Professional Documents
Culture Documents
QUALITY MANUAL
PHT-M0001 Rev. H
Date: 11/30/10
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Serial # _______________
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PHT
Quality Manual
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AS9100
QUALITY MANUAL
PHT-M0001 Rev. H
Date: 11/30/10
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AS9100
QUALITY MANUAL
PHT-M0001 Rev. H
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AS9100
QUALITY MANUAL
PHT-M0001 Rev. H
Date: 11/30/10
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Addendum to Quality Manual, titled AS9100 PHT Cross Reference Matrix is located in
SimpleTrak
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PHT-M0001 Rev. H
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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 companys quality system, to instruct and guide
employees whose actions affect product quality, and to inform the companys customers of
controls that are implemented to assure product quality, and fulfillment of the Quality Policy.
Precision Hermetic Technology, Inc. (PHT) has developed a quality management system to
improve the operations and management of the company and satisfy the needs of its customers.
The quality system is designed to operate within the requirements of ISO-9001:2008 and
AS9100 Revision B, all subsequent references to ISO-9001, and or AS9100 refer to these
revisions.
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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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AS9100
QUALITY MANUAL
PHT-M0001 Rev. H
Date: 11/30/10
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Revised
Page
Rev.
Level
Date
Initial Release
1/11/95
All
10/30/08
All
All
11/3/08
3.2
11
3/4/10
All
All
4/15/10
2.3, 2.4,
7.3, 7.5.1
8, 24
10/1/10
2.4, 4.2.4
5, 9, 13,
& 14
11/5/10
1.0, 2.4,
4.2.2,
8.3.4,
10.1
4, 5, 6
9,13, 14,
41, 47
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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AS9100
QUALITY MANUAL
PHT-M0001 Rev. H
Date: 11/30/10
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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
Approved by: Ventura Mejia Quality Manager
2.0 QUALITY VISION:
2.1. Corporate Vision Statement
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PHT will become a world-class provider of goods and services. We will focus on our customers
needs and strive for recognition in our industry as a distinctive and successful company. We will
employ processes kind to the environment and supportive of our employees & communities.
2.2. Quality System Procedures
The quality system is based on the requirements of this manual. The structure of the
documentation system is shown below. Quality system procedures reference the supporting
documentation that indirectly form a part of the quality system.
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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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 Customers, the qualification and or
validation is the Customers responsibility.
Paragraph 7.5.1.5 Service Provisions PHT does not provide aftermarket / warranty services for
their products.
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PHT initially began as an assembly plant with almost all components being purchased from
subcontractors, and although PHT experienced solid growth, Schachtel believed that the
companys potential was limited by its lack of vertical integration.
In 1994, Schachtel became president after buying out his remaining business partners. He
quickly focused on aggressively attracting long-term industry professionals and providing them
with the best possible tools for the job. As a result, the companys capabilities greatly expanded
over the next 10 years, growing from a handful of manual machines to more than a dozen CNC
machines in almost double the manufacturing space.
In December of 2004, PHT moved to its current 25,000 sq. ft. headquarters in Redlands, CA, and
currently operating two shifts with several dozen advanced CNC machine tools as well as a
variety of process equipment. We now manufacture virtually all of our component requirements
internally, and still continue to remain focused on developing new and better tools, continuous
process improvement, and expanding our capabilities.
We still have a significant focus on Military and Aerospace applications, yet serve a variety of
customers with an extremely diverse array of applications including spacecraft, military and
commercial aircraft, missile and defense systems, ship borne systems, semiconductors, industrial
process equipment, oil and gas industries, high reliability batteries, communications, cryogenics,
and medical, to name a few. We will continue to expand our capabilities in order to support new
and existing customers with an expanding range of products and solutions.
Our parts range in size from the size of a match head for a sensor application, to a two-foot
diameter bulkhead for use on the International Space Station. The one thing that all our products
share in common is that they are used in mission-critical applications. We recognize that
peoples lives often depend on the performance of our products, and it is a responsibility that we
accept with great pride.
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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;
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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 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
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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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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
PHT-P0007 & 8
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7.2.2
Sales
PC&L
PHT-P0009
Receiving
Manufacturing
Quality
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Customer PO
Contract Review PHT-F0001
Feasibility/Risk PHT-F0004
Sales Order PHT-F0009
Order Acknowledgement PHT-F0056
PHT-P0025
Evidence
PHT-P0016
PHT-P0001 & 2
Continual Improvement
PHT-P0003, 4, 5 & 6
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
AS9100
QUALITY MANUAL
PHT-M0001 Rev. H
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Management Responsibility:
5.1. Management Responsibility
PHT operates a quality system that meets the requirements of the International Quality
Standards ISO-9001 and the Aerospace Standard AS9100. PHTs top management has been
actively involved in implementing the quality management system (QMS). It has provided the
vision and strategic direction for the growth of the QMS, and established quality objectives and
the quality policy. The Management Responsibilities are documented in (PHT-P0011).
To continue to provide leadership and show commitment to the improvement of the QMS,
management will do the following.
Communicate the importance of meeting customer, statutory, and regulatory
requirements.
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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.
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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, FMEAs, production flows,
and procedures. The methods used for verification of the product or technology including
inspection methods and equipment are also defined and specified. Control systems, process
equipment and skills that may be required to execute new projects, currently not available,
are acquired in sufficient time to meet planned release dates.
c. PHT reviews the compatibility of designs, for our production processes, and our inspection
and test processes with applicable documentation.
d. The updating, as necessary, of the quality control, inspection, and testing techniques to
accommodate the output of a new technology, or the development of new techniques or
instrumentation.
e. The identification of any measurement capability requirement that exceeds PHTs current
standard, in sufficient time for the needed capability to be developed or acquired. (The cost
to develop or acquire this needed capability should be established at the outset, and
considered a cost associated with the new technology).
f. The identification of suitable verification data at appropriate stages in the development of
new product or processes.
g. The clarification of standards of acceptability for all features and requirements, including
those, which contain a subjective element.
h. The identification and preparation of quality records.
5.4.1. Quality Objectives
1. To obtain and retain certification to the AS9100 Revision C Specification.
2. To define measures of effectiveness for all clauses of our quality system and gather data to
effectively manage and improve these activities.
3. To satisfy all customer requirements and exceed their expectations whenever possible.
5.4.2. Quality Management System Planning
The quality system has been planned and implemented to meet our quality objectives and the
requirements of 4.1 of the AS 9100 standard. Quality planning takes place as changes that affect
the quality system are planned and implemented.
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Department managers are responsible to assure that their employees are adequately trained in the
policies, procedures, and work instructions pertaining to the employee's function. It is the
responsibility of all employees of PHT, Inc. to work within the established Quality System and
to comply with operating procedures and work instructions.
a. Authority has been given to PHT manufacturing and quality personnel to stop production
and to initiate action to prevent the occurrences of any nonconformity.
b. All supervisory personnel along with quality inspectors and internal auditors have been
given the authority and responsibility for the identification and recording of any problems
relating to the product, process or quality system.
c. Quality Assurance personnel and management personnel at all levels have been given the
authority to initiate, recommend or provide solutions through designated channels.
d. Quality Assurance personnel along with internal auditors verify the implementation of
solutions.
e. All personnel, whose work affects quality, are responsible to control further processing,
assembly, production or delivery of non-conforming product until the deficiency or
unsatisfactory condition has been corrected.
f. There are numerous positions throughout PHT where people have the responsibility to
represent the needs of our customers. These positions include Sales Personnel, Design
Team Personnel, Quality Assurance Personnel, Contract Review Personnel, Production
Control Personnel and Management Personnel at all levels. Employees with such
responsibilities must be honest and faithful in carrying out these activities. The selection
of PHT Special Characteristics, Quality Objectives, Training Activities, Corrective &
Preventive Actions, and Product and Tool Designs are undertaken with the best interests
of the Customer always the primary consideration. All personnel who represent the
customers needs are responsible to report to the management chain whenever the
execution of processes may be contrary to the needs and expectations of customers.
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5.6.1. 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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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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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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To ensure competence of our personnel, job descriptions have been prepared identifying the
qualifications required for each position that affects product quality. Qualifications include
requirements for education, skills and experience. Appropriate qualifications, along with
required training, provide the competence required for each position.
6.2.2. Competence, Awareness and Training
Qualifications are reviewed upon hire, when an employee changes positions or the requirements
for a position change. Department Managers maintain records of employee qualifications. If any
differences between the employees qualifications and the requirements for the job are found,
training or other action is taken to provide the employee with the necessary competence for the
job. The results are then evaluated to determine if they were effective. Training and evaluation
are conducted according to the Training Procedure (PHT-P0035).
All employees are trained on the relevance and importance of their activities and how they
contribute to the achievement of the quality objectives.
6.3. Infrastructure
To meet quality objectives and product requirements PHT has determined the infrastructure
needed. The infrastructure has been provided, and includes buildings, workspace, utilities,
process equipment and supporting services. As new infrastructure requirements arise, they will
be documented in quality plans. Existing infrastructure is maintained to ensure product
conformity.
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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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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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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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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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If PHT or the customer will perform verification at the suppliers premises, the verification
arrangements and method of product release are documented in the purchasing information.
Where specified in the contract, the customer or the customers representative is given the right
to verify at the suppliers premises and organizations premises that product conforms to specified
requirements.
7.4.3.1.Supplier Verification at Subcontractors Premises
When PHT intends to verify product quality at the suppliers premises, the purchase order shall
clearly specify the verification requirements, acceptance criteria, and release methods. Quality
records of source inspection shall be determined by the Quality Department and maintained in
accordance with appropriate procedures.
7.4.3.2.Customer Verification of Subcontracted Product
When customers of PHT have specified, in approved contracts, a right to inspect their product at
our facilities or those of our suppliers, any such verification that products are conforming, shall
not be used as the basis to determine our product quality. Such verification does not absolve
PHT or our suppliers of the responsibility to provide acceptable product or services. When
customers have indicated a requirement to inspect their products at the subcontractors premises,
PHT shall notify the supplier, and shall accompany the customer during the inspection.
7.4.4. Approved Materials for Ongoing Production
When our customers require that material or components be purchased from their approved
subcontractors, these subcontractors are added to our Approved Supplier Listing (ASL) and are
not changed without approval from the customer. Purchased materials are obtained from
suppliers on the ASL. Additional suppliers are only used after they have met the established
supplier approval process as outlined in the Supplier Quality Manual (PHT-M0003).
7.4.5. Evaluation of Subcontractors
The assessment and selection of a supplier is made based upon their capability to furnish
continuous delivery of quality products, materials or services to agreed upon requirements in a
cost effective manner. Terms and conditions for doing business with PHT are provided to all
subcontractors prior to completing purchasing agreements.
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7.5. Production
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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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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
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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7.5.1.6.Cleanliness of Premises
PHT employs a clean-as-you-go philosophy supported by facility janitorial staff. In addition,
general housekeeping and the work environment are evaluated, as a part of every internal audit to
insure it is suitable for the activity being undertaken.
7.5.1.7.Contingency Plans
Management has prepared appropriate contingency plans to address such things as utility
interruptions, labor shortages, and key equipment failures. These plans are designed to protect
the customers supply of product in the event of emergency. Contingency planning does not
include disruptions caused by natural disasters and acts of God. These plans are reviewed and
approved by appropriate personnel.
7.5.1.8.Designation of Special Characteristics
All Special Characteristics, as specified by our customers, are clearly identified on process or
assembly instructions, Control Plans, FMEAs, and related engineering documentation. The use
of Special Characteristic symbols is intended to focus attention on controlling the variation of the
labeled characteristic and to highlight the heightened concern for this feature. Customer
designated special characteristics that affect a product or process are identified, documented, and
controlled.
7.5.1.9.Preventive Maintenance
PHT maintains a preventive maintenance system that addresses the maintenance requirements
for plant and manufacturing equipment as well as the packaging/preservation of equipment,
tooling and gauging. The system includes schedules for maintenance, maintenance procedures
where necessary, predictive maintenance methods and the availability of replacement parts for
key manufacturing equipment.
7.5.1.10. Process Monitoring and Operator Instructions
Shop travelers, and work instructions are accessible within the work area for operators, who have
the responsibility for operation of processes. Process monitoring is conducted and recorded by
the accomplishment of first article, and in-process inspection, as defined in the control plan.
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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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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
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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.
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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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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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,
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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 subcontractors 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 Cpks 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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8.2.4.10.
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8.2.4.11.
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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 customers 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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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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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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8.5. 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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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:
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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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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.
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
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 employees training requirements are noted on the employees 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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