Ketinlly Yasmyne Nascimento Martins
Universidade Estadual da Paraíba, Brasil
E-mail: yasmynefisio@hotmail.com
Kléber Cavalcanti Nóbrega
Universidade Potiguar, Brasil
E-mail: klebercnobrega@gmail.com
Nadja Maria da Silva Oliveira Brito
Universidade Estadual da Paraíba, Brasil
E-mail: nadjamso@gmail.com
Rodolfo Ramos Castelo Branco
Universidade Estadual da Paraíba, Brasil
E-mail: rodolfo.ramos@outlook.com.br
Jorge Vicente Lopes
da Silva
Centro de Tecnologia da Informação Renato Archer, Brasil
E-mail: jorge.silva@cti.gov.br
Submission: 08/06/2015
Revision: 12/07/2015
Accept: 22/07/2015
ABSTRACT
Based on a case study, this paper presents a
methodology to adopt ISO 9001 standards for organizations, which make use of
additive manufacturing to build products for medical use. Starting with a
conceptual model, guidelines were identified to guide planning and operation of
the management system, as well as its maintenance and improvement.
1. INTRODUCTION
In
the last decade we have witnessed a major breakthrough in technological
innovation, especially with regard to the emergence of new products and services
being made available to the consumer, and this has become increasingly
demanding. Given this statement, organizations are faced with the need to
implement or even optimize quality management systems. Thus, a technological
modernization must be performed with criteria, adding value to processes that
comprise each organization to achieve a continuous improvement of its products
/ services.
In
this context, the modernization of production processes, the Additive
Manufacturing (AM) process by which objects are created in three dimensions,
using CAD software (Computer-Aided Design), and print 3D printers, has
revolutionized the world market, bringing numerous benefits to companies and
organizations that have implemented this technology in its process (VOLPATO,
2007).
Thus,
with the purpose of standardizing the entire production process, including the
MA, the Quality Management System (QMS) ISO 9001 series seeks to provide
confidence to stakeholders, especially customers, and denotes the certification
bodies which the company manages the quality, aiming to fully meet the standard
requirements (CARPINET, MIGUEL and GEROLAMO, 2007).
Second
Meulen and Rivera (2014), the year 2015 will be a milestone in labor
relations between man and machine, where more than 90% of the producers of
durable goods will actively pursue external partnerships to support new
business models customized products, and by 2017, approximately 20% of these
will use 3D printing to meet the demands of the market.
Historically,
demand for products and services with fast delivery, low cost and adaptable to
consumer needs, are encouraging a revolution of the manufacturing market.
Within this reasoning, the use of 3D printing has caused a profound impact on
the viability of new businesses by reducing production costs. All categories of
durable goods feel the need to customize the product made possible by
increasingly easy access, and the trend is for manufacturers to develop ways to
bring consumers closer to the project development experience.
Traditionally,
MA is best known in the areas of industrial production, construction and
architecture, but its use in the medical field has been widespread since the
90s, when their application was extended for the manufacture of custom implants
and prostheses, Anatomy of study and surgical plans in cases of trauma or
squeals. (BERTOL, 2008).
This
article aims to present through case study, a methodology to adapt the ISO 9001
standards for additives manufacturing organizations for printing products for
medical use.
2. THEORETICAL FOUNDATION
2.1 ISO 9001
The
Quality Management Systems (QMS) are an interesting alternative to optimize
processes in organizations as they develop a pattern of improvement from the
motivation of the workforce, the process control, identifying requirements and
meeting the needs clients (CALARGE; LIMA, 2001).
It
is appropriate that the adoption of a quality management system is a strategic
decision of an organization. So we use the ISO 9001:2008 to promote the
adoption of a process approach when developing, implementing and improving the
effectiveness of a management system looking for customer satisfaction by
meeting customer requirements (ABNT, 2008), establishing which the quality
policy of an organization, as well as its quality manual where procedures,
objectives, indicators and internal and external audit cycles should be
described.
This pattern of adoption of ISO 9001 applies, at least in theory, to all
organizations, regardless of type, size or product / service offered and can be
considered a basic and introductory element to establish structured and
organized process, making it the fundamental basis for the advancement of
quality and hence of business management (MAEKAWA ; CARVALHO; OLIVEIRA, 2013).
As
Magd (2008), the most important perceived benefits with the implementation of
ISO 9001 in organizations are improved documentation, quality system
efficiency; clear statement of work, procedures and responsibilities (aid in
the selection of suppliers and product quality).
The
form is used to demonstrate the quality of the production process is the
certification, which is issued by an institution accredited by INMETRO. The ISO
certification was created to prove the quality standard of a company, also used
as a way to avoid waste, increase productivity and efficiency and provide a
higher level of internal organization of the company. (MIRANDA et al., 2006).
External certification bodies carry out certification of an organization, since
the ISO itself cannot issue certificates.
2.2 Additive Manufacturing applied
to Health
The
technologies applied strategically in health have played key role in the
contemporary world, creating increasingly frequent search update from
professionals with regard to the areas of technological innovation (CASTELO BRANCO, 2014). As a
concrete example of this innovation is the three-dimensional printing.
The
rapid prototyping term has been replaced by Additive Manufacturing since 2010,
a technical committee formed by the American Society for Testing and Materials
(ASTM) agreed that a new technical term should be adopted. The purpose of this
new nomenclature is clear that some machines with this technology can be built
to final objects from templates generated in CAD (NASCIMENTO, 2013).
The
MA process involves high technology and complexity, since alloy materials,
layer by layer, in order to construct an object, called biomodel, in health
care (GORNI, 2007).
The
acquisition of bio models compatible with the human anatomy has been developed
due to the integration of CAD technology to technological advances in medical
imaging. This integration enables images Computed Tomography (CT), Magnetic
Resonance Imaging (MRI), ultrasound (US) or 3D Scanner properly saved in DICOM
(Digital Imaging and Communications in Medicine) are processed by specific
programs, creating a together dimensional (3D) data in .STL format
(Stereolithographic), sent to the stations Rapid Prototyping (RP) where,
through the CAM system (Computed Aided Manufacturing), the bio models are
manufactured (SUGAR et
al,. 2004).
Currently,
there are many efforts in order to reduce more and more mistakes and / or
secondary issues in medical surgeries, since the results obtained these must be
the most accurate possible. Therefore, a set of information is needed before
this procedure, and an accurate clinical examination, laboratory tests and
imaging to be no complications in bringing further damage to the patient.
Thanks to the additive manufacturing technology, a complete surgical planning
is possible by studying the three-dimensional model to simulate the possibility
of still making the surgical procedure more realistic (GIROD et al., 2001). A
large area that has benefited from additive manufacturing is to the maxillofacial
complex surgeries (SAFIRA et al., 2010)
Another
major use for this technology is in the manufacture of molds for custom
prostheses used in reconstructive surgery of bony parts to repair congenital
deformities or trauma of any part of the body (BERTOL, 2008).
Among
all the advantages cited in the use of Additive Manufacturing can cite
independence in geometric complexity of any piece because the component is
manufactured in a single process step built into a single unit from start to
finish, it is carried out almost automatically by and dedicated systems is
still done in less time and at lower cost, and can also be made in large
quantities (VOLPATO,
2007).
2.3 ISO 9001 in Additive
Manufacturing environments for medical use
The adoption of quality management
systems in environments that use the Additive Manufacturing process is reduced,
we can mention the few that exist, this happens because it is a new technology
and which is on the rise (AHRENS et al., 2012). However, when we speak only in
the medical field as a whole, we can mention hospitals, clinics, laboratories
and many other environments that have ISO 9001 certification, as they have to
present a standard of excellence to put on the market (MIRANDA; ALMEIDA, 2007).
When we set off for
environment specifically work with Additive Manufacturing, we have difficulty,
the AM process is not yet fully finalized, as there are many applications in
the medical, industrial, civil, bioengineering, among others, and each area
uses a method differentiated process, thus difficult to standardize. But it is
already publicly known certification of dimensional Technologies Division
(DT3D) of the Information Renato Acher Technology Center (CTI) to ISO 9001,
which was the subject of this study.
3. METHODOLOGY
3.1 Type of Study
This
study is characterized as a descriptive research, the case study type, through
interviews.
According
to Cervo et al (2007), descriptive studies, observe, register, analyzes and
correlates collected facts of reality itself. According to Barros and Lehfeld
(2000), case studies turns to the collection and registration information on
one or more individualized cases, developing critical reports organized and
evaluated, giving margin to decisions and interventions on the chosen object
for research, which can be a community, an organization, a business, etc. Cervo
et al (2007) also reports that data collection involves several steps such as
preparing the collection instrument, the schedule of collection and also the
type of data and collection.
Taking
theoretical basis for these claims, this case study was conducted through
interviews and monitoring of the organization's activities. A research screenplay
was elaborate from data collected from the guidelines governing the ISO 9001:
2008. Contains questions related to the items of this standard and even some
made by the authors in order to extract information about the implementation of
the quality management system as well as the impacts, benefits and achievements
of the organization chosen for this study. This script can be seen in the table
1:
Table 1 -
Screenplay interview Case Study
Interview
script |
|
Organization
Profile |
Name |
Start up
date |
|
Location |
|
Industry/playing
field |
|
No of
employees |
|
Certification
Scope |
Standard
adopted |
Product
line(s) certified |
|
Certification
date |
|
Assessment
entity |
|
Nº of
certificate renewal |
|
Process
Deployment |
Motivation
to certificate |
Decision
maker |
|
Implementation
start |
|
Implementation
finish |
|
Implementation
leader |
|
Number of components of implementation team |
|
Profile of
implementation team |
|
Supported
by external consultant? |
|
Main difficulties faced during the implementation. |
|
Implementation
methodology |
Documents created (procedures, instructions, records) - Quantity? |
Documents created (procedures, instructions, records) – Which? |
|
Benefits
and Outcomes |
Direct
benefits |
Indirect
benefits |
|
Qualitative
outcomes |
|
Quantitative
outcomes |
3.2 Procedures
Taking as theoretical
basis of the above statements, this case study was conducted through interviews
and monitoring the activities of the chosen organization. The application of
this case study was made in Three-Dimensional Technology Division (DT3D) of the
Renato Archer Information Technology Center (CTI),
which has a certified quality management system and seeks to continuously
improve the efficiency of their system, and quality of offered services and for
this reason has been selected for this study.
The case study was
developed in DT3D between December 01 and 05, 2014, by a previously trained
interviewer, from Center for Strategic Technologies in Health (NUTES) - 3D
Technologies Laboratory (LT3D) . The monitoring of activities in the division
was made by observation in their sectors, as these are part of the quality
management system of this Division.
After this step, an
interview with the director of DT3D was made, according to the above script in
table 1, in which it was possible to gather information about the quality
management system, from the decision of the ISO 9001: 2008, to the results
achieved with the implementation. In sequence, the management consultant,
presented all documentation used for ISO implementation, which served as a
subsidy for the construction of this case study.
4. CASE STUDY
4.1
Organization History
The organization selected
for this case study is the three-dimensional Technologies Division (DT3D), one
of units of competency of the Information Technology Renato Archer Center
(CTI). The Center is a research institute affiliated to Brazilian Ministry of
Science, Technology and Innovation (MCTI) and is engaged in research and
development in information technology.
The DT3D Division started to operate in 1997, and since
then has been dedicated to research, development and technological applications
in various areas of knowledge, supporting the Brazilian industry and medical
service providers by means of either internal endeavors or projects in
partnership with several universities. Currently, special attention and great
effort is put in the medical field by DT3 division, by mean of support to hundreds
of hospitals, and services and technology provision to support Brazilian
industrial development, as well as pure and industry applied research. These
activities are housed in three major programs: the ProMed - focused on
research, development and medical applications; the ProInd – dedicated to
support the industrial development; and the ProExp - a program focused on the
development and broadcast of 3D technologies unconventional applications in
industry and scientific experiments. These programs work together as a strategy
to seek partnerships in the industry, universities and other R& D centers
with the purpose to empower the raise of innovation, scientific publications
technological diffusion and relevant services to society (Silva 2013).
4.2
QMS Implementation Process
The Quality Management System Implementation in the organization was
made by ISO 9001:2008 in order to gain reliable and demonstrate that their
processes and, consequently, its projects and services were performed in order
to meet the requirements and customer satisfaction;
The implementation process spent 32 months, from mid-April 2009 to
November 2011, when the DT3D was granted with certification after audit process
conducted by BUREAU VERITAS certification body. The certificate was first valid
until November 2014 and is now through its renewal path. To make data
collection possible and data analysis feasible to our research team resources,
that limited the case study scope to DT3D Research Project and Development
(R&D) and services based on three-dimensional technology to the industrial
areas, medical service providers and experimental research, including the
activities of prototyping, 3D printing, technical evaluation and image
reconstruction.
During
the construction of this case study, the DT3D was prompt to be re-certified,
adding to the certification renewal the Project Development process as a new
candidate process to be granted with ISO 9001:2008 certification.
Dr.
Jorge Vicente Lopes da Silva, current head of DT3D, made the initial decision
to introduce a QMS in the unit. The unit director and four other members, from
which three internal staff, an external consultant, composed the implementation
team assembled to implement the quality management system.
4.3
Implementation Methodology
We used the
turtle diagram to identify each service delivery process, including the
activities of the support processes that composes the quality management system
and its application. Barnes (1982) states that turtle diagram is a good
technique to express process dynamics in a compact view in order to make it
easier to understand and further improvement.
One turtle diagram was made for each DT3D
processes required to the development of the Quality Management System, such
as: Management, Quality Management, Administration, Production, PROIND, PROMED,
PROCEXP, Projects, according to the format shown in Figure 1.
Figure 1: Diagram displaying the DT3D processes
Source: Quality Manual DT3D
In
each item of the diagram, it is described what each process needs to be
executed. Special attention is required to items Documentation and Monitoring
and Measurement, because in these processes entail the quality procedures (PQ),
work instructions (WI) and the quality control documents (QD) that each process
needs to be performed as well as the quality registers (QR) that must be made
at the end of each procedure.
According to item 4.1 which deals
with ISO 9001:2008 general requirements, the organization must: determine the
processes that compose the quality management system and its application
throughout the organization; determine the execution sequence and interactions
of these processes; determine criteria and methods needed to ensure
effectiveness in operation and control of these processes; ensure the necessary
information and resource provision to support the operation and monitoring of
these processes; monitor, measure where applicable and analyze these processes;
implement actions that these processes require to achieve planned results and
keep in continual improvement.
With this organization the Quality
Manual (QM) was described in levels, how would be the structure of the
documentation DT3D. Level 1 document is the QM itself, which describes all QMS
in its policies, objectives and the Division responsibilities. Level 2
documents were prepared in terms of quality procedures, in each process step is
described in detailed instructions. Level 3 documents were prepared in form of
work instructions and quality control documents in which are as well described
in detail and sequentially every activity that must be done to get the result
of a particular procedure. In the DT3D case it was determined that IT only
would be done when the activity performed was considered critical in the QMS.
In level 4 documents the procedures are registered in the form of quality
records, which are issued to objectively show that the activities have been
actually executed.
According
to the item 4.2.1, which refers to generalities of ISO Documentation
Requirements 9001:2008, the quality management system documentation shall
include: documented statements of a quality policy and quality objectives; a
quality manual; documented procedures and records required by this Standard;
documents including records, determined by the organization as necessary to
ensure the planning, operation and the effective control of its processes.
In
compliance with the 9001:2008 standard DT3D has ten documented procedures,
which are one DT3D Quality manual, eight quality procedures as required by the
standard, and one work instruction for rapid prototyping. There are also six
Quality Documents related to the quality objectives and indicators, the
responsibility and authority matrix, the personal protective equipment (PPE) ,
the division professional profile, the specification of critical items such as
materials, supplies and services and the failure report processes.
Also
according to the standard several quality records have been made, among them
master list of QMS documents, minutes of meetings, action and training plans
and assessments of their effectiveness, critical analysis of products requests
and offers, records of proceedings and check-list of all 3D printers division,
record control of production, maintenance reports of 3D printer, control and
application of corrective and preventive actions, consolidated indicators and
internal audit plan, customer satisfaction survey.
All
procedures, records and work instructions are performed by key stakeholders, in
digital format, but with manual movement within the division, thus making up a
risk, since it can happen any human error in the proceedings. Even with this
documentation format, there are no reports of errors, and have been developed
over three million cases of success in PRE MED program for surgery and cost
reduction.
The DT3D also executes support processes, since
this organization is a unit of CTI. They are: DSC - Computer Support Division,
the division responsible for support and maintenance of IT infrastructure; DINF
- Division responsible for take care of DT3D facilities; DSUP - Division of
Supplies and Services division responsible for carrying supplies purchases and
services when purchased with direct funds from the Federal Budget (Brazilian
Federal Government), in these cases it is up to DT3D the technical
specification of the purchase of items and after receipt, verify that they are
in accordance with specified requirements; HRD - Human Resources Division, the
division responsible for the safekeeping documentation related to DT3D
employees CTI work contracts; and finally
FACTI - a legal entity private, non-profit, Information Technology
Foundation with full administrative autonomy dedicated to CTI operations,
providing complementary human resources and materials in order to speed up
CTI interaction with the market. (SILVA,
2013).
Within DT3D the QMS FACTI takes intermediation
between the division and its customers, in what concerns to sale, service and
goods acceptance and administration of the resources earned by the division,
through the provision of services. FACTI is responsible for purchasing supplies
and services, provide skilled labor to complement the team DT3D and keep
documentation of these employees. (SILVA, 2013)
Note that the printed prototypes in PROMED
program are mostly free, because prototyping services requests come from
physicians and / or hospitals in the Brazilian public health system. When
request comes from private sources prototypes are made at the request of the
physician, for patients who afford prototype. Requests processed in DT3D come
from all over the country and even from other countries.
4.4
Benefits and Results achieved with implementation
The DT3D
directive board claim that the ISO 9001:2008 - based QMS introduced in the
division came to standardize and systematize activities already practiced in
their service and products providing routine, since they had been already
trying to adopt a systematic management model while they did not have
certification yet. With the QMS implementation DT3D has achieving an
standardized the entire system according to ISO 9001:2008, made indicators
collection and demonstration to Brazilian Ministry of Health straightforward,
being able to express more clearly express in numbers and processes every
advance that the organization reached. In addition a complete activity map was
built, which enabled clear communication and comprehension to all levels staff,
thus harmonizing the work environment. Standardization of procedures enable
also more security to perform DT3D processes activities.
5. CONCLUSIONS
In
the course of this study, was described the whole methodology of implementation
of the Quality Management System in the 3D Technologies Division of Renato
Archer Information Technology Center. As products of the
implementation process we had the Quality Manual, a document that defines the
scope of the QMS, the Quality Procedures according to the standard, the work
instructions for the correct development of activities, quality documents that
include the information in the procedures and documents define a
standardization of reports and records used by the organization through quality
records.
Throughout this study,
we can see that the implementation of the QMS was conducted smoothly without
causing any harm to the organization. Was efficient, since before the
implementation of the standard already intuitively followed a pattern for the
proper functioning of the system. We
conclude the implementation of ISO 9001:2008
a concrete advance to the DT3D, consolidating and standardizing processes by
means of its the Quality Management System.
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