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ISO 9001:2008
This manual is governed by comprehensive documentation as referenced herein.
Procedures, practices, forms, drawings, and similar documentation used by
organizations whose direct or supportive participation in processes affect product
quality, are formally documented and controlled. All such documents are contained
in readily identifiable, easily accessible through Optima’s intranet based (Optima
Quality Management Information System) at any work station. "The right
information at the right time!"
Table of Contents
0 INTRODUCTION .................................................................................... 5
0 INTRODUCTION
Optima Electronic Packaging Systems was established in 1962 as a
Division of Scientific Atlanta to provide attractive, high quality enclosures
for the electronics industry.
In 2012 Optima EPS change its name to Optima Stantron due to the
acquisition of Stantron Broadcast Cabinets and APW Mayville Datacenter
Cabinets.
1.0 SCOPE
1.1 GENERAL
1.2 APPLICATION
3.0.3 Instructions
start with Department followed by a number e.g. PUR-I, MFI, and QAI.
3.0.4 Procedures
start with Department followed by a number e.g. QAP, SDP, and ENG.
3.0.5 Forms
start with Department followed by number then a revision e.g.ENG-FR, SDF,
and Form QC.
Optima Stantron also defines quality objectives and goals which are
monitored periodically.
4.2.1 GENERAL
The quality management system is structured in three levels.
Level One,
Documentation in the form of a Quality Manual which contains the
company policies and method of implementation.
Level Two,
Contains the standard operating procedures which encompass the day to
day routines carried out within the facility to insure consistency and
compliance to ISO 9001:2008 standard and the quality policy.
Level Three,
Specific function support documentation, forms, and logs.
WWW.ELMA.COM
David Speak
------------------------------- -----------------------
Senior Manyfacturing Manager Date
Ron Hall
-------------------------------- ------------------------
Director of Sales Date
Urs Mangold
-------------------------------- ------------------------
Engineering Manager Date
Carmen Theumer
------------------------------- ------------------------
Quality Manager Date
David Cook
-------------------------------- --------------------------
Senior Quality Manager Date
1.) This section describes the company policy for document and data
control, including, to the extent applicable, documents of external
origin such as standards and customer drawings. Engineering drawings
and specifications are controlled by the Engineering Department.
2.) Documents and data can be in the form of any type of media, such as
hard copy or electronic media.
B. RESPONSIBILITY
1.) The Quality Assurance Manager is responsible for setting standards for
document preparation, approval, release, and change.
4.) The Engineering Manager is responsible for document and data control
in the Engineering Department.
4.2.3.1 GENERAL
1.) Draft versions of documents and data are forwarded to the appropriate
authorized personnel and are reviewed and approved prior to issue.
Master lists are maintained to preclude the use of invalid and/or
obsolete Documents.
2.) The issue and amendment control procedures shall ensure that:
b.) obsolete documents are removed from all points of issue or use.
2.) Where practical, the nature of the changes shall be identified in the
document or appropriate attachments.
Quality records include but are not limited to, Sales Orders and
Contracts, Inspections & Test records, Non-conformances, Corrective
and Preventive Actions, Internal and External Audit records, Training
records, Supplier Performance Ratings, Assembly Work Order
Packages, etc.
a) Management Review
b) Quality Records
c) Contract Review
d) Design Review
e) Design Verification
f) Design Validation
NUMBER: QPM001 REV G Page 12 of 41
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QUALITY MANUAL ISO 9001-2008
5 MANAGEMENT RESPONSIBILITY
5.1 MANAGEMENT COMMITMENT
Quality Policy
Awareness.Commitment.Improvement
Awareness
Commitment
Improvement (trough Process)
By this we mean,
“Awareness” of the importance of quality is a key element in our daily activities at
Optima Stantron. We strive for excellence by practicing completeness, accuracy,
timeliness and by meeting the expectations and requirements in all our
assignments.
We understand that quality is a living matter. We continuously aim for better quality
by “improvement (trough process)” and measuring process effectiveness. We
encourage improvements and suggestions for improvements from our employees
and business partners. This continuous drive for improvements in our processes in
turn ensures the effectiveness of our quality management system.
5.4 PLANNING
Objectives -
OPTIMA STANTRON
Fig 1
5.6.1 General
6 Resource Management
6.1 Provision of Resources
6.2.1 General
All tasks within the Company, which are adversely affected by the lack of
acquired skill, will be identified and made the subject of a job description that
reflects the extent and evidence of skill required. This will be used to appraise
the level of competence of personnel both before and during engagement by
Optima and to identify training needs accordingly.
6.3 Infrastructure
The company’s quality philosophy involves a “do it right the first time”
approach rather than inspecting quality into the product at a later stage. This
philosophy is lived up to and implemented in every facet of the business and
in every department. This is sustained and improved upon by virtue of having
documented procedures and work instructions to define how all operations
will be carried out. Manufacturing department headed by the Operation
Manager is responsible for providing tactical support to the main stream
manufacturing.
Production will be carried out against schedules, which take into account
customer requirements.
The Production Planning Team is responsible for the planning and scheduling
of work orders.
The Quality Manager is responsible for ensuring that the Process and Quality
Control Instructions are established and maintained
7 Product Realization
7.1 Planning and Product Realization
The Design Engineering Group shall create the documentation that is needed
to express in terms necessary to verify that the input requirements have
been met and validated.
For any change, Optima’s sales issue a Product Impact Form (PIF) to address
any change requirement to the engineering department who will incorporate
the changes into the product/project.
Limited reviews will be performed for standard catalogue orders. The review
covers relevant catalogue product information.
The quality manager is the right source for all quality related issues as well as
customer feedback and complaints.
4. Feedback from all relevant sources shall be used to improve the quality
of design and to identify areas for new product development. Feedback
may be provided as validation, from but not limited to Optima
Stantron’s shop, sales, and production departments.
The Design Engineering Group shall create the documentation that is needed
to express in terms necessary to verify that the input requirements have been
met and validated.
Design Reviews shall be conducted before the release of the documents. These
reviews should include, but not limited to Manufacturing, Quality, Production
and Customer for custom design.
The design stage outputs need to have a verification that they meet the
design inputs by verifying quotes, BOM, 3D drawings when applicable
and customer inputs.
7.4 Purchasing
1. Optima Stantron will make prior arrangements for any source inspection of a
Product required (to be performed by Optima’s personnel) at the supplier
location prior to the acceptance of the product.
1. The company’s quality philosophy involves a “do it right the first time”
approach rather than inspecting quality into the product at a later stage.
This philosophy will be implemented by having detailed process instructions
to define how all operations will be carried out. Details of in-process and post-
process quality control checks will be included in the Process Instructions and
Quality Control Instructions. Records of Quality checks will be used as the basis
of feedback for process quality improvement.
3. Production will be carried out against schedules, which take into account
customer requirements.
5. The Production Planning Team is responsible for the planning and scheduling of
work orders.
7. The Quality Manager is responsible for ensuring that the Process and Quality
Control Instructions are established and maintained.
Stantron seeks to Provide for its customers continued product support and after
sales liaison.
9. The Company will provide for its customers technical, product, and application
Support.
10. The Company will ensure that its products meet the immediate requirements of
its customers and will work with its customers to establish and meet their future
needs. Where required, the Company will provide product/system manuals,
which will detail use, installation, commissioning, maintenance, safety and
disposal information.
4. No product will be shipped unless the quality standards and activities as outlined
in Optima Stantron quality system have been met. The quality assurance
inspectors have the right to withhold any product from shipment which does not
meet these requirements.
5. Inspection and test records will be maintained on file to provide evidence that
the product has been inspected and /or tested. These records are retained a
minimum of three years and may be disposed of at the retention period.
Final inspection records shall have the inspector’s signature/stamp and date on
the traveler of the product inspected.
7. If a product fails any inspection and/or test, the procedure for control of
nonconforming product shall be followed.
8. All materials and products will be suitable identified throughout each stage of
manufacturing.
9. All products that are subject to mechanical and electrical inspection and test and
have passed this test will be identified appropriately throughout production.
Production that fails inspection and test or is rejected by the quality department
for any reason will be identified accordingly, and will be returned to production
for repair or replacement. The assembler or inspector will generate non-
conforming material reports. Refer to section 8.3 of this manual for non-
conforming material control.
10. Assembly work orders will be signed or stamped by assembler or inspector after
performing the inspection or test functions. All test and inspection reports will be
recorded as required. Inspection records will reflect any secondary or inspection
performed on reworked material.
Applicable Documents
1. All customer property will be examined upon receipt for condition, quantity and
conformance with delivery details.
2. All items will be positively identified and stored by location in the stockroom.
Customer property, which is received at Optima Stantron, will be handled and
stored in a manner, which will prohibit damage or deterioration. The customer
will be notified by formal documentation that will be retained as a record of this
transaction, if any lost or damaged material and material shortages are
identified during receiving process.
Material will only be issued against those orders for which it was supplied.
7.5.5.1 Handling
7.5.5.2 Storage
7.5.5.3 Packaging
7.5.5.4 Preservation
Material will be stored in a way that will preserve the material from damage
or deterioration from surrounding elements such as heat, moister, and
weather elements.
7.5.5.5 Delivery
All operators and supervisors who use inspection, measuring, and test
equipment shall be responsible for verifying the calibration is current before
use. The Quality Assurance Department shall perform or procure the
necessary calibration services and maintain complete records.
c) Define the process employed for the calibration of inspection, test, and
measuring equipment, including details of equipment type, unique
identification, location, frequency of checks, check method, acceptance
criteria, and the action to be taken when results are unsatisfactory;
d) Identify inspection, measuring, and test equipment with a suitable
indicator or approved identification record to show the calibration
status;
The need for statistical techniques required for establishing, controlling, and
verifying process capability and product characteristics shall be identified. The
identification of need for a statistical technique may be generated by one of
the following sources:
Where statistical techniques are used for product verification, due regard will
be made to the contractual requirements of the customer.
The statistical techniques used will be documented and defined the way
the technique is to be applied and the rules governing its use.
3. Results of the audits will be recorded and brought to the attention of the
personnel having responsibility in the area audited. Department managers
shall be responsible for taking timely actions to correct any deficiencies
identified during an audit.
4. Follow-up audit activities shall verify and record the implementation and
effectiveness of the corrective action taken.
5. The results of the internal quality audits will be reviewed by the Management
Team to ascertain that the quality system is effective in achieving its
objectives and continues to reflect the Company’s mission.
Optima Stantron has applied suitable methods for monitoring, and where
applicable, measurements of the quality management system processes.
Optima demonstrates that these processes achieve planned results and
ensures conformity of the product.
RMA reports are logged and a copy filled in the Customer Issue / RMA
completed file.
4. Material which does not conform to the customer’s specification will only be
used or supplied with the customer’s prior knowledge and written consent.
1. The need for statistical techniques required for establishing, controlling, and
verifying process capability, product characteristics, vendor performances
and customer satisfaction shall be identified. The identification of need for a
statistical technique may be generated by one of the following sources:
2. Where statistical techniques are used for product verification, due regard will be
made to the contractual requirements of the customer.
Manufacturing Data
Vendor Performance Data
Customer Feedback Data
4. New Quality goals are defined and addressed at least once a year during the
annual management review.
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QUALITY MANUAL ISO 9001-2008
8.5 Improvement
2. The top management’s commitment to the quality system and its quality
policy of continuous improvements in processes shall be demonstrated by a
listing of continuous improvements achieved in each department during the
year and reviewed in the management review meeting. The same should be
documented on the Quality Management Review document.