FDA GMP Training - The Quality Audit
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The document discusses various topics relating to quality audits, including definitions, the purpose and types of audits, auditor skills and conduct, and potential problems auditors may encounter. It defines key terms like assessment, audit, compliance, and defines a quality audit. It outlines the purpose of audits is to provide objective feedback to enable management decisions. It also discusses auditor skills like competence, communication, listening, independence, observation, objectivity, and judging. Finally, it discusses problems like antagonism, time wasters, evasiveness, sympathy, glossing, and bribery and how auditors should address them.
FDA GMP Training - The Quality Audit
- 1. FDA GMP Training:FDA GMP Training: The Quality AuditThe Quality Audit Compliance Insight, Inc. 5850 Boymel Drive, Suite 1 Fairfield, OH 45014 513-860-3512
- 2. Terms and DefinitionsTerms and Definitions Assessment An estimate or determination of the significance, importance or value of something Audit A planned, independent and documented assessment to determine whether agreed upon requirements are met Compliance An affirmative indication or judgment that the supplier of a product or service has met requirements
- 3. Terms and DefinitionsTerms and Definitions Conformance An affirmative indication or judgment that a product or service has met the requirements of the specs or regulations Finding A conclusion of importance based upon observations Observation An item of objective evidence found during an audit
- 4. Terms and DefinitionsTerms and Definitions Quality Audit A systemic and independent examination and evaluation to determine whether quality activities and results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.
- 5. Purpose of an AuditPurpose of an Audit To examine the effectiveness of management directed control programs (or lack of directive) Provides management with objective feedback based upon facts, enabling management to make informed decisions Primary directive of an audit is to be beneficial to the function being audited
- 6. Audit PhilosophyAudit Philosophy Quality Audits are formal, systematic and independent Based upon facts Auditors must be fact finders (not fault finders) Audits should not be conducted in a covert manner
- 7. Types of AuditsTypes of Audits •Product Audit •Process Audit •System Audit
- 8. Type of AuditsType of Audits Product concentrate on one or more products or services Process concentrates on the results achieved as a result of the process System focus is on the overall quality systems which result in management directed activities and programs
- 9. Auditor Skills and ConductAuditor Skills and Conduct Important to success of audit Continuation of services Correcting problems Finding problems Skill development takes time (usually years) and dedication you will always be learning and adapting to new ways!!!
- 10. ProfessionalismProfessionalism Appearance dress to present a competent and favorable impression Punctuality don’t be late or excessively early Preparedness plan and prepare - safety, trade secrets, union policies Fairness be willing to make allowances for infrequent, insignificant human error
- 11. ProfessionalismProfessionalism Remain calm don’t over-react watch your demeanor don’t incite nor participate can nullify the audit Polite and courteous considerate and helpful “please” and “thank you”
- 12. ProfessionalismProfessionalism Direct and concise ask questions clearly make statements clearly may have to take time out to formulate response Recognize effort see that activities are on-going to correct observations make note in report
- 14. CompetenceCompetence Has to be developed and maintained formal training experience technical language skills verbal and written exposure to various processes and equipment assist in other audits
- 15. CommunicationCommunication Very complex process of sending and receiving messages/data Hidden messages that may be transmitted include anger, confusion, apathy, boredom, hostility, concern, contempt and fatigue These hidden messages effect the atmosphere positively or negatively Will have a direct impact upon the audit
- 16. CommunicationCommunication Ask the same question in a different way if you suspect something/or want to verify How do you clean the equipment? Ask open ended questions When you clean the equipment, you dismantle part A and then part B - Right? Ask other people not immediately present when the previous answers were given. Ask the same question the next day. Ask to be shown how to clean the equipment Verify what was conveyed to you with the SOP
- 17. Communication (cont.)Communication (cont.) Hidden messages can be intentional or not body movements facial expressions vocal intonations Once a message is received (intentional or not), it is impossible to “unreceive” it It is the auditor’s responsibility to be clear and understood with the messages sent
- 18. Communication (cont.)Communication (cont.) International obstacles Different cultures (Japanese often nod when someone else speaks. This should NOT be interpreted as agreement. This is only an acknowledgment that you are speaking. They may not have any idea what you are saying.) Interpreters Often lack technical expertise Regional dialects are also frequent barriers
- 19. Communication (cont.)Communication (cont.) Although communication is very important, an equally (perhaps even more important) and often overlooked skill is LISTENING
- 20. ListeningListening Not only to what is being said but also what is NOT being said Necessary to filter “external noise” from unfamiliar surroundings and activities Excess “external noise” may lead to lack of concentration, the loss of a thought, misplaced documents. Sends a very poor message
- 21. Listening (con’d)Listening (con’d) Non-listening Information overload Thinking about the last response or the next question Since a person can hear over 3x faster than one speaks in average conversation, it is very easy for the listener’s mind to wander
- 22. Listening (con’d)Listening (con’d) Good listening takes practice and concentration Paraphrasing is a good technique to test your level of comprehension and concentration
- 23. Listening (con’d)Listening (con’d) Four Types of non-listening behavior Defensive Listeners Listen beyond what is being said and often “reads” more into what is being said than what is spoken Often take offense when none was intended
- 24. Listening (con’d)Listening (con’d) Insensitive listeners Do not pay attention to non-verbals being communicated and may not receive the entire message clearly Communication hogs Talk constantly and say little, often repeating themselves. Often don’t comprehend returned responses when they stop to come up for air.
- 25. Listening (con’d)Listening (con’d) Pseudo listeners May exhibit appropriate listening cues (nodding, or “uh-huh”) but are not really paying attention Often indicates the listener is bored, preoccupied, or believes what you’re saying is common knowledge or redundant
- 26. IndependenceIndependence Auditors should not hold bias toward the department, operation or system which is being audited Should be NO monetary involvement or prior personal involvement Should have no influence from management Auditors should have freedom and trust to report audit findings with the knowledge that management will support the findings
- 27. ObservationObservation Requires attention to detail Analytical thought substantiated with objective evidence Includes: receiving messages have an inquisitive outlook notice the obvious and the obscure Need ability to “connect the dots” or draw the observations together
- 28. ObjectivityObjectivity Pertains to the facts as they are presented or found during the audit One’s personal bias and opinions must not be an influencing factor Auditor must have the ability to overcome personal beliefs and preconceived value judgments
- 29. JudgingJudging What interpretation of documents is correct? Do you need clarification? Is an observation outside the scope of the audit? Is it worthwhile to include? Is the level of compliance acceptable? Is the audit progressing as planned? Judging requires you to be open minded and aware of your own filtering system Don’t draw a conclusion until all the facts are in
- 30. Auditor ProblemsAuditor Problems “Come to the dark side, Luke” - Darth Vader
- 31. AntagonismAntagonism Must be prepared to encounter it and prevent it May be an attempt to end or nullify the audit It is crucial that you remain firm in the audit purpose and objective without engaging in argument Reassure the auditee that the audit is for the benefit of both parties Explain the purpose of the audit at the start, this will often prevent problems
- 32. Time EatersTime Eaters Auditee is talkative or long winded usually about subjects not pertinent to the audit Long lunches Waiting for data to be gathered Inform auditee of time frame Keep on track Ask for data to be pulled ahead of time
- 33. EvasivenessEvasiveness Usually one of two categories does not have the information does not want to reveal the information Evasive answers should be a red flag You have to listen carefully - pick out pertinent info or key elements Probe the response, continue to return to the original question until it has been answered Restate your understanding of the response (without the superfluous info)
- 34. SympathySympathy Human relations may interfer with the outcome Any question of integrity impropriaty will undermine the effectiveness of the audit Although the auditee may be someone you can empathize with, an objective audit is the best “gift” you can give After an unfavorable audit, financial allotments, and other support often become suddenly available to the responsible individual being audited.
- 35. GlossingGlossing “Glossing” refers to the last minute Band- Aid on a problem just before an audit Glossing will not hide neglected issues expecially of a serious nature Of course, last minute housekeeping is expected
- 36. BriberyBribery One of the oldest games in the book Usually occurs when a big contract is at stake Often does not involve the presentation of cash
- 37. Bribery (con’d)Bribery (con’d) Usually involves the auditee befriending the auditor and involves outside hours entertainment wining and dining sports game or concert On the few occasions when a bribe, especially money, is overtly offered, the audit should be immediately terminated
- 38. Tactics ChartTactics Chart Auditee Tactic Auditor Response Amnesia Verify availability of needed documents and then provide a reminder Bribes Refuse and report them. Advise client firm to deal with others. Cook's Tour Cut it short - stick to audit plan Extended Lunch Auditors can eat alone. Ask for substitute escort Goobledy Gook "Interesting, but the audit is my primary concern." Insincerity Ignore it. Proceed with audit. Language Barrier Prepare in advance. Provide a translator. No-Show Go to head auditee contact and ask for substitute escort Sympathy Ignore it. Proceed with audit.
- 39. Tactics Chart (con’d)Tactics Chart (con’d) Auditee Tactic Auditor Response Power Play State facts. Be professional, but firm. Provided Sample Refuse it. Take your own sample. Provocation Keep composure. Remain professional. Special Circumstances Take notes. Confirm facts. See if auditee keeps their facts straight Time Wasting Advise auditee that if progress remains slow, you will need to extend the audit.
- 40. ““DIMWYT”DIMWYT” Do It My Way, You Twit! Ego trip for auditor Rules by intimidation Blasts the auditee’s self esteem Remember the auditee is ultimately responsible for implementing corrective actions DIMWYT tends to be counter-productive
- 41. Auditor ResponsibilitiesAuditor Responsibilities Keep client informed of the audit progress Effectively lead audit team members Support, intervene and resolve conflicts Conduct a professional audit with a factual report that benefits the auditee Honor confidentialities of the auditee Internal audits External audits
- 42. Audit EthicsAudit Ethics Any auditor must remove themself from any upcoming audit that may be considered a conflict of interest Previous employer, Personal friendship Monetary involvement
- 43. Audit Ethics (con’d)Audit Ethics (con’d) The auditing group has a responsibility to the audit team to provide adequate training of the auditing function Providing retraining to hone skills Keeping auditors up-to- date with newest recognized standards
- 44. Audit Ethics (con’d)Audit Ethics (con’d) The auditor group has the responsibility to support the audit team and respect the authority and professionalism of their auditors.
- 45. For more help in yourFor more help in your training…training… Contact us at: 513-860-3512 www.Compliance-Insight.com Free consultation via phone info@compliance-insight.com