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etron e-tron systems cable harness wiring harness electrical assemblies mechanical assemblies electromechanical assemblies renewable energy wiring/cable assemblies solar cable assemblies automotive wiring harnesses medical wiring harnesses hospital power cordsQuality

E-Tron's Quality Assurance System is designed to meet or exceed your quality control requirements. Following we proudly present our ISO-9002 compliant Quality Manual.

We believe that quality begins and ends with the person doing the work. We focus on knowledge and training because if the assemblers as well as management are not focused on doing the work correctly any quality system is destined for failure. The second focus is on feedback from the customer to us and then to the assembler doing the work.

Equally important is response. If problems do arise - and we hope they don't - you can count on E-Tron to respond quickly and without question to problems, whether they are caused by our mistakes or by incorrect information that we have been given. We have been known to be at a customers door within an hour of a call with tools in hand and ready to correct the problem. We strongly believe in the old adage that "the customer is always right."

We are committed to providing you with the quality that you need.

QUALITY SYSTEM MANUAL

Revision Control History
1.0 Management Responsibility
2.0 Quality System
3.0 Contract Review
4.0 Design Control
5.0 Document and Data Control
6.0 Purchasing
7.0 Purchaser Supplied Product
8.0 Product Identification and Traceability
9.0 Process Control
10.0 Inspection and Testing
11.0 Inspection, Measuring and Test Equipment
12.0 Inspection and Test Status
13.0 Control of Nonconforming Product
14.0 Corrective and Preventive Action
15.0 Handling, Storage, Packaging, Preservation and Delivery
16.0 Quality Records
17.0 Internal Audits
18.0 Training
19.0 Servicing
20.0 Statistical Techniques


 
Revision Control History

REV
DATE
DOCUMENT NAME
DOCUMENT #
Orig
10-1986
Quality Manual
ETQM
G
10-15-98
Quality Manual
ETQM
Orig
07-14-99
Quality System Manual
ETQM9002


1.0 Management Responsibility

1.1 Quality Policy
1.1.1 This ANSI/ASQC Q9002-1994 compliant Quality System policy has been formulated by E-Tron System's Inc. Quality Assurance and approved by the General Manager. The policy is explained and discussed during general training given to all existing and new employees. The policy is posted in conspicuous locations throughout the company including the Corporate WEB page.

1.2 Responsibility and Authority
1.2.1 Director, Chief Financial Officer and General Manager are responsible for the overall establishment of the Quality Policy and for ensuring that the Management Team (Appendix A) understands, implements, and maintains the intent of the Quality Policy and Quality Systems Manual.
1.2.2 The Management Team is responsible for the development, implementation and effective operation of the Quality Management System. The quality requirements of the QMS are documented at various levels and reflect the Quality Policy and Quality Manual objectives.
1.2.3 Quality Assurance Director is responsible for verification of the effectiveness of the Quality Management System. The results of internal audits, corrective and preventive actions and other matters relevant to the Quality System will be reviewed by management and appropriate actions will be taken when required.
1.2.4 Quality Assurance Organization facilitates the development, implementation and continuous improvement of the Quality Management System. Quality Assurance possesses the independence and authority to stop shipment if deemed necessary. E-Tron employee's at all levels are responsible for initiating action which will remove or prevent nonconformity's in the product, process and Quality Management System in accordance with documented procedures.

1.3 Resources
1.3.1 E-Tron Systems is committed to providing adequate resources to ensure the success of our documented requirements.
1.3.2 The Management Team is responsible for ensuring that adequate resources for management, performance of work and verification activities are identified and communicated to the appropriate level of management.

1.4 Management Representative
Quality Assurance Director for E-Tron Systems has been designated by executive management as the management representative for our ANSI/ASQC Q9002-1994 compliant Quality System. The representative and their designated representative have the authority and responsibility for ensuring that the requirements of this standard are implemented and maintained. The Quality Assurance Director has the freedom and authority to:
• Initiate action to prevent product nonconformity.
• Identify and record any product quality problems.
• Initiate, recommend and provide solutions through designated channels.
• Verify the implementation of solutions.
• Control further processing, delivery or installation of nonconforming product until the deficiency or unsatisfactory condition is corrected.

1.5 Management Reviews
Management review meetings are conducted at a minimum once a year. The purpose of the review is to assess compliance with corporate policy, World class performance and continuous improvement. Management reviews will be chaired by the General Manager or his designee. Conclusions of the reviews are recorded. Detailed rules for scheduling, conducting, and recording management reviews are provided in the Management Review procedure.

1.6 Reference Documents
1.6.1 Management Review Procedure ETQM-part 7.0
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2.0 Quality System

2.1 General
E-Tron Systems Inc. is committed to an effective Quality Management System (QMS) based on the ANSI/ASQC Q9002-1994 "Quality Systems - Model for Quality Assurance in Design, Development, Production, Installation and Servicing." The Quality Policy (Figure 1) documents our objectives for quality and our commitment to meet or exceed our customer's needs. E-Tron's quality strategy is based on the following principals:
2.1.1 E-Tron Systems Inc. maintains a documented Quality Management System designed to meet the requirements of ANSI/ASQC Q9002-1994. It is through the implementation of this Quality Management System that our quality policy commitments are realized.
2.1.2 Through the use of documented repeatable processes, quality plans, corrective and preventive action, internal audits and effective management reviews, continuous improvement in service, reliability and network technology can be achieved by every E-Tron employee.

2.2 Quality System Documents
2.2.1 The Quality Management System is defined in the quality manual, procedures, instructions, product specifications, design engineering documentation, and quality control plans.
2.2.2 These documents collectively define a Quality Management System that complies with the ANSI/ASQC Q9002-1994 and identifies the methodology for implementing our quality policy commitments. Quality procedure ETQM-6, Record Retention, explains the purpose and the methods for controlling these documents.
 

2.3 Quality System implementation
2.3.1 All personnel who manage, perform, and verify work effecting quality are responsible for implementing the quality system. The Director of Quality or designee is responsible for coordinating, monitoring, and auditing the system.
2.3.2 Implementation of the quality system is assessed regularly by way of internal and external audits and management review.

2.4 Quality Planning
2.4.1 Requirements for quality are stated or referenced in the documentation that defines the Quality Management System. Within this system quality plans are used to meet specified requirements for new products, projects, and contracts.
2.4.2 Departments or individuals creating a quality plan are responsible for identify required resources, define standards, identify quality criteria, clarify verification methods, and define the necessary quality records.
2.4.3 Quality plans will be processed in accordance with ETQM-3.8 and 8.0.


2.5 Reference Documents
2.5.1 Drawing Control ETQM-3.8
2.5.2 New Processes ETQM-8.0

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3.0 Contract Review

3.1 General
Sales is responsible for defining and documenting the contract review and acceptance process. They are also responsible for the coordination of the activities involved. Sales orders are issued using E-Tron Systems part numbers (generally end Customer part numbers are used directly as E-Tron part numbers).

3.2 Review and Amendment
Sales reviews customer orders, verbal and documented, to confirm agreement to the requirements and ensure that they are adequately defined and documented prior to acceptance. Any variance or amendment to the original tender will be performed through the Change Order Process. All changes will be negotiated with the customer for resolution. The necessary resources will be used in coordination of these activities to ensure E-Tron Systems has the capability to meet specified requirements.

3.3 Administration
Sales and Sales Administration will coordinate the control and maintenance of quality records generated by contract review activities.

3.4 Reference Documents
3.4.1 Contract Review ETQM-5.0
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4.0 Design Control
4.1 Policy - E-Tron Systems Inc. does no product design, but strictly provides manufacturing services and products to customer-provided specifications, therefore, design control is not a specified requirement. When we use our expertise to make suggestions and design recommendations the customer remains solely responsible for the design of his product.
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5.0 Document and Data Control

5.1 General
5.1.1 The quality management system is defined in three levels. The levels are comprised of the Quality manual, procedures, instructions, product specific documents, design engineering documentation, control plans, and external standards.
5.1.1.1 Responsibility and methods for control and distribution of these documents is defined in ETQM-3.8 and 6.0.
5.1.2 Level one, two, and three documents collectively define a quality management system that complies with the ANSI/ASQC Q9002-1994 and identifies the methodology for implementing our quality policy commitments.

5.2 Document and Data Approval and Issue
5.2.1 Quality System Documents are reviewed and approved for acceptability by authorized personnel prior to distribution. Approval criteria is established for level one, two, and three documents. Master copies and current revision status are maintained in accordance with documented requirements.
5.2.2 Documents are distributed to personnel and locations where they are used. When appropriate and relevant, documents display a distribution list. Invalid or obsolete documents will be removed from points of issue and revised copies will be issued.


5.3 Document and Data Changes
5.3.1 Modification of any controlled document is evaluated prior to issue to ensure it is applicable, accurate and subject to approval by the same level of authority as the level of authority responsible for implementation. Changes to documents are identified and maintained.

5.4 Reference Documents
5.4.1 Drawing Control ETQM-3.8
5.4.2 Record Retention ETQM-6.0

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6.0 Purchasing

6.1 General
The Purchasing Department is responsible for defining and documenting the methods used to ensure that purchased product conforms to specified requirements. The procurement process is led by Purchasing and Material Acquisition Teams. They have the responsibility for providing material and services that meet agreed upon requirements, lead times, and pricing from approved suppliers based on the lowest total cost of ownership. Purchasing has the sole authority to make purchasing commitments for E-Tron Systems.

6.2 Evaluation of Subcontractors
Supplier base management is achieved through careful selection, continuous monitoring, and a comprehensive feedback loop consisting of Incoming Inspection history records, on-time delivery reports, financial stability, technology level, pricing, and supplier audits. The goal is to develop suppliers from full inspection status to Ship-To-Stock.

6.3 Purchasing Data
The Purchasing department will document each Purchase Order (PO) to assure that every requirement is clearly passed on to the supplier. Each PO for production material shall at a minimum contain:
6.3.1 A complete description of the product or service ordered including part number, revision, generic P/N (where applicable), and approved manufacturer.
6.3.2 Reference to all applicable specifications which pertain to the product ordered, such as: general specification for product class, packaging requirements, bar code specification, safety requirements, special testing requirements, and certificates of conformance, materials or process.
6.3.3 The title and revision of any applicable domestic, international, and/or government quality specifications which pertain to the product or service ordered.
6.3.4 Where applicable, the PO document is promptly sent to the supplier, with instructions to the supplier to review the PO documents and to sign and return the acknowledgment copy.
6.3.5 Purchase orders are be kept in the purchasing department while the order is active. Purchase orders may then be filed in storage in accordance with company requirements.
6.3.6 Purchasing documentation is reviewed and approved in accordance with Purchasing procedure ETQM-3.1.


6.4 Supplier Verification at Subcontractor's Premises
Where specified in the contract, E-Tron Systems will reserve the right to visit suppliers to verify purchased product. The method of verification and conditions of product release will be identified in purchasing documents.

6.5 Customer Verification of Subcontracted Product
Where specified in the contract with customers, E-Tron Systems will ensure the right of customer's or the customer's representative to visit suppliers premises and assess their capability to deliver quality products conforming to specified requirements.

6.6 Reference Documents
6.6.1 Purchasing Process ETQM-3.1
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7.0 Purchaser Supplied Product

E-Tron's main activities do not normally involve the use of customer supplied material. When required by contract, material is carefully controlled and protected as required by our Quality Management System procedures. In the event of material being damaged or lost, the customer is notified and agreed actions are taken.
7.1 Reference Documents - ETQM-3.2.4

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8.0 Product Identification and Traceability

8.1 E-Tron ensures material and products can be identified from receipt and during all stages of design, development production, delivery and installation. This is achieved by a unique assembly or part number that will be placed on the item, packaging, paperwork, or container.
8.2 Product racks in manufacturing are marked with traveler tags. If required by the customer, Traceability of assemblies is maintained through a serial number format in accordance with documented procedures. If required by the customer, Serial numbers are recorded and maintained per documented procedures at the end of the manufacturing process.
8.3 Identification of purchased material is achieved through labeling in accordance with documented procedures which may include E-Tron part number, manufacturer's part number, PO number, and quantity.

8.4 Reference Documents
8.4.1 Material Traceability ETQM-3.3.3
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9.0 Process Control

Process control begins with the formalization of product release packages. Operations Engineering identifies the resources and controls necessary to facilitate a new product introduction to manufacturing. The product release package represents the cumulative results of the production design process and is the basis for product characteristic requirements.
9.1 Activities performed by Production, Manufacturing Engineering, Process Engineering and Quality Assurance ensure that the product requirements are adhered to and sound quality practices are maintained. Production operators and supervisors, through compliance with manufacturing workmanship standards, assembly specifications and training, will exercise primary control over the manufacturing processes. Production operations follow the documented quality procedures, work instructions, and check sheets. In-process inspections, system audits, and testing occur throughout the production process to help assure quality of the product.
9.2 Process control parameters are identified and controlled by Quality Assurance and Process Engineering. These systems monitor the changes in the process and product quality while measuring the effectiveness of changes made to improve the process.
9.3 Installation and servicing activities are identified and documented were the absence of procedures would adversely affect product quality. Personnel involved in these activities receive training to supplement the process documentation. Customer installation is controlled through the use of manuals provided with the product.
9.4 Documented instructions are provided to personnel to assure process conformance and compliance to applicable standards and codes. The criteria for workmanship standards and assembly specifications are defined by written standards, photographs, engineering drawings, and visual aids.
9.5 The approval of new or modified processes and equipment is the responsibility of Process Engineering. When required, analysis and approval is performed.
9.6 Equipment maintenance is identified by Process Engineering to ensure continuing process capability. Studies are conducted, as necessary, to evaluate and improve the capability of meeting quality, workmanship, and continuous improvement objectives.
9.7 Processes that cannot be fully verified by subsequent inspection and testing of the product are documented and controlled. Special processes which require prequalification of capability and operational parameters will be defined and documented.

9.8 Process control requirements are defined in Process Control procedure ETQM-3.4.2 and 8.0.


9.9 Reference Documents
9.9.1 New Processes, ETQM-8.0
9.9.2 Job Instruction Detail Level, ETQM-3.4.2

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10.0 Inspection and Testing

10.1 General Product and material specifications are subject to inspection and testing. This verification is performed in accordance with documented Quality Procedures and instructions. Verification requirements are determined by Component Quality Engineering, Process Engineering and Quality Assurance.

10.2 Receiving Inspection and Testing
10.2.1 Material used in the manufacturing of products is subject to verification to the required specifications. Verification requirements are determined by Component Quality Engineering. Records are maintained in the Materials Quality Assurance Department.
10.2.2 Material which qualifies as a SSTs part shall be directed to the Raw Material Stockroom or production. Ship-To-Stock qualification is determined by the Material Acquisition Team responsible for the part and processed per documented procedures. Material Acquisition Team representation consists of Component Quality Engineering, Purchasing, and Inventory Control.
10.2.3 Where material is released for urgent use prior to verification traceability is maintained to ensure conformance to specified requirements.

10.3 In-process Inspection and Testing
10.3.1 In-process inspection and testing will be performed as required throughout the manufacturing process to establish product conformance.
10.3.2 All products are subject to final acceptance testing. Upon successful completion of final acceptance testing, the product will be marked using a stamp or label that can be traced to the individual who performed the test. Test stamps and labels are distributed and controlled in accordance with documented procedures.

10.4 Final Inspection and Testing
All finished products are subject to final inspection. Quality Assurance will audit for verification of completed functions such as receiving inspection, in process inspection, and all other inspections or tests including final that are performed. Only product which processed in accordance with Inspection and Test procedure ETQM-3.5 can be shipped.

10.5 Inspection and Test Records
Records clearly show acceptance, rejection or test results of product or material. Records generated identify personnel responsible for the release of product and are maintained in accordance with documented procedures, ETQM-6.0.

10.6 Reference Documents
10.6.1 Final Inspection ETQM-3.5
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11.0 Inspection, Measuring and Test Equipment

11.1 General
All inspection, test, and measurement equipment, including test software, used at E-Tron Systems in demonstrating the conformance of products or material to specified requirements, are uniquely identified and maintained in a known state of calibration.

11.2 Control Procedure
11.2.1 Calibrations are performed in accordance with documented procedures that ensure that the accuracy of the instruments calibrated is suitable to the tolerances being measured with the equipment.
11.2.2 Equipment is calibrated and used in controlled or monitored environments to ensure that valid measurements take place when verifying conformance to product specifications.
11.2.3 Calibrations are performed at defined frequencies and traceable to the National Institute of Standards and Technology where applicable.
11.2.4 Records of all calibrations, including the results obtained, are maintained.
11.2.5 Equipment failing, or found to be suspect in use, is withdrawn from use until re- calibration takes place. The validity of previous tests and inspections is to be assessed when equipment is found to be out of calibration, including whether re- test of product is necessary.

11.3 Reference Documents
11.3.1 Calibration Procedure ETQM-3.7
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12.0 Inspection and Test Status

12.1 The inspection and test status will be identified and maintained throughout production servicing of the product. This is defined in documented Quality Procedures and instructions to ensure that only product which has passed required inspections and tests is ultimately shipped to customers.
12.2 Nonconforming material is clearly identified and segregated.


12.3 Reference Documents
12.3.1 Inspection and Test Status ETQM-3.0
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13.0 Control of Nonconforming Product

13.1 General Quality procedures are in place to assure that all nonconforming products and materials are identified and segregated from conforming product or material and retained for disposition.
13.2 Review and Disposition of Nonconforming Material
13.2.1 Materials, components, or finished products suspected of nonconformance are identified and/or physically segregated (when practical) from conforming materials. Materials may become suspect at Incoming Inspection, raw goods inventory, during production, or in Finished Goods. Nonconformance may be discovered by routine inspection, testing, or other means.
13.2.2 Suspected nonconforming materials are evaluated and dispositioned by the Material Review Board (MRB) in accordance with documented procedures.
13.2.3 Material Review Board meetings are conducted by the MRB coordinator and held as needed. The MRB consist of representation from Purchasing and Management. When dispositioning material from Work-In-Process the responsible Manufacturing Engineer also has representation as required.
13.2.4 Material in the MRB hold areas shall not be removed until dispositioned by the MRB representatives. Material can be dispositioned as Scrap, Return to Vendor, Rework, or Use-As-Is. Material which is dispositioned REWORK, is subject to inspection after rework is performed.
13.2.5 Root-cause problems are identified and corrective actions taken as necessary to minimize recurrence of suspected and/or verified nonconformance.


13.3 Reference Documents
13.3.1 Control of Nonconforming Product ETQM-3.9
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14.0 Corrective and Preventive Action

14.1 Corrective action is taken to help assure identified problems are quickly resolved to minimize potential quality issues and implement permanent solutions. Corrective actions are issued, recorded, and verified in accordance with documented procedures.
14.2 Preventative action is taken to assist management in continuous improvement efforts. Preventative actions are issued, recorded, and verified in accordance with documented procedures.
14.3 Everyone in the organization is responsible for instituting, monitoring, or requesting corrective/preventative actions. Problems are evaluated for potential impact on production processes, safety, quality, performance, reliability, or customer satisfaction. Sources of data and information used in the evaluation may come from failure analysis results, manufacturing operations, or customers.
14.4 Problems are analyzed to determine whether immediate corrective action is required. Action may include production stoppage, shipping hold, stock purge, supplier hold, or product recall. Once immediate control action has been taken, the cause is analyzed to determine required corrective action. Short-term corrective actions may include customer notification, rework, or product screening. Long-term corrective actions include product redesign or production process revision.
14.5 After the cause of the problem has been identified, measures are also taken to prevent its recurrence. Nonconforming items are properly disposed of or corrected. The effects of these measures are audited to assure the desired goals are met and the permanent changes are in place, documented, and communicated.
14.6 Preventive actions plans will be created to address longer term trends as represented by quality related data.


14.7 Reference Documents
14.7.1 Corrective / Preventive Action ETQM-3.1
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15.0 Handling, Storage, Packaging, Preservation and Delivery

15.1 General
All material and product is handled, stored, packaged, preserved and delivered in a manner which prevents damage, deterioration, and contamination as defined in documented Quality Procedures.

15.2 Handling
Product handling is performed in a manner which prevents damage or deterioration. Personnel are instructed in proper methods of ESD control and general methods of handling in accordance with documented Quality Procedures.

15.3 Storage and Preservation
Raw material and Finished Goods are stored in appropriate areas, pending use on product assemblies or shipment to customers. Material is received, verified and dispatched from the stock areas as outlined in the Inventory Control and Finished Goods procedures.

15.4 Packaging and Delivery
Requirements for the proper packaging and identification of purchased material and products are defined and communicated to suppliers.
Products manufactured or assembled by E-Tron are packaged to prevent damage or degradation during normal handling and shipping operations. Packaging for finished products is sufficient to protect the item from damage during shipment.
Where contractual agreements exist, shipments are made according to specific customer instructions.

15.5 Reference Documents
15.5.1 Handling, Storage, Packaging, Preservation and Delivery ETQM-3.3 and 3.6
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16.0 Quality Records

16.1 Quality systems records are used to demonstrate the effectiveness of our overall Quality System and to ensure conformance to specified requirements. The Quality Director is responsible for the Quality Records System.
16.2 A written procedure shall exist that describes the collection, indexing, access, filing, storage, maintenance, disposition, and retention times of quality records. Quality records shall be legible, identifiable, and readily retrievable.
16.3 Statutory and Regulatory Agency records, and Vendor supplied records related to the quality of purchased goods shall be part of this system. Computer based records will also be backed-up according to the electronic data retention requirements.
16.4 Quality records will be made available to E-Tron customers when required.

16.5 Reference Documents
16.5.1 Quality Records Procedure ETQM-6.0
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17.0 Internal Audits

17.1 The compliance and effectiveness of the Quality System is verified by conducting internal quality audits on a regular basis. The results of these audits are used by management to identify the state of the Quality System.
17.2 Internal quality audits are performed by auditors who are independent of the product, process or system that is audited. Audits are planned and performed in accordance with documented procedures.
17.3 Records of all audits are maintained and reviewed with the responsible management personnel.
17.4 Nonconformances identified during the audit process will be issued corrective actions. These will be discussed and issued during the management review. Corrective action follow-up will be performed in accordance with documented procedures.

17.5 Reference Documents
17.5.1 Internal Audit Procedure ETQM-7.0
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18.0 Training

18.1 The methods established for identifying training needs and providing training for all personnel performing activities affecting quality are documented in Quality Procedures.
18.2 All personnel will have the necessary level of experience or training to enable them to undertake designated tasks competently. In-house training and certification, where specified, is provided. Where necessary, external training resources and facilities will be utilized.
18.3 Training records are maintained in accordance with documented procedures. Records are maintained for all training carried out on all employees, including internal, external, and on- the-job, courses attended, and the qualification, and certificates received.

18.4 Reference Documents
18.4.1 Training Policy ETQM-3.4.2
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19.0 Servicing

19.1 Servicing, as defined by the ISO-9002 standards, is not currently done by E-Tron Systems Inc.
19.2 E-Tron Systems Inc. does provide corrective action for it's own mistakes.

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20.0 Statistical Techniques

20.1 Identification of Need

20.1.1 Management will establish policy and direction for Statistical Process control implementation and maintenance. Management may consist of: Directors of Manufacturing or Engineering, Quality Assurance Director or their designee.
20.1.2 Statistical Control Techniques will be used throughout the manufacturing process as a method of determining material, product and process quality. An examination of the opportunity for Statistical Control Techniques will be performed as new processes are developed.

20.2 Procedures
20.2.1 Guidelines for the implementation of Statistical Control Techniques are defined and documented. Identification of statistical techniques that may be used, the basis for selecting each method used as well as a component for identifying when to use the method to verify customers needs will be defined. Training requirements for effective implementation of SPC techniques are supported by the Training department.

20.3 Reference Documents
20.3.1 Statistical Processes ETQM-3.4, 3.5, 6.0 and 8.0


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