New Product Introduction (NPI) is the process of launching an improved existing product or a new product in production. NPI requires detailed planning and preparation of the Pilot Run because it has a huge impact on the execution also on the future behavior of the process flow. I assume that the product already exists as a prototype and analysis regarding material, structure, dimensions, surfaces are finished too so major design changes will be not required. That being said let’s dig into the product introduction process.
The following scheme is your map with must-have tools and steps, and based on that, it will be easy for you to create an effective implementation plan.
- Design Failure Mode and Effects Analysis (DFMEA)
Design FMEA is a tool used in design and prototype phases to identify possible design failures before the pilot run. DFMEA is usually developing together with the product design and is modified several times until the last version of the prototype is tested and accepted. The DFMEA contains dimensions, tolerances, material, and surface requirements regarding quality and safety, also known as critical and special characteristics.
You can imagine this document as a summary of the product functions ensuring the design team that the product will not fail either during production or used by the customer. Without FMEA is almost sure that failures will occur during the pilot run and will cost the company time and money.
2. Process Failure Mode and Effects Analysis (PFMEA)
The PFMEA (Process FMEA) is built on the Design FMEA and is based on predetermined specifications. This method is used to point out weak points of the processes, the critical characteristics that can cause breakdowns and defects. Future extreme events can be predicted and controlled even before product launch.
Yes, I know, it’s a time-consuming team effort BUT it’s worth it to not produce defects. Otherwise, a Six Sigma Project is necessary to fix the problems.
Note! Both FMEA are living documents and they should be updated whenever design, process, or any type of changes are made.
3. Process Control
The third phase of the project is Process Control, which is the process for preparing the production-related activities including the operators on the shop floor, to know how to do their job properly. In this category, I mention the 5S System, Control Plan, and Statistical Process Analysis (SPC).
5S (Sort-Set in order-Shine-Standardize-Sustain) stands for visual management and is a helpful system in organizing ergonomic, safe, and efficient working areas. The next one is the Control Plan, which is really important from the quality point of view because indicates what to measure/ check, how often, how to measure it, which tool to use, and where to register the data. As speaking about processes, we need constant feedback and traceability about cycle time, defects, breakdowns.
Here it comes the Statistical Process Analysis (SPC) paired with Quality with helpful tools for process analysis such as:
4. Pilot Run
Last but not least the Pilot Run. This step includes a sampling process, which may sound insignificant for you, but it should be done properly. As we know these are the first live results of the entire effort we put into this project as a group.
When we are talking about sample size, a minimum batch should be between 30-50 pieces. Why is it not enough to select just 10 pieces? Because you could randomly select only good parts and based on those data, the results are good enough to move the pilot to series production. Then you wake up with defects and everybody’s wondering how that happened because the production indexes were fine. The answer is simple, fewer parts you measure less variability you get. Mathematically, a bigger lot can capture the outliers too. In the case of pass/ fail inspection, you should select even more parts.
A mistake that we tend to do is to adjust the process after a few defects.
Remember! Do not touch the process! Hands off! Let things just happen, because the chance is high, that you are going to ruin the process by starting to adjust it. Then after few good parts, the defects will reappear.
The collected data from sampling is presented in form of a Histogram, Run Chart, and Process Capability. The Run Chart indicates if the process is between upper and lower control limits and the variability, tendency of it. The Histogram shows the data dispersion but you can’t predict future defect rate so this is why you need Process Capability. The remaining SPC tools I have already talked about feel free to use for defect analysis.
Obviously, the last step is to adjust the process, set the parameters and machines based on the results, then run the series again and when it runs as it should, transfer to series production.