Mentoring a New Internal Auditor
Offering a helping hand to beginners can ensure continuous improvement for years to come
Imagine, for a moment, a regulated medical-device manufacturing facility where employees freely share information that sheds light not only on performance strengths but also on weaknesses within, and among, organizational processes. Strengths, sure, but openly shedding light on weaknesses? Sounds like a nightmare situation for any manager, doesn’t it? Not really. Not if an organization’s leaders want to maximize the value that internal quality auditing adds to the company’s continuous improvement efforts, its overall quality system, and customer satisfaction.
Every organization has strengths and weaknesses that enhance or inhibit its effectiveness to provide goods and/or services. Indeed, in proactive organizations it’s these weaknesses that are the likely targets of continuous improvement efforts. Some organizations know what these targets are but don’t know how to hit them. Others know that there are targets out there somewhere that need to be met but don’t have enough process control to know what the targets are. Either way, thriving organizations know that their viability dictates that they constantly identify and improve upon weaknesses that could limit their competitive position. To do this, an organization has to create
an environment of transparency where weaknesses are on display for open problem solving without fear of finger-pointing or, worse, retribution.
It’s as simple as this: How can your organization get it right if it doesn’t know what it’s getting wrong? Ensuring that internal auditors—especially experienced auditors—endorse this concept is crucial to the effectiveness of a manufacturing organization’s internal auditing program. This is where the auditor’s information gathering, observations, and interpretations can add to the 35organization’s value. In essence, the internal auditor is the conduit between the organization’s weaknesses and its quest for effective continuous improvement, an effective overall quality system, and satisfied customers.
Having served as an internal quality auditor in the highly regulated medical-device manufacturing industry for more than 10 years, I’ve learned the training strategies that maximize one’s efforts to become an effective internal quality auditor. Competent and motivated people who enter the auditing field often sell themselves short. They’re unsure of themselves, intimidated, and lack confidence. This is particularly true in the Food and Drug Administration (FDA)-regulated medical device environment. Just hearing the term “FDA” makes many people shudder; it can be like hearing “IRS.” Both are nationally recognized regulatory bodies that can be intimidating because their respective authoritative reputations precede themselves.
As with any industry or field, the cornerstones of effective, value-added quality auditing in an FDA-regulated environment are objectivity, reason, and accountability. With this in mind, a lesson that experienced quality auditors should take to heart is to make the roles of mentor and protégé inclusive and participatory. Participation begets comfort, comfort begets confidence, and confidence begets competence. This positions the internal auditor to mine and interpret audit observations and findings so they add value to the organization through collective continuous improvement initiatives.
Check Points
✓ Even competent and motivated people entering the auditing field can be unsure and intimidated.
✓ The roles of mentor and protégé should be inclusive and participatory.
✓ Passing on the ideology underlying auditing can help new auditors maintain the organization’s standard of excellence.
✓ Experienced auditors have a responsibility for shaping an inclusive culture that encourages new people to participate in the quality system learning process.
✓ Observing and helping to shape the organization deepens the contribution of new internal auditors.
A matter of perspective
Ultimately, the ideological perspective an organization embraces regarding the strict documentation, process, and environmental manufacturing requirements of the FDA is a glass-is-half-empty or half-full proposition. Will the organization’s leadership frame FDA requirements as burdensome obstacles that must be overcome, or will it embrace the notion that such requirements ensure the corporate responsibility that can help drive standards of excellence that improve customer satisfaction?
Experienced, effective quality auditors understand that these standardized benchmarks are the result of a greater ideology at work, not just a set of oppressive requirements to be satisfied. Like other meaningful ideologies in life, the process of adhering to requirements must be ritually passed on through education and mentoring from one person and generation to the next. Over time, it becomes a way of doing business that appears seamless and effortless to customers.
Opening the auditing circle
I felt like a fish out of water during the first half-dozen internal audits I participated in. I’d worked in the organization for about year and had barely an understanding of the organization’s product line, operations processes, and organizational culture. Just two days of internal auditor training under my belt left me feeling like I’d taken a crash course in Greek and then been deposited on the streets of Athens to fend for myself. I wasn’t comfortable, confident, or competent.
A key lesson for more experienced quality auditors to consider when training inexperienced auditors is to understand the importance of education and mentoring as the foundation for training a competent auditor. Experienced auditors are often guilty of speaking in acronyms, jargon, and shorthand. This insular lexicon makes it difficult for inexperienced auditors to develop a confidence level as they learn their way. It’s not an inviting environment that makes new auditors feel comfortable or part of the team. When aspiring auditors become discouraged to the point of withdrawal or failure, it’s a reflection on us as experienced internal auditors and mentors, not them.
Why do we create this uninviting environment? In large part, it’s the unintended byproduct of working in a specialized discipline. Like engineers, lawyers, or software developers, quality auditors operate in a disciplined subculture that’s unique to our way of perceiving and tackling issues. This isn’t a bad thing. Indeed, we do this intentionally to bring professionalism, integrity, and ethical conduct to the quality auditing profession. We must realize, however, that this byproduct is an explanation, not an excuse. Experienced auditors have a responsibility for shaping an inclusive culture that invites and encourages new people with fresh perspectives and viewpoints from a variety of disciplines to participate in the quality system learning process and the continuous improvement process. In return, those aspiring auditors must accept responsibility for the charge they’ve been given. Serving as a quality auditor is serious business. Sometimes, deadly serious.
During my first three or four years of internal auditing, I concentrated on listening. I knew that resources both from colleagues and reading materials were available, but I was struggling to figure out how to tap them. When I sought out my co-workers for perspective and insight, they were generally helpful. My problem was individualized; I craved specific direction, such as that provided by a mentor. In retrospect, I can’t help but wonder how much my internal auditing development would have been enhanced by having an experienced auditor at my side who guided me along the way.
Not becoming discouraged too easily while gaining more quality auditing experience proved to be an asset for me. For many internal auditors, though, this may not be the case. They have “regular” duties and responsibilities they must attend to first. On some level, the organization must sell internal auditors on the value of the process to them as professionals. This is in addition to pointing out internal quality auditing’s positive effect on the overall quality system. The organization and its auditors must believe that internal auditing is every bit as crucial to the organization’s competitive position in the marketplace as its auditors’ “regular” duties and responsibilities.
The backstage pass
When training internal auditors, one of the key selling points for this glass-is-half-full ideology is the advantage afforded to internal auditors by virtue of their lateral and vertical exposure to the organization’s inner workings. As I was gaining valuable internal auditor experience, I perceived such exposure as an exclusive ticket to behind-the-scenes workings of the organization. Certainly, had I not taken on auditing responsibilities, I’d never have had such a “backstage pass” to the organization. Without realizing it, this dynamic experience allowed me to learn the interrelationships between organizational processes. As an internal auditor I was beginning to contribute to the organization’s pursuit of continuous improvement through observation and interpretation.
If handled properly, this backstage pass can be a beneficial, stimulating, and enviable ticket for the internal quality auditor to possess. It exposes the auditor to the synergistic effect that defines thriving organizations. This is a rare opportunity that few within medium and large organizations have. The internal auditor comes to understand how the organization functions as an organism that creates and produces outcomes greater than the sum of its parts.
Internal auditors are a crucial line of defense in continuously improving the organization’s competitive position and customer satisfaction. For the organization to reap the value-added benefits of the internal auditor’s contributions, both the internal auditor and the organization must pay attention to this mutually beneficial relationship. In other words, how best do I, the internal auditor, fulfill my commitment to the organization’s quality system needs and, conversely, how does the organization maximize my success as an internal auditor? Ensuring success in either direction starts with the organization’s top leadership.
Auditing against reality
In the FDA-regulated medical-device manufacturing industry or any other manufacturing industry, effective training of internal auditors requires that the organization perceive them as vital tools for measuring continuous improvement based on customer feedback rather than tools used simply to satisfy third-party requirements.
Does the organization say what it does, and do what it says? This simple question captures the essence of what it means to be an internal auditor. When I begin an internal audit with inexperienced auditors, I always encourage them to keep this question in mind as they undertake their work. The question demands objectivity, reason, and accountability on the part of the internal auditor.
Like so many aspects of the workplace, however, success or failure is largely dictated by interpersonal skills, and internal auditing is no exception. Knowing how to communicate with people will dictate the degree of success that an internal auditor will enjoy. Role-playing during internal auditing training is helpful in this regard. Have one person play the internal auditor while another plays the auditee who’s been asked to discuss the information being gathered by the internal auditor. It’s like shopping for a new car: You may love a particular car, but if the salesperson makes you uncomfortable, then chances are you’ll pass it up. Similarly, you may be the most knowledgeable and experienced internal auditor in your organization, but if you’re not able to put people at ease, you’ll get little or no information out of them. When this happens, the internal auditor, the auditees, and the organization all lose because no value is added to the quality system.
The role of interpersonal skills
Effective internal auditors must know what information to look for, have the critical-thinking skills to find and interpret it, and, above all, know how to extract this oftentimes uncomfortable and awkward information from their colleagues. Herein lies a unique challenge facing internal auditors that second- and third-party auditors may not have to overcome. Internal auditors are gathering information from people they must work with side by side, day after day. Their interview subjects aren’t new faces. For better or worse, internal auditors have established relationships with their auditees. This can be an asset or liability for the auditor, the audit goals, and the organization.
It’s the experienced auditor’s job to manage the audit with professionalism and creativity. Our charge as internal auditors is to observe, mine, and interpret the gathered information so that it adds value to the organization. This approach best serves the interests of the organization by ensuring that internal quality auditing maximizes continuous improvement efforts, the overall quality system, and customer satisfaction.
About the Author
Louis Boram is a medical-device production manager for Haywood Vocational Opportunities Inc., a manufacturer of custom medical drapes in Waynesville, North Carolina. He’s been a lead internal quality auditor for more than 10 years and has also been a certified quality auditor. He earned his MBA last year and lives in Asheville, North Carolina.
This article first appeared in the September-October 2007 issue of "The Auditor" www.theauditoronline.com




