Effective Follow-up Strategies to GMP Training
David C. Markovitz
President and Founder – GMP Training Systems, Inc.
The ultimate measure of the effectiveness of a training process is its
positive impact on the performance of a business. Viewing training as an
ongoing process rather than as an isolated or periodic event helps ensure
that training will have a positive impact. Very often, participants of a
training session complete the session excited and enthused. Interest drops
off rapidly if management shows no or little interest in sustaining the
drive to keep GMP alive, making GMP a Lifestyle within the organization.
That’s why effective follow-up is crucial to making your investment in
training pay off.
Successful training consists of three important phases; Planning the
Training, Conducting the Training, and Effective Follow-up after the
training. This article addresses the third phase - Effective Follow-up.
Planning the Training was addressed in an article in the April 1999 issue -
Practical Preparation for Effective GMP Training: 6 Steps to Success.
Conducting the Training was addressed in an article in the July 1999 issue,
Conducting Effective GMP Training: Do’s and Don’ts for Success.
Training should not stop when a training session is complete. A follow-up
strategy or strategies should be developed to reinforce what the
participants have learned. This article will explore several proven
techniques for ensuring that the training conducted will have the desired
impact.
Training as a Process
First and foremost is to view training as a process. Many organizations use
the term “Training Program.” This in itself is limiting. The word program
usually denotes something that has a start and a finish. A process, on the
other hand, is generally regarded as having no end. It’s like a river,
flowing constantly. You may call that river by the same name every time you
see it, but there’s different water flowing down its banks. Like a river,
our training process can be comprised of an ongoing series of programs or
modules. Each of these programs or modules can be developed, delivered, and
documented. Consider the “c” in cGMP, which stands for current. The GMP
regulation itself is open to interpretation and is constantly being
reevaluated. We must strive to keep our GMP training process current. The
cGMP 21 CFR – Part 211 (cGMP for Drugs) states that “Training in current
good manufacturing practice shall be conducted by qualified individuals on a
continuing basis and with sufficient frequency to assure that employees
remain familiar with cGMP requirements applicable to them.”
“On a continuing basis and with sufficient frequency” is included to ensure
that we not only stay current with the law, but also share that new
knowledge with everyone in our organization, where it applies to their jobs.
This means that we have some translation to do. The interpretation of “on a
continuing basis” is fairly clear. It is generally meant to mean that an
employee will be expected to receive some dose of GMP training throughout
his or her career with the company.
“With sufficient frequency” is not as clear. One way to help determine
sufficient frequency is by asking the question, “What’s the right dose?”
That is – what’s the right dose of training for each particular work group?
Sufficient frequency of GMP training for people working in a sterile filling
environment may be monthly. For someone working in Accounts Payable, an
annual overview of GMP may be considered sufficient.
Our job as training professionals is to determine the “Right Dose” of GMP
training for each work group, and design a process to deliver the
appropriate training at the appropriate intervals. “One size fits all” is
not an appropriate strategy for most organizations. Deliberate and careful
thought must be given to design an optimal strategy to make GMP come alive
and stay alive in your company. And effective follow-up to training is
crucial to making a GMP mindset or GMP Lifestyle come alive stay alive.
Follow-up Tips
Feedback Sheets at the Session.
Distribute feedback sheets at the conclusion of the training. Allow five
minutes at the end of the session for this activity. Ask the participants to
complete these and leave them with the instructor before they leave the
room. One question to ask on this feedback sheet is “What is the most
important point(s) you learned in this session?” The responses will help you
determine whether your objectives in conveying the planned message got
through. It also causes each participant to summarize in her/his own mind
what was covered in the training session, thus, starting the follow-up
immediately at the conclusion of the event.
Feedback Sheets after the Session.
Distribute feedback sheets two to three weeks after the conclusion of the
training session. In some organizations, this can be done electronically,
using the company E-Mail system or Intranet. One important question to ask
here is “What is the most important point(s) you remember from the GMP
training session you attended recently? This causes the recipient to think
back and review the content of the class. They may even look up the handouts
from the training session to determine their response. Wow! – actually look
at the material again after the session – for many people that alone is an
achievement.
Reference Material.
Refer to the handouts from the training as Reference Workbooks. Encourage
participants to treat these as their personal GMP reference guide. Prepare a
personalized three-ring binder for participants to keep all their GMP
handouts in. They bring their binder to each training session. In some
areas, you may have to provide a place for the employees to keep these. We
want to avoid treating the handouts from the training sessions as if they
were trophies – sitting on a shelf gathering dust.
GMP Training Team or Advisory Team.
Consider forming a GMP training team or GMP advisory team. This team would
determine the follow-up activities for the facility. This team can be
cross-functional in structure and be comprised of individuals selected to
serve for a limited time, perhaps six months. The rotating membership keeps
viewpoints fresh and sustains ongoing energy to keep the follow-up efforts
moving. A GMP trainer(s) should be a permanent member(s) of the team to
ensure continuity.
Newsletter.
Many organizations have a company newsletter that is published on a regular
basis. Create a GMP Corner in your newsletter. Include a short paragraph or
two highlighting a section of the regulation and how it applies to your
company. Identify the task of writing the copy for the newsletter as a
career development activity and assign it to someone from one of your
operations areas. This can be a one-month assignment, or a three-month
assignment, depending on the frequency of the newsletter. Having the person
sign their name as a byline to the column gives them recognition throughout
the company – often a reward for doing extra work.
Table Toppers.
Develop a GMP message of the week and print these on heavy cardstock. When
folded in half, the cards can stand up (like a name tent at a training
session). Place one of these on each table in the cafeteria, lunchroom, or
breakroom. These should be changed weekly. This is another career
development activity for some “rising stars” in your organization. This
gives then an opportunity to contribute to the performance of their company
in ways usually not associated with their functional responsibilities.
Department Meetings.
Include GMP as a topic for every departmental meeting. Sometimes just a
mention of GMP keeps people alert and reinforces that management takes GMP
seriously enough to include it as an agenda item along with discussing
performance measures, goals and objectives, safety, and other issues
commonly covered in departmental gatherings.
Monitor and Measure Performance.
Identify key metrics for your work group and measure them on a regular
basis. It may be number of mistakes per month, the score on an audit, or the
number of documents returned from the Documentation Control department
needing corrections or completion before a product can be shipped. Post
these measurements, best displayed as run charts or control charts, for
everyone in the group to see.
Peer Audits.
Identify audit teams within work groups. After appropriate training on
conducting audits, have teams perform audits on other areas of the company.
This is an effective technique for getting people to “brush-up” on their GMP
knowledge on their own. They take the time to prepare themselves for the
upcoming audit. Auditing is also a great way to change the mindset of both
those serving as auditors and those being audited. This process expands the
sphere of GMP knowledge.
Safety.
Most organizations have regular safety trainings and safety meetings.
Management’s commitment to the safety and welfare of their employees, along
with federal regulations developed and enforced by OSHA, as well as state
regulations, drive these activities. The focus is on the safety of the
employees. GMP focuses on the safety of the customers. So in that sense, GMP
can be considered a safety issue. Combining forces with those responsible
for safety can help stretch training budgets, reduce the time employees
spend in meetings, and create a mindset that safety for everyone (employees
and customers alike) is important to the success of the company.
Current Events.
Special sessions can be convened to discuss current events. This may be a
GMP issue that occurred in your company – either at your site or at another
location. It may be an issue that occurred with one of your competitors. It
may be something you found in the newspaper, or in FDA Consumer , a regular
publication from the FDA, or something you saw on last night’s news
broadcast. Excerpt the article or summarize the event and ask how the
problem could have been prevented. If the company produces products that are
similar to yours, ask if your systems can prevent similar problems at your
facility. If a meeting isn’t possible, post the material on a bulletin
board.
Bulletin Board.
Display GMP information on bulletin boards. These can be located at
strategic places where people pass by frequently. These can also be
electronic bulletin boards – for those with electronic access. The
maintenance of these bulletin boards can be another career development
activity for high performing individuals. Often, original artwork or photos
can be included as part of the display. Find the hidden talent, the artists
or photographers in the various work groups. They are often excited and
proud to “show off” their work to their colleagues.
GMP Contests.
Conduct GMP contests periodically. Pass out a word search puzzle or a
crossword puzzle. Completed entries must be submitted by a certain date. All
the correct entries will be combined and one will be chosen at random to win
some nominal prize. Or all winning entries win some nominal prize. The
objective is getting people to review GMP, learning on their own. Keep these
simple and fun. Inexpensive software exists for creating crossword puzzles
and word searches – check your local software store.
GMP Themes.
Declare a company wide GMP theme for the quarter. This calls for four themes
each year. Go through the regulation. One theme can be “Keep it Clean,”
focusing on cleanliness and organization. The office areas can participate
by having everyone clean out their offices or cleanse the memory of their
computer of old E-Mail messages. Another theme can be “Write it Down,”
focusing on accurate documentation. With the GMP regulations, there are
enough themes to sustain this activity for about three years – then start
over by repeating the first theme again. The GMP training conducted during
the theme period can stress the theme. This is a good solution to on-going
training efforts once people have gone through the initial comprehensive GMP
training for their area of responsibility.
Put a Face on Your Customer
For many organizations, the customer is called a patient. This individual
often isn’t choosing to purchase your product, he or she is getting your
product perhaps in an Emergency Room, or at an accident scene, or at a
pharmacy. Many customers are parents purchasing infant formula for their
newborn, or just the weekly groceries to feed their families. Many customers
are generous donors of blood and blood plasma. All of these people trust
that everyone in your company knows their job and performs their job
diligently every day. They trust that no shortcuts were taken to design,
manufacture, process, pack, store, or distribute these products.
Each training session should serve as a reminder that there’s a customer
who is putting their trust in you. This serves as a vivid reminder as to why
the regulations were promulgated and are enforced. Even though the word
customer and patient cannot be found in the GMP regulations, they are why we
do what we do. Consider taking photographs of some customers and displaying
those photos where everyone can see them every day. Place a banner along
with the photos that says, “We trust you.” or “We’re counting on you.”
Reaching employees as caring human beings, as parents and family members,
goes a long way in helping them take GMP seriously.
Work with your Sales and Marketing departments and invite a customer in
to address your employees in person, or even on videotape. This is a
powerful way to reinforce the importance of GMP and that it’s more than just
a regulation.
Summary
These are only a few ways you can follow-up on your training efforts.
There are probably many more that you can think of that would work in your
company. Choose those activities that will work with your people. Offering a
variety of activities over time keeps your GMP training efforts “fresh.”
Don’t try to implement them all at once. Remember to consider the resources
available to make these things happen as well.
Making GMP a Lifestyle, and not just a regulation, goes a long way in
making compliance easy. When people have an understanding of why things are
done a certain way, and why strict adherence to Standard Operating
Procedures is required, we all stand a better chance of producing high
quality products, services, and information and assuring our customers that
they are receiving the very best efforts of all of our employees.
David Markovitz is the Founder and President
of GMP Training Systems, Inc, and the Institute for Effective Innovation, a company created to help people
in organizations become self sufficient with innovation by equipping them
with time tested tools, the best resources, and expert coaching. Learn more
at
www.TheInnovatorsWay.com
David can be reached at 714-289-1233 or
David@GMPTrainingSystems.com
1Markovitz, David C., “Practical Preparation for Effective GMP Training:
6 Steps to Success,” Journal of cGMP Compliance, Vol. 3, No. 2, April 1999,
pp 68 - 72.
2Markovitz, David C., “Conducting Effective GMP Training: Do’s and Don’ts
for Success,” Journal of cGMP Compliance, Vol. 3, No. 3, July 1999, pp 59 -
62.
3FDA Consumer is available on the Internet at www.FDA.gov
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