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AUDITING An Overview Discussion Joel Schwartzman Retired

AUDITING An Overview Discussion Joel Schwartzman Retired. I am a retired. Certified Quality Auditor Certified Quality Engineer IATCA Senior Lead Auditor I was 6’7 ”. Candy and Gum manufacturers An Army Tank Plant

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AUDITING An Overview Discussion Joel Schwartzman Retired

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  1. AUDITING An Overview Discussion Joel Schwartzman Retired

  2. I am a retired • Certified Quality Auditor • Certified Quality Engineer • IATCA Senior Lead Auditor I was • 6’7”

  3. Candy and Gum manufacturers An Army Tank Plant The company that makes car trunk openers A manufacturer of $3000 drill bits The engineering department for the NYC subways The largest aerosol valve manufacturer in the world Some of the companies I have audited are:

  4. Companies I audited (cont’d): • The company that makes coin exchangers for candy machines • A company that extracted seaweed for a ingredient used in chocolate milk • Electronic component distributors and warehouses • A telephone cable manufacturer

  5. More Companies (cont’d.) • A biotech manufacturing company • A toxicology lab • An aerosol filler • An auto dashboard manufacturer ETC, ETC, ETC…………..

  6. THERE ARE A MILLION STORIES ASSOCIATED WITH ALL OF THESE AUDITS I might tell you some of these and I might tell you where a good restaurant is nearby.

  7. What do all these have in common? ALL HAVE QUALITY SYSTEMS THAT MUST CONFORM TO A SPECIFIC QUALITY STANDARD THAT WAS AUDITED TO

  8. QS 9000 ISO 9000 TL 9000 GMPs for Drugs GMPs for Foods Industry Standards Company SOPs The standard might have been:

  9. ISO 19011-2011 IS A GUIDELINE DOCUMENT FOR QUALITY MANAGEMENT SYSTEMS AUDITING

  10. ISO 17021 IS A NEW STANDARD USED FOR 3RD PARTY CERTIFICATION AUDITS

  11. Audit Purpose • The purpose of quality auditing is to examine the effectiveness of management directed control programs. • The philosophy of quality assurance programs is based on prevention rather than detection of problems. Audit Scope • To determine the areas of investigation that the audit will encompass.

  12. Audit Terms: • Appraisal - A form of the quality system audit, normally conducted to examine the quality program effectiveness and implementation. • Audit - Planned and documented assessment to determine whether requirements are met. • Audit Standard - Description of characteristics that reflects current practice. • Auditee - An organization or person being audited. • Auditor - Individual carrying out the audit • Client – Determines the scope and purpose of the audit and receives the report.

  13. Management priorities or system requirements Statutory, regulatory and contractual requirements A need for supplier evaluation Risks to the organization Whatever the boss dictates Audit objectives can be based on:

  14. Audit program objectives may be designed to: • Evaluate and maintain confidence in a supplier • Verify conformance to contractual requirements • Become certified to a management system • Follow up a corrective action program

  15. General Types of Audits • System audit • Process audit • Product audit

  16. AUDITORS WHAT PERSONALITY TYPES ARE AUDITORS?

  17. AUDITOR QUALIFICATIONS For the first time in the USA, a new psychometric test was part of the ISO certification process in 2005. (These same requirements should be applied to all audits.)

  18. Must Haves 1.Ethical and Principled Honest, truthful, sincere, discrete 2. Proactive and organized Will take the initiative with issues 3. Systematic Shows balanced affiliation for both tasks and people 4. Logical Makes decisions based on facts and reasoned logic 5. Decisive Will expedite decisions methodically

  19. 1. Observant Shows the ability to identify both patterns and exceptions in complex systems 2. Diplomatic Shows tact in appropriate situations 3. Flexible Shows a balanced global and detail focus 4. Process Preference Demonstrates the ability to follow a predetermined method Should Haves

  20. Should Haves (cont’d.) 5. People Sensitive Distinguish and identify a person’s emotional state and operating style 6. Adaptable and Resourceful Match and work with different types of people in a range of situations 7. Confident Demonstrates calm and poise in challenging situation

  21. Auditors should: • Remain with the audit scope • Collect and analyze evidence • Act in an ethical manner

  22. Auditors are responsible for: • Complying with the applicable audit requirements • Documenting and reporting audit results • Maintaining confidentially of the audit

  23. THE AUDIT

  24. Audit Planning • Establish the audit objectives • Plan resources needed • Select lead auditor and audit team • Develop an audit plan • Notify the auditee & obtain confirmation • Coordinate schedules with management • Determine time requirements

  25. Audit Planning (cont’d.) • Determine the critical areas to be audited • Plan resources needed • Determine time requirements • Track progress on action plans • Respond to new emphasis from FDA, International regulations etc.

  26. THE QUESTIONS

  27. Interviewing Techniques • Open ended questions • Probing • Silence • Pauses • Paraphrasing

  28. Variety of Non Verbal Communication Signals • Facial expressions • Body movements • Vocal intonation and speech pattern Often dictate the direction of the conversation.

  29. Hidden communication factors: • Hostility • Contempt • Concern • Anger • Fatigue • Boredom • Confusion • Apathy

  30. Communication Barriers • Lateness • Unavailability of key people • Exceptions • Lack of time, resources • Long lunches • Interruptions • Amnesia • Lack of preparedness

  31. AUDIT LOGISTICS

  32. Communications During Audit • Opening meeting - Introduce the audit team to the auditee - Review the scope and objectives of the audit - Set the time and date for the closing meeting - Finalize the agenda

  33. The audit (cont) • Plant tour This is a walk through the facility to familiarize the audit team with the site. During this walk through, information concerning the raw material receipts, storage, processing and quality control inspections are reviewed with notes taken concerning items to be reviewed further.

  34. Audit (cont) • Evidence is collected through - Interviews - Examination of documents - Observation of activities and conditions - Records

  35. Audit (cont) • All observations should be: - Documented - Reviewed - Reported as nonconformities - Clear and Concise - Supported by evidence - Acknowledged by the auditee

  36. Audit (cont) • Daily review This gives the auditee an opportunity to discuss and findings Closing meeting - Present observations to management that will be incorporated into the report.

  37. Afterwards • The project is not finished until the paperwork is completed. • For external audits, the expense report is written first. • Audit Report is drafted within two weeks.

  38. Follow-up • Corrective Action Plan (CAP) is requested within 30 days from auditee

  39. THAT’S ALL FOLKS Biguy25103@aol.com

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