QUALITY MANUAL
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 QMIS System -ELMA’s 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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Table of Contents
0 INTRODUCTION .................................................................................... 5 1.0 SCOPE .................................................................................................. 7 1.1 1.2 GENERAL ............................................................................................... 7 APPLICATION ........................................................................................... 7 2.0 NORMATIVE REFERENCE ....................................................................... 8 3.0 TERMS, ABBREVIATIONS AND DEFINITIONS ........................................ 8 3.0.1
3.0.3
3.0.4
3.0.5
3.0.6
QPM (Quality Program Manual) ................................................
QMIS (Quality Management Information System) .......................
EESP (Elma ELECTRONIC STANDARD PROCEDURE) ...................
EF (Elma FORM) ...................................................................
Supply Chain .......................................................................
8 8 8 8 8 4.0 QUALITY MANAGEMENT SYSTEM .......................................................... 8 4.1 GENERAL REQUIREMENTS ............................................................................ 8 4.2 DOCUMENTATION REQUIREMENTS ................................................................ 12 4.2.1 General........................................................................................ 12 Applicable Documents 4.2.1 ................................................................. 13 4.2.2 Quality Manual .............................................................................. 13 Applicable Documents 4.2.2 ................................................................. 13 4.2.3 Control Of Documents .................................................................... 15 4.2.3.1 General.............................................................................. 15 4.2.3.2 Document And Data Approval and Issue ................................. 15 4.2.3.3 Document And Data Changes (Internal documents only) ........... 15 4.2.4 Control Of Records ........................................................................ 16 Applicable Documents Chapter 4 .......................................................... 17 5 MANAGEMENT RESPONSIBILITY ........................................................ 17 5.1 MANAGEMENT COMMITMENT ....................................................................... 18 5.2 CUSTOMER FOCUS .................................................................................. 18 5.3 QUALITY POLICY ..................................................................................... 18 5.4 PLANNING ............................................................................................ 20 5.4.1 Quality Objectives ......................................................................... 20 5.4.2 Quality Management System Planning .............................................. 20 5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION .......................................... 21 5.5.1 Responsibility and Authority ............................................................ 21 5.5.2 Management Representative ........................................................... 21 5.5.3 Internal Communication ................................................................. 22 5.6 MANAGEMENT REVIEW ............................................................................. 22 5.6.1 General........................................................................................ 22 5.6.2 Review Input ................................................................................ 23 5.6.3 Review Output .............................................................................. 23 Applicable Documents Chapter 5 .......................................................... 24 NUMBER: QPM001
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6 RESOURCE MANAGEMENT ................................................................... 24 6.1 PROVISION OF RESOURCES ........................................................................ 24 6.2 HUMAN RESOURCES ................................................................................ 24 6.2.1 General........................................................................................ 24 6.2.2 Competence, Awareness and Training .............................................. 25 6.3 INFRASTRUCTURE ................................................................................... 25 6.4 WORK ENVIRONMENT ............................................................................... 26 Applicable Documents Chapter 6 .......................................................... 27 7 PRODUCT REALIZATION ..................................................................... 27 7.1 PLANNING AND PRODUCT REALIZATION .......................................................... 27 7.2 CUSTOMER RELATED PROCESS .................................................................... 29 7.2.1 Determination Of Requirements Related To The Product ...................... 29 7.2.2 Review Of Requirements Related To The Product................................ 30 7.2.3 Customer Communication ............................................................... 30 Applicable Documents Chapter 7.1 & 7.2 ............................................... 31 7.3 DESIGN AND DEVELOPMENT ....................................................................... 32 7.3.1 Design And Development Planning ................................................... 32 7.3.2 Design And Development Inputs ...................................................... 33 7.3.3 Design And Development Outputs .................................................... 33 7.3.4 Design And Development Reviews ................................................... 33 7.3.5 Design and Development Verification ............................................... 34 7.3.6 Design And Development Validation. ................................................ 34 Applicable Documents Chapter 7.3 ........................................................ 35 7.4 PURCHASING ......................................................................................... 36 7.4.1 Purchasing Process ........................................................................ 36 7.4.2 Purchasing Information .................................................................. 37 7.4.3 Verification of purchased product ..................................................... 37 Applicable Documents Chapter 7.4 ........................................................ 38 7.5 PRODUCTION AND SERVICE PROVISION ......................................................... 38 7.5.1 Control Of Production And Service Provision ...................................... 38 7.5.2 Validation Of Processes For Production And Service Provision. .............. 41 7.5.3 Identification And Traceability ......................................................... 41 7.5.4 Customer Property ........................................................................ 43 7.5.5 Preservation Of Product .................................................................. 44 7.5.5.1 Handling ............................................................................ 44 7.5.5.2 Storage.............................................................................. 44 7.5.5.3 Packaging .......................................................................... 44 7.5.5.4 Preservation ....................................................................... 44 7.5.5.5 Delivery ............................................................................. 45 Applicable Documents Chapter 7.5 ........................................................ 45 7.6 CONTROL OF MONITORING AND MEASURING DEVICES ........................................ 46 Applicable Documents Chapter 7.6 ........................................................ 47 8 MEASUREMENT, ANALYSES AND IMPROVEMENT................................. 47 8.1 GENERAL ............................................................................................. 47 8.2 MONITORING AND MEASUREMENT ................................................................ 48 8.2.1 Customer Satisfaction .................................................................... 48 NUMBER: QPM001
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8.2.2 Internal Audits .............................................................................. 48 8.2.3 Monitoring And Measurement Of Processes ....................................... 49 8.2.4 Monitoring And Measurement Of Product .......................................... 49 8.3 CONTROL OF NONCONFORMING PRODUCT....................................................... 50 8.4 ANALYSES OF DATA ................................................................................ 50 8.5 IMPROVEMENT ....................................................................................... 50 8.5.1 Continual Improvement .................................................................. 50 8.5.2 Corrective Action ........................................................................... 51 8.5.3 Preventive Action .......................................................................... 51 Applicable Documents Chapter 8 .......................................................... 52 NUMBER: QPM001
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0
INTRODUCTION
Elma 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. Elma
offers 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.
Elma is the industry expert in standard and custom design of high speed
backplane with applications catering to the computing needs of various
industries like Telecom, Aerospace, Defense, Semi conductors etc. The
standard product portfolio includes both Industry Standard architectures like
AdvancedTCA, MicroTCA, Compact PCI/2.16 and VITA based architectures
like VME, VME64x, VXI, VXS and recently VPX. Elma is also capable of
developing custom backplanes to meet customer specifications, from initial
concept to finished product. It was decided to merge Elma Bustronic Corp
into EEI in late 2013 since the Eco system of both the companies are the
same and the board level products manufactured at Elma Bustronic are being
used in various system offerings at EEI. This merge took place on July 1st
2014 and hence the QA Manual is being revised for the combined entity. The
current Quality policy at EEI has been retained for the combined entity.
However the operating procedures ( Level 2 Documents ) and Forms as well
as Level 3 documents ( Process instructions ) for the backplane portion has
been retained in most cases since , either the process is specific to
backplanes or to lessen the impact of the change to daily operations in the
transition period ( July to Dec 2014).
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.
EEI‘squalitymanagementsystemwasauditedin2011intwostagesforcomplianceto
AS9100CrequirementsandwascertifiedtobecompliantinNov2011afterthestage
2audit.ThecurrentscopeoftheQualityManagementsystemandcertificationis
shownbelow.
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ElmaBustronic’squalitymanagementsystemwasauditedin2012intwostagesfor
compliancetoAS9100CrequirementsandwascertifiedinJan2013afterstage2
auditcompletion.ThescopeoftheQMSisalsoshownbelow.
ThisQualitymanualwillthereforeserveasaparentdocumentthatoutlinestheQMS
incompliancewithboththeISO9001:2008andtheAS9100RevCstandardforthe
newentity.
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1.0
Scope
1.1
General
Thescopeoftheregistrationforthecombinedentitywillbe–
Design,manufactureanddistributionofcomputingsolutions,enclosures,high
performancebackplanes,electronicboardsandrotarycomponents.
The primary purpose of this manual is to describe and document the quality
management system currently in practice at Elma Electronic Inc. This manual
is 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 all
customers, 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
AS9100C standards.
1.2
Application
Elma Electronic Inc did not exclude any requirements of the ISO 9001:2008
STD.
HoweverwithregardstotheAS9100Crequirements,itistobenotedthatonlyasmall
percentageofordersexecutedfortheMil/Aeroindustryarecontractuallyrequired
tobecompliantwiththeAS9100STD.
Giventhissituation,andtakingintocognizancetheneedtobecostcompetitiveona
vastmajorityofotherorders,thecompanyhaschosentobefullycomplianton
AS9100Cstandard’sspecificrequirementsonapplicableMil/Aerocontractswhile
stillcomplyingwiththesespecificrequirementsonabasiclevelforallother
commercialandQuasiMilorders.
ExceptionstoAS9100Crequirements
ElmaElectronicIncisnottakinganyexceptionstotheAS9100Crequirementsother
thantostatethatitemsd)ande)ofSection7.5.1.4–Postdeliverysupport arenot
applicableasitrelatestoaircraftmaintenance.
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2.0
Normative Reference
This quality manual acts as a normative document for the rest of the quality
system. For undated references, the latest edition of the normative document
referred to applies.
3.0
Terms, Abbreviations and Definitions
3.0.1
QPM (Quality Program Manual)
ELMA’s previous term of the Quality Manual.
3.0.2
QMS (Quality Management system)
3.0.3
QMIS (Quality Management Information System)
The QMIS is an Intranet based information system that links all information
around ELMA’s Quality Management System.
3.0.4
EESP (Elma ELECTRONIC STANDARD PROCEDURE)
All procedures start with EESP followed by a number and revision index. E.g.
EESP-110A.
For Backplanes and board related product, procedures and work instructions
in Engineering, Manufacturing and Quality has the nomenclature starting with
the dept followed by a number. E.g. ENP-101 (Engineering), QAP-100
(Quality), MFG-101 (Manufacturing) etc. Procedures in Sales department and
purchasing have been combined for respective departments.
3.0.5
EF (Elma FORM)
All forms starts with EF followed by a number and revision index.
E.g. EF-123A. For Backplanes related product, all forms have the
nomenclature starting with the department followed by a number. E.g. ENF101, QAF-101, MAF-101. All work instructions have similar nomenclature E.g.
EWI-101, QWI-101, MWI-101.
3.0.6
Supply Chain
The supply chain is defined as:
Supplier -> Organization -> Customer
4.0
Quality Management System
4.1
General Requirements
Elma Electronic Inc has established and maintains a documented process
based Quality Management System as described in this Quality manual. The
top management approach shall be to continually monitor and improve the
effectiveness of the QMS. To this effect the company has identified and
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implemented processes needed for the effective functioning and monitoring
of the QMS. The necessary resources have been deployed by way of having a
structured organization managed by various functional departments in the
organization. The functional departments ensure that customer requirements
are met while at the same time being in conformance with this Quality
Management System.
The sequence and interactions between these identified processes are
depicted in the illustration under 4.1.1.
Thecriteriaandmethodusedtomeasuretheeffectivenessoftheinteractionofthese
processesisbasedontheAS9101approachofProcessEffectivenessAssessmentand
isexplainedindetailinadocumentedprocedureEESP‐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 Std and the company’s quality policy. The quality
manual includes or makes reference to the quality management system
procedures, processes and measurements used in the quality management
system.
TheQMSisintendedtoensureproductconformancetocustomerrequirements,
nationalandinternationalstandardsaswellasanyapplicablestatutoryand
regulatoryrequirements.
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 and the B-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 and
monitoring of various processes takes place in each functional department.
The Organization 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 are
inspected in-house for compliance to specific requirements. The sheet metal
is in sourced 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.
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The outsourced processes on the backplanes side is mainly the fabrication of
the bare circuit boards to established and certified PCB board shops and
conformal coating on partially completed assemblies to established conformal
coating vendors . To ensure product conformity to customers and ELMA’s
design requirements, the controls exercised are in accordance with
documented procedures (EESP- 119 and ENP-101). These parts/ services
procured from these outsourced products are inspected in-house for
compliance to requirements.
4.1.1 - Continual Improvement of the Quality Management System.
ELMA’s Quality Management System incorporates a Quality policy as below
•
•
•
Awareness.
Commitment.
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.
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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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4.2
4.2.1
Documentation Requirements
General
The quality management system is structured in three levels.
Level One,
is documented in the form of a Quality Manual which contains the company
policies and method of implementation.
Level Two,
contains the standard operating procedures which encompass the day to day
routines carried out within the facility to insure consistency and compliance to
ISO 9001:2008 standard , AS9100C Standard and the quality policy.
Level Three,
is the specific function support documentation, forms, and logs.
All documents are available online at the QMIS-System and can be easily
accessed by all personnel. The awareness of the QMS to all employees is
ensured by way of structured annual trainings
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Applicable Documents 4.2.1
EF-101
EF-105
BF-001
BF-002
ISO 9001:2008
AS9100 REV C
Form Control Log
EESP Status Log
Forms related to backplane
Procedures related to backplanes
Quality Management System Requirement
Aerospace Standard for QMS
Remark: Please Review EF-101 and EF-105 for 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 at
the 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, Elma’s 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 actual
Quality Manual from our Homepage at:
HTTP://WWW.ELMA.COM.
Applicable Documents 4.2.2
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QUALITY MANUAL APPROVAL
Valarie Guinn
____________________________
Director, Materials
__________
Date
Badri Rajan
____________________________
VP, Manufacturing
_________
Date
David Cook
____________________________
Sr QA Manager
_________
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
Shan Morgan
____________________________
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 customer
drawings. Documents and data may be either in the form of hard copy or
electronic media.
SOP’s are controlled per procedure EESP-101. Other internal and external
documents are controlled per EESP-175 & QMP-003. 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, & Product Configuration Form.
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 knowledgepreservation 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.
The nature of the change shall be identified in the document or the
appropriate attachments.
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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 customer’s representative as required. QMP002.
Quality records include but are not limited to, Sales Order and Contracts,
Inspection & Test records, Non-conformances, Corrective and Preventive
Action, 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
PO’s
Preventive actions and Internal Quality Audits are employed in the
Management review process as noted in this manual.
Quality Records are
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Management Review
Quality Records (checklists, test reports, CofC’s, 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 & All Quality checklists –
AWO/MPI/Photo)
Positive Recall Records
Inspection, Measuring & Test Equipment (Calibration Records)
Non-conformance
Corrective Action
Internal Quality Audit
Training
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RMA Records
Applicable Documents Chapter 4
EESP-101
EESP-128
EESP-140
EESP-175
EF-101
EF-105
EF-128
EF-254
EF-248
QMP-002
QMP-003
QAF-119
SOP Copy Control (EESP&EF)
Document Request
Control of Records
Document Control
Form Master List (EF-xxx)
Procedure Master List (EESP-xxx)
Source Control Document
Standard Master List (ELMA, MIL, etc.)
Packaging Instruction Master List
Control of records (backplanes)
Control of documents (backplanes)
Master List Log
(Examples: Form Master List)
5
Management Responsibility
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5.1
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 its effectiveness by ƒ
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5.2
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
EnsuringCorrectiveandpreventiveactionsareinitiatedandimplemented
Conducting management reviews
Ensuring that quality objectives are established and monitored
Ensuring that the interactions of these processes are in accordance
with the QMS.
Ensuring that the key processes are monitored and assessed for
effectiveness periodically
Customer Focus
Executive Management ensures that customer requirements are determined and
met or exceeded with the aim of enhancing customer satisfaction.
The executive management team reviews the ‘On time delivery performance’
besides other Key metrics during the monthly review meetings and appropriate
actions are discussed if the results are not satisfactory.
Customer satisfaction is monitored by Sales Department and Quality
Management.
5.3
Quality Policy
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Executive Management of Elma Electronic Inc. has established the following
Quality Policy:
Awareness
Commitment
Improvement (through Process)
By this we mean,
“Awareness” of the importance of quality is a key element in our
daily activities at ELMA. We strive for excellence by practicing
completeness, accuracy, timeliness and by meeting expectations and
requirements in all our assignments.
We show “commitment” to quality in whatever we do. ELMA's
philosophy is that customers are our first priority and customer
satisfaction is achieved at all levels. Only a satisfied customer is a long
term customer. It is our goal to provide our customers with reliable
and economical products and solutions.
We understand that quality is a living matter. We continuously aim for
better quality by “improvement (through process)” and measuring
process effectiveness. We encourage improvements and suggestions
for improvements from our employees and business partners. This
continuous drive for improvements in our processes in turn ensures
the effectiveness of our quality management system.
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Elma Electronics’ quality policy is displayed in various locations
throughout the facility.
5.4
5.4.1
Planning
Quality Objectives
The processes that sustain the QMS must support the Quality Policy, improve the
effectiveness of the QMS as well as achieve the company’s corporate business
plan (Market leadership thru Customer focus, Growth and EBIT). An effective
quality management system will guide the company in achieving customer
satisfaction through on time delivery of competitive error free products and
services. The quality management system will provide for timely and effective
corrective action and provide a factual basis for continual improvement and
defect prevention.
As part of the QMS and in line with the corporate business plan, Elma Executive
Management sets quality objectives /goals for all key/ critical processes
including those that affect product quality and ‘on time’ delivery. These
processes are measured daily, analyzed monthly, and reviewed at periodic
intervals including the management review. This is available on QMIS and is the
primary tool deployed to drive actions for continuous improvement.
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:
ƒ Actual budget versus planned budget
ƒ Shipments versus bookings and backlog
ƒ Review of critical orders and projects.
ƒ Review of available resources.
ƒ Review of improvements
ƒ Forecasts
ƒ Review of KPI and Quality metrics
ƒ Miscellaneous topics
ƒ Implementing of necessary adjustments to achieve the fulfillment of
the yearly plan
ƒ Implementing of necessary adjustments to ensure the integrity of
the quality management system especially when changes to the
quality management system are planned and implemented
The review of the quality objectives and goals is done periodically at various
levels, in weekly MFG meeting, quarterly/semi-annually by the entire Mfg and
Quality team involving managers and finally in annual MR meeting with top
management.
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5.5
5.5.1
Responsibility, Authority and Communication
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 chart
and 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 designated
channels.
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.
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 Inc’s. 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 ISO9001:2008 and 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 Quality
Director/ Manager in this capacity reports directly to the President of Elma
Electronic Inc.
Promotion of awareness of customer requirements is communicated from Sales
department. The awareness takes place through documents like customer
specification, Engineering document, and 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 Inc’s. Executive management ensures that appropriate
communication process is established and maintained within Elma's
organization.
Information’s are distributed by (and / or)
ƒ Email
ƒ Postings at dedicated News area
ƒ Executive Management member and the team meetings
ƒ ELMA's Intranet system
ƒ Company meetings ( all hands meeting )
ƒ Elma’s quarterly newsletter
ƒ ELMA desktop
5.6
5.6.1
Management Review
General
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The quality management system shall be reviewed once a year by the President,
Vice President's and Functional Department Heads as required in conjunction
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 ISO9001:2008 standard and Elma
Electronics’ quality policy and objectives.
5.6.2
Review Input
The review shall address as a minimum the following:
ƒ Quality Policy
To ensure that it is still relevant to Elma Electronics’ current needs
ƒ 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 the
QMS
– Review of improvements initiated in each department for the current
year as objective evidence of living the Quality policy
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5.6.3
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 the
network drive. Records are retained for at least five (5) years and
may be disposed at the end of the retention period.
Review Output
The output of Elma's management review includes any decisions and actions
related to:
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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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Applicable Documents Chapter 5
EESP-109
EESP-110
EESP-140
EESP-148
EESP-151
EESP-152
EESP-199
EF-113
EF-115
EF-116
EF-279
QMIS
JDData
EESP- 227
QAP-107
QAP-102
QAP-115
QAP-108
QAF-101
QAF-112
QAF-113
QAF-127
QAP-116
Material Incoming Inspection
Corrective and Preventive Action
Quality Records
Inspection and Test Stamp Control
Internal Quality Audits
Management Quality System Review
Paint Chip Control
Internal Audit Report
Corrective Action Request
Corrective Action Request Log
Customer Corrective Action Request Log
QMIS-System (B-QMIS for backplanes)
Job Description Database
Process Effectiveness Measurement
Quality Control Inspection
Corrective and Preventive Action
Inspection and Test Stamp Control
Internal Quality Audits
Internal Audit Report
Corrective Action Request
Preventive Action Request
Corrective Action Request Log
Process Effectiveness Measurement
6 Resource Management
6.1
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
6.2.1
Human Resources
General
ELMA personnel performing work affecting product quality are competent on the
basis of appropriate education, training, skills and experience.
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6.2.2
Competence, Awareness and Training
All tasks within the Company, which are adversely affected by the lack of
acquired 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
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 for
retraining.
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
Infrastructure
ELMA’s 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 every
department. 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 tactical
support to the main stream manufacturing.
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This ME function is responsible for documentation of detailed process instructions
wherever warranted and feasible depending on the nature of the
product/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 coordinating equipment
maintenance and/or equipment repair.
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 ordinate 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 account
customer 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 Environment
The 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
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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
Applicable Documents Chapter 6
EESP-112
EESP-147
EESP-161
EF-168
EF-187-1
EF-187-2
EF-187-3
EF-228
ESD Handbook
WS-102
WS-103
WS-104
CRIMPCAL
MFGTRAINLOG
Assembly Work Order Creation (Process Control Production)
Employee on the Job Training
Manufacturing Procedure
Training Form
ESD Wrist Strap performance Log, MFG, QA
ESD Wrist Strap performance Log, Misc.
ESD Wrist Strap performance Log, Visitors
Workmanship Standard
ESD Handbook and Guidelines
Cosmetic Workmanship Standard
Cable and Harness Workmanship Standard
ELMA Wiring Guidelines
Crimping and Calibration Handbook
Manufacturing Training Log Sheet
MAP-101
ESD Handbook
QAP-111
QAF-104
Manufacturing Procedure
ESD Handbook and Guidelines
ESD Check sheet
Training Record
7 Product Realization
7.1
Planning and Product Realization
During the quoting and/or engineering design review process, Elma Electronic
will evaluate the customer’s 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 interpreted
and 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:
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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
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 subjective
elements;
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 Management
EEI has implemented project management to ensure product realization is achieved in a
structured and controlled to manner to meet requirements at acceptable risk and within
resource and schedule constraints.
Project management is performed on all system orders as documented in the procedure
listed below
Applicable documents –
EESP-221 - Program/ Project management procedure
ENP-102 - Program/ Project Management Procedure- Prototype Orders
MAP-104- Program/Project Management Procedure-Repeat Order
7.1.2
Risk Management-
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ELMA Electronic has established, implemented and maintains a documented process for
managing risk for the achievement of applicable requirements relevant to both the
organization as well as the products executed for specific orders. Risk management
process defines the risk criteria, assigns the responsibilities, identifies the risk and
associated mitigation action and manages the implementation of the mitigation actions.
Finally the residual risk remaining after the implementation of the mitigation actions are
evaluated and accepted. The records of the risk analysis and mitigation actions are
maintained in a defined format.
Applicable documents –
EESP-217 - Project Risk Management & Mitigation Procedure
EF- 380 – Risk Analysis & Mitigation record.
QAP-114 - Project Risk Management & Mitigation Procedure
QAF-125 – Risk Analysis & Mitigation record.
7.1.3
Configuration Management–
Configuration management has been established, implemented and maintained to
encompass configuration planning, identification, change control, configuration status
accounting and configuration audit.
Applicable documents –
EESP- 222
ENP-101 Design and Development Procedure
7.1.4
Control of work transfers
Elma Electronic has established and maintains a procedure that involves the planning and
control thereof for the temporary or permanent transfer of work from one facility to another,
from the organization to a supplier , from one supplier to another supplier and to verify the
conformity of the work done to requirements.
Applicable documents –
EESP – 225
QMP-004 Control of Work Transfers
7.2
7.2.1
Customer Related Process
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 by
Elma to ensure that:
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7.2.2
the requirements are adequately defined and documented including
requirements for delivery and post delivery
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, the Design Engineering
Group shall create the documentation that is needed to verify that
the input requirements have been met as applicable.
Review Of Requirements Related To The Product
Elma shall establish and maintain documented procedures for contract review
and for the coordination of these activities.
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 to show that Elma has the
capability to meet the contract or accepted order. Where the customer provides
no documented statement or requirements, the customer requirements shall be
obtained and 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. Any differences between the contract or accepted order,
PO requirements and those in the tender are resolved.
Where applicable a preliminary risk analysis is done to identify risks related to special
requirements, 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 has determined and implemented effective arrangements for
communicating with customers in relation to the product.
Sales is the primary source for
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Contracts
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Enquires, contracts or order handling, including amendments
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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
EESP-113
EESP-114
EESP-115
EESP-138
EESP-139
EESP-157
EESP-163
EESP-169
EESP-170
EESP-173
EESP-189
EF-109
EF-120
EF-122
EF-127
EF-157
EF-160
EF-161
EF-167
EF-172
EF-174
EF-180
EF-183
EF-184
EF-197
EF-211
EF-217
EF-218
EF-225
EF-226
EF-227
EF-229
EF-233
EF-239
EF-283
WS-102
SPECS
SAF-104
Customer communication
Project Impact Form
Offer Process
Contract Review And Order Process
Systems Returned Material Authorization
Returned Material Authorization – Component
Credit Memo
Account Receivable
Component Div. Quote Procedure
Quoting And Documenting For Custom Panel Or Part
Component Div. Procedure Order Entry
Stop Order
RMA Receipt Log
Order Work Sheet
Project Impact Form (PIF)
Component Sales Order Log
Order Expedite Delivery Form
Component Part Number Log
ELMA Part Number Naming Convention Reference
System Retune Material Authorization (RMA)
R.M.A. Receiving Inspection Checklist
Systems RMA Log
Corrective Action Report (Comp. Deviation)
Fax server Document Request
Marketing Materials Request
System Order Process Control Chart
C.O.D. Customer Information
Lost Order report
Offer Quality Checklist
Enclosure Specification
Terms And Conditions Of Sale And Limited Warranty
Reschedule/Cancellation Procedures Foe Built-To-Order-Parts
Standard Warranty Policy
Components Applications Request Form
Change Order Work Sheet
System Order Pricing Sheet
Cosmetic Workmanship Standard
Design Info’s, Guidelines, Specifications and Listings
Cal_Mod_BT_Template
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QAP-104
QAF-105
QAF-109
7.3
7.3.1
Returned Material Authorization
RMA Receipt Log
RMA Traveler
Design And Development
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 and
external 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.
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 customer’s 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 design
and to identify areas for new product development. Feedback may be provided
as validation, from but not limited to Elma Shop, Sales, and Production and
Quality departments to ensure producability, 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 be
conducted both internally and externally.
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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
o
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Applicable statutory and regulatory requirements.
Functional and performance requirements
Information from previous designs of a similar nature
Any other requirement essential to the design and development
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. Contract review
outcomes shall also be given consideration before releasing Design output.
7.3.3
Design And Development Outputs
The design and development outputs shall
•
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•
•
•
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
customer’s representative and if needed personnel from Manufacturing, Quality,
Sales and Purchasing.
Design outputs shall be in a format that clearly identifies the product to be
manufactured. 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.
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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 shall
include 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 shall be performed prior to
product delivery. All such results of the validation shall be maintained as
Quality records.
For the backplanes sold directly to the end customer, the design validation
for the products shall be performed at a system level by the end customer
after the prototype is delivered. Any feedback warranting changes is
incorporated either by way of upgrade to the delivered product (if feasible) or
on the next order.
7.3.6.1
Design and Development Verification and Validation testing
EEI shall plan and perform verification and validation tests where contractually
required. 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 configuration and
conditions, define how the tests are planned and controlled, resources used if any,
parameters to be recorded and relevant acceptance criteria. The actual performance of
the test is also described.
For backplanes, Electrical continuity testing is performed by the Backplane Division
before product is shipped. In most cases backplanes by themselves cannot be
functionally verified and validated. When backplanes are used in system platforms,
partial verification and validation is done during System level testing at Elma .The
complete verification and validation is typically performed by the end customer at the
system level. For custom designs and where contractually agreed upon, special test
fixtures are developed for electrical testing.
7.3.6.2
Design and Development Verification and Validation documentation
The Design Verification and Validation documentation of system platforms are in the
form of ATP, ESS and Qual test reports containing all of the information as defined in
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7.3.6.1. These shall be maintained as records to demonstrate that the product meets the
specification requirement for all identified operational conditions.
For backplanes sold directly to the customer, testing documentation for Verification and
Validation is generally available with the end customer since most of this data is
confidential and proprietary to the customer. A repeat order for the same product is
considered a successful verification and validation of the design.
Standard test documents per the Quality Assurance plan QAF-113 are attached to the
Manufacturing Traveler and archived in ‘shipped file’ cabinet.
7.3.6.3
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
Assembly Work Order Creation
EESP-112
EESP-118
New Part Number Entry
EESP-127
Drawing Development
Document Request
EESP-128
EESP-129
Engineering Change Request (ECN)
EESP-132
Develop Design Plan
Design/Documentation Change Request
EESP-133
EESP-134
Design Review
Drawing Redline
EESP-135
New Product Development
EESP-142
EESP-167
BOM Entry Requirement
Repeat Order Procedure
EESP-174
Document Control Coordinator Instruction
EESP-175
EESP-181
ECN Release Instruction For Document Control
Engineering Documentation Guidelines
EESP-188
Stop Order
EESP-189
EF-121
Assembly Work Order (AWO)
Source Control Document
EF-128
EF-140
Document Request
ECN
EF-143
EF-144
ECN-Log
Beta Test Record
EF-154
Design Guidelines
EF-158
EF-175
Design Review Record
Production Traveler
EF-196
Design Request
EF-214
AWO For Modified Standard/Repeat Orders
EF-235
EF-238
Design & Development Plan
ESD Handbook ESD Handbook
CRIMPCAL Crimping and Calibration Handbook
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ENP-101
ENP-102
ENP-103
ENF-101
ENF-102
ENF-103
ENF-104
ENF-107
ENF-109
ENF-111
ENF-112
ENF-113
ENF-114
ENF-115
ENF-116
ENF-117
ENF-122
ENF-119
ENF-120
ENF-121
ENW-101
ENF-123
ENF-124
ENF-126
ENF-127
SAF-110
7.4
7.4.1
Design & Development
Program management
Verification test procedure for backplane continuity.
Design Review and Approval
Design & Development Plan
Design Document Change request
Engineering Notification
Backplane Report
New Design Review & Verification Record
Design Overview
Deviation Log
Deviation Form
Rework Log
Rework Form
Part Request Form
Purchase Alert
Advance ordering form
Design Review Record
EN Log
Continuity Test Report
Work Instructions for Part Number Assignment
Design release form
Design verification checklist
Fab Quote Sheet
Specification Form
Project Impact form
Purchasing
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 onsite survey of the supplier
or may request completion of the supplier survey by a qualified supplier
representative.
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Elma’s supplier survey is designed to assess the effectiveness of the supplier’s
quality system. Elma will also use other methods for determining a supplier’s
ability 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.
Supplier surveys and supplier attachments will be maintained on file and will be
updated periodically. The frequency of supplier audits is dependent upon the
supplier’s 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 classified as
Approved, Conditionally Approved and Disapproved. All critical suppliers are tracked for their
performance and score cards maintained. The Purchasing procedures detail the extent of
controls on these suppliers, the purchased product as well as the process, responsibilities and
authority of approval status decision, changes of approval status and the controlled use of
suppliers 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 product
required (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 supplier’s 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 customer’s 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
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responsibility for the verification and control of materials utilized in the
manufacture of our product.
Applicable Documents Chapter 7.4
EESP-102
EESP-103
EESP-106
EESP-119
EESP-126
EESP-143
EESP-144
EESP-145
EESP-177
EESP-178
EESP-189
EF-110
EF-111
EF-112
EF-129
EF-147
EF-148
EF-212
EF-224
EF-248
EF-277
WS-102
ESD Handbook
ROI
QAP-107
QAP-106
QAF-104
WHP-101
PMP-101
WHP-106
WHP-104
WHP-105
WHP-103
QATS
WHF-106
QAF-128
PMF-104
7.5
7.5.1
Material Receipt
Handling Of Non-Conforming Material
Control Of Customer Supplied Material
Purchasing
Kit Picking
Material Storage and Handling
Packing And Shipping
Limited Life Time Materials
Kit Pulling
Cycle Count
Stop Order
Miscellaneous Item Receiving Log
Incoming Inspection Stamp
Non Conforming Material Report
Material Requisition Form
Work Order Label
Kit Issue Log
Shipping Log
Supplier Self Assessment Questionnaire
Packaging Instruction Master Log
Cycle Count Order Worksheet
Cosmetic Workmanship Standard
ESD Handbook & Guidelines
Approved Supplier List (ROI LIST, MRP-System)
Quality Control
Non-Conforming Material
Receiving Inspection Log
Control Of Customer Supplied Material
Purchasing
Kit Picking
Material Storage and Handling
Packing And Shipping
Cycle Count
Non Conforming Material Report
Material Requisition Form
Vendor Performance Evaluation Record
Vendor Master List
Production And Service Provision
Control Of Production And Service Provision
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Production will be carried out against schedules, which take into account
customer 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 work order routings ,
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 the
assessment 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 the
customer 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 Elma’s
standard shipping procedures, or by customers specified shipping instructions.
Elma will utilize Elma’s approved shipping carriers only, based on customer
requirements, and will promote safe transit of product to its receiving
destination.
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In line with the Company mission and its total commitment to quality, ELMA
ELECTRONIC INC. seeks to provide for its customers continued product support
and 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 future
needs.
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
All production processes shall be verified by an inprocess inspection by the
manufacturing personnel followed by final inspection by the QA inspector. For
backplanes SMT and manual solder processes shall be verified by the in-process QA
Inspector / AOI to ensure components are installed per drawing and BOM
specifications. Installation of press-fit, through-hole and hardware are verified by the
final QA inspector per drawing and BOM specifications. Where applicable and
contractually required a representative item from the first production run of a new part
or assembly is verified to ensure that the production processes, production
documentation and tooling are capable of producing the parts and assemblies to
conform to specified requirements. This is called as ‘ First article verification ‘
process and is repeated if there are any changes to design , mfg process or in toolings.
Applicable documents –
EESP-218 – First article verification procedure
EF-118 - First article verification record
AS9102 - FAV in Aerospace defined formats when contractually flowed down
MAP-101 - MFG Traveler
QAF-103 - General Quality Checklist
QAF-107 - Final Inspection Log
QAF-108 - In-Process Inspection
QAF-110 - Certification of Conformance
QAF-120 - SMT Sub-Assy Checklist
QAF-138 - AOI Inspection Verification and Software Operation Verification
QAP–112 - First Article Inspection Procedure
QAF-117 - First Article Report
7.5.1.2
Control of Production process changes –
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The Manufacturing Engineering function is responsible for approving
changes to production processes as well as control and document changes
affecting process to ensure product is conforming to requirements .
Applicable documents –
EESP – 226 Control of production process changes
MAP-103 Control of production process changes
7.5.1.3
Control of production equipment , tools and software program.
Production equipment , tools and software program used to automate
and control / monitor product realization processes are controlled per
documented procedure below . Any storage and preservation conditions
for production equipment or tooling in storage is defined and followed per
this procedure
Applicable documents –
EESP-224 – Control of production equipment , tools & non deliverable
software
QMP–005 Control of production equipment, tools & non deliverable
software
ENF-128 Test Equipment Software Validation Record
QAF-138 AOI Inspection Verification and Software Operation
verification
7.5.1.4
Post delivery support
ELMA Electronic Inc takes exception to d and e of this clause of the
AS9100C STD
7.5.2
Validation Of Processes For Production And Service Provision.
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..
For Backplanes and electronic boards the process and process control
Instructions that ensure quality include workmanship criteria, identification of
the equipment to be used and make reference to visual aids, sample. Where
applicable AOI and X-ray inspection process is performed as part of in-process
and final inspection to validate workmanship quality .
7.5.3
Identification And Traceability
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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 model
Number, 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.
For backplanes all finished products will be individually identified by both a Part
Number and serial number to enable full product history to be traced. Part
number, serial number, and Work Order for all products are recorded on the
Final Inspection Log.
Where identified as FRU’s by Engineering department , sub assemblies shall be
traceable by virtue of being built on separate WO’s and issued to the parent
WO. Where applicable these FRU’s/ 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 inspections
and tests have been carried out with satisfactory results.
No product will be shipped unless the quality standards and activities as outlined
in Elma’s 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
inspector’s stamp of acceptance on materials inspected, incoming inspection
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 operator’s signature or initials performing the test. These
records shall be attached to the assembly work order package. Final inspection
and test records shall have the inspector’s signature/stamp and date on the
traveler of the product inspected.
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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
production for repair or replacement. The assembler or inspector will generate
non-conforming material reports. Refer to section 8.3 of this manual for nonconforming 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.
Applicable documents –
EESP-148 – Inspection test stamp control
EESP-176 – Final inspection procedure
MAP-101
Manufacturing procedure
QAP-107
Quality Control procedure
QAP-109
Identification and Traceability
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 stored
in 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.
Applicable documents –
WHP-101 Control of Customer Supplied Material
PMP-101 Purchasing Procedure
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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 housekeeping and
cleanliness , prevention of FOD , ESD precautions , shelf life control and special
safety labeling/ handling for hazardous substances whichever is applicable .
Applicable documents –
EESP-143 – Material storage and handling
EESP-145 - Limited life materials
EESP-140 – ESD damage prevention
EESP- 210- FOD prevention
WHP-104 Material storage and handling
QMP-006
ESD damage prevention
QMP-007
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 manner
in 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 Elma
approved 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.
Applicable documents –
WHP-105
7.5.5.4
Packaging and Shipping
Preservation
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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
Delivery or shipment of product will be conducted in accordance with Elma’s
standard shipping procedures, or by customer specified shipping instructions.
Elma will utilize Elma’s approved shipping carriers only, based on customer
requirements, and will promote safe transit of product to its receiving
destination.
Applicable Documents Chapter 7.5
EESP-102
EESP-103
EESP-106
EESP-125
EESP-126
EESP-143
EESP-144
EESP-145
EESP-147
EESP-150
EESP-161
EESP-177
EESP-182
EESP-183
EESP-184
EESP-185
EESP-186
EESP-187
EESP-192
EESP-193
EF-118
EF-119
EF-124
EF-125
EF-132
EF-148
EF-156
EF-166
EF-194
EF-195
EF-207
EF-208
EF-212
EF-216
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Material Receipt
Handling Of Non-Conforming Material
Control Of Customer Supplied Material
Work Order Release
Kit Picking
Material Storage and Handling
Packing And Shipping
Limited Life Time Materials
Employee On The Job Training
Equipment Maintenance
Manufacturing Procedure
Kit Pulling
Production Scheduling
Change Order Worksheet
Manufacturing Process Planning
Test Fixture Validation
Harness Work Orders
Custom Front Panel Processing Procedure
Wire Harness Preparation
Hi Pot And Continuity Test
First Article Inspection Report
Incoming Inspection History Report
Material Requirements Hot List
System Order Entry Log
HiPot Test Report
Kit Issue Log
Sheet Metal Manufacturability Review
Design/Documentation Change Request
Shop Order Request Form
Shop Traveler Request Form
QC Receiving Log
Power Test Report
Shipping Log
HIPOT Test Report
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EF-228
EF-229
EF-232
EF-234
EF-237
EF-243
EF-246
EF-247
EF-248
EF-252
EF-266
EF-324
WS-102
ESD Handbook
7.6
Workmanship Standard
Standard Warranty Policy
Workmanship Standard Manual Issue Record
Equipment Maintenance Record
Man Hour Spread Sheet
General Manufacturing Checklist
Paint Chip Control Log
Inspection Documentation Master Log
Packaging Instruction Master Log
Cover Sheet, Final Acceptance Test Report
ESD Inspection Log Sheet
Acceptance Test Procedure (APT)
Cosmetic Workmanship Standard
ESD Handbook & Guidelines
Control Of Monitoring And Measuring Devices
Procedures 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 the measurement
certainty is known and is consistent with the required measurement capability.
An online data base available on respective QMIS’s , 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. The
frequency 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 a
requirement specified by the customer or customer’s 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 callin 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.
Applicable Documents Chapter 7.6
EESP-131
EF-149
EF-151
EF-222
EF-223
EF-272
EF-311
CRIMPCAL
QAP-103
QAF-116
QAF-118
QAF-121
Control of Inspection, Measuring, and Test Equipment
Equipment Calibration Record
Equipment Out of Calibration Evaluation
Air/Electric Tool Calibration Sheet
Wire Crimping Tool Calibration Sheet
Calibration Tool List Fremont
Wire Stripper Calibration Sheet
Crimping and Calibration Handbook
Control of Calibration
Tool Calibration Record
Equipment Out of Calibration Evaluation
Air/Electric Tool Calibration Sheet
8 Measurement, Analyses And Improvement
8.1
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 the
following sources:
•
A manager requests that a product or process problem be
analyzed using statistical techniques,
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•
•
The Material Review Board reviews nonconforming product and
request a statistical analysis, or
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
8.2.1
Monitoring And Measurement
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 and
displayed 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 & QAP-116 .
As part of the Quality system the Exec Mgmt team shall review key performance
indicators and assess the process effectiveness at the overall operational level
related to customer satisfaction like OTD and High level Quality ( based on
product returns ) in line with the PEAR procedure EESP-227 & QAP-116.
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
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be audited. The audits shall be conducted by personnel independent of those
having direct responsibility for the activities being audited.
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 continues
to ensure the quality of the outgoing 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 the
product realization process.
The measurement requirements for the products shall be documented in
relevant forms (EF,ENF,MAF,QMF etc ) that defines what is measured ,
acceptance criteria as well 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 Product
All 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 nonconformance’s will be maintained and will be periodically
reviewed to establish trends and thereby determine the need for further
preventative action.
Material which does not conform to the customer's specification will only be used
or supplied with the customer's prior knowledge and written consent.
It is the responsibility of all personnel detecting a non-conformance to ensure
that this is properly identified, segregated and reported.
The responsibilities for determining corrective action and disposition of nonconforming material are defined in the procedures which implement this policy.
8.4
Analyses Of Data
The QMS at Elma Electronic Inc incorporates a structured process of collecting
and analyzing inspection data at defined stages in the manufacturing process as
well as vendor performance data , on time delivery data , post delivery data (
RMA’s )and customer feedback/ satisfaction. The results are compared against
monthly and annual goals and posted on the QMIS system on a monthly basis.
This demonstrates the effectiveness of the QMS.
Statistical techniques for verifying process capability and product characteristics
are applicable and performed only for continuous volume production and / or
when there is a clear and continuous trend observed in nonconforming product
/process.
Quality goals are defined and addressed at least once a year during the annual
management reviews.
8.5
8.5.1
Improvement
Continual Improvement
Elma is continually improving the effectiveness of the quality management
system through the use of quality policy, quality objectives, audit results,
analysis of data, corrective and preventive actions and management review.
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The top management’s commitment to the quality system and its quality policy
of continuous improvements in processes shall be demonstrated by a listing of
continuous improvements achieved in each departments during the year and
reviewed in the management review meeting. The same shall be documented in
the QMR document . In addition to this the top management shall identify and
recommend areas of planned improvements for the next year in the MR meeting
which shall also be documented and implemented by the functional heads .
Elma will establish and maintain documented procedures for implementing
corrective and preventive action.
Any corrective or preventive action taken to eliminate the causes of actual or
potential nonconformities shall be to a degree appropriate to the magnitude of
problems and commensurate with the risks encountered.
Elma shall implement and record any changes to the documented procedures
resulting from corrective and preventive action.
8.5.2
Corrective Action
Elma’s procedures for corrective action shall include:
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8.5.3
The effective handling of customer complaints and reports of product
nonconformities
Investigation of the cause of nonconformities relating to product,
process, and quality system, and recording the results of the
investigation
Determination of the corrective action needed to eliminate the cause of
nonconformities
Application of controls to ensure that corrective action is taken and that
it is effective.
Flowing down Corrective actions to the supplier when warranted
Specific actions when timely CA’s are not achieved
Preventive Action
Elma’s procedures for preventive action shall include:
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The use of appropriate sources of information such as processes and
work instructions which affect product quality, audit results, quality
records, service reports, and customer complaints to detect, analyze, and
eliminate potential causes of nonconformities
Determination of the steps needed to deal with any problems requiring
preventive action
Initiation of preventive action and application of controls to ensure that it
is effective
Confirmation that relevant information on actions taken is submitted for
management review.
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QUALITY MANUAL ISO 9001-2008 & AS9100 REV C
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Conducting risk analysis on applicable projects to prevent any potential
negative impact on product functionality or schedule .
Applicable Documents Chapter 8
EESP-103
EESP-110
EESP-140
EESP-147
EESP-151
EESP-176
EESP-189
EESP-190
EF-113
EF-123
EF-293
QMIS
Handling of Non-conforming Materials
Corrective and Preventive Action
Quality Records
Employee On The Job Training
Internal Quality Audits
Final Test And Inspection
Stop Order
Customer Service Survey Process
Audit report Form
Audit Check List
Customer Service Survey
QMIS System
QAP-106
QAP-102
QAP-108
QAP-107
Non-conforming Materials
Corrective and Preventive Action
Internal Quality Audits
Quality Control
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