Getting the Getting the Most Out of Your Internal QMS Most Out of Your Internal QMS and EMS Audits and EMS Audits - - Building Building Innovative, Value Innovative, Value - - Added Practices Added Practices Ann W. Phillips President Quality Techniques, Inc. 256-883-3554 [email protected]

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  • 1. Getting theMost Out of Your Internal QMS and EMS Audits - BuildingInnovative, Value-Added Practices Ann W. PhillipsPresidentQuality Techniques, [email protected]

2. Experience From Participants! What has been particularly effective inyour audit program? What have you implemented that has beenespecially successful for you? What experience have you had with processauditing or integrated auditing that has beenpositive? Have you had successes that you can sharewith others? 3. Experience From Participants! What challenges have you faced in your auditprocesses? Buy-in from management? Buy-in from employees? Timely, thorough corrective action? No time for preparation? Struggling to understand process auditing? Lack of expertise in integrated auditing? Evaluating effectiveness of processes? Others? 4. Buy-In From Management! Speak in terms of facts, data, and return oninvestment! Where has your audit process generated savingsto the bottom line? Capture the dollars Report potential savings/losses in the audit report Has this caused a problem for you? Can you point me in the right direction to get the data so that I can write this up for you? 5. Buy-In From Employees! What is the purpose of the internal audit?! Who is the customer of the internal audit?! Communicate these points!! Basis of process audits: Have competencies for this position been defined?Has appropriate training been provided? Are you getting the information that you need toachieve the desired results? Are there any repetitive problems with your rawmaterials, equipment, tools, spare parts, etc.?! Who benefits from this audit? 6. Timely, Thorough CorrectiveAction! Has this caused a problem for you?! Document the impact on the organization! Use a Corrective Action Log and trackconformance to estimated completion dates(for items that are verified as effective thefirst time)! Reward effective corrective actions 7. Effective Audit Nonconformances Of the five customer specificationsreviewed in the QC Lab, three were at least one revision out of date and none were approved by the Customer ServiceManager as required in BP-01. (Ref: 4.2.3.a/d) Auditors Note: Two of the lastthree returned shipments were due to obsolete specifications. 8. Effective Audit NonconformancesThere is no defined process to review customer satisfaction data and initiate CARs where indicated. Responsibilities relative to this reviewhave not been defined. (Ref:8.2.1/8.4/8.5.1/5.5.1) Auditors Note: There are two specific areas that have been rated very low in the last two surveys: on-time delivery and customer service. We havelost two customers in the last six months due tothese two issues. 9. Effective Audit NonconformancesDuring the audit, three reject products were noted on the D line that were not identified or segregated. (Ref: 8.3 and BP-13, Section 5.4) Auditors Note: Three customer complaints were noted in the past six months due toour shipping products that had already been found to be reject. 10. Effective AuditNonconformancesThe training program in the press operation needs further evaluation. Accident rates show a significant increase after each round of new hires.Auditors note: Incident rates increased 76% in the first three months after the last hiring and 103% after the previous hiring. 11. Effective Audit NonconformancesThere was no documented action takenfollowing the last emergency response drill. Auditors note: Several items were discovered that could have resulted in anundetected environmental release. 12. No Time For Preparation! Step 1: Understand the scope and purpose of the audit! Step 2: Read, study, and understand the requirements ofthe standard(s) against which the audit will take place! Step 3: Read, study, and understand any applicabledocumentation! Step 4: Prepare/review a process model! Step 5: Review previous audit results! Step 6: Create an effective audit checklist/plan! Step 7: Conduct a pre-audit meeting with auditees 13. No Time For Preparation! Pre-audit meetings Participation of process owners and other auditees Participation from all active auditors! Preparation lunches! Off-Site Planning 14. Struggling to UnderstandProcess Auditing! See handout 15. Lack of Expertise in IntegratedAudits! Knowledge of the applicable standard(s)! Knowledge of the organizations documentedprocedures! Ability to collect information throughinterviewing, listening, observing, or reviewingappropriate documents! Ability to record appropriate evidence ofconformance and nonconformance! Ability to communicate effectively 16. Lack of Expertise in IntegratedAudits! Open-minded! Diplomatic! Ethical! Curious! Energetic! Ability to treat others with dignity andrespect (*) 17. Evaluating Process Effectiveness! What is the desired output of the process?! What metrics are maintained to determinethe effectiveness?! Are goals and objectives being achieved?! If not, are action items initiated? 18. Evaluating Process EffectivenessProduction! Desired output: Acceptable products producedon-time at a competitive! Potential metrics: On-time delivery performance First-pass rate Productivity! Other verification Interview Shipping personnel and review customer feedback 19. Evaluating Process EffectivenessPurchasing! Desired output: Acceptable products arriving on-time at a competitive price! Potential metrics: On-time delivery performance of incoming products Pass rate at incoming inspection Performance in Operations! Other verification Interview customers Receiving and Operations personnel 20. Evaluating Process Effectiveness Maintenance! Desired output: Process equipment reliability! Potential metrics: Unscheduled downtime Number of breakdowns Conformance with planned preventive and predictive maintenance activities! Other verification Interview customers Operations personnel 21. The Checklist: Advantages andDisadvantages! Advantages: Saves time in preparation Improves consistency among auditors Ensures thorough coverage of your quality system Requires the recording of facts and data! Disadvantages Audits become stale Discourages adequate preparation Discourages auditor follow through! Resolution Developing an effective checklist Using the checklist effectively 22. Audit Matrices! Facilitates the audit process! Facilitates the collection and recording ofdata! Speeds up conformance verification toallow more time to explore processinterfaces 23. Conducting the Audit! Key secret: Treating the auditee withdignity and respect! I cant do anything with generalities. Canyou give me specifics? ! Help me find the evidence so that I canwrite this up for you.! Has this caused a problem in the past? 24. Questions and Comments Ann W. [email protected]: ISO 9001:2000 Internal Audits Made Easy (August2002)Co-Author: Integrating Quality, Environmental, and SafetySystems (October 2001)