![Page 1: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/1.jpg)
Auditing 101
Practical Aspects of Auditing
Rick Perlman
13 October 2017
![Page 2: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/2.jpg)
Auditing 101
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
{Graphic}
![Page 3: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/3.jpg)
Autiding 101
• What is an audit
• Type of audits
• How does an audit fit the ‘big picture’
• Phases of the Audit
• After the Audit – What next?
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 4: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/4.jpg)
What is an Audit?
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
• A review of practices and procedures against an
accepted standard:
– 21CFR210/211
– IS02000
– ICHQ7A
![Page 5: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/5.jpg)
What is an Audit
• A dialogue
• A learning experience
– Auditor/Auditee
– Quality Systems
• A relationship builder
– Customer/Supplier
– Quality/Quality
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 6: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/6.jpg)
Types of an Audit
• Two main types
– Regulatory
– Customer
• Scope or Reason
– For cause
– Routine
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 7: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/7.jpg)
Audit Programs
• Compliance
• Risk Assessment
• Part of Supplier Management
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 8: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/8.jpg)
Auditing 101
• Negotiating Date(s)
– Send audit requests early
• Include proposed timeframe and number of auditors
– Be flexible
– Understand things may change
– Request travel recommendations
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 9: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/9.jpg)
Auditing 101
• Number of Auditors
– SMEs
– Trainees
• Audit Standards
– CFR
– ISO
– EU
– TGA
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 10: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/10.jpg)
Auditing 101
• Agendas
– Developed Early
– Communication Tool
– Sets Expectations
– Starting point
– List of Basic Documents
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 11: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/11.jpg)
Auditing 101
• Opening Meeting
– Introductions
– Scope/Audit Standard
– Agenda Review
– Auditee Presentation
– Auditor Presentation (optional)
– Audit Process
• Reporting
• Responses
• Close out
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 12: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/12.jpg)
Auditing 101
• Tour
– Observe everything
– Ask questions
• What is employee doing
• Why are they doing it
• What is the relevant procedure
• Assure understand of the question
– Take your time
– Look at Documents/Forms/Logbooks
• Compare to approved versions/master document
– Take lots of notes
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 13: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/13.jpg)
Auditing 101
• Document Review
– Start With Questions From Tour
– Pick Broad Systems
• Documentation
• Training
• Deviation
• Validation/Qualification
– Dig into system/documentation until satisfied
– Keep digging if you have questions
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 14: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/14.jpg)
Auditing 101
• Types of Documents
– Batch Records
– Master Plans
– Process Validation
– Equipment Qualification
• Water Systems
– Environmental Monitoring
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 15: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/15.jpg)
Auditing 101
• Record every document reviewed
• Ask for clarification/understanding
• Record who was interviewed
• Document, Document, Document
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 16: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/16.jpg)
Auditing 101
• Auditors Luck
– Trust it
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 17: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/17.jpg)
Auditing 101
• Observation Do’s
– Clearly communicate what requirement is not being met
– Cite examples
– Differentiate ‘one offs’ vs systemic issues
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 18: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/18.jpg)
Auditing 101
• Observation Don’ts
– Hide anything
– Personal preferences
– Argue
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 19: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/19.jpg)
Auditing 101
• Close out
– Daily for multiple day audits
• Positives
• Negatives
• Potential issues
– Final close out
• Thank Auditee
• Review each day
• Summarize observations
– Don’t categorize
• Review audit process
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 20: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/20.jpg)
Auditing 101
• Next steps
– Audit report
• Use as much ‘canned’ information that Auditee provided
• Level of background detail is dependent on previous visits and
changes
– Deliver draft
• Draft for review only, not for response
– Rate observations
– Final review audit publication
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 21: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/21.jpg)
Auditing 101
• Audit close out
– Review response
– Routine follow up on CAPAs
– Level of proof depends on observation rating
– Continued dialogue from audit
– Close audit when all CAPAs satisfied
– Communicate closure to Auditee
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 22: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/22.jpg)
Auditing 101
• Final thoughts
– Audits have a life of their own
– Build relationships
– Not antagonistic
– Auditees requests
– Keep things focused on issues
– Don’t trust your memory
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 23: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/23.jpg)
Auditing 101
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
![Page 24: Auditing 101 Practical Aspects of Auditingrube.asq.org/audit/2017/10/auditing/auditing-101... · Auditing 101 •Tour –Observe everything –Ask questions •What is employee doing](https://reader036.vdocuments.net/reader036/viewer/2022070901/5f496b4f58b2ce6b8b66e334/html5/thumbnails/24.jpg)
October 12 - 13, 201726th Annual ASQ Audit Division Conference: The Intercontinental
Addison
Questions?