Meeting Traceability Requirements

iBASEtMeeting Traceability Requirements

Dec

12

Meeting Traceability Requirements

Speaker: Slavko Jovanovic

Organizations struggle with meeting traceability requirements for many reasons. 

They do not have a way to project traceability requirements into the supply chain. Some of the delivery requirements may include material certifications, product feature inspection reports, serialization or other traceability and identification designations. 

They do not have a capability for a more finite control of traceability. The most finite traceability is a serial unit, and in some cases, you cannot trace by serial unit because the cost becomes prohibitive or the manufacturing process is too fast. The next-best method of traceability is lot traceability. The trick to doing lot traceability is to control when a new lot gets identified. Events to identify a new lot may include things such as end-of-shift, retooling, machine setup, or defects that are found. 

They do not have an electronic system to allow for searches of “where used” information.

Meeting traceability requirements is mandated by regulations. If you do it poorly, the impact may be heavy fines, expensive recalls, or unsatisfied customers at the very least. Having good traceability may be the difference between having an expensive, wide recall versus a more targeted, less expensive one. Another less visible impact of poor traceability is the missed opportunity for process improvement. Controlling traceability will open opportunities for analytics to evaluate issues, pinpoint sources and find underlying causes.

One best practice that helps with traceability is to have an electronic system that allows you to implement traceability requirements in the way that you need them. The system needs to allow for “where used” queries so that you can see what was installed, what people worked on, what product, and what tools were used in the process. It should also actively monitor for problems. For example, if a lot control part has been found to have a defect, there should be a containment event to make sure all the other parts are stopped and evaluated before the problem is propagated and made worse.

At the end of the day, in order to compete in today’s digital manufacturing revolution, companies must find a solution to integrate all interfaces into one digital thread. Download our eBook to learn how Solumina can make this a reality.

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