gmp · gmp makes good business sense david c. markovitz 7 this leads us to another question....

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


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?


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?


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.


“ 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)


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


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.


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


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.


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


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


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


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!


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


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]

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gmp · gmp makes good business sense david c. markovitz 7 this leads us to another question....

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