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1. Clarify the reason for the requested audit 2. Appoint the audit team leader 3. Define objectives, scope, and criteria (Document Review) ISO 19011:2002, 6.3 1. Review documents before onsite audit 2. Take into account audit objective and scope 3. Consider organization size and complexity 4. Include relevant documents and records (Audit Preparation) ISO 19011:2002, 6.4 1. Prepare audit plan as basis for agreement 2. Use plan to schedule and control the audit 3. Keep flexible to permit changes during audit
4. Determine the feasibility of the audit 5. Select the audit team members 6. Establish initial contact with the auditee 5. Defer until onsite audit if not detrimental 6. Determine conformity with audit criteria 7. Report any documentation concerns 8. Decide to continue audit or postpone it 4. Assign work to the audit team members 5. Prepare process diagram and audit checklist 6. Confirm audit arrangements and logistics
Process Diagram
What (Resources) equipment; tools; software. Inputs what received; when; from who. Methods procedures; forms; instructions; controls. WHAT WHO Who (Resources) people; skills; experience. Outputs what delivered; when; to who. Measures quality objectives; performance results.
INPUTS
PROCESS
OUTPUTS
METHODS
MEASURES
Requirement Sources:
12. Follow trails to other areas based on scope 13. Check the facts (use other sources) 14. Record the evidence (checklist notes) 15. Make tentative conclusions (no secrets) 16. Give opportunity to discuss other subjects 17. Avoid consulting on cause and solution 18. Thank for time and cooperation 19. Review progress periodically with audit team 20. Compare audit evidence to audit criteria 21. Generate findings and prepare conclusions 22. Conduct closing meeting and report results
1. Standard (e.g., ISO 9001:2000) 2. Company (policies and procedures) 3. Customer (contracts and orders) 4. Legal (statutes and regulations)
Evidence Sources:
1. Interviews (personnel statements) 2. Observations (demonstrated practices) 3. Documents (plans, procedures, specs) 4. Records (tests, minutes, completed forms) V1.R2
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1. Prepare audit report per audit procedure 3. Ensure it is complete, correct, clear, concise 2. Include in any nonconformity statements: 4. Approve audit report per audit procedure - requirement (with source) 5. Issue audit report in agreed timeframe - problem (with evidence) 6. Distribute to client-designated recipients (Audit Completion) ISO 19011:2002, 6.7 1. Ensure all activities in plan are carried out 3. Keep or destroy documents per agreements 2. Ensure the audit report has been distributed 4. Remember audit not closed until F/U audit (Follow-Up Audit) ISO 19011:2002, 6.8 1. Notify auditee if need for corrective action 4. Ask auditee to notify you of completed action 2. Agree with the proposed corrective action 5. Verify action was effective to avoid problem 3. Ensure action is taken in agreed timeframe 6. Close out the nonconformity based on action Audit Principles (Reference: ISO 19011:2002, 4) 1. Carry out the audit in an ethical manner 4. Conduct an impartial and objective audit 2. Present truthful, fair, and accurate results 5. Base conclusions on verifiable evidence 3. Perform audit with due professional care
Audit Questions
1. What is the primary purpose of this process? 9. How is the process monitored and controlled? 2. Who is the manager (owner) of the process? 10. What are its outputs and who receives them? 3. What are its inputs and who supplies them? 11. Do these outputs meet the requirements? 4. How do you know if these inputs are good? 12. What do you do if the outputs are not right? 5. What are your responsibilities in the process? 13. What are the process quality objectives? 6. How do you know what to do? 14. How is the process performance measured? 7. What training and skills are needed? 15. Please show me the records you maintain. 8. Please show me how you do it. 16. How could this process be improved? Audit Definitions (Reference: ISO 19011:2002, 3 and ISO 9000:2000) Audit: systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled. Criteria: set of policies, procedures, or requirements against which audit evidence is compared. Evidence: verifiable records, statements of fact, or other information relevant to audit criteria. Findings: results of the evaluation of collected audit evidence against audit criteria. Program: set of one or more audits planned for a specific timeframe and directed to specific purpose. Plan: description of the activities and arrangements for an audit. Scope: extent and boundaries of an audit. Nonconformity: non-fulfillment of a requirement. Corrective Action (Reference: ISO 9001:2000, 8.5.2) 1. Determine if similar deficiencies exist 6. Implement planned corrective action 2. Implement immediate fix (correction) 7. Reflect changed process in documentation 3. Identify root cause of nonconformity 8. Verify the action was an effective solution 4. Develop action to prevent recurrence 9. Record the results of the investigation 5. Assign responsibilities and due dates 10. Inform audit function of completed action
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Audit Status
Conducted = Audit carried out according to plan Reported = Approved audit report distributed
Audit Strategy
Completed = Audit report and other records filed Closed = Corrective actions verified as effective Horizontal: Assess process across departments Trace: Follow a transaction through the system
Vertical: Assess processes within department Clause: Assess a clause across departments
Vertical
Horizontal D D D D=Departments D D
Benefits 1. Establishes the audit sampling plan 7. Prepares audit team to conduct the audit 2. Provides balanced audit coverage 8. Allows lead auditor to evaluate planning 3. Helps acquire objective evidence 9. Controls the audit pace (time manager) 4. Encapsulates the audit methodology 10. Keeps focus on audit objective and scope 5. Guides auditor on timing and content 11. Serves as memory aid (confidence builder) 6. Serves as repository for audit notes 12. Become the record of investigated areas Format Reference: Specific source of requirement - clause or section number Requirement: Applicable requirements to look at standard, company, customer, and legal Evidence: Expected evidence to look for statements, observations, documents, and records
Checklist Example
Reference (Source of Requirement): ISO 9001:2000, 4.2.3.a Look at Requirement: Approve documents for adequacy before issue
Look for Expected Evidence: 1. Statements Understanding of process 2. Observation Demonstration of process 3. Documents Covered in required procedure 4. Records Document approvals
Plus information from turtle diagram Inputs, Outputs, Resources, Methods, Measures Audit Notes (Reference: ISO 19011:2002, 6.5.4) 1. Explain why you are taking the notes 4. Use statements as requirement or evidence 2. Note what was heard, seen, and read 5. Spot different answers for audit follow-up 3. Jot down specific facts and references 6. Determine activities for further investigation
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Audit Benefits
1. Verifies conformity to requirements 2. Initiates needed corrective actions 3. Evaluates effectiveness of system 4. Identifies opportunities for improvement
5. Increases quality awareness of organization 6. Reduces risk of product or service failures 7. Provides information for management review 8. Satisfies requirement of Standard for audits
This Audit Quick Reference may not be reproduced, stored electronically, or transmitted in any form without the prior written permission of the author, <Larry@WhittingtonAssociates.com>.
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