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Rob Packard
Ship & Print Your FDA eCopy
December 2015
How to handle auditor ego and incompetencies
3 min reading time

This topic was submitted to my suggestion box from a colleague in Australia. For brevity sake, I’ll limit my comments here to ISO certification body auditors and exclude FDA inspectors. The basic approach is the same, but there are some important nuances. Maybe FDA inspectors will be a future blog…http://medicaldeviceacademy.com/blog/.

Auditor Personality
100% of auditors are a little weird (yep, takes one to know one). You travel for a living and tell people what’s wrong with their quality system. If you don’t start out drinking scotch, you probably will eventually. However, a little patience, understanding and over communication helps. For example, provide directions (that are accurate). Recommend a hotel (middle of the road, not the Ritz or a flea bag). Tell them about the corporate discount. Ask them in advance if they have food allergies (I’m gluten-free, and not by choice), and then try to remember not to serve only the things they are allergic to (yes, Panera Bread is a crappy choice but a gluten-free pizza is heaven). If Uber makes sense recommend it, because nobody wants to negotiate with Payless Rent-A-Car at 11:59pm.

Ego
Everyone has one. Auditors typically have a big one. I’m not shy, I’m smart and I love a good debate. If I’m you’re auditor, you’re lucky because I’ll admit when I’m wrong or make a mistake. Most auditors will not admit mistakes. In fact, the stronger they argue a point the more likely that they are insecure on the topic or that they have a personal preference that is a result of a bad experience.

Don’t ask them to prove it to you. Don’t ask them to show you in the standard. Instead, try reading Habit 5 by Covey (7 Habits of Highly Effective People). You need to be an empathic listener. The auditor doesn’t hate you. They might even be trying to help you. They also might be wrong, but try restating what the auditor is saying in your own words and try explaining why it’s important. This shows them that you were listening, you understand what they said and you understand how they feel about the issue. Pause. Then tell them how you were trying to address this issue.

Incompetencies
You don’t have time during the audit to retrain your auditor. Don’t even try. I do this for a living and we’re a stubborn bunch of orifices. Instead, try the empathic listening first. 99% of the time one or both of you is not communicating clearly. Either they can’t find what they are looking for, or they misunderstood what you were telling them. It could be a difference of interpretation, but it’s probably not. If it is, then say “We were interpreting that requirement as…”. Say this once. If they argue, let it drop for now.

Resolution
You shouldn’t just take incorrect findings lying down. Do your homework. Send me an email. Get help. If you’re right, then contest it at the closing meeting in a factual and persuasive way. If the auditor holds their ground, ask what the policy is for resolving disputes. This is supposed to be covered as part of the closing meeting of every audit. If your auditor is just lazy, sloppy and incompetent–request a new auditor. You might even disagree in writing, address the finding anyway and then request the new auditor. That shows the management of the certification body that you’re not lazy, sloppy or incompetent.

Caution
If you make a habit of disputing everything, your auditor will come prepared for war. You also will have little credibility with the managers at the certification body. Dispute only things that are justified and provide a written, factual justification that is devoid of all emotion.

PS – I just announced a CE Marking and 510(k) submission workshop to be hosted at University of Oxford on February 9, 2016:

http://medicaldeviceacademy.com/ce-marking-workshop-and-510k-submissions-workshop/

source: https://www.linkedin.com/groups/2070960/2070960-6077845574726537219

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Posted by Rob Packard
Asked on December 2, 2015 8:00 am
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Ginger Cantor Great post Robert!
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spot on..
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Larry Stevens, RAC Many of your comments are accurate. Of course why debate ones that might not be. In any case, the most important one I see is to not go head to head with any auditor and ask "where does it say that in the regulations" After all the auditor might be (almost always is?) right.
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Daniel John Very good post. It is always wise to side on the auditors comments till audit completion and can update our views if the discussed issue is raised as a minor/major deficiency. I always respond to minor/major deficiencies as it is, but also include my views with clear supporting objective evidence.
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It is a very good post. And very relevant one.
However, I disagree on "Don’t ask them to show you in the standard.". I think that is presicely what should be done. One time it saved my company 2 minor nonconformities almost wrongfully given by the auditor. There are a lot of interpretations the auditors are using as if they are requirements by the standard. If we start fulfilling each auditor's wishful thinking, we (1) are getting far from the standard and (2) on the long run may find ourselves fulfiling their requirements rather than regulatory requirement. In addition, the next auditor might ask for the opposite from the request of the previous one. I had this experience as well and have learned from it.
Of course, the ability to argue with the auditor strongly depends on the level of company/QA manager knowledge of regulatory requirements and experience of applying them.
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Michael Chellson, RAC To quote "The Captain" from the film "Cool hand Luke"..."What we have here, is a failure to communicate." Robert is absolutely correct his assertion that communication problems are the primary issue.
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Richard Reilly We do very well with our overall communications with auditors. I too have specifically pointed out items in the standards if we interpreted them differently, but we do it respectfully. Overall, we have had little to complain about there. Much of what Robert has said is how we conduct our communications throughout the audit.

On hotel, traveling expenses and food, there were a few things on one occasion that we were not happy with. The NB mistakenly scheduled the audit 1 day prior to the agreed dates and once notified of this, tried to charge us for the rescheduled airline fees. During the same audit we provided them (2 auditors)lunch for 4 days and the NB also added lunch charges on the final invoice. Once we notified them of these, they were removed from an already outrageous bill. Be well aware of the invoices for these services as well as traveling expense estimations.
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David Turner Robert, I really chuckled reading your commentary. Yes, I too enjoy a good single malt, and I also was a registered lead auditor (9001, 14001, QS/TS, AS) for over 10 years. I also admit to having a bit of an ego - I'm good at what I do and I know what works and what doesn't. But I also listen. In fact, I always told the clients that if I bring up what appears to be a finding, they should always talk with me to ensure we're all on the same page. If I've misunderstood something, I'll make the necessary adjustments. But that doesn't mean to challenge everything or to be argumentative.

One sure-fire way to get the auditor charged up is to attempt to hide the truth or the obvious. If one tries to snowball me, I'll start digging - and NOBODY wants the auditor digging. Be transpareent, especially if you know it's a weakness in your system. Many times I overlooked some minor defficiencies if there was evidence the client was already working on correcting the issue.
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