A 6 Step Approach if You Disagree With a Notified Body Auditor

My first certification audit experience is discussed and review six different approaches to take if you disagree with a notified body auditor.

My first certification audit ever didn’t go so well. It didn’t go well because the auditor wrote nonconformities that my boss and our regulatory consultant disagreed with. At the time, I was too inexperienced to know how to handle it. My boss and the consultant, however, totally lost it. I’ve never seen veins that big in someone’s forehead–even in cartoons.

I asked them both to leave the room because I feared to “push back” on the auditor. Many Management Representatives feel like I did during that initial certification audit. The best way to summarize our concerns is with the following picture:

Recently, another LinkedIn group member emailed me to say that they have seen several auditors for registrars identifying nonconformities that represented their personal opinions rather than specific requirements of the Standard. For example, there is a requirement to assign and document management responsibilities, but there is no requirement to have an organizational chart.

Another common mistake is when auditors insist that a company must create a turtle diagram for every single process. I support using turtle diagrams 100%, but the only requirement in the Standard is to use the process approach–not specifically turtle diagrams.

My favorite is my own personal mistake. I wrote a nonconformity for not having a process for implant registration cards for a company planning to ship a high-risk implant product to Canada. There is a requirement for implant registry cards, but I forgot that Canada defines “implants” in this case as only a very short list of implant devices–not implants in general.

Auditors are human. These are audit findings–not a jail sentence. Everyone needs to remember that the worst that can happen is that you receive a nonconformity. If the auditor finds a nonconformity, you must develop a CAPA plan. If the auditor finds nothing, you still need to do your own internal audits to identify non-conformities and continuously improve processes.

What Should You Do When an Auditor is Wrong?

I recommend you “push back,” but you need know-how. Many consultants suggest saying, “Can you show me in the Standard where it says I have to do that?” That’s just like poking a bear. If you do it once, it isn’t very pleasant. If you do it multiple times, an auditor might just eat you.

One Management Representative did that to me after I took the time to review the requirements with him. I responded by holding the ISO 13485 Standard in front of him and reciting clause 7.3.2. He replied, “Well, that’s up for interpretation.” I offered to recite the ISO 14969 guidance document for him, but his boss told him to shut up.

This certainly wasn’t the only time a client pushed back during a registration audit, but other clients have had the sense to argue about things they understood.

One of the clients I audited said he would change the topic to the auditor’s favorite sports team. That’s one approach. I’m sure that more than one client has taken the approach of asking me to explain where they can learn about best practices. I’m sure that they were somewhat successful. Another approach is to slide the lunch menu in front of them; I have only met one auditor who would not be distracted by a lunch menu.

6-Step Approach When You Disagree With an Auditor

1. Shut up and look it up (before you open your mouth, grab the applicable external Standard and locate the information you are looking for).

2. If you are still convinced that the auditor is wrong, then tell that you are having trouble finding the requirement. Show them where you are looking, and then ask them to help you find the requirement.

3. If the auditor can’t show you where you are wrong, or it appears that the auditor is interpreting the Standard as they see fit, then focus on asking the auditor for guidance on what they will be looking for in your CAPA plan.

4. If the CAPA plan the auditor is looking for is something you think is a good idea, then shut up and implement the improvements. If the CAPA plan is not acceptable to you, then you should ask what the process is for resolving disputes.

5. No matter what, don’t start an argument with the registrar. They enjoy it. They like a challenge and resent people who have less experience criticizing them.

6. If you still disagree with your auditor, then you should ask if the auditor can explain the process for appealing findings and follow that process.