Annelies Tjebbes

Medical Device Internal Auditing – Making Friends with “Bad News”

Internal Audits are vital in medical device development, but the results of an internal audit are not always the easiest to hear.  Depending on the level of depth that an internal audit goes into, the results and feedback can seem nit-picky and extremely negative.

If this resonates with you, and you too fear  the letters NC (non-conformance), you are not alone.  Given that a simple Google search for “how to receive criticism” returns 363,000 results, it is apparent that quite a few people struggle with accepting scrutiny and feedback.   Often times internal audits are based on a daunting checklist that picks apart the documentation of your project.  It can seem overwhelming in its detail and instill a fear of what appears to be a mountain of documentation ahead of you.

When you break it down though, the goal of internal audits is to ensure that you keep organized records, get sign off on your documentation, and keep documents up to date.  All good things right? Even though we might not be very skilled at receiving criticism, it can be of huge value to improving processes and productivity.

In order to fully unearth the value of an internal audit there are three myths we need to dispel:

1. Paperwork is getting in the way of my productivity.  

Have you ever walked to the office supply room to get something and by the time you get there you completely forget what you were looking for?  The brain is easily distracted, and without records, things that seem crystal clear in your mind today will surely be blurry when the 5 year documentation retention period is up.  Well organized documentation shows professionalism in addition to helping you keep track of important information.

2. The internal auditor is out to get me! 

It is important to set your defensiveness aside for a moment, and understand that this audit is for your own good; The auditor is on your team!  An internal audit is a much better place to get a non-conformance than in an external audit, and this audit is a great prep to ensure that all of your documentation is in order before going into an external audit.

3. I feel just like I’m back in grade school, with every red pen mark a slap in the face

Framing this as a purely negative evaluation process is going to make it feel like a grade school exam.  If instead you can view it as an opportunity for improvement and an opportunity to showcase the hard work you have put into your project then this will help to remove the stigma around it.

If you have successfully been able to put aside these myths, here are a few useful tips to get the most value out of an internal audit:

1.  Review the checklist the internal auditor will work though.

This will give you a sense of where you are at and what you are in for in the audit.

2. Gather together all of your documentation in one place.

This will help simplify the audit process, and will eliminate the embarrassment of rooting around on desks and in drawers to find that one rogue document during the audit.   

3. Have a plan of action for how the internal audit will translate to action   

Many companies have CAPA (Corrective and Preventive Action) programs to deal with audit findings and observations.  It is important to make good use of the recommendations made since they will help to improve your projects/processes and you will be able to apply what you have learned in your future work.

No longer do you need to fear the red pen, you can go into an internal audit excited to learn and improve your processes.  An internal audit will help you pay closer attention to detail in your project organization in future, and will hopefully open your eyes to the benefits of documentation.  On a more tangible note, thorough and well organized records will dramatically ease the stress of otherwise painful and lengthy 60601 edition 3 and technical file submissions for medical device approval.


4 responses to “Medical Device Internal Auditing – Making Friends with “Bad News””

  1. Great article! I’ve seen ISO audits make people lock themselves in their offices or call in sick on audit day. Too bad they hadn’t read this.

  2. Annelies Tjebbes says:

    Hi Paul,

    Thanks so much for your comment. I know what you mean about people being so worried about audit feedback that they go to great lengths to avoid it.

    In your experience are there any other tips you would add to this blog?

    Take care,

  3. Gilbert says:

    Financial internal audit is a very positive process once you understand how it works. The company int auditor looks at history to check for compliance to company int control policies and adherence to accounting principles. Findings can seem negative because they represent things that are not functioning as they should. But the reason for doing it, is to recommend positive changes from those findings to correct the situation for future operations. There’s no blame for past activities; it’s all positive future-oriented. Auditees usually pick-up on this fact pretty quickly, partly because they want to avoid blame (but there’s none going around).

    The one big exception is fraud or similar activities caught by the int auditor. This role is important but only applies to thieves anyway and not honest employees.

  4. Annelies Tjebbes says:

    Hi Gilbert,

    Thank you for your comment. I completely agree that the internal audit process is not one that is meant to inflict any blame, but rather is intended to focus on positive changes that will improve operations. I wonder if there is a way to get the employees/employers that Paul Jackson was mentioning (who will do almost anything to avoid audits) to understand the positive nature of this process. Any suggestions?


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