Quality Systems

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Quality Systems

• Eastern Illinois University
• TEC 5133 Total Quality Systems
• Fall 2002
• Instructor Mr. Glenn Gee

By Jeremy Rodebaugh ChunChieh Wang Matt
White Sung Joon Choi
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In the beginning

• As the game we are familiar to childhoods, we may
  make different paper airplanes and the flying
  patterns can be vary with different process.

It is a GAME
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Quality Control

• The result of this game shows that everyone made
  the different design, and production of airplane
  using the same material (paper).
• In final test for flying, everyone might use the
  same way to make the paper airplane flown.
• But, the flying distance of each paper airplane
  was totally not the same after all.

Why ?
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What are standards?

• Standards are documented agreements containing
  technical specifications or other precise
  criteria to be used consistently as rules,
  guidelines, or definitions of characteristics, to
  ensure that materials, products, processes and
  services are fit for their purpose.
• International Standards contribute to making life
  simpler, and to increasing the reliability and
  effectiveness of the goods and services we use.

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What is ISO

• The International Organization for
  Standardization (ISO) is a worldwide federation
  of national standards bodies from more than 140
  countries, one from each country.

• ISO is a non-governmental organization
  established in
• 1947. The mission of ISO is to promote the
• development of standardization and related
  activities in
• the world with a view to facilitating the
  international
• exchange of goods and services, and to
  developing
• cooperation in the spheres of intellectual,
  scientific,
• technological, and economic activity.

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ISO/QS 9000 Elements

• Control of Inspection, measuring, and Test
  Equipment
• Inspection and Test Status
• Control of Nonconforming product
• Corrective and Preventive Action
• Handling Storage, Packaging, Preservation, and
  delivery
• Control of Quality Records
• Internal Quality Audits
• Training
• Serving
• Statistical Techniques

• Management responsibility
• The Quality System
• Contract Review
• Design Control
• Document and Data Control
• Purchasing
• Control of Customer-Supplied product
• Product Identification and Traceability
• Process Control
• Inspection and Testing

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Management Responsibility

• Quality Policy It should be a short statement
  that defines the organizations objective in
  easy-to-understand language.
• Responsibility and Authority It must be defined
  for all personnel affecting quality
• Management Review Management review is required
  to ensure that the system remains effective

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The Quality System

• Requires the establishment and maintenance of a
  documented quality system

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Contract Review

• Are the requirements of the contract clearly
  defined?
• Are there any unusual quality requirements?
• Does the organization have the capability to meet
  the requirements?

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Design Control

• The general requirement of design control is the
  establishment and maintenance of procedures to
  control and verify that product design meets
  specified requirements and is aligned with the
  contract review.
• Planning the development of a design

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Document and Data Control

• Procedures and master list to control all
  documents and data the affect quality
• Methods must be in place to provide for the
  review and approval of documents for adequacy
  before they are issued

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Purchasing

• Ensure purchased materials or products will
  conform to specified requirements
• Evaluation, approval, and monitoring of
  subcontractors

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Control of Customer-Supplied Product

• It must take precaution to ensure the
  identification and segregation of them from any
  similar organization-owned items.

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Product Identification and Traceability

• Methods for the identification of products during
  all stages of production, delivery, and
  installation
• Lot numbers, batch numbers, serial numbers, etc.

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Process Control

• Identify and plan the steps necessary to produce
  the product or service
• Document instructions
• Monitoring system
• Development of controls

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Inspection and Testing

• Three main elements
• 1. Receiving inspection
• It is used to verify that purchased items
  comply with required standards and to ensure that
  they are not used prior to such verification.
• 2.In-process inspection
• It should be designed for early detection of
  nonconfromities
• 3.Final inspection
• Completed products meets the required
  specification

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Control of Inspection, Measuring, and Test
Equipment

• Control, calibration, and maintenance of all
  equipment used to ensure product quality
• The accuracy of the calibration must be traceable
  to the National institute of employee
• Procedures must be provided for reporting
• Provisions must also be made to ensure that
  unauthorized adjustments are not performed on
  inspection equipment

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Inspection and Test Status

• 1. Inspected and accepted
• 2. Inspected and rejected
• 3. Inspected and on hold for a decision as to
  accept or reject
• 4. Not yet inspected

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Control of Noncomforming Product

• Reworked to meet the specified requirements
• Accepted without repair by agreement of the
  customer
• Regraded for alternative use
• scrapped

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Corrective and Preventive Action

• Detection of any suspected nonconformance through
  appropriate action to correct the deficiency and
  prevent its recurrence

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Handling, Storage, Packaging, Preservation, and
Delivery

• These activities take place throughout the
  manufacturing process
• Material and product in storage must be easily
  identified
• Packaging must provide protection against damage,
  deterioration, or contamination
• Container must provide clear description of their
  contents

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Control of Quality Records

• This element requires that the records be
  maintained for the established retention period
  or as prescribed by contractual requirements.
• They must be stored in a stored protected
  environment

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Internal Quality Audits

• Ensure quality system is working according to
  plan and to provide opportunities for improvement

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Training

• The requirements for training are very general,
  leaving the decision of appropriate training to
  the organization involved

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Servicing

• This element simply requires procedure for
  performing after-delivery service

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Statistical Techniques

• They are useful in every area of an
  organizations operations and may be applied to
  market analysis, product design, data analysis,
  process capability studies, and sampling
  inspection techniques

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Implementation

• Steps necessary to implement a quality management
  system

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Senior Management Commitment

• Most important step
• Management must be willing to commit needed
  resources

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Appoint the Management Representative

• Responsible for coordinating the implementation
  and maintenance of the quality system
• Contact person for all parties involved in the
  process

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Awareness

• Everyone should understand the quality system and
  how it will affect day-to-day operations

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Appoint an implementation team

• All levels and areas of the organization should
  be represented

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Training

• Implementation team, supervisors, and internal
  audit team

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Time Schedule

• Schedule for the implementation and registration
  of the system

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Select Element Owners

• Owners selected for each of the system elements.

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Review the Present System

• Quality manuals, procedures, work instructions,
  and forms

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Write the Documents

• Quality policy and procedure manuals
• Work instructions

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Install the New System

• Integrate policies, procedures, and work
  instruction

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Internal Audit
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Management Review

• Determine the effectiveness of the system in
  achieving the stated quality goals

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Preassessment

• Optional if a good job is not being done in
  previous steps

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Registration

• Choose a Registrar
• Submitting an application
• Conducting the registrars system audit

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Documentation

• Policy
• Procedure
• Work Instruction
• Records

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Policy

• Policy Manual
• What will be done?
• Why it will be done?

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Procedure

• Quality Procedures
• Who should perform specific tasks?
• When the task should be done.
• Where documentation will be made showing that the
  task was performed.

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Work Instructions

• How a Job will be done.

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Records

• Documenting that policies, procedures, and work
  instruction have been followed
• Data for corrective action

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Document Development

• Guidelines for internal quality management

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Writing the Documents

• Create a format that can be used throughout the
  documentation hierarchy
• Simplicity and ease of use

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Internal Audits

• Objectives
• Auditor
• Techniques
• Procedure

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Objectives

• Five Objectives of the internal audit
• Determine that actual performance conforms to the
  documented quality system
• Initiate corrective action activities in response
  to deficiences
• Follow up on noncompliance items of previous
  audits
• Provide continued improvement in the system
  through feedback to management
• Cause the auditee to think about the process,
  therby creating possible improvements.

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Auditor

• Qualified individuals
• Objective, honest and impartial

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Techniques

• Examination of documents
• Observation of activities
• Interviews

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Procedure
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Registration

• Selecting a registrar
• Registration process

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Selecting a Registrar

• Qualifications and Experience
• Certificate Recognition
• The Registration Process

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Registration Process
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Show Time
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Widgets, Inc.
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Lessons Learned

• Quality Systems
• Fewer on-site audits
• Improved quality, both internally and externally
• Greater awareness of quality by employees
• Reduced operating costs

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To be arranged
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Quality Systems

• Questions???