The 5´s methodology is very important for both industrial and service organizations, since it improves safety, order and cleanliness in the workplace, which is why many companies are currently implementing Japanese techniques as innovation and search for continuous improvement.
The process of implementing each continuous improvement technique requires both personal and financial resources, but like all plans in which an institution is involved, the benefits are expected to be noticed from the early stages of introduction.
This article presents the basic procedures and criteria that a pharmaceutical laboratory must perform, with the aim of implementing a 5´S model in its areas and describing the benefits it generates for both the pharmaceutical industry and organizations in general. After specifying the procedures, it is concluded that when a 5´S model is implemented in a production process, higher productivity permanently arises, improving safety, the work environment, quality, efficiency, and therefore, the organization competitiveness.
Keywords: Continuous improvement, laboratory, implementation, model, industry
Abstract
The 5's methodology is very important for both industrial organizations and services, and improving safety, order and cleanliness in the work area, which is why many companies are currently implementing Japanese techniques such as innovation and seeking continuous improvement.
The process of implementation of each technique demand continuous improvement resources both personnel and financial, but like all plans in which an institution is involved, it is expected that the benefits are felt from the early stages of introduction.
they present the procedures and basic criteria that a pharmaceutical laboratory must perform, with the aim to help a model 5'S in his areas and describing the benefits that it generates both to the pharmaceutical industry and to the organizations in general. After specifying the procedures, one concludes that when in a productive process there is implemented a model 5'S, a major productivity originates from permanent form, improves the safety, the labor climate, the quality, the efficiency, and consequently, the competitiveness of the organization.
Keywords: Continuous improvement, laboratory, implementation, model, industry
Continuous improvement is a concept that was created in Japan to generate an organizational and perception change in people, as well as to allow teamwork through standardized activities that are maintained over time. In this, the principles of human behavior such as self-discipline and respect intervene to give merit to permanent improvement, order and cleanliness in order to abide by hygiene standards and preserve the environment around us (Martinez, 2009).
The 5´s methodology was born in Japan thanks to the executive Hiroyuki Hirano, in order to innovate process management and establish or maintain improvements in any organization. A clear example was the Toyota company, who at the time implemented this tool (Torres, 2008).
Among the main contributions of Dr. WE Deming and J. Juran regarding quality, it is essential to highlight the Kaizen administration as a restructuring of Japanese industry that was destroyed in the Second World War. This was a great help for the economic activity of that country to start again. The Kaizen method allows everyone to participate and is based on the fact that human beings contribute to improving their workplace through conditions such as order, cleanliness and security (Carro, 2012).
The 5's are tools for lean manufacturing, the latter in charge of eliminating operations that do not add value to the product, increasing the value of each activity carried out and eliminating waste to improve operations (Díaz, 2009).
The main objectives of the 5´s methodology are to create a philosophy of continuous improvement at the organizational level, allowing a reduction in workplace accidents, as well as providing greater safety, visualizing the order and clarity of the space, reducing time in execute the job and facilitate access to materials. This requires a cultural change and the cooperation of all staff to achieve great results.
The need to increase productivity, competitiveness and continually improve the quality of an organization's processes has determined the appearance of various techniques ranging from the application of standards such as ISO 9001, ISO 9004, ISO 14000 (environmental standard) and the ISO 18000 (occupational health and safety standard) up to the application of Japanese tools that are framed as models for continuous improvement.
In the case of a pharmaceutical laboratory, the 5´s methodology is opportune to improve the different areas it has, as well as to favor the performance of the industry and its employees.
To start the implementation of the integrated model 5´sa for the pharmaceutical industry, one of the basic considerations is to carry out a diagnosis with which the current situation of the areas is observed and thus determine the problems present in each process. Then the planning and execution of each of the pillars of the methodology is carried out and finally a follow-up to the implemented model (Martinez, 2010).
Therefore, this article aims to show the benefits that a pharmaceutical laboratory can obtain by implementing a 5's model in its areas, as well as the basic procedures and criteria to be developed for the application of these continuous improvement tools. It also seeks to deepen the implementation of 5's techniques in the areas of production, administration, storage and quality control in various companies, to generate application in the pharmaceutical industry.
2. METHODOLOGY
The study design in this article corresponds to a descriptive investigation, since it aimed to identify and specify the possible sources of waste in pharmaceutical laboratories and thus describe the procedures for the implementation of continuous improvement tools called 5's.
Primary sources of information such as the report 32 of the World Health Organization of 1992 were reviewed to verify the fundamental aspects of order and cleanliness in the pharmaceutical industry and secondary sources such as theses and research articles about the 5´S model and its implementation..
3. A MANAGEMENT MODEL FOR CONTINUOUS IMPROVEMENT
Every organization at an industrial level needs the use of raw materials, equipment and tools, along with the good performance of its collaborators for its optimal operation. However, sometimes safety, order and cleaning activities are not planned to prevent accidents in work areas. That is why it is required to develop continuous improvement activities through a methodology that modifies work habits and attitudes and that favors the competitiveness and productivity indexes of a company (Corporation, 2010).
A Colombian pharmaceutical laboratory must meet various parameters stipulated in Report 32 of the World Health Organization (WHO, 1992).
It is emphasized that all facilities must protect manufacturing operations so as not to contaminate materials or products, in addition to facilitating cleaning and proper sanitation according to detailed procedures.
3.1 Origin of the management model
5´s
The 5's arose from the Second World War that hit Japan in 1960, resulting in a decline in economic activity in that country. At that time, the executive Hiroyuki Hirano created the methodology with the aim of improving organizational performance by monitoring five parameters, which would lead to performing tasks safely for the worker and his environment (Bazurto, 2012).
3.2 Meaning of each of the
5´s
3.2.1 Seiri (整理): Classify
The first of the 5's seeks to separate the necessary materials from the unnecessary ones and eliminate the latter. That is, keep only the elements necessary for daily activities in the workplace, while the unnecessary ones can be transferred, donated or eliminated depending on their function.
Through this process, more space is achieved both in the plant and in offices, waste is eliminated and inventory control is improved.
3.2.2 Seiton (整頓): Order
The second of the 5's is the stage where the useful or necessary is located. The site for each item should be set so that any contributor knows where to find and return it. Locating materials and documents improves the image of the area before clients and favors coordination to carry out the work. This process helps to identify when something is missing and gives a better appearance, also having everything organized, you are in a position to create standards to maintain classification, order and cleanliness (Sorooshian, 2012).
3.2.3 Seiso (清掃): Cleaning
The Seiso implementation aims to find and remove sources of dirt, ensuring that all media is in good working order.
At this stage, worker participation is important. The company must provide you with the conditions and resources for the cleaning principle to be applied and you must be given full responsibility for your job.
Only with proper cleaning, the worker can realize that something is wrong with his machine or workplace (Hirano, 1998)
3.2.4 Seiketsu (清潔): Standardize
Defines consistency in the application of the first 3 pillars of the methodology, developing rules that tend to preserve what has been achieved. At this stage, we seek to create habits to keep the workplace in perfect condition.
The application of this fourth S, implies having reached the state in which the person develops all his functions in a comfortable and easy way. It consists of maintaining a healthy mind and body in each collaborator, implementing safety measures and working conditions without contamination, with a healthy and convenient environment to work (Ho, 1999)
3.2.5 Shitsuke (躾): Discipline
The last of the S's has the greatest weight in the application of the model, since if the work discipline is not maintained, the conditions return to the undesirable starting levels and the expected results will not be achieved.
A work culture must be created with the firm support of senior management and a clear allocation of the activities to be carried out.
It is also a control stage in the application of the management model.
3.3 Assessment and implementation of the 5´S management model
The laboratory management is the main responsible for evaluating and implementing the 5´S model. You must be convinced and committed to the change that will take place within the organization. If managers are not convinced, it will be difficult for staff to appreciate the importance of applying the program in the areas of the institution.
Standards must be followed, activities must be recorded and new habits must be adapted so that the application of the model is orderly and systematic.
3.4 Steps for the design and implementation of the 5´S model in the pharmaceutical industry
The process of designing and implementing the model has several steps, which are summarized in: 1-Diagnosis of the pharmaceutical laboratory, 2-Design and execution of the 5'S model and 3 Monitoring and control (Camejo, 2009)
From this, information on the level of 5S in the designated areas must be collected, establishing what kind of waste is generated in the industry and its possible causes to design and implement each of the phases of the model and finally carry out a follow-up and control of the implemented.
3.4.1 Diagnosis of the pharmaceutical industry
The pharmaceutical industry has adopted few Lean manufacturing techniques due to the concern that such adoption reduces the quality control of products. However, the high production costs and the high working capital associated with higher inventories, demonstrate the need to seek improvement in their operations.
Possible sources of waste from the pharmaceutical industry are due to excess production, reprocessing, waiting times, movements and transportation, excess inventories and processing (Arrieta, 2007)
3.4.2 Design and execution of the 5´S model
The development of this model for the pharmaceutical industry involves, in a first step, classifying the existing elements between necessary and unnecessary (Seiri). In the laboratory there are possibly unused machines, defective tools and products, raw materials, document files, shelves, among other items that require proper organization. Putting this phase into practice requires hard work from collaborators to determine the elements that will not be used, after training them. For the implementation of this first phase, the following diagram will be followed. (Figure 1).
Classification and selection of elements. Taken from (Camejo L. 2009)
Laboratory staff will set aside half an hour a day for a week to accumulate unnecessary documents, equipment, and tools. To do this, they will rely on red labels that must mark all the objects collected and thus deliver a list of what is not useful to management (Santander, 2008).
The next phase covers the functional arrangement (Seiton), which should be given to the necessary objects in the areas, and for this reason the staff will locate things according to criteria of safety, quality and efficiency. It will then be necessary to take into account the following table to determine the location of each element (Table 1).
Table 1: Order of the elements
| Frequency of use |
Location |
| In every moment | Along with the worker |
| Several times a day | Close to worker |
| Many times per week | Close to work area |
| A few times a month | In common areas |
| A few times a year | In warehouse |
| It may be used | In dead file area |
Modified from (Camejo L. 2009)
This order will be applied both for the administrative areas where files, papers and furniture are handled, as well as for the production, quality and storage areas where equipment, materials and tools are found.
Having the list of useful elements in each area, the next step will be to define a space for their location, which will also have a description and a code.
In the case of administrative areas of the laboratory, contour identification will be used. In this procedure, drawings or templates will be made to indicate the placement of tools, parts of an equipment or machine, cleaning and cleaning elements, pens, calculators and office supplies; The folders of each drawer will be identified with an adhesive sticker to observe the existing documents in it. It is important that all personnel identify and locate each tool within its said contour. Regarding the storage or warehouse area, marking with colors or paints may be used, defining a floor space to delimit furniture, equipment, starting and packaging materials, finished products and / or authorized for dispatch, intermediate materials and in bulk (Third, 2005).
It is important that the paint chosen for the areas does not deteriorate the soil. An example of this would be to delimit the space with the colors yellow and black in the form of zebra lines to adapt the quarantined products, products returned or recalled.
The next stage of the model is cleaning (Seiso). This parameter is necessary for pharmaceutical laboratories to obtain a higher performance measured through results in quality, maintenance costs, quantity of production, safety and employee commitment (Bresko, 2012)
Cleaning means removing dirt and dust from all elements of the company.
For its execution, the technical management must carry out an awareness process, through a cleaning campaign. This will make workers prepare for the practice of permanent cleaning and observe the way equipment and tools should be left on a daily basis. The participation of the human resources area is essential for the training of new employees. Each person will complete their daily work if their area is clean and tidy. The activities of order and cleaning must be obligatory for each of the workers.
The cleaning activities to be considered are the following:
- Pick up and remove what gets in the way. Clean items with adapted products. Barrier. Vacuum
Likewise the useful employees are the following:
- Vacuums, brooms, mops and dustpans. Trash receptacles. Large containers for areas that generate enormous waste.
After the cleaning, visual systems must be established that allow the three previous phases to be easily managed (Dobiotech, 2012). To do this, we continue with the next pillar, which is Seiketsu. This parameter aims to develop a clear system of rules that ensure the maintenance of the previous phases.
For standardization or normalization in the laboratory areas, an application manual for the 5´S model must be prepared, containing the following specifications:
- Initial conditions of the work area such as the occupied surface and the distribution in the plant. Layout or general distribution of the areas, equipment and tools that constitute it, including the person in charge of each area. Procedures for maintaining order and cleanliness.
The information contained in the manual must be available to anyone at the plant.
It should be noted that the information must be regularly updated (Espejo, 2011).
In addition to this procedure, laboratory equipment that is complex to clean will be marked with an orange adhesive and this will have a standard to be followed by the production assistant, quality analyst or any worker who requires its use. Each area of the laboratory will adapt a space on the wall, where a visual or informative management board will be placed, in which the procedures to be carried out must be reflected and must be located near the equipment.
The fifth and last phase called Shitsuke is of high importance, since it is related to the cultural change of people in the company. The correct work habits must be maintained and daily classification, ordering and cleaning activities must be integrated, that is, all these tasks are seen as a necessity that must be satisfied to work in a more pleasant environment.
To implement this phase, firm management support is required. Management must choose a person responsible for each area and clearly assign the tasks to be carried out.
It is relevant that motivational and leadership talks are scheduled in the organization in order to promote in them the culture of order and cleanliness (Miranda, 2010)
3.4.3 Monitoring and control
At this stage, compliance with the established regulations must be verified by means of a checklist specifying the actions, times and level of execution. Additionally, audits are a pillar of great importance to verify the learning process of the 5´S model in the laboratory areas.
3.5 Benefits of implementing the 5´S model in the industry
Pharmaceutical
Next, the benefits obtained by the pharmaceutical industry with the implementation of the 5's will be mentioned (Fajardo, 2013):
| SEIRI (Classification) |
| • Decrease objects that deteriorate when stored.
• Generate more space • Better inventory control. • Elimination of waste. • Reduces accidents in work areas. |
| SEITON (Order) |
| • Helps to easily find work documents, saving time and movements.
• Facilitates returning to their place objects that have been used. • Identifies when something is missing. • It confers a better appearance. • You are in a position to create processes or standards that maintain classification, order and cleanliness. |
| SEISO (Cleaning) |
| • Increases the useful life of equipment and facilities.
• Recover and fix items necessary for the job. • There is a lower probability of contracting diseases. • Better appearance in the workplace. • Avoid damage to ecology. |
| SEIKETSU (Standardize) |
| • The knowledge produced for years is kept.
• Improves staff well-being by creating habits of keeping the workplace permanently clean. • Employees know how to carry out a certain operation. • Engage administrative staff and workers with established standards. • Cleaning errors that can lead to unnecessary work risks |
| SHITSUKE (Discipline) |
| • Promote discipline to respect established guidelines.
• Reprocesses are avoided. • Improve the image of the company. • Staff is more appreciated by bosses and colleagues. • Create a culture of order and cleanliness in all members of the organization. |
Additionally, pharmaceutical laboratories that implement a 5´S model will have advantages over other laboratories:
- This model allows to increase the competitiveness of the laboratory, thanks to the reduction in manufacturing deadlines and the decrease in quality defects of the products. The procedures developed in each area are improved day by day, through compliance with each stage of the management model.Increase in productivity.Improves the image of the laboratory.It creates an organizational culture for the development of operations.Improves communication between managers and plant workers.
3.6 Limitations to the implementation of the 5´S model
Although the benefits generated by the implementation of the 5's to the pharmaceutical industry have already been reviewed, there are resistance from the company (Fajardo, 2013).
The following resistance is presented by the managers:
- Staff do not keep jobs clean: employees do not have the initiative to keep their workplace tidy. It is better to produce than to stop production: it is thought that with the 5's there will be losses in production, however, the benefit of having an area free of contamination should be assessed. Why waste time cleaning if there are orders to be delivered: the 5´S model is not a priority because there are orders to be delivered on time, but it must be emphasized that in a clean and orderly place it is more productive. I know my order, why change: managers believe that the 5's should be executed in the operational part of the company, although on the contrary it should be applied by all members of the organization.It is cheaper to hire a person to clean: all staff should be involved to get the best results.
On the other hand, the following resistance is presented by the collaborators:
- To clean up: employees take on clutter as part of their job, regardless of the damaging factors that lead to their safety. Who is going to clean: more experienced people delegate cleaning functions. Where what we have is stored: it is thought that applying the 5´S model requires more space to store the elements, however, the benefit obtained by classifying and separating is the liberation of space. There is no need to apply the 5's:Sometimes it is difficult to apply the 5's in companies due to their culture, but it should be emphasized that if an organization is efficient and clean, it will have benefits such as better visual control of the operation of equipment, processes and good care of tools. of work.
3.7 Relationship of the 5's with other continuous improvement techniques
A pharmaceutical laboratory should implement continuous improvement techniques for both its production systems and facilities. To start, the 5's must be implemented, seeking the participation and commitment of all company collaborators. It is recommended to start with the 5´S model since it generates the greatest visual impact and prepares the areas to implement more specific techniques. However, other production techniques have emerged in search of industrial excellence and complement each other. These are the following (Arrieta, 2007):
- SMED (Single Minute Exchange of Die): tool change in a single digit of minutes. It is a technique used to reduce time.Poka Yoke: it is a technique used to reduce defects in products that are manufactured in a company.Kaizen groups: seek permanent improvement through the contribution of ideas from each worker. TPM: Total productive maintenance to reduce machine downtime. Process value analysis: it is a technique applied to identify at which point in the production system the greatest waste is presented.
The 5's are related to the SMED and Poka Yoke systems, since with their application the times and defects are reduced almost to zero, since everything that is required is prepared in advance, is at hand and in good condition of operation (Arrieta, 2003).
4. Analysis and Discussion
In Colombia, the 5´S methodology has become increasingly present in organizations such as Colcafé, Compañía Nacional de Chocolates, Noel, Zenu, Incolmotos, Cervecería Unión, Grupo Corona and the pharmaceutical company Novartis, since for the benefits previously mentioned, they are a necessity to reach the adequate level of competitiveness against other companies (Arrieta, 2010). It has been proven that the implementation of the Japanese techniques is a requirement of the clients and / or suppliers that the industries assume the continuous improvement for the sustainability of the same (Arrieta, 2003).
Implementation of continuous improvement techniques in
Colombia
Modified from (Arrieta J. 2003)
As can be seen in figure 2, the techniques that have been implemented in the country are different, of which the 5's stand out with 23% and the visual factory with 20%. However, the percentage could be higher if the tool were not unknown to some companies.
Currently in the country there is the SCORE program that aims to promote responsible practices in the workplace, improve the working environment and increase the productivity of SMEs. Among its modules is that of Cooperation in the workplace, where communication issues, 5's and indicators are addressed, forming a business team responsible for the execution of improvement plans. To date, 60% of the 30 companies participating in SCORE Colombia report cost savings, 55%, a reduction in the defect rate, 20% a reduction in energy consumption, 30% reduction in the staff turnover rate and 30% report a decrease in complaints from workers (Enplanta, 2013)
In the review carried out, an exact model that integrated the fundamental aspects for the application of 5's in the pharmaceutical industry was not observed.
5. Conclusions
The different procedures that a pharmaceutical laboratory must perform to implement a 5's model in their areas were presented. Additionally, the benefits generated by this tool to the pharmaceutical industry were determined by comparing it with other continuous improvement techniques.
Within the review carried out, different industries were found that implemented the 5's in some of their areas, obtaining beneficial results in their operations. An example of this is the pharmaceutical company Novartis that has reported a series of benefits such as: reduction in manufacturing lead times, increase in quality, decrease in quality defects, increase in productivity and increase in safety, among others..
It has been observed that customers or suppliers increasingly demand companies to continuously improve their processes and thus fully trust the products or services offered.
It is necessary to have a good understanding of the current situation of the pharmaceutical laboratory and the personnel it has to carry out the implementation of the 5´S model. Training in each phase is essential for each collaborator to participate in the project and appreciate its importance.
One of the reasons for not implementing continuous improvement tools in the pharmaceutical industry is due to their lack of knowledge. However, the fact that equipment is used in the laboratory in each area shows that there is a degree of integration of the personnel, which is positive for the implementation of an improvement system such as the 5's.
Each pharmaceutical laboratory should evaluate the feasibility of implementing the model through a technical, economic and financial analysis. Once the project is implemented, the important thing is to keep it, as long as each of the 5's parameters is met.
6. Bibliographic references
- Arrieta J. 2003. Study of the best manufacturing practices known as Production tools applied in the metal-mechanical sector of the city of Medellín. In REVISTA Universidad EAFIT. Arrieta J. 2007. Interaction and connections between 5s, SMED and Poka Yoke techniques in continuous improvement processes. In Tecnura. Arrieta J, Botero, Victoria., Romano, Maria. 2010. Benchmarking on lean manufacturing in the garment sector in the city of Medellín, ColombiaBazurto C. 2012. IMPROVE WITH QUALITY MANAGEMENT TOOLS ¨5 S¨ MECHANICAL WORKSHOP OF FOOD INDUSTRY In Instituto de Tecnología Programa de Tecnología of Industrial Mechanics ESCUELA SUPERIOR POLITÉCNICA DEL LITORAL.Bresko M. 2012. The 5S Method of Improvement - Enhancing Safety, Productivity and Culture.http://reliabilityweb.com/index.p hp / articles / the_5s_method_of_i mprovement__enhancing_safety_productivit y_and_culture /Camejo L. 2009. Order and Cleaning Program, Seguros Bolivar.Carro R, González, Daniel. 2012. Total Quality Management. Operations management. Corporation LI. 2010. Implementing 5S Workplace Organization Methodology Programs In Manufacturing Facilities. http://www.onlinetmd.com/File Uploads / file / AMD-TMDTES / Lista-5S-and-lean-mfgwhite- paper.pdf.Díaz F. 2009. Lean manufacturing. In Engineering Readings 6. Faculty of Higher Studies c (ed.). Dobiotech. 2012. 5S METHODOLOGY AND IMPLEMENTATION PROCEDURE. Plant. 2013. SCORE Colombia, the first time in Latin America. http://www.enplanta.com/index. php / news / productividadenmedellin / item / 79-score, - primera-vez enlatinoam% C3% A9rica.html.Espejo L. 2011.APPLICATION OF TOOLS AND TECHNIQUES TO IMPROVE PRODUCTIVITY IN A WRITING ARTICLES MANUFACTURING PLANT. In Department of Business Organization (OE). Polytechnic University of Catalonia (UPC). Fajardo M, Jachero, Teresa. 2013. Design of a model of the order and cleaning system (5S) to improve the production area of the Corruastro Factory. Hirano H. 1998. 5 pillars of the visual factory. TGP HOSHIN. TECHNOLOGY S. S. 1999. Japanese 5-S - where TQM begins. http://www.emeraldinsight.com/ journals.htm? articleid = 841906.Martinez C, Barcia, Kleber. Proposal for the Implementation of the 5s Improvement Methodology in a Bread Loaf Production Line In Faculty of Engineering in Mechanics and Production Sciences. Higher Polytechnic School of the Litoral.Martinez, Maria. 2009.The importance of Kaizen in productive companies. Veracruzana University: Faculty of Accounting and Administration. Miranda V. 2010. Implementation of the 5S Improvement Methodology in the Production Line of University Notebooks in a Graphic Arts Industry. In Faculty of Engineering in Mechanics and Production Sciences Escuela Superior Politécnica del Litoral.OMS. 1992. Current good manufacturing practices. In Report 32 World Health Organization, Geneva. Santander CArd. 2008. Implementation manual 5´s program. http://www.eumed.net/cursecon/libreria/2004/5s/2.pdfSorooshian S, Salimi, Meysam., Bavani, Shanthi., Aminattaheri, Hasti. 2012. Experience of 5S Implementation. In Journal of Applied Sciences Research. Third O. 2005. Application of the five-E methodology within the continuous improvement process,of the company Inmoka SA In Faculty of Engineering. Universidad de San Carlos de Guatemala. Torres J. 2008. Continuous improvement: Implementation of 5S in a health system. http: //www.clinicainternacional. com.pe/descarga/revista/cuart a_edic / Mejora_Calidad.pdf.
