Core Standard III - Traceability

CORE STANDARD III

TRACEABILITY

(Applicable unless State or Federal regulatory requirements dictate a higher or different standard or procedure for traceability.)

Tenants

  • Trace-back is required for all commodities raw or finished sold under this agreement, the “One back, one forward” concept will be used.
  • This system can use any combination of alpha, numerical, Julian date, calendar date, batch or other system of numbering the lot, container or product. Which system is used it must be available to a requesting party and consistent in its practice and application.
  • Lot numbering is required between the exchange of any commodity, raw material or finished product. Examples include, compost, natural fertilizer, salad components, vegetables, fruit sold at a roadside stand, seed and water.
  • “One back” (and one forward) means that a producer needs to record the lot number of the seed purchased for the crop he intends to grow and if the producer purchases product from another producer for his sale, that producer must record the lot number of the seed used for the crop sold to the first producer. “One forward” means that the product sold by the producer must have a lot number and that lot number can be applied to the product, tie, container or invoice if applicable. This final lot number must be able to be traced back though the producer to the seed (one back in this example).

Issues Bearing On the Use of a Trace-Back System

  • Lot numbering is needed to trace-back any issue, normally those of contamination to the point of inoculation. This process allows for corrective action to take place for lessons learned and future food safety standards adjustments.
  • Lot numbering (meaning any form of a code to use for trace-back, two back and one forward) must be recorded by the originator of the item.
  • The lot number on the product or container must be reasonably indelible and may be placed on the item using an automatic, manual or hand written process. Stickers, invoices, stamps are all means to perform the recording process.
  • Lot numbering may not occur at the time of sale and best practices include the purchaser placing a form of a trace-back system on the item.
  • Use good record keeping practices.

Best Practices

  • Good management practices to develop a reasonable and workable trace-back system of handling and record keeping.
  • Proper handling of material during all stages of production to ensure a viable trace-back system is maintained.
  • Written program detailing source, field identification, commodity, inputs, harvest date and chain of custody drawing of product flow.

 Trace-back Standard 

Source

Criteria

Frequency

Target

Records

Primary

Record keeping system with lot numbers per definition above.

Each item

All items, Two back and one forward.

Note: One back may be applicable in situations where the item first originated.

Records maintained on site for a period not to exceed 3 years.

Pick Your Own

See GHP

 

 

 


Preferred Process 
None.

References

http://www.fda.gov/OHRMS/DOCKETS/98fr/04-26929.htm

http://www.cfsan.fda.gov/~dms/fsbtac23.html

http://www.cfsan.fda.gov/~ffregui4.html

http://www.cfsan.fda.gov/~fsbtac12.html

Major Non-Compliance

  • Numerous examples of the trace-back system not reflecting what is actually happening.
  • Numerous examples of clarity issues in the trace-back system.
  • Single or isolated instance(s) of incorrect or missing elements of the system that limits or stops efficient tracing back or tracing forward. 

Minor Non-Compliance

  • Single or isolated examples of the trace-back system not reflecting what is actually happening.
  • Single or isolated examples of clarity in the trace-back system.
  • Omitting packaging traceability.
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