Your scheduled process names the critical factors. Your batch record is the proof you hit them.

If you make an acidified food, you have a scheduled process. It was established by someone with expert knowledge of acidification (21 CFR 114.83). Its details went to FDA on Form 2541e: for each product in each container size, the conditions for heat processing and for control of pH, salt, sugar, and preservative levels as needed, plus the source of the process and the date it was established (21 CFR 108.25(c)(2)).

That filing can feel like the finish line. It's one event, with one date on it. FDA doesn't approve what you file, either; the rule says so directly (21 CFR 108.25(c)(2)).

Everything after the filing repeats. Every lot has to show it was made the way the filing says. The filing tells FDA what your critical factors are; your batch records show whether you hit them.

01. The filing says what. The batch record says whether.

The rule is specific about what the record has to carry. Processing and production records must show adherence to the scheduled process, including pH measurements and other critical factors, along with enough supporting detail (product code, date, container size, and product) to permit a public health hazard evaluation of each lot or batch (21 CFR 114.100(b)).

Read that as a test you can run on any lot in your history. Pick one. Can you show, for that lot, which critical factors were measured, what each reading was, what the limit was, and that the product met it? Can you show the code, the date, and the container size that tie those readings to the jars on a shelf somewhere?

If you can, you have a record. If the answer lives in a notebook that says "pH good" or in a spreadsheet row with no limit and no name next to it, you have notes.

02. pH is the factor the rule watches closest

pH gets its own instruction. The rule calls for sufficient control, "including frequent testing and recording of results," so that finished equilibrium pH stays at 4.6 or below (21 CFR 114.80(a)(2)). The rule does not put a number on "frequent."

It also tells you how to measure. If your finished equilibrium pH is above 4.0, that measurement has to be potentiometric, meaning a pH meter, and any in-process checks done by titration or colorimetry have to be related back to finished equilibrium pH. At 4.0 or below, any suitable method is allowed (21 CFR 114.80(a)(2)).

That makes the meter part of the record. A reading is only as good as the instrument that took it, which is why calibration records matter as much as the readings themselves. We covered that side in Every CCP log you've signed assumes the thermometer was right.

03. Every other factor you filed needs a reading too

pH is rarely the whole scheduled process. The 2541e filing covers heat processing and the control of pH, salt, sugar, and preservative levels as they apply to your product (21 CFR 108.25(c)(2)). The records rule names pH and "other critical factors" in the same breath (21 CFR 114.100(b)).

So if your process depends on a fill temperature, a salt percentage, or a preservative level, each of those needs its own reading on each lot, against its own limit.

In a spreadsheet, a reading is a number in a cell. Whether it was in limit, who took it, which meter took it, and what happened when it missed depend on what someone remembered to type in the next column. When a recall or an inspection asks for proof, that column is the liability.

04. "Review" is in the rule

Keeping records is half of the requirement. Processors must "prepare, review, and retain" their processing, deviation, pH, and other Part 114 records for three years from the date of manufacture, at the plant or another reasonably accessible location. During an inspection, an FDA investigator can make a written demand to inspect and copy them to verify pH and the adequacy of processing (21 CFR 108.25(g)).

The rule doesn't say how often to review, or in what format. It does say review. A record nobody reads meets two of those three verbs.

A simple way to meet it: set a recurring time to read the batch records for the period, and record who did it and when.

05. What happens when the record isn't there

The stakes are written into the same section that requires registration and filing. If FDA finds, after investigation, that a processor has failed to meet the requirements, which include the production records, the departure records, and the distribution records in Part 114, that failure is a prima facie basis for FDA to require the establishment to operate under a temporary emergency permit (21 CFR 108.25(a)).

Two more obligations sit next to it:

• Departures get their own file. Any departure from the scheduled process with a possible bearing on safety has to be noted, the affected product identified, and the departure recorded in a separate file or log covering what happened, what you did about it, and where the product went (21 CFR 114.100(c)). That's a different requirement from the corrective-action records we covered in When a CCP goes out of spec.
• Some deviations get reported. If spoilage, a process deviation, or contamination with potential health significance affects a lot that has already entered distribution, the processor must promptly report it to FDA (21 CFR 108.25(d)).

And the distribution side: records identifying the initial distribution of finished product are required too, so specific lots can be pulled if needed (21 CFR 114.100(d)). Forward tracing is covered in Trace a flagged lot forward.

06. What this looks like in FourFoxes

FourFoxes doesn't establish your scheduled process, file your forms, or decide what your critical factors are. That's your processing authority's job and yours. What it does is keep the per-lot proof.

Each critical factor becomes a check with a limit. Add a pH test from the template library, or build a check from scratch for anything you measure as a number. A numeric check carries its critical limit as a value, a unit, and a direction. Attach the checks to a product and they show up on the packaging screen for every batch of it, with a count of how many have been recorded (how CCP setup works).

Pass or fail isn't a judgment call. FourFoxes grades each reading against the limit, so an out-of-limit reading can't be marked as a pass, and a skipped check needs a reason. A failed check won't save until someone writes the corrective action, and admins who opt in get an alert.

The rest of the record holds up the same way:

• A check can record which instrument took the reading. If that instrument fails an accuracy check, it's marked suspect and its readings are flagged in the HACCP master log.
• Monitoring and calibration records lock once saved. Batches can't be deleted, and each one keeps a change history.
• Each row of the HACCP log carries the date, recipe, batch code, package size and count, the instrument's calibration status, the measured value, whether the limit was met, corrective actions, and who verified it. It exports as PDF or CSV (how exports work).
• Each shipment records the lots, quantities, date, and customer.

Review is still a person's job. FourFoxes keeps the record; someone still has to read it.

Your scheduled process was established once. Your records have to prove it on every lot.