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Quality Systems

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Quality Systems International Standards for Quality by Randy Gooden and David Juriga – PowerPoint PPT presentation

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Title: Quality Systems


1
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

3
Question
  • Why do you think it is necessary to have ISO
    standards?

4
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

5
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

6
Toyota Manufacturing
  • Perceived quality image
  • Continuous improvement
  • Employee participation
  • Willingness to work in teams and share ideas
  • Continue to change

7
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

8
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

9
How Toyota Does It
  • Continuous improvement concepts
  • Team member participation
  • Using Kaizens (suggestion cards to improve
    process)
  • Rely on Toyota Production System

10
Kaizens
  • Last year had over 75,000 suggestions
  • 7,000 team members
  • 99.8 implementation of ideas

11
5 Standards in the Series
  • ISO 9000
  • ISO 9001
  • ISO 9002
  • ISO 9003
  • ISO 9004-1

12
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

13
ISO 9001
  • Quality Systems a model for quality assurance
    in design, development, production, installation,
    and servicing
  • Most comprehensive of standards

14
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

15
ISO 9003
  • Quality Systems a model for quality assurance
    in the final inspection and testing
  • Least comprehensive
  • Focuses on detection and control problems

16
ISO 9004 - 1
  • Quality Management and Quality System Elements
    guidelines
  • Provides guidelines for developing and
    implementing a quality system

17
Other Quality Systems
  • QS 9000
  • TE 9000
  • AS 9000

18
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

19
TE 9000
  • Characteristics
  • Tooling and Equipment supplement
  • Interprets QS 9000 as it relates to tooling and
    equipment

20
AS 9000
  • Characteristics
  • Aerospace industry
  • Attempt to unify requirements of NASA, DoD, and
    FAA
  • Very similar to ISO 9000

21
Questions
  • When implementing a quality management system,
    where do you first begin?
  • What are some fundamental elements that are
    necessary for a successful implementation?

22
Implementing a Quality Management System
  • 1. Senior Management Commitment
  • CEO support
  • Committing necessary resources
  • 2. Appointing Management Representative
  • Coordinates implementation
  • Contact person for everyone

23
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)

24
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

25
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?

26
Implementation Continued
  • 12. Management Review
  • To see if the system is achieving quality goals
  • 13. Registration
  • Submit application
  • Choose registrar
  • Registrar audit

27
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

28
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

29
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)

30
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?

31
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)

32
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

33
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

34
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

35
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

36
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

37
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

38
Elements
  • 19. Servicing
  • After-delivery service
  • Does service meet spec requirements
  • 20. Statistical Techniques
  • Implement where suitable for improvement/control
    of quality

39
Question
  • What are some of the benefits associated with
    quality?

40
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

41
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

42
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.

43
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.

44
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.

45
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

46
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)

47
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

48
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

49
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

50
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

51
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

52
Internal Audits How to do it
  • Training
  • Availability
  • Conduct the audit
  • Submit audits to management
  • Take corrective action

53
Registration
  • Two parts
  • Selecting Registrar
  • Registration Process

54
Four criterias for selecting a Registrar
  • Qualification / Experience
  • Certificate Recognition
  • Registration Process
  • Cost time constraints

55
Six Basic Steps of Registration
  • Application for Registration
  • Document Review
  • Reassessment
  • Assessment
  • Registration
  • Follow up Surveillance

56
Thank you for your attention
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