Quality Systems

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Quality Systems

• International Standards for Quality
• by
• Randy Gooden and David Juriga

2
Background

• ISO International Organization for
  Standardization
• Founded 1946 in Geneva, Switzerland
• Purpose to promote international standards to
  facilitate the exchange of goods/services
  worldwide

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Question

• Why do you think it is necessary to have ISO
  standards?

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Reasons for a Quality System

• Demand for quality from the customer
• Snowball effect requires subcontractors and
  suppliers to have built-in quality
• Helps to maintain market share

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ISO 9000 Series of Standards

• Designed to be generic and thus can be tailored
  to any organizations needs
• Simply requires an organization to say what it is
  doing to ensure quality
• Documents what it says it is doing

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Toyota Manufacturing

• Perceived quality image
• Continuous improvement
• Employee participation
• Willingness to work in teams and share ideas
• Continue to change

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Toyota Achievements

• Camry 1 selling car in U.S.
• TMMKs assembly and powertrain ranked 1 in North
  America for productivity by Harbour Report
• ISO 14001 Certification

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ISO 14001

• Voluntary standard that deals with the companys
  environmental management system.
• Verifies that each Toyota plant has a formal
  environmental policy as well as a management
  system

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How Toyota Does It

• Continuous improvement concepts
• Team member participation
• Using Kaizens (suggestion cards to improve
  process)
• Rely on Toyota Production System

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Kaizens

• Last year had over 75,000 suggestions
• 7,000 team members
• 99.8 implementation of ideas

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5 Standards in the Series

• ISO 9000
• ISO 9001
• ISO 9002
• ISO 9003
• ISO 9004-1

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ISO 9000

• Quality Management Quality Assurance Standard
  Guidelines for Selection and Use
• Defines key terms
• Provides guidelines for tailoring ISO 9001, ISO
  9002, and ISO 9003 standards
• Road map for entire series

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ISO 9001

• Quality Systems a model for quality assurance
  in design, development, production, installation,
  and servicing
• Most comprehensive of standards

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ISO 9002

• Quality Systems a model for quality assurance
  in production, installation, and servicing
• Does not focus on design
• Focuses on prevention, detection, and correction
  standards

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ISO 9003

• Quality Systems a model for quality assurance
  in the final inspection and testing
• Least comprehensive
• Focuses on detection and control problems

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ISO 9004 - 1

• Quality Management and Quality System Elements
  guidelines
• Provides guidelines for developing and
  implementing a quality system

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Other Quality Systems

• QS 9000
• TE 9000
• AS 9000

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QS 9000

• Characteristics
• Developed by General Motors, Ford, Chrysler
• Broader than ISO 9001
• Adds automotive/heavy trucking requirements
• Adds continuous improvement
• Establishes customer requirements unique to Ford,
  General Motors, Chrysler

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TE 9000

• Characteristics
• Tooling and Equipment supplement
• Interprets QS 9000 as it relates to tooling and
  equipment

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AS 9000

• Characteristics
• Aerospace industry
• Attempt to unify requirements of NASA, DoD, and
  FAA
• Very similar to ISO 9000

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Questions

• When implementing a quality management system,
  where do you first begin?
• What are some fundamental elements that are
  necessary for a successful implementation?

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Implementing a Quality Management System

• 1. Senior Management Commitment
• CEO support
• Committing necessary resources
• 2. Appointing Management Representative
• Coordinates implementation
• Contact person for everyone

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Implementation Continued

• 3. Awareness
• Everyone should understand the system
• Training sessions
• 4. Appoint Implementation Team
• Should be from all levels
• 5. Training
• Should involve everyone (Teams, supervisors)

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Implementation Continued

• 6. Time Schedule
• Schedule for implementation/registration
• Should take less than 1.5 years
• 7. Select Element Owners
• Owners for each of system elements
• 8. Review Present System
• Should be first step in process

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Implementation Continued

• 9. Write Documents
• Written quality policy and procedure manuals
• Everyone should be involved
• 10. Install New System
• Integrate policies/procedures, work instructions
• 11. Internal Audit
• Conduct audit of system working effectively?

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Implementation Continued

• 12. Management Review
• To see if the system is achieving quality goals
• 13. Registration
• Submit application
• Choose registrar
• Registrar audit

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Documentation

• 1. Policy
• Defines what will be done and why
• Should be clear and easy to understand
• 2. Procedure
• Describes methods that will be used to implement
  and perform stated policies
• Who, When, Where

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Documentation Continued

• 3. Work Instructions
• Department, machine, task spells out how to do
  job
• Very detailed
• 4. Records
• Documents that policies, procedures, and work
  instructions have been followed

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Elements of ISO/QS 9000

• 1. Management Responsibility
• Quality Policy short/concise statement that
  defines organizations objectives for quality
• Responsibility Authority should be defined
  for all personnel affecting quality
• Management Review to remain effective (customer
  feedback, internal audits)

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Elements

• 2. Quality System
• Establish and maintain documents in QS
• Policies, procedures, work instructions
• Prevents problems (not detection)
• 3. Contract Review
• Reviews contracts/POs Are requirements clearly
  defined?, Are there any unusual quality
  requirements? Can we meet specs?

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Elements

• 4. Design control
• Establishes and maintains procedures to
  control/verify that product design meets specs
• 5. Document and Data Control
• Procedures and a master list is established to
  control documents and data that affects quality
  (blueprints, work instructions, task procedures)

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Elements

• 6. Purchasing
• To establish and maintain documented procedures
  to ensure that purchased materials will conform
  to specs
• 7. Control of Customer-Supplied Products
• Organization does not own item
• Segregate so only used for that customer

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Elements

• 8. Product Identification/Traceability
• Identify product throughout all stages of
  production, delivery, and installation
• 9. Process Control
• Controlling processes best way to prevent
  problems
• Monitoring systems/documented instructions

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Elements

• 10. Inspection/Testing
• Receiving purchased items comply?
• WIP Early detection/Nonconformity
• Final Inspection final product meets specs?
• 11. Control of Inspection,Measuring, and Test
  Equipment
• Requires control, calibration, and maintenance of
  all equipment

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Elements

• 12. Inspection and Test Status
• Look at products condition throughout production
• Conforming to quality plan?
• 13. Control of Nonconforming Product
• Identify, remove, and segregate
• 14. Corrective Preventive Action
• Should have documented procedures to detect
  nonconformity
• Be able to identify and fix problem

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Elements

• 15. Handling, Storage, Packaging, Delivery
• Incoming material/Finished goods handled to
  ensure protection from damage
• Easily identify
• Storage area secure
• 16. Control of Quality Records
• Demonstrate achievement of required quality and
  verify the effective and economical operation of
  the quality system
• Should be made available to customer

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Elements

• 17. Internal Quality Audits
• To ensure that quality system is working
  according to plan
• 18. Training
• Plant safety, technical skills, basic statistical
  concepts.
• Document that training requirements have been
  fulfilled

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Elements

• 19. Servicing
• After-delivery service
• Does service meet spec requirements
• 20. Statistical Techniques
• Implement where suitable for improvement/control
  of quality

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Question

• What are some of the benefits associated with
  quality?

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Results of Quality Systems

• Reduced operating costs
• Fewer audits (by the customer and internally)
• Improved quality (internally/externally)this
  helps promote a perceived quality image

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Suggestions for Writing Documentation

• Keep it short and simple. Dont over-document
• Flowchart a process, if appropriate.
• Keep the audience in mind
• Make the meaning very clear have someone else
  read it and explain to you what it said.
• Make the text grammatically correct

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Suggestions for Writing Documentation

• Search out errors in spelling and punctuation.
• Avoid jargon
• Separate ideas into sentences or paragraphs.
• Ask the user to help write the documentation.

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For Every Task, Identify

• Who is responsible for making sure that it is
  done?
• Standards to be met / completion
• What resources are needed?
• What records are kept?
• What to do if it doesnt work.
• Pretest procedures. Have those who will use them
  try them and provide feedback.

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Writing DocumentationQuality Manual

• Step 1
• Use the format that can be used throughout the
  documentation hierarchy.
• Step2
• Helpful if documents follow the numbering systems
  of the 20 elements.
• Step3
• Simplicity ease of use should determine the
  structure to be used.

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Writing DocumentationQuality Manual

• To do this you should do the following
• A) Cover Page (Title, Organization Name,
  Location)
• B) Table of Contents (Revision Number or letter
  for each document, location)
• C) Quality Policy Statement
• D) A Distribution Page (controlled and
  uncontrolled copies

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Outline Quality Manual

• Quality Policy
• Quality Organization
• Statement of Authorization and Responsibility
• Distribution List of Controlled Copies
• Quality System
• Procedures Index
• Form Index (Included or Referenced)

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Outline Quality Procedure

• Cover Sheet
• Table of Contents (with current revision level)
• Purpose/Objective Aim of the procedure
• Scope What the procedure does or doesnt do
• Responsibilities who (by job function) has the
  responsibility for the task or actions

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Outline Quality Procedure

• Reference To all documents covered under the
  procedure
• Definitions Of key terms and acronyms
• Procedure Description of the action or task to
  be carried out, by whom and in what sequence
• Documentation What documentation is needed

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Work / Job Instructions

• Start from existing writing work / job
  instructions
• Consider using the team approach
• Verify existing instructions
• Adopt improved practice, if necessary
• Flowchart complex operations
• Verify instructions are being followed
• Use work instructions for training

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Internal Audits Five Objectives

• Determine that it actually conforms to the
  documentation quality system.
• Initiate corrective action activities in response
  to deficiencies.
• 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,
  thereby creating possible improvements

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Internal Audits How to do it

• Develop an overall plan
• Identify the activities to be audited
• Schedule audits
• Establish the qualifications of audit personnel
• Experience

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Internal Audits How to do it

• Training
• Availability
• Conduct the audit
• Submit audits to management
• Take corrective action

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Registration

• Two parts
• Selecting Registrar
• Registration Process

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Four criterias for selecting a Registrar

• Qualification / Experience
• Certificate Recognition
• Registration Process
• Cost time constraints

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Six Basic Steps of Registration

• Application for Registration
• Document Review
• Reassessment
• Assessment
• Registration
• Follow up Surveillance

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Thank you for your attention