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ISO/TS 16949
The
ISO/TS-16949
Standard is an ISO Technical Specification that defines the quality
system requirements for the design/development, production,
installation, and servicing of automotive-related products. It was
written by the International Automotive Task Force (IATF) in conjunction
with the International Standardization Organization (ISO). The IATF
consists of an international group of vehicle manufacturers and national
trade associations.
The
ISO/TS-16949:2002 aligns into one global specification all existing
standards erstwhile used in the automotive industry: the Americans'
QS-9000, the Germans' VDA6.1, the French's
EAQF, and the Italians' AVSQ. It will be used throughout the
entire supply chain of the automotive industry, and is now gaining
acceptance to be the replacement of QS-9000 when the latter is phased
out, since it is based on the already obsolete ISO-9001:1994.
It would be
worthwhile to take a look at the similarities and differences among the
QS-9000, the ISO/TS-16949:1999 (the older version of the
standard), and the ISO/TS-16949:2002 (the latest version of the
TS-16949, released in March, 2002).
A process for
measuring customer satisfaction is one of the notable requirements of
both the ISO/TS-16949:1999 and the
QS-9000.
The newer ISO/TS-16949:2002, however, additionally specifies the
following requirements: 1) a continuous process for monitoring
customer perception of whether their contractual requirements have been
met exactly or not; 2) a continuous evaluation and analysis of
technical, manufacturing, and testing data; and 3) demonstration with
evidence of compliance with customer requirements and efficiency of
processes.
Employee
motivation, empowerment, and satisfaction are addressed by the TS-16949,
but not by the QS-9000. The TS-16949:1999 required a process that
measures employee satisfaction. On top of this, the TS-16949:2000 has
the following requirements with regard to employee satisfaction: 1) a
process for measuring personnel satisfaction levels in relation to
achieving quality objectives and make continual improvements; 2)
promotion of quality awareness at all levels; and 3) making people aware
of the relevance of their activities to the quality goals of the
company.
As a whole,
the process-oriented concept inherent to the
ISO-9001 standard is also carried by the
ISO/TS-16949:2002, since the latter is indirectly based on the former.
The elements of any process are: suppliers, inputs, the
value-adding activity, outputs, and customers. The
ISO-TS-16949:2002 gives importance to all these process elements, with
the ultimate goal of satisfying the customer, who receives the output
after all.
Benefits
offered by the ISO/TS-16949:2002 to its users
include:
improved/consistent registrar oversight and auditor training;
process-based
audits focusing on customer satisfaction;
global
acceptance of the standard in place of 3 European standards and QS-9000;
incorporation of improvements learned through the implementation
of QS-9000; improved product realization integrations; supplier
development; development of organizational performance requirements;
customer-oriented process; development of manufacturing process design
requirements; better engineering change control; employee motivation,
empowerment & satisfaction; better understanding of customer perception.
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.
Scope
This
Quality Management System described hereafter complies with all the
requirements of
ISO/TS 16949 Revision 2009,
is focused on the enhancement of customer satisfaction through continual
improvement of processes and products, and demonstrates compliance with
customer and regulatory requirements.
Applicable Standards
The content and application of this quality manual
makes reference to the following publications and documents:
-
ISO/TS 16949:2009,
Quality Management Systems - particular requirements for the
application of ISO 9001:2008 for automotive production.
-
ISO 9000: 2000,
Quality Management Systems - fundamentals and vocabulary
-
ISO 9001: 2008,
Quality Management Systems - requirements
-
ISO 9004: 2000,
Quality Management Systems - guidelines for performance improvement
For
this quality manual, the terms and definitions for the automotive
industry specified in clause 3.1 of
ISO/TS 16949
are
applied.
Issued: 2010/April/9
The
quality manual includes the scope of the Quality Management System with
no exclusions from the requirements of ISO/TS 16949 and their
justification, makes reference to applicable operating procedures and
other pertinent documents. Process is a description of the Quality
Management System interaction of processes
Management Structure
The management of OPTEK consists of the President/CEO.
Reporting to the President/CEO and his Executive Staff are the
department managers of Quality Assurance, Business Unit Managers,
Manufacturing, Engineering and Administration.
1 Management Processes
1.1 Quality Management System Implementation &
Maintenance
It is the responsibility of the Management
Representative
-
to ensure that the Quality Management System of OPTEK is
established, documented as required, implemented, managed and
maintained according to the requirements of
ISO/TS 16949
- 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
Assurance, Purchasing, Warehouse, Tool room, Sales and Customer
Service and Quality Management System Administration are in
compliance with
ISO/TS 16949.
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/TS 16949.
b) It is the responsibility of the Management
Representative 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
Representative 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
President/CEO, Management Representative 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.
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e) It is the responsibility of the Management
Representative 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.
f) As required, the Management Representative
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.
In the event that processes, which affect
product conformity, are outsourced, Quality Assurance 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 OPTEK from the responsibility of supplying products
that meet customer requirements.
g) QMS Documentation requirements As a
minimum, the documentation of OPTEK’s Quality Management System
includes
- a Quality Policy and objectives
-
this quality manual
-
required documented procedures or maps for
ISO/TS 16949
clauses: 4.2.3 Control of Documents; 4.2.4 Control of
Records; 6.2.2.2 Training, 8.2.2 Internal Audit; 8.3
Control of Nonconforming Product; 8.5.2 Corrective
Action and 8.5.3 Preventive Action
- • other documents needed by OPTEK for
the effective planning, operation and control of
processes of the Quality Management System
-
records required by
ISO/TS 16949
and by OPTEK to ensure appropriate control and evidence of
compliance with requirements.
The document structure of OPTEK’s Quality
Management System consists of two levels:
1) The Quality Manual, describing the Quality Management System
of OPTEK and its compliance with
ISO/TS 16949
2) Operating procedures, work instructions,
forms, master lists, operating instructions,
quality plans, control plans and other
documents needed by OPTEK for the effective
and efficient operation of the Quality
Management System.
In addition, records are created as required by
ISO/TS 16949,
as well as records necessary to meet other internal and external
requirements.
It is the responsibility of the Management
Representative to ensure the availability of corporate documents
of the Quality Management System and documents required by
ISO/TS 16949.
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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 OPTEK 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
President/CEO 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
- 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.
1.1.3 Customer Focus
The President/CEO ensures that procedures for
determining and meeting customer requirements are established
and implemented. The effectiveness of these procedures is
measured through customer satisfaction surveys, which are part
of Management Reviews (see 2.1.1 & 1.2.4).
1.1.4 Quality Policy
The management of OPTEK has developed a
Corporate Quality Policy, which meets the needs of OPTEK and its
customers.
Corporate Quality Policy
OPTEK is dedicated to delivering Reliable
World Class competitive products on time to meet the
requirements of our customers. OPTEK is committed to its Quality
Management System, Quality Objectives and will continually
improve their effectiveness.
Bob Taber President / CEO March 2010
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It is the responsibility of OPTEK’s management to
implement and maintain this Quality Policy. The Quality Policy
includes OPTEK’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 and the third quarter of the year, the Management
Representative 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
General Requirements
of clause 4.1 of
ISO/TS 16949
are included in this planning process.
The output of these planning activities includes the
identification of required resources. As appropriate, results
from audits of the Quality Management System as well as
permissible exclusions according to
ISO/TS 16949
are considered. Planning activities are documented and are
consistent with other requirements of the Quality Management
System.
It is the responsibility of the Management
Representative 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.
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, operating procedure, etc
for his/her department, showing the workflow of the department
as well as evidence of compliance with the requirements of the
quality system.
1.1.6 Responsibility and Authority
It is the responsibility of the Management
Representative to develop and maintain an organization chart of
OPTEK. Updated charts are distributed to Department Heads and
are available to employees on a need to know basis.
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1.1.6.1 Responsibility for quality
It is the responsibility of personnel in
Quality Assurance, 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.
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.
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 adheres 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 the Management Representative 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.
Issued: 2010/April/9
1.1.7 Management Representative
The management of OPTEK appoints a Management
Representative who, irrespective of other duties and
responsibilities, has the defined authority and responsibility
for
-
ensuring that a Quality Management System is established,
implemented and maintained in accordance with the
requirements of the international standard
ISO/TS 16949
- reporting on the performance of the
Quality Management System to management for review and
corrective action, including needs for improvements
- the proper coordination - where required
- of quality related issues and activities within the
company, with external customers and suppliers and other
external partners and authorities
- promoting the awareness of customer
requirements and expectations throughout the company
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 OPTEK has assigned the
inter-departmental coordination of customer requirements to
the manager of the Sales Department, and the direct
responsibility of addressing customer requirements to the
Department Heads of Sales, Engineering and Manufacturing.
Responsibilities related to customer
requirements include:
Sales:
- 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
Engineering:
- recommendations for corporate
quality objectives, including quality objectives for
other departments
- quality planning activities
- product design and development
- communication with customers on
technical issues
- customer prototype support
Manufacturing:
•
recommendations for corporate quality objectives, including
quality objectives for other departments
Issued: 2010/April/9
- special training requirements for
production and warehouse
- production planning
- issues related to customer supplied
products (in coordination with Purchasing and/or
Supplier Quality Engineering)
•
delivery requirements - shipping inspection
The Sales Department is informed of
corrective actions taken by the responsible department
regarding the compliance with customer requirements.
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.
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 or other
actions are taken in order to meet defined qualification
requirements. The effectiveness of provided training or of
related actions is evaluated.
Employees are made aware of the importance
and the impact of their work in relation to product quality,
to the achievement of quality objectives and customer
satisfaction
Records of employees’ education,
experience and other qualifications are maintained.
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.
Issued: 2010/April/9
1.1.9.3 Training
The Management Representative establishes and maintains the
documented procedure
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.
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. This applies only to on-site 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
.
1.1.9.5 Employee motivation and
empowerment
To promote innovation, to motivate
employees in accomplishing quality objectives and to
participate in the continual improvement process, the
Management Representative publishes quarterly at least one
article in the company’s bulletin regarding the importance,
advantages, challenges and past achievements of these
activities. Promoting the awareness for quality and
technology to all employees is part of this process. An
alternative would be to post these articles on the company’s
bulletin boards/electronic bulletin boards.
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.
1.1.10 Planning of Product Realization
The Engineering Department is responsible for the quality
planning 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
Records for providing evidence that
manufacturing processes, and manufactured product meet
requirements are defined and specified.
Issued: 2010/April/9
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 .
1.1.10.3 Confidentiality
Confidentiality of information and data about
customer-contracted products/projects is ensured .
1.1.10.4 Change control
Changes to production processes , 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 and the Management
Representative have a formal meeting to discuss and review 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 and customer
satisfaction, and the cost of poor quality according to clauses
8.4.1 and 8.5.1 of ISO/TS16949.
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 his/her area of
responsibility are discussed.
The Management Representative, with the input
from 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, 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:
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- performance of production processes,
product conformity, including performance trends
- status and effectiveness of
corrective and preventive actions
- follow-up actions from previous
management reviews
- planned changes that could affect
the Quality Management System
- assessment of improvement
opportunities and recommendations for improvements
- employees’ knowledge, understanding
and adherence to quality policies, directives and
procedures, and their involvement in the quality
improvement process
- availability and effectiveness of
internal and external information within the company, at
all levels
- human resources, training and
staffing requirements
- suitability of working environment
- availability of material resources
- effectiveness of quality planning
(quality system, design/development of products and
processes)
- achievement of corporate quality
objectives, including those specified in the business
plan
- achievement of departmental quality
objectives
- effectiveness of continual
improvement activities of products, processes, and
Quality Management System
- results of internal and external
audits of the quality system, incl. audits of
manufacturing processes
- statistical results of operational
performance, based on the analysis of
collected data, which includes:
ƒ
quality system audits conducted by the Registrarƒ
internal quality auditsƒ
customer satisfaction surveys and other customer feedback
regarding
customer satisfaction
ƒ
customer complaints
ƒ
suppliers performance
ƒ
product and service quality and nonconformitiesƒ
direct and indirect costs and benefits of the quality system
(relation
cost - benefit)ƒ
cost of poor quality - scrap, rework, returns, warranty
repairs, excessive freight charges, etc.
ƒ
analysis of field-failures (returns, warranty repairs),
their impact on quality, safety, environmentƒ
the impact or potential impact of changes that could affect
the Quality Management Systemƒ
opportunities for improvement resulting from additions or
changes
Issued: 2010/April/9
1.2.1.2 Review Output
Results of the assessment and conclusions
of management reviews include the following output:
- effectiveness of corrective and/or
preventive actions
- the suitability and effectiveness of
the Quality Management System
- improvement of the effectiveness of
the Quality Management System and its processes
- improvement of product with focus on
customer requirements
- availability of human and material
resources
- suitability of the corporate Quality
Policy
- frequency of Management Reviews
- required corrective and or
preventive actions regarding items reviewed
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.
Established quality objectives are consistent
with the Quality Policy, include - as appropriate - objectives
to meet product requirements (see 1.1.10), and are defined in
such a way that their degree of achievement and results can be
measured.
At least two quality objectives of the
departments Manufacturing and Quality Assurance 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 OPTEK
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
- Be the industry benchmark for
manufacturing capability
- Provide a work environment that promotes
competency, teamwork, empowerment and accountability
- Deliver exceptional financial
performance over time
Issued: 2010/April/9
The translation from a Corporate Quality Initiative to a
measurable index for demonstrating results and continual
improvement is demonstrated in the following example:
Established by top management to set the
direction for the business
Deployment strategies are Optek’s Quality
Objectives
Objectives are deployed to the function or
department with specific goals defined
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
the Management Representative
, these quality initiatives are reviewed during management
reviews regarding their continuing suitability.
Departmental quality objectives
Each year, the Department Heads of
Administration, Sales, Engineering, Manufacturing, Warehouse,
Toolroom and Quality Assurance 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 the President/CEO 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 the President/CEO.
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, the Management Representative develops
and distributes quarterly statistics
. 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.
1.2.3.1 Identification of Statistical
Tools
During product quality planning , 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.
1.2.3.2 Knowledge of Basic Statistical
Concepts
Department Heads, with the assistance of the Management
Representative ensure that personnel are trained in the use
and application of basic statistical concepts defined by
quality planning and used in their respective departments.
Training records are maintained
.
1.2.4 Customer Satisfaction
Periodic customer satisfaction surveys are conducted by
management to verify if customer satisfaction has been achieved.
Survey results, which include customer complaints and feedback,
customers’ business disruptions
, customer returns of nonconforming product
and delivery performance are analyzed and evaluated
. As required, management takes corrective or preventive action.
The Management Representative monitors the effectiveness of
these corrective or preventive actions.
Issued: 2010/April/9
1.2.5 Analysis and Use of Data
The Management Representative 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 and/or Quality Assurance
. The statistics are analyzed by the Management Representative
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
and
customer returns
.
A summary report is issued by the Management
Representative, providing information on: customer satisfaction
or dissatisfaction, product quality, characteristics and trends
of processes and products including opportunities for preventive
action, and supplier performance.
The Management Representative controls and
coordinates the implementation of required corrective or
preventive actions. Analysis results of statistics and actions
are reported by the Department Heads to the Management
Representative 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 the Management
Representative to form and implement a Quality Planning Team for
the handling of assigned activities related to the Quality
Management System. Members should be from Quality Assurance,
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 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.
Issued: 2010/April/9
1.2.6 Continual Improvement
The planning, coordination and control of activities for
continual improvement
is the responsibility of the Management Representative and the
Quality Team. Continual improvement activities include - but are
not be limited to - the following:
- activities of the Quality Team under the
responsibility of the Management Representative
-
actions on results from analysis of data
-
evaluation of suppliers
- achievement of departmental quality
objectives
- results from internal quality audits
- quality improvement proposals (QIP)
- corrective actions and preventive
actions (CAR)
-
periodic review of controlled documents
The objectives of the corporate Quality Policy
are taken into consideration for planning of improvement. During
Management Reviews, the effectiveness of continual improvement
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
.
1.3Communication
1.3.1 Internal Communication
Effective internal communication is essential
for the proper functioning of the Quality Management System. The
Management Representative, 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 the Management
Representative for corrective action.
1.3.2 Customer Communication
In order to meet customer requirements and to
ensure the proper and effective communication between the
various departments within OPTEK and the customer, Sales
establishes a list with some main contacts within OPTEK
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.
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Issued: 2010/April/9
Internal and external communication related to the planning of
products and processes 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 IS-department, to install and use
electronic communication and design systems (such as CAD) that
are compatible with the customers’ systems, in order to
effectively communicate and interchange information with the
customers.
It is the responsibility of Sales, with the
assistance of the IS-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.
1.4 Internal Auditing
1.4.1 Internal Audit of the Quality
Management System
Following the established documented Internal Quality Audits,
the Management Representative is responsible for internal
audits. Internal audits are planned and scheduled in such a way
that all applicable clauses of
ISO/TS 16949
and other additional quality system requirements are audited
regarding compliance with this implemented Quality Management
System and
ISO/TS 16949.
Audits do also verify if the Quality Management System is
effectively implemented and maintained, and that it meets the
requirements of OPTEK, including planned actions, objectives and
results.
The Management Representative selects the
auditors and ensures that they have required experience and
knowledge to perform auditing activities.
Audits are scheduled on the basis of the
importance of the activity to be audited. Audit activities are
assigned to personnel not responsible for the area or activity
to be audited.
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. The
Management Representative 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 the Management Representative
. Due to special circumstances, such as nonconformities and
customer complaints, the auditing frequency is increased as
appropriate.
Issued: 2010/April/9
1.4.3 Internal Auditor Qualification
It is the responsibility of the Management Representative to
ensure that internal auditors of the Quality Management System
have the necessary experience and qualification for performing
internal quality audits
. Training needs are identified and training is provided as
required
.
1.4.4 Manufacturing Process Audit
In addition to the normal internal audits of
the Quality Management System, the Management Representative
coordinates with the Manufacturing department the auditing of
all manufacturing processes. Audits of manufacturing processes
are performed at least once per year. 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 labelling requirements. As
appropriate, physical product can be inspected and tested by the
auditor to confirm the product’s conformance to requirements and
proper functionality.
1.5 Corrective & Preventive Action
1.5.1 Corrective Action
It is the responsibility of the Management Representative to
implement and maintain the documented procedure
Corrective
Action that defines a corporate approach for corrective action.
Following the established procedure for corrective action
, 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. 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/Service department of all customer complaints
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 as outlined in the work instruction
, or any other suitable method, is used as appropriate.
Issued: 2010/April/9
1.5.1.2 Error-Proofing
As appropriate, the Quality Team applies
error-proofing methods in the corrective
action process to prevent recurrence of
the problem.
1.5.1.3 Corrective Action Impact
As applicable, the Quality Team applies
implemented corrective action to other
similar processes or products in order to
correct nonconformity.
1.5.1.4 Rejected Product Test / Analysis
Product returned from customers is analyzed by Quality
Assurance in order to initiate appropriate corrective action
and to prevent recurrence .
1.5.2 Preventive Action
It is the responsibility of the Management Representative to
implement and maintain the documented procedure Preventive
Action that defines a corporate approach for preventive action
to prevent the occurrence of potential nonconformities,
deficiencies or problems. Any employee can suggest a preventive
action to the responsible Department Head by initiating a CAR .
The process of preventive action includes the
following steps:
- identify potential nonconformities,
deficiencies or problems
- determine the root causes
- determine the necessary preventive
action
- implement the action
- follow-up on status and results
- review the effectiveness of preventive
action.
- update all related documents with
preventive action taken
Department Heads analyze and evaluate data of statistics
and
perform periodic reviews of procedures in order to detect
deficiencies and problems and to take preventive action as
required.
It is the responsibility of the Department
Heads to establish and maintain records of preventive actions
and their results. The Management Representative ensures that
relevant information on preventive action is on the agenda of
management reviews.
Issued: 2010/April/9
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.
Potential new or modification to standard products will
be reviewed per the New or Modified Standard Product
Selection Procedure 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 , including
regulatory and statutory requirements . 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 , Department Heads
ensure that other 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 , order taking and
processing , customer returns 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.
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.
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Issued: 2010/April/9
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
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
- OPTEK 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 OPTEK’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 . 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.
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
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
will be followed.
2.2.2 Design and Development Planning
The planning and control of design and development of
product is the responsibility of Engineering. During the
planning process , 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.
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Issued: 2010/April/9
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.
2.2.3 Multidisciplinary Approach
Organizational and technical interfaces, including
customer communication, are defined in the Project Plan
and Schedule 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 folderidentifies 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 includes
product design output data, targets for productivity,
capability, cost, and customer requirements, as
applicable .
Any past 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 OPTEK, are
identified and included in control plans, FMEAs and
applicable documents in order to ensure proper
identification of special requirements of product and
processes .
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 makes reference to acceptance criteria and includes
critical and crucial characteristics for safety and
functionality of the product or process. As applicable,
design and development output provides 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
Issued: 2010/April/9
plans,
process performance and other information and data to
ensure that manufacturing processes meet requirements .
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 the Management Representative 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.
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 . 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. In the event that services for prototype
development are outsourced, it is understood that OPTEK
is still responsible for the quality and performance of
the prototype. As required, OPTEK 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
the Quality Assurance. 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.
OPTEK is responsible for contracted materials and
services.
Issued: 2010/April/9
As appropriate, production part approval is extended for
engineering approval of purchased products.
The Quality Planning Team properly
validates engineering changes.
2.2.12 Control of Design and
Development Changes
Requests for design and development changes, including
proposed changes from suppliers, are documented .
Requests are reviewed and approved by Engineering.
Results and necessary actions are documented and records
are maintained.
2.3 Purchasing
2.3.1 Purchasing Process
The Purchasing department is responsible for the
effective and efficient operation of purchasing
functions and activities.
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 Assurance.
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 the manufacturing
involving supplied product, delivery performance to
acknowledged date and continual improvement.
2.3.2 Regulatory Conformity
Quality Assurance verifies that incoming purchased
products and materials are in compliance with applicable
regulatory requirements .
2.3.3 Supplier Quality Management
System Development
The Purchasing staff encourages suppliers to prepare for
and/or implement the necessary procedures in order to
meet the requirements of ISO 9001:2000 and to become
certified. All suppliers receive the manual TT
Electronics/OPTEK
Supplier
Quality Requirements
as an initial step for getting familiar with quality
system requirements. As required, the assistance of the
Management Representative is requested. Purchasing &/or
Supplier Development follows up on the suppliers’
progress
Issued: 2010/April/9
with
the implementation of ISO 9001:2001 or an acceptable
quality management system
.
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 Assurance . For the
supply of materials for other applications, the
customer-approved supplier must be approved according to
OPTEK’s approval criteria
.
2.3.5 Purchasing Information
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 identify clearly 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.
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 Quality
Assurance 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
performed and recorded by Quality Assurance when
supplier product is non-certified.
In the event that OPTEK or one of
OPTEK’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 Assurance 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 OPTEK or OPTEK’s customer.
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.
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Issued: 2010/April/9
Purchasing/Supplier Quality develops periodic
performance ratings of approved active suppliers and
distributes on a regular basis to the top suppliers,
others on request or at OPTEK’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 . As applicable, this includes building
facilities, necessary workspace and utilities as well as
needed equipment and services such as maintenance,
warehousing and transportation.
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
Manufacturing and involves departments and functions
concerned. The productivity and effectiveness of
existing operations is reviewed, monitored and
evaluated considering
-
human factors
•
operator and line balance
- availability of supplies
- use of automation
- work plans
Records of planning activities are
maintained as per applicable master list of
records.
2.4.1.2 Contingency plans
The Management Representative,
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.
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
.
These special conditions are included in the quality
Issued: 2010/April/9
plan, manufacturing plan, process sheet or other
documents. It is the responsibility of the
Department Head to implement these requirements.
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 with copy 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 OPTEK 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 Quality Assurance according to defined
inspection requirements .
The responsible Department Head
ensures that customer owned product is identified,
stored, used, handled and shipped in an appropriate
manner in order 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 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.
Issued: 2010/April/9
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, the Quality Assurance,
Manufacturing, Toolroom and Engineering ensure that
monitoring and measuring equipment and devices are
controlled, calibrated and maintained .
The type of monitoring and measuring
equipment/device/software to be used in
Manufacturing, by Quality Assurance and Toolroom,
and the required accuracy of these monitoring and
measurement activities are defined during quality
planning and specified in the manufacturing plan ,
process traveler and/or inspection reports .
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
In the event that 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 Quality Assurance to
ensure that a Repeatability and Reproducibility
study is conducted for each measuring device
referenced in control plans. 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.
Issued: 2010/April/9
2.4.4.3 Calibration /
Verification Records
The department 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.
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 .
2.4.4.4 Laboratory Requirements
2.4.4.4.1 Internal
Laboratory
It is the responsibility of
Quality Assurance to define and document the
scope of the capability of tests and inspection
activities, which can be performed by the
inhouse laboratory facility of the Quality
Assurance department. Quality Assurance has
specified and implemented technical requirements
for the
ƒ
suitability of implemented procedures
ƒ
competency of personnelƒ
testing of productƒ
capability to perform these services correctly
and according to pertinent
process standards,
ƒ
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 other 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, as long as the requirements of clause
7.6.3.1 of ISO/TS 16949 are met.
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.
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Issued: 2010/April/9
It is
the responsibility of the Management Representative
to implement and maintain the documented procedure
Control of Documents, 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
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.
As required, it is the
responsibility of the IS 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 outside of the company’s premises.
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 records according to the established
documented procedure.
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
, 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
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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
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
- the methods used for
monitoring applied controls over special
characteristics (customer)
- 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 . 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
work place. Work instructions and operating
instructions are derived from the output data from
quality planning, such as the quality plan or
control plan.
2.5.3.4 Verification of job
set-ups
Manufacturing is responsible for
proper set-ups of production equipment. In case of
set-up difficulties, Quality Assurance performs a
last-off comparison, as appropriate.
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First-Offs are approved by Quality Assurance. As
applicable, statistical verification methods are
used.
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.
2.5.3.6 Management of Production
Tooling
As applicable, the departments of
Manufacturing, Engineering, Tool room and Quality
Assurance are responsible for the design,
construction, review and approval of production
tooling and fixtures.
-
The Tool room 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 Tool room 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
Tool room for implementation.
- Tool modification and
revision to documentation are coordinated
between Engineering and the Tool room.
- As required, the Quality
Planning Team is involved in the planning of
changes to tooling and fixtures.
In the event that design or construction is
contracted to outside sources , a tracking and
follow-up system is put in place by Engineering or
Manufacturing.
Issued: 2010/April/9
Customer-supplied tooling is inspected and approved by
Manufacturing, Toolroom and Quality Assurance.
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, the
Management Representative issues quarterly
statistics
which
are analyzed by the heads of Engineering, Sales,
Manufacturing and Quality Assurance. Corrective or
preventive action is taken as required.
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 Quality Assurance,
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 .
Using the implemented computerized
system in Manufacturing, sensors manufactured by
OPTEK are traceable by date codes.
Issued: 2010/April/9
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 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 , 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 the
Management Representative 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 . Results are documented and
include instructions for production processes,
verification and maintenance as well as objectives
for manufacturing process capability, reliability,
maintainability and availability.
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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.
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 QS10 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 Assurance 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 labelling requirements are met.
In the event that purchased
product is released for urgent production prior to
inspection and acceptance by Quality Assurance, the
product is recorded and controlled in order to
permit recall and replacement in case of
nonconformity of the product.
Issued: 2010/April/9
Product that does not meet specified requirements is
rejected and quarantined per established documented
procedure.
As required, Quality Assurance
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 Assurance
performs a dimensional inspection and functional
verification
(QA12)
for each product specified in control plans. Results
are available to the customer upon request.
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
. The nonconformity of the product is verified and
confirmed by Quality Assurance and verification
results and recommended disposition or action are
recorded. Functions concerned are notified.
Quality Assurance, 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 Assurance.
As appropriate and required, the
customer is notified by Sales of the proposed use or
repair of nonconforming product. Where applicable,
Manufacturing ensures that
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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 Assurance 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 issued by Supplier Quality Assurance
.
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 . As required, customer production part
approval is obtained .
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.
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