quality systems international standards for quality by randy gooden and david juriga
TRANSCRIPT
BackgroundBackground
ISO – International Organization for Standardization
Founded 1946 in Geneva, SwitzerlandPurpose – to promote international
standards to facilitate the exchange of goods/services worldwide
Reasons for a Quality SystemReasons for a Quality System
Demand for quality from the customerSnowball effect – requires subcontractors
and suppliers to have built-in qualityHelps to maintain market share
ISO 9000 Series of StandardsISO 9000 Series of Standards
Designed to be generic and thus can be tailored to any organization’s needs
Simply requires an organization to say what it is doing to ensure quality
Documents what it says it is doing
Toyota ManufacturingToyota Manufacturing
Perceived quality imageContinuous improvementEmployee participationWillingness to work in teams and share
ideasContinue to change
Toyota AchievementsToyota Achievements
Camry #1 selling car in U.S.TMMK’s assembly and powertrain ranked
#1 in North America for productivity by Harbour Report
ISO 14001 Certification
ISO 14001ISO 14001
Voluntary standard that deals with the company’s environmental management system.
Verifies that each Toyota plant has a formal environmental policy as well as a management system
How Toyota Does ItHow Toyota Does It
Continuous improvement conceptsTeam member participationUsing Kaizens (suggestion cards to improve
process)Rely on Toyota Production System
KaizensKaizens
Last year had over 75,000 suggestions– 7,000 team members– 99.8% implementation of ideas
ISO 9000ISO 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
ISO 9001ISO 9001
Quality Systems – a model for quality assurance in design, development, production, installation, and servicing– Most comprehensive of standards
ISO 9002ISO 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
ISO 9003ISO 9003
Quality Systems – a model for quality assurance in the final inspection and testing– Least comprehensive– Focuses on detection and control problems
ISO 9004 - 1ISO 9004 - 1
Quality Management and Quality System Elements – guidelines– Provides guidelines for developing and
implementing a quality system
QS 9000QS 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
TE 9000TE 9000
Characteristics– Tooling and Equipment supplement– Interprets QS 9000 as it relates to tooling and
equipment
AS 9000AS 9000
Characteristics– Aerospace industry– Attempt to unify requirements of NASA, DoD,
and FAA– Very similar to ISO 9000
QuestionsQuestions
When implementing a quality management system, where do you first begin?
What are some fundamental elements that are necessary for a successful implementation?
Implementing a Quality Implementing a Quality Management SystemManagement System
1. Senior Management Commitment • CEO support• Committing necessary resources
2. Appointing Management Representative• Coordinates implementation• Contact person for everyone
Implementation ContinuedImplementation 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)
Implementation ContinuedImplementation 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
Implementation ContinuedImplementation 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?
Implementation ContinuedImplementation Continued
12. Management Review• To see if the system is achieving quality goals
13. Registration• Submit application• Choose registrar• Registrar audit
DocumentationDocumentation
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
Documentation ContinuedDocumentation 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
Elements of ISO/QS 9000Elements of ISO/QS 9000
1. Management Responsibility• Quality Policy – short/concise statement that
defines organization’s objectives for quality• Responsibility & Authority – should be
defined for all personnel affecting quality• Management Review – to remain effective
(customer feedback, internal audits)
ElementsElements
2. Quality System• Establish and maintain documents in QS• Policies, procedures, work instructions• Prevents problems (not detection)
3. Contract Review• Reviews contracts/PO’s – Are requirements
clearly defined?, Are there any unusual quality requirements? Can we meet specs?
ElementsElements
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)
ElementsElements
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
ElementsElements
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
ElementsElements
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
ElementsElements
12. Inspection and Test Status• Look at product’s 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
ElementsElements
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
ElementsElements
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
ElementsElements
19. Servicing• After-delivery service• Does service meet spec requirements
20. Statistical Techniques• Implement where suitable for
improvement/control of quality
Results of Quality SystemsResults of Quality Systems
Reduced operating costsFewer audits –(by the customer and
internally)Improved quality (internally/externally)—
this helps promote a perceived quality image
Suggestions for Writing Suggestions for Writing DocumentationDocumentation
Keep it short and simple. Don’t “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
Suggestions for Writing Suggestions for Writing DocumentationDocumentation
Search out errors in spelling and punctuation.
Avoid jargonSeparate ideas into sentences or paragraphs.Ask the user to help write the
documentation.
For Every Task, IdentifyFor Every Task, Identify
Who is responsible for making sure that it is done?
Standards to be met / completionWhat resources are needed?What records are kept?What to do if it doesn’t work.Pretest procedures. Have those who will use
them try them and provide feedback.
Writing DocumentationWriting DocumentationQuality ManualQuality 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.
Writing DocumentationWriting DocumentationQuality ManualQuality 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
Outline Quality ManualOutline Quality Manual
Quality PolicyQuality Organization Statement of Authorization and ResponsibilityDistribution List of Controlled CopiesQuality System Procedures IndexForm Index (Included or Referenced)
Outline Quality ProcedureOutline Quality Procedure
Cover SheetTable of Contents (with current revision
level)Purpose/Objective: Aim of the procedureScope: What the procedure does or doesn’t
do Responsibilities: who (by job function) has
the responsibility for the task or actions
Outline Quality ProcedureOutline Quality Procedure
Reference: To all documents covered under the procedure
Definitions: Of key terms and acronymsProcedure: Description of the action or task
to be carried out, by whom and in what sequence
Documentation: What documentation is needed
Work / Job InstructionsWork / Job Instructions
Start from existing writing work / job instructions
Consider using the team approach Verify existing instructionsAdopt improved practice, if necessaryFlowchart complex operationsVerify instructions are being followedUse work instructions for training
Internal Audits Internal Audits Five ObjectivesFive 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
Internal Audits Internal Audits How to do itHow to do it
Develop an overall planIdentify the activities to be audited Schedule audits Establish the qualifications of audit
personnelExperience
Internal Audits Internal Audits How to do itHow to do it
TrainingAvailability Conduct the auditSubmit audits to managementTake corrective action
Four criteria’s for selecting a Four criteria’s for selecting a RegistrarRegistrar
Qualification / ExperienceCertificate RecognitionRegistration ProcessCost & time constraints
Six Basic Steps of Six Basic Steps of RegistrationRegistration
Application for RegistrationDocument Review Reassessment AssessmentRegistration Follow up Surveillance