gmp · gmp makes good business sense david c. markovitz 7 this leads us to another question....
TRANSCRIPT
A GMP Lifestyle Publication www.GMPTrainingSystems.com
David C. Markovitz
GMP Makes Good Business Sense
w w w . G M P T r a i n i n g S y s t e m s . c o m D a v i d C . M a r k o v i t z2
The PriCe of aDMiSSion into the food, drug,
medical device, blood, biologics, and dietary
supplement industries in the United States is
a commitment to abide by current Good
Manufacturing Practice (cGMP). cGMP is a
federal regulation enforced by the U.S. food
and Drug administation (fDa). Some organi-
zations view this as a curse - an overbearing
government imposing a series of strict regu-
lations. While others view this as a blessing,
as leverage in order to rally their employees
around a set of standards designed to en-
sure that their business operates in a state
of control.
Those organizations which have chosen the
latter view tend to 1) have a better working
relationship with the regulatory agencies, in-
cluding the fDa, and 2) have more success-
ful and profitable businesses. Sometimes, it’s
all in one’s perspective.
GMP Makes Good Business Sense
w w w . G M P T r a i n i n g S y s t e m s . c o m D a v i d C . M a r k o v i t z3
YeS, fDa haS SiMPlY ProviDeD our industries
with a framework, a business plan, for build-
ing a successful company. it is in our best
interest to understand the GMP regulation
and Make GMP a Lifestyle in our organiza-
tions. at the foundation of the regulation it-
self is the premise that a business should be
operated with systems in place to minimize
the chance of contamination, mix-ups, and
errors, with the ultimate goal of preventing
contamination, mix-ups, and errors altogeth-
er. essentially, GMP states that you should op-
erate your company in a state of control.
GMPDoes Following Make Good Business Sense?
w w w . G M P T r a i n i n g S y s t e m s . c o m D a v i d C . M a r k o v i t z
Lower
Improve
Improve
4
an organization without scrap and rework
rewards itself with higher productivity. Morale
among the workforce can only improve with
predictable work schedules and work loads.
This leads to people taking pride in their
work.
iT DoeSn’T Take an accountant to determine
the condition where costs are down and pro-
ductivity is up. This condition is called making
money, profits, and a healthier bottom line.
an organization without contamination, mix-
ups, and errors operates with lower costs
than one that endures some level of con-
tamination, mix-ups, and errors. a company
operating in a state of control can plan and
predict with a greater degree of accuracy
than one where rework and re-scheduling
wreak havoc with the organization and the
employees.
Would You Like to Costs?
Would You Like to Productivity?
Would You Like to Profits?
w w w . G M P T r a i n i n g S y s t e m s . c o m D a v i d C . M a r k o v i t z
GMP
5
Would You Like to Costs?
Would You Like to Productivity?
Would You Like to Profits?
leT’S STarT bY aSkinG a simple question
about your business.
“What is the aim of your business?”
here are some likely answers.
• To make a profit.
• To satisfy our customers.
• To exceed our customers’ expectations.
• To solve problems our customers have.
• To provide jobs.
• To provide high quality, high value
products and services.
• To expand market share.
• To develop new products and services.
Which of these answers is “the right answer?”
They are all correct. Some answers may be
“more correct than others” based upon your
experience and/or personal bias. let’s examine
the relationships between these “right answers.”
How Does Lead to Lower Costs, Improved Productivity, and Higher Profits?
w w w . G M P T r a i n i n g S y s t e m s . c o m D a v i d C . M a r k o v i t z
Start With The Customers
6
although we can start exploring the relation-
ships among these answers with any individ-
ual answer, let’s choose to start with the cus-
tomer. after all, without customers, a business
does not exist. So, let’s say that our aim is to
not only satisfy, but to exceed our customers’
expectations as well as to provide solutions to
existing and future problems they may have.
G M P M a k e s G o o d b u s i n e s s S e n s e D a v i d C . M a r k o v i t z7
This leads us to another question.
“ What must we do to ensure that we are ex-
ceeding our customers’ expectations?”
“ First, we must know our customers’ expec-
tations, and understand their wants and
needs. We must also know what problems
they currently face, or are likely to face in
the future. This requires market research -
collecting and analyzing data.”
Then, we must provide our customers with high
quality, high value products and services. So,
“ What must we do to ensure that we are ex-
ceeding our customers’ expectations?”
“ Provide high quality, high value products
and services.”
a new question then arises.
“ What must we do to ensure that we are
consistently providing high quality, high
value products and services.”
answer: “Optimize and improve the methods
used to produce those products and services.”
examine the systems, processes, and proce-
dures in place. ensure that these are all operat-
ing in a state of control. Predictable systems and
processes yield predictable results.
This now leads to the next questions.
“ What does our organization look like when
our systems and processes are operating
in a state of control? What happens to our
organization when our systems and pro-
cesses are operating consistently day in
and day out, hour after hour, yielding the
same predictably good results?”
“ Rework is down. Scrap is down. Contami-
nation is reduced. Mix-ups and errors are
virtually non-existent. Accidents are re-
duced when people aren’t scrambling to
make up lost time due to schedule chang-
es resulting from rework and scrap. Over-
all, trouble is greatly reduced.”
“ What happens to operating costs when
your systems and processes are operating
in a state of control, predictably yielding
consistently good results day after day,
hour after hour, with contamination, mix-
ups, and errors virtually non-existent?”
“Costs go down.”
First, we
must know our
customers’
expectations,
and understand
their wants
and needs.
w w w . G M P T r a i n i n g S y s t e m s . c o m D a v i d C . M a r k o v i t z8
“ What happens to productivity when costs
are down and your systems and processes
are yielding near perfect results?”
“Productivity goes up.”
“ What do you call the condition when costs
are down and productivity is up?”
“ All together now, “MAKING MONEY!!!!!!!!”
“GREATER PROFITS!!!!!!!!”
“ What can we do with this money we’ve made?”
“ First, provide a Return on Investment (ROI)
to the owners.”
(Shareholders if a public corporation, or
owners if privately held.) Shareholders and
owners expect a better return on their invest-
ment than stashing their money in a bank.
So pay them what they deserve.
“Then, re-invest in the business.”
Developing new products and services requires
money. So does market research. expand-
ing market share usually requires investment.
Training and development for your employees
requires an investment. being a good corpo-
rate citizen in your community costs money.
“How do I spend my money wisely?”
“ It comes back to the customer.” Don’t spend
time developing a product or service no-
body wants or needs. There are strategic
decisions to be made. Planning processes
can help here.
This completes the GMP Chain reaction
(figure 1). in the example we’ve just drawn,
it starts with the customer, and returns to
the customer. This GMP Chain reaction can
be viewed as a roadmap to business suc-
cess. any business, in any industry, would be
served well by following this roadmap.
The nine components need to be taken to-
gether and viewed as a system. These com-
ponents must be integrated into one oper-
ating system. GMP can provide the glue to
keep these components sticking together,
ensuring optimal success whereby every-
body wins. owners and shareholders win,
customers win, employees win, suppliers win,
and the community wins.
That’s why GMP makes good business sense!
Don’t spend
time developing
a product or
service nobody
wants or needs.
G M P M a k e s G o o d b u s i n e s s S e n s e D a v i d C . M a r k o v i t z
Chain Reaction
GMPThe
9
ImprovedProfitability
SuccessfulBusinesses
ExceedCustomers’
Expectations
MarketResearchROI Stay in
Business, Ex-pand Market-share, Invest in R&D, Provide
Jobs
ReducedCosts
Optimize and Improve the Systems,
Processes and Procedures
Reduce Rework, Scrap,
Mix-ups, Errors & Contamination
IncreasedProductivity
Provide High Quality, High
Value Products and Services
(fig. 1)
w w w . G M P T r a i n i n g S y s t e m s . c o m D a v i d C . M a r k o v i t z
ExceedCustomers’
Expectations
Optimize and Improve the Systems,
Processes and Procedures
Provide High Quality, High
Value Products and Services
10
The GMP Chain reaCTion can be divided
into two sides - the left side and the right
side. in looking back over the last fifty years
or so, american industry has focused most
attention on the left side of the GMP Chain
reaction. Many companies have conduct-
ed profit improvement programs, produc-
tivity improvement programs, and cost re-
duction programs. american industry has
become very adept at managing this side
of the GMP Chain reaction.
it’s only been since the late 1980’s that in-
dustry has begun to focus on the right side
of the GMP Chain reaction as well. lean
manufacturing and six sigma programs
have been implemented. Some organiza-
tions have swung their focus totally towards
the right side, ignoring the left side, and
have run into trouble.
The focus must be on the entire GMP Chain
reaction as a system. imagine higher qual-
ity at reduced costs. Possible? Yes, by op-
timizing and improving the systems and
processes used to produce those products
or services. achieving higher quality by in-
spection and sorting, a traditional method
employed when focused on the left side, re-
sults in increased costs.
Those organizations with their eye on thriv-
ing in the future will view the GMP Chain
reaction as an integrated system. and they
will deliberately and proactively manage
and optimize that system. They will provide
their people with the knowledge and skills
required to manage their work systems
and processes as well as the interfaces
where two or more work processes come
together. They will ensure that all parts work
well together.
BackLooking
G M P M a k e s G o o d b u s i n e s s S e n s e D a v i d C . M a r k o v i t z11
Fueling the Chain Reaction
There are TWo keY CoMPonenTS which fuel this Chain reaction.
These two components were identified by the fDa in 1968 in their
GMP training film, No Margin for Error. Two major problems identi-
fied in this film were Poor Planning and Faulty Procedures.
Planning is addressed in the middle circle at the top of the GMP
Chain reaction (figure 1). Plans on where to invest resources need
to be focused on what will please the customer. Planning is the
domain of management. This often determines whether an orga-
nization can stay in business, not just keeping up with customer
demands, but leading their customers into the future. The medical
device industry has countless examples of new and innovative so-
lutions to age old problems.
faulty Procedures (a 1968 term) is addressed by the box in the
lower right corner of the GMP Chain reaction (figure 1). This com-
ponent is the domain of every single person in the organization. ev-
eryone is working in a process. everyone is using procedures, writ-
ten or not. This is the area emphasized in both the iSo standards
and the GMP regulation.
Managing systems, processes, and procedures is the key to yielding
consistent results. Most organizations monitor and measure results.
The number of shipments, value of shipments, and number of trans-
actions are a few examples. few organizations monitor and measure
their processes and process variables, and then actually use the
data to make adjustments and improvements to those processes.
w w w . G M P T r a i n i n g S y s t e m s . c o m D a v i d C . M a r k o v i t z12
ManaGinG ProCeSSeS iS The real opportu-
nity to prevent contamination, mix-ups, and
errors and ensure that your business is oper-
ating in a state of control. The focus should
be on Prevention - preventing problems from
occurring. The fDa has given us the acronym
CaPa, meaning Corrective and Preventive ac-
tion. Corrective action is solving problems. Pre-
ventive action is preventing those problems
from occurring in the first place. a better way
to express this is caPa – with the emphasis on
Preventive action.
however, many organizations and individu-
als pride themselves on their problem-solving
prowess – the ca in the acronym caPa. They
wait for problems to occur, then spring into ac-
tion, sometimes performing heroic tasks to solve
the problem, while operating in a crisis mode.
The drama associated with dealing with a
crisis can cause the adrenaline to flow. our
research of over three decades of working
with manufacturing organizations in the
food, drug, medical device, blood, biologics,
and dietary supplement industries has clear-
ly shown that certain types of people are
attracted to work in these environments. We
characterize these people as action-orient-
ed people. They tend to thrive on the action,
and the drama created when things don’t go
according to plan. The superhuman efforts
required to “get us out of this mess” create
great satisfaction for some individuals. They
thrive on the attention, taking great fulfillment
that they are important. They also know that
they will be called upon again when this
same problem resurfaces, which inevitably it
will, if no one is working to improve and opti-
mize the systems and processes associated
with that particular event.
the ProcessManage
G M P M a k e s G o o d b u s i n e s s S e n s e D a v i d C . M a r k o v i t z13
Paradoxthe
herein iS The ParaDox. When efforts are focused on optimizing
and improving the systems, processes, and procedures used to
manufacture the high quality, high value products or produce
the high quality, high value services, the problems begin to be-
come fewer in number. Things start operating in a state of con-
trol - with fewer and fewer problems occurring.
how, then, are these adrenaline junkies (the problem “fixers”)
going to get their fix? The actions required to optimize and im-
prove systems and processes – the Pa in the acronym caPa - are
normally not done during a crisis. They are the results of ongoing
efforts usually by teams of people working together to identify
causes of variation and brainstorming possible solutions, then
trying these solutions under controlled conditions. There is little
drama here, only patience, perseverance, and hard work.
The challenge is in redirecting the energy of our talented work-
ers into optimization activities. There are significant gains to be
made in designing systems and processes that will yield consis-
tently good results. There are significant gains to be made in cre-
ating procedures based upon the current best method which
are understandable and usable by those charged with using
them. optimization means making things the best that they can
be. ensuring that all components, all departments, are working
together to produce the very best result, just as the sections of a
symphony orchestra work together to produce good music.
w w w . G M P T r a i n i n g S y s t e m s . c o m D a v i d C . M a r k o v i t z14
We have DeveloPeD a fraMeWork for in-
tegrating the GMP regulations with qual-
ity management standards. This framework
provides guidance in deploying the energy
and resources to bring any organization into
a state of control. essentially the framework
is a vehicle for making GMP a Lifestyle in
your organization.
The Framework consists of seven sections:
• General Controls
• Design Control
• Facility Control
• Equipment Control
• Material/Component Control
• Operational Control
• Finished Product Control
the
Framework
w w w . G M P T r a i n i n g S y s t e m s . c o m D a v i d C . M a r k o v i t z15
each section contains several specific
categories which outline the systems and
processes relevant to that section.
1. General Controls
• Organizational and management
responsibilities
• Document control system
• Employee orientation, quality awareness
and job training systems
• Plant safety and security systems
• Internal quality/GMP audit systems
• Quality Cost program
2. Design Control
• Product design and specification
control systems
• Production process design control systems
• Quality assurance design and
specification control systems
• Design validation systems
• Design change control systems
3. Facility Control
• Facility design and layout
• Environmental control systems
• Facility maintenance and good
housekeeping systems
• Outside contractor control system
w w w . G M P T r a i n i n g S y s t e m s . c o m D a v i d C . M a r k o v i t z16
4. Equipment Control
• Equipment design and placement
• Equipment identification and log books
• Equipment maintenance program
• Measurement equipment
calibration program
• Equipment qualification program
5. Material/Equipment Control
• Material/Component specification and
purchasing control systems
• Material/component receipt, inspection,
sampling, and laboratory testing systems
• Material/Component storage
and handling systems
• Inventory control program
• Vendor/Supplier control program
6. Operational Control
• Material/Component/Label verification,
storage, and handling systems
• Equipment/Line/Area clearing,
preparation, and clearance systems
• Operational process validation and
production change order control systems
• In-process inspection, sampling, and
laboratory control systems
• reprocessing/Disposition of material systems
7. Finished Product Control
• Finished product verification, storage,
and handling systems
• finished product inspection, sampling,
testing, and release for distribution systems
• Distribution controls
• Marketing controls
• Complaint handling and customer
satisfaction systems
w w w . G M P T r a i n i n g S y s t e m s . c o m D a v i d C . M a r k o v i t z
GMPMaking a Lifestyle
17
The fraMeWork oUTlineD above represents a comprehensive
approach towards making GMP work for you. each component
of the GMP regulation can be traced back into the framework.
Deploying your people into designing consistent processes and
procedures for each of the systems outlined in the framework
should provide them with the challenge as well as the satisfac-
tion in knowing that they are creating systems designed to:
• Meet or exceed customers’ expectations.
• Produce high quality, high value products and services.
• Reduce the chance of contamination, mix-ups, and errors.
• Reduce costs.
• Increase productivity.
• Improve profitability.
• Increase market share, thus providing opportunities for
advancement and new jobs in the future.
• And many more benefits.
GMP, applied correctly, can bring financial rewards as well
as the rewarding experience of designing and managing
systems operating in a state of control. This controlled en-
vironment is the leverage towards providing your customers
with consistently high quality products and services.
Indeed, GMP does make Good Business Sense!
w w w . G M P T r a i n i n g S y s t e m s . c o m D a v i d C . M a r k o v i t z
GMPTraining Systems
18
GMP Training Systems, Inc. is a leading edge, top tier provider of compli-ance products and services. Our aim is to help you make GMP a Lifestyle in your organization.
We do this by providing:
GMP Boot Camps – open enrollment workshops conducted throughout the year in
multiple locations.
In-plant training – we design and conduct training specifically to meet your needs at your
location. Let Our Experts be Your Experts!
Web seminars – regularly scheduled web seminars with leading industry experts.
GMP Training Products – our GMP Training System™ is available in three
formats and in english and Spanish.
• Instructor-led format for you to use in classroom training.
• Interactive Computer-based format where you set up a
workstation for your people.
• Web-based format where your people access the
training using the internet.
FDA Survival Kits – Products to help you stay compliant
on specific topics.
Breaking News – our blog, www.GMPTrainingSystems.com/GMPtips,
helps you stay abreast of industry trends.
Learn more – www.GMPTrainingSystems.com
w w w . G M P T r a i n i n g S y s t e m s . c o m D a v i d C . M a r k o v i t z19
About the AuthorDavid C. Markovitz is the founder and President of GMP Training Systems, inc., an education,
training, and consulting firm whose mission is to help organizations make Good Manufactur-
ing Practice a lifestyle, and not just a regulation.
Specializing in those industries regulated by the food and Drug administration, David has
over three decades of practical experience working in the industry and as a consultant help-
ing hundreds of companies become and remain compliant.
David is the author of Becoming the Best: Making Optimization Happen, and 212 Tips to
Improve Performance, Productivity, and Profits. he is the host and moderator of fDa-focused
web seminars and the creator of the GMP Training System™, a GMP training toolkit for com-
panies to use to meet federal GMP training requirements.
Invite David to speak at your next event or to conduct a workshop for your company,
please contact him at [email protected]
Subscribe to our popular GMP Tips blog at: www.GMPTrainingSystems.com/GMPtips
Copyright Info© 2009 GMP Training
Systems, inc.
Copyright holder has licensed
this under the Creative
Commons license,
attribution 3.0
What You Can DoYou are given the unlimited
right to print this ebook and
to distribute it electronically
(via email, your website,
or any other means). You
may not alter this ebook in
any way, though, and you
may not charge for it.
Send This: Pass along a copy of
this ebook to others.