BACK HOME
 
 
 
 
 
 
 

Quality Systems Manual

REVISION RECORD

Revision

Date

Description of Change

1

6-28-95

New Release

2

10/26/95

Format Change

3

5-1-97

Converted from DOS To Windows 95

4

7-13-98

Modified Mission Statement, Modified Quality Policy

5

6-1-00

Changed 1.3

 

DOCUMENT APPROVALS

Revision

Date Approved

Approved By

Title

4

7-13-98

Manuel Barahona

Quality Manager

5

6-1-00

Manuel Barahona

Quality Manager

 

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

  1. 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.
  1. 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.
  1. 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

 

  1. 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 it’s 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.

 

  1. 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.

    1. The System is arranged in three tiers comprised of:
  1. Level 1: This Quality System
  2. Level 2: A Detailed Procedures Manual.
  3. Level 3: Work Instructions in the form of drawings, and where applicable, process sheets,
    inspection sheets, test records and computer programs.
    1. 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

  1. 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.
  1. Contract Review - Contracts and orders are formally reviewed to ensure that the requirements are consistent with the design of the product.

  1. Record Maintenance - Records of all contracts with customers including any amendments are maintained.

 

4.0 DOCUMENT AND DATA CONTROL

  1. 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.

 

  1. 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

  1. 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.
  1. 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.
  1. 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
    1. 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.
  1. 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.
  1. Procedure Manual - The responsibility for the maintenance of product identification is defined in the Procedure Manual.
  1. 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

  1. 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:
      1. A work force of trained and experienced personnel;
      2. Documented work instructions;
      3. Suitable manufacturing facilities;
      4. Inspection and test during manufacturing;
      5. Approved processes and equipment;
      6. Defined standards of workmanship;

 

9.0 INSPECTION

  1. 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.
    1. First Piece Inspection - The 1st piece inspector shall check the first piece after a machine set-up.
  1. 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.

 

 

  1. 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.

 

  1. 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

  1. 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.
  1. Contract Requirements - During the final acceptance, Decimal Engineering's personnel carry out appropriate inspections to confirm that contract requirements have been met.
  2. Customer Approval - If contractually required the customer’s representative approves inspections and manufacturing processes.
  1. Records
      1. 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

  1. 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.
  1. 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.
  1. 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.
  1. 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.
      1. 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

  1. 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.
  2. Materials and Products - Material and products are checked upon receipt and stored in known locations.
    1. 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

  1. 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

  1. 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.
  1. 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.

    1. Customer Complaints - Any complaints from customers relating to product quality are investigated by the Quality Control Manager and reported to the President.
  1. 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.
  2. 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

  1. 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.
  1. 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.
  1. Packaging and Delivery - Products are delivered to the customer in suitable packaging and per customer specifications.
  2. 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.
  1. 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

  1. Manufacturing Process - During the manufacturing process, Decimal Engineering generates records of all the activities needed to manufacture the products to specification.
  2. Record Retention - Decimal Engineering according to the applicable procedures retains Records.

 

16.0 INTERNAL QUALITY RECORDS
    1. 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.

  1. Trained Audit Team - The audits are carried out by a trained audit team independent from any particular procedure that is audited.
  2. Formal Records - Formal records of all audits are kept and analyzed and the results of the analysis are reported in the Management meetings.
  1. Corrective Action - Appropriate corrective actions arising out of any deficiencies found during audits are taken and fully documented.

 

17.0 TRAINING

  1. 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.
  2. 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

    1. Repair Service - Decimal Engineering does supply warranty and non-warranty repair services for its products.
    2. Failure Analysis - Products returned for repair is analyzed to determine the failure cause and repairs are performed.
    3. 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

  1. 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.
    1. 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. 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.

  Back to the Top