Memoria Investigaciones en Ingeniería, núm. 28 (2025). pp. 287-302
https://doi.org/10.36561/ING.28.17
ISSN 2301-1092 ISSN (en línea) 2301-1106 Universidad de Montevideo, Uruguay
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On-Time Delivery Improvement in an Injection Molding Process Applying a
Problem-Solving Approach Based on Lean-Sigma and the MSA Effect
Mejora del índice de Entregas a Tiempo en un Proceso de Moldeo por Inyección de
Plástico Utilizando un Enfoque Orientado a la Solución de Problemas Basado en
Lean-Sigma y el Efecto del Sistema de Medición
Melhorar a Taxa de Entrega Pontual num Processo de Moldagem por Injeção de
Plástico Utilizando uma Abordagem Orientada para o Problema Lean-Sigma e o
Efeito do Sistema de Medição
Omar Celis-Gracia
1
, Jorge Luis García-Alcaraz
2
(*), Fabiola Hermosillo-Villalobos
3
Recibido: 21/01/2025 Aceptado: 02/03/2025
Summary. - Mexico’s manufacturing industry is vital to the global economy. This industry has recently faced
challenges due to the COVID-19 pandemic and globalized markets. Some developed countries can adopt innovative
technologies; however, Mexico focuses on improving production processes with little investment, combined with
existing resources and technology. Mexican companies use improvement techniques such as Six Sigma and Lean
Manufacturing to achieve this goal. This study reports a method called Lean-Sigma that, unlike traditional methods
that take months or even years to solve a problem, our method offers results in weeks, avoiding waste generation and
speeding up decision-making. The proposed method consists of the following phases: identifying and measuring the
problem, analyzing the root cause, developing a solution, and verifying the solution and control plan. The main
characteristic of this approach is that it acts at the speed of Lean and uses engineering tools to solve problems and to
demonstrate how the measurement system error could affect the achievement of the single-minute exchange of die
(SMED). To validate the proposed method, a case study is presented in a plastic injection molding process in a
manufacturing company located in Ciudad Juárez (Chihuahua, xico), which has a late delivery rate that causes
delays in the final assembly lines. Implementing the suggested strategy increased on-time deliveries from 77% to
99.36% in six weeks.
Keywords: Lean-Sigma, problem-solving, SMED, OTD, MSA.
(*) Corresponding author.
1
PhD Student, Department of Electrical Engineering and Computer Science, Universidad Autónoma de Ciudad Juárez (México),
al232735@alumnos.uacj.mx, ORCID iD: https://orcid.org/0000-0003-2061-3384
2
Full-Time Professor PhD, Department of Industrial Engineering and Manufacturing, Universidad Autónoma de Ciudad Juárez
(México), jorge.garcia@uacj.mx, ORCID iD: https://orcid.org/0000-0002-7092-6963
3
PhD Student, Department of Electrical Engineering and Computer Science, Universidad Autónoma de Ciudad Juárez (México),
al232735@alumnos.uacj.mx, ORCID iD: https://orcid.org/0000-0003-1644-7598
O. Celis-Gracia, J. L. García-Alcaraz, F. Hermosillo-Villalobos
Memoria Investigaciones en Ingeniería, núm. 28 (2025). pp. 287-302
https://doi.org/10.36561/ING.28.17
ISSN 2301-1092 ISSN (en línea) 2301-1106 Universidad de Montevideo, Uruguay 288
Resumen. - La industria manufacturera de México es vital para la economía mundial. Esta industria ha enfrentado
recientemente algunos retos debido a la pandemia COVID-19 y a la globalización de los mercados. Algunos países
desarrollados pueden adoptar tecnologías innovadoras; sin embargo, en México, la atención se centra en la mejora
de los procesos de producción con poca inversión, combinada con los recursos y la tecnología existentes. Las empresas
mexicanas utilizan técnicas de mejora como Seis Sigma y Manufactura Esbelta para lograr este objetivo. Este estudio
reporta un método denominado Lean-Sigma que, a diferencia de los métodos tradicionales que tardan meses o incluso
años en resolver un problema, nuestro método ofrece resultados en semanas, evitando la generación de desperdicios
y agilizando la toma de decisiones. El método propuesto consta de las siguientes fases: identificación y medición del
problema, análisis de la causa raíz, desarrollo de una solución y verificación de la solución y del plan de control. La
principal característica de este enfoque es que actúa a la velocidad de Lean y utiliza herramientas de ingeniería para
resolver problemas, así como para demostrar cómo el error del sistema de medición podría afectar a la consecución
del cambio de troquel en un minuto (SMED). Para validar el método propuesto, se presenta un caso de estudio en un
proceso de moldeo por inyección de plástico en una empresa manufacturera ubicada en Ciudad Juárez (Chihuahua
México), la cual tiene una tasa de entrega tardía que ocasiona retrasos en las líneas de ensamble final. La aplicación
de la estrategia sugerida aumentó las entregas a tiempo del 77% al 99,36% en seis semanas.
Palabras clave: Lean-Sigma, Solución de Problemas, SMED, Entregas a Tiempo, MSA.
Resumo. - A indústria transformadora do México é vital para a economia global. Esta indústria tem enfrentado
recentemente alguns desafios devido à pandemia da COVID-19 e aos mercados globalizados. Alguns países
desenvolvidos podem adotar tecnologias inovadoras; no entanto, no México, a tónica é colocada na melhoria dos
processos de produção com pouco investimento, combinada com os recursos e a tecnologia existentes. As empresas
mexicanas utilizam técnicas de melhoria como o Six Sigma e o Lean Manufacturing para atingir este objetivo. Este
estudo relata um método chamado Lean-Sigma que, ao contrário dos métodos tradicionais que levam meses ou mesmo
anos para resolver um problema, o nosso método oferece resultados em semanas, evitando a geração de resíduos e
acelerando a tomada de decisões. O método proposto consiste nas seguintes fases: identificação e medição do
problema, análise da causa raiz, desenvolvimento de uma solução e verificação da solução e do plano de controlo. A
principal caraterística desta abordagem é que actua à velocidade do Lean e utiliza ferramentas de engenharia para
resolver problemas, bem como para demonstrar de que forma o erro do sistema de medição pode afetar a realização
da troca de moldes num minuto (SMED). Para validar o método proposto, é apresentado um estudo de caso num
processo de moldagem por injeção de plástico numa empresa de produção localizada em Ciudad Juárez (Chihuahua,
México), que tem uma taxa de entrega tardia que causa atrasos nas linhas de montagem finais. A implementação da
estratégia sugerida aumentou a pontualidade das entregas de 77% para 99,36% em seis semanas.
Palavras-chave: Lean-Sigma, Resolução de problemas, SMED, Entrega atempada, MSA.
O. Celis-Gracia, J. L. García-Alcaraz, F. Hermosillo-Villalobos
Memoria Investigaciones en Ingeniería, núm. 28 (2025). pp. 287-302
https://doi.org/10.36561/ING.28.17
ISSN 2301-1092 ISSN (en línea) 2301-1106 Universidad de Montevideo, Uruguay 289
1. Introduction. - The On-time delivery is a challenge faced by manufacturing companies today, negatively impacting
product quality, customer satisfaction, and overall organizational efficiency [1]. According to Kholil et al. [2], the
internal factors make this a difficult challenge to solve, including internal process capabilities, maintenance strategies,
and supply chain coordination. However, external factors, such as the COVID-19 pandemic, have also caused the
closure of raw material manufacturing companies worldwide, delaying supply and reducing the time required for
transformation into finished products [3][4].
Horzela & Semrau [5] stated that one of the factors that contribute negatively to on-time delivery is the machine
availability, which is a critical factor in ensuring on-time delivery in the manufacturing industry. Trakulsunti et al. [6]
stated that by maintaining high levels of machine availability, minimizing downtime, and effectively managing
production schedules, manufacturers can improve their ability to meet customer demands, fulfill delivery commitments
and remain competitive. To achieve increased machine availability, companies must work on becoming more flexible
and with little economic investment; therefore, they use continuous improvement (CI) approaches [7], [8], which play
a crucial role in organizations [9].
Furthermore, CI initiatives, such as Total Quality Management, Lean Manufacturing (LM), and Six Sigma (SS), are
critical in achieving flexibility [10]. These initiatives emphasize the importance of process improvement, employee
training, and flexible production processes as key elements [11]. The benefits of such CI programs are that they enable
organizations to adapt to changing and uncertain environments, stabilizing performance on the one hand and improving
adaptability to change on the other [12]. This adaptability is critical for organizations to remain flexible in dynamic
market conditions [13][14].
To improve flexibility and operate in a more stable state, responding to changing market demands and conditions,
companies use approaches such as Lean Six Sigma (LSS) and Lean-Sigma (LS) [15]. The LSS approach is a process
improvement methodology that combines the principles of Lean Manufacturing and Six Sigma [16]. This is because
by integrating Lean's focus on waste reduction and value creation with the data-driven analytical tools and problem-
solving methodologies of Six Sigma, organizations improve process performance, efficiency, and customer satisfaction
[17]. On the other hand, LS differs in the problem-solving-oriented approach, which provides results in a short period,
unlike LSS, which is more oriented to CI projects that can take, on average, 12 months to obtain results and determine
if decisions have been correct [18].
In Mexico, using these continuous improvement tools is of great importance as it is a country with a developed
manufacturing sector that contributes to the national economy. For example, by 2023, there were 579,828 companies
in the manufacturing sector in the country, of which 486 were in the state of Chihuahua and 330 in Ciudad Juarez,
representing 70% of the total in the entire state. These companies generate approximately 3 million jobs nationwide,
500,000 in Chihuahua state and more than 300,000 in Ciudad Juarez. This means that 60% of jobs in this sector in the
state are generated in Ciudad Juarez, representing 11% at the national level [19]. Therefore, it is important to examine
the industrial sector.
Currently, some publications demonstrate how these CI tools are used and the advantages they provide to the
organization, such as Estrada-Orantes et al. [16] show an application of the LS approach in a manufacturing company
dedicated to the production of plastic components by injection, where one of the machines that made up the process
experienced difficulties in meeting on-time deliveries with a highly demanded product Initially, 99% of the product
had burs (excess material) on one side, and an operator was removed manually, representing a rework; thus, the
process's Cpk index was -1.64, out of the specification limits. The LS approach solves the problem using process
mapping, root cause analysis, brainstorming, five whys, design of experiments (DOE), and Kaizen.
On the other hand, Gracia & Moctezuma [17] present another application of LS in a gear and chain assembly process;
the process had problems with on-time deliveries due to the addition of a new model, and a daily shipment sequence
was required, gaining greater flexibility. Initially, the process had an on-time delivery rate of 66%, and by applying
the LS, a work team was integrated to solve the problem. Using LM tools, the production line was balanced using takt
time calculation and just in time (JIT) to increase productivity from 1.8 to 2.5 pieces/min*man, which positively
impacted the manufacturing lead time from 26.07 to 17 seconds, equivalent to a 35% improvement. Consequently, the
percentage of on-time deliveries increased from 66% to 100%, and the sequence of shipments complied with. This
approach solved the problem within four weeks, and the process capability increased from 2.6 to 3.4 sigmas.
Condé et al. [20] show an LSS approach through the Define, Measure, Analyze, Improve, Control (DMAIC)
methodology, employing a design of experiments to reduce defects in an automotive company. First, the main defects
O. Celis-Gracia, J. L. García-Alcaraz, F. Hermosillo-Villalobos
Memoria Investigaciones en Ingeniería, núm. 28 (2025). pp. 287-302
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ISSN 2301-1092 ISSN (en línea) 2301-1106 Universidad de Montevideo, Uruguay 290
and factors that result in nonconforming parts in the casting and machining processes are identified. The design of
experiments allowed for an increase in the quality level from 3.4 to 4 sigma’s, which is an acceptable sustainable level.
This indicates that LSS increases the quality levels of the process. However, it is necessary to wait six months to see
the results, which generates the company incurring poor quality costs during that time.
Based on the previously mentioned applications, it is concluded that traditional continuous improvement approaches
such as LSS and SS provide good results to organizations with efficiency, delivery, quality, and cost problems;
however, the time required to provide acceptable results averages between six and 12 months, which has a negative
impact on the costs and performance metrics of the organization. Furthermore, while the improvements achieved are
acceptable, the original philosophy of these approaches, which is to bring processes to Six Sigma levels, has not been
achieved. This approach stands out for LS and presents a more attractive form for companies because of its reaction
time. It acts at the speed of lean, identifies the causes of problems, and resolves them in weeks, preventing companies
from continuing to generate waste.
Therefore, this study aims to present the application of Lean Sigma in a manufacturing process with a problem-solving
approach using industrial engineering principles. The novelty of this study is that results can be obtained in weeks, but
it also shows that the error percentage of the measurement system could result in a milestone in achieving SMED. By
solving the problem quickly, manufacturing companies can be flexible and cope with external factors, such as changes
in demand, by improving on-time delivery rates and increasing customer satisfaction.
This case study was conducted in a company that manufactures gasoline pumps in the automotive sector. The demand
for the plastic injection molding process fluctuated, and the number of parts delivered to the final assembly process
was insufficient. This caused line stoppages and delayed deliveries to customers. The process of interest had 20 plastic
injection molding machines, where the noncompliance rate ranged between 20% and 30%, resulting in late deliveries
and high costs owing to low machine availability.
After this introduction, section two includes the methodology for this research. Section three discusses the results,
section four reports the conclusions, and section five presents some of the limitations and future research.
2. Methodology. - The methodology used in this research is based on the DMAIC cycle and the Lean-Sigma approach,
which consists of 5 stages, as shown in Figure I, which includes the steps and engineering tools used.
2.1 Step 1: Identify and measure the problem. - This step aims to define and delimit the problem and obtain initial
data from the production process under initial conditions to determine the condition of the problem in terms of process
capability. It starts with the formation of a multidisciplinary team dedicated full-time to the problem under analysis so
that personnel from different departments can contribute ideas from different perspectives. Including the production
supervisor, process engineer, manufacturing engineer, quality engineer, planning, and, if possible, at least two
operators who perform the operation function are recommended. Once the work team is formed, it meets to identify
and delimit the problem, using elements of a Project charter and defining the fundamental aspects, which include the
Macro problem statement, project objective, project scope and limits, response variable, conditions, magnitude,
performance, period, and specifications. This allows us to have a clear vision of the problem and to obtain important
data, mainly to define the response variable that needs to be improved.
Subsequently, the work team collected initial data on the identified response variable. The data collection consists of
obtaining the reports of the last weeks, where the value or performance of the response variable can be visualized, and
tests are performed to confirm the normality of the data. If they are not normal, it is necessary to determine the type of
distribution they follow for better analysis. Next, a control chart is created for individual data using Minitab software
to analyze the trends and behavior of the response variable; however, the work team continues to monitor it to see
trends and relate the out-of-control points with special events that occur in a specific period. Subsequently, a capability
analysis is performed using the previously collected data and the specification limits to determine the parts per million
defects and observe the size of the problem.
O. Celis-Gracia, J. L. García-Alcaraz, F. Hermosillo-Villalobos
Memoria Investigaciones en Ingeniería, núm. 28 (2025). pp. 287-302
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ISSN 2301-1092 ISSN (en línea) 2301-1106 Universidad de Montevideo, Uruguay 291
Figure I.- Flowchart of the proposed methodology based on the Lean-Sigma approach [16].
2.2 Step 2: Root cause analysis. - Once the problem is identified and the magnitude of the problem is determined, the
team finds the potential causes that are generating the problem. First, the team engaged in brainstorming, where each
participant brainstormed why the problem occurred, and the round continued until the ideas were exhausted. The
moderator then refined the ideas to eliminate repeated ideas. With the list of ideas reduced, the nominal group technique
was used to weigh ideas for each participant. Once the ideas have been weighed, the sum of the ideas is obtained, and
the idea with the highest score is chosen. Finally, the 5 whys technique is applied, which consists of asking five times
why the problem occurs, and the technique is stopped once a cause is found that does not point to a person or a
department but is a cause that is under the control of the team and can provide a solution.
2.3 Step 3: Develop a solution. - Once the root cause is identified, a lean manufacturing or Six Sigma tool is used to
solve the problem. In this case, the selected tool was SMED, which reduced the model to less than ten minutes. SMED
is a Lean Manufacturing tool that reduces model changeover or setup times. This tool follows a well-structured
methodology consisting of four phases, as Figure II illustrates.
Figure II.- Stages for the SMED Technique.
Preliminar Stage
Setup process is
documented
Stage One
Identify internal and
external activities
Stage Two
Convert internal into
external
Stage Three
Internal activities
reduction
O. Celis-Gracia, J. L. García-Alcaraz, F. Hermosillo-Villalobos
Memoria Investigaciones en Ingeniería, núm. 28 (2025). pp. 287-302
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ISSN 2301-1092 ISSN (en línea) 2301-1106 Universidad de Montevideo, Uruguay 292
The purpose of the preliminary stage is to document the activities involved in the model change, which is performed
by mapping the process. It is recommended that a video of the process be captured to perform a detailed analysis,
where the activities and times are recorded. Once the activities are identified and listed, the next step is to classify them
into two categories based on their current performance and not on how they should be or are believed to be. This
classification is based on both internal and external activities.
The external activity is performed while the equipment is still operating or has not finished producing the previous
model. In contrast, internal activity is necessary when the equipment is stopped. Subsequently, in step two, the activities
that can be eliminated because they are considered unnecessary or wasteful are identified, and the internal activities
that can be carried out externally are listed. In this step, checklists can be developed to validate that external activities
have been completed before the machine is stopped. Finally, in stage three, an action plan is made to work on process
improvements that require investment to reduce the time of internal activities, some of which can be to perform
activities simultaneously, purchase more tools, design and implement fixtures, and poka yokes, among others.
Once the SMED technique was implemented, the team monitored the duration of the model changeover time. It makes
a control chart comparing before and after to determine if there is a significant reduction.
2.4 Step 4: Verify the solution. - This step is of great importance because it validates that the tool implemented in the
previous step is practical for the response variable. After improvements were made, data were collected on the response
variable, and a 2-sample T statistical test was performed at a 95% confidence level.
2.5 Control plan. - Finally, in this step, we carry out Kaizen events to train personnel in the new tool implemented in
step three. In addition, work instructions, procedures, standards, and process control plans are modified as applicable.
3. Results and Discussion. - This section is divided into sections based on the information reported.
3.1. Identifying and measuring the problem. The following information was obtained during the team meeting,
during which important aspects of the problem were defined.
- Macro Problem Statement: The production schedule in the molding area is not followed. On average, 30% of the
time, the program is not completed on time, resulting in delayed delivery to the internal customer.
- Project Goal: To reduce schedule noncompliance from 30% to 15%.
- Project scope and limits: The project was conducted in a plastic injection molding area.
- Response variable: Y=Compliance with production schedule. A defect occurs when scheduled production is not
100%.
- Conditions: Defects occur on different days of the week and in different months.
Magnitude: The cost of non-compliance with the production program in March 2024 amounts to $31,000, and a
projection shows that the annual cost amounts to $372,000.
- Performance: The measurement scale was equivalent to the % of compliance with the program.
- Period: It was estimated that defects generally occur when downtime is triggered.
- Specifications: Compliance with the program should exceed 99.2%.
It is important to note that the company's goal of achieving an on-time delivery rate above 99.2% was unmet, and the
annual loss was $372,000.
Next, the work team collected information on the on-time delivery rate using six months of production reports. A total
of 120 data points were plotted weekly, resulting in 24 subgroups. The data was then subjected to a normality test, as
shown in Figure III. A p-value above 0.100 indicated that the data was normal.
O. Celis-Gracia, J. L. García-Alcaraz, F. Hermosillo-Villalobos
Memoria Investigaciones en Ingeniería, núm. 28 (2025). pp. 287-302
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ISSN 2301-1092 ISSN (en línea) 2301-1106 Universidad de Montevideo, Uruguay 293
Figure III.- Normality test of the initial data for compliance with the production program.
Once the normality of the data was confirmed, a control chart was created to observe the behavior of compliance with
the production program to observe trends, as shown in Figure IV, where the on-time delivery rate was within statistical
control and exhibited normal behavior. It can also be seen that, on average, the compliance rate was 77.42%, with
behavior ranging from 63.89% to 90.95%. With this data, in the worst-case scenario, the molding process delivered
37% fewer parts required by the following process, affecting the final assembly lines.
Figure IV.- Control chart of initial data regarding compliance with the production program.
Based on the company's goal of 99.2% compliance, a capability study was conducted to determine the process's sigma
level and existing defective parts per million (DPPM). Figure V shows the analysis from which the following can be
concluded: the process's initial Cpk is -1.61, which means that 100% of the time, the level of compliance was outside
the goal set by the company; therefore, the initial sigma level can be set equal to zero.
2321191715131197531
0.9
0.8
0.7
0.6
Observation
Individual Value
_
X=0.7742
UCL=0.9095
LCL=0.6389
2321191715131197531
0.16
0.12
0.08
0.04
0.00
Observation
Moving Range
__
MR=0.0509
UCL=0.1662
LCL=0
I-MR Chart of % Cumplimiento
O. Celis-Gracia, J. L. García-Alcaraz, F. Hermosillo-Villalobos
Memoria Investigaciones en Ingeniería, núm. 28 (2025). pp. 287-302
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Figure V.- Process capability analysis performed on the OTD under initial conditions.
3.2. Root cause analysis. - Based on the information obtained and analyzed, basic quality tools were used to determine
the root cause of the problem. First, the production area's multidisciplinary team, consisting of the production
supervisor, group leader, maintenance technician, quality engineer, industrial engineer, tool crib technician and two
equipment technicians, met to brainstorm ideas. Approximately 30 ideas were generated, some of which are listed in
Table I.
No.
Idea
1
The machine does not achieve the production rate
2
Quality defects
3
Tool damaged
4
Training
5
Changeover time
6
Scheduling fluctuations
7
The production Schedule is not being followed
8
Missing materials
9
Failure in the dryers
10
Absenteeism
Table I.- Ideas generated by the multidisciplinary team
The team used the nominal group technique with a generated list of ideas, and each member assigned weights to the
ideas. Table II shows the scores for each of the ideas, and it was found that the time required to change the model was
the major contributor to not delivering on time.
No.
Idea
1
The machine does not achieve the production rate
2
Quality defects
3
Tool damaged
4
Training
5
Changeover time
6
Scheduling fluctuations
O. Celis-Gracia, J. L. García-Alcaraz, F. Hermosillo-Villalobos
Memoria Investigaciones en Ingeniería, núm. 28 (2025). pp. 287-302
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ISSN 2301-1092 ISSN (en línea) 2301-1106 Universidad de Montevideo, Uruguay 295
7
The production Schedule is not being followed
8
Missing materials
9
Failure in the dryers
10
Absenteeism
Table II.- List of ideas with weights when applying the nominal group technique.
The team decided to focus primarily on problems with high model changeover times, which scored 40; therefore, it
collected data on model changeover times in minutes in the production area. Figure VI presents the data collected for
280 events.
Figure VI. - Model changeover times under initial conditions.
The average changeover time was 318 min (~ 5 h). This indicates that more than half of the workday shift is lost when
a model change is made, resulting in lower production and efficiency. Therefore, there is a correlation between high
model change times and on-time deliveries owing to the loss of time available on the production line.
3.3. Develop a solution. - Once the root cause of the problem has been identified, the team discussed possible lean
tools to counteract the adverse effects of model change over time. It identified the single-minute exchange of die
(SMED) tool, a lean manufacturing tool that seeks to reduce setup and model changeover times to less than 10 min.
Four phases of the SMED technique are described, and the results are shown below.
3.3.1. Identify model change activities. - The main purpose of this step is to identify the activities involved during a
changeover; to do so, different model changes were analyzed. The changeover process was mapped to one of the
machines, selecting one of the models that, according to the team's experience, generated the most problems, causing
the setup time to increase up to 8 hours in the worst-case scenario. Once the process is mapped, the activities were
identified and are listed in Table III.
No.
Activity Description
Time in Minutes
1
Go to the tool room to get the mold cavity and tools
13
2
Turn off heaters
3
3
Waiting to release a crane
35
4
Go to the tool room to get tools
15
5
Place holder and attach mold to the crane
4
6
Go to the tool room to get support to replace
17
7
Go to the tool room to get hoses
15
8
Disconnect hoses and clean
33
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Memoria Investigaciones en Ingeniería, núm. 28 (2025). pp. 287-302
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9
Place locks on the mold
2
10
Take off eight supports
11
11
Open the clamp and disassemble the arrow
16
12
Take down the mold
3
13
Put in place next to the mold
6
14
Close clamps
3
15
Place supports on the mold (2)
6
16
Open the clamp and install the arrow
2
17
Install six supports to the mold
27
18
Take off holders to the crane and detach the mold.
1
19
Upload the program
2
20
Open the mold and adjust
4
21
Install 40 hoses
30
22
Go to the tool room to get a zip tie
16
23
Install the zip tie
6
24
Change the fixture to the robot
4
25
Adjust the water level
5
26
Review and fix the leakage
1
27
Go to the tool room to get resin to purge the machine
27
28
Preheat and purge
30
29
Make parts for setup validation
10
Total Time in Minutes
347
Table III.- Documentation of changeover activities under initial conditions.
Some of the most relevant aspects to mention in this step are that, as shown in Table III, 29 activities can be identified
in the model-change process. Similarly, it can be observed that the model changeover time is 347 min, equivalent to
5.78 hours, considering that the shift is 9 hours. This means that approximately 64.25% of the machine time is
unavailable for production because of this increase in setup times, resulting in the company's current symptoms, that
is, noncompliance with deliveries to the assembly lines.
3.3.2. Separate internal and external activities. - Once the process has been mapped and the activities involved have
been identified, the work team classified each activity as internal or external. In this case, during the analysis, it was
identified that all activities were performed internally, that is, while the equipment was stopped.
3.3.3. Convert internal activities into external. The team analyzed each activity in detail to convert those that can be
performed externally before the equipment is stopped. Figure VII shows in the left graph that 24.1% of the activities
can be performed externally, resulting in a ~39.8% reduction of the total changeover time, as shown in the right chart.
Figure VII.- Impact of converting internal into external in the total changeover time.
O. Celis-Gracia, J. L. García-Alcaraz, F. Hermosillo-Villalobos
Memoria Investigaciones en Ingeniería, núm. 28 (2025). pp. 287-302
https://doi.org/10.36561/ING.28.17
ISSN 2301-1092 ISSN (en línea) 2301-1106 Universidad de Montevideo, Uruguay 297
Using the fundamental principle of converting internal activities into external ones, the model changeover time for the
analyzed setup was reduced from 347 to 209 min, which represents a decrease of approximately 40%. In addition,
there were 7 external and 22 internal activities.
A setup preparation checklist was developed to list all necessary activities to achieve activity conversion. The tools
must be available before the previous model's production ends. This ensures that when the machine stops, everything
is available and within the reach of an efficient setup change. This step implemented a checklist and monitored the
setup times to ensure that external activities were prepared before executing a model change.
3.3.4. Reduce internal activities. - Because the proportion of internal activities was still considerably high (76%), the
team worked on reducing the time spent on internal activities in this phase. For this, the team proposed strategies such
as developing fixtures, executing activities in parallel, and standardizing and documenting model change activities.
Once these activities were implemented, the model change time was monitored for two weeks, collecting 25 data
points, and a before vs. after graph was made.
As shown in Figure VIII, once the SMED technique was implemented, the model changeover times were reduced by
approximately 73%, from 344.6 to 92.7 min on average.
Figure VIII.- Control chart of setup time before and after the SMED Implementation
Even though the model change was reduced to 92.7 min on average, this value is still well above the SMED technique.
Therefore, the team investigated why this was considerably high. After a brainstorming session, it was found that the
first part of releases consumed 40% of the model changeover time. This was because of the multiple quality rejections
of the parts.
When investigating the root cause of the high rate of rejections, it was identified that the measurements varied owing
to various factors. Therefore, the team decided to conduct a measurement system analysis (MSA) on different days
involving the personnel and instruments used in the release of the machine. The results of the MSA error and the sigma
level of the corresponding day are presented in Table IV, which was used to perform a regression analysis in Minitab.
Figure IX shows the regression analysis and the corresponding equation.
Day
% Error
(X)
Sigma Level
(Y)
Day
% Error
(X)
Sigma Level
(Y)
1
31.72
1.044
11
25.98
2.363
2
39.91
0.771
12
25.33
2.56
3
23.99
2.246
13
30.66
1.002
4
29.82
0.872
14
29.4
1.302
5
31.81
0.021
15
36.68
0.448
6
40.78
0.472
16
35.58
0.139
7
30.03
1.891
17
33.43
0.774
O. Celis-Gracia, J. L. García-Alcaraz, F. Hermosillo-Villalobos
Memoria Investigaciones en Ingeniería, núm. 28 (2025). pp. 287-302
https://doi.org/10.36561/ING.28.17
ISSN 2301-1092 ISSN (en línea) 2301-1106 Universidad de Montevideo, Uruguay 298
8
23.23
1.98
18
20.68
2.017
9
20.76
2.676
19
40.12
0.683
10
23.23
1.973
20
17.38
2.702
Table IV.- Error of the measurement system and sigma level
The measurement system error had a significant variation, and it had a relationship with the quality level of the process.
Regression analysis shows an R-squared value of 71.2%, which means that the measurement system error explains
71.2% of the process's sigma level value.
Figure IX.- Regression analysis using the Measurement error (x) vs the Sigma level (y).
3.4. Verify the solution. - Once the solution was developed and implemented, an experimental design was conducted
to verify the impact of the model change on compliance with the production schedule. For this purpose, data on
compliance with the production schedule was taken for two weeks, and then a comparison was made using a 2-sample
t-test in Minitab software. The results are presented in Table V.
Sample
N
Mean
StDev
SE Mean
Before
24
0.7742
0.0495
0.010
After
22
0.9936
0.0162
0.0035
Null hypothesis
H₀: μ₁ - µ₂ ≥ 0
Alternative hypothesis
H₁: μ₁ - µ₂ < 0
Table V.- 2 Sample test and hypothesis tests to validate the solution.
Based on the confirmation run and hypothesis test shown in Table V, it is concluded that the model change time is
directly correlated to the compliance with the production schedule. Once the solution was implemented, compliance
with the production schedule increased from 77% to 99.36%.
3.5. Control plan. - As the last step of the proposed methodology, a series of Kaizen-type events involving staff from
all shifts involved in the model changes were carried out. These events were theoretical-practical training given to
quality, maintenance, production, manufacturing and test engineering to notify them about the implemented
improvements and the new work method for standardization. Initially, there was no properly documented method to
perform the changeover process; after implementing the SMED technique, a work instruction was developed, including
a sequential flow with tools, materials and information needed before and after the changeover initiation. It is important
to mention that the kaizen events were carried out using the Gemba approach. To monitor and react on time, a board
was placed next to the machines to document the setup times, including the challenges and milestones found during
the process. Also, an Andon was implemented with a color code properly defined to visually identify the machine's
status and support immediately in case any showstopper appears.
O. Celis-Gracia, J. L. García-Alcaraz, F. Hermosillo-Villalobos
Memoria Investigaciones en Ingeniería, núm. 28 (2025). pp. 287-302
https://doi.org/10.36561/ING.28.17
ISSN 2301-1092 ISSN (en línea) 2301-1106 Universidad de Montevideo, Uruguay 299
4. Discussion of results and conclusions. - The initial information showed that the analyzed plastic injection process
had a sigma level of zero, initially having a production schedule compliance rate of 77% on average, below the
company's goal. Using the proposed methodology based on Lean sigma, it is concluded that the root cause of the
problem was that model changeover times sometimes shoot up to 8 hours, affecting the availability of machinery and
flexibility and the ability of the process to adapt to fluctuations in demand. The SMED technique was used to reduce
model changeover times and achieve a 75% reduction in setup times, with the fundamental principle of converting
internal activities into external ones. In the solution verification step, it was possible to demonstrate that there was a
correlation between the reduction of model changes and compliance with the production schedule according to the 2-
sample-t test; it was demonstrated with a confidence level of 95% that compliance with the schedule was increased
from 77% to 99.36%.
This case study was carried out over eight weeks, solving the root problem with an approach where the contribution
or novelty lies in the fact that this approach is oriented to solving problems at the speed of lean, unlike traditional Six
Sigma approaches, where projects are based on annual savings and on average improvements can be seen between 6
and 12 months. It is important to mention that companies need to solve problems quickly to reduce Lead time; for
example, Kulkarni et al. [22] show an application of traditional Six Sigma, where a company is scraping 10% of the
daily production which represents a loss of $10K daily that means a total loss of $200,000 per month, using the
traditional approach which took eight months to solve the problem this represented a total loss of over a million dollars
compared to the proposed method which would have a loss of $300,000. Guleria et al. [23] applied the traditional Lean
Six Sigma approach, showing results in eight months; in this case, the company lost $800,000 versus $150,000 if the
proposed approach had been used.
Another scientific contribution proposed by this research is the correlation between the measurement system error and
the sigma level of the process, which was presented in the phase of reduction of internal activities of the SMED
technique. However, the team managed to reduce the model change time significantly. It was observed that it was still
high, so it was decided to investigate in more detail, finding that the root cause was the high rate of rejection, and it
was found that the error in the measurement system was an important contributor. It is concluded that the measurement
system explains 71.2% of the fluctuation in the sigma level of the process, which means that the measurement system
does not correctly classify good and bad parts; bad parts are accepted, and good parts can be rejected. This finding
opens a line of research focused on further studying the relationship between these two components and strategies to
counteract the error in the measurement system so that the quality of the processes is maintained at acceptable levels.
Considering this case study, the measurement system error is ~ 29%; this value means that, on average, 29% of the
time, parts are categorized incorrectly; in other words, 29% percent of the parts are rejected and scrapped when these
are acceptable. This error can represent a high contribution to the increase of the manufacturing costs of the company,
considering only one part number with a scrap cost of $10.53, considering a monthly production of 25,000, if the worst
scenario is assumed that 29% of the parts are scrapped because of the error of the measurement system this could be
an annual cost of ~$900,000.
This methodology and its approach, including the engineering tools used, can be applied to any manufacturing
company around the world. It includes fabrication, powder coating, final assembly, metals, molding, and PCBAs,
among other processes.
5. Limitations and future research. - It is important to mention that this research was carried out using a plastic
injection molding process; however, the methodology can be used in any manufacturing process. One of the limitations
is that for its implementation, the work team must be led by a person with knowledge of Lean and Six Sigma topics,
preferably a Black Belt, to be able to guide and direct the team in the right direction and with an analytical and statistical
approach. Likewise, it should be noted that a multidisciplinary work team must be dedicated and committed because
it requires time to achieve the expected results. The proposed approach initially focused on addressing the main cause
of the problem; it is recommended to continue applying the approach to address other identified causes to improve the
process continuously. In future research, it is recommended that the effect of the measurement system analysis be
investigated at the sigma level of the process to quantify and develop a solution for this cause of variation.
O. Celis-Gracia, J. L. García-Alcaraz, F. Hermosillo-Villalobos
Memoria Investigaciones en Ingeniería, núm. 28 (2025). pp. 287-302
https://doi.org/10.36561/ING.28.17
ISSN 2301-1092 ISSN (en línea) 2301-1106 Universidad de Montevideo, Uruguay 300
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O. Celis-Gracia, J. L. García-Alcaraz, F. Hermosillo-Villalobos
Memoria Investigaciones en Ingeniería, núm. 28 (2025). pp. 287-302
https://doi.org/10.36561/ING.28.17
ISSN 2301-1092 ISSN (en línea) 2301-1106 Universidad de Montevideo, Uruguay 302
Author contribution:
1. Conception and design of the study
2. Data acquisition
3. Data analysis
4. Discussion of the results
5. Writing of the manuscript
6. Approval of the last version of the manuscript
OCS has contributed to: 1, 2, 3, 4, 5 and 6.
JLGA has contributed to: 1, 2, 3, 4, 5 and 6.
FHV has contributed to: 1, 2, 3, 4, 5 and 6.
Acceptance Note: This article was approved by the journal editors Dr. Rafael Sotelo and Mag. Ing. Fernando A.
Hernández Gobertti.