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Are You Prepared for Your Next Customer Audit?

by Bob Lucchesi

Welcome to my first in a series of auditing blogs. I hope you find them interesting, useful, and sometimes entertaining, because if you are like me, I am bombarded with information surrounding the Life Sciences industry and I am always seeking relevant information to aid in my career. First, allow me to introduce myself. I am a long-time consultant who has spent the majority of his life helping customers with a variety of both complicated and not-so-complicated problems and issues in the areas of compliance, regulatory, validation, and all things Pharmaceutical, Medical Device, and Biotech. I also play in a rock cover band, and have been doing so for years. My broad-based background, keen insight into industry trends, the variety of clients I have worked with, and my reputation in the industry should hopefully serve well to ensure that what I am saying is real, relevant, and most critical – important to you! I like to weave stories into my blogs, so I hope you enjoy and welcome to my world.

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The American Society for Quality (ASQ) defines an audit as “…the on-site verification activity, such as inspection or examination, of a process or quality system, to ensure compliance to requirements. An audit can apply to an entire organization or might be specific to a function, process, or production step.” I define it as a pain in the behind, but lo and behold, there are ways to prepare for these audits to make them as painless and efficient as possible. Statistically speaking, I have found that over 90% of my audits contain some type of failure. So even the best preparation will probably not prevent a completely “clean” audit, but it should significantly reduce the number of findings. And to be clear, these findings are typically not “show stoppers.” Over the past 6 years, I have only had 3 audits where the findings were critical enough to cause my client to cease from using that vendor’s services. And to be even clearer, I am NOT one to use a checklist and then consider the number of findings as the basis of a good audit. I have had a few audits with absolutely no findings or recommendations.


That said, the first thing you need to do to prepare for an audit is get your own house in order well before audit requests come flooding in. If you have recently added a functionality to your core business and it’s aligned with your sales and marketing activities, then there is a good chance you will be hosting audits for those customers that will be using these new services. But along with this is the simple fact that you will most likely be audited by your current customer base. You should already know this based upon experience and history. But as your customers evolve into more mature external qualification programs, there will be an increasing number of audit requests. I dealt with one client who made one simple change to their portfolio that caused an increase of vendor qualifications by over 60%! If you have a history of audits from one particular customer, look at their frequency. If they are on a two-year cycle, then there is a good chance you will continue to be audited every two years. Sounds simple, right? But you will be surprised how many firms I contact requesting an audit that are shocked to hear from me! Why? Because they are either not prepared, or there is someone new in that position. Since 2010, the turnover rate for the Life Sciences sector–quality, in particular–has jumped about 6% to a staggering 19%! If you are new to your position and responsible for hosting audits, then please do your research when you are hired. Know what to expect for the upcoming year.

The other most glaring area that I see that results in unprepared audits concerns the agenda. I recently sent out an agenda to a vendor requesting very specific items, including a list of documents for me to review. Upon arrival, there were no documents staged and the host took all morning to find what I requested. Finally, at noon, I gave up and informed the auditee that I was coming back the following morning, and proceeded to write several things I needed to see on the white board. I told the person that if I did not have these when I came in, that I would recommend to my client that they stop using their services because they failed to comply. When I came in the next morning, there was a stack of documentation on the table. Apparently, the host spent the entire night gathering this, which could have been avoided by taking the agenda seriously! So do yourself a favor and pay attention to the agenda. Don’t think that what YOU want to give an auditor is what THEY want.

Other areas of preparation include conducting internal or mock audits, research everything pertaining to your customer (recent complaints, history of purchases, interactions with other departments), and notifying other departments of the audit. This last one always fascinates me in that so many times I ask to speak to other departments (environmental monitoring, laboratory, warehouse, and others), and the personnel seem surprised that they have to answer questions from an auditor. A trick I always use with my customers is to have a flip chart or white board available in the conference room, and write down everything I need to see that day. If this is done fairly early on in the process, then affected departments can be notified and ready by early afternoon. Trust me, this works! And it keeps the auditee and the auditor on the same page. I really do not like keeping people from their jobs and keeping them after hours. The worst part of an unprepared audit is to review the action items at the end of the day and realize that you still need to provide a litany of items! Don’t be that auditee!

Okay, I’ve kept you from your job long enough…more next time!



About the Author

Bob Lucchesi 3Bob Lucchesi is the Vice President of Global Regulatory Compliance, Quality Assurance and Auditing at USDM Life Sciences. Bob offers nearly 30 years of experience in quality assurance and regulatory compliance in pharmaceuticals, bio-tech, medical device, engineering and nuclear industries. Bob has led audit teams for Quality, mock FDA, policies and procedures, Part 11, NIST, supplier-vendor (internal, external, sterile, non-sterile, manufacturing, logistics), mock recalls, and major life sciences assessments. Bob is also an expert in risk based validation methodologies, GAMP, enterprise content management, data and content migrations as well as overall pharmaceutical and medical device regulatory issues.

About USDM Life Sciences

USDM Life Sciences is a global life science and healthcare services company, providing strategy and compliant technology solutions to regulated industries. If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easy to accelerate innovation and maximize productivity. USDM Life Sciences only focuses on regulated industries and has built trusted partnerships with the most innovative technology companies in the world, and boast a staff of industry leading experts in the areas of technology and compliance.



  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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