1 M Quality-Manual-for-Juarez-Site

OPTRON de Mexico S.A. de C.V.
Sensors and Specialist Components
Quality Manual
JRZ.QM-1
ISO 9001:2015
Quality Management System
RELEASED
DATE:
3/20/2023
Document Control
MANUFACTURING:
CORPORATE HEADQUARTERS:
OPTRON Technology OPTRON de Mexico S.A de C.V.

2900 E. Plano Parkway, Suite 200 Ave. Rio Bravo #1551-A
Parque Industrial Rio Bravo JRZ.QM-1
Plano TX 75074
Cd. Juarez, Chihuahua 32557
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Table of Contents
ABOUT THIS MANUAL ............................................................................................................. 6
APPROVALS: ............................................................................................................................ 6
OVERVIEW OF TT ELECTRONICS / OPTRON ....................................................................... 6
SCOPE ...................................................................................................................................... 7
APPLICABLE STANDARDS ...................................................................................................... 8
MANAGEMENT STRUCTURE .................................................................................................. 8
CORPORATE RESPONSIBILITY ............................................................................................. 8
PROCESS OWNERS ................................................................................................................ 8
CONTEXT OF THE ORGANIZATION ....................................................................................... 8
1 MANAGEMENT PROCESSES .......................................................................................... 9
1.1 Quality Management System Implementation & Maintenance ....................................... 9

1.1.1 QMS General Requirements.................................................................................... 9
1.1.2 Management Commitment..................................................................................... 10
1.1.3 Customer Focus .................................................................................................... 11
1.1.4 Quality Policy ......................................................................................................... 11
1.1.5 Quality Management System Planning .................................................................. 11
1.1.6 Responsibility and Authority .................................................................................. 12
1.1.6.1 Responsibility for Quality .................................................................................... 12
1.1.6.2 Departmental Responsibility for Quality ............................................................. 13
1.1.6.3 Individual Responsibility ..................................................................................... 13
1.1.7 Management Representative ................................................................................. 14
1.1.7.1 Customer Representative................................................................................... 14
1.1.8 Provision of Resources .......................................................................................... 16
1.1.9 Human Resources - General ................................................................................. 16
1.1.9.1 Competence, Awareness and Training .............................................................. 16
1.1.9.2 Product Design Skills ......................................................................................... 17
1.1.9.3 Training .............................................................................................................. 17
1.1.9.4 Training on the Job ............................................................................................ 17
1.1.9.5 Employee Motivation and Empowerment ........................................................... 17
1.1.10 Planning of Product Realization ............................................................................ 17
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1.1.10.1 Planning of Product Realization - Supplemental............................................. 18

1.1.10.2 Acceptance Criteria ........................................................................................ 18
1.1.10.3 Confidentiality ................................................................................................. 18
1.1.10.4 Change Control .............................................................................................. 18
1.2 Management Review ................................................................................................... 18

1.2.1 General - Quality Management System Performance (Mgmt. Review) ................. 18
1.2.1.1 Review Input ...................................................................................................... 19
1.2.1.2 Review Output.................................................................................................... 20
1.2.2 Quality Objectives ................................................................................................. 20
1.2.3 Measurement Analysis & Improvement - General ................................................ 23
1.2.3.1 Identification of Statistical Tools ..................................................................... 23
1.2.3.2 Knowledge of Basic Statistical Concepts ........................................................... 24
1.2.4 Customer Satisfaction ........................................................................................... 24
1.2.5 Analysis and Use of Data ..................................................................................... 24
1.2.6 Continual Improvement ......................................................................................... 25
1.3 Communication ............................................................................................................. 26

1.3.1 Internal Communication ........................................................................................ 26
1.3.2 Customer Communication .................................................................................... 26
1.4 Internal Auditing ........................................................................................................... 26

1.4.1 Internal Audit of the Quality Management System ................................................ 26
1.4.2 Internal Audit Plans ............................................................................................... 27
1.4.3 Internal Auditor Qualification .................................................................................. 27
1.4.4 Manufacturing Process Audit ................................................................................. 28
1.4.5 Product Audit ......................................................................................................... 28
1.5 Corrective & Preventive Action .................................................................................... 28

1.5.1 Corrective Action ................................................................................................... 28
1.5.1.1 Problem Solving ................................................................................................. 29
1.5.1.2 Error-Proofing..................................................................................................... 29
1.5.1.3 Corrective Action Impact .................................................................................... 29
1.5.1.4 Rejected Product Test / Analysis ....................................................................... 29
1.5.2 Preventive Action ................................................................................................... 29
2 REALIZATION PROCESSES: .......................................................................................... 30
2.1 Requirements Determination & Review ....................................................................... 30

2.1.1 Determination of requirements related to product ................................................. 30
2.1.2 Review of Requirements Related to Product, Manufacturing Feasibility ................ 31
2.2 Design & Development ................................................................................................ 32

2.2.1 Design and Development ...................................................................................... 32
2.2.2 Design and Development Planning ........................................................................ 32
2.2.3 Multidisciplinary Approach ..................................................................................... 32
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2.2.4 Design and Development Input.............................................................................. 32

2.2.5 Special Characteristics .......................................................................................... 33
2.2.6 Design and Development Output ........................................................................... 33
2.2.7 Design and Development Review, Monitoring ....................................................... 33
2.2.8 Design and Development Verification .................................................................... 33
2.2.9 Design and Development Validation ...................................................................... 33
2.2.10 Prototype Program ................................................................................................ 34
2.2.11 Product Approval Process .................................................................................... 34
2.2.12 Control of Design and Development Changes ...................................................... 34
2.2.13 Product Safety ...................................................................................................... 34
2.2.14 Software Embedded Product ................................................................................ 35
2.3 Purchasing .................................................................................................................... 35

2.3.1 Purchasing Process ............................................................................................... 35
2.3.2 Regulatory Conformity ........................................................................................... 35
2.3.3 Supplier Quality Management System Development ............................................. 35
2.3.4 Customer-Approved Sources................................................................................. 36
2.3.5 Purchasing Information .......................................................................................... 36
2.3.6 Verification of Purchased Product and Incoming Product Quality .......................... 36
2.3.7 Supplier Monitoring ................................................................................................ 37
2.4 Facilities & Equipment Management............................................................................ 37

2.4.1 Infrastructure.......................................................................................................... 37
2.4.1.1 Plant, Facility and Equipment Planning .............................................................. 37
2.4.1.2 Contingency Plans ............................................................................................. 37
2.4.2 Work Environment ................................................................................................. 38
2.4.2.1 Work Environment .............................................................................................. 38
2.4.2.2 Personnel Safety to Achieve Product Quality ..................................................... 38
2.4.2.3 Cleanliness of Premises ..................................................................................... 38
2.4.3 Customer Property................................................................................................. 38
2.4.3.1 Customer Property ............................................................................................. 38
2.4.3.2 Customer Owned Production Tooling ................................................................ 39
2.4.4 Control of Monitoring & Measurement Devices...................................................... 39
2.4.4.1 Control of Monitoring and Measuring Devices.................................................... 39
2.4.4.2 Measurement System Analysis .......................................................................... 40
2.4.4.3 Calibration / Verification Records ....................................................................... 40
2.4.4.4 Laboratory Requirements ................................................................................... 40
2.4.4.4.1 Internal Laboratory....................................................................................... 40
2.4.4.4.2 External Laboratory ..................................................................................... 41
2.5 Company Control Specifics .......................................................................................... 41

2.5.1 Document Control .................................................................................................. 41
2.5.1.1 Control of Documents and Engineering Specifications ...................................... 41
2.5.2 Records Control ..................................................................................................... 42
2.5.2.1 Control and Retention of Records ...................................................................... 42
2.5.3 Control of Production Provision ............................................................................. 42
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2.5.3.1 Control of Production ......................................................................................... 42

2.5.3.2 Control Plan ....................................................................................................... 42
2.5.3.3 Work Instructions ............................................................................................... 43
2.5.3.4 Verification of job set-ups ................................................................................... 43
2.5.3.5 Preventive and Predictive Maintenance ............................................................. 43
2.5.3.6 Management of Production Tooling ................................................................... 43
2.5.3.7 Production Scheduling ....................................................................................... 44
2.5.3.8 Feedback of Information .................................................................................... 44
2.5.4 Validation of Processes ......................................................................................... 44
2.5.5 Identification of Traceability .................................................................................. 45
2.5.6 Preservation.......................................................................................................... 45
2.5.6.1 Preservation of Product ...................................................................................... 45
2.5.6.2 Storage and Inventory ........................................................................................ 45
2.5.7 Monitoring & Measuring of Processes .................................................................. 46
2.5.7.1 Monitoring and Measurement of Processes ....................................................... 46
2.5.7.2 Monitoring and Measurement of Manufacturing Processes ............................... 46
2.5.8 Monitoring & Measuring of Product........................................................................ 47
2.5.8.1 Monitoring and Measurement of Product ........................................................... 47
2.5.8.2 Dimensional Inspection and Functional Testing ................................................. 47
2.5.9 Control of Nonconforming Product......................................................................... 47
2.5.9.1 Control of Nonconforming Product and Reworked Product ................................ 47
2.5.9.2 Customer Waiver ............................................................................................... 48
APPROVALS & REVISION HISTORY .................................................................................... 51
APPENDIX A: CROSS REFERENCE TO THIS MANUAL ...................................................... 52
APPENDIX B: ISO/IEC 80079-34 ATEX CERTIFICATION REFERENCES ............................ 54
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About this Manual

This manual was developed for a quality management system aimed primarily at achieving
customer satisfaction by meeting customer requirements through the application of the system,
the continual improvement of the system and the prevention of nonconformity. The quality
management system developed by this manual was based on & demonstrates throughout its
wording good quality principles such as leadership, customer focus, continual improvement,
involvement of the employees, mutually beneficial supplier relationships, process focus,
management by a system of processes and ultimately decisions that are based on good sound
data.
OPTRON de Mexico S.A de C.V. hereafter OPTRON Management maintains the latest version
of this manual for the Quality Management System and for OPTRON employees’ use in Q-Pulse
system (QP).
Requests for changes should be submitted to Management. Updates of the manual are issued
as required. The online version of this quality manual is available to all employees via computers.
The online version is to be considered the most current and takes precedence over any printed
copy.
It is the responsibility of the Department Heads to ensure that employees are familiar with the
manual’s content related to their work and responsibilities, and that they are kept informed of
any changes and updates.
Effective date of this quality manual: May 3, 2004
Approvals:
Juan A. Gonzalez Juan A. Gonzalez Salvador Arellano Salvador Arellano

March 20, 2023 March 22, 2023
Mgmt. Representative Director de OPTRON Campus
Juarez
Overview of TT Electronics / OPTRON
TT Electronics / OPTEK Technology Inc., hereafter called OPTRON, is headquartered at 2900

E. Plano Parkway, Suite 200, Plano, Texas 75074 with manufacturing facilities at OPTRON de
Mexico S.A de C.V., Ave. Rio Bravo #1551-A Parque Industrial Rio Bravo, Cd. Juarez,
Chihuahua Mexico 32557. OPTRON’s business activities are the design, manufacturing, and
sale of electronic sensors. OPTRON provides sensor technologies such as optical (IR, visible,
UV & VCSEL), magnetic (Hall-effect) and fiber optic (LED & VCSEL to 2.5G). OPTRON sensors
are found in office equipment, industrial applications, encoders, military & Hi-Rel applications,
medical diagnostic equipment, automotive engine and door controls and ignition security and
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fiber optic data communication applications. Sensors can be standard product or custom made
to customer’s specification.
This quality manual describes the Quality Management System of OPTRON. Its purpose is:
• for internal use, to communicate to employees the company’s Quality Policy and quality
objectives, to make the employees familiar with the method of compliance with ISO 9001
requirements, to facilitate the implementation and maintenance of the Quality Management
System and to ensure its continuity and required updates during changing circumstances, to
provide effective communication and control of quality related activities and a documented base
for quality system audits.
• for external use, to inform OPTRON customers and other interested external partners about
OPTRON Quality Policy, OPTRON implemented Quality Management System, and measures
of compliance with the requirements of ISO 9001.
Scope
This Quality Management System described hereafter complies with all the requirements of ISO
9001, is focused on the enhancement of customer satisfaction through continual improvement
of processes and products and demonstrates compliance with customer and regulatory
requirements.
The scope of the Quality Management System covers the design and new product introduction
process in E. Plano Parkway, Suite 200, Plano TX. and manufacturing of sensor systems, the
manufacture of custom-made piece parts and final product at OPTRON manufacturing site.
OPTRON de Mexico Quality Management System meets all requirements of ISO 9001.
Exclusions / Justifications:
Exclusions as applied to the OPTRON manufacturing site are all those as related to the Product
Design Functions, such functions are based at OPTRON Technology Plano Texas site where
the company headquarters are located. The processes about New Product Introduction are
initiated and controlled from OPTRON’s Plano Texas facility. Appropriate communication
channels exist between the Design site and the Manufacturing site for product documentation,
product validation and product change approvals. Ultimate approval of product changes remains
at the Design Product Engineering Function out of OPTRON.
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Applicable Standards
The content and application of this quality manual makes reference to the following publications
and related documents:
• ISO 9001:2015
• ISO/IEC 80079-34
The quality manual includes the scope of the Quality Management System and makes reference
to applicable operating procedures and other pertinent documents. JRZ.MAP-2 Process
Map#057 is a description of the Quality Management System interaction of processes.
Referenced specific procedures or MAP’s may vary from site to site.
Management Structure
The management at OPTRON is led by the Sensors and Specialist Components Division
leadership which consist of VP Operations and General Manager. Reporting directly to the
VP/GM are VP Engineering, Global Sales Director, VP Quality, Strategic Sourcing Director,
and Site Directors. Reporting dotted line to VP/GM are VP Human Resources and VP
Finance.
Corporate Responsibility
TT Electronics maintains corporate responsibility policies and periodically communicates to
management.
• TT Electronics Statement of Values and Business Ethics Code
• Anti-Bribery & Corruption (ABC)
• TT Bribery Act Group Policy
Process Owners
Process owners are responsible for management of the organization processes and related
outputs, process owners understand their roles and are competent to perform those roles.
Process owners are assigned to functional department heads for Top Management,
Maintenance, Production, Control, Purchasing, Logistics, Continuous Improvement, Process
Engineering, Human Resources, Finance, Quality, Information Technology, HS&E Sales, and
Customer Service.
Context of the Organization

OPTRON determines, reviews and monitors information on external and internal issues,
positive and negative conditions, that are relevant to its purpose and strategic direction and
that affect its ability to achieve the intended results of its quality management system through
opportunities for improvement identified by (SWOT) Strengths Weaknesses Opportunities and
Threats analysis.
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1 Management Processes
1.1 Quality Management System Implementation & Maintenance

It is the responsibility of Management
• to continually improve the effectiveness of the Quality Management System
1.1.1 QMS General Requirements

a) Operational and administrative activities affecting quality of the departments
Engineering, Manufacturing, Quality, Purchasing, Warehouse, Toolroom, Sales and
Customer Service and Quality Management System Administration are in compliance
with ISO 9001. It is the responsibility of the Management Representative and Department
Heads to ensure that the activities/processes included in the scope of this Quality
Management System are identified and are performed in compliance with ISO 9001.
b) It is the responsibility of the Management and Department Heads to ensure that the
sequence and interaction of processes or activities of this Quality Management System
are determined in a suitable manner, utilizing tools such as process maps, quality plans,
flow charts, operating procedures, etc.
c) It is the responsibility of the Management and Department Heads to apply the

necessary techniques and criteria in order to verify that established processes/activities
and their implemented controls are effective.
d) It is the responsibility of the division EVP, Management, and the Department Heads to
ensure that the necessary human and material resources, as well as the necessary
information, are available to ensure the effective operation and control of the processes
of the Quality Management System.
e) Compliance of product with IECEx Certificate of Conformity # IECEx BAS 11.0123u
f) It is the responsibility of the Management and Department Heads to ensure that the
processes / activities which are part of the Quality Management System are monitored,
measured, and analyzed regarding their achievement of planned results.
g) As required, the Management and Department Heads ensure that action is taken to
obtain expected results of processes/activities, as well as the continual improvement of
these processes/activities.
h) In the event that processes, which affect product conformity, are outsourced,
purchasing via Supplier Quality establishes and implements the necessary controls for
approval processes to ensure conformance to specified requirements. These
implemented controls however do not absolve OPTRON from the responsibility of
supplying products that meet customer requirements.
i) QMS Documentation requirements
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As a minimum, the documentation of OPTRON’s Quality Management System includes

• a Quality Policy and objectives
• this quality manual
• other documents needed by OPTRON for the effective planning, operation and control
of processes of the Quality Management System
The document structure of OPTRON’s Quality Management System consists of two

levels:
1) The Quality Manual, describing the Quality Management System of OPTRON and its
compliance with ISO 9001
2) Operating procedures, work instructions, forms, operating instructions, quality plans,

control plans and other documents needed by OPTRON for the effective and efficient
operation of the Quality Management System.
In addition, records are created as required by ISO 9001, as well as records necessary
to meet other internal and external requirements.
It is the responsibility of Management to ensure the availability of corporate documents
of the Quality Management System.
It is the responsibility of the Department Heads to ensure the development and availability
of documented procedures, work instructions, operating instructions and any other
documents related to their departments, that are necessary to ensure the effective
implementation, control and functioning of the Quality Management System and its
processes.
1.1.2 Management Commitment

The management of OPTRON is committed to the development, implementation and
optimum functioning of the Quality Management System and the continual improvement
of its effectiveness. In order to provide this evidence, the division EVP ensures that:
• A corporate Quality Policy is established
• Quality objectives are established by selected departments based on the company
business plan
• The importance of meeting customer requirements and statutory and regulatory
requirements is part of the training of each employee JRZ.PRO-577 (245-0015-M01)
• Resources for the implementation and maintenance of the Quality Management
System and its processes are provided in a timely manner
• At a minimum, yearly management reviews are conducted to verify the effectiveness,
efficiency, and proper functioning of the Quality Management System, including
product realization processes and support processes.
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1.1.3 Customer Focus

The division EVP ensures that procedures for determining, and meeting customer
requirements are established and implemented. The effectiveness of these procedures
is measured through customer satisfaction data, which are part of Management Reviews
(see 2.1.1 & 1.2.4).
1.1.4 Quality Policy

The management of OPTRON has developed a Corporate Quality Policy, which meets
the needs of OPTRON and its customers.
Corporate Quality Policy
TT Electronics is committed to being Trustworthy and

Responsible, delivering defect-free and competitive products on
time while meeting all customer requirements and striving to
continually improve customer satisfaction.
Stewart Partridge
Vice President / General Manager
It is the responsibility of OPTRON’s management to implement and maintain this Quality

Policy. The Quality Policy includes OPTRON’s commitment for continual improvement,
for meeting internal requirements and customer requirements, and provides a basis for
the establishment and review of quality objectives. The Quality Policy is made known
within the organization and understood and adhered to by employees. During
management reviews, the Quality Policy is reviewed for its continuing suitability.
1.1.5 Quality Management System Planning

In the first quarter of the year, Management calls for a meeting of the Department Heads
with the purpose to review, coordinate and plan the efficiency and effectiveness of the
Quality Management System and the realization of established quality objectives of the
departments, as well the coordination of improvement opportunities.
The output of these planning activities includes the identification of required resources.
As appropriate, results from audits of the Quality Management System are considered.
Planning activities are documented and are consistent with other requirements of the
Quality Management System.
It is the responsibility of Management to ensure that resulting organizational changes and

their consequences are identified and defined, that changes resulting from planning
activities are coordinated and implemented in a controlled manner, that changes to the
Quality Management System are documented, implemented, and approved, and that the
Quality Management System is properly maintained during these changes.
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Note: The Quality Planning Team under the responsibility of the Manufacturing
Department performs Quality planning for manufacturing process activities.
Each Department Head develops and maintains a process map, flow chart, quality plan
or operating procedure, etc. as required for his/her department, showing the workflow of
the department as well as evidence of compliance with the requirements of the quality
system.
Planning of the quality system includes the risks and opportunities that need to be
addressed to:
a) Give assurance that the quality management system can achieve the intended results.
b) Enhance desirable effects.
c) Prevent or reduce un-desirable effects.
d) Achieve improvements.
e) Integrate and implement actions into the quality management system processes.
f) Evaluate the effectiveness of the actions.
Planning for changes

Changes to the quality system are carried out in a planned manner considering:
a) The purpose of the change and its potential consequences.
b) The integrity of the quality management system.
c) The availability of resources.
d) The allocation or reallocation of responsibilities and authorities.
Risk analysis
Risk analysis includes lessons learned from product recalls, product audits, filed returns
and repairs, complaints, scrap and rework as applicable.
Customer Specific Requirements

Where applicable customer specific requirements are addressed thru new product
introduction and maintained as changes occur.
1.1.6 Responsibility and Authority

It is the responsibility of the site HR to develop and maintain an organization chart of
OPTRON. Updated charts are distributed to Department Heads and are available to
employees on a need-to-know basis.
1.1.6.1 Responsibility for Quality

It is the responsibility of personnel in Quality, or personnel in Production and
Warehouse, to inform the responsible Department Head of any nonconformity of
products or processes. Corrective action is taken as appropriate, including action for
the review and improvement of processes. Documents are updated as required.
If necessary, the Department Head can transfer the nonconformity to the Quality
Planning Team for review and action.
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In the event of nonconformity in production, all personnel are responsible for product
quality and have the authority to stop production in order to correct any quality
problems. It is ensured that an employee responsible for quality is present at all times
during production.
Quality Management ensures that non-conforming product is not shipped to

customers and that potential non-conforming products are identified and contained.
Management ensures that production operations on all shifts are staffed with
personnel in charge of or, delegated responsibility for insuring conformity to product
requirements.
1.1.6.2 Departmental Responsibility for Quality

The responsibility for quality in each department rests with the Department Head. The
Department Head is responsible for the development and approval of the
department’s procedures and work instructions. The Department Heads ensure that
the department staff understands and follows the applicable policies and guidelines
outlined in the Quality Manual, that the department’s personnel adhere to all
applicable procedures and work instructions and participates, as appropriate, in the
quality improvement process.
In addition, employees are made aware of the importance to meet customer

requirements and expectations. It is the responsibility of the Department Heads to
ensure that customer requirements and customer expectations, which relate to
activities under the department’s responsibility, are identified, defined, documented,
and met.
Department Heads ensure that the responsibility of employees or functions whose

activities affect quality, are defined in procedures and job descriptions. In yearly
performance reviews, or when required, these responsibilities for quality, together with
other responsibilities of the function, are reviewed and discussed between the
Department Head and the employee and are assessed and re-defined as necessary.
1.1.6.3 Individual Responsibility

All employees follow the policies and guidelines outlined in the quality manual and in
established procedures. It is the duty of each employee to inform the Department
Head or Quality Management when performed activities do not match the established
procedures, or when established procedures and work instructions are unclear or
ambiguous. The Department Head is notified of any identified nonconformity or
deficiency where the correction or prevention of such nonconformity or deficiency is
out of the employee’s scope of responsibility.
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1.1.7 Management Representative

The management of OPTRON appoints a Management Representative who, irrespective
of other duties and responsibilities, has the defined authority and responsibility for
a) Ensuring that the processes are delivering their intended outputs.

b) Reporting on the performance of the quality management system and on
opportunities for improvement, particularly to top management.
c) Ensuring the promotion of customer focus throughout the organization.
d) Ensuring that the integrity of the quality management system is maintained when
changes to the quality management system are planned and implemented.
The Management Representative is responsible for the overall coordination,

implementation, and administration of the Quality Management System.
1.1.7.1 Customer Representative

The management of OPTRON has assigned the inter-departmental coordination of
customer requirements to the Customer Service Supervisor and the direct
responsibility of addressing customer requirements to the Sales task force in every
region, Engineering and Manufacturing.
Responsibilities related to customer requirements include:
Sales task force for every region/ Customer Service:

• Coordination of issues related to customer requirements
• Recommendations for corporate quality objectives, including quality objectives
for other departments
• Conveyance of temporary deviations to customers
• Analysis of feedback from customers regarding nonconformities
• Follow-up on corrective actions
• Provides information relating to products and services
• Handling enquiries, contracts, or orders including changes
• Handling or controlling customer property
• Establishing specific requirements for contingency actions when relevant
Product Engineering:
• Quality planning activities
• Product design and development
• Communication with customers on technical issues
• Customer prototype support
• Selection of Special Characteristics
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Manufacturing:
• Special training requirements for production
• Production resources planning
• Issues related to customer supplied product
Supplier Quality Engineering

• Delivery requirements - shipping inspection
Quality:
• Ensures customer requirements are met.
• Communication with sales task force or customer service of on corrective
actions
• Corrective and preventive action
• Customer score cards
• Authority to stop shipments and stop production to correct correction of quality
issues
Process Engineering:
• Communication with quality, sales task force and customer service on technical
issues
• Customer prototype support
• Selection of Special Characteristics
• Capacity analysis
Human Resources:
• Provides training needed to achieve quality objectives
Logistics:
• Logistics information (outgoing)
Purchasing:
• Logistics information (incoming)
The Sales Department and / or customer service is informed of corrective actions

taken by the responsible department regarding the compliance with customer
requirements.
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1.1.8 Provision of Resources

Management ensures that approved material and human resources, which have been
identified by the Department Heads during budget planning and quality planning, are
available in a timely manner. This refers to resources required for the implementation,
maintenance, and continual improvement of the processes of the Quality Management
System, for meeting customer requirements and achieving customer satisfaction. Also
included are resource requirements for new projects and other quality related activities.
Related expenses are included in the company’s financial budget. JRZ.MAP-10 (Process
Map#058).
Consideration is given to capability and constraints of internal resources and what needs
to be obtained from external providers.
1.1.9 Human Resources - General

It is the responsibility of the Department Heads to identify qualification requirements of
functions or personnel assigned to defined activities that affect quality of product.
Qualification requirements include education, training, skills, and experience as
appropriate. In the department’s budget are provisions for the employment and
assignment of qualified and trained personnel.
1.1.9.1 Competence, Awareness and Training

Department Heads ensure that the qualification requirements (such as education,
skills, training, experience) for each job are identified, determined, and documented
in job descriptions. Training is provided to employees JRZ.PRO-577 (245-0015-M01)
JRZ.MAP-10 (Process Map#058) or other actions are taken in order to meet defined
qualification requirements. The effectiveness of provided training or of related actions
is evaluated, actions are taken where applicable.
Employees are made aware of the importance and the impact of their work in relation
to product quality, the quality policy, to the achievement of quality objectives and
customer satisfaction and how their contribution affects the performance and
effectiveness of the quality system and the benefits of improved performance, and the
implications of not conforming to the quality management system requirements.
Records of employees’ education, experience and other qualifications are maintained.
Employees receive Communication internal and external as relevant to the quality

system during induction presentations, tier meetings, periodic all hands meetings and
other communication activities from sources such as internal and external ppm
performance, internal and external ppm events, and customer feedback as applicable.
Organizational knowledge is maintained throughout. Documented procedures,

specifications, people experience, education and training support maintenance of
organizational knowledge. When needs change and trends change, the available
knowledge is validated and/or needs identified for additional requirements.
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1.1.9.2 Product Design Skills

It is the responsibility of Engineering to ensure that personnel with responsibility of
product design are qualified for the job and have the necessary skills and experience
as specified in the applicable job description.
1.1.9.3 Training
Management establishes and maintains the documented procedure JRZ.PRO-577
(245-0015-M01) for identifying training needs and for providing required training to
employees who are performing activities affecting product quality. The procedure
includes training for the fulfillment of specific customer requirements. The HR
Representative provides training for safety and the handling of hazardous materials.
HR prepares annual training plans thru prioritization and according to budget to
address training needs as identified by department heads including awareness and
achieving competence of all personnel performing activities affecting conformity to
product and process requirements.
1.1.9.4 Training on the Job

Department Heads ensure that personnel, assigned to new or modified responsibilities
affecting product quality, are trained on-the job. Including customer, internal regulatory
or legislative requirements training where applicable, including contracted personnel.
Personnel performing activities that can affect quality are informed of potential
consequences to the customer in the event that defined requirements will not be met
JRZ.PRO-577 (245-0015-M01).
1.1.9.5 Employee Motivation and Empowerment

Performance reviews conducted by the Department Heads include and document the
degree of employee’s awareness regarding the importance of their work and their
contribution in achieving quality objectives.
Employees throughout the whole organization are continuously motivated and
empowered to achieve quality objectives, to make continual improvements and
promote innovation.
1.1.10 Planning of Product Realization

The Engineering Department is responsible for the quality planning JRZ.MAP-9 (Process
Map #065) of the production processes of new products and for changes of existing
products. Planning activities are consistent with other requirements of the Quality
Management System. Prior and during the planning process, quality objectives and
quality requirements for product related to the planning project are established by the
quality planning team.
As appropriate, the planning process covers provision of resources necessary,

manufacturing processes and documents, required verification, validation, monitoring,
inspection and test activities, and criteria for product acceptance
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Records for providing evidence that manufacturing processes, and manufactured product
meet requirements are defined and specified.
1.1.10.1 Planning of Product Realization - Supplemental

Customer requirements and references to technical specifications are included in the
quality plan.
1.1.10.2 Acceptance Criteria

Acceptance criteria are defined in the planning process and as required, approved by
the customer. Acceptance for attribute data sampling is zero defects JRZ.MAP-9
(Process Map #065).
1.1.10.3 Confidentiality
Confidentiality of information and data about customer-contracted products/projects is
ensured JRZ.MAP-9 (Process Map #065).
1.1.10.4 Change Control

Changes to production processes JRZ.MAP-9 (Process Map #065), including
changes to products/materials from suppliers, are assessed, validated, and approved
by Engineering prior to use and implementation. For proprietary designs, the impact
of changes is reviewed with the customer. If requested by the customer, additional
verification/identification requirements are met.
1.2 Management Review
1.2.1 General - Quality Management System Performance (Mgmt. Review)

At planned intervals, management have a formal meeting to discuss and review
JRZ.MAP-2 (Process Map #057) the continuing effectiveness and adequacy of the
Quality Management System. The review includes the evaluation of the need for changes
to the Quality Management System, the Quality Policy and quality objectives, as well as
the assessment of improvement opportunities based on the review and analysis of
performance trends, achievement of quality objectives, customer satisfaction, the cost of
poor quality, and improvement opportunities identified by (SWOT) Strengths Weaknesses
Opportunities and Threats analysis.
The frequency of management review is increased based on risk of compliance with

customer requirements resulting from internal or external changes impacting the quality
management system and performance related issues.
The management review ensures the continuing suitability, adequacy, effectiveness, and
alignment with the strategic direction of the organization.
This review covers all clauses of the Quality Management System. As required,
Department Heads and employees are invited to attend the meeting when issues of
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his/her area of responsibility are discussed. The person(s) responsible for the
ATEX/IECEx quality systems, as defined in 99-00726-088, shall participate in the review.
Management prepares the agenda of upcoming meetings, ensures that the required data
and documents are available for management review, writes the minutes of the meeting,
and informs results to the Department Heads and individuals concerned and follows-up
on required actions resulting from these meetings. Management is kept informed on the
status of follow-up activities. Records of management reviews are maintained.
1.2.1.1 Review Input

As a minimum, the following inputs are to be considered for at least one meeting
during the year:
a) The status of actions from previous management reviews.
b) Changes in external and internal issues that are relevant to the quality
management system.
c) Information on the performance and effectiveness of the quality management
system including trends in:
1) Customer satisfaction and feedback from relevant parties.
2) The extent to which quality objectives have been met.
3) Process performance and conformity of products and services.
4) Nonconformities and corrective actions.
5) Monitoring and measurement results.
6) Audit results.
7) The performance of external providers.
d) The adequacy of resources.
e) The effectiveness of actions taken to address risks and opportunities.
f) Opportunities for improvement.
g) Cost of poor quality (cost of internal and external nonconformance).
h) Measures of process effectiveness.
i) Measures of process efficiency.
j) Product conformance.
k) Assessments of manufacturing feasibility made for changes to existing
operations and for new facilities or new product.
l) Customer satisfaction.
m) Review of performance against maintenance objectives.
n) Warranty performance (where applicable).
o) Review of customer score cards (where applicable).
p) Identification of potential filed failures identified thru risk analysis (such as
FMEA).
q) Actual field failures and their impact on safety or the environment.
r) ISO/IEC 80079-34 standards for “Equipment for use in explosive atmospheres”
s) Review of internal audit, and overall processes & external (authorized product
line engineer must attend meeting).
t) Improvement opportunities from SWOT analysis.
u) Internal and External interested parties needs and expectations.
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v) Improvement opportunities from risk analysis in process maps.
1.2.1.2 Review Output

Results of the assessment and conclusions of management reviews include the
following output:
a) Opportunities for improvement.
b) Any need for change to the quality management system.
c) Resource needed.
d) Action plan when customer performance targets are not met.
1.2.2 Quality Objectives

Each year, management defines Corporate Quality Initiatives in the Business Plan. Yearly
quality objectives and measurements are established by Department Heads for their
departments based on these Quality Initiatives. Management approves these
departmental quality objectives. Internal and external Interested parties and their relevant
requirements, needs and expectations are considered when the objectives are
established
Established quality objectives are consistent with the Quality Policy, are measurable, take
into account applicable requirements, be relevant to conformity of products and services,
enhance customer satisfaction, are monitored, are communicated, are updated as
appropriate include - as appropriate - objectives to meet product-customer requirements
(see 1.1.10), and are defined in such a way that their degree of achievement and results
can be measured.
Determination is made about what will are done, what resources are required, who is
responsible, when will they be completed, how the results will be evaluated.
Quality objectives for Manufacturing and Quality are related to the performance of
product.
The completion and achievement of yearly quality objectives included in the business
plan and departmental quality objectives are reviewed during management review
regarding their level of achievement.
Corporate Quality Initiatives

Based on the corporate Quality Policy, the management of OPTRON has established
the following corporate quality initiatives based on one premise – that of Exceeding the
Customer’s Expectations. These quality initiatives will be reviewed each year to ensure
alignment with the business plan.
• Provide Exemplary Customer Satisfaction

• Be a leader in Advanced Technology Development
• Eliminate waste wherever it exists
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• Be the industry benchmark for manufacturing capability

• Provide a work environment that promotes competency, teamwork, empowerment,
and accountability
• Deliver exceptional financial performance over time
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The translation from a Corporate Quality Initiative to a measurable index for demonstrating
results and continual improvement is demonstrated in the following example:
Corporate Business Plan
Corporate Quality Initiatives Established by top management

to set the direction for the
Consistent compliance with customer business
requirements
Corporate Quality Objectives
Meet on time shipment requirements Deployment strategies are

OPTRON’s Quality Objectives
Sales Department will improve accuracy Objectives are deployed to the

in the identification of customer & function or department with
product info during the quote cycle
specific goals defined
Measurement: Track the number of errors

in this information & graph.
Specific measurements are
tracked to demonstrate results
with continual improvement
The end result of this process is to clearly tie the business plan into operational
terms that have meaning to front line personnel at all levels within the organization.
Our business objectives are our Quality Objectives.
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Based on internal and external audit results and statistics issued by Management
JRZ.MAP-7(Process Map #069), these quality initiatives are reviewed during
management reviews regarding their continuing suitability.
Departmental Quality Objectives

Each year, the Department Heads of Administration, Maintenance, Production,
Purchasing, Logistics, Continuous Improvement, Process Engineering, Human
Resources, Finance, Quality, Information Technology, Customer Service and HS&E.
establish quality objectives for his/her department. These quality objectives are in
accordance with the corporate Quality Policy and are focused on the improvement of
departmental processes/activities (see process maps). The departmental quality
objectives for the coming year are submitted to management for review and approval. A
summary of the achievement of the department’s quality objectives of the past year is
documented by the applicable Department Head and submitted to management.
1.2.3 Measurement Analysis & Improvement - General

In order to demonstrate the conformity of manufactured product, the conformity of the
Quality Management System and its continual improvement, Management develops and
distributes frequent statistics JRZ.MAP-7 (Process Map #069). These statistics are
analyzed by Department Heads and corrective and preventive action for the continual
improvement of the Quality Management System is taken as appropriate.
Key metrics are defined from such subjects as Safety, Quality, Delivery, Cost, and
Inventory. Tier meetings are set for continual monitoring of performance to key metrics,
and the identification of actions where appropriate thru the PDCA cycle.
1.2.3.1 Identification of Statistical Tools

During product quality planning JRZ.MAP-2 (Process Map #057), appropriate
statistical tools are determined for each process and are included in the control plan.
This includes statistical methods for product development (variation analysis,
dependability analysis, etc.), for product verification (process capability, variation
analysis, control charts, etc.), and other processes.
New processes are evaluated thru process capability studies on key special
characteristics to verify process capability and provide additional input to process
control.
Process flows or product routings, PFMEA’s and control plans are implemented by
product or by product families as applicable. Significant process events such as tool
change or machine repair are recorded.
1.2.3.2 Knowledge of Basic Statistical Concepts

Department Heads, ensure that personnel are trained in the use and application of
basic statistical concepts defined by quality planning and used in their respective
departments.
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Statistical concepts such as variation, control, process capability and the

consequences of over adjustment are understood by employees involved in the
collection, analysis, and management of statistical data. Training records are
maintained JRZ.PRO-577 (245-0015-M01)
1.2.4 Customer Satisfaction

Periodic monitors of customer perceptions of the degree of which their needs and
expectations are being fulfilled thru customer meetings, delivery parts quality
performance, customer satisfaction data, which include customer complaints and
feedback, customers’ business disruptions JRZ.PRO-573 (245-0011-M01) customer
returns of nonconforming product (field, recalls, warranty) and delivery performance,
premium freight, customer notifications related to quality or delivery issues, including
special status are analyzed and evaluated. As required, management takes corrective or
preventive action. Management monitors the effectiveness of these corrective or
preventive actions.
1.2.5 Analysis and Use of Data

Management issues statistics regarding the performance of the Quality Management
System thru the analysis and use of data. Ratings on supplier performance are issued by
Purchasing JRZ.MAP-3 (Process Map# 059). The statistics are analyzed by Management
regarding the effectiveness, suitability, and opportunities for improvement of the
processes of the Quality Management System, and by Department Heads regarding the
performance and suitability of activities and processes under their responsibility. This
includes the analysis of customer complaints JRZ.PRO-573 245-0011-M01 and customer
returns JRZ.MAP-2 (Process Map# 057).
A summary report is issued by Management, providing information on customer

satisfaction or dissatisfaction, product quality, characteristics and trends of processes and
products including opportunities for preventive action, and supplier performance.
Management controls and coordinates the implementation of required corrective or

preventive actions. Analysis results of statistics and actions are reported by the
Department Heads to Management who monitors the progress and results of these
actions.
In addition, trends in quality and operational performance are compared with progress
toward objectives and lead to action to support: the development of priorities to resolve
customer-related problems, to determine customer related trends and correlation for
status review, decision making and longer-term planning, and an information system for
reporting of product information related to usage.
Improvement
It is the responsibility of Management to form and implement a Quality Planning Team for
the handling of assigned activities related to the Quality Management System. Members
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should be from Quality, Manufacturing, Engineering, Sales, Purchasing and any other
additional members deemed necessary.
The purpose of the Quality Planning Team is to review, analyze and make final decisions
on Corrective Action Requests JRZ.PRO-587 (245-0024-M01) and Quality Improvement
Proposals, to make recommendations for preventive actions and quality improvements,
to coordinate and implement preventive actions and quality improvement projects,
monitor results, and to provide a forum for any quality issue which requires a cross-
functional approach. Nonconformities and deficiencies are analyzed, root causes are
determined and required action is taken or recommended as appropriate.
As required and/or decided by management, selected Quality Improvement Proposals

are referred to the Quality Planning Team for review regarding their feasibility and
benefits.
1.2.6 Continual Improvement

The planning, coordination, and control of activities for continual improvement JRZ.MAP-
7 (Process Map# 069) or JRZ.PRO-595 (245-0029-M01) is the responsibility of
management and continuous improvement leader. Continual improvement activities
include - but are not limited to - the following:
• activities of the Quality Team under the responsibility of Management
• actions on results from analysis of data
• evaluation of suppliers JRZ.MAP-3 (Process Map# 059)
• achievement of departmental quality objectives
• results from internal quality audits
• quality improvement proposals (QIP)
• corrective actions and preventive actions (CAR) JRZ.PRO-587
• periodic review of controlled documents JRZ.MAP-2 (Process Map #057)
The objectives of the corporate Quality Policy are taken into consideration for planning of
improvement. During Management Reviews, its outputs, and the effectiveness of
continual improvement for the suitability, adequacy and effectiveness of the quality
management system is reviewed and opportunities for improvement are identified.
Manufacturing process improvement

It is the responsibility of personnel in Manufacturing to continually monitor the
performance of manufacturing processes regarding conformity with product
characteristics and process parameters. In monthly meetings with the production staff,
process performances of production areas are analyzed, and opportunities for
improvement are identified and implemented JRZ.PRO-595 (245-0029-M01).
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1.3 Communication
1.3.1 Internal Communication

Effective internal communication is essential for the proper functioning of the Quality
Management System. Management, with the assistance of the Department Heads,
ensures that required communication and information between departments and
functions is defined in documented procedures, memos, forms and/or documents, and
staff meetings.
Any communication problem regarding the Quality Management System is reported to

Management for corrective action.
1.3.2 Customer Communication

To meet customer requirements and to ensure the proper and effective communication
between the various departments within OPTRON and the customer, Sales establishes
a list with some main contacts within OPTRON regarding customer inquiries. This list is
updated as required, is distributed to functions concerned and is attached to the main
directory available at the front lobby.
Internal and external communication related to the planning of products and processes
JRZ.MAP-9 (Process Map #065) is defined by Engineering and/or Sales and/or the quality
planning team, as applicable.
It is the responsibility of Engineering, with the assistance of the IT-department, to install

and use electronic communication and design systems (such as CAD) that are compatible
with the customers’ systems, to effectively communicate and interchange information with
the customers.
It is the responsibility of Sales, with the assistance of the IT-department, to develop,

implement and maintain a computerized system (such as EDI) for the receipt of planning
information of customer orders, shipping schedules and shipping information.
Written and verbal communications are made in the language agreed with the customer.
1.4 Internal Auditing
1.4.1 Internal Audit of the Quality Management System

Following the established documented JRZ.MAP-2 Process Map #057 Internal Quality
Audits, Management is responsible for internal audits. Internal audits are planned and
scheduled in such a way that all applicable clauses of ISO 9001 and other additional
quality system requirements are audited regarding compliance with this implemented
Quality Management System and ISO/IEC 80079-34. Audits do also verify if the Quality
Management System is effectively implemented and maintained, and that it meets the
requirements of OPTRON, including planned actions, objectives, and results.
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Internal audits take into consideration the importance of the processes concerned,
changes affecting the organization and the results of previous audits.
Internal audits are prioritized based on risk, internal and external performance trends, and
criticality of the processes. Where applicable, software development capability
assessments are included in the internal audit program.
Management selects the auditors and ensures that they have required experience and
knowledge to perform auditing activities.
Audits are scheduled based on the importance of the activity to be audited. Audit activities
are assigned to personnel not responsible for the area or activity to be audited. Frequency
of audits is reviewed, and where appropriate adjusted based on occurrence of process
changes, internal or external nonconformities, and/or customer complaints. The
effectiveness of the audit program is reviewed as part of management review.
Audit results are recorded, and corrective action is taken as required. Where applicable,
follow-up audits are conducted to ensure that corrective action was implemented and is
effective.
Records of internal audits are maintained. As appropriate, management is informed of

the results of audits and follow-up audits and takes additional corrective action.
Management ensures that audit results are part of Management Review.
1.4.2 Internal Audit Plans

Internal audits cover the entire Quality Management System and its processes, including
all shifts of these processes, and are scheduled according to a yearly auditing plan and
schedule prepared by Management JRZ.PRO-601 (245-0037-M01). Due to special
circumstances, such as nonconformities and customer complaints, the auditing frequency
is increased as appropriate.
The entire quality system processes are audited on a three-year calendar period
according to an annual program using the process approach. Integrated to these audits
are samples of customer specific quality management system requirements for effective
implementation.
1.4.3 Internal Auditor Qualification

It is the responsibility of Management to ensure that internal auditors of the Quality
Management System have the necessary experience and qualification for performing
internal quality audits JRZ.PRO-601 (245-0037-M01). Training needs are identified, and
training is provided as required JRZ.PRO-577 (245-0015-M01). Internal auditors conduct
audits ensuring objectivity and impartially of the audited process.
Internal auditors are competent and consider customer requirements. Quality system
auditors, manufacturing process auditors and product auditors have competence on:
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a) Understanding of the automotive process approach for auditing, including risk-based

thinking
b) Understanding applicable customer specific requirements
c) Understanding of applicable ISO 9001 requirements.as related to the scope of the
audit
d) Understanding of applicable core tool requirements as related to the scope of the audit
e) Understanding how to plan, conduct, report, and close audit findings
Additionally manufacturing process auditors have technical understanding of the

manufacturing process they audit including PFMEA and control plan. Product auditors
understand product requirements and relevant test and inspection equipment to verify
product conformance.
Second party audits (where applicable) are conducted by competent, qualified internal
Quality System auditors.
1.4.4 Manufacturing Process Audit

In addition to the normal internal audits of the Quality Management System, Management
coordinates with the Manufacturing department the auditing of all manufacturing
processes. Audits of manufacturing processes are performed on a three-year calendar
period including the effective implementation of process risk analysis thru PFMEAs,
control plans and manufacturing instructions. Responsible personnel in Manufacturing
take required corrective actions. A summary of audit results of the manufacturing
processes is prepared and included in Management Reviews.
1.4.5 Product Audit

During the auditing of process in Manufacturing and the Warehouse, inspection, and test
results of product in process and finished product are audited to verify conformity to
specified requirements. Incoming product, product in inventory and product ready for
shipping is audited regarding compliance with packaging and labeling requirements. As
appropriate, physical product can be inspected and tested by the auditor to confirm the
product’s conformance to requirements and proper functionality JRZ.MAP-2 (Process
Map#057)
1.5 Corrective & Preventive Action
1.5.1 Corrective Action

It is the responsibility of Management to implement and maintain the documented
procedure JRZ.PRO-587 (245-0024-M01) corrective action that defines a corporate
approach for corrective action.
Following the established procedure for corrective action JRZ.PRO-587 (245-0024-M01),

nonconformities are identified, root causes are determined, corrective action is evaluated
and defined, recurrence of the nonconformity is prevented, corrective actions and their
results are recorded, and the effectiveness of corrective action taken is reviewed.
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Corrective actions are appropriate to the importance and impact of the addressed
nonconformity.
It is the responsibility of the Department Heads to inform the Sales/ Customer Service
department of all customer complaints JRZ.MAP-8 (Process Map#068) and related
corrective actions.
It is the responsibility of the Department Heads to establish and maintain records of

corrective actions and their results.
1.5.1.1 Problem Solving

To determine the root cause of a problem or deficiency, and to establish required
corrective action, a disciplined problem-solving method defined in QP system or any
other suitable method, is used as appropriate.
Customer specific prescribed processes, tools and systems for problem solving will
be applied where applicable and specifically required by customers.
1.5.1.2 Error-Proofing
As appropriate, error-proofing methods are applied in the corrective action process
to prevent recurrence of the problem. And as part of the preventive action process
thru FMEAS. Challenge parts a
re identified, controlled, and verified.
1.5.1.3 Corrective Action Impact

As applicable, the Team applies lessons learned implemented corrective action to
other similar processes or products in order to correct nonconformity, or potential
nonconformity.
1.5.1.4 Rejected Product Test / Analysis

Product returned from customers is analyzed by Quality to initiate appropriate
corrective action and to prevent recurrence JRZ.MAP-2 (Process Map #57)
1.5.2 Preventive Action

It is the responsibility of Management to implement and maintain the documented
procedure JRZ.PRO-587 (245-0024-M01) Preventive Action that defines a corporate
approach for preventive action to prevent the occurrence of potential non-conformities,
deficiencies, or problems. Any employee can suggest a preventive action to the
responsible Department Head JRZ.PRO-587 (245-0024-M01). Preventive actions
eliminate causes of potential nonconformities to prevent their occurrence and are
appropriate to the severity of the potential issue.
Processes are established to lessen the impact of negative effects of risk including:
a) Determination of potential non-conformances and their causes
b) Evaluation of the need for action to prevent occurrence of non-conformities
c) Determination and implementing the action needed
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d) Documentation of the action taken

e) Review of effectiveness of the preventive action
f) Utilization of lessons learned to prevent recurrence in similar processes
Department Heads analyze and evaluate data of statistics and perform periodic reviews
of procedures JRZ.MAP-4 (Process Map #061) to detect deficiencies and problems and
to take preventive action as required.
PFMEA’s are used as a tool for preventive actions, daily monitors of the Manufacturing
factors allow for identification of conditions that may potentially create a non-conformity.
It is the responsibility of the Department Heads to establish and maintain records of

preventive actions and their results. Management ensures that relevant information on
preventive action is on the agenda of management reviews.
2 Realization Processes:
2.1 Requirements Determination & Review
2.1.1 Determination of requirements related to product

It is the responsibility of the Sales department to ensure that customer requirements
related to product are identified and defined. Requirements include recycling,
environmental impact and other characteristics identified because of the organization
knowledge of the product and manufacturing processes.
Potential new or modification to standard products will be reviewed per the New or
Modified Standard Product Selection Procedure (99-00726-086) prior to the design and
implementation into manufacturing.
Potential new or modification to existing ISO/IEC 80079-34 products will be reviewed

per specification 99-00726-087 prior to the design and implementation into
manufacturing.
It is the responsibility of Engineering, represented by the Quality Planning Team, to

identify and determine requirements not specified by the customer but necessary for the
proper and intended use of the product or service, as well as other requirements
identified during product development and quality planning JRZ.MAP-9 (Process Map
#065), including regulatory and statutory requirements JRZ.MAP-9 (Process Map #065).
Once these requirements are determined, they are used as input for product
development and quality planning, and other functions concerned are informed as
appropriate.
In addition to customer requirements included in design, development, and quality

planning JRZ.MAP-9 (Process Map #065), Department Heads ensure that other
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requirements specified by customers, as well as customer needs and expectations are

identified, determined, and documented by the responsible department, and that these
requirements are met as appropriate. The Sales department or responsible Department
Head also ensures that during set-up and maintenance of new customer files (217-
0020-001), order taking and processing (217-0014-001, 217-0011-001), customer
returns (217-0027-001) and shipping of products, customer requirements are identified
and documented, and understood by all functions concerned.
Based on sales forecast and/or other special requirements documented by the Sales
department, Manufacturing prepares production schedules and material requirement
reports to ensure availability of product for the fulfillment of customer orders.
OPTRON has established an International Traffic in Arms Regulations (ITAR)

compliance Manual (89-00015-179) that addresses legal and ethical compliance and
more specifically, compliance with International Trade Regulations.
Customer-designated special characteristics

It is the responsibility of Engineering, the quality planning team and Manufacturing to
apply, document and control special characteristics designated by the customer, with
focus on processes affecting safety, compliance with regulatory requirements, the fit or
function of a product, or any other requirement of importance. Symbols to be used for
these special characteristics are those designated by the customer or other commonly
used symbols used in the industry.
2.1.2 Review of Requirements Related to Product, Manufacturing Feasibility

The Sales department is responsible for the review of product specifications and
customer requirements JRZ.MAP-8 (Process Map#068, 217-0020-001) SDQA. Prior to
the submission of a quotation to the customer, or the acceptance or confirmation of an
order from a customer, the order or quotation is reviewed to ensure that
• the product and customer requirements are clearly defined and documented
• OPTRON has the capability to meet the requirements of the quotation or order
• requirements of verbal orders are recorded and confirmed prior to acceptance
• any differences between the customer’s order and OPTRON’s quotation are clarified
and resolved.
Waiving the requirement for a formal review requires customer approval. Manufacturing
feasibility is analyzed, and a risk analysis is performed, confirmed, and documented (217-
0020-001). The results of reviews and required actions are documented.
In the event of changes to product requirements, or other changes to a quotation or order,

it is ensured that relevant documents and data are updated and that other functions
concerned are notified. Records of contract reviews are maintained.
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2.2 Design & Development
2.2.1 Design and Development

If there is a need for the design and/or development of a new custom product or for a
change of the design or manufacturing process of a custom product, the originating
department submits a Red folder (217-0020-001) request to Engineering.
If there is a need for a design and /or development of a new standard product or for a
change of the design or manufacturing process of a new standard product, the New or
Modified Standard Product Selection Procedure (99-00726-086) will be followed.
Design and development activities focus on error prevention rather than error detection.
2.2.2 Design and Development Planning

OPTRON products development and design are responsibility and activities performed in
OPTRON corporate offices OPTEK technology Inc. located in Plano TX. USA. The
planning and control of design and development of product is the responsibility of Process
Engineering JRZ.MAP-9 (Process Map #065). During the planning process (Design
Control Handbook), the project team determines the stages of the design and
development project, defines the review, verification and validation of each design and
development stage as appropriate, and assigns responsibilities of required tasks and
actions.
It is the responsibility of the Project Team Leader to ensure the effective communication
and distribution of information between the team members and other functions
participating in the planning process.
As the planning process develops, planning output is updated as appropriate, and thru
the gate review process of New Product Introduction.
2.2.3 Multidisciplinary Approach

Organizational and technical interfaces, including customer communication, are defined
in the Project Plan and Schedule (Design Control Handbook) and are reviewed during
each meeting of the team. As required, other functions are consulted within their areas of
expertise. A multidisciplinary approach is also used for the development and monitoring
of special characteristics, and the development and review of FMEAs and control plans.
2.2.4 Design and Development Input

The originator of the Green folder (217-0010-001) identifies and documents the input
requirements, which are reviewed by Engineering. Input for product design and
development includes functional and performance requirements, statutory and regulatory
requirements, customer requirements, product quality and performance objectives, and
any other identified requirements. Input for the development of manufacturing processes
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includes product design output data, targets for productivity, capability, cost, and
customer requirements, as applicable (Design Control Handbook).
Any experience or information from similar projects is applied as appropriate. Ambiguous,

missing, or conflicting information is clarified and resolved with the originator of the
request before proceeding with the project. Records of design input are maintained.
2.2.5 Special Characteristics

Special characteristics for product and processes, and which are specified by the
customer or by OPTRON, are identified and included in control plans, FMEAs and
applicable documents to ensure proper identification of special requirements of product
and processes JRZ.MAP-9 (Process Map #065).
2.2.6 Design and Development Output

The Project Team produces design output, which is documented, is expressed in terms
that can be verified and validated against design input requirements, meets design input
requirements, contains, or refers to acceptance criteria and includes critical and crucial
characteristics for safety and functionality of the product or process. As applicable, design
and development output provide data and information for product design, manufacturing
process design. Additional outputs for product design include FMEAs, special
characteristics, product definitions, design reviews and other defined output results.
Additional outputs for process design include drawings, FMEAs, control plans, process
performance and other information and data to ensure that manufacturing processes
meet requirements (Design Control Handbook).
Design outputs are reviewed prior to release.
2.2.7 Design and Development Review, Monitoring

The Project Team performs formal design reviews to identify any potential problems in
meeting requirements and design goals. Problems are identified and appropriate action
is taken.
Progress and end results of design and development planning (such as effectiveness,
costs, lead time) are recorded at defined stages of the planning and are submitted to
Management for input to management reviews.
Records of design reviews and resulting actions are maintained.
2.2.8 Design and Development Verification

The Project Team performs periodic design verifications to verify that design and
development outputs meet the design and development input requirements. Results of
design verifications and resulting actions are recorded and maintained.
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2.2.9 Design and Development Validation

The Project Team performs design validation to ensure that the designed product meets
defined customer/user needs and requirements. Validation is according to customer
requirements and includes program timing. If possible, this validation should be
performed prior to production. However, if required, partial validation is acceptable.
Results of validations and necessary actions are recorded and maintained.
2.2.10 Prototype Program

If required by the customer, the product development includes the development of a
control plan and a prototype JRZ.MAP-9 (Process Map #065). Processes, equipment,
and materials used for the prototype should be the same as those used for final production
runs. Testing activities are monitored regarding timely completion and compliance with
requirements. If services for prototype development are outsourced, it is understood that
OPTRON is still responsible for the quality and performance of the prototype. As required,
OPTRON provides technical assistance and support to contractors/suppliers.
2.2.11 Product Approval Process

Sample submission of production parts for consequent customer approval is the
responsibility of Quality. Methods and guidelines specified by the customer are followed.
Production part approval is requested for production parts, engineering change of
production part, manufacturing location, material suppliers and production process
environment. Any change to these conditions requires customer notification and possible
re-submission of production parts for approval. OPTRON is responsible for contracted
materials and services. JRZ.MAP-8 (Process Map#068).
As appropriate, production part approval is extended for engineering approval of

purchased products.
The Change Review Board (CRB) approves the implementation of engineering

changes.
2.2.12 Control of Design and Development Changes

Requests for design and development changes, including proposed changes from
suppliers, are documented (217-0010-001, Design Control Handbook). Requests are
reviewed and approved by Engineering. Results and necessary actions are documented,
and records are maintained.
2.2.13 Product Safety

Product safety considerations:
a) Identification of statutory and regulatory product safety requirements
b) Customer notification of requirements per a) above
c) Special approval for design FMEA
d) Identification of product safety characteristics
e) Identification and controls of safety related characteristics of product and at the
point of manufacturing
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f) Special approval of control plans and process FMEA’s

g) Reaction plans
h) Defined responsibilities, definition of escalation process and flow of information,
including top management and customer notification
i) Training identified by the organization or the customer for personnel involved in
product safety related products and associated manufacturing processes
j) Changes of products or process shall be approved prior to implementation,
including evaluation of potential effects on product safety from process and product
changes
k) Transfer of requirements regarding product safety throughout the supply chain,
including customer-designated sources
l) Product traceability by manufacturing lot (at a minimum) throughout the supply
chain
m) Lessons learned for new product introduction
2.2.14 Software Embedded Product

Product software development assessments and verifications are carried on such
products where applicable to ensure the quality of the product.
2.3 Purchasing
2.3.1 Purchasing Process

The Purchasing department is responsible for the effective and efficient operation of
purchasing functions and activities JRZ.MAP-3 (Process Map# 059).
Depending on the effect of the purchased product on the final product or production
processes, the type of control applied to the supplier and the method used for verification
of purchased product are identified and established by Engineering and/or Quality.
Production materials, products and services are only purchased from approved suppliers.
Suppliers are evaluated and selected according to defined selection criteria and their
ability to supply product that meets specified requirements. Records of evaluation and
selection of suppliers as well as related actions are maintained by Supplier Quality
Engineering (SQE) and/or Supplier Quality Development (SQD).
Supplier performance is monitored per the Supplier Quality Requirements paragraph 4

page 12 through the evaluation of product quality, problems reported by manufacturing
involving supplied product, delivery performance to acknowledged date and continual
improvement.
2.3.2 Regulatory Conformity

Supplier Quality Engineering verifies that incoming purchased products and materials are
in compliance with applicable regulatory requirements (245-0009-M01)
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2.3.3 Supplier Quality Management System Development

The Purchasing staff encourages suppliers to prepare for and/or implement the necessary
procedures to meet the requirements of ISO 9001 and to become certified. All suppliers
have access to the manual TT Electronics/OPTRON Supplier Quality Requirements as
an initial step for getting familiar with quality system requirements. As required, the
assistance For products and services purchased, including customer supplied product,
Purchasing, SQE and/or SQD ensures that required records are set up and maintained.
The data describe and clearly identify the product to be ordered, requirements for the
approval of product, procedures, processes and equipment, statutory and regulatory
requirements, requirements for qualification of personnel, and Quality Management
System requirements, as applicable. As appropriate, standards or other documents are
referenced. The adequacy of specified purchase requirements is ensured prior to
submission to the supplier.
of Management is requested. Purchasing &/or Supplier Development follows up on the
suppliers’ progress with the implementation of ISO 9001 or an acceptable quality
management system JRZ.MAP-3 (Process Map# 059).
2.3.4 Customer-Approved Sources

Where according to customer contract, a product or material is to be purchased from a
customer-designated supplier, it is the responsibility of the Purchasing department to
ensure that these materials, products, or services are only purchased from the customer-
designated supplier. The customer must approve alternate suppliers for this product,
material, or service. Materials supplied by customer-designated suppliers are subject to
receiving inspection by Quality JRZ.PRO-569 (245-0009-M01). For the supply of
materials for other applications, the customer-approved supplier must be approved
according to OPTRON’s approval criteria. Supplier Quality Requirements
2.3.5 Purchasing Information
2.3.6 Verification of Purchased Product and Incoming Product Quality

The extent of quality control exercised over a supplier or over the supplied product is
determined by Supplier Quality and depends on the importance of the product or product
class, the initial evaluation of the supplier, and/or type and extent of inspection performed
by the supplier, and/or the results of ongoing performance ratings of the supplier.
Incoming purchased product is submitted to an incoming inspection JRZ.PRO-569 (245-
0009-M01) performed and recorded by Supplier Quality when supplier product is non-
certified.
In the event that OPTRON or one of OPTRON’s customers wants to verify purchased
product at the supplier’s premises, these verification requirements and/or the method of
product release are requested and defined by either Engineering, Quality or Sales, and
are specified either in the purchase order and/or part specification. Verification activities
at the supplier’s premises are coordinated through the Purchasing and/or Quality
department. Verification at supplier’s site does not exclude subsequent rejection after
receipt at OPTRON or OPTRON’s customer.
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2.3.7 Supplier Monitoring

Supplier performance is monitored through evaluation of product quality, cost
competitiveness, continuous improvement efforts, problems reported by manufacturing
involving supplied product, delivery performance, and customer feedback.
Purchasing/Supplier Quality develops periodic performance ratings (Supplier Quality

Requirements) of approved active suppliers and distributes on a regular basis to the top
suppliers, others on request or at OPTRON’s discretion. Suppliers are informed of their
rating and corrective action is taken as required. Records of supplier performance ratings
are maintained.
2.4 Facilities & Equipment Management
2.4.1 Infrastructure
The required infrastructure and resources for manufacturing activities are identified
during quality planning JRZ,MAP-9 (Process Map #065). As applicable, this includes
building facilities, necessary workspace, and utilities as well as needed equipment and
services such as maintenance, warehousing and transportation, information, and
communication technologies.
Management ensures the timely availability of identified and approved resources.
2.4.1.1 Plant, Facility and Equipment Planning

Plant, facility, and equipment planning of the effectiveness of existing equipment and
facilities are the responsibility of a multidisciplinary approach and involves
departments and functions concerned, plant, facilities and equipment plans in
designing plant lay outs are aimed at optimization of material flow, material handling
and value-added use of floor space including control of non-conforming product and
to facilitate synchronous material flow. The productivity and effectiveness of existing
operations is reviewed, monitored and evaluated considering JRZ.MAP-7 (Process
Map#069).
• Human factors
• Operator and line balance
• Availability of supplies
• Use of automation
• Work plans
• Capacity planning
• Lean manufacturing
Records of planning activities are maintained as per applicable master list of

records.
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2.4.1.2 Contingency Plans

The Management team, with participation from Manufacturing, Engineering and
Sales, develops contingency plans to meet customer requirements in the event of a
production halt or labor shortage. Contingency plans are reviewed in the first quarter
of each year regarding their validity. New plans are developed as required.
JRZ.PRO-667 (240-0165-M01)
2.4.2 Work Environment
2.4.2.1 Work Environment

The quality planning team defines special conditions of the work environment that
are necessary for the processes to meet defined requirements of product quality and
regulatory requirements JRZ.MAP-9 (Process Map #065). These special conditions
are included in the quality plan, manufacturing plan, process sheet or other
documents. It is the responsibility of the Department Head to implement these
requirements.
Environment factors such as social (i.e., non-discriminatory), psychological (i.e.,
stress reducing) and physical (i.e., hygiene) are provided and maintained.
2.4.2.2 Personnel Safety to Achieve Product Quality

It is the responsibility of the Department Heads to ensure the safety of employees
and to minimize risk of injuries when performing their duties. Accidents at the
workplace are recorded, JRZ.PRO-474 (240-0055-M01), JRZ.MAP-10 (Process
Map# 058). and sent to the HR Representative who keeps a master list of accidents
for corrective or preventive actions.
The HR Representative forms the Health and Safety Committee that includes
representatives of applicable areas. Any issues or concerns regarding health and
safety of processes are reported to the departmental representative.
Product safety is addressed during the design and development process under the
responsibility of Engineering.
2.4.2.3 Cleanliness of Premises

It is the responsibility of management to ensure that the premises of OPTRON are
kept clean and in a good state of order. It is the responsibility of Manufacturing and
Warehouse to ensure that production facilities and the warehouse are kept clean
and in good order. As required, housekeeping procedures are developed and
implemented by individual Department Heads.
2.4.3 Customer Property
2.4.3.1 Customer Property

Customer owned product supplied for production is inspected by Supplier Quality
according to defined inspection requirements.
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The responsible Department Head ensures that customer owned product is identified,
stored, used, handled, and shipped in an appropriate manner to ensure its suitable
condition for use.
During periodic cycle counts conducted by designated personnel in Manufacturing or

Warehousing, a visual inspection of products, including customer owned product, is
performed to verify the product’s condition and proper identification. Any loss, damage
or deterioration of customer-supplied product is recorded, and the customer is notified.
2.4.3.2 Customer Owned Production Tooling

It is the responsibility of the Toolroom & Manufacturing under direction of finance to
ensure that customer owned tooling and fixtures are clearly identified with a metal
plate or permanent marking method showing the ownership of the equipment.
2.4.4 Control of Monitoring & Measurement Devices
2.4.4.1 Control of Monitoring and Measuring Devices

To ensure accurate and reliable monitoring and inspection results, Quality,
Manufacturing, Toolroom and Engineering ensure that monitoring and measuring
equipment and devices are controlled, calibrated, and maintained.
Resources are provided to ensure valid and reliable results are achieved when
monitoring or measuring devices are used to verify conformity of products and
services to requirements.
The type of monitoring and measuring equipment/ device/ software to be used in

Manufacturing, by Quality and Toolroom, and the required accuracy of these
monitoring and measurement activities are defined during quality planning and
specified in the manufacturing plan JRZ.MAP-9 (Process Map #065), process traveler
and/or inspection reports JRZ.FORM-27.
It is the responsibility of the applicable department to ensure that monitoring and

measuring processes are capable for their intended purpose and are performed in a
manner that is consistent with requirements.
To ensure valid results, measuring equipment is

• Calibrated and/or checked in defined intervals or prior to use, and according to
a recognized standard; where no recognized standard is used, the basis
applied for the calibration is documented
• Adjusted and re-adjusted as necessary to ensure required accuracy
• Identified with a unique identification number and the current calibration status
• Kept in a secure and restricted location to prevent misuse and improper
adjustments that could invalidate calibration settings
• Protected from damage and deterioration during handling, maintenance, and
storage
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If monitoring and measuring devices are found out of calibration, previous measuring
results are reviewed regarding their validity. Corrective action on the measuring device
or product affected is taken, including recall of nonconforming product, if required.
Prior to the use of computer software for monitoring and measuring activities, it is
verified and confirmed that the software produces defined results. Records of these
verifications are maintained
2.4.4.2 Measurement System Analysis

It is the responsibility of Process Engineering to ensure that Measurement System
Analysis (as minimum Repeatability and Reproducibility study) is conducted
JRZ.PRO-575 (245-0012-M01) for each measuring device referenced in control plans
with prioritization to those sued for critical or special product or process
characteristics. Records of these studies provide evidence of the variations present in
the results of each type of measuring device and are taken into consideration when
inspection reports are developed.
2.4.4.3 Calibration / Verification Records

The department of Quality is performing the calibration of monitoring and measuring
devices is responsible for the record keeping of calibration activities. These records
include the identification of the equipment and the calibration standard, revisions due
to engineering changes, and calibration results such as out-of-specification/conformity
to specifications JRZ.MAP-2 (Process Map#057).
When monitoring and inspection equipment is found out-of-specifications, the impact

on products previously measured with this equipment is reviewed and validated and
an Out-Of-Calibration Report is initiated as appropriate. If suspect product/ material
has been shipped, the customers are informed, and the product is recalled as
required.
Verification that monitoring and inspection equipment is in specification shall be

confirmed by a current calibration certification sticker on the equipment. In the event
that the calibration certificate is found to have expired and has not been used in the
production and testing of product the equipment shall be removed from the lab and
scheduled for the next calibration cycle.
2.4.4.4 Laboratory Requirements
2.4.4.4.1 Internal Laboratory

It is the responsibility of the Quality function to define and document the scope of
the capability of tests and inspection activities, which can be performed by the in-
house laboratory facility which has specified and implemented technical
requirements for the
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▪ Suitability of implemented procedures

▪ Competency of personnel
▪ Testing of product
▪ Capability to perform these services correctly and according to pertinent
process standards,
▪ The review of related records
2.4.4.4.2 External Laboratory

As required, qualified laboratories are used for inspection, test and calibration, and
other contract services. Only laboratories are used which include in their defined
laboratory scope the required service to be performed, and which are either
capable based on business history and/or previous services provided, or
laboratories that are accredited to ISO/IEC 17025 or another equivalent national
standard. If a specific calibration service cannot be performed by an external
laboratory, or in the absence of such a laboratory, the original equipment
manufacturer or their accredited representative can provide this service.
2.5 Company Control Specifics
2.5.1 Document Control
2.5.1.1 Control of Documents and Engineering Specifications

Documents required by the Quality Management System are controlled documents.
It is the responsibility of the Department Heads to implement and maintain the

Document Control procedure JRZ.PRO-579, which defines the responsibilities for the
development of controlled documents, their approval for adequacy, changes and re-
approval, revision status, document formats, identification, and distribution.
Following the documented procedure (224-0001-001) (245-0020-M01) Document and

Data Control, the Engineering Department is responsible for the identification, control
and distribution of technical engineering documents, including documents and data of
external origin such as standards and customer drawings. Engineering documents
developed by Engineering or engineering documents from the customer, including the
distribution of these documents, are recorded. Incoming customer engineering
standards and specifications, including changes, are reviewed as soon as possible,
not to exceed two weeks, by Engineering, and are then distributed and implemented
as required. Records of implementation dates in production are maintained.
It is the responsibility of the applicable Department Head to ensure that current

revisions of controlled documents are legible, readily available where needed, that
obsolete copies are replaced and destroyed or invalidated, and that obsolete
documents retained for any purpose are clearly identified.
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As required, it is the responsibility of the IT Department to establish a schedule for

producing back-ups of defined computer data. These back-ups on tape or CD-ROM
are kept in a secure place. Schedules for backup responsibilities and compliance are
documented.
2.5.2 Records Control
2.5.2.1 Control and Retention of Records

Records are maintained to provide evidence of activities and their results, of
conformance to requirements and of the effective operation of the Quality
Management System. Department Heads are responsible for the proper identification,
storage, retrieval, protection, retention time and disposition of quality records
according to the established documented procedure JRZ.PRO-580 (245-0021-M01).
2.5.3 Control of Production Provision
2.5.3.1 Control of Production

Manufacturing processes activities are performed under controlled conditions. Based
on the output from quality planning JRZ.MAP-9 (Process Map #065), Manufacturing
and Document Control ensure that the necessary documents, data and operating
instructions for the performance of manufacturing processes are developed and
available to personnel. These documents or data describe in sufficient detail the
product characteristics, production processes, the equipment to be used, as well as
the activities for monitoring and measuring of these processes. Included are
procedures for release, delivery, and post-delivery activities.
The Manufacturing department ensures that operating instructions, including

instructions for special processes, are available at the workstation, that production
activities, verification results and SPC records are recorded, and that activities for the
monitoring and measurement of production processes are implemented and followed.
It is also the responsibility of the Manufacturing department to ensure that the work
environment is appropriate for the work being performed and meets statutory
requirements. The HR Representative is responsible for compliance with regulatory
requirements.
2.5.3.2 Control Plan

Control plans are developed during quality planning JRZ.MAP-9 (Process Map #065)
and define the development of prototypes, pre-launch, and production processes, as
applicable. Control plans are available for all production stages of products or parts,
including assembly. Pre-Launch control plans heed the outputs of DFMEAs and
PFMEAs.
As applicable, control plans specify

• The required controls for manufacturing processes
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• The methods used for monitoring applied controls over special characteristics
(customer/OPTEK Technology Inc./OPTRON)
• Customer-required information
• The reaction plan to be initiated when the process becomes unstable or not
capable
With changes of product specifications, or any changes affecting the product,

manufacturing processes, inspection activities, logistics, supply sources or FMEAs,
control plans are updated by the quality planning team JRZ.MAP-9 (Process Map
#065). If required, customer approval is obtained for the change.
2.5.3.3 Work Instructions

It is the responsibility of the Department Heads to develop and maintain documented
work instructions and operating instructions that are necessary for the performance of
processes and activities affecting quality of products. These documents are made
accessible to personnel at the workplace. Work instructions and operating instructions
are derived from the output data from quality planning, such as the quality plan or
control plan JRZ.MAP-4 (Process Map#061).
2.5.3.4 Verification of job set-ups

Manufacturing is responsible for proper set-ups of production equipment. Quality
performs a last-off comparison, as appropriate. First-Offs are approved by Quality. As
applicable, statistical verification methods are used. Set ups are documented thru
manufacturing instructions, records are retained as applicable. Product compliance to
be verified after prolonged line shutdowns.
2.5.3.5 Preventive and Predictive Maintenance

A master list of machinery and equipment that requires preventive maintenance to
ensure continuous process capability is developed and maintained by Manufacturing.
Preventive maintenance objectives are established and documented in the first
quarter of each year. These objectives are evaluated at least yearly regarding their
achievement and opportunities for improvement.
Designated staff in Manufacturing performs required preventive maintenance. The

actual maintenance status of each piece of equipment is identified. The maintenance
system includes a MIN/MAX - inventory system of frequently used replacement parts
and a predictive maintenance analysis that assists in the review of preventive
maintenance cycles, maintenance methods and inventory of replacement parts.
Equipment and tooling and gauging that are kept in Manufacturing are packaged and
preserved according to manufacturer’s guidelines and recommendations JRZ.MAP-4
(Process Map #061)
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2.5.3.6 Management of Production Tooling

As applicable, the departments of Manufacturing, Engineering, Toolroom and Quality
are responsible for the design, construction, review and approval of production tooling
and fixtures JRZ.MAP-6 (Process Map #064)
• The Toolroom is responsible for the construction of tooling and fixtures.

Established controls are followed to effectively coordinate all activities,
including a full dimensional inspection of the tooling and the monitoring of timely
completion.
• The status or availability of tooling and fixtures is clearly identified.
• The Mexico Toolroom is responsible for preventive maintenance, repair,
storage, and recovery of production tooling.
• The set-up of tooling and equipment is the responsibility of Manufacturing.
• Manufacturing establishes programs for changes of perishable tools in
production.
• The Engineering department is responsible for design changes of tooling and
fixtures, including engineering change level. As required, these changes are
passed on to the Toolroom for implementation.
• Tool modification and revision to documentation are coordinated between
Engineering and the Toolroom.
• As required, the Quality Planning Team is involved in the planning of changes
to tooling and fixtures.
If design, or construction is contracted to outside sources, a tracking and follow-up

system is put in place by Engineering or Manufacturing.
Customer-supplied tooling is inspected and approved by Manufacturing, Toolroom

and Quality.
2.5.3.7 Production Scheduling

Manufacturing is responsible for production scheduling. The production scheduling of
custom-made parts is forecasted.
Quarterly, the inventory turnover rate is calculated, and corrective action is taken in
case that the turnover rate is below the established minimum.
2.5.3.8 Feedback of Information

Based on customer feedback provided by Sales, Management issues quarterly
statistics which are analyzed by the heads of Engineering, Sales, Manufacturing and
Quality. Corrective or preventive action is taken as required.
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2.5.4 Validation of Processes

Validation of processes for production
Where the resulting process output cannot be verified through monitoring or
measurement, the Quality Planning Team validates production processes with the
assistance of Manufacturing and Engineering, regarding their ability to achieve planned
results.
The quality planning team establishes procedures for the review, approval, and
requirements of these processes, including - as applicable: criteria for review and
approval, approval of equipment and qualified personnel, the use of methods and
procedures, required records, and re-validation in case that expected results are not
achieved.
Attention is given to special processes where the results cannot be verified through
measurement or testing, where deficiencies become apparent when the product is
already in use.
2.5.5 Identification of Traceability

Identification and traceability
Designated personnel in Supplier Quality, Manufacturing and Warehouse identify
incoming product and material, product and material during production, and product and
material in storage with the product identification and inspection status JRZ.PRO-458 (241-
0032-M01).
Using the implemented computerized system in Manufacturing, sensors manufactured by

OPTRON are traceable by date codes.
2.5.6 Preservation
2.5.6.1 Preservation of Product

It is the responsibility of Manufacturing and the Warehouse to ensure the proper
identification, handling, packaging, storage and protection of product and materials
during receiving, handling and storage, shipping, and production. This includes
constituent parts of a product.
Temperature sensitive products and materials are stored in the temperature-

controlled room.
2.5.6.2 Storage and Inventory

During periodic cycle counts, the condition of materials and products in the warehouse
is verified to ensure that any deterioration or damage is detected and recorded, and
that required corrective action is taken.
The MRP-system in Manufacturing is used to ensure optimized inventory turns over

time, minimum inventory levels and appropriate stock rotation (FIFO) of product and
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raw materials. Manufacturing is responsible for keeping established inventory levels

of finished product, using the computerized production scheduling system.
The inventory turnover rate is periodically reviewed, and corrective action is taken in
the event that the turnover rate is below the established minimum.
When processing shipping orders (217-0014-001), the staff in Warehousing ensures
that FIFO is applied.
2.5.7 Monitoring & Measuring of Processes
2.5.7.1 Monitoring and Measurement of Processes

During Quality Management System Planning and based on statistics of operational
performance and the achievement of quality objectives, the processes of the Quality
Management System are analyzed by Management and responsible Department
Heads regarding their effectiveness. As required, corrective action is implemented to
achieve planned results and product conformity, to correct nonconformities or to
improve the operational effectiveness and efficiency of the processes of the Quality
Management System.
2.5.7.2 Monitoring and Measurement of Manufacturing Processes

To verify process capability and provide additional input for process control, the quality
planning team arranges for the monitoring of new and modified manufacturing
processes JRZ.MAP-9 (Process Map #065). Results are documented and include
instructions for production processes, verification, and maintenance as well as
objectives for manufacturing process capability, reliability, maintainability, and
availability.
Manufacturing ensures that processes are implemented according to control plans

and other applicable procedures or documents in order to ensure that process
capability and process performance is maintained according to customer part approval
process requirements.
Control plans and process flow diagrams are implemented, including adherence to
specified measurement techniques, sampling plans, acceptance criteria and reaction
plans.
It is the responsibility of Manufacturing to monitor process capability and to ensure

that process capability and performance is according to applicable control plans. In
case of nonconformity of processes, defined reaction plans are followed.
Important events that are occurring during production, such as down times are
recorded.
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If identified characteristics on the control plan become unstable or non-capable, the

applicable reaction plan is followed. If appropriate, these reaction plans include
containment of produced parts or products and 100% inspection. Corrective action is
taken as per established procedure JRZ.PRO-587 (245-0024-M01) in order to restore
required process capability and product quality. If required, these corrective action
plans are reviewed with and approved by the customer.
Effective dates of process changes are documented by Manufacturing.
2.5.8 Monitoring & Measuring of Product
2.5.8.1 Monitoring and Measurement of Product

It is the responsibility of Quality to establish and maintain procedures and inspection
reports for receiving inspection, in-process inspection and final inspection of product
and materials.
Product is not released until all specified requirements have been met, unless
otherwise approved by an authorized function - and where applicable by the customer.
The warehouse staff performs a visual inspection of outgoing product to ensure that
the product and packaging is in good condition and that marking and labeling
requirements are met.
In the event that purchased product is released for urgent production prior to
inspection and acceptance by Quality, the product is recorded and controlled in order
to permit recall and replacement in case of nonconformity of the product.
Product that does not meet specified requirements is rejected and quarantined per
established documented procedure.
As required, Quality selects accredited laboratories for certain inspection or testing

activities. Records of these inspection results are verified, reviewed, and maintained.
Inspection results are recorded, and records are maintained. These inspection records
document acceptance criteria, inspection results, whether the product was accepted
or rejected and the inspection authority responsible for the product release.
2.5.8.2 Dimensional Inspection and Functional Testing

At least once every twelve months, or as otherwise specified by the customer, Quality
performs a dimensional inspection and functional verification for each product
specified in control plans. Results are available to the customer upon request. This
applies to Automotive products only.
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2.5.9 Control of Nonconforming Product
2.5.9.1 Control of Nonconforming Product and Reworked Product

Nonconforming product and product without proper identification is quarantined and
controlled according to the documented procedure JRZ.PRO-602 (245-0040-M01).
The nonconformity of the product is verified and confirmed by Quality and verification
results and recommended disposition or action are recorded. Functions concerned
are notified.
Quality, Manufacturing, Engineering or Sales review and authorizes the release of

quarantined product for its final disposition, according to the following options:
• Rework to meet specified requirements
• Accept with or without repair by concession
• Re-grade for alternative applications
• Reject or scrap
If the acceptance with or without repair requires the concession of the customer or the
approval or permit of a regulatory body or other authority, Manufacturing ensures that
the required concession is received prior to initiation of the repair.
Qualified personnel in manufacturing process rework orders. Detailed instructions for

required rework are available to operators in work instructions.
Reworked product is re-inspected by Quality.
As appropriate and required, the customer is notified by Sales of the proposed use or
repair of nonconforming product. Where applicable, Manufacturing ensures that the
reworked product is identified with the actual condition of the product, including the
customer’s release authorization.
Records of nonconforming product, including the type of nonconformity, actions taken,

and concessions obtained are maintained in First Time Quality reports.
In the event that nonconforming product is detected after the product was shipped to
the customer, or after its use in production or service, the Engineering department
with Manufacturing & Quality and Sales department analyze the impact of the
nonconformity and take appropriate action. As required, the customer is informed, and
the nonconforming product is recalled.
Nonconforming purchased product and material is returned to the supplier with a

Supplier Corrective Action Request JRZ.MAP-3 (Process Map: #059) issued by
Supplier Quality. Supplier Quality Requirements
JRZ.QM-1
Page No.: 49 of 54
Revision: V
Quality Manual
2.5.9.2 Customer Waiver

In the event that manufactured product, or purchased product, or manufacturing
processes are different from the product or process approved by the customer, or that
temporary change to product and processes is required, the request for temporary
change or deviation is submitted to Engineering for approval JRZ.MAP-9 (Process
Map #065). As required, customer production part approval is obtained.
Concessions outside of original design are not permitted by ISO/IEC 80079-34
Manufacturing keeps records of expiration dates and quantities of authorized

deviations and ensures that normal production activities are re-instated after
expiration of engineering deviations.
Products manufactured and shipped on customer authorization are identified as

such on each packaging unit or container.
JRZ.QM-1
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Revision: V
Quality Manual
Approvals & Revision History
OPTRON Quality Manual - revision control

Page Reference Revision Date Description of Change Initials
No.
All (1-45) 1st issue 0 2004/Mar/11 No change - first issue
35, 44 051689 A 2007/May/3 Added prototype process maps #015, #016 to M.T.
section 2.5.1.1 .
6, 10 052767 B 2009/March/18 Change Jerry Gallagher to Bob Taber. Delete L.T.

Magnetoresistive and add UV.
052939 C
26, 27 2009/July/10 Update sections 2.1.1 (under Requirements L.T.
Determination & Review), 2.2.1 (Design and
Development)
1, 7, 10, 053405 D 2010/ Feb/23 Updated ref. to ISO/TS 16949 to 2009 rev &
26 ISO9001 to 2008 rev. Updated Corporate Quality R.B.
Policy – added ITAR Compliance Manual hyperlink
in para 2.1.1. Adding numeric revision to all
process maps.
7, 8, 17, 053950 E 2011/June 16 Updated to include IECEx/EN13980 Baseefa L.T.
23, 26, references. Update 003, 005, 006, 007, 012 & 013
43, 46 Process Maps from HP to SAP.
9, 47 054425 F 2012/August Updated IECEx Certificate of Conformity L.T.
17
All 054919 G 2014/March/28 Change Bob’s title from President/CEO to Vice L.T.
President/General Manager. Update Process
Maps 003, 004, 010, 011 & 012 and operating
procedure QS07. Update the TT Electronics logo.
Process 055002 H 2014/July/8 Updated process maps #003 to rev 5 and #011 to L.T.
Maps 003 rev 3
& 011
Process 055157 I 2015/January/ Updated process maps #003 to rev 6 and #011 to L.T.
Maps 003 28 rev 4
& 011
Process 055179 J 2015/April/13 Updated process map #010 to rev 3, only first page L.T.
Map 010 of process map changed.
26, 43 055229 K 2015/April/23 Clarify process map #s under section 1.5.1.4 L.T.
change (Process Map – Process Flow) to (Process
Map 010) and under section 2.5.9.1 (Process Map:
SCAR Process) to (Process Map 009).
5, 7, 18, 055317 L 2015/July/27 Replace all references to EN13980/IECEcOD005 L.T.
24, 27, to ISO/IEC 80079-34.
44, 47
16 055319 M 2015/July/31 Add the maximum interval between management L.T.
reviews to section 1.2.1.
6, 10 055487 N 2016/Feb/23 Replace Bob Taber with Tim Roberts and update L.T.
the Corporate Quality Policy.
36 055489 2016/Feb/25 Add paragraph to section 2.4.4.3
JRZ.QM-1
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Revision: V
Approvals & Revision History
OPTRON Quality Manual - revision control

Page Reference Revision Date Description of Change Initials
No.
8-12, 14- 055534 O 2016/April/6 Updated the following L.T.
16, 20- 1) OPTRON address
22, 31- 2) Management Structure
37, 39-41 3) removed references to “President/CEO” replace
& 43 with “division EVP”
4) Delete all of the references to non-existent
operating procedures
5) References to Management Representative
Updated sections 1.1.5, 1.1.6, 1.1.9.5, 1.2.2 thru
1.2.5, 2.3.2, 2.3.6, 2.4.1.2, 2.4.3.1, 2.4.3.2, 2.4.4.2,
2.5.5, 2.5.8.2
6) Corrected typos
7) Section 2.5.1.1
1, 6 & 8 055750 P 2017/Feb/10 Remove “make possible” from the TT logo. L.T.
Replace Sensing and Control with Industrial
Sensing and Control and Passives and remove
OPTRON logo.
Update management structure.
Replace Jeff Beatty with Ismael Rodarte as
management representative.
Replace Tim Roberts with Tim Wallaert on
approval page.
16 055784 Q 2017/Feb/24 Add “The person(s) responsible for the L.T.
ATEX/IECEx quality system, as defined in 99-
00726-088, shall participate in the review.” to
section 1.2.1.
1, 4,6-22, 056236 R 2018/June/28 Replace ISO/TS 16949:2009 with IATF L.T.
24-31, 16949:2016 / ISO 9001:2015, Replace Industrial
33-49, Sensing and Control and Passives with Sensors
53-54 and Specialist Components. Added section for
Product Safety, Exclusions / Justifications,
Corporate Responsibility, Process Owners,
Planning for changes, Risk Analysis and Customer
Specific Requirements. Removed most references
to Management Representative. Replace Ismael
Rodarte with Hilda Bejarano. Updated Quality
Manual to the revised standards ISO 9001:2015
and IATF 16949:2016.
1, 6-12, 056979 T 2022/January/ Eliminated IATF 16949:2016 references. Replaced L.T.
14, 15, 31 management representative with Juan Gonzalez
18, 24, and VP & General Manager with Stewart Partridge.
26, 27 & Replaced Carrollton address with Plano. Updated
41 process map #s.
8, 18-20 057013 U 2022/March/23 Added “Context of the organization” section. L.T.
Updated Management Review section 1.2.1.
Added t thru v to Review Input section 1.2.1.1.
Updated Quality Objectives section 1.2.2.
Various JRZ.ECM-24 V 2023/March 20 Updated with- Q-pulse implementation and new J.G
nomenclature in documents referenced in manual
JRZ.QM-1
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Revision: V
Appendix A: Cross Reference to this Manual

OPTRON Quality Manual
Description Paragraph
Quality Management System
QMS General Requirements 1.1.1
QMS General Requirements 1.1.1
Quality Manual About this Manual
Scope Scope
Document Control 2.5.1
Engineering Specifications 2.5.1.1
Records Control 2.5.2
Records Retention 2.5.2.1
Management Responsibility
Management Commitment 1.1.2
Process efficiency 1.1.2
Customer Focus 1.1.3
Quality Policy 1.1.4
Quality Objectives 1.2.2
Quality Objectives - Supplemental 1.2.2
QMS Planning 1.1.5
Responsibility, Authority & Communication 1.1.6
Responsibility for Quality 1.1.6
Management Representative 1.1.7
Customer Representative 1.1.7
Internal Communication 1.3.1
Management Review 1.2.1
Corporate Responsibility About this manual
Process Owners About this manual
Resource Management
Provision of Resources 1.1.8
Human Resources 1.1.9
Competence, awareness & training 1.1.9.1
Product design skills 1.1.9.2
Training 1.1.9.3
Training on the job 1.1.9.4
Employee motivation & empowerment 1.1.9.5
Infrastructure 2.4.1
Plant, facility & equipment planning 2.4.1.1
Contingency plans 2.4.1.2
Work Environment 2.4.2.1
Personnel safety to achieve product quality 2.4.2.2
Cleanliness of premises 2.4.2.3
JRZ.QM-1
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Revision: V
Quality Manual
Product Realization
Planning of Product Realization 1.1.10
Planning of product realization - supplemental 1.1.10.1
Acceptance criteria 1.1.10.2
Confidentiality 1.1.10.3
Change Control 1.1.10.4
Determination of Requirements 2.1.1
Customer designated special characteristics 2.1.1
Review of Requirements related to the product 2.1.2
Review of Requirements related to the product - Suppl. 2.1.2
Organization manufacturing feasibility 2.1.2
Customer Communication 1.3.2
Design & Development 2.2.1
Product Safety 2.2.13
Purchasing 2.3.1
Control of Production Provision 2.5.3
Validation of Processes 2.5.4
Identification & Traceability 2.5.5
Customer Property 2.4.3
Preservation 2.5.6
Control of Monitoring & Measurement Devices 2.4.4
Measurement, Analysis & Improvement

Measurement Analysis & Improvement: General 1.2.3
Customer Satisfaction 1.2.4
Internal Auditing 1.4.1
Monitoring & Measuring of Processes 2.5.7
Monitoring & Measuring of Product 2.5.8
Control of Nonconforming Product 2.5.9
Analysis of Data 1.2.5
Continual Improvement 1.2.6
Corrective Action 1.5.1
Preventive Action 1.5.2
New Product Requirements 2.1.1 27

Customer Waivers 2.5.9.2 44
JRZ.QM-1
Page No.: 54 of 54
Revision: V
Appendix B: ISO/IEC 80079-34 ATEX Certification References

QMS Description QMS Section QMS Page #
QMS Table of Contents Table of Contents 5
Applicable Standards Applicable Standards 7
Management Processes – QMS 1.1.1 9
General Requirements
Records Control 2.5.2 37
Records Retention 2.5.2.1 37
Management Commitment 1.2.1.1 18
Responsibility, Authority & 1.1.6 12
Communication
Management Review Input 1.2.1.1 18
Internal Auditing 1.4.1 24
JRZ.QM-1

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OPTRON de Mexico S.A. de C.V.

Sensors and Specialist Components

OPTRON Technology OPTRON de Mexico S.A de C.V.

ABOUT THIS MANUAL ............................................................................................................. 6

OVERVIEW OF TT ELECTRONICS / OPTRON ....................................................................... 6

APPLICABLE STANDARDS ...................................................................................................... 8

MANAGEMENT STRUCTURE .................................................................................................. 8

CORPORATE RESPONSIBILITY ............................................................................................. 8

PROCESS OWNERS ................................................................................................................ 8

CONTEXT OF THE ORGANIZATION ....................................................................................... 8

1 MANAGEMENT PROCESSES .......................................................................................... 9

1.1 Quality Management System Implementation & Maintenance ....................................... 9

1.1.10.1 Planning of Product Realization - Supplemental............................................. 18

1.2 Management Review ................................................................................................... 18

1.3 Communication ............................................................................................................. 26

1.4 Internal Auditing ........................................................................................................... 26

1.5 Corrective & Preventive Action .................................................................................... 28

2 REALIZATION PROCESSES: .......................................................................................... 30

2.1 Requirements Determination & Review ....................................................................... 30

2.2 Design & Development ................................................................................................ 32

2.2.4 Design and Development Input.............................................................................. 32

2.3 Purchasing .................................................................................................................... 35

2.4 Facilities & Equipment Management............................................................................ 37

2.5 Company Control Specifics .......................................................................................... 41

2.5.3.1 Control of Production ......................................................................................... 42

APPROVALS & REVISION HISTORY .................................................................................... 51

APPENDIX A: CROSS REFERENCE TO THIS MANUAL ...................................................... 52

APPENDIX B: ISO/IEC 80079-34 ATEX CERTIFICATION REFERENCES ............................ 54

About this Manual

Effective date of this quality manual: May 3, 2004

Juan A. Gonzalez Juan A. Gonzalez Salvador Arellano Salvador Arellano

Overview of TT Electronics / OPTRON

TT Electronics / OPTEK Technology Inc., hereafter called OPTRON, is headquartered at 2900

Context of the Organization

1.1 Quality Management System Implementation & Maintenance

1.1.1 QMS General Requirements

c) It is the responsibility of the Management and Department Heads to apply the

e) Compliance of product with IECEx Certificate of Conformity # IECEx BAS 11.0123u

i) QMS Documentation requirements

As a minimum, the documentation of OPTRON’s Quality Management System includes

The document structure of OPTRON’s Quality Management System consists of two

2) Operating procedures, work instructions, forms, operating instructions, quality plans,

1.1.2 Management Commitment

1.1.3 Customer Focus

1.1.4 Quality Policy

Corporate Quality Policy

TT Electronics is committed to being Trustworthy and

It is the responsibility of OPTRON’s management to implement and maintain this Quality

1.1.5 Quality Management System Planning

It is the responsibility of Management to ensure that resulting organizational changes and

Planning for changes

Customer Specific Requirements

1.1.6 Responsibility and Authority

1.1.6.1 Responsibility for Quality

Quality Management ensures that non-conforming product is not shipped to

1.1.6.2 Departmental Responsibility for Quality

In addition, employees are made aware of the importance to meet customer

Department Heads ensure that the responsibility of employees or functions whose

1.1.6.3 Individual Responsibility