Batch Record

A batch record is the complete documented history of a specific production batch: which materials were used and from which supplier lots, what quantities were charged, what process conditions were applied, who carried out each step, and what the results were.

It exists to make production reconstructable. If a quality problem emerges weeks or months later, the batch record is what allows the manufacturer to establish what actually happened - whether a raw material lot was implicated, whether a process parameter drifted, whether a step was missed. Without it, investigation becomes guesswork and containment becomes a recall.

Batch records are normally created from a master template specifying the intended process, with actual values recorded against intended ones as production proceeds. Deviations - a temperature outside range, an addition made late - are recorded and assessed rather than corrected out of the record, which is the point: the record shows what happened, not what should have happened.

For buyers, the relevant questions are how long records are retained and whether you can access them. Retention periods should outlast your product's shelf life by a sensible margin, and access rights are worth securing in the quality agreement rather than requesting during a dispute. See batch traceability.

Secure a right of access to batch records in writing, along with a retention period that comfortably outlasts your product's shelf life. Requesting access for the first time during a quality investigation is a poor moment to discover you have no contractual right to it.

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