The Importance of Traceability for Medical Parts

At Midstate, we make molds and parts for all kinds of products. One of our leading markets is making high-quality parts for the medical field. We understand the importance of absolute certainty and consistency when creating these parts due to their significance. We have molded parts for the medical industry for many years and we are ISO 9001:2008 certified to uphold our high standards and quality.

What is Traceability?

The concept of traceability is to trace and identify a part’s origin backward along the supply chain and forward along the distribution chain based on identifying characteristics and records. At Midstate, full and detailed traceability is built into our inventory system, machine operations system, and all other aspects of manufacturing execution technology.

Legality of Traceability

A manufacturer involved in the medical sector must adopt a method of tracking devices whose failure or defect would be likely to have serious health consequences. Especially if they are life-sustaining, life-supporting, or parts being implanted into the human body.

Legislation such as RoHS and Reach documentation and certificates such as ISO (learn more about ISO certification in our blog, The importance of Being ISO Certified) create guidelines, standards, and adds to the importance of traceability. It is a legal requirement for manufacturers to self-declare compliance and respond to traceability inquiries on demand.

Being ISO 9001:2008 certified, we must identify the product as well as monitor and measure the status of the product. This is all done throughout the product realization process. Where traceability is a requirement, records are kept of the unique identification of the product.

Benefits of Traceability

For any manufacturing business involved with the medical sector, traceability is an essential requirement. Should an issue arise, traceability helps to mitigate liability, where the issue lies, and which products it has impacted—increasing safety.

When problems of this nature occur, manufacturers would shut down production, recall parts and incur financial loss. With solid tracing systems in place, we are able to minimize disruption to production.

Short-term Goals:

• Eliminate recalls in the first place by providing real-time reports on the machines, components, stations, shifts, and operators involved in the defective product/process before it is shipped.
• Identify products affected by the defect after customer delivery to minimize recall costs by identifying only the specific serial numbers that were built with the faulty component.

Long-term Goals:

• To identify defects prior to customer delivery to reduce in-process costs and to eliminate the need and costs of a recall.
• Expeditiously remove potentially dangerous or defective devices from the market.

At Midstate, we assume full responsibility for the whole process from start to finish. Our clients know that the mold was handled by Midstate exclusively. By doing this, we have eliminated the option of shifting the blame to someone else. This means you will get a straight answer and resolve any issues from one company instead of playing the arbitrator between two separate companies. Contact us today if you have any other inquiries concerning our traceability systems for your medical products.