We’ve all been there as an Auditee – nervousness, anxiety, sleepless nights when we realize it’s that dreaded time of year – Audit time!

When taking an exam, what do we typically do beforehand - prep and study. These two items are key in facilitating a successful audit outcome.

What is a successful audit outcome: zero nonconformances, one nonconformance, five nonconformances (probably not!)? The answer is…it depends. Are these Major or Minor nonconformances? What is the risk to the end user? What is the risk to the business? Note – companies should always be in an “Audit Ready” state, however, this shouldn’t preclude you from putting in the study work prior to the exam!

Below are a few tips and tricks that will help to facilitate a successful audit outcome:

• Review all company Standard Operating Procedure (SOP’s), Work Instructions (WKI’s), Quality Manual, and Data Logs (i.e., CAPA, NMR, etc.) in advance of the Audit date to ensure they reflect current practice in advance of the Audit. If not – revise them prior to the Audit date. As Certification Body Audits are typically scheduled months in advance, there is no excuse not to perform this task. Remember, SOP’s should work for us and not vice-versa. Even if you have to revise a document a day before the Audit, the time of the revision should have no bearing on the Audit results, provided they show compliance.
• Never asked the Auditor “would you like to see this document”. They will always tell you what documents they want to see so there is no need to offer.
• Take detailed notes of the Audit for reference the following year. Many times, you will have the same Auditor for multiple years therefore you will already know the list of items they will request to review, which in turn facilitates a Successful Audit Outcome.
• Always review quality records prior to handing to the Auditor. This should be done in the back room or by the runner prior to bringing documents into the Audit room. This is very important to ensure you are only giving the Auditor what they request to review.
• Have a copy of the appropriated Standard (ISO, FDA QSR, AS9100, etc.) available so you can review the Standard if there are any questions that arise or nonconformities cited that you may not understand or agree with.
• Do not get annoyed with the Auditor. Maintain professionalism at all times. If not, the Auditor may consider you an “obstacle” to completing the Audit which will result in additional costs to complete the Audit at a different time with a different Auditor.
• If the Auditor allows you to “pick the quality records”, always provide the ones that will solicit the least questions. For example, if the Auditor asks you to provide five (5) Nonconforming Material Reports, stay away from showing the Auditor those with Use as Is (Concessions) dispositions unless specifically requested. If asked to present five (5) calibration records, do not show the Auditor those records wherein a piece of equipment may have been noted as “out of tolerance” in the as found condition prior to being calibrated.
• Do not be afraid to question the Auditor if something is not clear. Asking for clarification in advance is better than possibly giving the Auditor inaccurate information.

We’ve all heard the phrase “you only get out of it what you put into it” in our lives and Audits are no different. Do the prep work, study for the exam, and remember, a Successful Audit Outcome is well within your reach. Sleep well.