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Quality
Systems Manual
REVISION
RECORD
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Revision
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Date
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Description of Change
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1
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6-28-95
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New Release
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2
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10/26/95
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Format Change
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3
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5-1-97
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Converted from DOS To Windows 95
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4
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7-13-98
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Modified Mission Statement, Modified
Quality Policy
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5
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6-1-00
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Changed 1.3
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DOCUMENT
APPROVALS
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Revision
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Date Approved
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Approved By
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Title
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4
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7-13-98
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Manuel Barahona
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Quality Manager
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5
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6-1-00
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Manuel Barahona
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Quality Manager
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TABLE
OF CONTENTS
1.0
Management Responsibility
1.1 Quality Policy
1.2 Organization
1.3 Management Review
2.0 Quality System
3.0 Contract Review
4.0 Document and Data Control
5.0 Purchasing
6.0 Customer Supplied Materials
7.0 Product Identification and Traceability
8.0 Process Control
9.0 Inspection and Tests
10.0 Control of Inspection, Measuring and Test Equipment
11.0 Inspection and Test Status
12.0 Control of Non-conforming Products
13.0 Corrective and Preventative Action
14.0 Handling, Storage, Packaging, Preservation and Delivery
15.0 Control of Quality Records
16.0 Internal Quality Audits
17.0 Training
18.0 Servicing
19.0 Statistical Techniques
Appendix A Quality Policy
Mission
Statement
Decimal
Engineering recognizes its responsibilities as a manufacturer to fully
comply with all contractual and governing regulatory specification requirements.
Decimal Engineering has initiated a comprehensive Quality Management System
and Quality Awareness Program. The Quality Management System establishes
control throughout the entire manufacturing cycle from proposal to delivery.
The Quality Management System is complete and responsive to all requirements
of the ISO Standard, ANSI/ASQC Q9002-1994.
The
associated Procedures and Work Instructions detail how Decimal Engineering's
Quality Policy is to be implemented. All employees are required to understand
and adhere to the procedures and instructions at all times.
The
Q.C. Manager for Decimal Engineering has been delegated the responsibility
and authority for assuring full implementation of the complete ISO 9002
Quality System. The only person authorized to overrule the Q.C. Manager
is the President of Decimal Engineering.
This
manual will be revised and added to as necessary to reflect changes in
quality requirements and is issued on a controlled copy basis.
1.0
MANAGEMENT RESPONSIBILITY
1.1
Quality Policy
- Decimal
Engineering Management - Decimal Engineering's management has developed
a policy for quality. The President authorizes this policy. This policy
has been communicated to and trained to all employees and is displayed
throughout the company. Appendix A details Decimal Engineering's Quality
Policy.
- Quality
System - Through its sound Quality System, Decimal Engineering seeks
to ensure customer satisfaction by providing high quality, service,
and product value. Management is committed to reviewing all aspects
of Decimal Engineering's operations with an objective of continuing
improvement.
- World
Class Supplier - Decimal Engineering has established itself as a world
classes supplier to its customers and is committed to maintaining
this position.
1.2
Organization
1.2.1 Responsibilities
- President/Quality
Control Manager - The overall responsibility for Quality in Decimal
Engineering rests with the President. He has delegated to the Quality
Director the responsibility for the maintenance of Decimal Engineering's
Quality System and for ensuring that all employees conform to its
requirements. The Quality Director as the management representative
has full organizational freedom to:
a.)
Initiate action designed to prevent the occurrence of product non-conformities.
b.)
Identify and record any quality problems.
c.)
Initiate, recommend or provide solutions through designated channels.
d.)
Verify the implementations of solutions.
e.) Control
further processing or delivery of non-conforming product until the
deficiency or unsatisfactory condition has been corrected.
1.2.1.2
Employees of Decimal Engineering - Each employee working for Decimal
Engineering is responsible for ensuring that the activities they control
are operated in accordance with this manual and the associated Procedure
Manual.
1.2.1.3
Authority - The organization structure of Decimal Engineering defines
the relationships between the members of the company and shows how the
authority to assure quality is delegated.
1.2.1.4
Procedure Manual - Detailed quality related responsibilities of the
key members of the organization are given in the Procedure Manual.
Quality System Audits - a trained audit team carries out Quality System
Audits with the members selected for specific audits on the basis of
their independence from the function being audited.
1.3
Management Review - Decimal Engineering's Quality System is formally
reviewed every three months by the Decimal Engineering's management
under the chairmanship of the President. The review covers the results
of quality audits, corrective action report, customer feedback, capital
investments, new or changed policies, training requirements and other
matter considered to be relevant to Decimal Engineering's Quality System.
2.1 ISO 9002 Requirements - Decimal Engineering has defined an
effective Quality System which meets the requirements of ISO 9002.
This system is defined in this manual and fully documented in
the associated Decimal Engineering Procedures Manual.
2.2 Implementation of Quality System - The system has been implemented
and shown to be effective in the control of the quality of Decimal
Engineering's products and services.
- The
System is arranged in three tiers comprised of:
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Level 1: This Quality System
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Level 2: A Detailed Procedures Manual.
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Level 3: Work Instructions in the form of drawings, and where
applicable, process sheets,
inspection sheets, test records and computer programs.
- Quality
Planning - When Product, project or contract requirements dictate,
Decimal Engineering shall define the document and the specified
quality objectives shall be achieved in a Quality plan.
3.0
CONTRACT REVIEW
- Inquiries
and Orders - It is the policy of Decimal Engineering to ensure that,
on receipt, all inquiries and orders are checked to confirm that the
requirements are adequately defined and documented and that Decimal
Engineering has suitable technical and production resources to satisfy
any contract based on those inquiries or orders.
- Contract
Review - Contracts and orders are formally reviewed to ensure that
the requirements are consistent with the design of the product.
-
Record
Maintenance - Records of all contracts with customers including any
amendments are maintained.
4.0
DOCUMENT AND DATA CONTROL
- Document
Authorization and Control - All procedures, specifications, work instructions
and drawings used within Decimal Engineering are normally authorized
and controlled. All revisions and changes are confirmed in writing
to ensure that there is no danger of Decimal Engineering personnel
working with outdated information.
- Formal
Documentation Procedures - Document control is achieved through formal
documented procedures which include the control of this manual, the
associated Procedure Manual and all Work Instructions. If the documents
used by Decimal Engineering are provided by customers, the Sales and
Marketing Manager will control the documents to ensure that correct
revisions are used at all times.
5.0
PURCHASING
- Approved
Suppliers - It is the policy of Decimal Engineering to ensure that
all materials and services it purchases conform to the specified requirements.
This is achieved by the use of approved suppliers who are committed
to quality and have demonstrated their ability to supply goods and
services of required quality within a specified time.
- Purchasing
Data - The products purchased by Decimal Engineering are fully defined
in the purchasing data and all orders are reviewed to ensure their
adequacy prior to their release to the suppliers.
- Right
to Suppliers Visits- If contractually required by customers, Decimal
Engineering ensures that its customers have the right to visit Decimal
Engineering and Decimal Engineering's suppliers, to assess the capability
to deliver quality products conforming to requirements.
6.0
CUSTOMER SUPPLIED MATERIALS
Decimal
Engineering's main activities do not normally involve the use of
customer supplied material, but on the occasions when this does
occur, such material is carefully controlled and protected. In the
event of such material being damaged or lost, the customer is notified
and mutually agreed actions are taken.
7.0
PRODUCT IDENTIFICATION AND TRACEABILITY
- Quality
System - Decimal Engineering's Quality System ensures that all products
can be identified throughout the manufacturing cycle. This is achieved
through the use of paperwork and by having clearly defined locations
for specific products.
- Manufacturing
Process - The manufacturing process enables the identification of
the products from appropriate drawings, specifications or other documents
during all stages of production and delivery.
- Procedure
Manual - The responsibility for the maintenance of product identification
is defined in the Procedure Manual.
- Full
Traceability - A system, which maintains full traceability of completed
products, is available if contractually required. Full records of
traceability are maintained.
8.0
PROCESS CONTROL
- Decimal
Engineering's Process Control Policy - It is the policy of the company
to assure the quality of the products and services it supplies by
controlling the processes. This is achieved primarily through operator
control of the processes and is facilitated by:
- A
work force of trained and experienced personnel;
- Documented
work instructions;
- Suitable
manufacturing facilities;
- Inspection
and test during manufacturing;
- Approved
processes and equipment;
- Defined
standards of workmanship;
9.0
INSPECTION
- Incoming
Inspection - Upon receipt, all material is verified for nonconformance
to the required specification and no material is used until such verification
is performed. This verification is based on the Incoming Inspection
Procedure.
- First
Piece Inspection - The 1st piece inspector shall check the first
piece after a machine set-up.
- In-Process
Inspection - No product shall be released until all planned inspection
has been completed as required by documented work instructions and
procedures. All nonconforming products shall be clearly identified
and properly segregated.
- Operator
Inspection -During production the operators are responsible for the
inspection and control of the manufacturing process and for checking
the items produced from each operation.
- In-Process
Inspectors - The In-Process Inspectors will carry out inspections
of all manufactured parts to confirm that the processes are under
control.
9.4
Final Inspection
- Prior
to Release to Customer - Prior to release to the customer, all products
are subject to appropriate final inspection. At this stage it is confirmed
that all verification activities required during processing have been
carried out and that the results are to specification.
- Contract
Requirements - During the final acceptance, Decimal Engineering's
personnel carry out appropriate inspections to confirm that contract
requirements have been met.
- Customer
Approval - If contractually required the customers representative
approves inspections and manufacturing processes.
- Records
- Records
of all inspection activities are maintained by Decimal Engineering
for the period defined in the Procedure Manual.
10.0
CONTROL OF INSPECTION AND MEASURING EQUIPMENT
- Calibration
Identification and Maintenance - All equipment used for inspecting,
measuring or testing the processes and product quality is positively
identified and is maintained in a known state of calibration. The
equipment used for these activities is of accuracy, which ensures
that the measurements taken are meaningful when, related to the tolerances
required.
- Calibration
to National Standards/Natural Physical Constants - Calibration is
carried out at defined frequencies and traceability to National Standards
or Natural Physical Constants is assured. Calibration frequencies
are adjusted based on known wear of the instruments.
- Calibration
Done by Decimal Engineering - Where the company carries out calibration,
care is taken to ensure that the environmental conditions are suitable,
taking account of tolerances for which the instruments are to be used.
- Calibration
Procedures - Calibration is performed in accordance with defined procedures
that ensure that the accuracy of the instruments calibrated is suitable
to the tolerances being measured with the equipment.
- Out
of Calibration - If equipment is found to be out of calibration,
the Quality Control Manager or the Vice President of Operations
reviews the implication of any measurements taken with the equipment
and appropriate actions are taken and recorded. If considered
necessary the customer will be notified and a recall action initiated.
11.0
INSPECTION
- Quality
System - Decimal Engineering's Quality System ensures that inspection
status of all items is evident at all stages of the manufacturing
cycle. The maintenance of this identification is the responsibility
of the employees carrying out the activities associated with the items.
- Materials
and Products - Material and products are checked upon receipt and
stored in known locations.
- Process
Documentation - Process documentation enables the inspection and
test status of all material in Decimal Engineering to be known at
all times.
12.0
CONTROL OF NONCONFORMING PRODUCTS
- Segregation
of Non-conforming Material/Products - All defective material or non-
conforming products are clearly identified and segregated to prevent
their unauthorized use.
12.2
Review of Records - Records of such material and parts are maintained
and reviewed by the Quality Control Manager.
12.2 Disposal
of Non-conforming Products - Documented procedures exists to control
disposal of non-conforming products through rework, deviations,
scrap or return to the supplier. This control is exercised by the
Material Review Board who has full authority to ensure that Production
Management takes the agreed action.
13.0
CORRECTIVE ACTION AND PREVENTATIVE ACTION
- Quality
System - The Quality System provides the means to identify when corrective
and preventative action should be taken to eliminate the causes or
potential causes of non-conformity to specifications. Decimal Engineering
places great emphasis on corrective and preventative action as being
the major benefit, for both the company and its customers.
- Non-conforming
Data Analysis and Reporting - All data relating to non-conforming
products found within the manufacturing and delivery processes is
analyzed by the Quality
Control Manager or the Vice President of Operations and reported
to Decimal Engineering's President.
- Customer
Complaints - Any complaints from customers relating to product quality
are investigated by the Quality Control Manager and reported to
the President.
- Formal
Review of Process - Decimal Engineering conducts formal reviews under
the chairmanship of the President to determine the need for corrective
or preventative action arising from all of the above and to confirm
that the actions taken have been effective.
- Records
of Problems and Corrective Actions - Full records of problems resolved,
and actions taken, are maintained according to the applicable procedures
in the Procedures Manual.
14.0
HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY
- Product
Quality - It is the policy of the Decimal Engineering to ensure that
all items are protected throughout the manufacturing and shipping
processes in such a way as to ensure that the product quality is maintained.
- Training
Personnel - Product quality is achieved by the training of personnel
in suitable handling methods, the protection of vulnerable components
and assemblies and usage of suitable storage facilities and appropriate
packaging of products before delivery.
- Packaging
and Delivery - Products are delivered to the customer in suitable
packaging and per customer specifications.
- Vehicle
loading and Protection - Drivers are responsible, together with the
shipping department, for ensuring that vehicles are correctly loaded
and properly protected against inclement weather.
- Subcontractors
- Subcontractors are required to take necessary measures to ensure
that products are suitably handled, stored and packed while they are
in their area of responsibility.
15.0
QUALITY RECORDS
- Manufacturing
Process - During the manufacturing process, Decimal Engineering generates
records of all the activities needed to manufacture the products to
specification.
- Record
Retention - Decimal Engineering according to the applicable procedures
retains Records.
16.0
INTERNAL QUALITY RECORDS
- Effectiveness
of the Quality System - Decimal Engineering maintains the effectiveness
of its
Quality
System by conducting formal audits of all procedures at defined
intervals. These audits are used by the management as an indication
of the effectiveness of the controls operating in Decimal Engineering.
- Trained
Audit Team - The audits are carried out by a trained audit team independent
from any particular procedure that is audited.
- Formal
Records - Formal records of all audits are kept and analyzed and the
results of the analysis are reported in the Management meetings.
- Corrective
Action - Appropriate corrective actions arising out of any deficiencies
found during audits are taken and fully documented.
17.0
TRAINING
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Dedicated
to Training - Decimal Engineering is dedicated to the training of
its personnel, in both production skills and process control. Assurance
of quality by production operators is the most effective way of controlling
the quality of the products it produces and the services it provides.
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Training
Program Implementation - A positive training program, building on
existing education, training and expertise has been implemented throughout
Decimal Engineering. The Vice President of Operations supervises the
operation of this program.
Record
Retention - Full records of all training provided by Decimal Engineering
are kept
18.0
SERVICING
- Repair
Service - Decimal Engineering does supply warranty and non-warranty
repair services for its products.
- Failure
Analysis - Products returned for repair is analyzed to determine
the failure cause and repairs are performed.
- Records
- Failure analysis data shall be recorded and reported back to the
customer (when required) as well as for internal analysis and corrective
action.
19.0
STATISTICAL TECHNIQUES
- Responsibility
for Statistical Techniques - The Quality Control Manager and the Vice
President of Operations are responsible for deciding what statistical
techniques are appropriate for verifying the process capability, for
statistical control of manufacturing processes and for data collection.
- Statistical
Techniques Requirement - When appropriate all Decimal Engineering
employees are required to receive training in Statistical Techniques.
APPENDIX
A - QUALITY ASSURANCE POLICY
TOTAL
QUALITY COMMITMENT
1.1 The concept of Total Quality Commitment embodies the following principles:
1.2 Decimal Engineering, Inc. is committed to continuously improving our
processes to achieve zero defects. Through proactive relationships with
our customers we are dedicated to providing the highest quality products
and reducing costs, while maintaining profitability. This is the foundation
for long term partnering with our customers, opening future business opportunities
and providing stable employment within the community.
2.0
APPLICATION
2.1 Only when these principles are understood and applied by everyone
in Decimal Engineering does a Total Quality Commitment exist.
3.0
RESULTS
3.1 The Total Quality Commitment at Decimal Engineering ensures
that we achieve our goal of Total Customer Satisfaction.
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