When choosing an injection molder for manufacturing of plastic medical devices or other specialty projects, there are mandatory guidelines that should be used to determine how to choose the right company.
1) What Quality Management System/Quality Standards do they Follow?
It is critically important to assure there is a robust Quality Control system in place. This shows that the company monitors the effectiveness of their supply chain and demonstrates traceability related to regulations of materials and finished goods. Correct documentation, data monitoring and storage is critical to any quality injection molding manufacturing process.
To this end, some things to remember include:
Asking your injection molder what quality management certifications they have and if that meets your requirements. For instance; FDA registration, or ISO 13485:2003 are common requirements for medical devices and components.
If these systems are in place they require a certain amount of documentation, assessing and minimizing of risks, as well as product realization.
These types of quality certifications also show that this injection molder takes their business seriously, which means they have higher-than-average quality standards.
2) Can They Support your Entire Product Life Cycle?
This means can they offer you a single source for procurement? This requires having a company that can provide services from the design phase through production - then have it immediately shipped out the door from the factory.
Will they provide design and development services either as your design team - or enhance your in-house staff. They offer insight and recommendations based on their own experience, they know the industry best practices, and then look at design for manufacturability.
An integrated team can provide sustaining engineering capabilities to better address improvements and changes to the product as feedback returns from the field for proper device operation.
An injection molder that can then provide mold building solutions provides a single-source company to ensure no information will get lost from the design phase. Always asses manufacturing variables that affect component quality and durability like wall thickness, draft and surface finish.
Does the injection molder have the ability to handle the fluctuations in demands starting at the prototype level and scaling up to high-volume production? Also by offering assembly, packaging, pad printing, and other secondary operations to complete your project you save time, resources and money. This also streamlines your production schedule and efficiency.
Also, your injection molder should provide inventory management solutions for your project such as Kanban shipping, Just-in-Time Approach and Blanket Orders.
3) What Project Support will I Receive Once I’ve Made My Choice?
Does the injection molder have a Project Management Office comprised of a group of professionals who focus on defining the scope and maintaining the standards you have set for your project from the design phase through to production?
They also follow every project related task from start to finish. This keeps decisions and implementation moving in a consistent manner toward the project goal. PMO is also responsible for all communications about the project to the customer, as well as internally.
Does your injection molder provide mold maintenance programs because all injection molds require maintenance at some point in order to continue to function properly. Regular maintenance and cleaning of your injection mold is required to maintain part quality, consistency and cycle time. This mandates a regular inspection and maintenance program that keeps molds in top condition, while detecting problems early. On-site tooling maintenance is a must if you wish to protect your investment and keep your injection mold running.
Will you receive customer service support; this provides you support and feedback to demonstrating value, better collaboration and more proactive responses from your injection molder.
Choose Industry Leaders for your Injection Molding Projects
Crescent Industries is an employee-owned injection molding company that has been setting the standards for injection molding quality and production for over 70 years. We are an injection molding partner with a broad scope of experience and industry-leading knowledge providing support through entire life cycle of your project.