Richard Meagher, PhD
Richard C. Meagher, PhD, is the Section Chief of Cell Therapy
Laboratory Services at Memorial Sloan Kettering Cancer Center in New York, NY. Although Dr. Meagher is a research scientist
by day, he is also a FACT inspector, and has been since the inception of the
FACT accreditation process. He performed his first inspection in the year 2000,
and has since completed 48 inspections (or an average of 3 inspections a year). In addition to volunteering as an inspector,
he is a co-chair of the FACT Cellular Therapy Processing Facility Standards Committee
and a member of the FACT Cellular Therapy Standards Steering Committee.
Becoming an Inspector
Dr. Meagher was motivated to become a FACT Inspector for the
educational experience. He has visited a
variety of programs both small and large with an amazing degree of
heterogeneity in complying with the Standards.
Given the experience he has gained as an inspector, programs in turn
frequently ask for his help to achieve compliance with the Standards. The following are additional benefits and
advantages Dr. Meagher believes FACT inspectors enjoy:
- Involvement with FACT helps inspectors remain
current with the regulations and provides ideas for complying with them.
- Inspectors’ own programs benefit from their gained
- Inspectors have many opportunities to meet their
peers and form new relationships.
- FACT provides an incredible amount of support to
inspectors free of charge, such as webinars, advice and recommendations about laudable
practices, and the online FACTWeb accreditation portal.
If considering whether to become a FACT inspector, Dr. Meagher says, “Just
do it.” He believes the benefits and rewards of becoming an inspector far
outweigh the time commitment spent preparing for and conducting an
inspection. “You will become much more
knowledgeable about the Standards, how to implement them, and how to
successfully conduct and/or pass an inspection.
Remember that your responsibility as an inspector is to help improve the
program and correct or modify identified deficiencies. The inspector experience teaches you very
quickly that your peers are looking for help to improve; as an inspector you
provide that help. “
Advice to Current Inspectors
Dr. Meagher is one of the most experienced FACT inspectors. Given the
number of inspections he has performed, he has a lot of advice to offer current
- Use the tools that FACT provides to you and
certainly take advantage of the collective knowledge of the FACT office staff,
which is exceptional.
- When requested to perform an inspection, it is
important to do your homework BEFORE you show up for the inspection. In the new
electronic age it is easier than ever to conduct a full review of the
documentation that is initially required by the FACT office prior to the
- Use your inspection preparation time to identify
issues that will need further clarification, and, if necessary, request
additional information before conducting the inspection.
- Use the previous accreditation reports to help
guide your current inspection, with an eye on new or revised standards that may
have been released.
- Establishing a cordial atmosphere is critical to
conducting a successful inspection. The
inspected program or facility personnel will likely be nervous. Assure them
that your responsibility is to help.
- During the inspection it is the inspectors’ responsibility
to ask questions to clarify any perceived issues. A useful tactic is to ask the question from
different perspectives to make sure the program personnel understand what
information you are seeking.
- Examination of the quality management plan and how
it is implemented lay a foundation for assessing compliance with the Standards.
Advice to Accreditation
- Starting the preparation process for an on-site
inspection early is the ultimate key to success.
- Check for applicable new or revised standards and
conduct a gap analysis to determine which standards apply, and whether you have
documentation to substantiate compliance.
- Assemble a binder with the applicable standards indicated
and the corresponding documentation.
- The inspection process is normally only a one day
event. Making sure that the inspector has all of the information needed to make
an informed recommendation for accreditation rests with the program or facility.
- Commonly observed deficiencies are related to communication
among personnel across departments and quality management activities.
FACT is incredibly grateful to Dr. Meagher’s commitment to FACT and the
organizations he has served as an inspector. We encourage all inspectors to
greet FACT inspections with the same enthusiasm he displays.