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Listen and Learn: Develop These Soft Skills and Become a Better Medical Device Auditor

business women auditing employee

You’ve heard it many times before: “Great (insert any profession here) are made, not born.” The saying is especially applicable to auditors. Truly effective auditors seem to have an ability to effortlessly extract nuggets of good information from their interviewees. They know how to use certain techniques to dig deeper even when their subjects are less than forthcoming. While some auditors may find it easier than others to develop these soft skills, they are very learnable skills. Here are three tips:

1. Focus on What Is Being Said, Not What You Will Ask Next

The best medical device auditors are first and foremost great listeners. They are present in the here and now – listening intently to what is being said rather than thinking about what they will say next. They rely less rigidly on a checklist of planned questions and will follow clues in responses or things left unsaid. Really skilled interviewers pay close attention to adverbs including “typically” and “sometimes,” or the absence of detail. Not all listening is effective listening. You must listen from a mindset of curiosity, not courtesy. Don’t spend the entire time hearing but not listening by not making any eye contact because you are typing. While you obviously want to capture salient points in a discussion, keep your eyes off your keyboard as much as possible. That goes for your phone, too! Leave it out of sight and silenced. The moment you peek at a new text on your phone, you’ll lose your train of thought and, more importantly, send a signal to your interviewee that you are not interested in what they are saying.

2. Get Familiar with Your Subject and Their Position

Steve Jobs, former CEO of Apple, was famous for his meticulous attention to detail and preparation. Anyone who ever saw him on stage knows that he made presentations look effortless. In reality, Jobs invested many, many hours into preparation and did so because he knew the planning would pay off.

Whether you are conducting internal audits or acting as a third-party auditor, don’t just arrive with a canned set of questions. To the extent possible, take the time to get familiar with the devices produced by the company, the role of your auditees in the company, and recent company successes and failures before stepping foot onsite. Why take the time to do this? Once your auditees recognize that you are well informed about the company’s operation and their respective roles, you’re likely to get more transparent answers. Having a deeper insight will allow you to see through smoke and mirrors and gain a more accurate understanding of how the company is functioning.

3. Make Your Subject Feel at Ease

If you already have several years of auditing under your belt, you know that you should never use your position of “power” for intimidation. Your ultimate goal is to deliver an accurate assessment of company performance, and that can best be achieved by making your interviewees feel comfortable talking with you. If you’re not naturally a “warm and fuzzy” person, how do you do that? Again, by listening to and engaging with them. Take a few minutes to get to know your subject personally before beginning the audit. Lower your laptop lid and just chat for a few minutes like two adults meeting in a coffee shop. Without taking notes, ask them to tell you a little bit about what they do, how long they have worked for the company, how they got the job, etc. You’d be surprised how your interviewees will loosen up and the information will flow more easily.

Types of Audit Questions Used by Medical Device Auditors

Listening is a critical skill, but so is understanding which types of questions to use at what times during the interview. While many interviewees will be cooperative, forthcoming, and hopefully articulate, others will require some prodding. Understanding which type of question to use in specific situations will allow you to extract more complete information while maintaining trust. Here are some examples of question types and when to use them.



When and How To Use These Questions


Examples: Questions beginning with who, what, when, where, why, how many, etc. Used to get information or opinions.


When to Use It: Can be used successfully to test understanding of material presented or start a conversation.


Examples: Does efficiency enter into this picture? Is time the only factor involved? What about effects on the people involved? That’s a good thing right?


When to Use It: To broaden discussion and channel it along certain lines; for example, the interviewer suggests an answer and the group analyzes the result. Also used to introduce additional facts. Since this is often a yes–no type of question, it must be followed by factual or justifying questions.


Examples: How will your suggestions help? In what way will that solve the problem? Why can’t we do that?


When to Use It: To deepen discussion by having people analyze and justify their reasoning. To challenge old ideas and develop new ones. To avoid snap judgments. To find the real causes of problems. With this type of question, people use information learned to think out problems and draw conclusions or make decisions. (Most effectively used to follow up on responses to all other types of questions.)


Examples: Which solution is best?


When to Use It: To cause people to make decisions between or among two or more possible courses of action. In this case, a person must compare and evaluate suggested solutions and choose the one that seems best.


Examples: If this process had deviated from procedure, what would you have done to assess risk of change and why?


When to Use It: Use this technique to make a tentative assumption to draw out and test the consequences. Involves applying what has been learned to a possible situation.


Examples: We are all interested in how effective questions can aid us to be better interviewers, aren’t we?


When to Use It: To address the entire group, with no answer required or expected. Used to stimulate thinking, often at the start of a presentation.


Examples: What do you think John?


When to Use It: To ask one specific person. Can be used to test his/her knowledge or draw that person into the conversation. The person’s name should be used at the end of the question.


Examples: Which is more effective, an open or closed question?


When to Use It: To present two or more possible answers. People must give reasons to back their positions, yet understand the merits of both answers.


Examples: Are there any questions?


When to Use It: To ask the group at large. Used to stimulate discussion, obtain feedback, and give people a chance to ask questions. Open ended – not tied to a specific topic.

If you are doing things correctly, most of your auditees will be forthcoming and detailed. However, sometimes you will get the sense that there’s more to the story. In these instances, the uncomfortable pause is a handy tool to employ. It can be excruciating for both parties; we cringe at the idea of staring at one another without a word being said, and we are hardwired to fill that dead air. But silence is a technique that can serve you well, as famed journalist Jim Lehrer notes below:

“If you resist the temptation to respond too quickly to the answer, you’ll discover something almost magical. The other person will either expand on what he’s already said or he’ll go in a different direction. Either way, he’s expanding his response, and you get a clear view into his head and heart.” – Jim Lehrer, former PBS NewsHour anchor

One word of advice: use this technique sparingly. Silence invariably creates discomfort, which can frustrate the interviewee and make them defensive.

Expand Your Auditing Skills

Oriel STAT A MATRIX has trained more than 130,000 auditors and conducted thousands of quality system audits. We offer auditor training for ISO 13485MDSAP and EU MDR; our auditing experts are also available to conduct outsourced audits on your behalf.

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