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EAGLE INSIGHT “EXPERIENCE SPEAKS OF LESSONS LEARNED” Quality People With Quality Advice! Presented to EAGLE INSIGHT “EXPERIENCE SPEAKS OF LESSONS LEARNED” Quality People With Quality Advice! Presented to Scioto Valley ASQ Section 815 Piketon, OH 1 © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Presented By: Tim Large Sales Manager, EAGLE Registrations • 20 Years Experience in Quality Presented By: Tim Large Sales Manager, EAGLE Registrations • 20 Years Experience in Quality Management • 12 Years Experience in Auditing - ISO Lead Internal Auditor and Malcolm Baldrige • Past Chairman of the Dayton Section of ASQ 0909 • Joined EAGLE in 2006 as Sales Manager • Received IRCA Lead Auditor Certification in 2007 Tab Lankford Lead Auditor, EAGLE Registrations • 25 Years Experience in Quality Management • Joined EAGLE in 2004 as RSM for TS and QS • Received IRCA Lead Auditor Certification in 2005 • Contract Auditor and Consultant 2 © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Auditor’s Insight From Auditor’s Insight Quality People With Quality Advice! 3 © EAGLE Registrations Auditor’s Insight From Auditor’s Insight Quality People With Quality Advice! 3 © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Auditor’s Insight Issue: Understanding If Quality Management System Is Ready To Be Assessed By Auditor’s Insight Issue: Understanding If Quality Management System Is Ready To Be Assessed By Registrar Corrective Action Strategies: ■ Strengthen Managements understanding of ISO Standard & Management Review ■ Analysis to see required documents in place ■ Processes are defined and in place ■ Measurables are collected ■ Internal audits effective ■ Corrective & Preventive actions taking place 4 ■ Effectiveness being tracked © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Auditor’s Insight Issue: Overcoming Perception That ISO Is A Function Of The QC Department Auditor’s Insight Issue: Overcoming Perception That ISO Is A Function Of The QC Department Corrective Action Strategies: ■ Top Management spear-heading involvement of all employees ■ Top Management needs to communicate the Company’s Quality Policy and Goals to all employees and clarify their understanding 5 © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Auditor’s Insight Issue: Lack Of Management Commitment TO ISO System Corrective Action Strategies: ■ Auditor’s Insight Issue: Lack Of Management Commitment TO ISO System Corrective Action Strategies: ■ Management attend ISO training classes (can be internal or external) ■ Clearly define Management team ■ Be committed to Management Review process ■ Management & ISO Management representative working together towards the same goal 6 © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Auditor’s Insight Issue: Lack Of Having Auditable Documented System Corrective Action Strategies: ■ Organization Auditor’s Insight Issue: Lack Of Having Auditable Documented System Corrective Action Strategies: ■ Organization chart – responsibilities ■ Process maps and charts ■ Policies & Procedures ■ Create & continually update documents 7 © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Auditor’s Insight Process Auditing §Turtle Diagram – Key Questions About a Process With WHAT? Auditor’s Insight Process Auditing §Turtle Diagram – Key Questions About a Process With WHAT? (Equipment, Materials) 3 SEQUENCE & LINKAGE TO OTHER PROCESSES INPUT PROCESS OUTPUT 7 1 2 8 SEQUENCE & LINKAGE TO OTHER PROCESSES 8 HOW MANY? (Performance Indicators) 6 8 With WHO? (Training, Knowledge, Skills) 4 © EAGLE Registrations Inc. 2008 CONFIDENTIAL HOW? (Instructions, Procedures, Methods) 5

Auditor’s Insight Issue: Excessive, Cumbersome Documentation Corrective Action Strategies: ■ Not everything needs a Auditor’s Insight Issue: Excessive, Cumbersome Documentation Corrective Action Strategies: ■ Not everything needs a written procedure unless the absence of written procedure would impact system performance ■ Say what you do; Do what you say! ■ Create simple, but precise documents and let people try them - if they are not understood then add more 9 ■ Take credit for what you already have in place- You do not have to reinvent yourself to become ISO certified © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Auditor’s Insight Issue: Consultant’s System In Place Instead Of Client’s System Corrective Action Strategies: Auditor’s Insight Issue: Consultant’s System In Place Instead Of Client’s System Corrective Action Strategies: ■ Create your ISO system around your business practices ■ Make sure your consultant understands your business and works to enhance/improve your system ■ Do not make it cumbersome (i. e. procedures/records/systems that do not add value) 10 © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Auditor’s Insight Issue: Lack Of Knowledge Of Customer Specific Requirements CSR Corrective Action Strategies: Auditor’s Insight Issue: Lack Of Knowledge Of Customer Specific Requirements CSR Corrective Action Strategies: ■ Contract review for CSR ■ Document them under your operational guidelines (in-house product specification) ■ Maintain current customer manual – assign ownership of this process ■ Include CSR requirements on production paperwork 11 © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Auditor’s Insight Issue: Determining What Measurables Are Important To Processes And Managing Them Corrective Auditor’s Insight Issue: Determining What Measurables Are Important To Processes And Managing Them Corrective Action Strategies: ■ Define what is already being measured ■ Define how currently defined measures link to current processes ■ Define the measurables for the balance of the key processes ■ Define what measurables are required by the standard (TS) 12 ■ Document, train, track and look for improvements © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Auditor’s Insight Issue: Auditing By Each Element of the Standard Rather Than By Process Auditor’s Insight Issue: Auditing By Each Element of the Standard Rather Than By Process Approach Corrective Action Strategies: ■ Process diagrams ■ Train internal auditor on process approach ■ Create key process auditing form and reference the ISO applicable elements of the standard ■ Understand the hand-off points between your processes, who is responsible and performance measurables 13 © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Auditor’s Insight Issue: Improper Identification Of Root Cause, Ineffective Corrective Action Plan & Ineffective Auditor’s Insight Issue: Improper Identification Of Root Cause, Ineffective Corrective Action Plan & Ineffective Implementation Corrective Action Strategies: ■ Appropriate personnel resource allocation ■ Training on root cause analysis ■ Corrective Action methodology (i. e. use of 5 Why, 8 D) ■ Internal auditing for effectiveness of corrective action plan 14 ■ Top Management reviewing corrective action effectiveness at Management Review © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Auditor’s Insight Issue: Past Due: Calibrations; Audits, Management Reviews Corrective Action Strategies: ■ Utilize Auditor’s Insight Issue: Past Due: Calibrations; Audits, Management Reviews Corrective Action Strategies: ■ Utilize computer to track and stay on top of schedule (software packages available) ■ Management review should be the tool for weaknesses in your system 15 © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Auditor’s Insight Issue: Preventative Action Records Corrective Action Strategies: ■ Take credit for your Auditor’s Insight Issue: Preventative Action Records Corrective Action Strategies: ■ Take credit for your “Plans/Suggestions” (i. e. FEMAS, POKA YOKE) ■ Companywide understanding on how to document your preventive actions 16 © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Client’s Insight From Client’s Insight Quality People With Quality Advice! 17 © EAGLE Registrations Client’s Insight From Client’s Insight Quality People With Quality Advice! 17 © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Client’s Insight Issue: How Do I Know I Am Interpreting The Standard The Way Client’s Insight Issue: How Do I Know I Am Interpreting The Standard The Way It Was Meant To Be Interpreted? Corrective Action Strategies: ■ Utilize web resources from Accreditation Bodies (i. e. IAOB/ANAB –Frequently Asked Questions & Lessons Learned) ■ Utilize Consultant ■ Look for User Group Web-ex – sharing knowledge 18 ■ ASQ networking © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Client’s Insight Issue: Making Sure I Am Meeting ISO Requirements For Customer Satisfaction Corrective Client’s Insight Issue: Making Sure I Am Meeting ISO Requirements For Customer Satisfaction Corrective Action Strategies: ■ Survey – “Would you recommend ME to a business associate? ” ■ Cover all aspects of your business ■ Follow-up 1 on 1 with any issue ■ Have a person in charge of reviewing this data and assigning responsibilities 19 © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Client’s Insight Issue: Perceived Audit Value Verses Audit Cost Corrective Action Strategies: ■ Look Client’s Insight Issue: Perceived Audit Value Verses Audit Cost Corrective Action Strategies: ■ Look at your internal and external audits to find areas for improvement and trends ■ ISO training adds value through better understanding of ISO requirements and their relationship to your processes ■ Potential resource sharing with other ISO companies (i. e. combined training course) ■ Research State/Federal Government for any grant money (usually for training) ■ Understand how Nonconformance’s (NCRs) and Opportunities for Improvement will strengthen your company’s processes 20 © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Client’s Insight Issue: Communication Misunderstandings Between Client And Registrar/Auditor Corrective Action Strategies: ■ Make Client’s Insight Issue: Communication Misunderstandings Between Client And Registrar/Auditor Corrective Action Strategies: ■ Make sure you understand the Registrar audit process – ask for documentation ■ Clarify with auditor their exact audit schedule – what/when ■ Clarify questions –during audit ■ Get a copy of the auditors report ■ Call your registrar if you need their help resolving any issues (before, during and after audit) 21 © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Client’s Insight Issue: How Do I Strengthen My Internal Auditing Team’s Performance? Corrective Action Client’s Insight Issue: How Do I Strengthen My Internal Auditing Team’s Performance? Corrective Action Strategies: ■ Shadow Registrar’s audit team ■ Consider External Lead Auditor’s Training Course ■ Consider Communication Skills training ─ Asking Open Ended Questions ─ Asking Questions in a non- threatening approach ■ Management support on the amount of time needed to complete an affective audit. 22 © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Client’s Insight Issue: Understanding Your Registrar’s Correction Action Timeline Corrective Action Strategies: For example Client’s Insight Issue: Understanding Your Registrar’s Correction Action Timeline Corrective Action Strategies: For example EAGLE’s requirements: ■ 30 Days From Close of Audit to Accept Corrective Action ■ 60 Days from close of audit to send objective evidence corrective action plan implemented ■ 90 Days from close of audit to close out the audit 23 ■ Following audit, Auditor will receive objective evidence of effectiveness of corrective action plan implemented © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Conclusion! For Questions and Answers contact EAGLE Registrations at: 800 -795 -3641 or info@eagleregistrations. Conclusion! For Questions and Answers contact EAGLE Registrations at: 800 -795 -3641 or [email protected] com THANK YOU! 24 © EAGLE Registrations Inc. 2008 CONFIDENTIAL

Thank You! 25 © EAGLE Registrations Inc. 2008 CONFIDENTIAL Thank You! 25 © EAGLE Registrations Inc. 2008 CONFIDENTIAL