Key Quality Dimensions 2

Quality Assurance is among the most important tasks that Medical Needs can undertake. Medical Needs Company wants to set-up a business in Memphis and Nashville. The company provides medical devices prescribed by the doctor to patients. The company have already performed a risk analysis so that they can ensure that all materials used meet ISO 14971 and the FDA QS regulations.

Medical Device Quality Management System commonly known as QMS involves structured processes and procedures which cover all aspects of product labelling, distribution, design, clinical data storage, risk management, complaint handling, and supplier management.

To start with quality management systems (QMS) ought to integrate strategic organization objectives into manufacturing processes. From this system there are four major deliverables, these are; management controls, design controls, process and production controls, and corrective and preventive action. The management control is used to provide adequate resources, making the necessary adjustment, and ensuring they are effective, conducting quality audits, conducting management reviews and establishment of functioning quality system. Design control deliverable is used to identify design inputs, verifying design inputs, and validating system design, the process and production controls is aimed at developing adequate processes, monitoring and controlling medical manufacturing processes, and verifying all the processes results. In addition, this deliverable will enable the development of production processes so as to ensure that the medical device conforms the specifications (Pate, 2016).

The initial and first stage in the development of a great quality management project will be to determine the quality management mechanisms that are employed by Medical Needs. The company will have a well-established quality management technique that it has been using to determine the manufacturing quality of the devices i.e. The Total Quality Management technique.

Successful companies like Google have stated that customer satisfaction has direct impact on the success of the company. Medical Needs Company has already created an environment that supports a quality culture and requires a systematic and structured process. To implement the selected project, the company has started off by performing risk analysis. In here the company is aimed at identifying some of the critical success factors. One of the reasons for this is to assist the company in meeting the company objectives. Some of the customer success factor which are employee satisfaction, customer satisfaction, product quality, and process improvement. In addition, risk analysis will assist in monitoring and tracking the organization progress. Also, with risk analysis, it will help in identifying the customer groups which are vendors, suppliers, employees, customers, and volunteers.

Lastly with risk analysis it shows Medical Needs readiness to the selected project as it will aid in developing an improvement plan and SMART goals which includes leadership development, process improvement, staff development, and performance management (ISO, 2017).

The technique is mainly focused on achieving the best quality for devices used in the health care facility. This comes at a price in the long run because the quality of those devices is already pre-defined ergo improvement is never achieved. The level of quality leads to a saturation point since no advancements are applied to the development process of the devices. Therefore, the company may find its devices to be outdated as new approaches/ methodologies to manufacturing are not be implemented using the Total Quality Management Technique (Juneja, 2019).

As a result, the company would use addition or change of the technique used to aid in the improvement of the quality of devices as explained next.

While trying to find a middle ground that will enable the company makes the best decision when it comes to quality, it is paramount to discuss some of the techniques that can be applied in performing the process; Six Sigma, ISO, and Lean (Westgard, 2005).

Among the tools that can be applied to quality management process, the Six Sigma is one of the best methods to do it. The technique involves the change of several small aspects of a product in order to improve its overall quality. It targets manufacturing devices that are error free. This is accomplished through a quantitative process that takes note of the number of defected products in a batch of production. To achieve the standards set by six sigmas, there are certain levels of the production quality that are tested for and appropriately reacted to depending on the scores achieved. This include changes in the process of manufacturing, improving the design, or just small obvious changes. Depending on the level of quality required, six sigma works to give the most out of the standards set i.e. it is more or a quantitative than qualitative process.

Another great tool used for quality management is ISO 9000. This generally depends on the set standard quality of devices. Once the standard is achieved, the quality of production is said to be up to standard. ISO can be applied to individual processes or the whole system of processes to improve the product that is being made. Specific ISO standards that should be met by a device/ machine produced are checked against the product, areas that should be improved are identified, and appropriate steps are taken to ensure continual improvement.

Taking ISO and Lean will give the company an edge in achieving high quality (standard) devices in its stock and at the same time ensure that the acquisition of inventory is done in an appropriate manner i.e. without any wastage. Lean and ISO also ensure continual improvement in quality by regularly checking for any vulnerabilities that may exist in the products. Further, the company could benefit from ISO and Lean implementation since it can continue with the quality improvement process over time i.e. it is not a one-time thing.

In this scenario, the company wishes to open two additional branches ergo the quality management task. Quality control will ensure that steps taken in establishing quality management techniques continue even after the process is finished. The use of ISO and Lean as management tools allows for regular audits to be done on the process as well as the products in stock. With a set-up audit, the company can easily improve as advancements are discovered over time.

This is the process of testing and maintaining quality over time. The set standards for devices are defined in the ISO 9000 manual. Therefore, every device being bought for the organization must pass the needed minimum requirements as stated. Depending on the changes that may come up, the standards are revised, and effective improvements adopted as soon as possible.

In conclusion, it is evident that quality management for the health care business is crucial to the business. Further, several techniques that the process can be undertaken have been discussed i.e. Lean, ISO, and Six Sigma. Medical Needs adoption of ISO and Lean ensures the process follows quality standards that have been set for the healthcare industry, as well as quick, waste removal steps, are taken to improve both the process and the devices used.

ISO. (2017). Guidelines for quality management system documentation. Geneve: International Organization for Standardization Press.

Juneja, P. (2019) Comparison of Six Sigma and Total Quality Management. Retrieved from https://www.managementstudyguide.com/six-sigma-and-total-quality-management.htm

Pate, S. (2016). The global quality management system: improvement... by Suresh Patel, (Quality management consultant) . Productivity Press: Productivity Press.

Westgard, S. (2005) Quality Management Cocktail ISO, Lean, and Six Sigma. Retrieved from https://www.westgard.com/guest30.htm