(Updated June 2019)

There are endless reasons as to why an OEM will choose to change their medial injection molding supplier or think to change. The main 6 categories that we often see as the culprit are:

  • Quality
  • Delivery
  • Technology
  • Production Capabilities
  • Financial Health
  • Continuation Plan / Succession Plan

Whether you’ve moved 5 projects in the past or 500, the process can still be nerve racking. Each new supplier has their own process they follow, some more comprehensive than others with the common goal of making you feel comfortable. Whatever the motivation, transferring injection molding tooling is a major undertaking, you’re not transferring just the tooling, but an entire manufacturing process.

Here’s 7 key questions you need to keep in mind from the OEM side:

1. How long will the qualification process take at your new supplier?

     a. This is going to determine how much of an inventory build you need to create as a buffer while the tool is being moved and production starts again.

2. When will the first products need to be shipped from your new supplier?

3. Does your current supplier have any requirements of all invoices being paid before releasing the tools?

4. What are your current assets associated with this project that you supplier has in their possession?

     a. Tooling & Related (end of arm tooling, mold, toolsets, mold bases, hot runner controllers)

     b. Production & Quality Fixtures

     c. Secondary operation equipment

     d. Automation equipment you purchased

5. How much raw material (resin, colorant, additives, packaging) does your current supplier have on-hand?

     a. They will likely want you to purchase it back

6. What is the current lead time on raw materials (same list as above) for your new supplier to receive them from the distributor?

7. What are the product approval requirements from your quality department with a new supplier?

If both the OEM and supplier communicate well, work together efficiently as one team, and follow the critical steps we list below, the mold transfer process will be successful. Hopefully, you’ve already requested your new suppliers’ mold transfer procedure or if you in the quoting phases then it would beneficial to request it before you finalize your supplier choice.

 

At Crescent Industries, we’ve successfully transferred over 400+ projects in the past 10 years with some of those containing over 25 different parts/tools. Here’s our 8-step process for a successful tool transfer:

  • Step 1: Assemble a Project Management team: The new molder will have to gather a team which consists of a Project Manager, Process Engineer, Quality Engineer, Toolshop Representative and Production Engineer. The vendor will also establish project schedules and a communication matrix.
  • Step 2: Gather Information: The new vendor will then have to obtain information from the customer including the 2D part drawing and 3D models, as well as the size, cavitation, and class of the mold. Other details such as the required mold clamping force, injection molding process parameters, and the type of validation necessary will also be gathered. Additional questions; What is the runner type, does it run automatic or require and operator, part weight, runner weight, EOAT required, quality specifications, last article inspection.

After all the above information (and more) is sent to the vendor, then the customer and vendor can get started on the more technical steps of the mold transfer process:

  • Step 3: Time Lines: Project time lines and expectations will be discussed and agreed upon by both sides, as will the frequency of project update communications.
  • Step 4: Tools Moved: The mold(s) are then physically moved to the vendor’s facility, where the tooling will be photographed, visually inspected and classified according to its condition (e.g. Poor or Excellent) and cleaned. A mold maintenance plan will also be developed.

Parts are made from the mold at the new facility, and those parts are evaluated, during the last phase of the mold transfer process, which is comprised of the following four steps:

  • Step 5: Tool Trial: The optimal molding parameters are determined via the Scientific Injection Molding process (including design of experiment D.O.E) before a small number of shots are run for the capability study and finally one more for the FAIR.
  • Step 6: Initial Quality: The capability studies and First Article Inspection Report (FAIR) are then performed with those first sample parts.
  • Step 7: Initial Approval: The complete FAIR and capability study documentation are sent to the customer along with samples for customer approval.
  • Step 8: Production validation: If the customer approves the FAIR, capability study, and the parts, then vendor can move forward with Operational Qualification (OQ) and Production Qualification (PQ). If the customer approves the OQ and PQ, then the transferred tooling and molding process is released to production.

If, however, the customer doesn’t approve the FAIR and capability study, then the mold or process can be revised, and new FAIR and capability studies performed and resubmitted to the customer.

 

Documentation and Adherence to Proper Processes Are Key to Transferring Medical Molding Tooling

The transfer of medical injection molding tools adds increased regulatory scrutiny and thus more thorough documentation, strict adherence to documented processes, and process validation—the same fundamental elements required when bringing up a new medical device production line.

Therefore, all of the above activities—along with the supporting data—must be recorded and documented to ensure passing results during future FDA and ISO 13485 audits.

By following all the above tips, the OEMs will enjoy a seamless transfer of production to the new medical molder, with little disruption to production volume and no drop-in part quality.

 

Your Medical Injection Molding Partner

Crescent Industries has been successfully executing medical injection mold transfers for 40+ years. Our Project Management Office (PMO) brings expert project management and technical expertise for every project and customer. The result: our customers enjoy medical molding success.

For additional information, please click below to get our white paper "Tips to Assist You in Selecting an Injection Molding Partner". 

Tips to Assist You in Selecting an Injectin Molding Partner

Topics: medical injection molding