vfd_qam_1-_aar_m-1003_rev_b_-_04_aug_2014

Vertex Rail Technologies LLC Quality Assurance Manual

QAM 1 Revision B Date of Issue: 04 Aug 2014

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VERTEX RAIL TECHNOLOGIES LLC

603 West Street Mansfield, MA 02048

QUALITY ASSURANCE MANUAL

IN ACCORDANCE WITH

ASSOCIATION OF AMERICAN RAILROADS

SPECIFICATION FOR QUALITY ASSURANCE M-1003

Quality Assurance Manual: QAM 01

Revision Level: B

Date of Issue: 4 August 2014



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REVISION HISTORY

Revision Change Date

A Original Issue 10 Feb 14

B Changed address and logo 04 Aug 14



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TABLE OF CONTENTS

1.0 Scope

2.0 Normative Reference

3.0 Terms and Definitions

4.0 Quality Management System

4.1 General Requirements – AAR M-1003 Sections 2.1, 2.2, 2.3

4.2 Documentation Requirements – AAR M-1003 Sections 2.7, 2.17

5.0 Management Responsibility – AAR M-1003 Section 2.4

5.1 Management Commitment

5.2 Customer Focus

5.3 Policy

5.4 Statement of Commitments

5.5 Quality Objectives

5.6 Quality Policy

5.7 Policy: Responsibility, Authority and Communication

5.8 Management Review

6.0 Resource Management

6.1 Provision of Resources

6.2 Human Resources – AAR M-1003 Section 2.22

6.3 Infrastructure – AAR M-1003 Section 2.15

6.4 Work Environment

7.0 Product Realization

7.1 Planning of Product Realization – AAR M-1003 Sections 2.23, 2.5

7.2 Customer-related Processes – AAR M-1003 Section 2.23, 2.5

7.3 Design and Development – AAR M-1003 Section 2.24

7.4 Purchasing – AAR M-1003 Section 2.9

7.5 Production and Service Provision – AAR M-1003 Sections 2.13, 2.14,

2.15, 2.16

7.6 Control of Monitoring and Measuring Devices – AAR M-1003 Section 2.8

8.0 Measurement, Analysis and Improvement

8.1 General

8.2 Monitoring and Measurement – AAR M-1003 Sections 2.10, 2.11, 2.12, 2.21,

8.3 Control of Nonconforming Product – AAR M-1003 Section 2.18

8.4 Analysis of Data – AAR M-1003 Section 2.20

8.5 Improvement – AAR M-1003 Section 2.6



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1.0 Scope:

1.1 General: This manual is issued and implemented to consistently provide quality product

meeting customer contractual, standards, or regulatory requirements. Its aim is continual

improvement and customer satisfaction. Changes and additions mandated by the addition of

AAR Specification M-1003 will be italicized. All additions dealing with ASME requirements

are identified as such. All revisions made to update the system to reflect actual current

practices will be listed in the revisions section.

1.2 Application: This manual applies all the processes defined by The ASSOCIATION OF

AMERICAN RAILROADS.

2.0 Normative Reference:

ASSOCIATION OF AMERICAN RAILROADS SPECIFICATIONS: M-1003, M-1002, M-

1001, S-2034

3.0 Terms and Conditions:

Terms and definitions per specifications cited above.

The Supply Chain is: supplier >>> organization >>> customer

Definitions: The organization is the entity producing product to the customer. The supplier is

a subcontractor or vendor supplying product or services to the organization.

4.0 Quality Management System:

4.1 General Requirements:

4.1.1 Purpose: Vertex Rail Technologies, LLC has developed this quality manual to establish,

document, implement, maintain, and continually improve its quality management system per

the requirements of the Association of American Railroads, M-1003.

4.1.2 Scope: This manual defines the program established regarding all activities at Vertex Rail

Technologies, LLC that directly affect the quality of our processes and products.



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4.1.3 Policy: The quality management system established puts the organization’s activities under

control by to produce quality products by: (a) identifying and applying the processes required,

(b) determining their interrelationships, (c) establishing criteria and methods to ensure process

effectiveness, (d) sufficiently documenting and communicating necessary data, (e)

monitoring, measure and analyze processes, and (f) taking action to achieve planned results

and continual improvement of processes. Outsourced processes that effect product

conformity, such as sub-contracted finishing operations or machining, are controlled under the

purchasing requirements of an approved supplier and are subject to qualification and

evaluation required of all suppliers.

4.1.4 Responsibility: All employees and suppliers in their area of control.

4.1.5 Reference: AAR M-1003, Vertex Rail Technologies, LLC SOP 3 specifically, and third level

forms and records in general.

Documentation Requirements:

4.2.1 Purpose: This policy is to ensure that that all documentation and data used by the quality

management system is controlled, reviewed /approved, and released for use.

4.2.2 Scope: This documentation and data includes all quality management system documentation

including documented statements of quality policy and objectives, the quality manual,

standard operating procedures, any other internal and external documents to ensure planning,

operation and control, and required records.

4.2.3 Policy - General:

4.2.3.1 Vertex Rail Technologies, LLC: has established a quality manufacturing system and the

organizational structure and resources to support it. The system consists of this quality

manual, secondary standard operating procedures and third level product centered procedures,

instructions and forms. Implementation is achieved by adherence of all employees to this

manual, documented procedures, and work instructions and forms. To ensure the

effectiveness of the established quality management system, quality audits of the quality

system are performed and documented. Vertex Rail Technologies, LLC has established a

system and procedures for quality planning to ensure that all products are manufactured in

accordance with all customer drawing, specifications and requirements. Quality planning

shall include a documentation of manufacturing/servicing and quality controls, processes,

testing, possible problem areas, verification hold points, acceptance standards, and record

requirements.

4.2.3.2 Vertex Rail Technologies, LLC: has documented and implemented a company slogan, quality

policy and quality objectives, which form the core of the quality management program at

Vertex Rail Technologies, LLC. These are detailed in section five of this manual and in

separate signed statements.



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4.2.4 Policy – Quality Manual: This quality manual has been established to outline the scope of the

quality management program at Vertex Rail Technologies, LLC documenting any exclusion,

referencing any secondary operating procedures and additional documentation, and describing

the various responsibilities involved.

4.2.5 Policy – Control of Documents: Documents utilized by the quality management system as

delineated above in paragraph 4.2.2 are controlled by approval, review, revision status,

availability for use, legibility and identification, and distribution Vertex Rail Technologies,

LLC has established and maintains procedures for the control of all documents and data.

These documents are reviewed and approved for adequacy by authorized personnel prior to

issue. The documents are made available to operations as required to ensure the proper

functioning of the quality system. Obsolete documents are properly identified and controlled.

Changes and revisions to documents are reviewed and approved by the same functional

groups or personnel that performed the original review and approval, unless designated

otherwise. The changes are identified on the original document or on appropriate change

authorizing approval documents. Documents shall be re-issued after a practical number of

changes have been made.

All documents and data are maintained in English both in hard copy form and by means of

electronic media. Master data lists and/or files are maintained to identify the current revision

of documents. At a minimum of once yearly, all documentation in the QMS shall be reviewed

and updated as needed by the management team to ensure relevancy in all areas of the

program and to foster continual improvement. All changes shall be examined closely to

ensure that only positive results are achieved.

4.2.6 Policy - Control of Records: Records are established and maintained to facilitate ease of

retrieval, minimize deterioration or damage, and to prevent loss. Records are legible,

identifiable and easily retrievable. Records are made available to customers as specified by

contract or regulation. Records shall be further controlled by procedure to control

identification, storage, maintenance, and retrieval. Records shall be maintained and stored as

hard copy and by electronic media. The records retention list shall denote record location and

guardian.

4.2.7 Responsibility: The Management Team consisting of the Chief Executive Member, Quality

Assurance Manager, and Operations Manager shall be responsible for the implementation of

this manual in its entirety. The Chief Executive Member of Vertex Rail Technologies, LLC,

shall retain ultimate responsibility for its successful execution.

Reference: Vertex Rail Technologies, LLC QM 2.1.3



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5.0 Management Responsibility

5.1 Purpose: This policy is to ensure that the management team at Vertex Rail Technologies, LLC

is completely committed to the development and implementation of the quality management

program at Vertex Rail Technologies, LLC, focusing on a determination of customer

requirements leading to complete customer satisfaction.

5.2 Scope: This policy includes all facets of the quality management system at Vertex Rail

Technologies, LLC.

5.3 Policy: Management Commitment and Customer Focus - The Chief Executive Member of

Vertex Rail Technologies, LLC has directed and given complete authority to the Quality

Assurance Manager to assume responsibility for the quality system implementation.

5.4 Statement of Commitments: We believe that…

Customer satisfaction can only be attained through continual improvement.

Our employees are experts in their particular line of work and as such are empowered to make

product quality decisions.

Vertex Rail Technologies, LLC is committed to nurturing professional development through

training and education.

World class quality is attainable by aligning the interest of customers, Employees and other

stakeholders through teamwork, open lines of communication and the constant measuring and

monitoring of business parameters.

Quality Objectives:

Customer satisfaction rating: + 90%

On time Delivery rating: + 90%.

Cost of Quality < 2%



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COMMITMENT AND AUTHORITY

The Chief Executive Member of Vertex Rail Technologies, LLC is committed to the continual

implementation of this Quality Assurance System and has delegated complete authority to the Quality

Assurance Manager to insure full compliance with, and proper implementation of, all systems

prescribed by this manual. The Quality Assurance Manager is committed to fulfilling all

responsibilities and duties delegated by this authority.

Donald G. Croteau Brian McAuliffe

Chief Executive Member Quality Assurance Manager

Vertex Rail Technologies, LLC Vertex Rail Technologies, LLC

The Quality Assurance Manager working in conjunction with the Chief Executive Member and

Managers of Vertex Rail Technologies, LLC have the authority and responsibility for ensuring that

the quality management system mandated herein is developed, implemented and maintained and shall

report status to the Managing Director for review and improvement; informally as needed and

formally during Management Review meetings. The QMS documentation shall be reviewed yearly at

a minimum by the Management Team.

The system is maintained by the quality management organization. The managers are responsible for

implementing and communicating the quality system in their departments to their employees.

Responsibility may be delegated to subordinates as required, but the delegator retains ultimate

responsibility. It is the responsibility of the Management Team of Vertex Rail Technologies, LLC to

create a system and an environment that supports the ongoing development and improvement of our

quality policy and quality objectives, and records are kept of the results and verification of the work

being performed. A special focus is made to ensure customer requirements are determined and

fulfilled to ensure customer satisfaction.

The Managing Director is ultimately responsible for ensuring that all employees are aware of the

importance of the development and implementation of the quality management system and

continuous improvement; the conducting of quarterly management reviews; adherence to quality

policy, quality objectives and management reviews; the maintenance of adequate resources; and the

communication to all the importance of fulfilling all statutory and regulatory requirements.



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5.6 Quality Policy: Vertex Rail Technologies, LLC has adopted a Quality Policy that is

appropriate to purpose of Vertex Rail Technologies, LLC and acts as the driver for the quality

management system. The Quality Policy initiates general goals to fulfill the requirements of

the quality management system, to achieve customer satisfaction and continuous

improvement, and a framework for establishing specific quality objectives. The quality policy

is subject to regular review to determine continued appropriateness. Vertex Rail Technologies,

LLC quality policy statement is as stated in Vertex Rail Technologies, LLC “Statement of

Commitments”.

5.6.1 Quality Objectives: To fulfill the goals set forth in our quality policy, Vertex Rail

Technologies, LLC has established measurable quality objectives, derived from the tenets set

forth in the quality policy. The quality objectives are developed from the various facets and

levels of the quality management system and are stated in Vertex Rail Technologies, LLC

“Statement of Commitments”. Additionally a slogan has been adopted to symbolize Vertex

Rail Technologies, LLC major drive. The slogan is as follows:

“RAILCARS SOLUTIONS”

5.6.2 Quality Management System Planning: Personnel so stated in the various quality documents

implement and maintain the quality management system. Personnel responsible for the

successful achievement of quality objectives are designated by procedure. This planning and

the results are reviewed as part of the management review input process. Any changes in the

Quality Management system are reviewed prior to implementation by the Management Team

to ensure that the integrity of the system is maintained.

5.7 Policy: Responsibility, Authority and Communication –

5.7.1 The Management Team: ensures that all personnel responsibilities are defined and

communicated by the quality manual, secondary standard operating procedures, and with a

personnel responsibilities matrix.

5.7.2 Management Representative: The Quality Assurance Manager of Vertex Rail Technologies,

LLC has appointed an official management representative for the quality management system

who ensures quality management system is established, implemented, maintained on a

continual basis, and reviewed for effectiveness at defined internals. The Management

Representative reports status and need for improvement to top management, and ensures

awareness of customer requirements to all personnel including suppliers.



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The Management Representative manages the corrective/preventive action programs that

work to prevent non-conformances and when they occur, ensues that nonconforming material

is segregated and initiates actions to ensure they are prevented from reoccurrence.

Additionally, the effectiveness and sustainability of all corrective/ preventive actions are

monitored to ensure continued compliance.

The Quality Assurance Manager is the Management Representative.

5.7.3 Internal Communication: Effective communication of the requirements of the quality

management system is done by strict implementation of provisions in the quality manual,

secondary procedures, and instructions and forms. All personnel are thoroughly trained in

their individual areas of responsibility and these responsibilities are documented on each

individual’s responsibilities sheet. Effective communication is achieved with daily verbal and

written communication between individuals and groups, weekly production meetings, and

quarterly review meetings. During this process all employees are instructed to remember that

at no time should quality assurance requirements be subordinated to manufacturing processes.

The Management Team periodically reviews the status of human resource requirements

against existing needs in all areas – management, production, inspection and test and training

– to determine adjustments that need to be make to ensure the work force is adequate.

5.7.4 Responsibility: The Management Team

5.7.5 Reference: Vertex Rail Technologies, LLC SOP 2.4, second level procedures in general.

5.8 Policy: Management Review

5.8.1 Purpose: This policy is to ensure that Vertex Rail Technologies, LLC conducts quarterly

management reviews of the quality management system to ensure its suitability, adequacy,

and effectiveness; to assess opportunities for continual improvement; to examine the

appropriateness of the system including the quality policy and quality objectives.

5.8.2 Scope: The entire quality management system is subject to review and change to effect

customer satisfaction through continuous improvement.

5.8.3 Policy: The Management Team examines the quality management system utilizing proscribed

review inputs as evaluation tools and issues review outputs to initiate actions for system

upgrades. Inputs and outputs include but are not limited to the following:

(a) Review inputs: results from internal and supplier audits; customer feedback ( from

customer satisfaction surveys, report cards, returns, verbal and written complaints, etc.); the

record of process performance and product conformity; results of quality objectives; status

preventive and corrective actions; action items results from previous reviews; appropriateness

of the quality management system; changes in the QMS and its quality policy and quality

objectives; and general recommendations for improvement from any source.



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(b) Review outputs: results from the analyzing of review inputs result in action items to improve the

quality management system and processes; improve product conformity; and fulfill resource needs.

5.8.4 Responsibility: The Management Team shall be responsible the management review process.

5.8.5 Reference Documents: Vertex Rail Technologies, LLC SOP 2.4

6.0 Resource Management

6.1 Provision of Resources

6.1.1 Purpose: This policy is to ensure that Vertex Rail Technologies, LLC has and maintains the

resources required to maintain the quality management system, effect continuous

improvement, and provide complete customer satisfaction.

6.1.2 Scope: This policy applies to all activities affecting customer product or services.

6.1.3 Policy: Vertex Rail Technologies, LLC shall encourage excellence in all members of our

organization. We will continually improve the methods we employ in marketing,

manufacture and service of our products to ensure industry leadership. This policy shall be

integrated and implemented through an active involvement by the entire organization. Our

ultimate goal is the absolute and complete satisfaction of our customers.

6.1.4 Responsibility: The Management Team

6.1.5 Reference: Vertex Rail Technologies, LLC SOP 2.4

Human Resources

6.2.1 Purpose: This policy is to establish and maintain procedures for the training and qualification

of Vertex Rail Technologies, LLC employees to ensure that work is competently executed.

6.2.2 Scope: This policy applies to all activities affecting customer product or services. It applies to

general training of quality requirements and specific training for special or key processes (e.g.

welding) and periodic evaluation of training effectiveness.

6.2.3 Policy: Management shall give our employees the resources, training, and support to provide

our customers with quality products and services that meet or exceed their expectations. This

quality manual supported by second level procedures and third level instructions and forms

will provide the framework and tools to implement a sound quality system. On a regular

basis, employees shall be made aware of the importance of their contributions to the

overall success of Vertex Rail Technologies, LLC achievements. Notification shall be made

via personal contract, memos and bulletin board postings.



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The Pre-Hire Evaluation Report determining if the applicant meets competency requirements

of Vertex Rail Technologies, LLC shall be used to evaluate prospective employees prior to

employment.

Personnel employed in special or key processes shall be qualified by function-specific training

and by work experience to achieve qualification status.

Training records are maintained of all training and evaluations.

6.2.4 Responsibility: Manufacturing Manager, Shop Foreman


Infrastructure and Work Environment

6.3.1 Purpose: This policy shall ensure machinery and equipment used to manufacture product and

effect servicing at Vertex Rail Technologies, LLC is properly maintained and serviced to

prevent failure during the manufacturing or servicing process, resulting in possible non-

conformances, delays and other detrimental effects. Additionally it shall ensure that all

work areas are maintained to create a safe and productive work environment.

6.3.2 Scope: This policy includes all machinery, equipment and work areas used to manufacture

products or effect servicing at Vertex Rail Technologies, LLC.

6.3.3 Policy: Elements of Maintenance Function: Maintenance personnel shall at a minimum be

responsible for the following: a) determining all machinery and equipment maintenance and

servicing requirements based on the manufacturer's recommendations and good maintenance

practices; b) develop complete maintenance and servicing schedules based on the

requirements delineated above; and c) ensure that all maintenance and servicing is performed

and properly documented.

Documentation: To provide adequate records of maintenance and servicing requirements all

machinery and equipment shall have individual written maintenance and servicing

requirement sheets with maintenance and servicing documented with appropriate sign-off

and dating.

6.3.4 Policy: Work Environment: All work areas shall be kept neat and clean to create a safe and

productive work environment. Individual employees shall be responsible for maintaining

their individual work areas.

6.3.4 Responsibility: Manufacturing Manager, Shop Foreman

6.3.5 Reference: Vertex Rail Technologies, LLC WIP 2.15-04, F 2.15-09, & F 2.15-11



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7.0 Product Realization

7.1 Planning of Product Realization

7.1.1 Purpose: This policy is to establish a procedure within the quality/manufacturing system

to provide for the planning of processes to achieve product realization.

.

7.1.2 Scope: This policy applies to all contracts that affect the manufacturing/servicing of products

produced by Vertex Rail Technologies, LLC.

7.1.3 Policy: The planning of product realization consists of the development of a Quality Plan to

determine product quality objectives and requirements, establish processes, resources,

documentation, and verification and validation techniques necessary to effect successful

completion of the work, and provide records as evidence that all product realization

requirements are realized. The Engineering and Production Packages provide for the

development of the contract review and Quality Plan report, development of shop drawings,

documents establishing manufacturing sequence and quality control hold points (Job

Travelers); and reports verifying inspection and testing activities.

The Inspection & Test Plan is encapsulated in the Shop Traveler and any related inspection /

test reports mandated by the traveler. Hold points are indicated to ensure inspection and test

requirements are satisfied before additional work is performed.

7.1.4 Responsibility: Project Manager and Quality Assurance Manager


7.1.6 Attachment: All forms associated with review, engineering, production, and inspection

activities.

7.2 Customer-Related Processes:

7.2.1 Purpose: This policy is to establish criteria to determine and review product requirements.

7.2.2 Scope: This policy extends to all product produced by Vertex Rail Technologies, LLC.

7.2.3 Policy:

7.2.3.1 Determination of Requirements: During contract review and Quality Plan development

process, Vertex Rail Technologies, LLC determines customer contractual requirements

including delivery requirements, mandated statutory and regulatory requirements, scope of

any ambiguous customer intended needs, and clarifies any additional requirements prior to

commencement of work.



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7.2.3.2 Review of Requirements and customer communication: Once the requirements are

determined, the contract review and Quality Plan development continues by defining

requirement scope, resolving any conflict between quote and contract, and reviewing ability

to effect successful completion of the contract. During contract requirements definition and

review an effective communication system is established with the customer to address

product information, changes, and complaints. Any changes or proposed made during the life

of the contract are subject to the same planning of product realization and determination /

review of requirements.

7.2.4 Engineering Processes: After the contract has been reviewed, Vertex Rail Technologies, LLC

thoroughly studies contract specifications and drawings to produce detailed shop drawings

used by production to manufacture the product. In many cases customer drawing approval is

required. The Engineering function closely monitors the progress of the contract with all of

Vertex Rail Technologies, LLC associated departments to ensure successful completion of the

contract.

7.2.5 Responsibility: Project Manager & Engineering Manager


7.3 Design and Development:

7.3.1 Design Inputs: Design personnel define design inputs from customer, potential customer or

authority defining product. Designer(s) conduct preliminary design reviews with customer

or authority as needed to ensure inputs are properly defined.

7.3.2 Design Outputs: Designer(s) formulate design concepts and design details including

drawings, calculations, material and processing requirements and any other essential

components to satisfy design inputs. During this design process, technical reviews are held

as necessary to ensure outputs will satisfy inputs and design release reviews to ensure the

design is suitable for manufacture. Once the design components are complete and prior to

release, all aspects are subject to through checking to remove any potential issues.

7.3.3 Design Verification & Validation: Prior to manufacture when required and/or mandated,

critical design reviews are held by the customer or authority and VRT management to verify

that the design outputs meet the requirements of design inputs and validate as much as

possible intended use. During this stage, the Factory Acceptance Test (FAT), and when

feasible, the Site Acceptance Test (SAT) are developed and issued for review and approval.



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7.3.4 Design Verification and Validation Tests: After completion of manufacture, product is

subjected to the factory acceptance test (FAT) to verify that the finished product does meet

acceptance criteria mandated by the design outputs and when feasible that intended use has

been validated. The FAT consists of two sections – an instrumentation qualification (IQ) and

an operational qualification (OQ) – to verify and validate design success.

7.3.5 Design Changes: During both the design and manufacturing processes, all changes shall be

identified and documented. Changes shall be subject to the same reviews, verification,

validation and approval processes as the original design. When applicable, the changes shall

be evaluated against existing and previously delivered product.

7.3.6 Responsibility: Engineering Manager


7.4 Purchasing

7.4.1 Purpose: Vertex Rail Technologies, LLC shall ensure that purchased products and services

conform to specified requirements and shall monitor and control suppliers as required to

achieve acceptable results.

7.4.2 Scope: This policy applies to purchased products intended for use that affects the

manufacture and servicing of products produced or serviced by Vertex Rail Technologies,

LLC.

7.4.3 Policy: Vertex Rail Technologies, LLC shall establish and maintain a purchasing system to

ensure that purchased products conform to specified requirements. Purchasing documents

will contain data that clearly describe the product ordered, any approval processes, personnel

qualifications, and quality management system requirements as appropriate.

Suppliers shall be selected and evaluated on their ability to meet contractual requirements as

specified in documents. Criteria shall be established for the evaluation of vendors, both new

and existing. Records shall be maintained of acceptable suppliers. The selection of

suppliers, and the type and extent of control executed by shall be based on the type of

product, and when appropriate, on records of their previous performance and/or

demonstrated capabilities.

Vertex Rail Technologies, LLC shall establish inspection or other verification measures as

necessary to ensure that purchased product or services meet purchase order requirements.

Where specified by contract, Vertex Rail Technologies, LLC, its representative, or Vertex

Rail Technologies, LLC customer may require the right to verify at source or upon receipt

that purchased product conforms to specified requirements. Verification by Vertex Rail

Technologies, LLC will not absolve the supplier of the responsibility to provide acceptable

product nor will it preclude subsequent rejection.



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When verification is required, such as source inspection at a vendor’s facility by Vertex Rail

Technologies, LLC or it’s designated representative, the product verification will not be used

by Vertex Rail Technologies, LLC as evidence of effective control of quality by the vendor.

Material and product verification from vendors if not otherwise inspected shall be subject to

incoming quality inspection on receipt and prior to any processing.

7.4.4 Responsibility: Purchasing Manager


7.5 Production Provision Vertex Rail Technologies, LLC: does not provide service activities.

7.5.1 Purpose: This policy shall ensure that production/servicing processes that affect product

quality and customer satisfaction are identified, planned and carried out under controlled

conditions. These processes shall be subject to validation processes to ensure that incoming

products, in process and finished products are inspected or otherwise verified as conforming

to specified requirements.

Product identification including unique identification where applicable and product status

shall be established and maintained through all stages of production and delivery including

proper care of customer property.

Product shall be preserved and maintained during internal processing and delivery by system

for handling, storage, packaging, preservation, and delivery to ensure product conformity.

Vertex Rail Technologies, LLC shall determine monitoring and measurement required to

produce evidence of conformity of product to customer and regulatory requirements and

monitoring and measuring devices required to achieve required evidence.

7.5.2 Scope: This policy shall apply to all processes used to produce products manufactured by

Vertex Rail Technologies, LLC. Procedures shall ensure that all measures that affect quality

are identified, planned and carried out under controlled conditions. All inspection and test of

products shall be identified as requiring inspection by purchase order, work in process and

finished product as mandated by instructions and quality plan. Vertex Rail Technologies,

LLC does not provide servicing of product.

7.5.3.1.2 Control of Production and Process Validation Provisions

7.5.3.1.2.1 Policy: Vertex Rail Technologies, LLC identifies and plans production processes to ensure

that they are performed under controlled conditions. Process planning includes

comprehensive receiving procedures, documented work instructions, use of suitable

production equipment, a suitable working environment and requirements for compliance to

applicable standards, codes and quality plans. Production processes are monitored and



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controlled after they are approved for use. Production equipment is monitored and

maintained to sustain product quality in accordance with a written preventive maintenance

procedure.

Criteria for workmanship are stipulated where possible in written standards or by

representative samples.

Special processes, where results cannot be fully verified by subsequent inspection and testing,

are qualified and continuously monitored. Compliance with documented procedures is

verified to ensure that specified requirements are met.

Records of qualified processes, equipment and personnel are maintained as appropriate to

meet the requirements of pertinent codes, standards, and specifications. If special processes

are not covered by existing codes, standards or specifications, adequate qualifications will be

established to ensure acceptable product is produced.

Records of system or technical approvals are maintained. Internal audits or checklists are

completed per system requirements and made available for review.

Inspection: Verification activities are to ensure that all requirements of the Quality Plan are

met without exception. Inspection and test activities are performed during all phases of the

production process prior to receipt by suppliers & sub-contractors, receipt inspection, in-

process inspection and test during the production process and final inspection before

shipment. All of these inspections and tests are performed to verify that all required work has

been performed and to validate that the finished product satisfies contractual obligations.

Inspection Status: In addition to inspection status being documented on the job traveler,

additional marking or tagging will be employed to further identify the inspection status of in

process product.

Statistical / Sampling Methods: Where and when applicable, statistical methods and

sampling plans are developed to evaluate and control process variability.

7.5.3.3-4 Product Identification and Traceability Including Customer Property

7.5.3.3-4.1 Policy: Materials affecting product quality are identified from applicable drawings,

specifications or other documents upon receipt. Products are tracked throughout the

production process. Products for delivery are clearly identified. Where required by contract

or regulation, materials or products are labeled to ensure traceability to the original supplier.

Records of identification and traceability are maintained per pre-established retention

periods, or as otherwise required by contract or regulation. Customer supplied property is

identified, verified, stored and maintained for use similar in manner to Vertex Rail

Technologies, LLC purchased property except additionally identified as Customer supplied.



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Lost, damaged or otherwise unsuitable product shall be reported to the customer and

corrective action requested.

7.5. 3.5 Preservation of Product

7.5.3.5.1Policy: Vertex Rail Technologies, LLC has established documents and maintains a

procedure for handling, storage, packaging preservation and delivery of products.

Vertex Rail Technologies, LLC provides material storage areas to prevent damage or

deterioration of product pending use or delivery. Vertex Rail Technologies, LLC has

established and maintains methods for authorizing receipt and the dispatch of product to and

from material storage areas. The conditions of product in inventory shall be assessed at

appropriate intervals in order to detect deterioration when applicable.

Vertex Rail Technologies, LLC controls packing, preservation and marking processes of

materials used that affect quality of product for delivery in order to ensure conformance to

specified customer requirements. Vertex Rail Technologies, LLC identifies preserves and

segregates product from time of receipt until its responsibility ceases. Preservation applies to

constituent parts of a product.

Vertex Rail Technologies, LLC has established and maintains procedures to ensure the

protection of the quality of product after formal inspection and test. Where required by

contract this protection is extended to include delivery to destination.

7.5.4 Responsibility: Manufacturing Manager & Quality Assurance Manager

7.5.5 Reference: Vertex Rail Technologies, LLC SOP 2.16.

7.5.6 Control of Monitoring and Measuring Devices

7.5.6.1 General: Vertex Rail Technologies, LLC shall determine monitoring and measurement

required to produce evidence of conformity of product to customer and regulatory

requirements and monitoring and measuring devices required to achieve required evidence.

This policy applies to the monitoring and inspection devices used to verify the manufacture

or servicing of product produced by Vertex Rail Technologies, LLC. Vertex Rail

Technologies, LLC shall exercise sufficient control over all measurement systems used in the

development, manufacture and servicing of product to provide confidence in decisions or

actions based on measurement data. This control shall be extended over monitoring and

measurement devices.

7.5.3.6.2 Policy: New equipment shall be initially calibrated prior to first use; placed under

automatic periodic recall for adjustment, repair and/or re-calibration; identified as to

calibration status; and protected from unauthorized adjustments and damage. Records of this



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activity will be maintained including methods utilized and traceability to standards of

known accuracy such as the National Institute of standards and Technology (NIST). When

monitoring and measuring devices are found out of calibration, the impact on product and

services performed shall be determined and action may be taken to correct any potential

nonconformance. When used as a monitoring or measurement tool, the effectiveness of

computer software shall be validated prior to use.

7.5.6.3 Responsibility: Quality Assurance Manager

7.5.6.4 Reference: Vertex Rail Technologies, LLC. SOP 2.8

8.0 Measurement, Analysis and Improvement

8.1 General

8.1.1 Purpose: This policy shall ensure that monitoring, measuring, analysis and improvement

processes are planned and implemented throughout the manufacturing cycle at Vertex Rail

Technologies, LLC to effect product acceptability, system conformity, customer satisfaction

and continual improvement.

8.1.2 Scope: This policy applies to all manufactured products produced or serviced by Vertex Rail

Technologies, LLC and all quality systems utilized by Vertex Rail Technologies, LLC during

the manufacturing cycle.

8.1.3 Policy: Vertex Rail Technologies, LLC shall define and implement monitoring, measurement,

analysis and improvement activities as part of the manufacturing quality plan. These

activities shall include the monitoring and measurement of customer satisfaction (compliant

logs, surveys), internal audits (quality system effectiveness), monitoring and measurement of

processes (special testing techniques such as non-destructive testing – visual inspection,

radiography, bore-scope inspection), monitoring and measurement of product (incoming, in

process, and final inspection), and control of nonconforming product. The data collected

using statistical techniques where applicable shall be analyzed to determine the effectiveness

of the quality management system and action to be taken to improve product conformity and

foster continual improvement. Continual improvement shall be implemented in part by

corrective and preventive action.

8.1.4 Responsibility: Quality Assurance Manager, Management Team

8.1.5 Reference: Vertex Rail Technologies, LLC. SOP 2.20

Monitoring and Measurement

8.2.1 Purpose: This policy is to verify extent of customer perception as to Vertex Rail

Technologies, LLC performance acceptability, conducts scheduled internal audits, and



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monitor and measure quality system processes and product realization to verify criteria

against planned results.

8.2.2 Scope: This policy applies to all activities at Vertex Rail Technologies, LLC affecting product

quality and quality system compliance.

8.2.3 Policy: Customer Satisfaction: Vertex Rail Technologies, LLC monitors its customer’s

perception to determine if their requirements have been met by:

(a) Reviewing each customer’s sales orders at a minimum of quarterly to determine quality,

delivery and cost results. This review is documented on the “Customer Satisfaction

Sheet”.

(b) Contacts each customer active minimally semi-annually.

(c) Either verbally or in writing to determine customer’s degree of satisfaction. This semi-

annual review is documented on a “Customer Satisfaction Sheet”.

The results of this review are forwarded to the Management Team for evaluation during the

quarterly management reviews.

8.2.4 Policy: Internal Audits

Vertex Rail Technologies, LLC has established and maintains procedures for conducting

internal quality audits and any follow-up action required. Audits shall be scheduled on the

basis of the status and importance of the activity. Personnel independent of the area being

audited shall conduct audits. Auditors shall received basic training in auditing procedures

and techniques and shall work from an audit plan.

The results of audits shall be documented and brought to the attention of the responsible

personnel in each area audited, and to the executive management of Vertex Rail

Technologies, LLC. Management personnel for each area are responsible for effecting timely

corrective action of audit deficiencies.

Internal quality audits shall be conducted on the entire quality management system at a

minimum of once yearly with critical and any problem areas examined more frequently. To

meet AAR Requirements, the QASE checklist is used to verify complete compliance.

8.2.5 Policy: Monitoring and Measurement of processes and product – During the product

realization process, Vertex Rail Technologies, LLC maintains process control by monitoring

the various processes used: material identification, assembly, welding, polishing, and

finishing by visual and measuring device inspection. Vertex Rail Technologies, LLC

maintains product control with receiving, in process and final inspection. Records of all these

controls are maintained.



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8.2.5.1 AAR Policy: Inspection status is maintained by the use of travelers accompanying the

product and by the use of tags or marking to further identify inspection status.

8.2.5.2 Responsibility: Quality Assurance Manager, Internal Audit Team

8.2.4.4 Reference Documents: Vertex Rail Technologies, LLC. SOP 2.21

Control of Nonconforming Product

8.3.1 Purpose: This policy is to establish a system for the control and disposition of nonconforming

material.

8.3.2 Scope: This policy applies to all products or materials for use in products manufactured /

serviced by Vertex Rail Technologies, LLC.

8.3.3 Procedure: Vertex Rail Technologies, LLC has established and maintains procedures to

ensure that products that do not conform to specified requirements are prevented from e or

delivery. Controls exist that provide for identification, documentation, evaluation,

segregation and when practical, disposition of nonconforming products, and for notification

to the appropriate functional groups. Discovery after delivery is investigated to determine

extent of possible nonconformance.

Personnel review any nonconforming product with authority for disposition and in

accordance with documented procedures. It may be reworked or repaired, used as is, or

scrapped. Where required be contract, the proposed use or repair of a product, which does

not conform to the specified requirements, is reported for evaluation to the customer. The

description of any nonconformity that has been accepted, and of any repairs, is recorded to

denote the actual condition. Repaired and reworked product is re-inspected in accordance

with documented procedures.

8.3.4 AAR Nonconforming Requirements: Non-conformances occurring on product

manufactured IAW AAR requirements shall be processed complying with Chapter 7 of M-

1003 using the forms and procedure outlined.

8.3.5 Responsibility: Quality Assurance Manager,


8.4 Analysis of Data

8.4.1 Purpose: This policy is to provide for the collection of data to determine effectiveness of

quality system and identification of areas for effecting continuous improvement.



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8.4.2 Scope: This policy applies to all relevant documentation and data collected during the

performance of the quality management system.

8.4.3 Policy: Vertex Rail Technologies, LLC has a procedure to collect and analyze data produced

by the quality management system established and implemented on a continual basis. The

data is collected and analyzed to provide information concerning customer satisfaction,

product conformity, and opportunities for preventive action, supplier status.

8.4.4 Responsibility: Management Team, Quality Assurance Manager

8.4.5 Reference Documents: Vertex Rail Technologies, LLC SOP 2.20

Improvement

8.5.1 Purpose: This policy is to ensure that a system exists for corrective and preventive action.

8.5.2 Scope: This policy applies to (a) nonconforming products or materials incoming, in process,

or finished that affect quality and (b) unfinished products or materials where potential

problem areas could affect quality.

8.5.3 Policy: Vertex Rail Technologies, LLC has established documents and maintains procedures

for:

(a) Continual improvement: using the data collected by quality policy, quality objectives,

supplier evaluations, internal audits, analysis of data, corrective and preventive action, and

management reviews, the Management Team is committed to proactively pursuing continual

improvement and documenting the results.

(b) Corrective action: investigating the cause of nonconforming product and the corrective action

needed to prevent re-occurrence; applying controls to ensure that corrective actions are taken

in a timely manner and that they are effective; implementing and recording changes in

procedures resulting from corrective actions to internal audit findings; and submittal of

corrective action for management review.

(c) Preventive action: initiating preventive actions to deal with problems to a level corresponding

to the risks encountered; analyzing processes, work operations, concessions, quality records,

corrective actions, and customer complaints to detect potential causes of nonconforming

product; initialing any actions to prevent potential non-conformances from occurring; and

reviewing such actions for effectiveness; and submittal of preventive action for management

review.

8.5.4 Responsibility: Management Team, Quality Assurance Manager
