Case Study

Supply Chains in Motion: A Manufacturing Transfer Success Story

Manufacturing transfers can vary widely depending on the circumstances, making it essential to partner with a reputable, experienced supplier to make the transition smooth and painless. Spectrum Plastics Group, a DuPont Business (Spectrum), shares the challenges, solutions, and what sets our team apart when facilitating a successful manufacturing transfer of medical devices or components.

Manufacturing Transfers and the Challenges

A manufacturing transfer is when a company moves its product assets and production of products from the existing manufacturer or even one of its own facilities to a new solution provider. There are many reasons a company decides to change its supply chain. In the Medical Device market, these changes are even more complex as many components and processes are carefully controlled, the manufacturing location needs to be registered, and the product line must undergo full validation.; this is particularly true for a manufactured product. Once a decision is made to initiate a transfer, the next step is to partner with a reputable, experienced supplier that will improve the overall reliability and efficiency of the supply chain and make the transition as smooth and painless as possible.

There are a lot of potential issues surrounding a manufacturing transfer. Some of the most common include:

  • Unexpected processing and production issues stemming from the new supplier’s lack of familiarity with the current manufacturing process.
  • Transferred equipment is incompatible with the new supplier’s equipment or facilities.
  • Because of new equipment being used, there could be product quality challenges.
  • The new manufacturer does not receive legacy information regarding the previously agreed-upon quality expectations and dimensional variances.
  • Legacy quality and manufacturing notes that do not comply with current cGMP guidelines.

If the customer is relocating the work from its existing supplier due to ongoing issues with product quality or strained relations between the two companies, it may be challenging for the new vendor to get the support and information they need from the legacy provider. In some cases, the new supplier takes delivery of the customer-owned equipment and is alone in figuring out how to make the process work. Without any process knowledge, lessons learned, previous experience with quality issues, and tribal knowledge attained over the years, making a manufacturing transfer a success can be extremely difficult. 

Tight Timelines Meet up Against Stringent Quality Control

In this particular application, the customer is a medical device company with stringent quality requirements –commonly found within the industry. They produce reusable patient electrode return pads, or “dispersive pads with multiple injection overmolds and some wire assembly,” that protect the patient from burns during electrosurgery.

The medical device company was forced to transfer production of their product to a new supplier when the current facility was scheduled to close due to another company acquiring their vendor. They needed to find a new supplier to meet an extremely tight timeline with full production as quickly as possible to avoid supply chain disruptions, which could lead to surgery cancellations.

It was a long-standing product line, and only a few select employees within the current supplier team truly understood the manufacturing process and, more importantly, how to adjust it to maintain quality control. One of the biggest challenges was to secure the current documentation and records for the product line and confirm they were current and under proper document control.

Because of this medical product’s critical nature and the risk to patients, it was of the utmost priority to implement this into the validation process as quickly as possible. As electrosurgery continues to grow, these pads become more critical. Lack of availability means postponed surgeries or long waitlists for surgery schedules.

The Spectrum Solution

The Spectrum team approaches a transfer project like we approach new product development. Despite the history of the product, it’s essential to build a project charter by understanding all the stakeholders and inputs to the process, including product, equipment, procedures, the complete supply chain, failure modes, and quality requirements. This information is required to complete a risk assessment and identify all the critical focus areas.

Once Spectrum has the inputs for this project charter, we work closely with the customer to develop a realistic plan that meets timing and quality expectations. We then break these projects into smaller increments to help cover any production scheduling gaps if necessary.

The most crucial aspect of any transfer project is open and honest communication. If the prior manufacturing site can be involved in this communication, it improves the process. Transparency leads to more effective decision-making and a better relationship between the customer and our team.

To minimize risk and avoid issues during the manufacturing transfer, Spectrum sent a team of specialists to the customer’s facility while they were still producing products. The team’s goal was to fully understand the product, equipment, inspection methods, potential quality issues, manufacturing process, packaging, etc. The team members included a Process Engineer, Quality Engineer, Manufacturing Engineer, and Press Operators. They studied the manufacturing process for several weeks until they fully understood the complete production methods.

Some other ways that Spectrum prepared for the transfer included:

  • Maintenance personnel were sent onsite during teardown and shipment of the customer’s equipment so we could confidently reassemble the equipment after Spectrum took delivery.
  • We requested detailed equipment specifications up front so all utilities and infrastructure were in place to make for a quicker and more efficient installation.
  • The customer’s engineers and operators were invited onsite during the installation and validation of the equipment to help get the process up and running smoothly.

The Spectrum Difference – It’s in our Systems

Spectrum takes pride in executing successful manufacturing transfers through a solid, well-designed system. Spectrum utilizes CT scanning or other quality measurement systems to compare the actual part being molded today to the original legacy print.  That initial print review is critical. 

The process steps include:

  • Initial mold bench assessment.
  • Initial production shots with Measurement Systems Development - Compares actual parts coming out of a mold to print.
  • Assistance in updating prints for current cGMP manufacturing.

Once the initial assessment is done, we put the transfer tool into our standard development/validation process.

Manufacturing transfers can be complicated, and Spectrum goes the extra mile to ensure customer satisfaction and successful completion of the project transfer. Some of the ways Spectrum sets itself apart include the following:

  • Whenever possible, Spectrum collects information on the front end to gain a complete understanding of the product and manufacturing process.
  • The team assembles all the necessary resources and allocates proper staff to oversee and manage the transfer to ensure a smooth transition.
  • Spectrum develops a comprehensive transfer plan outlining each step/phase of the transfer and executes them deliberately and carefully.
  • The team keeps the customer informed of the progress at each step.
  • Spectrum immediately contacts the customer to change the project schedule and realign expectations if delays are imminent.
  • Spectrum assigns a single point of contact to the customer to manage all transfer activities, streamlining communications throughout the process.        

Each manufacturing transfer involves a lot of people and a team effort. The main point of contact for the customer is the Project Engineer. Along with them, other teams involved include Project Engineering, Manufacturing Engineering, Quality Engineering, Process Engineering, Maintenance, and Operations/Production.

The Final Outcome

This particular project was extremely complex to manage. The program consisted of multiple SKUs and multiple purchased components. The validation process also included multiple players. After Spectrum executes our process, the components are sent down the supply chain to other suppliers, where additional procedures are performed before arriving at the customer’s location. So, this created multiple validation layers; Spectrum was validating the product with the end user and having additional partners involved.

Even with the complexities, the manufacturing transfer was a success. The equipment arrived as expected and without any damage. The equipment was installed and brought online and was ready to begin production within two weeks.

Dimensionally and cosmetically, the parts Spectrum produced (and are still producing today) match the same quality standards as those made by the previous vendor.

Validation was the biggest hurdle due to the updated quality expectations from the end customer. However, upon validation approval and final project transitioning, the manufacturing process quickly came online and became business as usual.

However, when validation activities began, it became clear that there was a validation scope change from different quality groups, which resulted in a disconnect. The customer informed Spectrum that they had to perform Gage R&R and dimensional characterization of the parts. This revealed many dimensions that were and had always been out-of-spec and would never have passed a Gage R&R. This led to additional engineering studies to ensure all stakeholders would approve the validation process.

*Gage R&R is the process of multiple operators inspecting and recording critical dimensions using the applicable measurement method for each one (calipers, gauge pins, CMM, etc.). The statistical variation in the measurements made by the various operators either confirms or disproves the repeatability and reproducibility of the measurement method and the percentage of the tolerance used by the measurement method.

Key Insights for the Future

Due to the validation issues, Spectrum learned how important it is to establish and fully agree upon solid validation criteria with the customer and other stakeholders at the outset of the transfer. During this project, throughout the preliminary stages right up to the time validation began, validation was presented as a “like-to-like” transfer. Meaning that once the line is up and running if Spectrum could produce a product that matches the product being made with the legacy provider, the product would be approved.

Another critical insight Spectrum learned from this project is the many benefits of sending a team to observe the production process ahead of a manufacturing transfer. A thorough understanding of the production process and learning potential challenges before the transfer helps the team fully prepare. This also allows the team to gather as much knowledge as possible of past (and recurring) quality issues and how the previous vendor addressed them.

Customer comment: “The supplier considered this one of their most complicated supply chain programs since multiple OEMs and purchased components were involved, and it was critical to maintain product traceability.”

Common with transfers, customers often imply that the previous molder could do no wrong. However, there is always a reason why the work is being transferred, and it becomes an opportunity for Spectrum to shine.

Contact a Spectrum Specialist
Contact Us