005). The acceptability of the selected tools is measured against the effectiveness of the internal audit process and overall organization performance.

Internal audits meet contract and/or regulatory requirements.

8.2.2.1.Internal Audit Schedules PHT 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 and to the quality management system requirements established by the organization

Is effectively implemented and maintained. The Management Representative prior to the start of each calendar year develops a semi-annual PHT Master Audit Schedule. The PHT Master Audit Schedule is developed based upon inputs from the Plant Quality Assurance Manager. Internal audits are planned and conducted based upon the significance of the activity and past audit results. External auditors (consultants) meeting the requirements of PHT may be assigned to conduct these audits. Sufficient audits are conducted to provide a basis for evaluation of system effectiveness. All clauses of the quality system, on all shifts, are audited at least once each year. Audits are scheduled based on the status and importance of the activity or when internal or external non-conformances necessitate the need to increase frequency. The Quality Manager is responsible to coordinate the audit activity.

8.2.3. Monitoring and Measurement of Processes PHT applies suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action is taken, as appropriate, to ensure conformity of the product. In the event of process nonconformity, the organization:

Takes appropriate action to correct the nonconforming process, Evaluates whether the process nonconformity has resulted in product nonconformity,

and Identifies and controls the nonconforming produc