Streamlined Internal Audits as a Means of Improving Project Quality Management Systems

1. Streamlined Internal Audits as a Means of Improving Project Quality Management Systems Funda Ristow Clyde Hedin, CQA Garabed H. Kassakhian, Ph.D. Quality Assurance Technical Support Program Shaw Environmental, Inc. Las Vegas, Nevada 89120 American Society for Quality Las Vegas Section 0705 May 17, 2006

2. EPA Quality Assurance Technical Support (QATS) Program • Supports the EPA Analytical Services Branch (ASB) of the Office of Superfund Remediation and Technology Innovation (OSRTI) • EPA ASB manages the Contract Laboratory Program (CLP) • Involved in special projects such as validation of World Trade Center (WTC) sample results

3. EPA Quality Assurance Technical Support (QATS) Program • QATS achieved QMS certification to the ISO 9002:1994 standard on October 11, 2001 and upgrade certification to the ISO 9001:2000 standard on May 1, 2003 • QATS has passed all of its surveillance audits without a single nonconformance

4. EPA Quality Assurance Technical Support (QATS) Program • QATS Program is the only EPA program of its kind that has achieved ISO 9000 registrations, an internationally recognized approach to a quality management system • For four consecutive rating periods the Client, U.S. EPA, rated QATS “Quality of Product or Service” and “Business Relations” as “Outstanding” (Evaluation of May 2004)

5. EPA Quality Assurance Technical Support (QATS) Program • QATS has developed an internal audit system that has proven to be extremely effective in achieving and maintaining compliance to the ISO 9000 standard • The internal audit system described in this presentation can also be used to improve any type of Project Quality Management

6. Why are Internal Audits Essential?

7. Why are Internal Audits Essential? • They ensure that products are developed in accordance with approved procedures and meet customer needs/requirements • They enhance customer satisfaction by ensuring adherence/compliance with the requirements • They provide opportunity to identify continual improvements to the quality system

8. Common Problems with Internal Auditing • Planning • Time consuming/manpower intensive • Trouble with audit preparation- lack of audit matrices that addresses all requirements • Difficulty with developing applicable checklists • Internal auditors lacking sufficient knowledge • Difficult to schedule

9. Common Problems with Internal Auditing (cont’d) • Implementing • Difficulty with conducting audit • Reporting • Difficulty with issuing and closing out NCRs in a timely manner • Inconsistency in the internal audit reports • Poor record keeping • Too much paperwork • Effectiveness Follow-up Non-conformance Report (NCR)/Corrective Action Report (CAR)

10. Streamlining Internal AuditsPlanning • Develop an internal auditing matrix • Process vs. requirement • Procedure vs. requirement • It reduces audit preparation time

11. Streamlining Internal AuditsPlanning • It focuses on the areas in need of audit • It can be used in the development of audit checklists and/or in the identification of the areas needed to be audited

12. Example of Auditing Matrix

13. Streamlining Internal AuditsPlanning (cont’d) • Develop and approve internal audit checklist: Process-specific targeted audit checklists • Comprehensive process-specific checklists are designed to address only those requirements particular to a process (e.g. purchasing, shipping) Procedure oriented checklists • Standard Operational Procedure (SOP), Work Instructions, Flowchart

14. Streamlining the Checklist • If the checklist already exists: • break it up into smaller process or procedure oriented checklists • shade the questions not applying to the area or procedure being audited

15. Example of Audit Checklist

16. Example of Audit Checklist

17. Streamlining Internal AuditsPlanning (cont’d) • Selection of internal auditors and training • All internal auditors must be trained • Internal audit effectiveness is enhanced with auditors trained and certified as ASQ Certified Quality Auditors (CQA), ISO Lead Auditors or equivalent • Objectivity is essential to the internal auditing process • The internal auditors must not have direct responsibility for the activity being audited

18. Streamlining Internal AuditsPlanning (cont’d) • Develop a schedule • Internal audit planning and scheduling will coordinate mutually convenient time for the auditors and the auditees in advance • Sufficient lead time will be provided in case substitutions are required • Internal auditors might have other responsibilities in the organization

19. Streamlining Internal AuditsImplementing • Complete the checklist including supporting notes, comments, improvements • Use a notebook tablet • Stay focused, do not let auditee ramble on

20. Streamlining Internal Audits Reporting • Preparing internal audit report • Develop a template audit report to provide a consistent format for internal auditors • Include objective evidence addenda to support the observations and findings • All the objective evidence, e.g. copies of documents, etc. provided to the internal auditor should be initialed and dated by the auditee to prevent future misunderstandings • Besides hardcopy, keep the internal audit reports electronically in PDF format

21. Internal Audit Report Template

22. Internal Audit Report Template • The internal audit report should contain: • To (Group Leader) • From (Internal Auditor) • Date • Audited Area (Process or Procedure) • Auditees/Observers • Audit Findings/Observations/Actionable Items • Audited Documents or Objective Evidence • List of distribution to all auditees and Management

23. Streamlining Internal AuditsReporting (cont’d) • Define corrective action and correction • A correction is an action to eliminate a detected nonconformity • A corrective action is an action to eliminate the cause of a detected nonconformity or other undesirable situation • The corrections do not require any nonconformance report-can be resulted as Actionable Items Reference: American National Standard ANSI/ISO/ASQ Q9000-2000

24. Example of NCR Form

25. NCR/CAR • It should contain: • Non-conforming item • Detected By • Description of Nonconformance • Reference Documents • Root Cause • Proposed Corrective Action • Implementation Date • Closeout / Signatures • Effectiveness Check

26. Streamlining Internal AuditsEffectiveness Follow-up • The purpose of an effectiveness check is to verify the ongoing efficiency of implemented corrective actions • Create a tracking system • Internal audit non-conformances (NCRs) have to be tracked in a timely manner for closure and effectiveness check • QATS devised an efficient and simple-to-use electronic report format and NCR tracking system that prevents late closures of NCRs

27. IQS-Integrated Quality System

28. Tracking (Handout #6)

29. Conclusion • The systems QATS has implemented for internal audits have successfully streamlined the maintenance of Project QMS • The processes QATS has used include logical, systematic approach for planning, implementing, reporting and effectiveness follow-up • Database to generate an electronic reports and tracking system have significantly streamlined the internal audit process • reduced the time and the paperwork • avoided inaccurate or late implementation of corrective actions

30. Contact • Funda Ristow, Shaw Environmental, Inc. ph: (702) 895-8706 e-mail: Funda.Ristow@shawgrp.com

31. Questions