Introduction to Internal Quality System Auditing
- 1. Basic Auditing Assumptions 1. Auditors are qualified 2. Quality system exists. 3. Adequate resources and support. 4. Evidential material. 5. Formally reported results . 6. Follow-up audits. 7. Audit's Quality assurance.
- 2. Audit Definitions Assessment Audit Auditee Auditor Exception Finding Observation Verification
- 3. Auditor Responsibilities 1. Comply with audit standards. 3. Implement audit effectively & efficiently. 4. Report observations to Auditee A.S.A.P. 5. Maintain independence. 6. Assist with the audit report.
- 4. Auditee Responsibilities 1. Appoint person to accompany auditor. 2. Access to facilities and evidence 3. Adequate working area. 4. Attend meetings. 5. Review report. 6. Take corrective action A.S.A.P.
- 5. Auditor Qualification Knowledge Skill Personality Experience Examination & Certification Independence
- 6. Audit Quality Assurance 1. Validity 2. Correctness 3. Absence of bias 4. Report’s information usefulness.
- 7. Audit Working Papers 1. What you did 2. What you found. 3. What you concluded.
- 8. Suggested Working Paper Techniques New topics on a new page 2 in. margin from the top & left sides. Copies of documents. Initial, date and number each page. Cross reference to procedure. Interim conclusions. List of findings, observations, and exceptions.
- 9. Lead Auditor Responsibilities Select & assign team members. Distribute background data. Audit notification. Conduct audit planning meeting. Lead audit opening meeting. Review audit status & findings with team. Periodic feedback to auditee. Prepare & issue report.
- 10. Audit Interview Tips 1. Organize your thoughts. 2. General sequence of questions. 3. Right setting. 4. Interviewee does most of the talking. 5. Take discrete notes. 6. Summarize your understanding.
- 11. Audit Plans 1. Scope and objectives. 2. Auditors. 3. Activitiy schedule. 4. Relevant Standard’s sections. 5. Past audits and other documents
- 12. Audit Report Structure 1. Audit purpose, objective, & scope 2. Auditors, dates, auditee. 3. Observations & supporting evidence 4. Recommendations for improvements. 5. Recommendations for follow-up audit of corrective actions.
- 13. Techniques for Understanding Quality Management Systems Interviews Document Review Observation Limited Verification Testing
- 14. Auditor Attributes Skills Traits Good communicator Tactful Flexible Persistant Objective Integrity
- 15. Inquiry Categories Definition of responsibilities Delegation of responsibilities & authorities Personnel training and experience Documentation Protective measures Internal verification
- 16. Interview Considerations Attitude and approach Setting Non-verbal communication Types of questions
- 17. Interview Don’ts Debate with interviewee. Be insensitive. Criticise people. Ask leading, tricky questions. Be nit-picky. Divulge thoughts about audit outcome. Fail to test conclusions.
- 18. Principles of Audit Reporting Don’t overstate facts. Performance vs. documentation. Avoid generalities. Communicate exception specifics. Avoid extreme language. Spell things out. Don't focus on individuals. Provide policy references.
- 19. Cast of Characters 1. External Standards’ Organiztions 2. Divisional HQ 3. Local Management Team 4. AUDIT COMMITTEE 5. DEPARTMENT MANAGERS 6. SUPERVISORS 7. EMPLOYEES
- 20. Process Requirements Business Process Objectives & Targets With what? With whom? Inputs Outputs How many? How? Linked to what other processes?
- 21. Process Audit Plan (what do we want to accomplish?) Do (are we implementing our plans?) Check (do we evaluate our progress?) Act (do we take action based on the results?)
- 22. Sampling Take the appropriate amount Don’t enlarge sample when nothing found Enlarge sample if something found To enable clear & complete reporting
- 23. Gathering Information Stay on track Agree on the facts Remain objective Select samples randomly
- 24. Non-conformities Failure to meet specified requirement ISO 9001-2000 FDA cGMP’s Customer’s contracts, specs, etc. Company SOP’s or Work Instructions Some more serious than others Risk of occurrence Impact of occurrence
- 25. Reporting’s 5 C’s Clear Correct Complete Concise Checked
- 26. Reporting Non-conformities Source of the requirement Requirement summary Source of the evidence Summary of the evidence
- 27. Audit Evolution Old Way evaluates Organization SOP’s Manuals Documentation Compliance New Way evaluates Availability of process data Training efforts Teamwork Customer awareness Quality cost analysis Customer & Supplier involvement
- 28. Audit Planning Planing Execution Reporting Closure