Quality on the same run as the schedule.
Checks, holds, and the file an auditor wants, attached to the production you already planned. Written for FDA, SQF, and retailer programs, not as a separate quality module you integrate later.
From receiving through release.
Every quality touchpoint is a record on the lot. That is how you answer “show me the file” without assembling it the night before.
Checklists on the floor
Receiving, in-process, and final QC on a phone or scanner, with photos, so the check happens where the product is.
Holds that actually hold
A failed inspection holds the lot. Non-conforming product should not ship because someone missed an email.
Lot history
Every ingredient lot from receipt through production to shipment. A mock recall is a query, not a war room.
Environment
Temperature and humidity with alerts, including sensors if you already have them on the line.
Certificates of Analysis
Incoming COAs stored against the lot, checked against the spec you already have on the material.
Quality over time
Defect rates, supplier scores, and trends, so a pattern shows up before it becomes a customer complaint.
The checks sit on the work.
Quality is a sequence, not a department. Receiving, the line, release, and the file are the same lot moving through the plant.
01
Receiving
Check incoming materials against spec. Capture the COA, inspect the sample, approve or reject the lot.
02
On the line
Checks at the control points: weight, visual, the parameters that actually matter for that run.
03
Release
End-of-run inspection and batch approval. Hold or release, with a record of who decided.
04
The file
Batch records and COAs from the work you already did. An auditor should not wait on a binder.
PASSED
47
PENDING
3
ON HOLD
1
FIRST-PASS QUALITY RATE
98.2%
Allergens on a shared line.
Co-packers run more than one allergen profile in a week. The board, the changeover, and the label all have to agree.
What is in it
Allergens by ingredient and finished product, with the statements labeling actually needs.
Changeover that is signed
Cleaning between allergen runs is verified and signed, with photos, before the next product starts.
The sequence matters
The board can warn you when a sequence creates an avoidable allergen changeover.
Ready when the auditor is.
Documentation is the work you already did, not a project you start when the visit is on the calendar.
- A batch record for every run, without a paper stack
- Mock recall in under two hours
- Electronic signatures that meet 21 CFR Part 11
- CAPA that does not live in a side spreadsheet
- Supplier quality you can show a customer
<2 hrs
Mock recall time
100%
Batch documentation
Zero
Paper batch records
Walk a batch record with your products.
The useful quality demo uses your specs, your allergens, and the checks you already run. We will show you where that file lives in ShiftERP.