ISO 9000, QS 9000, Six Sigma

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ISO 9000, QS 9000, Six Sigma
Douglas M. Stewart, Ph.D. Anderson Schools of
Management University of New Mexico
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What is ISO 9000?

• What are the standards, what were they intended
  for, and why do sites get certified.

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ISO 9000 1994 revision

• ISO 9000
• 9001, 9002, 9003 9004
• ISO 10000 Informative References

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The ISO 9000 2000 Revision

• Reasons for changes
• More logical flow of requirements and easier to
  understand language
• Increase emphasis on continuous improvement and
  customer satisfaction
• To allow the requirements to be tailored to
  companies that would otherwise fall between 9001,
  9002 and 9003.
• To allow for smoother transition for companies
  moving beyond their original requirements
• Better integration with ISO 14000

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New form of ISO 9001 A Guide to Transforming to
the New Standard

• Loss of ISO 9002 and 9003
• Essence of standard retained
• A process model
• The 20 sections have been rearranged into 4 new
  chapters
• Management responsibility
• Resource management
• Product and/or service realization
• Measurement, analysis and improvement
• Old sections in new chapters

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• New requirements
• Continuous improvement
• Customer satisfaction
• Resources
• Information
• Communication
• Infrastructures
• Work environment protection
• Changes for clarity and readability
• Organization instead of supplier
• Products and services instead of products

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The ISO 9000 Certification Process

• Implementing ISO 9000
• Quality policy
• Develop corrective action process
• Draft procedures for each ISO element
• Review and approve procedures
• Consolidate into quality manual
• Train employees in quality policies and audit
  procedures
• Conduct internal audits

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Certification Process Cont.

• Registration
• The third party auditor registrar
• The registration audit
• The Pre-assessment Review of quality manual and
  quality system documents
• The Assessment A Team of 2-3 auditors to confirm
  conformity between practices and systems as
  documented
• Certification is site specific and
  re-certification required every 3 years.

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QS 9000

• Extension of ISO 9000 for automotive suppliers
• Includes all of ISO 9000
• Adds
• Continuous improvement
• Manufacturing capability
• Production part approval process
• Elements of the Baldrige criteria
• ISO/TS 16949
• QS-9000 (US)
• VDA6.1 (Germany)
• EAQF (French)
• AVSQ (Italian)

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Six-Sigma Quality

• Ensuring that process variation is half the
  design tolerance (Cp 2.0) while allowing the
  mean to shift as much as 1.5 standard deviations.

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Six-Sigma Metrics

• Defects per unit (DPU) number of defects
  discovered ? number of units produced
• Defects per million opportunities (dpmo) DPU ?
  1,000,000 ? opportunities for error

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k-Sigma Quality Levels

• Six sigma results in at most 3.4 defects per
  million opportunities

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Six-Sigma Implementation

• Emphasize dpmo as a standard metric
• Provide extensive training
• Focus on on corporate sponsor support
• Create qualified process improvement experts
• Ensure identification of appropriate metrics
• Set stretch objectives

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GEs Six-Sigma Problem Solving Approach

• Define
• Measure
• Analyze
• Improve
• Control

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Six Sigma Belts

• Team Member
• Support project within work area
• Green Belt
• 10 days training
• Project with demonstrated improvement
• Training, mentoring team members
• Black Belt
• 4 weeks training
• Project
• Lead improvement teams across business, mentor
  green belts
• Master Black Belt
• Champions

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Black Belt Training

• Elementary statistics
• Advanced statistics
• DOE, ANOVA, Multivariate Regression
• Product design and reliability
• QFD, FMEA
• Measurement
• Capability, RR
• Process control
• Control Plans and SPC
• Process improvement
• Process improvement planning, process mapping,
  poka-yoke
• Implementation and teamwork
• Organizational effectiveness, team assessment,
  facilitation tools, team development