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Inspection Readiness: “Do’s and Don’ts” for Audits

“By failing to prepare, you are preparing to fail.” – Benjamin Franklin

Audit Do's and Don'ts image

Such a simple quote, but so profound in its application. Preparation is paramount to any audit. An audit or inspection can be a painless event if you follow some very simple suggestions. The following is an outline of basic ideas and proposals to help you and your organization prepare and carry out a successful inspection of your business. Remember: if audits are productive, they provide you with free consultation.

What the Auditor Expects
  • Availability of appropriate people during the audit
  • Availability of documentation
  • Knowledge of regulations, and company SOPs that apply to you
  • Clear discussion on audit findings
  • Access to appropriate areas
  • QMS in place and followed
What Auditees Should Expect
  • Clear audit agenda and scope
  • Flexibility during the audit
  • Clear communication about the audit process
  • Clear communication about the findings
  • Questions about what, how, and why
  • Daily wrap ups

 

Behaviors (Do’s and Don’ts)

No matter what anyone says, your attitude and behaviors can shape the audit and the outcome tremendously. I’ve seen both bad and good – and good is the way to go. Below are some “common sense” things to do and not to do during audits that should be communicated to all that participate in client or third party audits.

Do’s
  • Seek coaching from immediate management and/or QA if possible
  • Tell the truth
  • Be honest and open to questions
  • Answer only questions that are asked
  • If you don’t know – say so
  • Answer “Yes” or “No” – don’t continue to talk if not necessary
  • Paraphrase if needed – clearly know what you are being asked
  • Host: take notes on all questions and answers; list all documents reviewed
  • Be consistent with your answers – inspectors take notes and compare
  • QA: stamp all documents that auditor takes with “Copy” and “Confidential”
  • Try to fix problems during the inspection whenever possible
  • Ask the inspector to repeat questions for clarification
Don’ts
  • Don’t argue
  • Don’t speculate, guess, or make stuff up
  • Don’t keep talking – just answer the question – don’t even explain it unless asked
  • Don’t answer “open-ended” questions if possible – if you do, be specific
  • Don’t bring anything into the room unless asked
  • Don’t bring the “whole binder” – just what was asked for
  • Don’t take anything personally
  • Don’t lie
  • Don’t panic
  • Don’t sign affidavits (written sworn statement of fact)
  • Don’t cry! “There is no crying in audits.”

 

 

 

 

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Michael Brooks

Michael Brooks

Senior Quality Scientist at BioConvergence LLC
Michael is an auditing professional with extensive experience specializing in regulatory compliance. Michael’s experience includes compliance with Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs), and ISO 9001-2008. He is in expert in the System Development Life Cycle and has performed programming/coding standards audits including third party data analysis and data management software suppliers and CROs. Prior to joining BioC, he held positions at AIT Laboratories and Eli Lilly and Company in various roles.
Michael Brooks

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