Presentation of the Product
The presented medical device is a medical corset for the spine. It should not be confused with the surgical corset used by doctors in hospitals, as people will use this device without a medical background. The most important aspect of our devices is that people will use them without medical education. Corsets should be easy to use; this device can be used by children and adolescents, as using it is the most influential conservative method for helping a child with scoliosis. Today’s children spend a lot of time at the computer or phone (Rajan & Kumar, 2017). Their backs and necks are often tense, so our devices will help them straighten their posture.
Juran Trilogy Three Stages
According to the Juran Trilogy, quality planning is an essential aspect. It is a central approach in preparing medical products or medicines. At this stage, the most crucial task is risk forecasting (Salisbury, 2021). It is necessary to consider what materials will be used for corsets. Manufacturers should not rely on only one contractor to avoid risks. They should have several options, which will allow products to be diverse in terms of features and functionality. Contractors will present corsets in various shapes, sizes, and materials. These devices will be used by many people with different weights and degrees of scoliosis. Secondly, production will not incur losses if one contractor leaves but will be able to redistribute responsibilities. Risk management and design require high analytical skills from managers.
Professionals will closely regulate quality control; production managers will hire orthopedists and doctors of other specialties for verification. Poor-quality products can cause a deterioration in reputation, and health is an area where low-quality products do not belong; it is imperative to understand when developing medical devices for children and adolescents. Workers must fix products with defects, and internal departments or external structures (industrial and medical auditors, health officials) will inspect the causes of defects. The company must demonstrate that it is critical of its products.
When a defect is found, it should be identified, and employees should be notified of the incident; hiding a fault is a crime. After identifying a product’s defect, it is necessary to review all produced batches of corsets, including packaged ones, for the presence of the same defect or others. Usually, if a production machine breaks down, there is a high probability that there will be a large number of damaged corsets. In case of employees’ negligence, managers must issue a strict warning or reprimand. In machine breaking, the solution to the problem will be to repair the apparatus and test run; corsets will have to be carefully checked so that the workers can be sure that the repair is complete (Sim et al., 2021). In the future, managers and workers should monitor the quality of the products produced (Lean six sigma process improvement, 2021). These are the three stages of the Juran Trilogy: planning, control, and improvement. Following TQM, researchers and people in business identify several traps and restrictions that an enterprise or production may encounter.
Possible Pitfalls
The paper machine is the first and foremost TQM pitfall that concerns the entire field of pharmacology and healthcare. Production must be based on verified documents, which set many standards for medical devices; however, these papers can become massive. The second TQM pitfall is spending money on minor improvements. Corsets and other medical devices require constant testing and progress, and managers and bosses should take every opportunity to improve the product. However, production can quickly go bankrupt if the money is not spent properly. The third TQM pitfall is associated with possible costs and bankruptcy when managers are not aware of the quality costs.
The fourth pitfall has to do with measuring the wrong qualitative indicators. The top priority for production should remain people’s health in need of orthopedic care. Corsets should never adversely affect the health of children and adolescents; the most important indicator to check should be medical care and support. The fifth pitfall is the cultural background; it is essential in several aspects, in the production itself and because different cultures pay extra attention to health. In other cultures, it is customary to spend different amounts on health and undergo examinations in hospitals with different frequencies and detail.
The sixth and final TQM pitfall is a team competition; it is considered adequate when companies instruct different departments to cope with one mission. It will allow companies to create a high-quality product, and employees will be sincerely involved (Permana, Purba, & Rizkiyah, 2021). It would seem that for the production of medical devices, this is the essential thing: a quality product that has reached its quality through heated debates among different specialists. However, any competition has two sides; the pursuit of quality can again turn into a careless waste of money, a deterioration in the team atmosphere, and a loss of trust between departments. Such problems are solved only with the help of professional coaches, psychologists, and HR specialists.
References
Lean six sigma process improvement. (2021). GoLeanSixSigma.Com.
Permana, A., Purba, H., & Rizkiyah, N. (2021). A systematic literature review of total quality management (TQM) implementation in the organization.International Journal of Production Management and Engineering, 9(1).
Rajan, R., & Kumar, P. R. (2017). A literature review on the effectiveness of TQM implementation in healthcare sectors (Hospitals & medical devices servicing industries). Asian Journal of Research in Social Sciences and Humanities, 7(8).
Salisbury, J. P. (2021). Using medical device standards for design and risk management of immersive virtual reality for at-home therapy and remote patient monitoring.JMIR Biomedical Engineering, 6(2).
Sim, C. L., Li, Z., Chuah, F., Lim, Y. J., & Sin, K. Y. (2021). An empirical investigation of the role of lean six sigma practices on quality performance in the medical device manufacturing industry.International Journal of Lean Six Sigma.