Quality SystemsQuality Systems

International Standards for Qualityby

Randy Gooden and David Juriga

BackgroundBackground

ISO – International Organization for Standardization

Founded 1946 in Geneva, SwitzerlandPurpose – to promote international

standards to facilitate the exchange of goods/services worldwide

QuestionQuestion

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

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

5 Standards in the Series5 Standards in the Series

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

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

Other Quality SystemsOther Quality Systems

QS 9000 TE 9000AS 9000

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

QuestionQuestion

What are some of the benefits associated with 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

Registration Registration

Two partsSelecting RegistrarRegistration Process

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

Thank you for your attentionThank you for your attention