If you are familiar with medical device manufacturing, certainly you have heard the phrase, “Quality over Quantity.” This phrase is commonly used to denote that it is preferred to have a quality product over a larger quantity that may not satisfy customer needs. The reality is that there is a positive correlation between ensuring higher quality with the amount of effort put into continuous improvement; it is not something that comes easy and many will learn that over time hard work pays off.
Continual improvement is about maintaining incremental consistency of total quality over a period of time, along with continuously promoting quality activities regularly. Examples of this include quality planning and quality assurance. There are 3 ways to ensure continual improvement:
There are always more opportunities to reduce waste and streamline work, because no manufacturing environment will ever be perfect. It is a matter of taking advantage of the opportunity and ensuring that there are no outstanding tasks that have been lingering on a to-do list for weeks. Improvement is ultimately driven by quality and is a requirement for quality management systems as stated in ISO 9001. The definition of continual improvement is the recurring activity to increase the ability to fulfill requirements. The foundation for continual improvement is quality improvement which is a main part of quality management; this focuses on increasing the ability to fulfill quality requirements.
Quality should never be sacrificed just to complete a task faster or cheaper. It is important to note that quality is something that takes practice and a designated amount of time to perfect in terms of precision manufacturing of advanced flexible materials. It is something that can be achieved when Standard Operating Procedures are enforced and carefully aligned with personnel skill sets. There is a large monetary value associated with the time and resources needed to create a quality product; however, the monetary results of a quality product will far outweigh these investments.
The continual improvement process is a deeming cycle of Plan, Do, Check, Act. Process control is based on the monitoring of a process to ensure that it is working as intended while also making small and simple improvements along the way. Continual improvement management can be measured by implementing lean methodology into processes to reduce waste by driving quality and reducing costs. There are the 8 wastes that the lean practices strive to reduce; including, transport, inventory, motion, over-processing, over-production, defects, skills, and waiting as defined in Six Sigma methodologies.
There are two ways to approach the concept of lean manufacturing, that is by reactive and proactive improvement. The reactive approach is a passive way of dealing with improvements and the proactive approach is an aggressive strategy that strives for efficiency and excellence. In order to not just reduce the amount of issues that you have, but to eliminate them completely takes more proactive measures.
Implementing concepts of lean manufacturing into your workplace is about reducing variation in a process by improving quality and meeting demand requirements. This also advances the company’s profitability by cutting costs and reducing waste. This can be improved by focusing on work instructions, checklists, and visual improvements; these are basic techniques to make process improvements.
Another way to intensify continuous improvement within an organization is by broadening the scope of tools that are used to enhance processes. The ingredients for the recipe here, really include a variety of different tools that can be used to assist in the success of continual improvement over time and performance excellence. It may seem like your mind is being pulled in different directions when first brainstorming ways to continually improve on a process or product. All of the different tools are useful in their own way and it is advantageous to try to utilize as many as can be managed. You don’t want to overutilize tools and waste time; however, it is important to lay out a plan for improvement projects and utilize the right tools for each project.
Some examples of tools that can be used for continual improvement include Failure Mode and Effect Analysis (FMEA), which can be used to assess all the possible risks for a given scenario, and Design of Experiments (DOE), which is a systematic method used to determine the relationship between factors affecting a process and the output of that process. The goal of these tools of analysis is to detect the controllable and uncontrollable input factors within the process. This allows you to define the process output by analyzing all potential effects of failure. Risk analysis is something that builds continuous improvement within a Quality System and the usage of risk is found to be even more prevalent in the ISO 13485:2016 revision.
Different methodologies and tools can be used as reference material and as enhancements for processes that need improvement. There is no cookie-cutter approach, as each organization has its own culture. Most times, the process is usually the problem, not the people. This is why it is critical to continuously improve and help to reduce variation in processes, because unwanted variation can ultimately lead to unfavorable outcomes. Small incremental changes can accumulate and help to improve the process and the outcome, leading to better daily manufacturing practices.