TOTAL QUALITY MANAGEMENT IN THE BIOPHARMACEUTICAL
INDUSTRY: "PLANNING AND DEVELOPMENT OF QUALITY FUNCTION DEPLOYMENT (QFD)
FOR THE RESEARCH AND DEVELOPMENT OF PRODUCT AND PROCESSES OF HUMAN PLASMA
DERIVATE PRODUCTS”
Sergio Alejandro Oviedo Albarracin
Universidad Católica de Córdoba, Argentina
Universidad Nacional de Córdoba, Argentina
E-mail: soviedo.bioan@gmail.com
Submission: 04/12/2017
Revision: 06/03/2018
Accept: 22/03/2018
ABSTRACT
In
the industrial sector, the work of the research and development departments is
related both to the processes performed and to the products to be marketed, and
it includes everything from the design and development of a new product to the
redesign or development of the process of production. Therefore, response time represents
a key point in the structure of the company, provided that the response is fast
and effective. Besides, the quality of the development and design is not
limited to the benefits of the product. Quality Function Deployment (QFD) for
Pharmaceutical Products Research and Development appears as an important tool
that allows us to face the design or modification of a product or process
according to customer’s needs, and to their expectations about the product
quality requirements. In this work we deal with the development of a plasma
derived product, on the basis of QFD rules. The application of QFD fulfilled
the proposed objectives. QFD added simplicity and reliability to the production
as well security and highly competitive costs to both, the product development
and the final product itself. QFD was supplemented with Good Manufacturing
Practices (GMP), and it also proved to be highly applicable in the
pharmaceutical industry even in the case that certification for a quality
system is not pursued.
Keywords: QFD,
Biopharmaceuticals, Quality Management, Human Plasma Products
1. INTRODUCTION
1.1.
Research
and Development in the Pharmaceutical Industry
In
the industrial sector, the work of the Research and Development Departments
(R&D Departments) is related to the processes and products to be marketed,
and it includes everything from the design and development of a new product to
the redesign or development of the process of production.
Pharmaceutical
products, like other industrial products, have a life cycle that begins with
the development of an idea and culminates when the product is obsolete, and its
redesign, discontinuation, or removal from the market is decided (FERRÉ,
1990).
One of the objectives of R&D
Departments is to extend the mean lifetime of a product by improving its
design, with parallel development of a substitute for the moment when the
product is removed from the market (BATES; COLS, 1988).
Therefore,
response time represents a key point inside the structure of the company,
provided that the response is fast and effective. Besides, the quality of the
development and design is not limited to the features of the product but the
following should also be taken into account (GRAHAM; ENGLUND RANDALL, 1999;
RICO, 1995; NICHOLS, 1994):
·
Simplicity and reliability of the production process
·
Safety and accessibility for maintenance and handling
of the product
·
Quality and lack of defects during the product
estimated mean lifetime
At
the same time, it is necessary to work at competitive costs during the development
process and in obtaining the final product. It is known that cost decreases
considerably along time as the development of the product progresses towards
production scale-up, and the production process is optimized in a cycle of
continuous improvement (SPERY; COLS, 1999; TRHOM, 1990).
Thus,
another objective of an industrial R&D Department is defined as the
improvement of products and processes with a view to reducing costs and
increasing net profit margins (TINGSTAD, 1990; GORSKY; NIELSEN, 1992; TINGSTAD;
1994).
In
sum, the plans of an industrial R&D Department include two main groups:
a) Design
of new products and processes.
b) Maintenance
and improvement of existing products and processes.
1.2.
QFD
for Pharmaceutical Products Research and Development:
The
central focus of QFD establishes that one of the keys to achieve continuous
improvement is that internal and external customers get involved as early as
possible in the process of development of a product (MIZUNO; YOJI, 1994;
SULLIVAN,1986; AKAO, 1972).
Quality Function Deployment is a
practice used to design processes in response to the needs of the customers,
and it translates what customers want into what the organization produces. It
allows an organization to prioritize customer needs, to find innovative
responses for those needs, and to improve processes for maximum effectiveness.
QFD is a practice that leads to process improvements which allow an
organization to surpass its customers’ expectations (SULLIVAN,1986; AKAO, 1972).
In
the development and improvement of pharmaceutical products, external customer
needs and requirements are reflected in reliability, effectiveness and security
of the medication, while internal customers will demand speed, security and low
costs. (CLARCK; FUJIMOTO, 1991; BECKELL, 1989; SOWREY, 1987; RICO, 1996;
OVIEDO, 2002)
2. METHODOLOGY
2.1.
QFD
for the Research and Development of Human Plasma Derived Pharmaceutical
Products (Model of Application Developed):
In
this work we put forward that the development and application of a quality
system in R&D laboratories result in efficiency and effectiveness gain for
the manufacture of the product under research. We stated that quality flaws of
this process are to be found in the planning and programming stages of R&D
projects and that such flaw include excessive time demanded by the development
process as well as low attachment to normalized registration systems, among
others.
For the implementation of a quality
system in R&D groups, we consider that QFD can become an appropriate tool
that contributes to planning and execution of R&D projects. In order to
prove this, we carried out the development of a new product, applying QFD.
2.1.1. QFD
Methodology Flow:
In our work we apply the four basic
phases in the methodology of Deployment of quality functions, this occurs
throughout the process of product development (SINGGIH; COLS, 2013; LOWE, 2001; AKAO, 1990; COHEN, 1995).
During each phase, we prepare one or
more matrices to help plan and communicate the critical planning and design
information of the selected product and process in our case.
The applied QFD methodology flow is represented below, where each phase or matrix, that we developed represents a specific aspect of the product's requirements. The relationships between the elements were evaluated for each phase. Only the most important aspects of each phase were implemented in the following matrix.
Phase 1, Product Planning, incinerating the construction of the house of quality with information from the marketing department. Phase 1 documents customer requirements, warranty data, competitive opportunities, product measurements, competitive product measures and the technical capacity of the organization to meet the requirements of each client.Obtaining good customer data in Phase 1 was critical to the success of the entire QFD process.
Phase 2, product design: this phase included the development work of the pharmaceutical product in the Research and Development department. In this phase of product design, creativity and innovative ideas related to the product were expressed. The concepts of the product were created during this phase and its specifications are defined and documented. The clearances that are determined to be most important to meet the client's needs were then implemented in the process planning during Phase 3.
Phase 3, Planning of processes: process planning is
developed following the design and supported the assistance of manufacturing
engineering. During the planning of the process, the production flow diagrams,
the critical quantities and the process parameters (or reference values) were
determined. These are documented in the matrix.
Phase 4, Process control: Finally, the production
planning was determined, performance indicators are created to monitor the
production process, the maintenance schedules and the training of the
operators. In addition, in this phase the flow of decisions about which process
represents the greatest risk was determined and fixed and controls are
implemented to prevent and avoid failures. The controls executed by the quality
control department are established.
2.1.2. Method
of Production and Quality System:
The
method used is the purification of the plasmatic proteins by means of alcoholic
fractionation, which is known as the Cohn – Oncley Method. (COHN et al., 1946; CURLING,
1983).
The production, quality control and
process controls are carried out as prescribed by GMP, GLP (OMS, 1994; IRAM-ISO
9000:2000; IRAM-ISO 9001:2000; Disposición
ANMAT Nº 2819/2004) and other normative regulations (Farmacopea Nacional
Argentina 7°, 2003, 5° Real Farmacopea Española, 2015).
2.1.3. Selection
of an application project for QFD:
Within
the Pharmaceutical Industry, the alternatives for the development of products
and processes can be divided into:
1. A new
product, existing or not in the market, and completely different from the range
of products existing in the company up to that moment.
2. A new
product, existing or not in the market, and within the range of products
already existing in the company.
In
this work, QFD was aimed at the development of a product that is within the
existing range of products, considering two new alternatives:
a) Development
of a product already existing in the market (generic), manufactured using
similar processes and procedures as those already existing at the industrial
plant.
b) Development
of new product, already existing in the market, using a process of production
different from the process currently used at the plant.
Our
development of QFD was oriented towards an already existing product, using
production methods installed at the plant.
For
the Development of QFD, the reengineering and re-launching of a completely
renewed product which had been discontinued in our laboratory (IgG anti-D) was
selected. This product exists in the market and its process of production does
not differ much from the process used for the manufacture of the range of
products already existing in the company.
3. DEPLOYMENT THE CASE OF STUDY
3.1.
Description
of the Product:
Immunoglobulin
– Anti-D (Rho) is a biological generic medication. Its pharmacological action
consists in neutralizing D Antigens (Ag) present in the membrane of human red
cells (HRC).
The
medication is made from human plasma coming from healthy donors, mostly Rh-
women sensitized during pregnancy. In fewer cases, plasma is obtained from
sensitizations occurred as a result of blood transfusions or programmed and
controlled immunizations.
The
use of this medication is mainly directed to prevent the Hemolytic Disease of
the New Born (HDNB).
3.2.
Need
for the Product:
It is
estimated that 60.000 annual doses of anti-D are needed in the Argentine
Republic for the prevention of HDNB. According to National Law Nº 23674/89, it
is obligatory to satisfy that annual requirement, which demands a productive
effort in accordance with the above mentioned need.
3.3.
Market
for the product:
This product presents the following market values:
·
In the city of Córdoba, the product annual sale rate
reaches about 1000 units, which can be potentially increased by 30-40% through
a greater supply of low-cost, high-quality products.
·
In Argentina, 1699 units of the product are sold
monthly, distributed in dosage forms of 250 and 330 ug of anti-D antibodies/ml.
Foreign and private laboratories that market imported products occupy 94,97% of
this market.
Patients
can acquire the product, if prescribed by a doctor, in pharmacies that buy it
from wholesale pharmacy distributors. Public and private hospitals also
purchase the product, through bidding procedures.
The
market value of the product is of about
U$S15 per dose of 250 mg/ml, and of about U$S 21 per dose of 330 mg/ml. These values
correspond to prices of the medication in pharmacies.
3.4.
Determination
of the Customer Requirements:
As a
first step, prior to the beginning of the development of QFD, the product
internal and external customers were defined.
The internal customer is someone to
whom the R&D department should transfer the results of its work, and the
external customer is someone that receives the final pharmaceutical product
form. External customers can be categorized as follows:
a) Primary
Customer, who buys the product from the laboratory, and who is represented by
medical care units, wholesale pharmacy distributors and pharmacies.
b) Secondary
Customer, who prescribes the medication, and who is represented by the
physician.
c) Tertiary
Customer, represented by the patient, for whom the pharmaceutical product is
prescribed.
In a study on customer needs we
found that some needs are common to all external customers while others are
specific of each one of them.
Customer needs were determined
through interviews and a structured survey that allowed us to define the
customer satisfaction index in relation to our product and to the products of
other companies, and also to determine the quality and non-quality parameters
perceived by the customer. The following aspects were also determined: causes
of quality deficits, internal aspects that could cause bottlenecks on the way
to the goal of satisfying customer quality requirements, and the internal
perception with regard to the quality of the development project.
The objectives of this work are
oriented fundamentally to determine an administration and quality management
methodology applicable to R&D groups. The main customer is represented by
the sectors that receive findings and developments in order to transform them
into products. Therefore, QFD is considered to be applicable to any research
project that provides a result for a determined receiver.
Accordingly,
during the development of the model we put particular emphasis on internal
customer requirements. This did not mean to disregard external customers who
are considered in the global quality development process for every R&D
project and pharmaceutical product scale-up. When considering internal customers,
we determined that they are the first receivers of R&D work in an
industrial laboratory. In the case of university research laboratories, the
first receiver becomes an external customer.
Data
were processed statistically in order to determine our priorities and the
components of the QFD matrix.
The
most striking internal customers’ requirements and expectations, especially
those which must be necessarily satisfied, were identified in the analysis.
Among them, apart from those considered basic, the following were weighted:
·
Greater emphasis on project management.
·
Integration of the development projects into the
quality system (do it well from the start).
·
Management of development costs (time, results,
equipment, etc.).
·
Efficiency in project management, with an improved
planning/results relationship.
·
Greater interaction with internal customers, such as
Quality Control and Production.
·
Greater speed in development transfer for development
scale-up.
·
Transfer in accord with production manuals, standard
operational procedures and work manuals at the moment of scaling up.
·
Greater participation in the stage of final adjustment
of the development process.
·
Decrease in the percentage of post transfer and post
scale-up adjustments.
In order to determine which of the above
mentioned items were essential, they were evaluated through a Pareto diagram,
which showed the results displayed in Table 1, Figure 1 and Figure 2.
Table
1: Internal customer requirements values
|
Requirements |
Order |
Value |
% |
Accumulated % |
|
Project Management |
1 |
36 |
31.30 |
31.30 |
|
% Post Transfer Adjust |
2 |
27 |
23.48 |
54.78 |
|
Transfer Time |
3 |
22 |
19.13 |
73.91 |
|
R&D Costs |
4 |
20 |
17.39 |
91.30 |
|
Interaction with other Depts. |
5 |
7 |
6.09 |
97.39 |
|
SOPs and Manuals |
6 |
3 |
2.61 |
100 |
|
TOTAL |
|
115 |
100 |
|
Figure 1: Weighted Internal Customer Requirements
Figure 2: Percentage Distribution of
Internal Customer Requirements
Regarding
the external customer, it was observed that the most important requirements
were reflected in the need for products with adequate market availability and
supply, at low cost, and with more potent formulations and stability. Other
needs were related to the intravenous form of the product and to the
possibility of adjusting the doses according to the degree of sensitization of
the patient.
The
results of the Pareto diagram, designed to show the degree of importance of
each one of these requirements, can be seen in table 2, Figure 3 and Figure 4.
Table
2: External customer requirements values
|
Requirement/Need |
Order |
Value |
% |
Accumulated % |
|
Market supply |
1 |
411 |
35.55 |
31.30 |
|
Low Costs |
2 |
221 |
19.12 |
54.67 |
|
More Potency |
3 |
202 |
17.47 |
72.15 |
|
Expiration Date |
4 |
202 |
17.47 |
89.62 |
|
Intravenous form |
5 |
80 |
6.92 |
96.54 |
|
Multi Doses |
6 |
40 |
3.46 |
100 |
|
TOTAL |
|
1156 |
100.00 |
|
Figure 3.Weighted External Customer Requirements
Figure 4: Percentage Distributions of
External Customer Requirements
A spiderweb interrelationship
digraph (Figure 5) was used in order to identify the points in common between
both results. It was observed that the main interaction points were related to
the cost and time of development, that is, to the planning process and to good
project management.
This analysis facilitated the
stratification and selection of needs and it allowed building the QFD matrixes.
Figure 4 presents a practical scheme of the QFD applied.
Figure 5: Internal vs. External Customer
Interrelationship Diagraph (spider web)
Once
the matrixes were completed, we advanced in the
development of the project, the control parameters were determined for each
stage, and the project improvement indicators were defined. During the
realization of the project, the inspection points of the process were defined,
the techniques and control trials used were optimized and validated, and the
critical parameters of the production process were adjusted.
After
de product development was finished, the standard operative procedures (SOP)
involved in the production process of the new product, its manufacturing manual
and the engineering design process were written, for the subsequent scale-up
process.
4. RESULTS AND EVALUATION OF THE APPLICATION OF QFD IN A
PROCESS OF RESEARCH AND DEVELOPMENT
A
traditional point of view considers a product R&D from the market and
marketing perspectives; however, it should be taken into account that the
development of a new medical product requires a minimum of five years from the
beginning of the development until the product is obtained.
With the application of QFD we plan to reduce that time and achieve a sustained
increase in quality.
In
our case, one of the most important customer requirements was related to
efficient and effective R&D project planning and to appropriate
decision-making for the project evaluation.
Within
that framework, the results obtained are ordered under the following titles:
a) Project
Planning
b) Evaluation
of the QFD results
4.1.
Project
Planning:
For
efficient project planning, the application of five governing points was
determined, whose execution represents a considerable improvement in the
quality of the development of a new medicine.
a) The
R&D Manager, the Product Development Chief, or the Researcher must carry
out the project planning process as if acting on behalf of the Company
Direction, that is to say, they must assume the management role from a global
perspective, as from the moment the new idea is conceived.
b) The
project planning process should attain a balance between the conflicting
interests and requirements of a company on the path of quality, and some
conservative management practices applied when the production, marketing,
sales, finances and quality areas are involved.
c) The
planning process should contain the definition of pre-requirements for the
development process and the definition of the product to be obtained from the
said process.
d) The
project planning process should generate the creation of a New Project Committee, composed by the following members and areas
of the company: Researchers, Plant Managers, Technical Direction, Marketing,
Quality, and Executive Directors. The creation of the committee should allow a
global vision of external and fundamentally of internal customer requirements.
e) The
project planning process should generate awareness that beginning and defining
a project for a new medication or for a new production process represents only
one instant in the planning process as a whole. During the project planning
process, the project director should maintain an innovative vision of customer
requirements. Besides, the director must ensure that all the contents related
to quality as well as the commitment of all the members of the organization are
taken into account for the development and successful realization of the
project.
In this part of the work we will not
go into detail on how and when the above mentioned points should be applied.
Instead, we will simply analyze how the project planning process and the
quality function deployment influenced the development of the project. In the
chapter referred to project planning, a detailed explanation of how to execute
the planning process is provided. Planning involved an analysis of the
environment and of strengths and weaknesses of the project (Figure 6).
Subsequently, a strategic action plan was determined for the development of the
project.
Figure
6: Scheme of the SWTO Analysis for the R&D Project
The
project was then structured in five stages that in turn are composed by a group
of activities representing the development of the project. The finalization of
each stage signals a point of control and of decision making where the continuity
or the end of the project is decided.
Stages
1, 2 and 3 are the lengthiest ones and they represent the greatest investment
in the development of the project. It was decided that Stage 1, Evaluation and
Selection of the Project, would last longer than in previous projects. This
constituted an important aspect for making decisions at the beginning of and
during the research and development project (Figure 7).
Figure 7: Evaluation of multi-project implications
along the three-year development study: case study project (*), other simultaneous
projects (*).
Another
aspect considered was the development, quality and investment costs, which were
reduced by 18% in relation to the initial projection and by 30% as compared
with previous projects (Figure 8).
Figure 8: Project Costs vs. Project Investment, (---)
Planned Costs, (---) Actual Costs (QFD-based Project) and Costs of
other Project (---).
A
staggered schedule of activities as well as the participation and involvement
of different departments of the company allowed interaction with existing
projects and optimization of the employment of resources through the evaluation
of multi-project implications (Figure 7) (ALLEN, 1994).
This
allowed the company to generate an interactive planning process and almost
constant revision of existing projects so as to avoid and eliminate limitations
that might otherwise stay out of control.
In
this way, the developers and personnel in charge of other projects did not have
to wait until their respective projects were finished in order to become
involved in the planning of a new one. Otherwise, the result would have been
insufficient project planning.
Planning
implied taking into account assumptions about needs, such as the following:
·
Volumes: They refer to the capacity of the plant to
process and to obtain the new product, the degree of automation of the process,
the materials that can be used in product development and design and for the
corresponding process, the design of new components, and the cost of
application of the technologies adopted.
·
This practice was beneficial from the perspective of
team work, as all the departments involved in the project were consulted for
consensus decision making in order to advance, obtain results, and fulfill the
objectives. The result was that experimental development planning work was
carried out on the basis of realistic volume estimations and that the work was
adjusted to the capacity and infrastructure of the company. This impacted
significantly on the investment and on the reduction of the development costs (Figure
8).
·
Another planning aspect involved legal aspects: all
legislation related to the project was gathered and it was specially taken into
account during the evaluation, approval and start-up stages. This work
facilitated the task of stage five, related to the final development of the
complete Quality Assurance and Regulatory Documentation required for the
official registration of the new medicinal product developed.
On
the basis of the organization of specific activities for each department
participating in the project, parallel lines of work were generated so that the
responsibility for the execution of the project did not lie entirely on the
Research and Development Department (Figure 7).
This
implied that different aspects of the development process progressed
simultaneously: while experimental tests were conducted, Plant Engineering
solved the requirements for equipment and infrastructure, or Quality Management
advanced in the preparation of the necessary documentation. This allowed the
company to reduce development time by 35%, (we had said that a pharmaceutical
development requires at least five years to be completed), with the
corresponding reduction in arising expenses (Figure 9).
Figure 9: R&D Project Deployment Time
Planning
and the employment of quality tools generated joint tasks, consensus decision
making, and integration of teams generally acting in a stratified manner. The
most important result is not -as it could be presupposed- economic profit, but
the cultural and educational transformation achieved by using this method of
working.
Early
knowledge of internal and external customer requirements allowed the developers
of the project to value needs and demands, to determine quality standards, and
to make the necessary changes in the original plans of the project in order to
respond to customer requirements according to actual transfer and production
possibilities. In other words, in the pharmaceutical industry a new idea is
actually good only if it can be materialized into a quality product made at low
cost production.
One
of the planning keys was to translate the requirements into the product
specifications, in an economical way. QFD represents a good tool that allows
the company to ensure, in a structured way, that what began as a customer
requirement is considered all along the development process and is transferred
to production in the most economical way possible, always assuring the maximum
quality standard.
4.2.
Evaluation
of the Results of the QFD:
As we
said before, QFD means transferring the customer opinion to the product. We
also assert that the essence of planning a new project is to define the orientation towards the customer so that
researchers and technologists can transform that orientation into a technical
tool for quality and high profitability production.
In
our hypothesis we put forward that it was possible to achieve that requirement
by using QFD for the development of a medicine.
Planning
work brought about an action plan that is summarized in the following five
points:
·
New QFD Development
·
Determination and elimination of bottlenecks
·
Development of the new product
·
Putting the process under control
·
Production and sales
Quality
Function Deployment was completed as explained before. In order to evaluate the
results and to confirm the validity of the hypotheses formulated, the following
were defined as quality indicators:
(A) Time of realization of the development
(B) Percentage of delays in the development
(C) Investment
(D) Costs
(E) Percentage of reprocess and secondary developments
subsequent to transfer
(F) On the basis of market trends, compliance with
quality requirements
(G) Positioning in the market
(H) Competitiveness.
(I) Number of scientific publications derived from the
development of the product
In spite of the forecasts, in the
course of the experimental development there appeared some bottlenecks that
represented a constraint for the execution of the proposed objectives. Those
restrictions were often related to:
a) Delays
in the provision of equipment, reagents and drugs coming from abroad which was
due to the economic situation and bureaucratic problems of the country, related
to customs procedures that exceeded any previous planning. Besides,
insufficient equipment had to be shared among other simultaneous projects
(situation that had been taken into account in the multiproject analysis) as
well as with other sectors such as Quality Control.
b) Excessive
wear and fatigue in some equipment, which caused delays for repairs and
corrective maintenance.
c) Modification
of experiments and reagents as a result of experimental development, which
originated the need to buy new drugs and equipment.
It is
normal that experimental and research work result in changes in the original
plans leading to the need to find new and different ways to achieve the
objectives, which may give origin to new needs with the consequent delays in
the predetermined terms. It is normal and preferable for this to happen at this
stage of the development and not at later stages; in fact, this type of
modifications makes the measures taken at the moment of a new product transfer
and scale-up more reliable.
Regarding
bottlenecks, the first task was to determine their causes in order to eliminate
them. In some cases, such as those related to experimental work, the causes
were not eliminated completely since they were inherent in the research and
product development work. However, a solution was sought for those causes
related to equipment maintenance and repair, which consisted in an equipment
validation program and a preventive maintenance plan.
In
order to avoid stopping the development of the project and generating major
delays, the decision was made to carry on with the project, and continue
dealing with the constraints until their causes could be eliminated. For that
purpose, in some cases drug and reagent stocks and work shifts were rearranged
in accordance with the activities plan for each project in course.
The
results allowed the evaluation of the behavior of the quality indicators
considering two aspects, related to:
I.
Management and Internal Customer Requirements
II.
The Product, Market Positioning and External Customer
Requirements
Time
of Development: The development of products belonging to the same family took
between 6 and 7 years to be completed, while with the application of QFD that
time decreased to 4 years, which meant 35% less time. Figure 7 shows the time
required for the development of a process in which QFD was not applied,
compared with our process, in which QFD was applied.
The
most important difference is centered on stage 1, and during the planning
process time. This allowed the company to execute more efficiently the research
and development stages and also to reduce time in the final stages of the
project.
Delays:
Although with the application of QFD and process planning it was not possible
to avoid delays completely, their final incidence on the transfer from the
product development to production scale decreased. Figure 10 details the
corresponding reduction percentages.
Figure10: R&D Project Delays
Development
Investment: With the use of QFD we considerably modified the development
investment model, as we distributed the budget so that the greatest portion was
assigned to the initial stages. The decrease in expenditure or non-quality
costs allowed the company to make a total investment that resulted slightly
smaller than the estimate, thus improving the project profit (table 3).
Table
3: R&D Investment and Costs (U$D)
|
Stage |
R&D
Investments vs. Costs |
|||||
|
QFD-based Project |
Non QFD-based Project |
|||||
|
Investment $ |
Total Cost $ |
Non-Q cost$ |
Planned Inv. $ |
Total Cost $ |
Non Q cost $ |
|
|
1 |
30000 |
45000 |
260 |
15000 |
10000 |
2650 |
|
2 |
60000 |
50000 |
4100 |
45000 |
47000 |
2350 |
|
3 |
75000 |
65000 |
2350 |
60000 |
70000 |
7000 |
|
4 |
75000 |
50000 |
2040 |
75000 |
60000 |
6000 |
|
5 |
30000 |
30000 |
3200 |
60000 |
20000 |
10000 |
|
6 |
30000 |
5000 |
300 |
45000 |
113000 |
84000 |
|
Total |
300000 |
245000 |
12250 |
300000 |
320000 |
112000 |
|
% |
100 |
18 |
5 |
100 |
107 |
23 |
Assigning more funds to the initial
stages allowed the company to carry out trials and the necessary corrections
during the experimental development, adjusting the process so that in the
transfer and scale-up stages, the investment gradually decreased. This trend
becomes apparent when the new project is compared with previous ones, since in
general, in those developments the investment would become higher at the final
moments, often as the result of an increase in costs derived from corrections
and secondary developments subsequent to transfer of development (Figure 11).
Figure 11: Investment Planning
Multi-project
planning, team work, efficiency in the use of equipment and resources, and
continuous improvement from the “do it
well from the start” perspective generated savings in relation to the
initial investment forecast. QFD allowed the company to work under quality
standards that avoided deviations from the initial objective and unnecessary
experimental developments parallel to the main project, which generally respond
to matters that draw the attention of the researcher.
Development
Costs: An efficient project shows a rise in costs during the initial stages,
and a reduction to a minimum amount towards the end of the final stages.
In projects with inefficient
planning and poorly defined quality criteria the cost curve was shaped
inversely in relation to our proposed project (Figure 6). It showed a rising
trend even when the development product had already been totally transferred to
production -let us remember reprocess and secondary development necessary for
the correction of errors or to lack of foresight. All these costs often
responded to incorrect project planning and to non-quality (Figure 12).
Figure 12: Planned investment vs. project and Non
Quality costs.
As of QFD application, efforts were
aimed at improving the quality of the development process and of the project
administration and management. Besides, more attention was paid to the
customer's voice, and the development and experimental works were adjusted to
an action plan with finite life and exposed to continuous evaluations for the
purpose of making it more efficient (Figure 13).
Figure 13. Cost Distribution vs. Project Stages.
This group of actions produces a
decrease in the costs, especially on those related to non-quality, and a
distribution of expenditure that is close to an ideal distribution (Figure 13).
Reprocess and Secondary Developments
subsequent to Transfer: We put forward that one of the non-quality indicators
for product development is represented by the number of corrections made on a
complete development project. In fact, this situation illustrates the
consequences of lack of planning, managerial deficiencies and inadequate
decision making during the course of the project.
We often believe that these
corrections are related to technical aspects, but they actually involve all the
aspects of the project. Sometimes, poor advice on legal aspects may cause
countermarches that delay the definitive launching of the new product. In the
case developed a decrease in the percentage of changes was attained because all
the necessary corrections were made during the experimental stages so that only
final adjustments remained for the transfer and production stages (Figure 14).
Figure 14. Changes in the project
Quality Requirements: QFD
development allowed us to comply with quality requirements and to respond to
quality demands. Besides, the market trend for those requirements considered
most important was determined through a projection covering 3 to 5 years as
from the end of the development. Figure 15 shows the product potency trend and
the position occupied by the product developed.
The project allows us to obtain two
different potencies of 330 and 250 ug which respond to customer needs, and to
compete within the market trend for the coming years. The process of constant
feedback and continuous improvement should provide a more potent product by the
end of the abovementioned period. For that purpose, a new project is launched,
involving new production technologies.
Figure 15: Required Quality: Potency in ug
In
relation to potency, the solution volume presented in vials shows a tendency to
decrease (Figure 16) as a purer product with greater specific potency is
produced. Other aspects that responded to customer requirements were related to
the information appearing on the package, packaging type, final price of the
product and its availability in the market.
Figure 16: Required Quality: Volume per vial.
Figure
17 (A-B) shows how the said improvements affected the position of the product
in the market. Positioning in the Market: Figure 17 shows the product
behavior in the market, in terms of quality required by the customer.
Figure17 (A): Product
behavior in the market in terms of the quality required by the customer. Laboratory (H) vs. other Laboratories (B, P,
G). Before QFD
Prior
to QFD development, a projection was made starting from the product behavior
before it was redesigned. The improvement observed in the new product becomes
more evident in the growth of the market portion that it occupies and in its
quality/price relationship.
Figure17 (B): Product behavior in the market in terms
of the quality required by the
customer. Laboratory (H) vs. other
Laboratories (B, P, G). After QFD
Competitive
evolution of the product: As from the application of QFD to the development of
the product, the evolution of the product in relation to competitors’ products
showed continuous improvement. Figure 18 shows the behavior of the various
quality requirements expressing the external customer needs.
Figure18: Position in the market. QFD-based product
(Lab. H) vs. other Laboratories products (B, P, G).
5. FINAL CONSIDERATIONS:
In
every research and development process, the possibility of making good
decisions is lower at the initial stages of the project, hence the importance
of quality planning. Undoubtedly, good planning represents assurance of the
product development quality from the beginning itself, and reduction in
non-quality costs caused by making wrong decisions (CHENG; DE MELO FILHO, 2010; PRAMOD,
2018).
This
idea implies the decision of investing more and better resources in the initial
stages of the project, and avoiding expensive correction cycles after the
development is finished.
If something that is relatively
simple has not yet been appropriately dealt with within the realm of a research
and development group, it is due to an incorrect vision of multifunction work,
which requires correct project planning.
We
can assert that QFD is an appropriate tool for the management of a development
project since it allowed us to establish the necessary links between product
excellence, internal and external customer needs, and the opportunities
existing in a competitive market.
QFD
created the need to establish planning mechanisms for research and development
projects in the short, medium and long term, in order to avoid subjective
evaluations and decisions made by people wrongly believing to be project
management experts.
QFD
requires working methods that led to reductions in interdivisional clashes and
jealousy as well as in conflicts of power between researchers, product
developers, and control, production and marketing technicians. This allowed the
execution of projects with collaborative participation of personnel of the most
diverse areas and the consequent simplification of planning and control tasks.
Besides, QFD made it possible for the personnel to share the responsibilities
arising from the project.
The
opinion, suppositions or subjective desires of researchers were not mistaken
for customer requirements; thus, the satisfaction of customer needs was
attained and expressed in the final product. Besides, QFD proved to be
applicable to any area of the organization or to any of its processes,
culminating in the design of products in accord with customer requirements.
Once
the application QFD is finished, it becomes a knowledge tool that may be used
for later developments of components or systems specified for other products.
This avoids reinventing the wheel, so
that the transfer of knowledge from project to project is safeguarded and time
is saved.
The application of QFD required
training and discipline, which helps to attain a cultural change in the
research and development process even if such application is not easy when
dealing with completely new and creative ideas. In fact, in these cases the
most difficult task will be to determine customer requirements (STEFAN SCHURR;
ARCIDIACONO, 2011).
We
put forward that QFD contributes benefits to the research and development
process, mainly for industrial research teams, since it allows them to improve
competitiveness along with quality and productivity. The development process
acquires the characteristics of orientation towards the customer, efficiency in
time-management, orientation to team work, and permanent documentation of the
process (YACUZZI; MARTÍN, 2003; GORIYA, 2016).
An
organization with total quality management is an organization oriented towards
the customer. QFD requires gathering customer input and feedback, information
that is translated into a group of customer specific requirements. The
performances of the organization and of competitor organizations in relation to
requirements are carefully studied. This allows the organization to compare
itself with competitors with respect to customer needs satisfaction (VONDEREMBSE; RAGHUNATHAN,
1997).
QFD
reduces the time of development because it is centered on specific and clearly
identified customer requirements. As a result, there is no time waste in
developing features that have little or null value for the customer.
QFD
is an approach oriented to team work. All decisions are based on consensus and
they include thorough brainstorming and discussion. Since all the actions to be
taken are identified as parts of the process, individuals can visualize their
position within the organization, which fosters team work.
QFD
emphasizes the documentation aspect. One of the products of the QFD process is
a comprehensive and complete document which gathers all relevant data about all
processes and their performance in relation to customer requirements. That
document is constantly updated as new information is known and obsolete
information is discarded. Updated information on customer requirements and on
internal processes is particularly useful when problems arise.
Finally
we can assert that with QFD application the proposed objectives were fulfilled.
QFD added simplicity and reliability to the production, and security and highly
competitive costs not only to the product development but also to the final
product. QFD was supplemented with GMP and it proved to be highly applicable in
the pharmaceutical industry even in the case that certification for a quality
system is not pursued.
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