© EAGLE Registrations Inc CONFIDENTIAL 1 Experience Speaks of Lessons Learned ASQ Illiana February 15, 2011

© EAGLE Registrations Inc CONFIDENTIAL 2 INTRODUCTION  Jack Hamilton EAGLE Registrations Inc.

© EAGLE Registrations Inc CONFIDENTIAL 3 Top 12 Issues from Auditor Insight

© EAGLE Registrations Inc CONFIDENTIAL 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

© EAGLE Registrations Inc CONFIDENTIAL 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

© EAGLE Registrations Inc CONFIDENTIAL 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

© EAGLE Registrations Inc CONFIDENTIAL 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

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

© EAGLE Registrations Inc CONFIDENTIAL 9 EXAMPLE PROCESS MAP Product Realization Processes Customers Marketing/ Sales/Quote Human Resources Customer Requirements, Quotes, & Feedback 7.4 (7.5.2) Management/ Improvement Document and Record Control Internal Audit & CA/PA All 6 All Product DesignContract Review Packaging/ Shipping Manufacturing Products Raw Materials Purchasing Customer PO Customer Requirements Product Design Purchasing Requirements Products Information, Decisions, Actions Process Information & Improvements Documents Competency Requirements & Records

© EAGLE Registrations Inc CONFIDENTIAL 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

© EAGLE Registrations Inc CONFIDENTIAL 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

© EAGLE Registrations Inc CONFIDENTIAL 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

© EAGLE Registrations Inc CONFIDENTIAL 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

© EAGLE Registrations Inc CONFIDENTIAL 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

© EAGLE Registrations Inc CONFIDENTIAL 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

© EAGLE Registrations Inc CONFIDENTIAL 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

© EAGLE Registrations Inc CONFIDENTIAL 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

© EAGLE Registrations Inc CONFIDENTIAL 18 CLIENTS INSIGHT Top Six Issues from Client Insight Quality People With Quality Advice!

© EAGLE Registrations Inc CONFIDENTIAL 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)

© EAGLE Registrations Inc CONFIDENTIAL 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

© EAGLE Registrations Inc CONFIDENTIAL 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

© EAGLE Registrations Inc CONFIDENTIAL 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

© EAGLE Registrations Inc CONFIDENTIAL 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

© EAGLE Registrations Inc CONFIDENTIAL 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

© EAGLE Registrations Inc CONFIDENTIAL 25 Questions?

© EAGLE Registrations Inc CONFIDENTIAL 26 CONTACT INFORMATION Please call visit Thank you!