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QUALITY MANUAL ISO 9001-2008

OPTIMA STANTRON Corp.


QUALITY MANUAL

ISO 9001:2008
This manual is governed by comprehensive documentation as referenced herein.
Procedures, practices, forms, drawings, and similar documentation used by
organizations whose direct or supportive participation in processes affect product
quality, are formally documented and controlled. All such documents are contained
in readily identifiable, easily accessible through Optima’s intranet based (Optima
Quality Management Information System) at any work station. "The right
information at the right time!"

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Table of Contents

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

1.0 SCOPE .................................................................................................. 5


1.1 GENERAL...........................................................................................5
1.2 APPLICATION .....................................................................................6
2.0 NORMATIVE REFERENCE ...................................................................... 6

3.0 TERMS, ABBREVIATIONS AND DEFINITIONS........................................ 6


3.0.1 QPM (Quality Program Manual) ...................................................6
3.0.2 OQMIS (Quality Management Information System) ........................6
3.0.3 Instructions ..............................................................................6
3.0.4 Procedures ...............................................................................6
3.0.5 Forms ......................................................................................6
3.0.6 Supply Chain ............................................................................6
4.0 QUALITY MANAGEMENT SYSTEM .......................................................... 7
4.1 GENERAL REQUIREMENTS ...................................................................7
4.2 DOCUMENTATION REQUIREMENTS .......................................................8
4.2.1 GENERAL ....................................................................................8
4.2.2 QUALITY MANUAL ........................................................................9
4.2.3 CONTROL OF DOCUMENTS .......................................................... 11
4.2.3.1 GENERAL ............................................................................ 11
4.2.3.2 DOCUMENT APPROVAL AND ISSUE ......................................... 11
4.2.3.3 DOCUMENT CHANGES/MODIFICATIONS .................................. 12
4.2.4 CONTROL OF RECORDS .............................................................. 12
5 MANAGEMENT RESPONSIBILITY ........................................................ 13
5.1 MANAGEMENT COMMITMENT ............................................................. 13
5.2 CUSTOMER FOCUS ........................................................................... 14
5.3 QUALITY POLICY .............................................................................. 15
5.4 PLANNING ....................................................................................... 16
5.4.1 QUALITY OBJECTIVES ................................................................. 16
5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING .................................. 16
5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION ....................................... 17
5.5.1 Responsibility and Authority ........................................................ 17
5.5.2 Management Representative........................................................ 17
5.5.3 Internal Communication .............................................................. 19
5.6 MANAGEMENT REVIEW ........................................................................... 19
5.6.1 General ..................................................................................... 19
5.6.2 Review Input ............................................................................. 19
5.6.3 Review Output ........................................................................... 20

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Applicable Documents Chapter 5 ........................................................... 20


6 RESOURCE MANAGEMENT ................................................................... 21
6.1 PROVISION OF RESOURCES ..................................................................... 21
6.2 HUMAN RESOURCES ............................................................................. 21
6.2.1 General ..................................................................................... 21
6.2.2 Competence, Awareness and Training ........................................... 21
6.3 INFRASTRUCTURE................................................................................. 22
6.4 WORK ENVIRONMENT ............................................................................ 23
Applicable Documents Chapter 6 ........................................................... 23
7 PRODUCT REALIZATION ..................................................................... 24
7.1 PLANNING AND PRODUCT REALIZATION....................................................... 24
7.2 CUSTOMER RELATED PROCESS ................................................................. 24
7.2.1 Determination of Requirements Related To the Product ................... 24
7.2.2 Review of Requirements Related To the Product ............................. 25
7.2.3 Customer communication ............................................................ 25
Applicable Documents Chapter 7.1 & 7.2 ................................................ 26
7.3 DESIGN AND DEVELOPMENT .................................................................... 26
7.3.1 Design and Development Planning ................................................ 26
7.3.2 Design and Development Inputs................................................... 27
7.3.3 Design and Development Outputs ................................................ 27
7.3.4 Design and Development Reviews ................................................ 28
7.3.5 Design and Development Verification ............................................ 28
7.3.6 Design and Development Validation .............................................. 28
7.3.7 Control of Design and Development Design Changes ...................... 28
Applicable Documents Chapter 7.3 ........................................................ 29
7.4 PURCHASING ...................................................................................... 29
7.4.1 Purchasing Process ..................................................................... 29
7.4.2 Purchasing Information ............................................................... 30
7.4.3 Verification of purchased product ................................................. 30
Applicable Documents Chapter 7.4 ........................................................ 31
7.5 PRODUCTION AND SERVICE PROVISION ...................................................... 31
7.5.1 Control of Production and Service Provision ................................... 31
7.5.2 Validation of Processes for Production and Service Provision ............ 32
7.5.3 Identification and Traceability ...................................................... 32
7.5.4 Customer Property ..................................................................... 33
7.5.5 Preservation of Product ............................................................... 33
7.5.5.1 Handling ............................................................................. 34
7.5.5.2 Storage ............................................................................... 34
7.5.5.3 Packaging............................................................................ 34
7.5.5.4 Preservation ........................................................................ 34
7.5.5.5 Delivery .............................................................................. 34
Applicable Documents Chapter 7.5 ........................................................ 34
7.6 CONTROL OF MONITORING AND MEASURING DEVICES .................................... 35
Applicable Documents Chapter 7.6 ........................................................ 36
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8 MEASUREMENT, ANALYSES AND IMPROVEMENT ................................ 37


8.1 GENERAL........................................................................................... 37
8.2 MONITORING AND MEASUREMENT ............................................................. 37
8.2.1 Customer Satisfaction ................................................................. 37
Applicable Documents Chapter 8.2.1 ...................................................... 37
8.2.2 Internal Audits ........................................................................... 38
8.2.3 Monitoring And Measurement Of Processes .................................... 38
8.2.4 Monitoring And Measurement Of Product ....................................... 38
8.3 CONTROL OF NONCONFORMING PRODUCT ................................................... 39
8.4 ANALYSES OF DATA .............................................................................. 39
8.5 IMPROVEMENT .................................................................................... 40
8.5.1 Continual Improvement .............................................................. 40
8.5.2 Corrective Action ........................................................................ 40
8.5.3 Preventive Action ....................................................................... 40
Applicable Documents Chapter 8 ........................................................... 41

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0 INTRODUCTION
Optima Electronic Packaging Systems was established in 1962 as a
Division of Scientific Atlanta to provide attractive, high quality enclosures
for the electronics industry.

Optima EPS manufactures a large range of electronic packaging systems.


Products and services include vertical cabinets, consoles, instrument cases
and cabinets, desk systems, and engineering design capabilities for
prototypes or special needs.

In 2004 Optima EPS was acquired by Elma Electronics Inc., a global


manufacturer of electronic packaging products and rotary components.

In 2012 Optima EPS change its name to Optima Stantron due to the
acquisition of Stantron Broadcast Cabinets and APW Mayville Datacenter
Cabinets.

This manual supersedes the Optima E.P.S. Quality Assurance Program


Manual dated January 27, 2009.

1.0 SCOPE
1.1 GENERAL

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


quality management system currently in practice at Optima Stantron
Corp. This manual is the central source of general policies and procedures
that in turn authorize and govern creation of subsidiary related
documentation and activities. This manual provides comprehensive
evidence to all customers, suppliers, and employees that Optima Stantron
Corp. is committed to establishing and maintaining acceptable levels of
measurable quality in its products, processes. Optima Stantron is
committed to continuously review and improve the effectiveness of the
Quality Management System to meet customer requirements and enhance
customer satisfaction.
The requirements and procedures addressed in this manual are intended
to meet the requirements of ISO 9001:2008 and customer specifications.

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1.2 APPLICATION

Optima Stantron Corp. does not provide servicing or post-delivery


activities as maintenance services, installation of equipment or recycling
but under contractual obligations Optima offers warranty provisions when
needed or if required by the customer.

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


For the purposes of this International Standard, the terms, abbreviations
and definitions given in ISO 9001-2008 apply.

3.0.1 QPM (Quality Program Manual)


Optima’s term for Quality manual

3.0.2 OQMIS (Quality Management Information System)

3.0.3 Instructions
start with Department followed by a number e.g. PUR-I, MFI, and QAI.

3.0.4 Procedures
start with Department followed by a number e.g. QAP, SDP, and ENG.

3.0.5 Forms
start with Department followed by number then a revision e.g.ENG-FR, SDF,
and Form QC.

3.0.6 Supply Chain


The supply chain is defined as:
Supplier -> Organization - > Customer

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4.0 Quality Management System


4.1 GENERAL REQUIREMENTS

Optima Stantron Corp. has established and maintains a documented


process based in the Quality Management System as described in this
Quality Manual. The top management approach shall continuously
monitor and improve the effectiveness of the QMS. To this effect the
company has identified and 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 documented Quality Management System incorporates standard


operating procedures which define criteria and methods that ensure
operations and control of these processes, in accordance with the
requirements of the International Standard Organization, ISO
9001:2008.

Optima Stantron also defines quality objectives and goals which are
monitored periodically.

Optima Stantron Corp has in place an organization with adequate


resources infrastructure to ensure that operations and monitoring of
various processes takes place in each functional department. The
organization chart is depicted in sec 5.5.2

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4.2 DOCUMENTATION REQUIREMENTS

4.2.1 GENERAL
The quality management system is structured in three levels.

Level One,
Documentation 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 and the quality policy.

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Level Three,
Specific function support documentation, forms, and logs.

All documents are available online at the OQMIS-System.

Applicable Documents 4.2.1

OP-100 Master List for Procedures and Work Instructions


OF-101 Master List for Forms

4.2.2 QUALITY MANUAL

The Quality Manager is responsible for the issuing 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 the organizations or persons at


the discretion of the Quality Assurance Manager. This will be current at
the date of issue only and will not be subject to amendment action. These
copies will be annotated by “Uncontrolled Copy”.

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


requirements of the ISO 9001:2008 standard, Optima’s quality
requirements, and those of our customers. Revisions to this manual will
be reviewed and approved for use by at least the Quality Director and
Quality Assurance Manager. Updates of linked documents will be
implemented without changing the revision level of the actual manual.

Customers and Partners are welcome to download the actual


Quality Manual from our Homepage at:

WWW.ELMA.COM

Applicable Documents 4.2.2

QPM001 Quality Manual ISO 9001:2008

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QUALITY MANUAL APPROVAL

David Speak
------------------------------- -----------------------
Senior Manyfacturing Manager Date

Ron Hall
-------------------------------- ------------------------
Director of Sales Date

Urs Mangold
-------------------------------- ------------------------
Engineering Manager Date

Carmen Theumer
------------------------------- ------------------------
Quality Manager Date

David Cook

-------------------------------- --------------------------
Senior Quality Manager Date

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4.2.3 CONTROL OF DOCUMENTS

A. PURPOSE AND SCOPE

1.) This section describes the company policy for document and data
control, including, to the extent applicable, documents of external
origin such as standards and customer drawings. Engineering drawings
and specifications are controlled by the Engineering Department.

2.) Documents and data can be in the form of any type of media, such as
hard copy or electronic media.

B. RESPONSIBILITY

1.) The Quality Assurance Manager is responsible for setting standards for
document preparation, approval, release, and change.

2.) The Quality Assurance Manager is responsible for maintaining master


files of current documents for all departments except Engineering and
Human Resources.

3.) Human Resources is responsible for maintaining master files of current


documents for all Human Resources Procedures and Job Descriptions.

4.) The Engineering Manager is responsible for document and data control
in the Engineering Department.

4.2.3.1 GENERAL

Documented procedures to control all documents and data that relate to


the requirements of this Quality System including, to the extent
applicable, documents of external origin such as standards and customer
drawings, shall be established and maintained.

4.2.3.2 DOCUMENT APPROVAL AND ISSUE

1.) 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.

2.) 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.

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c.) any obsolete documents retained for legal and/or knowledge-


preservation purposes are suitably identified.

4.2.3.3 DOCUMENT CHANGES/MODIFICATIONS

1.) Any changes to documents 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.

2.) Where practical, the nature of the changes shall be identified in the
document or appropriate attachments.

4.2.4 CONTROL OF RECORDS

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


fully demonstrate the achievements 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.

Quality records include but are not limited to, Sales Orders and
Contracts, Inspections & Test records, Non-conformances, Corrective
and Preventive Actions, Internal and External Audit records, Training
records, Supplier Performance Ratings, Assembly Work Order
Packages, etc.

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


supplier shall be ensured by flowing down the requirements to the
suppliers on the purchase Order.

Preventive actions and Internal Quality Audits are employed in the


Management review process as noted in this manual.
Quality Records are e.g.:

a) Management Review
b) Quality Records
c) Contract Review
d) Design Review
e) Design Verification
f) Design Validation
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g) Acceptable Suppliers (maintained on the MRP System)


h) Customer-Supplied Service (product)
i) Identification and Traceability
j) Process Control
k) Inspection, Measuring & Test Equipment (Calibration Records)
l) Non-conformance
m) Corrective Action
n) Internal Quality Audit
o) Training
p) RMA Records

Applicable documents Chapter 4

QAP-401 Document and Data Control


OP-100 Master List for Procedures and Work Instructions
OF-101 Master List for Forms

5 MANAGEMENT RESPONSIBILITY
5.1 MANAGEMENT COMMITMENT

OPTIMA’S Executive Management understands and ensures the role of the


quality management system in relation of achieving business/quality
objectives and customer satisfaction.

Executive Management is committed to developing and implementing a Quality


Management System and to continually improving it’s effectiveness by:

 Communicating to all OPTIMA employees the importance of


meeting customer, statutory, regulatory and OPTIMA requirements.

 Establishing the quality policy.

 Ensuring the quality policy is understood throughout the Optima


organization.

 Conducting management reviews.

 Ensuring the availability of resources.

 Ensuring that quality objectives are established and monitored

 Ensuring Internal Audits are conducted and recorded.

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 Ensuring Corrective and Preventive actions are initiated and


implemented

 Conducting Management Reviews

 Ensuring that Quality Objectives are established and monitored

5.2 CUSTOMER FOCUS

Executive Management ensures that customer requirements are determined


and are met or exceeded with the aim of enhancing customer satisfaction.

Customer satisfaction is monitored by Sales Department and Quality


Management.

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5.3 QUALITY POLICY

Quality Policy

Awareness.Commitment.Improvement

Executive Management of Optima Stantron Corp. has established the following


Quality Policy:

Awareness
Commitment
Improvement (trough Process)

By this we mean,
“Awareness” of the importance of quality is a key element in our daily activities at
Optima Stantron. We strive for excellence by practicing completeness, accuracy,
timeliness and by meeting the expectations and requirements in all our
assignments.

We show “commitment” to quality in whatever we do. Optima’s philosophy is that


customers are our first priority and customer satisfaction must be 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 (trough 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.

Optima Stantron quality policy is displayed in various locations throughout the


facility.
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5.4 PLANNING

5.4.1 QUALITY OBJECTIVES

Executive Management establishes yearly quality objectives, quality goals


and a corporate business plan.

Objectives -

 Industry leading customer satisfaction as demonstrated by:


o Delivering products that exceed the customers requirements
o Continuous improvement in on-time performance
o Continuous improvement in the reduction of customer rejects
o Prompt and knowledgably customer service
 Ability to provide our products at a competitive price to market expectations:
o Accurate costing of projects by understanding customer requirements
evaluated against the companies capabilities
o Continuous improvement in efficiency of all departments
o Continuous improvement of cost and performance of the vendor base

 A high level of employee satisfaction by;


o Providing training and clear expectations for the job assigned
o Creating a safe and productive work environment

5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING

Quality Metrics are review on a monthly basis and at the Quality


Managemnet meeting.

Monthly planning includes the following:


 Actual budget versus planned budget
 Shipments versus bookings
 Forecasts
 Distribution of comprehensive quality statistics
 Miscellaneous topics
 Implementing of necessary adjustments to achieve the
fulfillment of the yearly plan
 Implementing of necessary adjustments to ensure the integrity
of the quality management system is maintained when changes
to the quality management system are planned and
implemented.

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5.5 Responsibility, Authority And Communication

5.5.1 Responsibility and Authority

a) Each staff department reports to Elma Senior Management: Production


reports to VP of Manufacturing, Engineering reports to VP of
Engineering, Director of Sales reports to President of Elma, Quality
reports to Senior Quality Manager, IT reports to Director of
Information and Technology. Departments of Finance, Human
Resources and Purchasing are located in Freemont California.

b) The Organization Chart shown in Figure 1 lists the staff departments


and their responsibilities as they relate to ISO 9001-2008. Each staff
manager has complete authority to implement and maintain the
responsible elements listed.

c) In addition to the designated elements, the Quality Assurance Manager


and the other staff department managers shall be responsible for
continuous quality improvement as follows:

1. Initiating action to prevent the occurrence of any


nonconformities relating to product, process, and quality
system;

2. Identifying and recording any product, process, and quality


system problems;

3. Initiating, recommending, or providing solutions through


designated channels;

4. Verifying the implementation of solutions;

5. Controlling further processing, delivery, or installation of


nonconforming product until the deficiency or unsatisfactory
condition has been corrected.

d) Department Supervisors are responsible for the overall, daily operation


of their departments which includes direct supervision of personnel,
work assignment, and disciplinary action. While these supervisors are
accountable to higher management for the quality of the product
produced in their departments, they do not have the authority for
quality acceptance of the product.

e) Quality Assurance Inspectors are responsible for inspecting the product


in their area of assignment and have the authority for quality
acceptance of the product within established criteria and guidelines.

5.5.2 Management Representative

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Optima Stantron Corp’s. Executive management has designated the


Quality 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 ISO 9001-2008. The
management representative also has the authority and responsibility for
reporting on the performance of the quality management system to
Optima’s management. The Quality Manager in this capacity reports
directly to the General Manager of Optima Stantron Corp.

Promotion of awareness of customer requirements is communicated from


Sales departments. The awareness takes place though documents like
customer specification, Engineering Document, MFG and Quality Checklists
provided by the customer. The Awareness is further promoted by way of
the Quality Management Information System.

OPTIMA STANTRON

MANAGEMENT ORGANIZATION CHART


AND ISO 9001-2008 RESPONSIBILITY

Fig 1

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President - Management Responsibility


Accounting
HR - Job Descriptions, Company Policies training

Operations - Purchasing, Product Identification and Traceability,


Process Control, Handling, Storage, Packaging
Preservation & Delivery
Engineering - Design Control
Sales - Contract Review, Control of Customer Supplied
Product
QA - Quality System, Document & Data Control, Inspection
& Testing, Control of Inspection, Measuring & Test
Equipment, Inspection & test status, Control of
Nonconforming material, Corrective & Preventative
Action, Control and Quality Records, Internal Quality
Audits, Statistical Techniques

5.5.3 Internal Communication

Optima Stantron Corp’s. Executive management ensures that appropriate


communication process is established within Optima’s organization.

Information’s are distributed by (and / or)


 E-mail
 Posting at dedicated News area
 Executive Management member
 Company Meetings (all hands meetings)

5.6 Management Review

5.6.1 General

The quality management system shall be reviewed once a year in the


management review by the General Manager, Functional Department
Heads as required in conjunction with the Quality Manager. The purpose
of this review is to ensure the continuing suitability and effectiveness of
the Quality Management System in satisfying the requirements of the ISO
9001:2008 standards and Optima Stantron quality policy and objectives.

5.6.2 Review Input

The review shall address as a minimum the following:


 Quality Policy – to insure that it is still relevant to Optima’s
current needs.
 Quality objectives – results achieved, modification of existing
Objectives and setting of new objectives by management.

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 Review of Improvements initiated in each department


for the current year as objective of living the Quality
Policy.
 Weaknesses and deficiencies in the Quality Management
system
identified as a result of the internal quality audits.
 Wastage, loss and customer complaints 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 actions are required
as a result of this review, the Quality Manager will initiate it in
accordance with the procedures as outlined in QM-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 (5) years and may be disposed at the end of the
retention period.

5.6.3 Review Output

The output of Optima’s management review includes any decisions and


actions related to:

 Improvement of the effectiveness of the quality management


system and its processes.
 Improvement of product related to customer requirements.
 Resource needs.

Applicable Documents Chapter 5

QAP-501 Receiving Inspection and testing


QAP-502 In-Process Inspection and testing
QAP-503 Final Inspection and testing
QAP-801 Control of Non-Conforming Product
QAP-901 Corrective Action System
QAP-1001Quality Records
QAP-1101Internal Quality Audits
QAP-202 Management Quality System Review
QC-021 Internal Audit Report
QC-094 Corrective Action Request
Corrective Action Request Log
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QAP-504 Process Effectiveness Assesment and Reporting

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 Human Resources

6.2.1 General

The Human Resources Manager is responsible for overall coordination and


direction of the training function. Department Managers are responsible for
the actual training of their personnel.

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 engagement by
Optima 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. New training requirements will be
addressed to ensure that training remains effective.

Functional Department Heads are responsible for ensuring that only


personnel who are suitably qualified perform tasks requiring acquired skill.

The Human Resources is responsible for establishing and maintaining the


appropriate training records relevant to new hires like company policies,
company orientation, safety and state/federal compliance information. All
other trainings that are related to processes affecting the product and /or the

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customer are identified, planned and executed by the respective department


heads. The records of these trainings are kept in QA Department.

6.3 Infrastructure

Optima’s infrastructure comprises mainly of its human resources,


Plant/machinery, and MRP/PLM platforms that interrelates the functioning of
every department.

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 to define how all operations
will be carried out. Manufacturing department headed by the Operation
Manager is responsible for providing tactical support to the main stream
manufacturing.

This Manufacturing function is responsible for documentation of detailed


process instructions wherever warranted and feasible depending on the
nature of the product/process/contract.

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


in the Process Instructions and Quality Control Instructions. Records of
quality checks will be used as the basis for process quality improvement.

Process and Quality Control Instructions will include workmanship criteria,


define the equipment to be used and make reference to visual aid, 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.

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The Manufacturing Department Function is responsible for establishing


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

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

All outside processes are contracted and controlled by purchase orders.

The Quality Manager is responsible for ensuring that the Process and Quality
Control Instructions are established and maintained

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 their respective departments for employees to carry out the daily activities.
This include and is not limited to work space, utilities, necessary equipment,
tools and supporting services like IT etc.
Any concerns are discussed during the monthly executive management
meeting.

Applicable Documents Chapter 6

PCD-001 Production Control Procedures


ENG-100 Drawing Development
SDF-010 Optima Multi Line Item AWO
SDF-011 Assembly Work Order
PER-001 Training Procedures
MFG-001 Manufacturing Procedure
PER-002 Cross Training Procedure
PER F-100 Training Record
Workmanship Manual

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7 Product Realization
7.1 Planning and Product Realization

During the quoting or engineering design review process, Optima Stantron


will evaluate the quality requirements. Documentation will reflect quality
issues implemented to meet the needs of the customer. The following issues
are considered during the quotation or quality planning phase of design:

 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;
 Ensuring the compatibility of the design with the production process,
inspection and test procedures, and the applicable documentation;
 The updating, as necessary, of the inspection and test 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;
 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 records to be established will be detailed in the documented
procedures.

7.2 Customer Related Process

7.2.1 Determination of Requirements Related To the Product

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


(Statement of requirement), the tender, contract or order shall be reviewed
by Optima Stantron to ensure that:

 Requirements are adequately defined and documented. Where no


statement of requirement is available for an order received by verbal
means, the salesperson shall ensure that the order requirements are
agreed before their acceptance.

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 Any contract or accepted order requirements differing from those in


the tender are resolved;

 Optima Stantron has the capability to meet contract or accepted


order requirements.

The Design Engineering Group shall create the documentation that is needed
to express in terms necessary to verify that the input requirements have
been met and validated.

Design output shall:


 Meet the design input requirements
 Contain or make reference to acceptance criteria

Reviews shall be conducted before the release of the documents.


These reviews should include, but not limited to Manufacturing, Quality,
and Production.

7.2.2 Review of Requirements Related To the Product

Optima Stantron shall establish and maintain documented procedures for


contract review and for coordination of these activities.

Optima Stantron shall identify the amendments made to a contract and


correctly transfer it to the functions concerning within its organization.
Records of contract reviews shall be maintained by Sales Department.

Where the customer provides no documented statement or requirements, the


customer requirements shall be confirmed by Sales before acceptance.

Where product requirements are changed, Optima Stantron ensures that


relevant documentation is amended and that relevant team members are
made aware of changed requirements.

For any change, Optima’s 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 catalogue orders. The review
covers relevant catalogue product information.

7.2.3 Customer communication

Optima Stantron determined and implemented effective arrangements for


communicating with customers in relation to the product.

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Sales is the primary source for all relation to


 Contacts
 Enquires, contracts or order handling, including amendments
 Customer feedback, including customer complaints
Sales shall coordinate the right team 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

SDP-001 Contract Review and Processing


SDP-002 Offer Process
SDP-004 RMA and Customer Issues
SDI-007 Change notices (COWs & PIFs)
SDF-001 Optima Costing Request (RFQ)
SDF-003 Optima Engineering Work Request
SDF-004 Order check list/Contract review
SDF-005 Return Material Authorization
SDF-008 Customer Maintenance & Data Entry
SDF-013 Project Impact Form
SDF-016 Return Material Autorizathion log
ENG-FR-035 Engineering Change Notice
QC-094 Non Conformance Report

7.3 Design and Development

7.3.1 Design and Development Planning

1. The Development engineering function is responsible for establishing,


implementing and maintaining the procedures which will control the
design and development of systems and networks 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.

2. Plans shall be prepared for all development and design activities.


This responsibility will include the use of qualified personnel
equipment with the adequate resources. As the design evolves the
plan shall be updated on a regular basis.

3. It is the policy of the company to design, develop and supply a


range of high quality, cost effective and innovative products
(including equipment, and systems) which will satisfy the
customer’s requirements.
In order to achieve this objective, the design and development
activities shall be based upon documented procedures.

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These will include: Design (design input, design output, design


validation and design changes) and Development Planning
(technical interfaces), Design Review, Transfer from Development
to manufacturing and purchasing, Control of documentation and
design verification.

4. 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 Optima
Stantron’s shop, sales, and production departments.

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


conducted in accordance with the Company’s Quality System Audit
program.

6. The design and development functions will be periodically and


systematically audited as part of the Company’s documentation
procedures. Audits shall be conducted both internally and externally.

7.3.2 Design and Development Inputs

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


Department. This shall include, but not limited to the applicable statutory and
regulatory requirements. These will be identified, documented and controlled in
the design package. Any ambiguous, incomplete or conflicting requirements
shall be resolved by all parties involved. Contract review activities shall also be
considered before turning package over to Design output.

7.3.3 Design and Development Outputs

The Design Engineering Group shall create the documentation that is needed
to express in terms necessary to verify that the input requirements have been
met and validated.

Design output shall


 Meet the design input requirements
 Provide appropriate information for purchasing, production and quality
 Contain or make reference to acceptance criteria
 Specify essential characteristics
 Specify any applicable validation test.

Design Reviews shall be conducted before the release of the documents. These
reviews should include, but not limited to Manufacturing, Quality, Production
and Customer for custom design.

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, assembly documents, supplier data sheets, acceptance criteria,
etc.

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7.3.4 Design and Development Reviews

For new proptotype or major designs or when contractually applicable Formal


documentation reviews will be held and the results will be logged on form ENG-
FR-038.

7.3.5 Design and Development Verification

The design stage outputs need to have a verification that they meet the
design inputs by verifying quotes, BOM, 3D drawings when applicable
and customer inputs.

7.3.6 Design and Development Validation

The design validation shall be performed where applicable to ensure


that the resulting products 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 control documents.

7.3.6.1 Design Development verification and Validation testing &


Documentation
 Optima Stantron shall plan and perform verification and
validation test where contractually required by the
customer or where Optima sees the need to validate a new
design. These tests are performed by documenting and
performing acceptance test standards like EMI, shock
vibration testing.

 These test when practical shall define the product being


tested, test objectives, test configuration and conditions,
relevant acceptance criteria. The actual performance of the
test is also described.

7.3.6.2 The design verification and validation documentation and other


reports containing all of the information as defined in 7.3.6.1
shall be maintained as records when applicable testing is
performed to demonstrate the product meets the specification
requirement for all identified operational conditions.

7.3.7 Control of Design and Development Design Changes

All design changes and modifications must be identified, documented,


Reviewed and approved before implemented. This shall be controlled in
accordance with configuration management process.

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Applicable Documents Chapter 7.3

SDF-003 Engineering Work Request


SDF-011 Assembly Work Order
SDF-013 Project Impact Form
ENG-FR-035 ECN
ENG-100 Drawing Development
ENG-101 New Part Number Entry
ENG-106 Design Review
ENG-108 BOMS Entry Requirements
ENG-200 Engineering Document Control
ENG-250 Document Revision Control
ENG-251 ECN Change Notice System
ENG-253 Documentation Guidelines
ENG-254 Design /Documentation Change Request
ENG-256 Redline Drawing
ENG-257 New Standard Product Development
ENG-258 Configuration Management Procedure
ENG-259 Design & Development Plan
ENG-260 Source Control Document
ENG-261 Repeat Order Procedure

7.4 Purchasing

7.4.1 Purchasing Process

1. 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.

2. Subcontractors or suppliers shall be selected by Optima Stantron on the


basis of their ability to meet our needs. Optima Stantron may choose to
conduct an on site survey of the supplier or may request completion of
the supplier survey by a qualified supplier representative.

3. Optima Stantron supplier survey is designed to assess the effectiveness


of the supplier’s quality system. Optima will also use other methods for
determining a supplier’s ability to meet our needs, such as tracking on
time delivery performance, and rejection history of non-conforming
material.

4. All information provided by suppliers will be reviewed by Optima Stantron


management, whereby a determination will be made as to whether
approval will be granted, or to identify which improvements need to be
made prior to becoming an approved supplier.

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5. 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.

6. Where Optima Stantron feels that 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, Optima will recommend disapproving the supplier for
future business.

7. Optima Stantron Purchasing departments maintains on the MRP system a


register of all suppliers classified as approved. All critical suppliers are
tracked for their performance and score cards are maintained. The
Purchasing procedures detail the extent of controls on these suppliers,
the purchased products as well as the process, changes of approval
status and the controlled use of suppliers based on their approval status.
Elma’s approved supplier are also considered Optima’s Stantron approved
supplier

7.4.2 Purchasing Information

Information provided to our subcontractor 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 other 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

1. Optima Stantron will make prior arrangements for any source inspection of a
Product required (to be performed by Optima’s personnel) at the supplier
location prior to the acceptance of the product.

2. When a contract between Optima Stantron and a customer exists, which


allows provisions for customer inspection at our supplier’s facility or in our
facility upon receipt of Optima Stantron purchased product, Optima will still
maintain responsibility for the product. A customer’s inspection of this product
will not absolve us of our responsibility to provide quality products to our
customers, nor preclude any subsequent rejection. We will maintain the
responsibility for the verification and control of materials utilized in the
manufacture of our product.

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Applicable Documents Chapter 7.4

INV-001 Inventory Control Procedures


INV-I-109 Kitting Operation
PUR-100 Purchasing
PUR-F-011 Facility Questionnaire
QAP-501 Receiving Inspection and testing
QAP-801 Control of Non-Conforming Product

7.5 Production And Service Provision

7.5.1 Control of Production and Service Provision

1. 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 will be implemented by having detailed process instructions
to 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. Records of Quality checks will be used as the basis
of feedback for process quality improvement.

2. Wherever possible, quantitative measures will be used for monitoring process.


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

3. Production will be carried out against schedules, which take into account
customer requirements.

4. The Manufacturing Engineer Function is responsible for establishing


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

5. The Production Planning Team is responsible for the planning and scheduling of
work orders.

6. All outside processes are contracted and controlled by purchase orders.

7. The Quality Manager is responsible for ensuring that the Process and Quality
Control Instructions are established and maintained.

8. Delivery or shipment of product will be conducted in accordance with Optima


Stantron Standard shipping procedures, or by customer specified shipping
instructions. Optima will utilize approved shipping carriers only, based on
customer requirements, and will promote safe transit of product to its receiving
destination. In line with Company mission and its commitment to quality, Optima

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Stantron seeks to Provide for its customers continued product support and after
sales liaison.

9. The Company will provide for its customers technical, product, and application
Support.

10. 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, safety and
disposal information.

7.5.2 Validation of Processes for Production and Service Provision

Process and Quality Control Instructions will include workmanship criteria,


defined the equipment to be used and make reference to visual aids, samples
and standards, where applicable.

7.5.3 Identification and Traceability

1. All production materials will be adequately identified on receipt and during


storage, pending issue and use.

2. All products in production will be identified by work order, shipping order, or


Optima Stantron part numbers throughout the manufacturing and test cycle.

3. All finished product will be subject to final inspection to assure conformance to


specified requirements. In addition to final inspection performed on finished
product, checks will be made to establish that all specified inspections have been
carried out with satisfactory results.

4. No product will be shipped unless the quality standards and activities as outlined
in Optima Stantron quality system have been met. The quality assurance
inspectors have the right to withhold any product from shipment which does not
meet these requirements.

5. 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 retention period.

6. At receiving, records of inspection include incoming inspection stamp or


signature and the inspector’s stamp of acceptance on material inspected when
applicable. A MDR report is issue when product has failed. In-process inspection
will include the operator’s signature or initials on the routing. Assembly
inspection will include the stamp or signature of the assembler on the assembly
checklist. These records shall be attached to assemble work order package.
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Final inspection records shall have the inspector’s signature/stamp and date on
the traveler of the product inspected.

7. If a product fails any inspection and/or test, the procedure for control of
nonconforming product shall be followed.

8. All materials and products will be suitable identified throughout each stage of
manufacturing.

9. All products that are subject to mechanical and electrical inspection and test and
have passed this test will be identified appropriately throughout production.
Production that fails inspection and test or is rejected by the quality department
for any 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 non-
conforming material control.

10. Assembly work orders will be signed or stamped by 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

QAP-503 Final Inspection and Testing

7.5.4 Customer Property

1. All customer property will be examined upon receipt for condition, quantity and
conformance with delivery details.

2. All items will be positively identified and stored by location in the stockroom.
Customer property, which is received at Optima Stantron, will be handled and
stored in a manner, which will prohibit damage or deterioration. The customer
will be notified by formal documentation that will be retained as a record of this
transaction, if any lost or damaged material and material shortages are
identified during receiving process.
Material will only be issued against those orders for which it was supplied.

7.5.5 Preservation of Product

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


product shall be documented and maintained. This includes house keeping and
cleanliness, prevention of FOD, and special safety labeling for hazardous
substances whenever is applicable.

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7.5.5.1 Handling

Material handling arrangements will be made during all stages of


manufacturing, 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 consideration
are identified. These will refer to any specials 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 condition of the
product.

7.5.5.3 Packaging

Packaging requirements will be as specified by the customer or by Optima


approved methods as defined by shipping personnel during the initial
packaging and shipment of the product, if customer specifications have not
been approved. Materials used will be designed to ensure that the product
quality is maintained during transit.

7.5.5.4 Preservation

Material will be stored in a way that will preserve the material from damage
or deterioration from surrounding elements such as heat, moister, and
weather elements.

7.5.5.5 Delivery

Delivery or shipment of product will be conducted in accordance with Optima’s


standard shipping procedures, or by customer specified shipping instructions.
Optima Stantron will utilize Optima’s approved shipping carries only, based on
customer requirements, and will promote safe transit of product to its receiving
destination.

Applicable Documents Chapter 7.5

INV-001 Inventory Control Operation


INV-I-101 Receiving Operation Stockroom
INV-I-102 Receiving of Steel & Aluminum
INV-I-103 Staging of Paint Line Material
INV-I-104 Issuing and Stocking Operation of Stockroom
INV-106 Unload Paint Line Conveyor

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INV-I-109 Kitting Operation


MAI-I-100 Preventive Maintenance
MFG-ALL Manufacturing Procedures
PCD-001 Production Control Procedures
PCD-I-101 Change to Sales Order Acknowledgment
PCD-I-102 Production Planning-Manufacturing Orders
PER-001 Personnel Training
PER-002 Cross Training
QAP-801 Control of Non-Conforming Product
SDP-003 Customer Supplied Product
SHIP-100 Shipping Procedures
SHIP-I-002 Packaging of Vertical Cabinets & Desk
SHIP-I-003 Packaging of Accessories & Cases
SHIP-I-004 Packaging of Customer Orders, Cases and Parts
ENG-FR-035 Engineering Change Notice Form
ENG-FR-036 Change Request Form
QC-124 First Article Inspection Report Form
PCD-002 On Time Delivery
AS9102 Aerospace First Article Form
Workmanship Manual

7.6 Control Of Monitoring And Measuring Devices

Procedures to control, calibrate and maintain inspection, measuring and test


equipment used by Optima Stantron 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 consistent with the required measurement
capability.

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.

All operators and supervisors who use inspection, measuring, and test
equipment shall be responsible for verifying the calibration is current before
use. The Quality Assurance Department shall perform or procure the
necessary calibration services and maintain complete records.

All calibration activities will be traceable to a national standards exist, the


basis used for calibration shall be a documented procedure.

Optima Stantron shall:

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a) Determine the measurements to be made, the accuracy required, and


select the appropriate inspection, measuring, and test equipment that
is capable of the necessary accuracy and precision;

b) Identify, calibrate, and adjust all inspection, measuring, and test


equipment, and devices that can affect product quality, at prescribed
intervals, or prior to use against certified equipment having a known
valid relationship to internationally or nationally recognized standards
or industry recognized standards.

c) Define the process employed for the calibration of inspection, test, and
measuring equipment, including details of equipment type, unique
identification, location, frequency of checks, check method, acceptance
criteria, and the action to be taken when results are unsatisfactory;
d) Identify inspection, measuring, and test equipment with a suitable
indicator or approved identification record to show the calibration
status;

e) Maintain calibration records for inspection, measuring, and test


equipment (see 2.16);

f) Assess and document the validity of previous inspection and test


results when inspection, measuring, and test equipment is found to be
out of calibration;

g) Ensure that the environmental conditions are suitable for the


calibrations, inspections, measurements, and tests being carried out;

h) Ensure that the handling, preservation, and storage of inspection,


measuring, and test equipment is such that the accuracy and fitness
for use is maintained;

Where test fixtures or comparative references are used as suitable forms of


inspection, they shall be checked to prove that they are capable of verifying
the acceptability of product prior to release for use during production and
installation and shall be rechecked at prescribed intervals. Quality Assurance
shall establish the extent and frequency of such checks and shall maintain
records as evidence of control (see 2.16).

Where the availability of technical data pertaining to the measurement


equipment is a specified requirement, such data shall be made available,
when required by the customer or customer's representative, for verification
that the measuring equipment is functionally adequate

Applicable Documents Chapter 7.6

QAP-601 Control of Inspection, Measuring, and Test Equipment


FORM QC-095 Calibration Data Record

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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 document
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 request that a product or process problem be


analyzed using statistical techniques,
 The Material Review Board reviews nonconforming product and
request a statistical analysis, or
 A Corrective Action Team request 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 defined the way
the technique is to be applied and the rules governing its use.

8.2 Monitoring And Measurement

8.2.1 Customer Satisfaction

1. Optima Stantron Corp. 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. Results are analyzed to improve customer satisfaction
continuously and displayed on the intranet.

2. All results are analyzed to improve customer satisfaction continuously.

Applicable Documents Chapter 8.2.1

SDP-005 Order Follow-up / Customer service survey


SDF-015 Customer service survey

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8.2.2 Internal Audits

1. Optima Stantron Corp. 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.

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


predetermined schedule based on the status and importance of the activities
to be audited. The audits shall be conducted by personnel independent of
those having direct responsibility for the activities being audited.

3. Results of the audits will be recorded and brought to the attention of the
personnel having responsibility in the area audited. Department managers
shall be responsible for taking timely actions to correct any deficiencies
identified during an audit.

4. Follow-up audit activities shall verify and record the implementation and
effectiveness of the corrective action taken.

5. 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

Optima Stantron has applied suitable methods for monitoring, and where
applicable, measurements of the quality management system processes.
Optima demonstrates that these processes achieve planned results and
ensures conformity of the product.

8.2.4 Monitoring And Measurement Of Product

Optima monitors and measure the characteristics of the product to verify


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

Customer Service Department receives and records complaint from customer


any issues that do not match their expected requirements.

RMA reports are logged and a copy filled in the Customer Issue / RMA
completed file.

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8.3 Control Of Nonconforming Product

1. 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.

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


corrective/preventative action and the subsequent material disposition.

3. 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.

4. 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.

5. It is the responsibility of the personnel detecting a non-conformance to


ensure that this is properly identified, segregated and reported.

6. The responsibilities for determining corrective action and disposition of non-


conforming material are defined in the procedures which implement this
policy.

8.4 Analyses Of Data

1. The need for statistical techniques required for establishing, controlling, and
verifying process capability, product characteristics, vendor performances
and customer satisfaction 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.
 The material Review Board reviews nonconforming product and
request a statistical analysis, or

 A Corrective Action Team request a statistical analysis of a product


or process.

2. Where statistical techniques are used for product verification, due regard will be
made to the contractual requirements of the customer.

3. Following data are analyzed and distributed at least once a quarter:

 Manufacturing Data
 Vendor Performance Data
 Customer Feedback Data

4. New Quality goals are defined and addressed at least once a year during the
annual management review.
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QUALITY MANUAL ISO 9001-2008

8.5 Improvement

8.5.1 Continual Improvement

1. Optima 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.

2. 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 department during the
year and reviewed in the management review meeting. The same should be
documented on the Quality Management Review document.

3. Optima will establish and maintain documented procedures for implementing


corrective and preventive action.
Any corrective or preventive action taken to eliminate the cause of actual or
potential nonconformities shall be to a degree appropriate to the magnitude
of problems and commensurate with the risk encountered.

4. Optima shall implement and record any changes to the documented


procedures resulting from corrective and preventive action.

8.5.2 Corrective Action

Optima’s procedures for corrective action shall include:

 The effective handling of customer complaints and reports of


product nonconformities
 Investigation of the cause of nonconformities relating to product,
Process, quality system, and recoding 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 suppliers when warranted.

8.5.3 Preventive Action

Optima’s preventive action shall include:


 The use of appropriate sources of information such a processes and
work instructions which affect product quality, audit results, quality
records and customer complaints to detect, analyze and eliminate
potential causes of nonconformities.

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QUALITY MANUAL ISO 9001-2008

 Determination of the steps needed to deal with any problems


requiring preventive action
 When applicable initiation of preventive action and application of
controls to ensure that is effective.

Applicable Documents Chapter 8

QAP-501 Receiving Inspection and testing


QAP-502 In-Process Inspection and testing
QAP-503 Final Inspection and testing
QAP-801 Control of Non-Conforming Product
QAP-901 Corrective Action System and Preventive
Action
QAP-1001 Quality Records
QAP-1101 Internal Quality Audits
QAP-202 Management Quality System Review
QC-021 Internal Audit Report
QC-094 Corrective Action Request Form

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