1. INTERNAL AUDITS A Management Tool
Mary Ellen Raub
Director, Quality Management Systems
Wyle Aerospace Group
Lexington Park, MD

2. Internal Audits – A Management Tool
Wyle Audit Structure
Wyle Internal Audit Process
Internal Audit Execution
Internal Audit Reporting & Follow up

3. Internal Audits What is an audit? *From ANSI/ISO/ASQ Q9000-2000
Audit* – systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
*From ANSI/ISO/ASQ Q
Ref: PMBOK - Audits are listed 32 times

4. Internal Audits Audit Types
First-Party or Internal Audits – conducted by, or on behalf of an organization itself for internal purposes and can form the basis for an organization’s self-declaration of conformity.
Second-Party Audits - external audit conducted by parties having an interest in the organization, such as customers, or by other persons on their behalf.
Third-Party Audits – external audit conducted by external independent organizations. Such organizations provide certification or registration of conformity with requirements .

5. Internal Audits What do audits measure? Compliance or Conformance
Strict adherence to a set of rules.
Fulfillment of a specified requirement (like ISO )
Examples: Regulatory or high-risk.
Adequacy and Effectiveness
Measure adequacy of processes and effectiveness of implementation
Continual improvement
Ref: PMBOK Develop Project Management Plan: Tools and Techniques ( support the audit of the products or components to verify conformance to requirements.)

6. Internal Audits Why do internal audits?
Provide input for management decisions.
Inform management of actual or potential risks.
Identify opportunities for improvement
Assess personnel training effectiveness & equipment capability.
Provide visible management support.
Verify compliance to regulations.
Act as internal control process for the quality management system

7. Internal Audits What should be audited? PMBOK
8.2.2 Perform Quality Assurance: Tools and Techniques (.2 Quality Audits)
Risk Monitoring and Control: Tools and Techniques (.2 Risk Audits)
Contract Administration: Tools and Techniques (.3 Inspections & Audits)
Contract Closure: Tools and Techniques (.1 Procurement Audits)
ISO 9001:2000 – Quality Management System described in the organization’s Quality Manual

8. Wyle Audit Structure

9. Wyle Audit Structure
Internal Audit Schedule

10. Wyle Audit Structure Audit Teams Lead Auditor (1 per audit)
1 hour QMS Awareness Training
4 hour Internal Auditor Training
40 hour formal Lead Assessor Training
Participate in 2 internal audits as a team member
Be appointed by senior management
Internal Auditor (1 or more per audit)
Optional 2-day formal Internal Audit Training
Observe 2 audits prior to participating

11. Wyle Internal Audit Process
Defines the internal audit process.
Lists responsibilities of participants.
Defines auditor qualifications.
Identifies the process for performing internal audits.
Identifies related documents and quality records.

12. Wyle Internal Audit Process
Lead Auditor Responsibilities
Set up date, time & location of internal audit with manager.
Develop audit agenda using Agenda Template.
Modify and/or review existing Audit Guides.
Review previous internal audit results.
Conduct “Opening Meeting”.
Record non-conformances and objective evidence.
Ensure audit is conducted according to Wyle Process.
Conduct “Closing Meeting”.
Brief findings and proposed corrective action.
Initiate corrective action in the Action Item database.
Complete and distribute formal Audit Report within 10 working days.

13. Wyle Internal Audit Process
Internal Auditor Responsibilities
Develop, modify and/or review the audit checklist.
Conduct audit according to Wyle Internal Audit Process.
Record non-conformances and objective evidence.
Communicate audit non-conformances to appropriate personnel and Lead Auditor.

14. Wyle Internal Audit Process
Manager or Process Owner Responsibilities
Ensure project plan or functional process is current and approved prior to the audit.
Cooperate with auditors during the audit.
Comply with requirements of Wyle Internal Audit Process.
Perform timely corrective action.
Complete Action Items in the Action Item database.

15. Audit Execution AUDIT GUIDES
Provides a step-by-step guide for the auditor.
Outlines areas for investigation.
Contains references to requirements.
Provides objective evidence that an audit was performed.
Provides information for briefing auditee.
Provides information for preparing the Final Audit Report.
Provides information base for planning future audits.

16. Audit Execution
Does the auditee know where the project plan and procedures are located?
Is the process or project plan up to date?
Are responsibilities appropriate?
Does the information in the project plan match the SOW or other attached documents?
Are appropriate records being maintained?

17. Audit Execution OPENING MEETING - Lead Auditor will: Provide agenda
Record attendees
Introduce auditors (if necessary).
Explain audit purpose, scope, range.
Confirm details of the audit are acceptable.
Confirm status of procedures and documents.
Explain how non-conformances are identified
Record those present at the opening meeting

18. Audit Execution DURING THE AUDIT…The Audit Team will:
Collect & record objective evidence
Verify observations
Record non-conformances
Evaluate information and ensure validity

19. Audit Execution Corroborate facts and data. Minimize interference.
Another person, preferably from another project or management level, says the same thing.
Another member of the audit team hears the same thing (from the same or different source).
An item, document, or record verifies the action.
Minimize interference.
Auditee may attempt to steer the auditor toward specific topic or interviewees.
Manager may answer for or intimidate the interviewee
Communication problems or conflicts between the auditor and interviewee.

20. Audit Execution Communicate goals. Make people feel at ease.
Why is the audit being done?
What are the benefits?
Make people feel at ease.
Auditees are our CUSTOMERS!
Create a relaxed atmosphere.
The auditor’s best tool is getting buy-in and cooperation.
Find facts, not faults.
Note the good as well as the bad.
Use open-ended questioning technique..

21. Audit Execution Make the auditee the central figure.
Build around their knowledge and expertise.
Ask questions; make observations.
Avoid Cross-examination.
“Does that mean you never follow the procedure?”
Avoid leading or “loaded” questions.
“So you deliver the deliverable without anyone
reviewing it?”
Use the paraphrasing technique.
Forces the auditor to understand intent.
Gives the auditee assurance that the auditors are listening.

22. Audit Execution People hear what they want to hear.
Think questions through.
Intimidation leads NOWHERE!
Provide encouragement.
Positive eye-contact
Positive body language
Neutral wording
Beware of emotional data
Be aware of personalities
Be aware of situations
Pursue different avenues to obtain facts.

23. Audit Execution VERIFY OBSERVATIONS Review findings and observations.
Do I have all of the facts?
Do I need more evidence?
Is there a clear, traceable path to documentation?
Can this be a matter of interpretation?
Will corrective action improve overall quality?

24. Audit Execution CLOSING MEETING – Lead Auditor will:
Meet with appropriate managers to discuss non-conformances and any opportunities for improvement
Highlight positive as well as negative
Give clear evidence for non-conformances
DO NOT SUGGEST CORRECTIVE ACTION!
Give date for delivery of Audit Report
Get tentative date for corrective action

25. Audit Reporting & Follow Up
AUDIT REPORT – Lead Auditor will:
Complete Final Audit Report, including:
Non-conformances with Action Item #
Opportunities for Improvement (OFI’s)
Observations
Positive results, process improvement successes
Expression of appreciation for cooperation
Distribute Final Audit Report

26. Audit Reporting & Follow-Up
CORRECTIVE, PREVENTIVE & IMPROVEMENT ACTIONS
Electronic Action Item Database
Lead Auditor initiates Action Item in Database.
ISO Coordinator assigns Action Item.
Responsible person takes action.
ISO Coordinator verifies action is complete and effective.
Lead Auditor reviews area during the next audit.
Unresolved issues reviewed by Senior Management.

27. Audit Reporting & Follow-Up
MANAGEMENT REVIEW
Internal Audit results and Action Items are categorized and analyzed for trends.
Reviewed during Management Reviews by the Aerospace Group President and Senior Management.
Senior Management assigns continual improvement Action Items.

28. Internal Audits – A Management Tool
Wyle Audit Structure
Wyle Internal Audit Process
Internal Audit Execution
Internal Audit Reporting & Follow up
QUESTIONS?