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ISO 9001:2000 and
 Competitiveness


Tijuana, Baja California, Mexico
       27 October 2006
          Jack West
Competition Is Not a New Idea

 • Organizations have long achieved
   improvements in competitive position
   during imple...
So, What Should We Do to Get
Ongoing Competitive Advantage?
Role of     ISO 9004:2000-Performance Improvement




      Business Vision
Competitive advantage:                        ...
Use ISO 9004 Not Just 9001



         ISO 9001:2000              ISO 9004:2000
    • Single requirements  • Guidelines fo...
Understand and Use The Eight
                          Quality Management Principles


• Customer focus           • Contin...
OK, but What Specific Actions Should We Take?



  1. Shift your Focus From Internal Operatios
     to the Customer
  2. U...
Action #1


  Shift Your Focus from
Internal Operations to the
         Customer
Customer
                     Satisfaction
Include “sales and marketing” in
 activities of the system that focus
         ...
Clause 8.2 Monitoring and
                                  measurement
                        Customer satisfaction info...
Clause 8.2.1 Customer satisfaction

                      Measuring

                       Customer
     Monitoring      ...
9004 Provides Ideas

• Start by asking questions :
      – What customer information do you
        have?
      – What cus...
Sources of Customer Satisfaction Data
                                    Surveys
                        Active      Focu...
Trade
  Key                     Shows            R&D
Measures


        Sales          Surveys
        Calls              ...
Key
             Measures              Trade
                                   Shows        R&D

                       S...
Aggregate customer and internal data
       Key
                          Trade
     Measures                      R&D
   ...
Process
  Audit                     Performance        Product
 Results                                      Conformity


...
Audit
                Results
                                        Process      Product
                               ...
Getting it All Together




© 2006 Jack West
All Rights Reserved
Getting it All Together




© 2006 Jack West
All Rights Reserved
Getting it All Together




© 2006 Jack West
All Rights Reserved
Action #2


Use Process Management
      Techniques
Process—Based Quality Management System



                                     CONTINUAL IMPROVEMENT OF
                 ...
Clause 4 Quality management system
                                                                                       ...
Clause 5 Management responsibility


                                        CONTINUAL IMPROVEMENT OF
                    ...
Clause 6 Resource management


                                               CONTINUAL IMPROVEMENT OF
                   ...
Clause 7 Product realization

                                               CONTINUAL IMPROVEMENT OF
                    ...
Clause 8 Measurement, analysis and improvement


                                                CONTINUAL IMPROVEMENT OF
...
Requirements Of ISO 9001 Clause 4.1 -Process   Approach




                       Identify processes
                 Act...
Requirements Of ISO 9001 Clause 4.1 -Process   Approach




    Determine sequence & interaction

   Input
               ...
Requirements Of ISO 9001 Clause 4.1 -Process   Approach




       Determine methods to operate &
             control pro...
Requirements Of ISO 9001 Clause 4.1 -Process   Approach




   Measure, monitor & analyze processes

   Input
            ...
Get Competitive Advantage


    When You Go Beyond Minimum
             Requirements
• Focus on Actions to Achieve Results...
Example Quality Management System Relationship Map



P
l
                                                                ...
Chart the Basic Processes of the System


P
l
a
                                                                          ...
Start With Process Outputs
         Process
                                    To Identify outputs ask questions:
Inputs ...
Start With Process Outputs
    Process
                           These are just some examples, your
                     ...
Align Process Objectives with
    Overall Quality Objectives


 Maintain this Alignment Forever!
• As Quality Objectives C...
Define the Process Inputs
These are just some examples, your process
may have many inputs, suppliers, targets and
        ...
Targets Not Met are
  Opportunities for Improvement



© 2006 Jack West
All Rights Reserved
Flow Chart The Process


                      Product Design Process

 Inputs                                        Outp...
Map the Process--As IS

 • Use simple flow charts for the process
   flow
 • Record data related to the process targets
  ...
Analyze the Maps to find
                        Improvements



© 2006 Jack West
All Rights Reserved
Improve the Process

                      Three Situations:
 • Obvious process disconnects
 • Data show process has some ...
Improve the Process

                       First Situation:
• Obvious process disconnects
    – Outputs go to the wrong p...
Improve the Process

                        Second Situation:
• Process has individual activities with problems
  – Overa...
Improve the Process

                      Third Situation:
• Process fails to meet target but results are
  stable with n...
Preventive Action—the “What If” of
             Process Management


• Clause 8.5.3 requires determination
  of action to ...
Preventive Action—Ask Two “Whats” and
                           Three “Hows”


Ask:
• What can go wrong?
• What would the...
Preventive Action -- Ask Two “Whats”
                           and Three “Hows”


Ask:
• How probable is each potential f...
Preventive Action—Act



Act:
• Prioritize the overall risk for each
  potential failure
• Define preventive actions
• Imp...
Revise The Process Maps to
   Reflect the Improvements
            And Do It All Over Again As
               Objectives C...
Getting it All Together




© 2006 Jack West
All Rights Reserved
Getting it All Together




© 2006 Jack West
All Rights Reserved
Getting it All Together




© 2006 Jack West
All Rights Reserved
Action #3


  Fully Embrace the
Continual Improvement
       Concept
Requirements related to Continual               Improvement



                                               Management r...
Example: Policy and Objectives
                               Related to Customers

  Business
  Objective:               ...
Example: Policy and Objectives
                                Related to Customers



                                   ...
Use Simple Analytical Tools

                      Continual improvement trend—WOW
     UP
                               ...
Getting it All Together




© 2006 Jack West
All Rights Reserved
Getting it All Together




© 2006 Jack West
All Rights Reserved
Getting it All Together




© 2006 Jack West
All Rights Reserved
Action #4


Change Your Thinking on
 Corrective Action and
   Preventive Action
Corrective and Preventive Action



               Two very different concepts
              and their use for performance...
Effective Corrective Actions



Clearly understand what Corrective Action
  really is and is not:
• It is correcting cause...
Effective Corrective Actions


 When you think of corrective action:
 • Think of PROBLEM SOLVING
 • Think of problem solvi...
Effective Corrective Actions


 • Integrate corrective action, team
   problem solving and other tactics




© 2006 Jack W...
Effective Preventive Actions


 Clearly understand what Preventive
   Action really is and is not:
 • It is action to prev...
Effective Preventive Actions



 When you think of preventive action:
 • Think RISK MANAGEMENT
 • Use FMEA and other risk
...
Effective Preventive Actions


 • Use preventive action during up-front
   activities:
       – New products
       – New ...
Getting it All Together




© 2006 Jack West
All Rights Reserved
Getting it All Together




© 2006 Jack West
All Rights Reserved
Getting it All Together




© 2006 Jack West
All Rights Reserved
Action #5


Change the Way You
      Audit
Auditing to ISO 9001:2000


                                 CONTINUAL IMPROVEMENT OF
                               THE Q...
Auditing to ISO 9001:2000



 • Audits are covered in clause 8.2.2
   which is part of measurement
 • Emphasizes determini...
Three categories of audits




• Internal audits -- 1st party
• Customer audits of suppliers -- 2nd party
• External indep...
Three categories of audits



External independent audits -- 3rd party
• Conformity to a specific standard
               ...
Three categories of audits



Customer audits of suppliers -- 2nd party
• Conformance to customer requirements
• Customer’...
Three Categories of Audits



  Internal audits -- 1st party
  • Conformance to the standard
  • Conformance to the Organi...
Auditing the Process




 • Processes flow through the
   functions of the organization
 • Auditing cross—functional proce...
Change the Way You Think About
                             Nonconformities


        UP
        Is
                      ...
© 2006 Jack West
All Rights Reserved
© 2006 Jack West
All Rights Reserved
Five Actions You Can Take

 1. Shift your Focus From Internal Operatios
    to the Customer
 2. Use Process Management Tec...
Remember

 • Success always requires two things
       – doing the right things and
       – doing them right
 • The new 9...
Remember

 • It is up to you to do those things
   right




© 2006 Jack West
All Rights Reserved
© 2006 Jack West
All Rights Reserved
Plus Two Pocket Guides:
Cracking the Case of ISO 9001:2000 for
• Service
• Manufacturing
And
• How to Audit the
   Process...
INTERNAL AUDITING
                                BASICS
        Video Training Program
             Film (30-minute VHS)
...
Thanks for your Attention


         Questions

            ?
About Jack West
                                                        www.SilverFox.org
Jack is a quality professional w...
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ISO 9001 y la Competitividad

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Autor: JACK WEST, de ASQ y Presidente del Consejo Mundial de la Calidad. En Semana de Innovación y Calidad de los gobiernos estatales de México (INNOVA), Tijuana 2006.

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ISO 9001 y la Competitividad

  1. 1. ISO 9001:2000 and Competitiveness Tijuana, Baja California, Mexico 27 October 2006 Jack West
  2. 2. Competition Is Not a New Idea • Organizations have long achieved improvements in competitive position during implementation of ISO 9000 systems • There are four strategies that have been important © 2006 Jack West All Rights Reserved
  3. 3. So, What Should We Do to Get Ongoing Competitive Advantage?
  4. 4. Role of ISO 9004:2000-Performance Improvement Business Vision Competitive advantage: Performance Excellence • Better customer satisfaction Six sigma, Baldrige, EFQM Competitive • Lower cost Advantage • Greater efficiency Efficient ISO 9004 The Baseline Quality Management System Performance Effective Improvement ISO 9001 Quality Management System From material developed by Joe Tsiakals © 2006 Jack West All Rights Reserved
  5. 5. Use ISO 9004 Not Just 9001 ISO 9001:2000 ISO 9004:2000 • Single requirements • Guidelines for standard performance • Useful for improvement demonstrating system • Not appropriate for conformance certification • Appropriate for • Use with 9001 to certification improve the system Common Structure and Language © 2006 Jack West All Rights Reserved
  6. 6. Understand and Use The Eight Quality Management Principles • Customer focus • Continual improvement • Leadership • Factual approach to • Involvement of people decision making • Process approach • Mutually beneficial supplier relationships • System approach to management © 2006 Jack West All Rights Reserved
  7. 7. OK, but What Specific Actions Should We Take? 1. Shift your Focus From Internal Operatios to the Customer 2. Use Process Management Techniques 3. Fully Embrace the Continual Improvement Process 4. Change Your Thinking on Corrective Action and Preventive Action 5. Change the Way You Audit © 2006 Jack West All Rights Reserved
  8. 8. Action #1 Shift Your Focus from Internal Operations to the Customer
  9. 9. Customer Satisfaction Include “sales and marketing” in activities of the system that focus on the customer You may have no greater opportunity to help them improve your market position!
  10. 10. Clause 8.2 Monitoring and measurement Customer satisfaction information Monitor Auditing the QMS (All?) product characteristics (All?) Processes Key product characteristics Measure Important parameters of key processes © 2006 Jack West All Rights Reserved
  11. 11. Clause 8.2.1 Customer satisfaction Measuring Customer Monitoring satisfaction Analyzing data Improving Define how data are used © 2006 Jack West All Rights Reserved
  12. 12. 9004 Provides Ideas • Start by asking questions : – What customer information do you have? – What customer information do you want? – Do you want your own internal customer study capability? – Do you want to selectively go to the outside for specific research projects? © 2006 Jack West All Rights Reserved
  13. 13. Sources of Customer Satisfaction Data Surveys Active Focus groups Site visits Interviews Complaints Methods of Methods of Receptive Warranty costs Gathering Gathering Allowances Letters Articles Indirect Trade Shows Repeat business © 2006 Jack West All Rights Reserved
  14. 14. Trade Key Shows R&D Measures Sales Surveys Calls Articles Credits & Complaints Customer Returns Ratings Often our customer data is like an incomplete puzzle © 2006 Jack West All Rights Reserved
  15. 15. Key Measures Trade Shows R&D Sales Surveys Articles Calls Credits & Complaints Customer Returns Ratings Get the pieces to fit together © 2006 Jack West All Rights Reserved
  16. 16. Aggregate customer and internal data Key Trade Measures R&D Shows Sales Surveys Articles Calls Credits & Complaints Customer Returns Ratings Customer Feedback © 2006 Jack West All Rights Reserved
  17. 17. Process Audit Performance Product Results Conformity Customer Preventive Feedback Changes Action Status Affecting System Corrective Follow-up Improvement Action Actions Recommendations Status Often managers look at the pieces © 2006 Jack West All Rights Reserved
  18. 18. Audit Results Process Product Performance Conformity Customer Changes Preventive Feedback Affecting Action Status System Corrective Improvement Action Follow-up Recommendations Status Actions Get the overall picture! © 2006 Jack West All Rights Reserved
  19. 19. Getting it All Together © 2006 Jack West All Rights Reserved
  20. 20. Getting it All Together © 2006 Jack West All Rights Reserved
  21. 21. Getting it All Together © 2006 Jack West All Rights Reserved
  22. 22. Action #2 Use Process Management Techniques
  23. 23. Process—Based Quality Management System CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM Management responsibility CUSTOMERS CUSTOMERS Measurement, Resource analysis and SATISFACTION management improvement Product REQURIEMENTS Input Product Output realization Key Value adding activities Information flow Figure 1 — Model of a process-based quality management system © 2006 Jack West All Rights Reserved
  24. 24. Clause 4 Quality management system ` The Quality Management System CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM Management responsibility CUSTOMERS CUSTOMERS Measurement, Resource analysis and SATISFACTION management improvement Product REQURIEMENTS Input Product Output realization Key Value adding activities Information flow Figure 1 — Model of a process-based quality management system © 2006 Jack West All Rights Reserved
  25. 25. Clause 5 Management responsibility CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM Management responsibility CUSTOMER CUSTOMER Measurement, Resource analysis and SATISFACTION management improvement Product REQURIEMENTS Input realization Product Output Key Value adding activities Information flow Figure 1 — Model of a process-based quality management system © 2006 Jack West All Rights Reserved
  26. 26. Clause 6 Resource management CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM Management responsibility CUSTOMER CUSTOMER Measurement, Resource analysis and SATISFACTION management improvement Product REQURIEMENTS Input realization Product Output Key Value adding activities Information flow Figure 1 — Model of a process-based quality management system © 2006 Jack West All Rights Reserved
  27. 27. Clause 7 Product realization CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM Management responsibility CUSTOMER CUSTOMER Measurement, Resource analysis and SATISFACTION management improvement Product REQURIEMENTS Input Product Output realization Key Value adding activities Information flow Figure 1 — Model of a process-based quality management system © 2006 Jack West All Rights Reserved
  28. 28. Clause 8 Measurement, analysis and improvement CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM Management responsibility CUSTOMER CUSTOMER Measurement, Resource analysis and SATISFACTION management improvement Product REQURIEMENTS Input Product Output realization Key Value adding activities Information flow Figure 1 — Model of a process-based quality management system © 2006 Jack West All Rights Reserved
  29. 29. Requirements Of ISO 9001 Clause 4.1 -Process Approach Identify processes Activity Activity Activity Input Output Process © 2006 Jack West All Rights Reserved
  30. 30. Requirements Of ISO 9001 Clause 4.1 -Process Approach Determine sequence & interaction Input Output © 2006 Jack West All Rights Reserved
  31. 31. Requirements Of ISO 9001 Clause 4.1 -Process Approach Determine methods to operate & control processes Input Output Resources and Information © 2006 Jack West All Rights Reserved
  32. 32. Requirements Of ISO 9001 Clause 4.1 -Process Approach Measure, monitor & analyze processes Input Output Measure at key points © 2006 Jack West All Rights Reserved
  33. 33. Get Competitive Advantage When You Go Beyond Minimum Requirements • Focus on Actions to Achieve Results • Avoid Adding Other Activities
  34. 34. Example Quality Management System Relationship Map P l Process a n Procurement Customer-Relationships Product Design n Design/Validation i n g Data & Management Production Operations Delivery and Service S t r a t Measurement Corrective Action and e g Management Review Records Management and Analysis Preventive Action y Information Product © 2006 Jack West All Rights Reserved
  35. 35. Chart the Basic Processes of the System P l a Procurement n n Customer-Relationships Product Design Process Design/Validation i n g Data & Management Production Operations Delivery and Service S t r a t Corrective Action and e g Measurement and Analysis Management Review Records Management Preventive Action y Information Product Example Quality Management System Relationship Map © 2006 Jack West All Rights Reserved
  36. 36. Start With Process Outputs Process To Identify outputs ask questions: Inputs • What are the outputs of the process Product Design Outputs • Who are the customers of the outputs • How do those customers use the output • How should the output be measured Involve the people working in the process Talk to the customers of the process © 2006 Jack West All Rights Reserved
  37. 37. Start With Process Outputs Process These are just some examples, your process may have many outputs, Product design Outputs - A simple example customers, targets and results. Outputs Customer Target Current Results • Designs that • Ultimate • No complaints • No complaints meet user product users • 6-month • 12 month design needs product cycle cycle • Specifications • Process • No process • $100,000 over for process Engineering budget process budget development variance due to for last year due design issues to design issues © 2006 Jack West All Rights Reserved
  38. 38. Align Process Objectives with Overall Quality Objectives Maintain this Alignment Forever! • As Quality Objectives Change, Process objectives are modified • Process must be Improved to Meet the new Objectives!
  39. 39. Define the Process Inputs These are just some examples, your process may have many inputs, suppliers, targets and Process results. Product A simple example - Inputs Design Inputs Supplier Target Current Results • Requirements • Sales • Zero orders • 50% of orders of specific Department returned to returned for customers sales for more more data over information last 12 months • Market needs • Marketing • New product • Last ten for new needs 12 products defined products months out 10 to 12 months © 2006 Jack West out All Rights Reserved
  40. 40. Targets Not Met are Opportunities for Improvement © 2006 Jack West All Rights Reserved
  41. 41. Flow Chart The Process Product Design Process Inputs Outputs •Suppliers •Customers •Targets •Targets •Results •Results © 2006 Jack West All Rights Reserved
  42. 42. Map the Process--As IS • Use simple flow charts for the process flow • Record data related to the process targets for key process activities – Defect trends – Resources Process maps are more than just flow charts: – Process capability they are supported by data – Etc. • Chart the process as it actually works NOW, Don’t make changes yet © 2006 Jack West All Rights Reserved
  43. 43. Analyze the Maps to find Improvements © 2006 Jack West All Rights Reserved
  44. 44. Improve the Process Three Situations: • Obvious process disconnects • Data show process has some individual activities with problems • Data shows process fails to meet target but individual activity data are stable with no clear problems © 2006 Jack West All Rights Reserved
  45. 45. Improve the Process First Situation: • Obvious process disconnects – Outputs go to the wrong place – Obvious missing processing steps – Obvious redundancies • Correct the obvious problems – Change routing of misdirected outputs – Introduce needed new steps – Eliminate redundant steps and reallocate resource © 2006 Jack West All Rights Reserved
  46. 46. Improve the Process Second Situation: • Process has individual activities with problems – Overall process may or may not meet targets – Not effective in meeting quality objectives – Not efficient • Identify and solve the problems in the process – Identify problems and root causes – Develop and implement actions to correct the causes – Measure improvements © 2006 Jack West All Rights Reserved
  47. 47. Improve the Process Third Situation: • Process fails to meet target but results are stable with no clear problems – Most activities seem OK but results are bad – Process has never meet expectations – Process is stable • Consider re-engineering the process – Clean sheet approach with out-of-the-box thinking – Apply new technology © 2006 Jack West All Rights Reserved
  48. 48. Preventive Action—the “What If” of Process Management • Clause 8.5.3 requires determination of action to eliminate the causes of potential nonconformities • This analysis phase is an ideal time to find opportunities for “preventive action” © 2006 Jack West All Rights Reserved
  49. 49. Preventive Action—Ask Two “Whats” and Three “Hows” Ask: • What can go wrong? • What would the failure look like? © 2006 Jack West All Rights Reserved
  50. 50. Preventive Action -- Ask Two “Whats” and Three “Hows” Ask: • How probable is each potential failure? • How likely is it for these potential failures to reach a customer? • How serious would these failures be if they did occur? © 2006 Jack West All Rights Reserved
  51. 51. Preventive Action—Act Act: • Prioritize the overall risk for each potential failure • Define preventive actions • Implement preventive actions © 2006 Jack West All Rights Reserved
  52. 52. Revise The Process Maps to Reflect the Improvements And Do It All Over Again As Objectives Change!! © 2006 Jack West All Rights Reserved
  53. 53. Getting it All Together © 2006 Jack West All Rights Reserved
  54. 54. Getting it All Together © 2006 Jack West All Rights Reserved
  55. 55. Getting it All Together © 2006 Jack West All Rights Reserved
  56. 56. Action #3 Fully Embrace the Continual Improvement Concept
  57. 57. Requirements related to Continual Improvement Management review Policy (5.3) (5.6) • Inputs Objectives (5.4.1) • Outputs • Monitor progress Planning Measures (8.2) 5.4.2, 8.1 • Product & Process Corrective action (8.5.2) • Customer satisfaction Preventive action (8.5.3) • Audit results Identify opportunities (8.4 & 5.6) Data collection (8.4) Analysis of data (8.4) © 2006 Jack West All Rights Reserved
  58. 58. Example: Policy and Objectives Related to Customers Business Objective: Quality Objective: 29% 15% Higher Improvement in Cust. Sat. Margin on Survey Scores for High Sales Margin Product Lines Others Quality Quality Policy: Objective Satisfied Customers Others Quality Objective © 2006 Jack West All Rights Reserved
  59. 59. Example: Policy and Objectives Related to Customers Measure Quality Objective: 29% Customer Improvement in Cust. Sat. Monitor Satisfaction Analyze Survey Scores for High Data Margin Product Lines Improve © 2006 Jack West All Rights Reserved
  60. 60. Use Simple Analytical Tools Continual improvement trend—WOW UP What would Is you work on? Oops, spoke to soon! good UP Is TIME bad Drivers of current performance Run Chart and Pareto © 2006 Jack West All Rights Reserved
  61. 61. Getting it All Together © 2006 Jack West All Rights Reserved
  62. 62. Getting it All Together © 2006 Jack West All Rights Reserved
  63. 63. Getting it All Together © 2006 Jack West All Rights Reserved
  64. 64. Action #4 Change Your Thinking on Corrective Action and Preventive Action
  65. 65. Corrective and Preventive Action Two very different concepts and their use for performance improvement requires different tools and tactics for each © 2006 Jack West All Rights Reserved
  66. 66. Effective Corrective Actions Clearly understand what Corrective Action really is and is not: • It is correcting causes • It involves nonconformities that have happened • It is not correction of nonconforming items © 2006 Jack West All Rights Reserved
  67. 67. Effective Corrective Actions When you think of corrective action: • Think of PROBLEM SOLVING • Think of problem solving tools © 2006 Jack West All Rights Reserved
  68. 68. Effective Corrective Actions • Integrate corrective action, team problem solving and other tactics © 2006 Jack West All Rights Reserved
  69. 69. Effective Preventive Actions Clearly understand what Preventive Action really is and is not: • It is action to prevent future nonconformities and problems • It addresses things that have not happened • It is not correcting the cause of existing problems © 2006 Jack West All Rights Reserved
  70. 70. Effective Preventive Actions When you think of preventive action: • Think RISK MANAGEMENT • Use FMEA and other risk management tools © 2006 Jack West All Rights Reserved
  71. 71. Effective Preventive Actions • Use preventive action during up-front activities: – New products – New processes – New equipment • Keep it separate from corrective action © 2006 Jack West All Rights Reserved
  72. 72. Getting it All Together © 2006 Jack West All Rights Reserved
  73. 73. Getting it All Together © 2006 Jack West All Rights Reserved
  74. 74. Getting it All Together © 2006 Jack West All Rights Reserved
  75. 75. Action #5 Change the Way You Audit
  76. 76. Auditing to ISO 9001:2000 CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM Management responsibility CUSTOMER CUSTOMER Measurement, Resource analysis and SATISFACTION management improvement Product REQURIEMENTS Input Product Output realization • Part of Clause 8.2 on Measurement • Key input to the improvement process © 2006 Jack West All Rights Reserved
  77. 77. Auditing to ISO 9001:2000 • Audits are covered in clause 8.2.2 which is part of measurement • Emphasizes determining effective implementation of quality management system © 2006 Jack West All Rights Reserved
  78. 78. Three categories of audits • Internal audits -- 1st party • Customer audits of suppliers -- 2nd party • External independent audits -- 3rd party © 2006 Jack West All Rights Reserved
  79. 79. Three categories of audits External independent audits -- 3rd party • Conformity to a specific standard REGISTRAR STANDARD (9001) LIST U DIT A ORGANIZATION CUSTOMER © 2006 Jack West All Rights Reserved
  80. 80. Three categories of audits Customer audits of suppliers -- 2nd party • Conformance to customer requirements • Customer’s special interest items STANDARD (9001) OTHER REQUIREMENTS AUDIT ORGANIZATION CUSTOMER © 2006 Jack West All Rights Reserved
  81. 81. Three Categories of Audits Internal audits -- 1st party • Conformance to the standard • Conformance to the Organization’s System • Performance to the Organization’s Objectives • Problem identification! • Opportunity finding! © 2006 Jack West All Rights Reserved
  82. 82. Auditing the Process • Processes flow through the functions of the organization • Auditing cross—functional process enables us to find problems between functions • Auditing all the processes that flow through an area or department © 2006 Jack West All Rights Reserved
  83. 83. Change the Way You Think About Nonconformities UP Is Oops, spoke to soon! Is this a good Nonconformity? TIME © 2006 Jack West All Rights Reserved
  84. 84. © 2006 Jack West All Rights Reserved
  85. 85. © 2006 Jack West All Rights Reserved
  86. 86. Five Actions You Can Take 1. Shift your Focus From Internal Operatios to the Customer 2. Use Process Management Techniques 3. Fully Embrace the Continual Improvement Process 4. Change Your Thinking on Corrective Action and Preventive Action 5. Change the Way You Audit © 2006 Jack West All Rights Reserved
  87. 87. Remember • Success always requires two things – doing the right things and – doing them right • The new 9001 requires a lot of the right things © 2006 Jack West All Rights Reserved
  88. 88. Remember • It is up to you to do those things right © 2006 Jack West All Rights Reserved
  89. 89. © 2006 Jack West All Rights Reserved
  90. 90. Plus Two Pocket Guides: Cracking the Case of ISO 9001:2000 for • Service • Manufacturing And • How to Audit the Process-Based QMS
  91. 91. INTERNAL AUDITING BASICS Video Training Program Film (30-minute VHS) Learning Guide (36-pages) Book: How to Audit the Process-Based QMS CD-ROM: Aids for Audit Program Implementation: Tools, Checklists and Questions (from above book) Order from: INFORM 877-463-6769 (toll free) Jim@TheInformedOutlook.com OR ASQ 800 248 1946 (toll free) © 2006 Jack West All Rights Reserved
  92. 92. Thanks for your Attention Questions ?
  93. 93. About Jack West www.SilverFox.org Jack is a quality professional who helps organizations improve productivity and quality. He has nearly thirty years of experience in industry with Tenneco, Inc. in a wide variety of industries including shipbuilding, packaging, automotive parts manufacturing, chemicals, and manufacturing of farm machinery and construction equipment. In his consulting work, Jack has led implementation of TQM and Cost of Quality processes. His extensive international experience includes working with organizations around the world to implement effective ISO 9000 quality systems focused on lower costs and higher customer satisfaction. In 1993 and 1994, Jack served as Tenneco’s Director of Quality for European operations based in Brussels. He is a fellow of ASQ. He served for four years (1990-1993) on the Board of Examiners for the Malcolm Baldrige National Quality Award and has implemented internal Total Quality Management Assessment processes based on the Baldrige Award criteria. Jack is now the Chair of the US TAG to ISO TC 176 and lead delegate for the United States to the International Standards Organization committee responsible for the ISO 9000 family of quality management standards. He is also a member of the board of directors of the Registrar Accreditation Board (RAB). Jack has authored many papers and articles. He is co-editor of the ASQ ISO 9000:2000 Handbook, and co- author of ISO 9001:2000 Explained, ISO 9001:2000, An Audio Workshop and Master Slide Presentation, Cracking the Case of ISO 9001:2000 for Manufacturing, Cracking the Case of ISO 9001:2000 for Service, How to Audit the Process-Based QMS , all published by the American Society for Quality, and Unlocking the Power of Your QMS. He also has produced the video programs on Internal Auditing Basics, Dealing with External Auditors, and Quality Basics published by INFORM and also available from ASQ. He was the 2003 recipient of the ASQ’s Freund Marquardt Award for his work related to standards. © 2006 Jack West All Rights Reserved

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