Connie FarrisProject Performance and Quality Assurance(M.docx
- 1. Connie Farris Project Performance and Quality Assurance (MPM357-1902A-02) Jason Lewis Introduction Several quality improvement process tools and techniques exist. They include Lean thinking, Value stream process mapping, Kaizen (The Japanese word for Continuous Improvement), Five Ss (separate, straighten, scrub, standardize, systematize), Kanban Primary and Task Response. In this paper, different strategies or philosophies for quality improvement in business shall be discussed. The tools and techniques that shall be compared are: Lean thinking, Kaizen and Five Ss (separate, straighten, scrub, standardize, systematize) Comparison All the techniques aim at improving quality of production processes. They involve the production units and department. All need planning and allocation of resources strategically. Contrasting Kaizen is a Japanese word for Continuous Improvement. The philosophy states that everything can be improved continuously. It involves employees in the improvement of quality processes. Workers give their feedback on the criteria and important reviewing issues in the performance of workers, supervisors and managers alike. It bases on many suggestions from employees from all ranks in the organisation. They are expected to consider and implement them with a key goal of improving managerial performance. The system encourages workers to provide suggestion, fosters employee education so that they are informed about improvement, and lastly it encourages employee efficiency (Pinto et al., 2018).
- 2. Lean Thinking on the other hand is a technique of quality process improvement aims at improving productivity, quality and lead-time reduction in order to support growth and competitiveness. It involves continuous improvement of the processes and relationships of employees through proven systematic methods, which reduce waste and maximise on customer value. It follows Plan, Do, Check, and Act systematic method. The system achieves low cost productivity, reduce waste, quick response to customer needs and high-quality production (Vlachos, 2015). Moreover, the Five S's (5S) tools and techniques improves the work place, making it clean, safe, organised and uncluttered thus reducing waste and increase productivity. It builds both mental and physical quality work place (Urick et al., 2018). The best quality process improvement tool or technique for my project is the 5Ss. This is because it is systematic and aims at making working environment of high quality, improves productivity, makes wastage low, increase employee morale, reduces cost of operation and improves safety (Urick et al., 2018). Conclusion In conclusion, tools and techniques for improving quality processes are key in any project. Thought they focus on diverse issues, the 5Ss seems to cover most aspects that increases quality production processes. References Pinto, J. L. Q., Matias, J. C. O., Pimentel, C., Azevedo, S. G., & Govindan, K. (2018). Lean Manufacturing and Kaizen. In Just
- 3. in Time Factory (pp. 5-24). Springer, Cham. URICK, M. J., LI, M., KONUR, S., & SMITH, T. (2018). Social Barriers to Implementing Continuous Improvement Initiatives. Journal of Management for Global Sustainability, 6(1), 99-128. Vlachos, I. (2015). Applying lean thinking in the food supply chains: a case study. Production Planning & Control, 26(16), 1351-1367.
- 4. References Medical Needs Quality Assurance Integration Connie Farris Colorado Technical University Project Performance and Quality Assurance (MPM357-1902A-02) Jason Lewis 04/17/.2019 Running head: MEDICAL NEEDS QUALITY ASSURANCE INTEGRATION 3
- 5. MEDICAL NEEDS QUALITY ASSURANCE INTEGRATION 3 Abstract Medical Needs is in the process of setting up business in Nashville and Memphis Tennessee. This company will provide any medical device the doctor prescribes for the patients, with an extensive line of medical products available. They are hoping to be securely established by the fall of next year. A risk analysis has been performed and the stakeholders requested a quality analysis to ensure all the materials used will meet FDA QS regulations and ISO 14971 device quality system requirements This will include all vendor materials and the equipment used to manufacture the devices in both locations. In the next few weeks we will cover all aspects needed to complete this step of the preparations to open these businesses. MEDICAL NEEDS QUALITY ASSURANCE INTEGRATION 3 Table of Contents Abstract2 Plan Quality Management Week 14 Outline4 Quality Planning4 Quality Improvement6 Quality Control8 Quality Assurance8 Perform Quality Management Week 29 Quality Dimensions and Criteria9 Quality Dimensions and Criteria Matrix9 Cost of Quality11 Control Quality Week 4 TBD13
- 6. Control Quality Week 514 Plan Quality Management Week 1Outline 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.Quality Planning 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
- 7. 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
- 8. 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.Quality Improvement 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.
- 9. Finally, the last technique to be mentioned is Lean. Lean is more of a quality improvement strategy that a company could take. The technique employs removal of any waste that could be in a process through careful identification of areas in the process/ product that does not have any value whatsoever. Additionally, the process of quality management through lean takes the shortest time possible i.e. 3 months; after which the company experiences a drastic change e.g. in inventory, space allocation, the timing of processes, or produced units per unit of time. In this case, the project will aim to combine several implementations of quality management techniques to come up with the most qualified strategy. 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.Quality Control 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.Quality Assurance 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
- 10. 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.Perform Quality Management Week 2 Quality Dimensions and Criteria There are eight important dimensional qualities that can serve a huge part in the development of a business. Product service or goods can rank high in one of the dimensions and rank low in another dimension. For Medical Needs business to give better results, they should focus on building in these dimensions, (Chvala & Johnson, 2017). These dimensions are used as guide lines and stepping stones more so for competence improvement and to attract more patients to the health facility. It’s therefore advisable to implement them with the seriousness it deserves for better results in growth of the business and providing best services. This is because most health care institutions desire to move to the next level of service.Quality Dimensions and Criteria Matrix Quality Dimension Description of What is in terms of project Criteria to Measure Meets or Exceeds Criteria Performance The concerned parties should ensure that all appliances as per doctor’s prescriptions are always available whenever required. Proper management techniques should be employed so that frequent checks are done, and reports made for replace or repair of equipment in case of any break down. Purchase to be done whenever necessary.
- 11. Features The company should provide high quality standards such as a good functioning weighing machine and other free medical services like BMI tests among other. Public satisfaction survey, regular inspection in the health facilities as well as assessment of third party about services rendered, (Shaw C (2003) Reliability The company should strive to provide services and products on the agreed time. This will build trust between them and the customers, thus reliability of one to another. The institution should be able to get views from customers and patients about their reliability. The institute has the mandate to prevent, identify and mitigate failures and re design its systems. Conformity It’s of great concern that the company should ensure that all medicals requirements and services at a diverse are always available The institution should diffuse technology in health services and appliances, ensure commercial communication. Durability Medical needs should ensure that they provide goods and services to customers that last for a long time before expiring (Garvin, 1987). Analysis of the devices should be done to ensure durability. Make follow up to the served customers to let them know the company cares about their well fare. Serviceability
- 12. The company should put customer’s interest as a priority and be competent in their undertakings. High quality products to customers should also be a priority. Frequent inspection, repairs and replacement of devices is essential as well as proper storage and maintenance. Aesthetics The company should ensure the environment is clean and appealing to customers as well as their products and services Benchmarking other health facilities will help in assessing the aesthetics and changes made for better appearance. Perception First site impression a customer gets gives them an impression of whether they will come back or not. One therefore needs to listen to the customer’s perception patiently and administer services to them in a welcoming way. (Ross, 2017). A random public satisfaction survey will do best since the patients will be able to say exactly how they were handled when being administered to. Cost of Quality The expense of quality is an effectively misconstrued term. It doesn't mean the amount it expenses to make a quality item or administration. This term alludes to the expenses caused from not creating a quality item or administration the first run through (American Society for Quality, 1999). This would incorporate the modify of a produced thing, it is retesting or the improving of a procedure, for example, the adjust of a drywall fix which is as yet noticeable (American Society for Quality, 1999). In short the expense of value is the complete expense to address what did not satisfy the quality guideline (American Society for Quality, 1999). When it comes to the cost of quality, there are many things to consider. Basically, what the expense would be if the dimensions of introductory quality are not up to a satisfactory
- 13. standard. These expenses can be in one of two classes, the expense of non-conformance and the expense of conformance. For Medical Needs, those expenses would be through enlisting capable employees to manufacture the devices, also guaranteeing legitimate testing of all devices produced. The vendor materials will make up a good portion of the budget to ensure these meet the quality standards required by the company, not to mention the cost for the equipment to manufacture the medical devices. The expense of non-conformance is the connection to disappointment and depends on the outside and inner expenses to fix the devices. The expense of conformance incorporates the deterrent costs where everything is done to attempt and keep low quality from happening, and after that the expense of evaluation which is the costs that it takes to test the nature of the item or administrations all through the entire procedure. Conformance costs are those caused while counteracting disappointments in the task, both amid improvement and after execution. Perform Quality Assurance Week 3 TBD Control Quality Week 4 TBD
- 14. Control Quality Week 5 TBD References: American Society for Quality. (1999). Cost of quality ( COQ). Retrieved August 4, 2014, from http://asq.org/learn-about- quality/cost-of-quality/overview/overview.html Chvala, R. J., & Johnson, W. C. (2017). Why Total Quality in Marketing. In Total Quality in Marketing (pp. 1-26). Routledge.
- 15. Garvin, D. (1987). Competing on the eight dimensions of quality. Harv. Bus. Rev., 101-109 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. Ross, J. E. (2017). Total quality management: Text, cases, and readings. Routledge. Westgard, S. (2005) Quality Management Cocktail ISO, Lean, and Six Sigma. Retrieved from https://www.westgard.com/guest30.htm