Traceability - Element ID

Traceability

With increased enforcement and regulation from the FDA and EPA, better traceability is a MUST-have for many of our customers. This requires capturing data throughout the production process to link work in process (WIP) to raw materials and finished goods to WIP. Not only do you avoid fines and get better compliance, a well designed system greatly reduces the production window involved in the event of a recall.

By capturing the data automatically and putting it into your existing ERP system, the cost of this type of project can be greatly reduced.

An automated system allows you to go beyond the compliance level and gain competitive advantage in the market. Production output and efficiency can be boosted by linking quality data to the machines and personnel that produced them (traceability gets you this data) and using that data for scheduling and preventive maintenance.

By automating, the cost of acquiring data is significantly reduced. An automated system will definitely get you a lot more data to work with than you have now. It is also likely to boost your production output by freeing worker time to do the jobs you hired them for instead of the manual data collection you have them doing now.

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Benefits

Having a tracking system in place is critical to reduce FDA fines1

  • Re-inspection fees have exceeded $8K
  • Inspection times have exceeded 27 operating hours

Having a tracking system in place is critical to reduce EPA fines2

  • Fines for mislabeling have been $23K-$54K
  • Improper record keeping fines have exceeded $200K
  • Large companies lacking traceability have been fined $2.5MM

Typical Equipment Used

Business Problems This Can Help Solve

  • How can I serialize my production output?
  • How can I get full traceability on my products?
  • How do I reduce FDA fines and/or improve compliance at a lower cost?
  • How do I reduce EPA fines and/or improve compliance at a lower cost?
  • How do I lessen the impact of a recall?
  • How do I reduce the cost of preparing for a recall?
  • How do I reduce the cost of full traceability?
  • How can I use traceability as a competitive advantage?

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References