Audit Survival Tips
1. Always Be Prepared: This is not just a Scout's motto to live by.
Don’t wait until the week of the audit to make corrections, change forms, or rewrite standard operating procedures. Auditors know when you have rushed to prepare the week before. If you are preparing, make sure you follow your corrective action and training process when implementing new things.
2. Listening and Communication Skills: Don’t say what you think an auditor wants to hear.
Always answer honestly. This does not mean you have to volunteer information. Don’t answer a question you don’t fully understand. It is ok to ask the auditor to repeat or explain in greater detail what they are asking. (P.S. It is also ok to refer to your SOP prior to answering! And more important – Tell the analyst that they can utilize their SOP as well! Sometimes people are nervous and they may forget a step.)
3. Respond to Findings Accurately & Timely: It is important to have a systematic approach to ensure your response is thorough and balanced.
Depending on the type of audit, you will only have 15 to 30 days to respond to the findings. A well-assembled response should include a full corrective action report, complete with root cause analysis, preventive action(s ), verification of effectiveness, timetable for implementation and verification and supporting documents and records. Follow your corrective action SOP!
4. Take Advantage of the Closing Meeting: Take advantage of this time to ask questions.
Assessors (3rd part auditors) cannot provide suggestions for ways to correct. However, this is your chance to clarify any findings and present any information that may have been missing during the assessment.
5. Follow Up From the Audit Findings: The top 3 audit findings are - Record Keeping, Method Deviations & Training.
- Record Keeping: All records should support the historical reconstruction of any result. The records should be traceable to the analyst, method, instrument (if applicable), reagents, standards, etc.
- Method Deviations: Make sure there aren’t discrepancies between the method and SOP - make sure analysts are actually performing the method as written in the SOP.
- Training: Make sure training records are accurate and up to date.
Contact a Labtopia Quality Expert today!