Experience Speaks of Lessons Learned

1. Experience Speaks of Lessons Learned ASQ Illiana February 15, 2011

2. INTRODUCTION • Jack Hamilton • EAGLE Registrations Inc.

3. Top 12 Issues from Auditor Insight

4. ISSUE 1 Not knowing if your Quality Management System is ready to be assessed by a Certification Body. • Corrective Action Strategies: • Strengthen management’s understanding of ISO standard and management review • Analysis of required documents in place • Processes defined and in place • Measurables collected • Effective internal audits • Corrective and preventive actions occurring • Effectiveness tracked

5. ISSUE 2 Overcoming the perception that ISO is a function of the Quality Control Department. • Corrective Action Strategies: • Top Management spear-heading involvement of all employees • Top Management communication of Quality Policy and Goals to employees and clarify their understanding

6. ISSUE 3 Lack of management commitment to the ISO system. • Corrective Action Strategies: • Management attend ISO training classes (internal or external) • Clearly define management team • Commitment to management review process • Management and ISO management representative working towards the same goal

7. ISSUE 4 Not having an auditable documented system. • Corrective Action Strategies: • Organization chart – responsibilities • Process maps and charts • Policies and Procedures • Create and continually update documents

8. PROCESS AUDITING Turtle Diagram – Key Questions About a Process With who? (training, knowledge, skills) 4 With what? (equipment, materials) 3 Sequence and linkage to other processes 8 Sequence and linkage to other processes 8 Input 7 Process 1 Output 2 How ? (instructions, procedures, methods) 5 How many ? (performance indicators) 6

9. Customers Customer Requirements, Quotes, & Feedback Products Product Realization Processes Information, Decisions, Actions 4.1 5 All 6 All 7.1 8.1 8.4 8.5.1 Marketing/ Sales/Quote Management/ Improvement 7.2 8.2.1 Customer PO Customer Requirements Process Information & Improvements Internal Audit & CA/PA Product Design Contract Review 8.2.2 8.5.2 8.5.3 7.3 7.2 7.5.1 7.5.3 7.5.4 7.5.5 8.3 7.4 (7.5.2) 7.5.3 8.3 Purchasing Requirements Customer Requirements Purchasing Packaging/ Shipping Document and Record Control Documents 4.2 4.3 Product Design Raw Materials Competency Requirements & Records Manufacturing Human Resources 6.3 6.4 7.5 7.6 8.2.4 8.3 6.1 6.2 Products EXAMPLE PROCESS MAP

10. ISSUE 5 Having excessive, cumbersome documentation. • Corrective Action Strategies: • Written procedures for processes that impact system performance • Say what you do; Do what you say! • Create simple and concise documents and test them • Use current documents – reinvention not needed to become ISO certified

11. ISSUE 6 Using a consultant’s system instead of a client’s personalized system. • Corrective Action Strategies: • ISO system around your business practices • Consultant understands your business and works to enhance/improve your system • Keep it manageable – eliminate procedures/ records/systems that do not add value

12. ISSUE 7 Not knowing your Contract and Customer Specific Requirements (CSR). • Corrective Action Strategies: • Contract review for CSR • Document under your operational guidelines (in-house product specification) • Maintain current customer manual – assign ownership • Include CSR requirements on production paperwork

13. ISSUE 8 Determining what measurables are important to processes and effectively managing them. • Corrective Action Strategies: • Define current measurables and their link to processes • Create measurables for the balance of key processes • Identify measurables required by the standard • Document, train, track and look for improvements

14. ISSUE 9 Auditing internally 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 • Knowing hand-offs between processes – responsibilities and performance measurables

15. ISSUE 10 Improper identification of root cause, ineffective corrective action plan and ineffective implementation • Corrective Action Strategies: • Appropriate personnel resource allocation • Training on root cause analysis • Corrective action methodology (i.e. use of tools: 5Why, 8D) • Internal auditing for effectiveness of corrective action plan • Top management review of corrective action effectiveness at management review

16. ISSUE 11 Past due calibrations, audits and management reviews. • Corrective Action Strategies: • Utilize computer software to manage schedule • Management review to identify weaknesses in system

17. ISSUE 12 Undocumented preventive action records. • Corrective Action Strategies: • Take credit for your “Plans/Suggestions” (i.e. FMEAS, POKA YOKE) • Companywide understanding documenting preventive actions

18. CLIENTS INSIGHT Top Six Issues from Client Insight Quality People With Quality Advice!

19. ISSUE 1 How do I Know I am Interpreting the Standard the Way it was Meant to be Interpreted? • Corrective Action Strategies: • Utilize Web resources – Accreditation Bodies (i.e. – IAOB/ANAB) • Utilize a qualified consultant • User groups, WebEx events and training • Association networking (i.e. – American Society for Quality)

20. ISSUE 2 Am I meeting ISO requirements for customer satisfaction? • Corrective Action Strategies: • Survey • Cover all aspects business • Follow-up one-on-one with issues • Person in charge of reviewing data and assigning responsibilities

21. ISSUE 3 Realizing perceived audit value verses audit cost. • Corrective Action Strategies: • Look to internal and external audits to find areas for improvement and trends • ISO training • Resource sharing with other ISO companies • Research State/Federal Government for grant money • Understand how Nonconformance’s (NCRs) and Opportunities for Improvement strengthen company processes

22. ISSUE 4 Communication Misunderstandings Between Client and Certification Body/Auditor. • Corrective Action Strategies: • Understand the Certification Body audit process – ask for documentation • Clarify audit schedule • Ask questions during audit • Obtain copies of auditor reports • Call your Certification Body to resolve issues

23. ISSUE 5 Not having strong internal auditing team performance. • Corrective Action Strategies: • Shadow Certification Body’s audit team • External Lead Auditor Training Course • Communication Skills training • ─ Ask open-ended questions • ─ Ask questions in a non-threatening approach • Management support appropriate time needed to complete an effective audit

24. ISSUE 6 Not Understanding Your Certification Body’s Corrective Action Timeline. • Corrective Action Strategies: • 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 • Following audit, auditor will receive objective evidence of effectiveness of corrective action plan implemented

25. Questions?

26. CONTACT INFORMATION Please call 800.795.3641 visit www.eagleregistrations.com e-mail jack.hamilton@eagleregistrations.com Thank you!