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Today’s instability in the global supply chain makes finding a reliable and trustworthy partner for plastic injection molding even more challenging. If you’ve ever had problems with your injection molded product quality or unreliability, then you know what a hassle it can be to change partners.  

It saves money and valuable resources if you take your time to select the right partner in the first place — one you can trust to help you avoid problems like product quality, unpredictable lead and delivery times, and gaps in capability.

When selecting a partner, your company will have several requirements unique to your organization and product. The right partner will work with you to explore common issues, problems, and pitfalls before providing an accurate estimate.

What steps can you take to avoid compromising product quality?

Consider the Total Cost of Ownership

One part of ensuring a quality product is to take a long view of the project’s lifespan.

It is essential to look beyond the tooling and per piece estimates to consider the Total Cost of Ownership when evaluating a proposal from an injection molder.

In general, a higher quality mold will cost more than a lower grade mold but will eventually save money for OEMs many times over if there is less unexpected downtime and reduced defects.

Some molding partners bring more to the table than others. For instance, some contract injection molders provide experienced engineering support—a necessary resource for Design for Manufacturing (DFM) reviews. This expertise can help keep production costs down while also meeting project requirements.

Traceability of Plastic Components

In addition to engineering support, potential partners should be able to provide traceability from resin raw material to the finished product. This requires a top-notch ERP system to be in place.

Ask for Quality Assurance & Certifications

There is no place for failed components or devices in this industry. When manufacturing components for medical devices, lives are at stake. There are several ways that plastic injection molding partners can demonstrate that they are best qualified to avoid compromising quality.

The injection molding provider can prove its ability to meet quality standards by showing potential customers that they have the necessary quality certifications and protocols for your industry segment.

FDA-registered and ISO-certified companies have proven their rigorous testing and inspection procedures. Look for these quality guarantees as you seek flawless parts for your project.

What are some specifics to consider?

FDA Registration  - Any manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user does need to register the relevant facilities and the parts involved.

ISO Certifications - The ISO 13485 certification is a sector-specific application that specifies requirements for a quality management system. An organization must demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Cleanroom Injection Molding - If your component or product requires cleanroom manufacturing, ensure your partner has certified cleanrooms that meet your project needs. There are different classifications of cleanrooms based on air purity – for example, ISO 8 cleanroom allows for a maximum of 100,000 particles per cubic foot, and ISO 7 cleanroom allows for a maximum of 10,000 particles.

Next, ensure your injection molding partner has their cleanroom validated by a third party to ensure that it is certified to the specific class indicated.

Think of the Lifetime of Your Injection Molds

A plastic injection molding supplier is a long-term partnership that needs to stand the test of time. They should maintain stringent process validations to include IQ, OQ, and PQ evaluations and planned periodic tooling equipment maintenance to prevent products from being manufactured that do not meet specifications.

They should be able to provide reassurances that production will not be held up by equipment malfunctions, needed repairs, or molds failing specifications.

Any problems requiring tooling redesign after the steel has been cut will affect the cost and timeline of the project.

It’s always best to avoid problems before they happen by selecting a vendor that provides DFM support.

Can the Injection Molding Partner Meet Your Demand?

When choosing a partner, you’ll want to know that they will be able to scale production if demand increases. The Society of Plastics Industry (SPI) has categorized standard injection molds into five classifications to guide quotes and orders into uniform mold types.  

The correct mold type is crucial to achieving quality, production, and cost objectives. If the supplier cannot scale the mold, the costs and risks of a mold transfer to another supplier can be considerable.

It pays to ask:

  • Do they have the capacity, the labor, and the equipment to manage larger orders?
  • What are the additional maintenance costs associated with increased production volumes of the tooling equipment?
  • At what point does more robust tooling need to be considered to meet production demands?

Get It Right the First Time

By selecting a partner with the experience and ability to guide you through the design, prototyping, and tooling process, you are on the first step to creating a lasting partnership that will serve your project’s needs.

Don’t short-change the design phase. That’s when your choices substantially affect the mold production's future success. Working with tooling design engineers with extensive knowledge of part designing, material selection, mold designing, part fill simulation, and material expertise helps avoid sacrificing quality or functionality.  

Look for experienced engineers trained in scientific molding principles and certified by RJG and GSP—recognized international leaders in injection molding training, technology, and resources.

Providers should also include 2D and 3D part and mold design models, 3D printing, and 3D mold fill simulation during the product development phase to identify and correct potential flaws or constraints in the molds to ensure manufacturability and consistency.

In the end, you’re looking to select a plastic injection molding partner that has demonstrated success in the market. Consider using a buyer’s guide to help your selection process to ensure your partner can meet your project needs at every step.

Topics: plastic injection molding