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.
…
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. Pretty obvious, right? 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!
OK, I’ve
kept you from your job long enough…More next time!
About the Author
Bob 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.
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