Quality Assurance

1.2 Quality Policy

The Quality Policy of Autoflex Systems, Inc. is to provide our customers with manufacturing equipment of the highest quality and reliability and, to assure that the equipment we provide has been designed, manufactured and documented in accordance with our customer's expectations and requirements.

1.3 Objectives

The general objective of this Quality Assurance Plan is to assure that general design, engineering, fabrication and programming methods and practices are adequate to produce quality manufacturing equipment.

1.3.1 General Plan Objectives

Objectives and requirements set forth in this document are intended to reflect minimal quality control criteria. Actual quality control requirements will be determined and performed on a project specific bases, as deemed necessary by the customer and by Autoflex Systems, Inc.

1.3.2 Specific Plan Objectives

The specific objectives of this Quality Assurance Plan are to:

• Assure that activities pertinent to the build life cycle of a machine are defined, documented and coordinated with customer specifications and regulatory requirements;
• Assure that all fabricated mechanical components of the machine are manufactured or in accordance with project specific engineering tolerances and specifications;
• Assure that all product critical instrumentation and/or control devices are identified and documented prior to fabrication.

2 Responsibilities and Organizational Structure

2.1 Organizational Structure

Autoflex Systems, Inc. operates as a consortium with other established entities to achieve the primary goal of providing quality industrial automation equipment and services to our customers. A consortium is:

• An association or a combination, as of businesses, for the purpose of engaging in a joint venture. The joint venture, in this case, encompassing and resulting in the design, engineering, fabrication, programming and/or integration of quality automated machinery and industrial equipment.
• An association of companies for some definite purpose
• A cooperative arrangement among groups or institutions.

Most equipment build requirements mandate the use of at least two primary disciplines, Mechanical Engineering and Electrical and/or Controls Engineering.

Autoflex Systems, Inc. partners with several entities and organizations to bring mechanical, electrical and software engineering expertise to our projects. Each project is evaluated at its conception and lead engineers are appointed per project specific requirements.

Some projects may require involvement by uniquely qualified personnel who specialize in applications and/or specialty sub-systems or machinery such as with lasers, welders, bowl feeders, etc. When projects require the use of such systems, Autoflex Systems, Inc. will draw on the equipment supplier's expertise to assure functional quality during integration with our equipment.

2.2 Quality Assurance Responsibilities

Quality is a top priority at Autoflex Systems, Inc. Consequently, it is an expectation that each and every associate involved with a project be aware that quality takes precedence over schedule and/or task oriented deadlines.

Autoflex Systems, Inc. encourages and expects pride in workmanship from all project associates. All personnel must perform to the highest level of integrity and professional competence, and be alert to problems that could compromise the quality of the end product. We practice open communications between associates of all disciplines as well as between associates and our customers.

Project leaders, as determined on a project specific basis, are responsible for compliance with this plan as well as with all quality procedures and documentation.

2.3 Mechanical Engineering

The lead Mechanical Engineer is responsible for:

• Assuring that generally acceptable mechanical design and engineering practices are utilized during the build life cycle of a specific project, including the incorporation all customer and/or government regulatory agency requirements.
• Defining project specific mechanical component tolerances and specifications;
• Approving project specific mechanical design and engineering packages;
• Generating and reviewing quality assurance documents pertinent to mechanical component tolerance and specification verifications;
• Assuring that quality control documents are utilized for fabricated mechanical component tolerance and specification verifications;
• Organizing and retaining all quality related documents pertinent to fabricated mechanical component tolerance and specification verifications.

2.3.1 Mechanical Fabrication and Assembly

Mechanical fabricators and/or assemblers are responsible for:

• Assuring all mechanical components are fabricated and assembled in accordance with engineering prints, bills of material and specifications.
• Assuring fabricated component tolerances and specifications are verified and are documented as compliant.

2.4 Electrical/Controls Engineering and Programming

The lead Electrical/Controls Engineer is responsible for:

• Assuring that generally acceptable electrical and controls design, engineering and programming practices are utilized during the build life cycle of a project, including the incorporation of all customer and/or government regulatory agency requirements.
• Documenting all project specific controls engineering and programming attributes.
• Approving project specific controls design, engineering and programming packages.
• Identifying and documenting product critical instrumentation and/or control devices.
• Generating and reviewing quality assurance documents pertinent to product critical instrumentation and/or control devices.
• Assuring that quality control documents are utilized for identified product critical instrumentation and/or control devices.
• Identifying, organizing, delivering and retaining all quality control documents pertinent to product critical instrumentation and/or control devices.

2.4.1 Control Fabricators and Assemblers

Controls fabricators and assemblers are responsible for:

• Assuring all control systems are fabricated and assembled in accordance with engineering prints, bills of material and specifications.

3 Training and Qualifications

3.1 Engineering Associate Qualifications

Autoflex Systems, Inc. manages projects such that project specific tasks are matched to engineering associates who have experience and qualifications pertinent to the tasks at hand.

All non-engineering associates are directly supervised, through all phases of a machine build, by project lead engineers.

3.1.1 Qualification Documentation

Qualification summaries and/or resumes of Engineering Associates will be retained on file.

3.2 Quality Assurance Plan and Procedural Training

Associate training with regard to this Quality Assurance Plan and all associated quality assurance, and other, procedures and/or documentation requirements will be documented on the Document Training Log.

4 Administration

Autoflex Systems, Inc., or its designees, will manage administrative activities associated with any given project.

5 Schedule of Machine "Build" Life Cycle

5.3 Project Kick-Off

Project leaders and customer contacts will be established after the receipt of an order.

5.3.1 Kick Off Meeting

A kick off meeting will be scheduled after an order is placed in order to review the requirements of the project and to build a team relationship between the project leaders and customer contacts.

5 Schedule of Machine Build Life Cycle

5.4 Project Design and Engineering

Autoflex Systems, Inc. will develop mechanical, electrical/controls and/or programming engineering packages to include top-level assemblies, sub-assemblies, electrical schematics, layouts, systems architecture plans, programming charts and/or Bills of Materials as required.

5 Schedule of Machine Build Life Cycle

5.5 Engineering Design Review

Upon completion of engineering packages, save detailing as deemed appropriate, a design review with project leaders and the customer will be scheduled.

A project Design Review Log will be utilized to document the design review.

5.5.1 Mechanical Design

All mechanical engineering drawings will be reviewed. Changes of any nature resulting from the design review will be recorded in minutes and distributed as required.

Mechanical design review issues will be recorded. Resolution of issues will be communicated to the customer upon completion.

5.5.2 Mechanical Component Detailing

Mechanical component detailing and subsequent releases to fabrication will resume after the design review.

5.5.3 Controls/Programming Design

All electrical engineering drawings and program related charts and/or strategies will be reviewed. Changes of any nature resulting from the design review will be recorded in minutes and distributed as required.

Controls/programming design review issues will be recorded. Resolution of issues will be communicated to the customer upon completion.

5 Schedule of Machine Build Life Cycle

5.5 Engineering Design Review

5.5.4 Instrumentation and/or Critical Control Devices

Instrumentation and/or control devices critical to product integrity and requiring integration into the customer's calibration and/or evaluation systems will be identified prior to, or during the design review.

These devices will be identified and documented on the project Design Review Log.

5.5.5 Design Review Signoff

Design review signoff by the customer will be documented on the project Design Review Log.

5 Schedule of Machine Build Life Cycle

5.6 Build Phase

After the design review signoff, machine component and sub-assembly detailing, procurement and fabrication activities will resume. Assembly will begin as soon as possible as components are procured.

5.6.1 Purchased Components

Project leaders are responsible for generating, reviewing and approving component purchase orders. Project leaders, or their designees, are responsible for receiving, inspecting, organizing and storing project specific purchased components.

5.6.2 Fabricated Component Procurement and Tolerance/Specification Verification

Project leaders are responsible for the issuance of detail drawings for fabricated components to fabrication personnel.

The issuing agent for the fabricated component detail drawing will verify compliance, and retain documentation of compliance with respect to the Fabricated Component Tolerance and Specification Verification Procedure.

5.6.3 Drawing and Specification Revision Control

Project leaders are responsible for charging out and controlling issuance and revisions of drawings and/or specifications.

5 Schedule of Machine Build Life Cycle

5.7 Machine Testing

Project leaders are responsible for defining, performing and documenting test procedures and protocols per customer specifications and project specific requirements.

Protocols and test procedures may include those required for:

• Machine Functionality Testing
• Software Functionality Testing
• Pre-Ship Factory Acceptance Testing
• Acceptance Testing At Customer Facility