We manufacture most orders in a Raw Material blending and packing batch process.
Many orders involve 10 or more batches.
The product is a low risk dry ingredient that is sold to customers for use as an ingredient in processed food of medium-high risk.
Past practice has been to micro test only the first batch manufactured and from those results, prepare a CoA for the entire run's production based on those results.
History has shown no concerning results from that machinery over a 10 year period of use at least once per week.
Clearly the current practice of testing only 1 batch is unacceptable to subsequently extrapolate the results to cover the entire order in the preparation of a Certificate of Analysis/Conformance.
I have proposed a change to test a composite sample from Start, Middle and End of production, but there is some consternation from my senior that this is still not sufficient and that we ought to be testing each batch individually and sending each batch out as a separate batch rather than as one lot.
What is the opinion of others here?
Is a Start, Middle and End testing regime (backed by history) sufficient to produce a CoA, or should it only be a CoC (since we are not testing every batch)?
Edited by StevoTheDevo, 19 January 2009 - 01:49 AM.