During the course of my 25 year career in QA/QC, I have hosted and/or participated in an estimated 70 audits. This includes both certification and customer audits. Over the course of those years, my approach has changed quite a bit. Early on, I would approach audits with angst and trepidation. In other words, I would dread them. But over the years, experience (and yes age) has changed that view, as I now see audits as tools for improvement. I’ve also come to realize that auditors are people too and not to be feared—especially since I have conducted many audits myself.
I have held numerous training sessions on how to handle oneself during an audit. I always tell the potential auditees to treat the auditor like a consultant. Ask he/she for suggestions and advice. Most auditors have seen both the good and the bad and are usually happy to provide guidance. Auditors generally want you to succeed and are typically not on a witch hunt.
It is important to remember that every auditor/audit is different. Unless you have been assessed by the same auditor, it is impossible to predict how it will go, as each auditor has a different style and areas of focus. In my case, when I audit a facility, I usually focus on the following systems: Corrective and Preventive Actions (CAPA), Document Control, Training and Equipment Control. Of course I look at other areas as well, but those to me are the basis for a solid quality system. Other auditors may take an entirely different approach by assessing a different collection of systems.
So regardless of the type/ style of the auditor, keep the following tips in mind:
- Always tell the truth! If an auditor feels he/she is not being told the truth, they will only dig harder and deeper. It can create a very nasty situation.
- If you don’t know the answer to a specific question, tell the auditor you need to reference the Quality Manual, SOP, or other document.
- Do not become combative, contentious, argumentative, or defensive! This will only create a negative situation and the auditor will always ‘win’. Again, the AUDITOR WILL ALWAYS WIN.
- Don’t become distracted. Remember that one deficiency does not mean the entire audit is a disaster. Get over it and move on.
- Answer only the question asked; do not ramble and provide more information than requested.
- Wait out the ‘pregnant pause’. Auditors will sometimes create awkward silence in order to extract information.
- If unsure of why an auditor finds an area deficient, ask for a reference to the clause of the standard. Challenge the auditor if you think personal bias in setting in.
- If an auditor asks for a specific record, retrieve it as quickly as possible. A long wait for records only creates suspicion.
- Keep in mind that auditors do not expect perfection, they are more interested in how imperfections are handled (e.g. was a corrective action report initiated? was an impact on quality assessment performed?, etc.)
So finally, try to shift your paradigm from looking at audits as negative events. Instead glean as much information and advice as possible and use it as a tool for improvement. Most importantly, RELAX!