AS9100

QUALITY MANUAL

PHT-M0001 Rev. H
Date: 11/30/10
Page: 1 of 47

Approved by: Ventura Mejia – Quality Manager

Serial # _______________

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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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Date: 11/30/10
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Table of Contents
1.0   GENERAL:  .....................................................................................................................................................  5  
1.1.  
1.2.  
1.3.  
1.4.  

QUALITY  MANUAL  APPROVAL  ......................................................................................................................  5  
REVISION  HISTORY  ........................................................................................................................................  6  
AMENDMENT  PROCEDURE  ............................................................................................................................  7  
DISTRIBUTION  LIST  .......................................................................................................................................  7  

2.0   QUALITY  VISION:  .......................................................................................................................................  8  
2.1.  
2.2.  
2.3.  
2.4.  

CORPORATE  VISION  STATEMENT  .................................................................................................................  8  
QUALITY  SYSTEM  PROCEDURES  ...................................................................................................................  8  
SCOPE  .............................................................................................................................................................  9  
EXCLUSIONS  ...................................................................................................................................................  9  

3.0   INTRODUCTION  TO  COMPANY  OPERATIOINS:  .............................................................................  10  

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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  

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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  

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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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PHT-M0001 Rev. H
Date: 11/30/10
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AS9100
QUALITY MANUAL
Approved by: Ventura Mejia – Quality Manager
1.0 GENERAL:

The purpose of this manual is to document the company’s quality system, to instruct and guide
employees whose actions affect product quality, and to inform the company’s 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.

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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

Rev.
Level

Date

Initial Release

A

1/11/95

Reason for Revision

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

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All

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

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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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AS9100
QUALITY MANUAL
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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.

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PHT will become a world-class provider of goods and services. We will focus on our customer’s
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.
AS9100
Quality Requirements

Quality Policy

Quality Manual

Procedures
Referenced by the
quality manual or other
level 2 procedures

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Level 0
Requirements

Level 1
Why

Level 2
Who, What, When, Where

Work Instructions

Level 3
How

Records Forms

Level 4
Evidence

AS9100
QUALITY MANUAL

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The quality system procedures used at PHT are structured to address the requirements of ISO9001 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.

2.3. Scope

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Level 4 - The forms used and the quality records produced by our defined system.

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 Customer’s, 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, PHT’s 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.

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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
company’s 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 company’s 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.

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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.

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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 PHT’s 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.

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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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Requirements

Process Flow Chart

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

Customer Service

Review of Requirements

7.4 Purchasing
7.4.5 Evaluation of Sub-Contractors

7.4.3
7.5.3
7.5.4
7.5.5

PHT-P0023

Verification of Purchased Prod.
Identification & Traceability
Customer Property
Preservation of Product

PHT-P0007 & 8

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7.2.2

Sales

PC&L

PHT-P0009

Receiving

Manufacturing

7.6 Control of Monitoring Devices
10.0 Control of Quality Records

Quality

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Request for Quote
Customer Communication
Customer Drawing Review PHT-F0045

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

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

Inspection Report PHT-F0038
Customer Property SimpleTrak

PHT-P0025

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

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

Evidence

PHT-P0016

PHT-P0001 & 2

Continual Improvement
PHT-P0003, 4, 5 & 6

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

Calibration SimpleTrak
Document Control SimpleTrak
ECN PHT-F0063

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

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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. PHT’s 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

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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 policy’s 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.”

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b. Documentation necessary to release the project to the “customer” may include, but is not
limited to, control plans, certifications, design documentation, FMEA’s, 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 PHT’s 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

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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
customer’s 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
company’s 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.

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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

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§ 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.

6.2.1. General

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6.2. Human resources

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 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. 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

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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

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▪ 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

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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 (PHTP0007).
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

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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 (PHTP0009).

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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.

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If PHT or the customer will perform verification at the supplier’s premises, the verification
arrangements and method of product release are documented in the purchasing information.
Where specified in the contract, the customer or the customer’s representative is given the right
to verify at the suppliers premises and organization’s premises that product conforms to specified
requirements.
7.4.3.1.Supplier Verification at Subcontractor’s Premises
When PHT intends to verify product quality at the supplier’s 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 subcontractor’s 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.

7.5. Production

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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. MSDS’s 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.

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

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▪ 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
Operating Procedure
Work Instructions
Documents of External Origin
Material Safety Data sheets

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Tooling Drawings
Customer Drawings and Specifications
CAM Database
CAD Database
Part Submittal and Approval Documentation

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Control Plans
Software for Process, Test and/or Inspection



Set-Up Sheets/Item Instructions
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.

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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
Organization’s Facilities
When planning to temporarily transfer work to a location outside the organization’s 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

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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 customer’s 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, FMEA’s, 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

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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.

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▪ 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

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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

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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

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▪ 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 product in accordance with clause 8.3.
The process for identifying and carrying out the required monitoring and measuring of processes
is documented in the Monitoring, Measuring and Analysis of Product Realization Processes
(PHT-P0023) and Management Responsibility procedures (PHT-P0011).

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8.2.4. Monitoring and Measurement of Product
PHT monitors and measures the characteristics of the product to verify that product requirements
are fulfilled. This is carried out at appropriate stages of the product realization process identified
in Monitoring, Measuring and Analysis of Product Realization Processes (PHT-P0023).
Evidence of conformity with the acceptance criteria is maintained. Records indicate the person
authorizing release of product. Product release and delivery does not proceed until all the
planned arrangements have been satisfactorily completed, unless otherwise approved by a
relevant authority, and where applicable by the customer.

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When key characteristics have been identified, they are monitored and controlled. PHT uses the
C=0 attribute sampling plan, when appropriate, to economically provide the company with a
reasonable amount of protection to assure good quality. The C=0 sampling plan may be used in
all phases of our operations, including receiving inspection, in-process inspection, and final
inspection. This supports our acceptance goal of zero defects. Non-Statistical Sampling Plans
are also used when appropriate process knowledge is available and documented. When other
acceptance criteria are established, such as the criteria associated with visual inspection, they are
documented and approved by the customer.
Product is not used until it has been inspected or otherwise verified as conforming to specified
requirements and completion of all required measurement and monitoring activities.
8.2.4.1.Inspection Documentation

Measurement requirements for product acceptance are documented. This documentation is part
of the production documentation, and includes:
▪ Criteria for acceptance and/or rejection,

▪ Where in the sequence measurement and testing operations are performed,
▪ A record of the measurement results, and

▪ Type of measurement instruments required and any specific instructions
associated with their use.
▪ Test records shall show actual test results data when required by specification or
acceptance test plan.
▪ Where required to demonstrate product qualification the organization shall
ensure that records provide evidence that the product meets the defined
requirements.
8.2.4.2.First Article Inspection
PHT provides a process for the inspection, verification, and documentation of a representative
item from the first production run of a new part, or following any subsequent change that
invalidates the previous first article inspection result.

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8.2.4.3.Receiving Inspection and Testing
PHT accomplishes Receiving Inspection in accordance with the requirements of (PHT-P0025).
The activities associated with receiving inspection will vary depending upon the type of material
received and the prior history of supplier/subcontractor performance. Materials on the ship to
stock program are inspected by QA on a non-statistical basis. Receiving inspection and testing
shall be in accordance with the appropriate Control Plan for the part or operation. Inspection
status is clearly identified on the inspection record.
• All incoming material is processed in accordance with the requirements contained in (PHTP0025). When receiving inspection is required such inspection shall be carried out in
accordance with appropriate work instructions.

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• The amount and nature of inspection for incoming material and components is based upon
the amount of control exercised at the subcontractor’s premises as well as our past experience
with the quality of a specific subcontractor. When source inspection is undertaken it is also a
factor in determining the amount of receiving inspection required.
• When incoming materials are released for urgent production purposes prior to completion of
receiving inspection, they will be positively identified and recorded in order to allow for an
immediate recall in the event of nonconformity to specified requirements.
8.2.4.4.Incoming Product Quality
Incoming material and components may be released for production purposes based upon one of
the following conditions.
• Receipt of statistical data from the subcontractor which indicates stable processes
for the features involved with Cpk’s of equal to or greater than 1.0.
• Receiving inspection and or testing. Once sufficient evidence of subcontractor
performance has been established, ship to stock status may be established.
• Second or third party assessments or audits of subcontractor sites when coupled
with records of acceptable quality performance.
• Part evaluation by accredited laboratories.
8.2.4.5.In-process Inspection and Testing
Both operators and quality assurance inspectors accomplish in-process inspection activities.
Inspections are carried out in accordance with the requirements specified on the appropriate
Control Plan. Records are maintained in accordance with documented work instructions.
Products will not move to the next operation until all the required inspection and testing has been
completed.
8.2.4.6.Final Inspection and Testing
Final inspections and tests are performed in accordance with a Control Plan. Final inspection
records provide evidence that products delivered to external customers comply with specified

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requirements. No product will be released until all required process and inspection procedures
have been satisfactorily completed and approved.
8.2.4.7.Layout Inspection and Function Testing
Appropriate layout inspection and function verification shall be performed for all products at a
frequency established by the customer. Appropriate records of these inspections/verifications
shall be maintained.
8.2.4.8.Final Product Audit
Final “Dock-Audits” is periodically undertaken of packaged product to verify conformance to all
specified requirements.

8.2.4.10.

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8.2.4.9.Inspection and Test Records
Receiving, in-process, and final inspection and test records, clearly show pass/fail to acceptance
criteria, and indicate person responsible for product release.
Supplier Laboratory Requirements

8.2.4.10.1. Laboratory Quality Systems
The PHT calibration laboratory shall develop and maintain laboratory-operating procedures.
Subordinate laboratory work instructions shall describe all laboratory policies, systems,
programs, procedures, instructions and processing of findings.
8.2.4.10.2. Laboratory Personnel
Current job descriptions for all laboratory personnel are maintained within the Human Resources
Department. Personnel assigned to laboratory positions shall have appropriate background and
experience to fulfill the requirements contained on these job descriptions.
8.2.4.10.3. Laboratory Product Identification and Testing
All PHT internal laboratories shall maintain documented procedures for the receipt,
identification, handling, protection and retention or disposal of test samples and/or calibration
equipment items, including all provisions necessary to protect the integrity of these items. Test
samples or calibration equipment shall be retained/controlled by the laboratory until final data is
complete and available. Data must be traceable from final data to raw data.
8.2.4.10.4. Laboratory Process Control
All PHT laboratories shall monitor, control, and record environment conditions as required by
relevant specifications or where they may influence the quality of results. Laboratory operating
procedures shall define the requirements for environmental conditions. Laboratory personnel
shall ensure these process control conditions are maintained as appropriate to the technical
activities concerned.

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8.2.4.10.5. Laboratory Testing and Calibration Methods
All PHT laboratory testing and/or calibration methods, including those for sampling, shall meet
the needs of the customer and be appropriate for the tests and/or calibrations being conducted.
Appropriate standards shall be established. Each laboratory shall verify its capability to perform
to these standards before carrying out laboratory tests and/or calibrations.
8.2.4.10.6. Laboratory Statistical Methods
Appropriate statistical techniques shall be used for verification activities when deliverables are
data. This includes the need for measurement system analysis associated with calibration
activities.

8.2.4.11.

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8.2.4.10.7. Accredited Laboratories
Effective on January 1st 2001, when PHT uses commercial or independent laboratory facilities
these laboratories shall be accredited. Accredited laboratories are those, which have been
reviewed and approved by a nationally recognized accreditation, body (e.g. American
Association for Laboratory Accreditation (A2LA or the Standards council of Canada SCC).
Control Of Inspection, Measuring and Test Equipment

8.2.4.11.1. General
All inspection, measuring, and test equipment used for any process monitoring is calibrated per
(PHT-P0021). Measurement uncertainty and capability is addressed by conducting Measurement
Systems Analysis. When required by the customer or customer’s representative, all pertinent
inspection, measuring, and test data will be made available for verification. PHT maintains a
system to control, calibrate and maintain appropriate Inspection, Measuring and Test Equipment
(IM&TE) used in inspection, testing, and manufacture of our products. This includes any
employee owned gages.
8.2.4.11.2. Control Procedure
Documented procedures defining the calibration or verification activities undertaken to confirm
the accuracy of measurement equipment are developed and maintained. Qualified personnel are
assigned the responsibility to review and approve such procedures. When Calibrations are
performed by outside service providers, the procedures used shall be subject to approval by PHT.
A computer based calibration system is used to record calibration histories and to provide recall
data for re-calibration activities. Measurement devices are labeled with appropriate stickers that
indicate calibration status. The control procedures established by PHT are defined in (PHTP0021).
a. During development of the control plan the specific measurements to be made and the
accuracy required are determined. Appropriate devices with the needed accuracy are then
identified.
b. All inspection, measuring and test equipment is logged.
c. The process employed for the calibration of inspection, measuring and test equipment is
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outlined in (PHT-P0021).
d. Calibrated equipment is identified with authorized calibration labels.
e. Records of calibrations are maintained in the Q.A. Department.
f. Any equipment found out of calibration will be reviewed by the Quality Department for
possible impact on product accepted with that equipment; appropriate corrective action and
customer notification are decided based upon this review.
g. A controlled environment is maintained for calibration of equipment.
h. The handling, preservation and storage of inspection, measuring and test equipment is
maintained. Records of training to these requirements are retained in the employee-training
log.
8.2.4.11.3. Calibration Services

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Calibration of PHT measurement devices may be conducted by an in-house laboratory meeting
the requirements of paragraph 8.2.4.10 Supplier Laboratory requirements, of this Quality Manual
or by accredited commercial/independent laboratories as defined by paragraph 8.2.4.10.7
Accredited Laboratories, of this Quality Manual. Customer-recognized government agencies
may also perform calibrations. The types of equipment to be calibrated by in-house or
commercial/independent laboratories or customer-recognized government agencies shall be
defined within the scope statement of laboratory operating procedures.
8.2.4.11.4. Inspection, Measuring, and Test Equipment Records
Records of calibration and verification activities are developed and maintained. The customer is
notified and records annotated to indicate when an out-of-tolerance condition might have
resulted in the shipment of suspect material. Calibration records provide evidence of gage
traceability to National Standards. Records include, out of specification readings as received for
calibration and statements of conformance to specification after calibration.
8.2.4.11.5. Measurement System Analysis
Measurement System Analysis is undertaken for each type of measuring system or device
referenced in the Control Plan. This analysis may include gage R&R studies when appropriate.
8.2.4.12.

Inspection and Test Status

8.2.4.12.1. General
All material is suitably identified throughout each stage of the manufacturing cycle. This
process is outlined in (PHT-P0022) Inspection and Testing to ensure only product that has passed
the required inspection and tests is dispatched, used, or installed. All Departments within PHT
are responsible for ensuring that products maintain identification of inspection and test status in
accordance with documented procedures. Only product that conforms to documented
requirements is released for further processing.
Inspection and Test Status is maintained during the manufacturing process through use of a
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Production Traveler, which travels, with each container of parts in accordance with the
requirements specified in Order Processing Procedure (PHT-P0008). Supplemental verification
or identification requirements such as “special lot” are used when required by the customer.
PHT does not use product location as a means of identifying the Test Status of product. All
product containers are identified with a Production Traveler that identifies the product and
indicates the current Test Status of product.
8.2.4.12.2. Supplemental Verification
When required by our customers, PHT uses supplemental verification processes such as early
launch controls, or those associated with DOE or first article inspection.
8.3. Control of Nonconforming Product

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8.3.1. General
PHT establishes and maintains procedures to ensure that product which does not meet the
customer's specifications is not used unless an exception is obtained and documented. Control of
nonconforming product will provide for identification, documentation, evaluation, segregation
when practical, disposition, and notification to areas affected. Shipment of material not
conforming to customer specification requires written authorization by the customer. All
nonconforming material shipped under the authorization of the customer is marked on the
shipping cartons.
8.3.2. Suspect Material or Product
Suspect material or product shall be treated in the same manner as nonconforming product.
8.3.3. Visual Identification
Each container of suspect or nonconforming material/product shall be visually identified with a
suitable label to clearly indicate its suspect/nonconforming status. When size permits these
containers shall be promptly moved to appropriate quarantine areas. All quarantine areas shall
be visually identified as such.
8.3.4. Review and Disposition of Nonconforming Product
Nonconforming material is defined as any material, whether purchased, or manufactured by
PHT, Inc., that does not meet the requirements of PHT or applicable customer specifications.
Non-conforming product is segregated, and dispositioned by a Preliminary Review Board (PRB)
as outlined in Nonconforming Material Procedure (PHT-P0004). Returned products are reviewed
to determine quantity and need for corrective/preventive action. The Preliminary Review Board
may disposition the product as Use-As-Is, Rework, Return To Vendor or Scrap. Product
dispositioned, as rework shall be re-inspected in accordance with the rework instructions and/or
documented procedures.
The Product Engineer prior to a disposition decision of “Use-As-Is” must approve that the
product conforms to customer requirements. Appropriate customer approved deviation or
waivers are required when less than full compliance is involved.
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8.3.5. Prioritized Reduction Plans
Defect codes are assigned to nonconforming product. Defect codes shall be quantified and
analyzed to establish a prioritized process to eliminate/reduce the causes of nonconformances.
The FMEA shall be reviewed as appropriate and revised when occurrence rates or detection
levels are different from those projected in the original FMEA. The Risk Priority Number (RPN)
of failure modes shall be consulted when establishing prioritized reduction plans. The plant
Quality Assurance Manger is responsible to ensure the development and implementation of these
plans.

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8.3.6. Control of Reworked Product
The rework of product shall be accomplished in accordance with Nonconforming Material
Procedure (PHT-P0004). Material Reject Reports are developed for all Nonconforming
products. Data is collected on Nonconforming product and is analyzed for corrective action
purposes. Customer approval for rework is obtained when appropriate; concessions are
documented and filed in accordance with appropriate procedures.
8.3.7. Engineering Approved Product Authorization
Shipment of nonconforming material requires written authorization by the customer, prior to
shipment. All material shipped under the authorization are marked on the shipping cartons to
identify the authorized shipments. PHT will assure compliance to the original specification when
the authorization expires. Records of customer authorizations (concessions) are maintained.
Deviations and Waivers shall be processed in accordance with documented procedures. When
product is being shipped under an authorized deviation or waiver, the plant Quality Assurance
Manager shall insure compliance with the original or superseding specifications and
requirements when the authorization expires. Product being shipped under an authorized
deviation or waiver shall display this fact on each shipping container.
8.4. Analysis of Data
PHT determines, collects and analyses appropriate data to demonstrate the suitability and
effectiveness of the quality management system and to evaluate where continual improvement of
the quality management system can be made. The process for determining, collecting and
analyzing this data is defined in the Management Responsibility procedure (PHT-P0011).
Appropriate data includes data generated as a result of monitoring and measurement and from
other relevant sources.
The analysis of data provides information relating to:
▪ Customer satisfaction
▪ Conformance to product requirements
▪ Characteristics and trends of processes and products including opportunities for
preventive action

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▪ Suppliers

8.5. Improvement
PHT maintains a Corrective/Preventive Action system, as outlined in (PHT-P0003), for the
investigation and correction of actual or potential non-conformities. Any employee may request
a corrective or preventive action.
8.5.1. Continual improvement
PHT 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.

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8.5.2. Corrective Actions
a. Customer complaints are recorded and reviewed to identify trends, and to assure that
corrective actions are effective in preventing re-occurrences.
b. Root causes of non-conformities, and potential non-conformities are investigated, and logged
into SimpleTrak in accordance with (PHT-P0003).
c. Responses to assigned CPAR’s, to eliminate the cause are conducted by utilizing a crossfunctional team approach.
d. The Quality Department verifies that the corrective action has been implemented, and is
effective. Changes to documented processes and procedures are recorded through the ECN
process.
8.5.2.1.Corrective Action Impact
When corrective actions are undertaken, it is the policy of PHT to evaluate whether or not the
action would be suitable for application to similar processes and products. The plant Quality
Assurance Manager in coordination with shall determine the appropriate extension of such
actions.
8.5.2.2.Problem Solving Methods
All corrective and preventive action systems are based upon a disciplined problem solving
approach. An 8D discipline, cross-functional style format has been implemented for Corrective
and Preventive Action Request (CPAR) investigation and response.
When external
nonconformances occur, the customer-supplied format will be adhered to when required.
8.5.2.3.Mistake Proofing
The PHT design and release to production methodology identifies opportunities for
implementation of simplified manufacturing processes, system lockouts, and other positive
methods of mistake proofing. These opportunities are refined during FMEA development and
advanced quality planning. Additional opportunities are identified by both process output data
and customer feedback. Unanticipated failure modes require the revision of the PFMEA and

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evaluation for mistake proofing to prevent reoccurrence. Mistake proofing methodology is used
to the degree appropriate for the CPAR process.
8.5.2.4.Returned Product Test/Analysis
Customer returns are evaluated and analyzed to prevent re-occurrence. The QA Department
maintains records of these reviews. When appropriate, PHT conducts tests/analysis of returned
product in an attempt to identify the causes of nonconforming material. These tests/analysis may
be conducted by internal or external sources.
8.5.3. Preventive Actions

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PHT determines action to eliminate the causes of potential nonconformities in order to prevent
the occurrence or reoccurrence of process problems identified. Information to support the
initiation of a preventive action can come from different sources, including; data obtained during
the corrective action process, review of quality records, customer complaints, historical trends,
and process problems. Preventive actions are appropriate to the effects of the potential problems.
A documented procedure (PHT-P0003) defines requirements for:

▪ Determining potential nonconformities and their causes

▪ Evaluating the need for action to prevent occurrence of nonconformities
▪ Determining and implementing action needed
▪ Records of results of action taken

▪ Reviewing preventive action taken

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9.0

HANDLING, STORAGE, PACKAGING, PRESERVATION
AND DELIVERY:
9.1. General

The handling, storage, packaging, preservation and delivery requirements of product are
accomplished in accordance with (PHT-P0020). These procedures are evaluated for effectiveness
by both inspection and internal audits. Product integrity is assured during all stages of
manufacture, inspection and test to prevent product damage or deterioration.
9.2. Handling

9.3. Storage

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PHT handles material and products in such manner as to prevent damage or deterioration during
storage, manufacturing, inspection, testing, packaging and delivery. Appropriate containers and
equipment are used to move product through the manufacturing process and to store work-inprocess as well as finished goods. Safety procedures are established and followed to prevent
injury to employees and to safeguard our products. Damaged containers are either repaired or
replaced. Only trained and/or certified employees operate transport equipment such as forklifts,
hoist, and dollies.

PHT utilizes designated storage facilities, stockrooms, and holding areas to prevent damage or
deterioration to components and products. Stockroom personnel assess the condition of product
in storage areas during cycle counting; any damaged or deteriorated product is handled in
accordance with (PHT-P0004). Receipt and dispatch authorization procedures exist in these
designated areas to ensure component and product integrity.
9.4. Inventory
All PHT inventories are managed to optimize inventory turns over time, assure stock rotation
and minimize inventory levels. Products are stored and released on a first-in-first-out basis,
except for product specifically designated for a customer or placed on hold. An MRP system is
used to manage inventory.
9.5. Packaging
Packaging methods are customer contract specified or developed by PHT. These methods
consider the type of product, environment, transportation methods and destination. Labels
meeting customer specific requirements are applied to finished goods. Packaging processes are
defined in (PHT-P0020), and lower level work instructions.
9.6. Customer Packaging Standards

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All customer packaging standards or guidelines are complied with, as applicable, and are made
available to appropriate personnel. The Engineering Department specifies packaging; and
customer service specifies marking requirements per customer and/or internal requirements.
9.7. Labeling
All customer packaging standards or guidelines are complied with, as applicable, and are made
available to appropriate personnel. Packaging and labeling requirements are evaluated during the
APQP process. Conformance to these procedures ensures that all materials shipped are labeled
according to customer requirements. Finished goods are labeled in accordance with specified
requirements.
9.8. Preservation

9.9. Delivery

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Methods for the preservation of material are used while under the control of PHT. Positive
activities such as shelf life constraints for both finished products and raw material inventory are
established and implemented. Preservation activities extend to our customer-supplied product
and related materials. Products or components with limited shelf life are identified to ensure
segregation from differing lots.

Delivery of product is accomplished in conformance with the customer’s contract specifications
or defined PHT delivery requirements. Delivery performance tracking is done to evaluate system
effectiveness and to meet customer on-time delivery requirements. Production Scheduling is
order driven, and lead times are established and maintained in accordance with (PHT-P0008)
Order Processing. When the customer does not specify delivery carrier requirements, delivery
services are selected from the record of approved carriers. Customer-specified delivery
requirements are documented on the sales order.
9.10.

Supplier Delivery Performance Monitoring

Customer delivery performance is monitored monthly, utilizing Dataflo to support 100% on-time
shipments. When delivery performance falls below 100% a corrective action to identify the root
cause for failed delivery performance will be issued. Records of premium freight costs are
maintained. Delivery performance is tracked using receipt history.
9.11.

Production Scheduling

Production scheduling activity is order driven; in the case of a ‘Demand Pull’; each lot will be
scheduled as supported by customer planning information, and shipped upon customer release
notification.

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10.0

CONTROL OF QUALITY RECORDS:

Quality Records are retained to demonstrate the achievement of specified requirements and to
show the effective maintenance of PHT's quality system. Records are suitably identified,
collected, indexed, accessed, filed, stored, maintained dispositioned in accordance with (PHTP0001).
10.1.

Record Retention

All records are stored in a manner that protects them from damage or deterioration. Retention
periods are established by PHT and/or as specified by contract requirements for each record and
all archived records are available upon reasonable notice.

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a. Production part approvals, tooling records, purchase orders and amendments are maintained
for one calendar year beyond the life of the component.
b. Quality performance records such as travelers, control charts and inspection records are
maintained for one calendar year after the year they are created.
c. Records of internal audits, corrective actions and management reviews are maintained for
three years.
d. Access to quality records is granted to the customer as required by contract or agreement.
e. Records of inspection and test are maintained for one calendar year after the year in which
they were created. This policy does not supersede any customer requirement.

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11.0

TRAINING:

PHT provides trained competent personnel at all levels of the organization. Training needs are
established and outlined in (PHT-P0035). Personnel performing specific assigned tasks where
their activities affect quality are trained to perform these functions.
PHT personnel are trained according to program and quality system needs.
All levels of Management are responsible to ensure that personnel under their control are
suitably trained to perform the tasks assigned to them. The relevant HR Department Manager
maintains training records in SimpleTrak for all personnel who influence the quality of PHT
products. Indirect employee’s training requirements are noted on the employee’s Personal
Performance Review form.
Training Effectiveness

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11.1.

Employee performance evaluations, audits, and training evaluation questionnaires are performed
to assure that qualifications and training remain effective, and to identify the need for any further
training.

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