While Kai-Lin was ambling along a crowded sidewalk, the breeze whispered, “You’re scared and cannot do this.” Kai-Lin, an evolving leader at the fictional medical device company, Mythical Medical, overheard this as a cruel, merciless, penetrating scream, not a weak, pathetic, faint murmur. She needed help to prepare for an upcoming audit and contacted me shortly after that.
The first time you prepare for an audit, it stimulates your private, rarely apparent insecure behavior. You find yourself with hallucinations of being hopelessly and woefully inadequate. Never let your insecurities limit your potential.
On the one hand, you have delusions of sound, fundamentally euphoric ideas that convince you that you can handle it, no problem. These debilitating symptoms blur the line between what is real and what isn’t, making it difficult to enter the audit room; unless you prepare in a simplistic, unsophisticated, rational, and unneurotic manner.
There are two rooms. One is the backroom where employees and consultants gather to create strategies and gather documents that the auditor wants to see during the audit process. There are processes in place for the back room, but for this exercise, we will focus on the other room—the audit room where the auditor is.
Let’s Keep It Simple
My first audit training session with Kai-Lin would set the stage for future success. I was unsuspecting then how easy it would be for her to go off script once a relaxed, comfortable environment was created in the audit room.
Whether it is responding to an audit required for (i) pre-approval, (ii) routine surveillance, (iii) compliance follow-up, or (iv) for-cause, this four-step, 15-minutes each preparation process can chill and soothe the hot seat that is waiting for you in the audit room.
To set the stage, we needed a technique to stay in character, but be flexible to go out of character when urgent teaching points came up. I would lay a Montblanc ballpoint pen on the table that signified, in character. I would reach out and take it away as the signal to go out of character. A simple visual.
Be An Active Listener
Speak less, listen more. Some people are just born to be active listeners. Unfortunately, most need to learn this skill. Kai-Lin was not the exception. She excelled at partial listening, lack of interest, and deep-rooted beliefs, but rarely showed pre-judgment, intolerance, or negativity towards speakers. I needed to address this before the real four-step training started.
The pen went down to the table. “Can you tell me your name?” I asked. “Kai-Lin Liu,” she said confidently and with an air of assertiveness.
I picked up the pen. “That was actually a yes or no question,” I replied. As an auditor, I had not asked her to say her name. What followed was a brief conversation that would transform her into a recognized, influential leader within the audit room. To drill that point firmly into her brain neurons, I started every four-step audit training session with that simple question. Kai-Lin needed to actively listen to every question and only answer the question. Stay in your lane and speak to what is relevant to your job responsibilities. This was not the time to develop a relationship or bond with the auditor. We discussed how to introduce herself at the appropriate time and to properly exchange business cards. Although there are other active listening skills to learn, during an audit just answer the question. No more.
Lesson #1 – Do you understand the issue you are being brought in to discuss?
I explained to Kai-Lin that this would be four simple lessons, but that she would have to pass each before being allowed to the audit room. The first session focused on do you know the audit exception you are being brought in to address. Sometimes there are no exceptions, but the auditor wants to understand certain procedures that are in place. A very common audit question is, “Please tell me in your own words about this procedure.” Procedures or Standard Operating Procedures (SOPs) are approved documents that can be brought into the room. It is a best practice to point to a figure (or two) and within two to three minutes highlight the essence of the SOP. If an exception was found that you are being asked to address, now is the time to briefly and factually state the exception along with the results of the investigation. This is not the time to be defensive or point fingers. The popular, widespread BLAME GAME should never be played in the audit room.
I reminded Kai-Lin that she would leave each lesson with a homework assignment. Practice on your own. Once you are confident that you know and can articulate why you are being brought into the audit room, lesson #2 can begin.
Lesson #2 – Do you believe it?
Each session began with a brief role-play of the previous lessons. This lesson is to wrestle, struggle, and grapple with what was done or written that the auditor knows about.
This may seem like a simple, obvious next step, but it profoundly can affect the outcome of your meeting. There are times when you cannot get there, and you will need to be a good corporate citizen, within the law, of course, and you will have to confidently convey that the internal investigation that was performed was correct and all the right steps were taken for you to believe it. If you cannot pass this step, you should not be taken into the audit room. I saw the challenge that she accepted. Kai-Lin wanted to be in the audit room and would do her homework assignments magnificently. She was brilliant and a perfect student.
Lesson #3 – Do you have and know the evidence?
The third, 15-minute meeting with Kai-Lin was to assess whether or not she had the actual objective evidence necessary to address the exception (or to show how the SOP is working). This simply will come with putting in more time to understand the evidence presented to the auditor. There are a number of thinking moves that are integral to developing knowledge and understanding. Although the training was for Kai-Lin, anyone in her organization could follow this audit preparation coaching. She paused and mentioned others on her broader team that could benefit, and we set up times for several members to participate.
The top three thinking moves that Kai-Lin needed to learn were (i) making connections, (ii) considering different viewpoints, and (iii) forming convincing conclusions based on the evidence. I mentioned to Kai-Lin that there are three places to go to in order to pass this lesson. First, be by yourself and ponder the evidence. Ask tough questions. Challenge yourself privately and then verbalize what the evidence is suggesting. Second, gather your friendly colleagues and present to them. Ask them to poke holes in your thought process and reasoning, but verbalize your responses to your friends. Finally, identify “the critics” within the organization and practice with them. This will naturally cause conflict, so don’t take it personally. Obviously, it is hard not to take it personally. I reminded Kai-Lin that it is better to make mistakes and be vulnerable outside the audit room. She should look at this as a “gift” that was being given to her.
You likely will need to uncover complexities you did not think about, going below the surface of things you thought you knew. After her voyage or journey to those three locations, when challenged, she should be ready to pass this lesson.
Lesson #4 – Can you put it all together?
We briefly reviewed all the previous lessons during our in character, pen on the table session. Kai-Lin was dazzling. She was well on her way. Then, we began the last session.
The purpose of this meeting with Kai-Lin is to evaluate if she could “in the moment” in front of me, the “mock” auditor, speak confidently as she describes the exception (or the SOP), verbalize and agree to what was done, and then speak to the evidence that supports it. This could be considered the final exam.
During this final session, we reviewed all four questions and Kai-Lin had all the talking points down. An element here that I threw in was what I refer to as curve balls—trying to distract or shake her. I wanted Kai-Lin to remember to stay in her lane and to speak only to areas that she was directly responsible for. It’s okay to say, “That’s not my area.”
I rattled off likely questions that she should not attempt to answer:
(i) How many critical suppliers do you have? Quality owns this in Mythical Medical, not your department.
(ii) How often do you audit your critical suppliers? Quality determines this, not you.
(iii) Is your supplier of X (solution or material supplier) a critical supplier? Quality does this, not you.
(iv) How does Mythical Medical process invoices? Procurement and finance take this question.
(v) How do you determine the selling price of your device? –They should not be asking this.
(vi) What international standard was followed during the development of X product? Bring R&D in for this one.
(vii) Can you speak to the sterilization methods that are used? That’s for the manufacturing engineers to address.
I thought this last piece of training was useful and reinforced the point to ensure Kai-Lin stayed in her lane in the audit room. I would be proved wrong.
The day of the audit
The day of the audit came and there was excitement and expectations in the backroom as preparations were being made. The usual opening meeting occurred flawlessly with introductions and reviewing the upcoming agenda. Then, the meeting was closed and employees were being escorted from the backroom into the audit room per the agreed-upon schedule of events.
Kai-Lin’s turn came and we all had confidence in her, although this was her first time to actually be in the audit room in front of an auditor. She was there for almost an hour doing remarkably. Extraordinarily, actually.
But then, the sly, sneaky auditor, still plagued by an unresolved issue previously noted within another department, asked her about the process for selecting suppliers. Kai-Lin’s department used suppliers. A legitimate question, per se. What followed was a sincere, but inaccurate answer. “We change suppliers all the time. We cannot keep up with them. Sometimes I wonder how they stay in business.” She smiled and let out a very brief, quiet chuckle.
The backroom was monitoring the audit room. Several leaders and the majority of employees gasped, sneered, gulped, and were taken back.
The somewhat reserved, organized audit preparation machine just went off the tracks as Kai-Lin left her lane and represented another department and their processes inaccurately.
The birth of a crisis with the all too familiar calamity had just occurred, and Kai-Lin was completely unaware as she left the audit room. The BLAME GAME had just started, outside of the audit room, and there were more than enough players ready to participate.
Auditors are trained to do their job and that job was done today. The clever, devious, scheming auditor had another “rabbit hole” to go down in order to find more facts that just did not seem to be adding up. A previous employee had been interviewed, and the evidence the auditor had before him was not consistent with what he heard. The frequency of new suppliers being brought on board at Mythical Medical might just explain the auditor’s suspicions about the facts. The auditor, now acting more like a purebred bloodhound, had just found the proverbial scent that had eluded the audit trail up to that point.
Kai-Lin comes back into the audit backroom
What happened to Kai-Lin today can be fixed. There were so very many things that she did correctly. In fact, she was a model employee as she prepared for the audit. Yes, she learned about staying in her lane during an audit, even when the auditor, doing their job, tries to disarm you to obtain more, not so readily apparent, information.
When the closing meeting occurred, the auditor pointed out a major nonconformity that was discovered. There was a lack of quality control over Mythical Medical’s suppliers in general, critical suppliers specifically. Several employees privately singled out Kai-Lin as the reason the auditor discovered that major nonconformity. It crushed Kai-Lin. She felt like she let down the organization. She was heartbroken. There may have been tears. But, had she let Mythical Medical down?
During the chaos in the backroom, the President of Mythical Medical stood up and looked, with a laser-like focus, around the room. Senior leaders know. Mostly they know from experience. What was said that day, set the company towards a path of greatness that few companies experience. In those companies, it seems to always start at the top.
“It’s been a long day. We will get through this together. Here at Mythical Medical where you can be anything, let’s be kind today. Kai-Lin, I know how you must feel. I have an embarrassing audit story for you and the rest of the team. You all need to hear it, but let’s get through this audit. I became a better leader because of it, and you will too, Kai-Lin. We have a lot of work yet to do. Tomorrow morning, we have two choices. Go back to sleep and dream, or get up and catch your dreams.”
That extra glance given to Kai-Lin would become an invitation to destiny.
There were a lot of discussions and assignments made. Kai-Lin, as in her nature, stepped up and became part of the solution. The audit eventually ended many months later. Mythical Medical was a stronger, more grounded company.
Sometimes there are people that can relate, in fact, even connect in moments of failure. They know that an expert in anything was once a beginner. No matter what happens, life goes on with new opportunities on the horizon. Although unknown to Kai-Lin, opportunities to continue to grow as a leader were already set in motion but remained unrevealed, hidden to her.
Final Thoughts
Audits and inspections occur all over the world. These four, simple audit training steps can easily be implemented in your organization. Global Strategic Solutions, LLC, has the expertise to assist you in preparing for upcoming audits. If your organization is preparing for EU MDR audits, here are three additional secrets for a successful audit readiness plan.
David R Rutledge, Pharm.D., FCCP, FAHA, President & CEO, Global Strategic Solutions, LLC, Silicon Valley in California.
+1 (630) 846-0350 cell.
Disclaimer:
This is just a bit of fun. The purpose of articles like these is for the free exchange of questions, ideas, or comments regarding issues of global interest involving medical regulations. It is not to be considered legal advice. These are just opinions and not advice; opinions may change over time, too. Use it at your own risk. This disclaimer will occasionally be posted or updated throughout the year.