EXECUTIVE SUMMARY (ABSTRACT)
In a modern global marketplace, quality is a key competency which companies derive competitive advantage. Accomplishing quality is essential to competition in business, including medical device industries.
The meaning of quality in medical industries has developed over time to create maintainable sources of competitive benefits.
A medical device industry will benefit most through concentrating on the key processes that provide their clients with quality products and services. Therefore, assuring quality management throughout the company and promoting staff members knowledge about quality standards and processes within the company is crucial for the organization success.
A medical device industry founded in 1891, has one of the main manufacturing plants for the assembly of medical devices in Costa Rica. The Corporation headquartered in Europe is formerly one of the largest electronics companies in the world, currently focused in the area of health technology, with other divisions being successfully divested.
New challenges faced by managers are addressed to improve organization’s performance and future competition. To date, the organization does not always have available quality inspectors trained and competent on quality inspections for all products that the company manufactures. For this reason, in case of absenteeism of any nature, coverage is assured, and it can cause serious problems to metrics and product release.
The general objective of this Final Graduation Project (FGP) was to develop a Cross-Training Program for Quality Process Inspectors and Quality Final Inspectors to balance workforce on a medical device industry in Alajuela, Costa Rica.
This Cross-Training Program design deals with what is quality, cost of quality, linking quality management system to organizational performance, its impact to an organization, its approaches of implementing the QMS (Quality Management System) and the quality journey.
The specific objectives were to perform a diagnosis of the Quality Management System at a medical device manufacturing plant in order to determine the gaps that Quality Process Inspectors have in terms of training in order to identify and address their training needs, to design a Training Program for Quality Process Inspectors at a medical device manufacturing plant that meets the needs of the Quality Management System and calibrate the Team´s capability and to plan a cross training among applicable areas of Quality Process Inspectors with identification of timing, costs, participants, logistics and methodology in order to have more inspectors trained on certain areas.
The methodology used for the development of this Cross-Training Program was analytical. The main sources used to gather information included interviews to the Company´s Quality Personnel (Inspector, Technicians and Managers) in order to understand the way Quality Inspectors are trained, the areas each one of them is trained on and the needed resources in order to provide them with a Cross-Training. A Guide to the Project Management Body of Knowledge (PMBOK® Guide) Sixth Edition was also used as a support source.
The diagnosis of the Quality Management System helped to determine the gaps that Quality Process Inspectors have in terms of training. Even though results
showed that certain Inspectors were already trained on different areas, it was identified that most of them don´t handle multiple certifications. Therefore, the need of a training made sense in order to maximize the use of the company resources and guarantee coverage when the resources report illness or take vacations.
It was also concluded that the lack of multitasked inspectors currently impacts the ability of having one single inspector in-charge of multiple tasks such as performing an inspection of a lot or batch and releasing the same production order, which is costing more money and resources to the organization.
The design of a Training Program for Quality Process Inspectors helped to structure the main elements required to provide adequately trained resources for quality inspection activities and therefore assure the quality system is functioning properly.
Thus, it was concluded that designing a Training Program to provide effectively trained and efficient resources will help decrease the current difficulties faced in terms of providing immediate coverage for unforeseen events such as resignations without notice or dismissals, maternity leaves, vacations and other long-term medical leaves. This will avoid denying vacation days requested by employees.
The cross training among applicable areas of Quality Process Inspectors considered the development of a model of a four-stage cross-training process to have more inspectors trained on certain areas and have them prepared in case of absenteeism of different natures. The training model was defined pairs between themselves and was designed based on areas that have affinity in terms of activities.
It was concluded that having crossed trained resources throughout this cross-training model will also help provide quicker answers to manufacturing teams in the organization when requesting overtime for quality inspectors upon increases in production lines. Given these requests are usually made in real time, fast coordination is required and having on-site trained resources will avoid having to call inspectors to check availability and paying for their transportation to the manufacturing plant.
Based on these conclusions, Supervisory and Management Teams should consider a new revision of the SWOT Analysis performed in this Final Graduation Project in aims to understand additional gaps not related to cross-training needs. A mapping of all tasks is recommended to be performed as well as a definition of each area´s metrics. In addition, activity times need to be tracked in order to establish standard times so a standard work can be created for Quality Process Inspectors that can will help understand capacity of each inspector per area.
Further research is needed to regulate performance of Quality Inspectors through a periodic evaluation system that needs to be designed by Quality Supervisor that can improve performance of the resources. Finally, analyzing the leadership system for an average of 50 Quality Inspectors across 24/7 shifts and several areas is also recommended to Quality Management.
Descargar Aquí :
https://www.uci.ac.cr/Biblioteca/Tesis/PFGMAP2122.pdf
Estudiante: ADRIANA MARIA BARRANTES GUTIERREZ
Tutor: Karolina Jiménez Monge
Lector: Sophia Crawford
Lector: Cristian Soto
