A certificate of analysis for every lot, checked against that customer's spec first.

The same base product can ship to three brands under three specs: different moisture or Brix ranges, different micro limits, a different method named for the same test, and a different certificate layout each time. For every lot, someone in QA pulls the results together, checks each one against that brand's limits, notes anything retested or held, and types the certificate.

For the test, AI reads copies of the lab and production records and the customer specs for lots you already released, and drafts each COA in that customer's layout: every value from a record, every limit from the brand's spec, and the source named beside each line. A missing test, a result outside a limit, a method that differs from the one the spec names, or a lot still waiting on a result goes to your reviewer as a question. No lot is released, and no certificate is signed or sent.

Your test procedure and the brand's spec have to line up. Where product testing is one of your verification activities under FDA's preventive controls rule, the written procedure has to name the organism or analyte, say how samples are identified and tied to specific lots, set the number of samples and how often they are taken, name the test and its analytical method, name the laboratory, and include the corrective action procedure. A brand's spec often adds its own list of tests and methods. The draft lines the two up: each test the brand asks for, the record that answers it, and the method actually used, and it marks any requested test your procedure doesn't cover for that product.

Some lots wait on results before they can ship. Costco's published supplier addendum asks suppliers of high-risk ready-to-eat items, and of some that are not ready to eat, to run a finished goods test and hold program on a science-based sampling plan and to keep every lot under their control until satisfactory results come back. The same applies to any lot tested for pathogens because a buyer asked, a spec requires it or a regulation does. When a food-contact surface is tested for pathogens, every lot run over that surface since the last validated sanitation stays under the supplier's control until results are in. The draft shows each lot's hold status and any result still open, and never prepares a certificate for a lot whose results are not in.

A positive is a corrective action, not a line on a certificate. FDA's rule expects written corrective action procedures for a pathogen or indicator organism that product testing finds in a ready-to-eat food, and those procedures must keep affected food out of commerce unless it can be shown not to be adulterated. Records under the rule hold the actual values observed, with the plant, the date, the initials or signature of the person who did the work and, where it fits, the product and the lot code, which the rule defines as the plant's own code for a period of production. So the draft carries the recorded value wherever the record has one, ties it to your lot code and the brand's item, and passes anything out of limit to QA in the record's own words.

The product decides which tests count and how often. For an acidified food whose finished equilibrium pH is above 4.0, FDA's rule calls for a potentiometric measurement, meaning a pH meter, and its processing records are kept for three years from the date of manufacture. A bottling plant analyzes a representative sample of each type of bottled water for total coliform at least once a week, following up for E. coli when coliforms turn up, and runs chemical, physical and radiological analyses at least once a year. A weekly or yearly result can stand behind a lot's certificate only as what it is, so the draft labels every value with the date and sample it came from.

What your reviewer watches. Usually the QA manager or the lab lead who signs certificates today. They check that each draft names the right brand item, spec revision and lot code; that every value matches its record and every limit matches that brand's spec, in the same units; that no held lot or open result reached a certificate; and that each out-of-limit, retested or reworked result went to a person instead of onto the page.

Once your reviewer says yes, each new lot's certificate is drafted the same way for about 30 days.

Every draft waits for your QA manager to review and sign it, and no lot moves on the draft's word: release stays with the people who release lots today.

The comparison continues on live lots, and nothing else is added until the month ends.