Only after, you fully comprehend all of the nuances of launching a new injection molding project, can you confidently begin analyzing and developing the processes that will deliver consistent product quality. Use these tips to help navigate your new injection molding project.
Quality Management System Standards and Certifications
The Quality Management System is a program for the systematic monitoring, evaluation and documentation of the various aspects of a project to ensure critical standards for quality are being met.
This means that quality standards like FDA registration ensure the injection molder complies with the rules established under FDA quality system regulation as established under the 21 code of Federal Regulation (CFR) Part 820 (Medical Devices). This means certification and government compliance can help validate the highest quality processes by establishing clear standards.
ISO 13845 certification is a manufacturing certification in line with the Food and Drug Administration’s QSR standards and are globally recognized for conforming to the medical device regulatory requirements.
A good quality management system incorporates quality process validations. Process validation is the process in which objective evidence is established that a process consistently produces a result or product meeting its predetermined specifications. This helps to diminish the risk of product failure
Product/Process Failure Mode and Effect Analysis; this refers to a quality engineering tool used to quantify and evaluate the process variables used in the injection molding process. Using a structured PFMEA approach to identify, estimate, evaluate and prioritize risk delivers a higher level of product quality. Process mode and analysis also helps to identify critical input and process variables that can affect product quality while evaluating the risk associated with product defects in order to mitigate that risk.
RPN is used to calculate the relative risk with the defects. This must be calculated for the entire process or design. After the RPN is calculated, the failure modes with the highest RPN are assigned to the highest priority, and then corrective action is considered.
Mold Fill Simulation Utilization
Mold fill software virtually simulates the filling, packing and cooling of a molded plastic part. Simulation sparks proactive communication, which will result in a successful tool launch into production.
Mold fill simulation improves the ability to predict melt filling and air venting behavior. The gates need to be placed at the most appropriate locations in order to allow enough melted plastic fill and pack/hold into the cavity. Flow distance will also have an effect on the amount of pressure required to fill the mold, this in turn will affect the amount of clamp force required to hold your mold shut during the molding process. If the machine cannot handle the pressure or clamping requirements, it might be time to add more gates.
Mold designers will be able to evaluate cold/hot runner scenarios and gate locations in order to allow enough melted plastic to fill and pack/hold into the cavity.
The ability to evaluate different cooling arrangements by comparing accurate cycle time is based on the whole system;
- Efficiency of each cooling loop
- Adequate cooling channel size and plastic frozen percentage
- An optimized cooling system will facilitate improved in mold temperature control that helps maintain a minimum cycle time
- Cooling analysis helps maintain part shrinkage and warp
Visual cues and decisions;
- Identify areas of the part that might not completely fill with plastic making it possible to make tweaks to the mold design to resolve this issue
- Show where weld lines develop and if these areas are structurally sound or not
- Make informed resin decisions by evaluating the material sheer rate, temperature and pressure. This can help you decide if a specific material will work with a given part design
Project Management Office
The PMO engages in a manner that controls budget, keeps projects on schedule and will assure compliance with all project requirements be it regulatory or customer based. This team of professionals delivers project updates internally and to the customer. They utilize effective time management by establishing a Gantt chart to track activities and time assessments for each task. It is reflected by its own bar, the position and length of this bar, reflects start and end dates.
Crescent Industries Delivering Effective Project Management and Products
Crescent Industries has been delivering custom injection molded components and devices for decades. We help focus to define the scope of the project and maintain the standards set for your injection mold building project.