us 13 quality manual qa

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QUALITY MANUAL

NUMBER: QPM001 REV. O 11/06/12 Page 1 of 47

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Elma Electronic Inc.

QUALITY MANUAL

ISO 9001:2008 ; AS9100C

This manual is governed by comprehensive documentation as referenced herein.

Procedures, practices, forms, drawings, and similar documentation used in the Elma

organization that directly or indirectly influences the processes that affect product

quality, are formally documented and controlled. All such documents are contained in

a quickly identifiable, easily accessible QMISSystem -ELMAs intranet based Quality

Management Information System at any work station.

Customers and Partners are welcome to download the actual Quality Manual from our

Homepage at:

HTTP://WWW.ELMA.COM


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QUALITY MANUAL ISO 9001-2008 & AS9100 REV C

NUMBER: QPM001 REV O Page 2 of 49

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BACK TO TABLE OF CONTENTS

Table of Contents

0 INTRODUCTION .................................................................................... 5

1.0SCOPE .................................................................................................. 61.1 GENERAL............................................................................................. 61.2 APPLICATION........................................................................................6

2.0NORMATIVE REFERENCE ...................................................................... 8

3.0TERMS, ABBREVIATIONS AND DEFINITIONS........................................ 8

3.0.1 QPM (Quality Program Manual) ................................................... 83.0.2 QMIS (Quality Management Information System) .......................... 83.0.3 EESP (ELMA ELECTRONIC STANDARD PROCEDURE) ...................... 83.0.4 EF (ELMA FORM) ....................................................................... 8

3.0.5 Supply Chain ............................................................................84.0QUALITY MANAGEMENT SYSTEM .......................................................... 8

4.1 GENERAL REQUIREMENTS......................................................................... 84.2 DOCUMENTATION REQUIREMENTS............................................................. 11

4.2.1 General ..................................................................................... 11Applicable Documents 4.2.1 .................................................................. 12

4.2.2 Quality Manual ........................................................................... 124.2.3 Control Of Documents ................................................................. 14

4.2.3.1 General ............................................................................... 144.2.3.2 Document And Data Approval and Issue.................................. 144.2.3.3 Document And Data Changes ................................................ 14

4.2.4 Control Of Records ..................................................................... 15Applicable Documents Chapter 4 ........................................................... 16

5 MANAGEMENT RESPONSIBILITY ........................................................ 16

5.1 MANAGEMENT COMMITMENT.................................................................... 165.2 CUSTOMER FOCUS............................................................................... 175.3 QUALITY POLICY.................................................................................. 175.4 PLANNING......................................................................................... 18

5.4.1 Quality Objectives ...................................................................... 185.4.2 Quality Management System Planning .......................................... 19

5.5 RESPONSIBILITY,AUTHORITY AND COMMUNICATION....................................... 19

5.5.1 Responsibility and Authority ........................................................ 195.5.2 Management Representative ........................................................ 205.5.3 Internal Communication .............................................................. 21

5.6 MANAGEMENT REVIEW........................................................................... 215.6.1 General ..................................................................................... 215.6.2 Review Input ............................................................................. 225.6.3 Review Output ........................................................................... 22


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Applicable Documents Chapter 5 ........................................................... 23

6 RESOURCE MANAGEMENT ................................................................... 23

6.1 PROVISION OF RESOURCES..................................................................... 236.2 HUMAN RESOURCES............................................................................. 23

6.2.1 General ..................................................................................... 236.2.2 Competence, Awareness and Training ........................................... 23

6.3 INFRASTRUCTURE................................................................................. 246.4 WORK ENVIRONMENT............................................................................ 25


7 PRODUCT REALIZATION ..................................................................... 26

7.1 PLANNING AND PRODUCT REALIZATION....................................................... 267.2 CUSTOMER RELATED PROCESS................................................................. 28

7.2.1 Determination Of Requirements Related To The Product .................. 287.2.2 Review Of Requirements Related To The Product ............................ 287.2.3 Customer Communication ........................................................... 29

Applicable Documents Chapter 7.1 & 7.2 ................................................ 297.3 DESIGN AND DEVELOPMENT.................................................................... 30

7.3.1 Design And Development Planning ............................................... 307.3.2 Design And Development Inputs .................................................. 317.3.3 Design And Development Outputs ................................................ 327.3.4 Design And Development Reviews ................................................ 327.3.5 Design And Development Verification ............................................ 327.3.6 Design And Development Validation.............................................. 327.3.7 Design And Development Design Changes ..................................... 33

Applicable Documents Chapter 7.3 ........................................................ 337.4 PURCHASING...................................................................................... 34

7.4.1 Purchasing Process ..................................................................... 347.4.2 Purchasing Information ............................................................... 357.4.3 Verification of purchased product ................................................. 35

Applicable Documents Chapter 7.4 ........................................................ 357.5 PRODUCTION AND SERVICE PROVISION...................................................... 36

7.5.1 Control Of Production And Service Provision .................................. 367.5.2 Validation Of Processes For Production And Service Provision. .......... 387.5.3 Identification And Traceability ...................................................... 397.5.4 Customer Property ..................................................................... 407.5.5 Preservation Of Product............................................................... 41

7.5.5.1 Handling ............................................................................. 417.5.5.2 Storage ............................................................................... 417.5.5.3 Packaging............................................................................ 417.5.5.4 Preservation ........................................................................ 417.5.5.5 Delivery .............................................................................. 41Applicable Documents Chapter 7.5 ........................................................ 42

7.6 CONTROL OF MONITORING AND MEASURING DEVICES.................................... 43Applicable Documents Chapter 7.6 ........................................................ 44


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8 MEASUREMENT, ANALYSES AND IMPROVEMENT ................................ 44

8.1 GENERAL........................................................................................... 448.2 MONITORING AND MEASUREMENT............................................................. 45

8.2.1 Customer Satisfaction ................................................................. 458.2.2 Internal Audits ........................................................................... 45

8.2.3 Monitoring And Measurement Of Processes .................................... 468.2.4 Monitoring And Measurement Of Product ....................................... 46

8.3 CONTROL OF NONCONFORMING PRODUCT................................................... 478.4 ANALYSES OF DATA.............................................................................. 478.5 IMPROVEMENT.................................................................................... 48

8.5.1 Continual Improvement .............................................................. 488.5.2 Corrective Action ........................................................................ 488.5.3 Preventive Action ....................................................................... 48



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0 INTRODUCTIONElma Electronic Inc is a leading designer, manufacturer and integrator of

electro-mechanical components and systems for the Telecommunications,

Medical, Industrial control, Instrumentation and Defense industries. Elmaoffers an extensive line of VME, VME64X, VXI, VXS, VPX , Compact PCI(CPCI), AdvancedTCA (ATCA) and MicroTCA enclosures and chassis for 19"

rack mount use. In addition to our systems products, our innovative selection

of Eurocard, IEEE1101.10 and front panel components (LEDs, knobs, test

points, etc) is the most comprehensive in the industry. Elma also

manufactures a premium line of rotary switches and encoders.

This manual outlines the policy of the company relating to its Quality

Management System (QMS) as an outcome of management driven initiatives

in 1995.The Quality Manual (QPM), issued and controlled by Elma Electronic

Inc. defines the Quality Management System which is effective across all

disciplines and at all levels within the company.

, ( / )

,

9100 2010.

2011 9100 2011

2 .

.


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9001: 2008 9100

1.0 Scope1.1 General

The primary purpose of this manual is to describe and document the quality

management system currently in practice at Elma Electronic Inc.This manualis the central source of general policies and procedures that in turn

authorizes and governs creation of subsidiary quality related documentation

and activities. This manual provides comprehensive evidence to allcustomers, suppliers, and employees that Elma Electronic Inc. is committed

to establishing and maintaining acceptable levels of measurable quality in its

products, processes, is committed to continuously review and improve the

effectiveness of the Quality Management system to meet or exceed customer

requirement and hence enhance customer satisfaction.

The requirements and procedures addressed in this manual are intended to

meet and exceed the requirements of both ISO 9001:2008 as well as

AS9100Cstandards.

1.2 ApplicationElma Electronic Inc did not exclude any requirements of the ISO 9001:2008STD.


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9100 ,

/ 9100 .

,

, 9100 /

.

9100

9100

) ) 7.5.1.4 .


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The sequence and interactions between these identified processes are

depicted in the illustration under 4.1.1.

9101

227

The documented quality management system incorporates standard

operating procedures which define criteria and methods that ensures

operation and control of these processes , in accordance with the

requirements of the International Standard Organization, ISO 9001:2008

standard, the AS9100C Stdand the companys quality policy. The quality

manual includes or makes reference to the quality management system

procedures, processes and measurements used in the quality management

system.

,

.

Elma Electronic Inc defines quality objectives, monitors and measures these

objectives / goals periodically at all stages to drive continuous improvement

throughout the organization through the Plan - Do- Check Act (PDCA)

Cycle. This is effected by implementing the QMIS system which is available

on a company wide internal online data base.

As explained earlier ,ELMA Electronic Inc has in place an organization with

adequate resources and infrastructure to ensure that operations andmonitoring of various processes takes place in each functional department .

The Organisation chart is depicted in Section 5.5.2.

When the company chooses to outsource any process that affects product

conformity to requirements, the controls over such processes are in

accordance with documented procedures (EESP-119). Such products areinspected in-house for compliance to specific requirements. The sheetmetal is

insourced and is manufactured by the ELMA sheet metal shop at Lathrop .

The control over the processes is the same as that applied on the operations

at the fremont location . The sheet metal components produced by the

Lathrop shop is subject to controls as documented per EESP -215.

4.1.1 - Continual Improvement of the Quality Management System.

ELMAs Quality Management System incorporates a Quality policy as below

Awareness.

Commitment.


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Improvement.

The depiction below better describes the interactions between the processes

of the Quality Management System at a macro level . A detailed flow chart

is below and available on QMIS.

Note The Color Coding of the key functions is defined below

Green Sales Function

Blue Design Function

Pink Materials Function

Gold Manufacturing Function

Red Quality Function


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Applicable Documents 4.2.1

EF-101 Form Control Log

EF-105 EESP Status Log

ISO 9001:2008 Quality Management System Requirement

AS9100 REV C Aerospace Standard for QMS

Remark: Please Review EF-101and EF-105for current documents

4.2.2 Quality Manual

The Quality Management Director/Manager is responsible for the issue of

amendments to the manual, withdrawal of obsolete information and the

maintenance of the master copy of the manual.

Uncontrolled copies may be distributed to organizations or persons at the

discretion of the Quality Assurance Director/Manager. This will be current atthe date of issue only and will not be subject to amendment action. These

copies will be annotated "Uncontrolled Copy."

Controlled copies of the Manuals may be revised as necessary to meet the

requirements of the ISO 9001:2008 and AS9100C standards, Elmas quality

requirements, and if required those of our customers. Revisions to this

manual will be reviewed and approved for use by at least the President and

Quality Assurance Director/Manager .Updates of linked documents will be implemented without changing the

revision level of the quality manual.

Customers and Partners are welcome to download the actualQuality Manual from our Homepage at:

HTTP://WWW.ELMA.COM.

Applicable Documents 4.2.2

QPM001 Quality Manual ISO 9001:2008 & AS9100C


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QUALITY MANUAL APPROVAL

Valarie Guinn

____________________________ __________Director, Materials Date

Badri Rajan____________________________ _________VP, Manufacturing Date

Troy Lauritsen____________________________ _________Director, Components Sales Date

Ram Rajan____________________________ _________VP, Engineering Date

Peter Brunner____________________________ _________VP, Finance Date

Urs Hess____________________________ _________

Director, IT Date

Shan Morgan_________ __ _________Senior VP, Sales Date

Badri Rajan____________________________ _________

Director QA & M R Date

Fred Ruegg

____________________________ _________President Date


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4.2.3 Control Of Documents

4.2.3.1 General

Procedures for controlling all documents and data that relate to Elma

Electronics quality system shall be documented including, to the extent

applicable documents of external origin such as standards and customerdrawings. Documents and data may be either in the form of hard copy or

electronic media.

SOPs are controlled per procedure EESP-101. Other internal and external

documents are controlled per EESP-175. Internal documents are ,but not

limited to, Assembly Work Orders, Design Drawings, Schematics, Bills of

Materials, Product Specifications, Standard Operating Procedures, Forms, and

Quality Manual Sections. External documents are Data sheets for vendor

supplied items , Customer SCD, Customer Product Specifications, and

Customer Quality Specs.

4.2.3.2 Document And Data Approval and Issue

Draft versions of documents and data are forwarded to the appropriate

authorized personnel and are reviewed and approved prior to issue. Master

lists are maintained to preclude the use of invalid and/or obsolete

documents.

The issue and amendment control procedures shall ensure that:

a) appropriate documents are available as required throughout the company,

b) obsolete documents are removed from all points of issue or use,c) any obsolete documents retained for legal and/or knowledge-

preservation purposes are suitably identified.

Documents of external origin such as customer specification , customer

drawings supplier data sheets etc shall be controlled in the same way as internal

documents

4.2.3.3 Document And Data Changes (Internal documents only)

Changes to documents and data shall be reviewed and reapproved by the

same functions/organizations that performed the original review and

approval, unless specifically designated otherwise. The designated

functions/organizations shall have access to pertinent background

information upon which to base their review and approval.


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The nature of the change shall be identified in the document or the

appropriate attachments.

4.2.4 Control Of Records

All essential quality related activities will be the subject of records that

demonstrates the achievement of specified requirements and the effective

operation of the company's Quality Management System.

Records will be suitably stored and maintained to ensure their safekeeping

and subsequent retrieval. The identification, collection, indexing, access,

filing, storage, maintenance, and disposition of quality records are defined in

the standard operating procedures for each applicable operation. Retention

periods and the authority for the disposal of records are also defined in each

standard operating procedure. Access to quality related records will be made

available to the customer or the customers representative as required.

Quality records include but are not limited to, Sales Order and Contracts,Inspection & Test records, Non-conformances, Corrective and PreventiveAction, Internal and External Audit records, Training records, Supplier test

reports ,Supplier Performance Ratings, Assembly Work Order Packages, etc.

The method of control of records created by and /or retained by the supplier

shall be ensured by flowing down the requirements to the suppliers on the

POs

Preventive actions and Internal Quality Audits are employed in the

Management review process as noted in this manual.

Quality Records are

Management Review

Quality Records (checklists, test reports, CofCs, SI Reports)

Contract Review

Design Review

Design Verification

Design Validation

Deviation Report

Acceptable Suppliers (maintained on the ERP system)

Customer-Supplied Service (product) Identification and Traceability

Process Control (All assembly instructions AWO/MPI/Photo)

Positive Recall Records

Inspection, Measuring & Test Equipment (Calibration Records)

Non-conformance

Corrective Action

Internal Quality Audit


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Training

RMA Records

Applicable Documents Chapter 4

EESP-101 SOP Copy Control (EESP&EF)EESP-128 Document Request

EESP-140 Control of Records

EESP-175 Document Control

EF-101 Form Master List (EF-xxx)

EF-105 Procedure Master List (EESP-xxx)EF-128 Source Control Document

EF-254 Standard Master List (ELMA, MIL, etc.)

EF-248 Packaging Instruction Master List

(Example: Form Master List)

5 Management Responsibility5.1 Management Commitment

ELMA's Executive Management understands the role of the quality management

system in relation to achieving the business and quality objectives and to

achieve customer satisfaction.

Executive Management is committed to developing and implementing a Quality

Management System and to continuously improving it's effectiveness by -

Communicating to all ELMA employees the importance of meeting

customer, statutory, regulatory and ELMA requirements

Establishing the quality policy

Ensuring the quality policy is understood throughout the ELMA

organization

Ensuring the availability of resources

Ensuring Internal audits are conducted and reported


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5.4.2 Quality Management System Planning

Each member of the executive management team monitors their departmental

objectives and provides a summary in monthly and other scheduled meetings.

Monthly planning and review includes following:

Actual budget versus planned budget

Shipments versus bookings and backlog

Review of critical orders and projects.

Review of available resources.

Review of improvements

Forecasts

Review of KPI and Quality metrics

Miscellaneous topics

Implementing of necessary adjustments to achieve the fulfillment

of the yearly plan

Implementing of necessary adjustments to ensure the integrity ofthe quality management system especially when changes to thequality management system are planned and implemented

5.5 Responsibility, Authority and Communication5.5.1 Responsibility and Authority

The responsibility, authority, and the interrelation of personnel who manage,

perform, and verify work affecting quality are listed on the organizational chart.

Specific responsibilities are defined in job descriptions. Both organizational chartand job descriptions are maintained by Human Resources. As well as on QMIS.

Elma Electronic is made up of the following departments: Sales & Marketing,

Finance, Human Resources, Manufacturing, Materials, Quality Assurance,Engineering, and Information Systems.

All personnel at Elma Electronic have the organizational freedom and authority

to identify and record any problems and to initiate action in order to prevent the

occurrence of any nonconformities relating to product, process, and quality

management system. All personnel also have the organizational freedom and

authority to initiate, recommend, or provide solutions through designatedchannels.

The Quality Management Director/ Manager has the organizational freedom and

authority to verify the implementation of solutions and to control the further

processing and delivery of nonconforming product until the deficiency or

unsatisfactory condition has been corrected.


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Each department manager is responsible to ensure that adequate resources are

available for all activities that impact quality. Adequate training is provided for all

employees for management, performance of work, and verification of activities

including internal quality audits.

5.5.2 Management Representative

Elma Electronic Incs. Executive management has designated the Director

/Quality Management Manager as the management representative. The

management representative has the authority and responsibility for ensuring

that a quality management system is established, implemented, and maintained

in accordance with the international Standard ISO9001:2008and AS9100C.The

management representative has the organizational freedom and unrestricted

access to top management to resolve quality management issues . The MR also

has the authority and responsibility for reporting on the performance of the

quality management system to Elma Electronics management. The

QualityDirector/ Manager in this capacity reports directly to the President of

Elma Electronic Inc.Promotion of awareness of customer requirements is communicated from Salesdepartment. The awareness takes place through documents like customer

specification, Engineering document, MFG and Quality checklists. The awareness

is further promoted by way of the Quality Management Information System

(QMIS).


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5.5.3 Internal Communication

Elma Electronic Incs. Executive management ensures that appropriate

communication process is established and maintained within Elma's organization

Informations are distributed by (and / or)

Email

Postings at dedicated News area

Executive Management member and the team meetings

ELMA's Intranet system

Company meetings ( all hands meeting )

Elmas quarterly newsletter

ELMA desktop

5.6 Management Review5.6.1 General

The quality management system shall be reviewed once a year by the President,

Vice President's and Functional Department Heads as required in conjunction


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with the Quality Management Manager. The purpose of this review is to ensure

the continuing suitability, adequacy and effectiveness of the quality management

system in satisfying the requirements of the ISO9001:2008standard and Elma

Electronics quality policy and objectives.

5.6.2 Review Input

The review shall address as a minimum the following:

Quality Policy

- To ensure that it is still relevant to Elma Electronics current needs

Quality objectives

results achieved, modification of existing objectives, and

setting of new objectives by management

Review of effectiveness of the key processes and its interactions in theQMS

Review of improvements initiated in each department for the currentyear as objective evidence of living the Quality policy

Weaknesses and deficiencies in the Quality management system

identified as a result of the internal quality audits

Wastage, loss and customer complaints/feedback incurred and

received throughout the year to identify possible savings and

reconsideration of existing working practices

Verification that corrective and preventive actions being taken are

effective. If corrective or preventive action is required as a result of

this review, the Quality Management Manager will initiate it in

accordance with the procedures as outlined in QPM-8.5.2 and 8.5.3,

Corrective and Preventive Action.

Follow-up actions from previous management reviews

Changes that could affect the quality management system Recommendations for improvements

The agenda and minutes of the management review meeting is the

responsibility of the Quality Assurance Manager. They are

documented, stored, accessed, and maintained electronically in thenetwork drive. Records are retained for at least five (5) years and

may be disposed at the end of the retention period.

5.6.3 Review Output

The output of Elma's management review includes any decisions and actions

related to:

Improvement of the effectiveness of the quality management

system and it's processes,

Improvement of product related to customer requirements

Resource needs


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EESP-109 Material Incoming InspectionEESP-110 Corrective and Preventive Action

EESP-140 Quality Records

EESP-148 Inspection and Test Stamp Control

EESP-151 Internal Quality Audits

EESP-152 Management Quality System Review

EESP-199 Paint Chip Control

EF-113 Internal Audit Report

EF-115 Corrective Action Request

EF-116 Corrective Action Request Log

EF-279 Customer Corrective Action Request Log

QMIS QMIS-System

JDData Job Description Database

EESP- 227 Process Effectiveness Measurement

6 Resource Management6.1 Provision of Resources

Each department manager is responsible to ensure that adequate resources are

available for all activities that impact quality. Adequate training is provided for all

employees for management, performance of work, and verification of activities

including internal quality audits.

6.2 Human Resources6.2.1 General

ELMA personnel performing work affecting product quality are competent on the

basis of appropriate education, training, skills and experience.

6.2.2 Competence, Awareness and Training

All tasks within the Company, which are adversely affected by the lack ofacquired skill, will be identified and made the subject of a job description that

reflects the extent and evidence of skill required. This will be used to appraise

the level of competence of personnel both before and during employment at

ELMA and to identify training needs accordingly.

All personnel will receive appropriate training before carrying out


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manufacturing operations. Training programs are devised to ensure complete

familiarity with all requirements of the process.

Records of training given will be maintained, and completion of training will be

subject to an end of training review. Periodic reviews of training requirements

will be made to ensure that training remains effective, and to identify needs forretraining.

Functional Department Heads are responsible for ensuring that only personnel

who are suitably qualified perform tasks requiring acquired skill.

The Human Resources function is responsible for establishing and maintaining

the appropriate training records relevant to new hires like company policies,

company orientation, safety program, and state/federal compliance information.

All other trainings that are related to processes affecting the product and /or the

customer are identified, planned and executed by the respective department

heads. The training status of each department is updated on QMIS system. The

records of these trainings are kept in QA department.

6.3 InfrastructureELMAs infrastructure comprises mainly of its human resources, Plant /

machinery, and ERP/ PLM platforms that interrelates the functioning of every

department.

The Organization Chart depicts and defines the responsibilities of all Staff and

functional departments that are required to sustain the business operations. The

respective department heads are responsible for developing and maintaining the

infrastructure and other resources necessary to support the business and in turn

the customers that depend on it.

The company's quality philosophy involves a "do it right the first time" approach

rather than inspecting quality into the product at a later stage. This philosophy is

lived up to and implemented in every facet of the business and in everydepartment. This is sustained and improved upon by virtue of having

documented procedures and work instructions. Manufacturing Engineering

department headed by the VP manufacturing is responsible for providing tactica

support to the main stream manufacturing.

This ME function is responsible for documentation of detailed process

instructions wherever warranted and feasible depending on the nature of theproduct/process/contract. A unique and effective documentation process is

developed and employed by the MFG personnel for all other projects/ products /

orders that ensure high quality and consistency.

The Manufacturing Engineering (ME) Function is responsible for establishing

Workmanship Standards , Process Instructions, co ordinating equipment

maintenance and/or equipment repair.


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The ME function shall also be responsible for control of production process

changes and identification/ control of tools and production equipment . Any

control required to be exercised for work transfers shall be co ordinated and

ensured by the ME function.

Details of in-process and post-process quality control checks will be included in

the Process Instructions and Quality Control Instructions. Monthly performance

monitoring and pareto analysis of data will be used as the basis of feedback for

process quality improvement.

Process and Quality Control Instructions will include workmanship criteria

description of the equipment to be used references to visual aids, samples and

standards, where applicable.

Wherever possible, quantitative measures will be used for monitoring processes.

Control chart techniques will be used as the basis for process control action.

Production will be carried out against schedules, which take into accountcustomer requirements.

The Production Planning Team is responsible for the planning and

scheduling of work orders.

All outside processes are contracted and controlled by purchase order.

The process for maintenance of equipment as needed, shall be call out in the

workmanship standard.

The Director of Quality/ QA Mgr is responsible for the QA instructions being

established and maintained. The Vice President - MFG and the Manufacturing

Engineering department is responsible for ensuring that the Process instructions

are established and followed.

6.4 Work EnvironmentThe executive management team determines and manages the work

environment needed to achieve conformity to product requirements .All

functional department heads ensure that adequate infrastructure is available in

their respective departments for employees to carry out the daily activities .This includes and is not limited to work space , utilities , necessary equipment,

tools and supporting services like IT etc.

Any concerns and shortcomings are discussed during the monthly executive

management meeting as well as in annual strategy meetings


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EESP-112 Assembly Work Order Creation (Process Control Production)

EESP-147 Employee on the Job Training

EESP-161 Manufacturing Procedure

EF-162 Employee Position Training Requirement

EF-163 Employee Definition RecordEF-164 Employee Responsibility Record

EF-168 Training Form

EF-169 Employee Training Requirement Form

EF-187-1 ESD Wrist Strap performance Log, MFG, QA

EF-187-2 ESD Wrist Strap performance Log, Misc.EF-187-3 ESD Wrist Strap performance Log, Visitors

EF-228 Workmanship Standard

ESD Handbook ESD Handbook and Guidelines

WS-102 Cosmetic Workmanship Standard

WS-103 Cable and Harness Workmanship Standard

WS-104 ELMA Wiring GuidelinesCRIMPCAL Crimping and Calibration Handbook

MFGTRAINLOG Manufacturing Training Log Sheet

7 Product Realization7.1 Planning and Product Realization

During the quoting and/or engineering design review process, Elma Electronic

will evaluate the customers requirements , plans and develops the processes

needed for product realization .The contract specific requirements are flowed

down to all departments by sales to ensure that requirements are interpretedand understood prior to quoting. These include but are not limited to

documentation that reflects quality requirements relevant to that order/

contract. The following issues are considered during the quotation or quality

planning phase of design:

Product requirements including quality objective such as .

Product and personnel safety

Reliability , availability and maintainability.

Producibility and inspectability

the identification and acquisition of any controls, processes,

equipment (including inspection and test equipment), fixtures,resources, and skills that may be needed to achieve the required

quality;The updating, as necessary, of the inspection and testing

techniques, including the development of new instrumentation;

The identification of any measurement requirement involving

capability that exceeds the known state of the art, in sufficient


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time for the needed capability to be developed;

The identification of suitable verification in the development and

manufacturing process;

The clarification and definition of acceptability standards for all

specified features and requirements, including those with subjectiveelements;

Configuration management appropriate to the product

The identification and preparation of quality records. .

Inspection and testing procedures will be documented in order to verify that the

specified requirements for the product are met. The required inspection and

testing and the records to be established will be detailed in the documented

procedures.

7.1.1 Project ManagementEEI has implemented project management to ensure product realization is achieved in astructured and controlled to manner to meet requirements at acceptable risk and withinresource and schedule constraints .

Project management is performed on all system orders as documented in the procedurelisted below

Applicable documents

EESP-221 - Program/ Project management procedure

7.1.2 Risk Management-ELMA Electronic has established ,implemented and maintains a documented process formanaging risk for the achievement of applicable requirements relevant to both theorganization as well as the products executed for specific orders . Risk managementprocess defines the risk criteria,assigns the responsibilities , identifies the risk andassociated mitigation action and manages the implementation of the mitigation actions .Finally the residual risk remaining after the implementation of the mitigation actions areevaluated and accepted . The record of the risk analysis and mitigation actions aremaintained in a defined format .


EESP-217 - Project Risk Management & Mitigation ProcedureEF- 380 Risk Analysis & Mitigation record.


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7.1.3 Configuration ManagementConfiguration management has been established , implemented and maintained toencompass configuration planning , identification , change control , configuration statusaccounting and configuration audit .


EESP- 222

7.1.4 Control of work transfersElma Electronic has established and maintains a procedure that involves the planning andcontrol thereof for the temporary or permanent transfer of work from one facility toanother, from the organization to a supplier , from one supplier to another supplier and to

verify the conformity of the work done to requirements.


EESP 225

7.2 Customer Related Process7.2.1 Determination Of Requirements Related To The Product

Before submission of a tender, or at the acceptance of a contract or order

(statement of requirement), the tender, contract, or order shall be reviewed byElma to ensure that:

the requirements are adequately defined and documented;

where no written statement of requirement is available for an order

received by verbal means, Elma shall ensure that the order

requirements are agreed before their acceptance;

Any statutory and regulatory requirements

any differences between the contract or accepted order

requirements and those in the tender are resolved;

Elma has the capability to meet the contract or accepted order

requirements.

7.2.2 Review Of Requirements Related To The Product

Elma shall establish and maintain documented procedures for contract review

and for the coordination of these activities.


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Elma shall identify the amendments made to a contract and correctly transfer it

to the functions concerned within its organization.

Records of contract reviews shall be maintained by Elma .Where the customer

provides no documented statement or requirements, the customer requirementsshall be confirmed by Elma before acceptance.

Where product requirements are changed, Elma ensures that relevant

documents are amended and that relevant team members are made aware of

changed requirements.

Where applicable a preliminary risk analysis is done to identify risks related to specialrequirements , new technology , short delivery etc.

For any change, Elma sales issue a Product Impact Form (PIF) to address any

change requirement to the engineering department who will incorporate the

changes into the product/project.

Limited reviews will be performed for standard catalogues order. The review

covers relevant catalogues product information.

7.2.3 Customer Communication

Elma determined and implemented effective arrangements for communicating

with customers in relation to the product.

Sales is the primary source for all relation to

Contracts Enquires, contracts or order handling, including amendments

Customer feedback, including customer complaints

Sales shall coordinate the right team and action for each occurrence.

The quality manager is the right source for all quality related issues as well as

customer feedback and complaints.

Applicable Documents Chapter 7.1 & 7.2

EESP-220 Customer communication

EESP-113 Project Impact FormEESP-114 Offer Process

EESP-115 Contract Review And Order Process

EESP-137 Customer Comments

EESP-138 Systems Returned Material Authorization

EESP-139 Returned Material Authorization Component

EESP-157 Credit MemoEESP-159 Component Design Quote Procedure


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EESP-163 Account Receivable

EESP-170 Quoting And Documenting For Custom Panel Or Part

EESP-173 Component Div. Procedure Order Entry

EESP-189 Stop Order

EF-109 RMA Receipt LogEF-120 Order Work Sheet

EF-122 Project Impact Form (PIF)

EF-127 Component Sales Order Log

EF-157 Order Expedite Delivery Form

EF-160 Component Part Number Log

EF-161 ELMA Part Number Naming Convention Reference

EF-167 System Retune Material Authorization (RMA)

EF-170 Customer Service Tracking Number

EF-172 R.M.A. Receiving Inspection Checklist

EF-174 Systems RMA Log

EF-180 Corrective Action Report (Comp. Deviation)

EF-183 Fax server Document Request

EF-184 Marketing Materials RequestEF-197 System Order Process Control ChartEF-211 C.O.D. Customer Information

EF-217 Lost Order report

EF-218 Offer Quality Checklist

EF-225 Enclosure Specification

EF-226 Terms And Conditions Of Sale And Limited Warranty

EF-227 Reschedule/Cancellation Procedures Foe Built-To-Order-Parts

EF-229 Standard Warranty Policy

EF-233 Components Applications Request Form

EF-239 Change Order Work Sheet

EF-283 System Order Pricing SheetWS-102 Cosmetic Workmanship Standard

SPECS Design Infos, Guidelines, Specifications and Listings

7.3 Design And Development7.3.1 Design And Development Planning

The design and development Engineering function is responsible for establishing,

implementing, and maintaining the procedures which will control the design and

development of systems for specific customer projects.

It is the responsibility of the Quality Manager to ensure that internal andexternal design and development activities are audited in accordance with the

Company's audit procedures.

Plans with target dates shall be prepared for all development stages and design

activities. This responsibility will include the use of qualified personnel equipped

with the adequate resources. As the design evolves the plan plans shall be

updated on a regular basis.


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It is the policy of the company to design, develop and supply a range of high

quality, cost effective and innovative products (including equipment, systems

and services) which will satisfy the customers requirements.

In order to achieve this objective, the design and development activities shall be

based upon documented procedures and shall include distinct activities. Each

distinct activity shall have necessary resources reviewed and deployed ,

constraints reviewed and responsibilities assigned

These distinct activities shall include design (design input, design output, design

validation, and Design changes) and development planning (technical

interfaces), design review, transfer of design from development to

manufacturing and purchasing, control of documentation and design verification.

The various design and development tasks shall take into cognizance the safety

and functionality required of the product and to comply with any applicable

statutory and regulatory requirements.

Feedback from all relevant sources shall be used to improve the quality of designand to identify areas for new product development. Feedback may be provided

as validation, from but not limited to Elma Shop, Elma Sales, and Elma

Production departments to ensure producibility , inspectability and

maintainability

Any design or development activity that is carried out externally will be

conducted in accordance with the Company's Quality System Audit Program.

The design and development functions will be periodically and systematically

audited as part of the Company's documented procedures. Audits shall beconducted both internally and externally.

7.3.2 Design And Development Inputs

Design Inputs relating to the product shall be reviewed by the Engineering

Department. This shall include, but not limited to

o Applicable statutory and regulatory requirements.

o Functional and perforamce requirements

o

Information from previous designs of a similar natureo Any other requirement essential to the design and developmento Information from contract reviews

The inputs shall be reviewed for adequacy and any ambiguous, incomplete or

conflicting requirements shall be resolved by all parties involved.


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7.3.3 Design And Development Outputs

The design and development outputs shall

Meet the design input requirements

Provide appropriate information for purchasing ,production and if

applicable product service

Contain or make reference to acceptance criteria

Specify essential characteristics

Specify any applicable test and acceptance criteria

Specify any applicable validation tests

Reviews shall be conducted and logged before the release of the documents.

These reviews on new custom designs should include as a minimum the

customers representative and if needed personnel from Manufacturing, Quality,

Sales and Purchasing .

Design outputs shall be in a format that clearly identifies the product to bemanufactured . Design output data shall be in the form of drawings , BOM,schematics , Mechanical models , assembly data , component data sheets,

Acceptance criteria etc .

7.3.4 Design And Development Reviews

Design reviews shall be performed in accordance with the design and

development plan and shall ensure that the design outputs meet the input

requirements . The intention of such reviews shall be to check adequacy of

the outputs and proactively identify any potential shortcomings prior to

release .

Formally documented reviews will be held where applicable and the results

logged for that project under itemized action lists .The participation of other

departmental personnel shall be considered if required . The review shallinclude the customer as a minimum.

7.3.5 Design and Development Verification

The design stage outputs shall be verified to ensure that it meets the input

requirements.The records of such verifications are maintained .

7.3.6 Design And Development Validation.

The design validation shall be performed where applicable to ensure that the

resulting product meets the requirements specified for that application or

intended use . Where practical the validation shal be performed prior to

product delivery . All such results of the validation shall be maintained as

Quality records .


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7.3.6.1 Design and Development Verification and Validation testing & Documentation.EEI shall plan and perform verification and validation tests where contractuallyrequired.These are performed by documenting and performing Acceptance test

procedures and other special tests like Environmental testing and ESS (Environmental stress screening) at prototype level etc .

These tests shall define the product being tested , test objectives , test configurationand conditions , define how the tests are planned and controlled , resources used if any, parameters to be recorded and relevant acceptance criteria . The actual performanceof the test is also described .

7.3.6.2 Design and Development Verification and Validation documentationThe Design Verification and Validation documentation in the form of ATP , ESS and

Qual test reports containing all of the information as defined in 7.3.6.1 shall bemaintained as records to demonstrate that the product meets the specificationrequirement for all identified operational conditions.

7.3.7 Control of Design And Development Design Changes

All design changes and modifications must be identified, documented,

reviewed and approved before being implemented. This shall be controlled

in accordance with configuration management process as defined in 7.1.3

.

Applicable Documents Chapter 7.3

EESP-112 Assembly Work Order Creation

EESP-118 New Part Number Entry

EESP-127 Drawing Development

EESP-128 Document Request

EESP-129 Engineering Change Request (ECN)

EESP-132 Develop Design Plan

EESP-133 Design/Documentation Change Request

EESP-134 Design Review

EESP-135 Drawing Redline

EESP-142 New Product Development

EESP-159 Develop Product SpecificationEESP-167 BOM Entry RequirementEESP-174 Repeat Order Procedure

EESP-175 Document Control Coordinator Instruction

EESP-181 ECN Release Instruction For Document Control

EESP-188 Engineering Documentation Guidelines

EESP-189 Stop Order


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EF-121 Assembly Work Order (AWO)

EF-128 Source Control Document

EF-140 Document Request

EF-143 ECN

EF-144 ECN-LogEF-154 Beta Test Record

EF-158 Design Guidelines

EF-175 Design Review Record

EF-193 Documentation Request Form

EF-196 Production Traveler

EF-213 Project Impact Form

EF-214 Design Request

EF-235 AWO For Modified Standard/Repeat Orders

EF-238 Design & Development Plan

ESD HandbookESD HandbookCRIMPCAL Crimping and Calibration Handbook

7.4 Purchasing7.4.1 Purchasing Process

All purchased materials and services required for the manufacture of products

will be the subject of written purchase orders, which will clearly describe all

requirements. All materials used in manufacture will be purchased to the

company's specification and verified to ensure that it meets purchase

requirements . The type and extent of control required to be applied on the

purchase product would depend on the effect of the purchased product on the

subsequent product realization of the end product.

EEI is responsible for the conformity of all purchased product including products

from sources defined by the customer.

Subcontractors or suppliers shall be selected by Elma on the basis of their ability

to meet our needs. Elma may choose to conduct an on site survey of the

supplier or may request completion of the supplier survey by a qualified supplier

representative.

Elmas supplier survey is designed to assess the effectiveness of the suppliers

quality system. Elma will also use other methods for determining a suppliersability to meet our needs, such as tracking of on time delivery performance, and

rejection history of non-conforming material.

All information provided by suppliers will be reviewed by relevant Elma

management team members and a determination will be made as to whether

approval will be granted, or to identify which improvements need to be made

prior to becoming an approved supplier.


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Supplier surveys and supplier attachments will be maintained on file and will be

updated periodically. The frequency of supplier audits is dependent upon the

suppliers ability to meet contractual or purchase order requirements.

Where Elma feels that if the quality or performance level of a customer specified

supplier is substandard, we will notify our customer. Where non-conformance

continues to be identified with no evidence of corrective action, Elma will

recommend disapproving the supplier for future business.

EEI purchasing department maintains on the ERP system a register of all suppliers classifiedas Approved , Conditionally Approved and Disapproved. All critical suppliers are tracked fortheir performance and score cards maintained . The Purchasing procedures detail the extent ofcontrols on these suppliers, the purchased product as well as the process , responsibilities andauthority of approval status decision , changes of approval status and the controlled use ofsuppliers based on their approval status.

7.4.2 Purchasing Information

Information provided to our Suppliers and subcontractors will be clear and

concise and will include the latest available documentation when required for

fabrication of custom parts. This may include but not limited to Fab drawings,

assembly drawings, and Step files. The purchase order is the defining document

and the part number referenced provides the necessary and essential

information.

7.4.3 Verification of purchased product

Elma will make prior arrangements for any source inspection of a productrequired (to be performed by an Elma personnel) at the supplier location prior to

the acceptance of the product.

When a contract between Elma and a customer exists, which allows provisions

for customer source inspection at our suppliers facility or in our facility upon

receipt of Elma purchased product, we will still maintain responsibility for the

quality of the product that we use in our assemblies. A customers inspection of

this product will not absolve us of our responsibility to provide quality products

to our customer, nor preclude any subsequent rejection. We will maintain the

responsibility for the verification and control of materials utilized in the

manufacture of our product.


EESP-102 Material Receipt

EESP-103 Handling Of Non-Conforming Material

EESP-106 Control Of Customer Supplied Material

EESP-119 Purchasing


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EESP-126 Kit Picking

EESP-143 Material Storage and Handling

EESP-144 Packing And Shipping

EESP-145 Limited Life Time Materials

EESP-177 Kit PullingEESP-178 Cycle Count

EESP-189 Stop Order

EF-110 Miscellaneous Item Receiving Log

EF-111 Incoming Inspection Stamp

EF-112 Non Conforming Material Report

EF-129 Material Requisition Form

EF-135 Vendor Performance Evaluation Record

EF-146 Picklist Stamp

EF-147 Work Order Label

EF-148 Kit Issue Log

EF-212 Shipping Log

EF-224 Supplier Self Assessment Questionnaire

EF-248 Packaging Instruction Master LogEF-277 Cycle Count Order WorksheetWS-102 Cosmetic Workmanship Standard

ESD Handbook ESD Handbook & Guidelines

ROI Approved Supplier List (ROI LIST, MRP-System)

7.5 Production And Service Provision7.5.1 Control Of Production And Service Provision

Production will be carried out against schedules, which take into accountcustomer requirements.

The Manufacturing Engineering Function is responsible for establishing

Workmanship Standards in the Process Instructions, Equipment Maintenance,and Equipment Repair.

The Production Planning Team is responsible for the planning and scheduling of

work orders.

All outside processes are contracted and controlled by purchase order.

The process for maintenance of equipment as needed, shall be call out in the

workmanship standard.

The company's quality philosophy involves a "do it right the first time" approach

rather than inspecting quality into the product at a later stage. The control of

production processes is achieved by implementing this philosophy ,which

involves having process instructions in the form of workorder routings ,


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drawings, schematics, Configuration documents like assembly work order,

photos, workmanship standards etc, that define how all operations will be

carried out. Details of in-process and post-process quality control checks will be

included in the Process Instructions and Quality Control Instructions and

checklists . The checklists measure the process effectiveness and theassessment is recorded on a monthly basis by the quality department

and displayed on the QMIS. Records of quality checks and the pareto

analysis of defects will be used as the basis of feedback for process quality

improvement.

Wherever possible, quantitative measures will be used for monitoring processes

and measuring actual outputs. Control chart techniques will be used as the basis

for process control action only where production quantities are high to warrant

the use of charts. Pareto analysis is employed to analyze inspection data and

arrive at main contributing factors.

The documented procedures for Planning , scheduling and manufacturing shall

be followed as listed below to ensure compliance to all requirements of thecustomer as well as the quality system requirements like verification operations, detection of foreign objects and other workmanship standards .

Manufacturing Engineering function is responsible for developing the process

instructions. The Quality Director /Manager is responsible for ensuring that the

Process and Quality Control Instructions are implemented and followed.

Delivery or shipment of product will be conducted in accordance with Elmas

standard shipping procedures, or by customers specified shipping instructions.

Elma will utilize Elmas approved shipping carriers only, based on customer

requirements, and will promote safe transit of product to its receivingdestination.

In line with the Company mission and its total commitment to quality, ELMA

ELECTRONIC INC. seeks to provide for its customers continued product supportand after sales support.

The Company will provide for its customers technical, product, and

applications support.

The Company will ensure that its products meet the immediate requirements of

its customers and will work with its customers to establish and meet their futureneeds.

Where required, the Company will provide product/system manuals, which will

detail use, installation, commissioning, maintenance, and safety and disposal

information.

7.5.1.1 Production process verification


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As such there are no special processes carried out in the Assembly operations at

ELMA . Validation all other production processes is demonstrated through the

effective deployment of the process control tools as elaborated in 7.5.1, usage of

appropriate equipment and qualified personnel..

Process and process control Instructions that ensure quality include

workmanship criteria, identification of the equipment to be used and make

reference to visual aids, samples and standards, where applicable.

7.5.3 Identification And Traceability

All production materials will be adequately identified on receipt and during

storage, pending issue, and use.

All products in production will be identified by either work order,

shipping order or Elma part numbers throughout the manufacturing and test

cycle.

All finished products will be individually identified by both an Elma modelNumber, manufacturing date and serial number to enable full product history to

be traced. Model number, serial number, and date of manufacture for all System

products are recorded on a Serial Number Log.

Where identified as FRUs by Engineering department , sub assemblies shall be

traceable by virtue of being built on separate WOs and issued to the parent WO

. Where applicable these FRUs/ sub assemblies shall be serialized . Overall all

critical components shall be serialized with bar coding and are recorded both

electronically in the ERP system as well as manually recorded in the

accompanying paper works and archived as QA records to ensure traceability .

All products will be subject to final inspection and testing to assure conformance

to specified requirements. In addition to the final inspection performed on the

finished product, checks will be made to establish that all specified inspectionsand tests have been carried out with satisfactory results.

No product will be shipped unless the quality standards and activities as outlined

in Elmas quality system have been met. The quality assurance inspectors have

the right to withhold any product from shipment which does not meet these

requirements.

Inspection and test records will be maintained on file to provide evidence that

the product has been inspected and/or tested. These records are retained a

minimum of three years and may be disposed of at the end of the retention

period.

At receiving, records of inspection include incoming inspection stamp and the

inspectors stamp of acceptance on materials inspected, incoming inspection


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history record showing whether product has passed or failed, and the material

transaction activity on the MRP system for tracking material location. In-process

inspection and test records will include the production checklist and the power

test report showing the operators signature or initials performing the test.

These records shall be attached to the assembly work order package. Finalinspection and test records shall have the inspectors signature/stamp and date

on the traveler of the product inspected.

If a product fails any inspection and/or test, the procedure for the control of

nonconforming product shall be followed.

All materials and products will be suitably identified throughout each stage of

manufacture.

All products that are subject to mechanical and electrical inspection and test and

have passed these tests will be identified appropriately throughout production.

Product that fails inspection and test or is rejected by the quality department for

any other reason will be identified accordingly, and will be returned to productionfor repair or replacement. The assembler or inspector will generate non-conforming material reports. Refer to section 8.3 of this manual for non-

conforming material control.

Assembly work orders will be signed or stamped by the assembler or inspector

after performing the inspection or test functions. All test and inspection reports

will be recorded as required. Inspection records will reflect any secondary or

inspection performed on reworked material.


EESP-148 Inspection test stamp control

EESP-176 Final inspection procedure

7.5.4 Customer Property

All customer property which could be either part supplied by the customers for

their products or returned material for repairs and upgrade will be examined

upon receipt for condition, quantity, and conformance with delivery details.

All items will be positively identified and stored by location in the stockroom or

appropriate location in the case of RMA units. These will be handled and storedin a manner, which will prohibit damage or deterioration. If any lost or damaged

material and/or material shortages are identified during the receiving process

the customer will be notified by formal documentation which will be retained as a

record of this transaction.

Material will only be issued against those orders for which it was supplied.


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7.5.5 Preservation Of Product

Procedures for handling, storage, packaging, preservation, and delivery of

product shall be documented and maintained. This includes house keeping and

cleanliness , prevention of FOD , ESD precautions , shelf life control and specialsafety labeling/ handling for hazardous substances whichever is applicable .


EESP-143 Material storage and handling

EESP-145- Limited life materials

EESP-140 ESD damage prevention

EESP- 210- FOD prevention

7.5.5.1 Handling

Material handling arrangements will be made during all stages of manufacture,inspection, and test in order to prevent any risk to material quality. The mannerin which material is handled and protected will be subject to written instructions

where critical handling and transportation considerations are identified. These

will refer to any special containers, and handling devices will be provided

accordingly.

7.5.5.2 Storage

Material awaiting use or shipment will be identified and segregated in designated

storage areas. Suitable measures will be taken to prevent damage or

deterioration including a periodic inspection for the condition of the product.

7.5.5.3 Packaging

Packaging requirements will be as specified by the customer or by Elmaapproved methods as defined by shipping personnel during the initial packaging

and shipment of the product, if customer specifications have not been provided.

Materials used will be designed to ensure that the product quality is maintained

during transit.

7.5.5.4 Preservation

Material will be stored in a way that will preserve the material from damage or

deterioration from surrounding elements such as heat, moisture, and weather

elements.

7.5.5.5 Delivery


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Delivery or shipment of product will be conducted in accordance with Elmas

standard shipping procedures, or by customer specified shipping instructions.

Elma will utilize Elmas approved shipping carriers only, based on customer

requirements, and will promote safe transit of product to its receiving

destination.


EESP-102 Material Receipt

EESP-103 Handling Of Non-Conforming Material

EESP-106 Control Of Customer Supplied Material

EESP-125 Work Order ReleaseEESP-126 Kit Picking

EESP-143 Material Storage and Handling

EESP-144 Packing And Shipping

EESP-145 Limited Life Time Materials

EESP-147 Employee On The Job Training

EESP-150 Equipment MaintenanceEESP-161 Manufacturing Procedure

EESP-177 Kit Pulling

EESP-182 Production Scheduling

EESP-183 Change Order Worksheet

EESP-184 Manufacturing Process Planning

EESP-185 Test Fixture Validation

EESP-186 Harness Work Orders

EESP-187 Custom Front Panel Processing ProcedureEESP-192 Wire Harness Preparation

EESP-193 Hi Pot And Continuity Test

EF-118 First Article Inspection ReportEF-119 Incoming Inspection History Report

EF-124 Material Requirements Hot List

EF-125 System Order Entry Log

EF-132 HiPot Test Report

EF-146 Picklist Stamp

EF-148 Kit Issue Log

EF-156 Sheet Metal Manufacturability Review

EF-166 Design/Documentation Change Request

EF-194 Shop Order Request Form

EF-195 Shop Traveler Request Form

EF-207 QC Receiving LogEF-208 Power Test Report

EF-212 Shipping Log

EF-216 HIPOT Test Report

EF-228 Workmanship Standard

EF-229 Standard Warranty Policy

EF-232 Workmanship Standard Manual Issue Record

EF-234 Equipment Maintenance Record


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EF-237 Man Hour Spread Sheet

EF-243 General Manufacturing Checklist

EF-245 Manufacturing Housekeeping Guideline

EF-246 Paint Chip Control Log

EF-247 Inspection Documentation Master LogEF-248 Packaging Instruction Master Log

EF-252 Cover Sheet, Final Acceptance Test Report

EF-266 ESD Inspection Log Sheet

EF-324 Acceptance Test Procedure (APT)

WS-102 Cosmetic Workmanship Standard

ESD Handbook ESD Handbook & Guidelines

7.6 Control Of Monitoring And Measuring DevicesProcedures to control, calibrate, and maintain inspection, measuring, and test

equipment used by Elma Electronic to demonstrate the conformance of a

product to specified requirements shall be documented. Inspection, measuring,and test equipment shall be used in a manner, which ensures that themeasurement certainty is known and is consistent with the required

measurement capability.

An online data base available on ELMA s QMIS maintains the list/ register of

monitoring and measuring equipment under the calibration program with details

of equipment location , frequency of checks etc .

Comparative references such as test fixtures shall be checked and validated to

prove that they are capable of verifying the acceptability of a product prior to

release for production use and shall be rechecked at prescribed intervals. Thefrequency of such checks shall be established and records shall be maintained as

evidence of control.

Where the technical data pertaining to the measurement equipment is arequirement specified by the customer or customers representative, such data

shall be made available for verification that the measuring equipment is

functionally adequate.

Engineering and/or QA shall determine the measurements to be made and the

accuracy required, and select the appropriate inspection, measuring, and test

equipment that is capable of the necessary accuracy and precision.

All equipment used for inspection, test, and measurements will be subject to

regular calibration. All calibration activity will be traceable to a national or

international recognized standard. Where no such standards exist, the basis

used for calibration shall be a documented procedure.


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Standards or procedures used for calibration/verification of test equipment

define where applicable,

The acceptance criteria and the actions to be taken when

calibration/verification results are unsatisfactory,

The environmental conditions suitable for the calibration /verification being carried out,

The handling, preservation, and storage of equipment such

that the accuracy and fitness for use are maintained, and

Facility safeguards to prevent any adjustments to the equipment

that would invalidate the calibration setting.

An appropriate calibration label will be applied on the equipment to show the

calibration status. Records of calibration will be maintained and a system of call-

in for calibration operated. When equipment is found to be out of calibration, the

effect of that error on the product will be reviewed and appropriate corrective

action taken.


EESP-131 Control of Inspection, Measuring, and Test Equipment

EF-149 Equipment Calibration Record

EF-151 Equipment Out of Calibration Evaluation

EF-222 Air/Electric Tool Calibration Sheet

EF-223 Wire Crimping Tool Calibration Sheet

EF-272 Calibration Tool List Fremont

EF-311 Wire Stripper Calibration Sheet

CRIMPCAL Crimping and Calibration Handbook

8 Measurement, Analyses And Improvement8.1 General

Inspection and testing procedures will be documented in order to verify that the

specified requirements for the product are met. The required inspection and

testing and the records to be established will be detailed in the documented

procedures

The need for statistical techniques required for establishing, controlling, and

verifying process capability and product characteristics shall be identified. The

identification of need for a statistical technique may be generated by one of thefollowing sources:

A manager requests that a product or process problem be

analyzed using statistical techniques,

The Material Review Board reviews nonconforming product and

request a statistical analysis, or


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A Corrective Action Team requests a statistical analysis of a

product or process.

Where statistical techniques are used for product verification, due regard will be

made to the contractual requirements of the customer.

The statistical techniques used will be documented and define the way

the technique is to be applied and the rules governing its use.

8.2 Monitoring And Measurement8.2.1 Customer Satisfaction

ELMA ELECTRONIC INC. has documented procedures for measuring customer

satisfaction. Sales, Customer Service and Quality Management monitor the

results.

Customer Service performs quarterly Customer Satisfaction Survey every year.All results are analyzed to improve customer satisfaction continuously anddisplayed on the QMIS system.

ELMA also receives score cards on its performance (Quality, Delivery and

Overall) from certain key customers on a monthly basis. These are used to

measure customer satisfaction and assess the process effectiveness at key

departments like Sales , Engineering , Quality as defined in the PEAR procedure

EESP-227.

As part of the Quality system the Exec Mgmt team shall review key performance

indicators and assess the process effectiveness at the overall operational levelrelated to customer satisfaction like OTD and High level Quality ( based on

product returns ) in line with the PEAR procedure EESP-227.

8.2.2 Internal Audits

ELMA ELECTRONIC INC. has documented procedures for planning and

implementing internal quality audits to verify whether quality activities and

related results comply with planned arrangements and to determine the

effectiveness of the quality system.

The internal audits shall be process based and will assess the process

effectiveness at identified stages in applicable departments .

Internal quality audits will be carried out systematically and on a regular

predetermined schedule based on the status and importance of the activities to

be audited. The audits shall be conducted by personnel independent of those

having direct responsibility for the activities being audited.


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Results of the audits will be recorded and brought to the attention of the

department managers. The department managers shall be responsible for taking

timely action to correct any deficiencies identified during an audit.

Follow-up audit activities shall verify and record the implementation and

effectiveness of the corrective action taken.

The results of the internal quality audits will be reviewed by the Management

Team to ascertain that the quality system is effective in achieving its objectives

and continues to reflect the Company's mission.

8.2.3 Monitoring And Measurement Of Processes

Elma has applied suitable methods for monitoring, and where applicable,

measurement of the quality management system processes.

Elma demonstrates that these processes achieve planned results and continuesto ensure the quality of the out going product.In the event of a nonconforming process ELMA s QA function will take

appropriate Corrective action to remedy the nonconforming process , evaluates

that the process conformity has not resulted in product nonconformity and

whether it has affected other processes / products and finally put in place

measures to control the non conforming product.

8.2.4 Monitoring And Measurement Of Product

Elma monitors and measures the characteristics of the product to verify that

requirements have been met and have been carried out of the stages of theproduct realization process.

The measurement requirements for the products shall be documented in

relevant ELMA forms (EF) that defines what is measured , acceptance criteria aswell as any relevant serial number information for product traceability . These

shall be maintained as Quality records

The recently established design verification and testing Lab conducts Product

verification tests on new products / designs and the results are analyzed for

further improvements. The results are recorded and reports generated for future

reference.

All deliverable documents shall be identified on the Assembly Work order to

facilitate the QA department to compile copies and ensure it is shipped to the

customer along with the product supplied .


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8.3 Control Of Nonconforming ProductAll non-conforming material will, immediately upon detection, be identified and

held pending investigation and disposition. Such arrangements will apply to

material received from suppliers or from internal or external non-conformances.

All non-conforming products will be reviewed to determine the need for

corrective/preventative action and the subsequent material disposition.

Records of all nonconformances will be maintained and will be periodically

reviewed to establish trends and thereby determine the need for further

preventative action.

Material which does n