In this guide 6 sections
Medical device manufacturing software must hold one connected record per device. That means the device history record, material lots, serial numbers, inspection results, nonconformances, complaints and service visits. When any of these lives in a separate file, a recall or audit turns into days of searching.
One record for each serial number
Start with the unit. One serial or lot number should open a single page that shows everything which happened to that device, from the first cut to the packing bench. It is simple to say. It is hard to find in most plants.
Work order, routing, operator sign-off, machine, fixture, cleaning step, packing date and label version all belong on that page. This is the device history record, and many makers still assemble it by hand from a binder after the batch has shipped.
The binder works until a regulator asks for ten records at once. Software should build the record while the work happens, so that nobody reconstructs a sign-off from memory three weeks later.
- Work order and traveller with each operation signed
- Machine, tool and gauge used at every step
- Operator and date for every sign-off
- Packing and labelling record with the label version
- Final release signature with date
Material lots tied to the work
Every bar of stainless steel, every bag of polymer granules and every box of sterile pouches arrives with a certificate. The system must link that lot to each work order which consumed it. A scanned certificate in a shared drive is not a link.
Receiving should capture supplier, heat or batch number, certificate and incoming inspection result. Issue to the floor should then force a lot choice. Nobody starts a job without naming the material.
Offcuts and returns need the same discipline, because a half-used bar goes back on the rack and feeds three different jobs next week.
Inspection results as data, not paper
First-article reports, in-process checks and final inspection all produce numbers. Store them as numbers against the drawing characteristic, the gauge and the drawing revision. A scanned inspection sheet cannot be searched for a dimension that is slowly drifting.
Calibration belongs in the same system. Suppose a micrometre is found out of tolerance at its yearly check. You then need every reading it touched since its last good check, and that list takes seconds when gauge IDs sit on each measurement.
Rejects matter as much as passes. A failed reading should open a nonconformance automatically, with the lot, the operator and the machine already attached, so the quality engineer starts with facts instead of questions.
- Characteristic, nominal, tolerance and measured value
- Gauge ID with its calibration due date
- Accept, reject or rework decision with the inspector
- Link to the nonconformance when a reading fails
Complaints and service on the same page
A complaint reaches you by phone, email or a distributor’s form. It names a device, often only by a serial number scribbled on a returned carton. The system should answer with the device history, the lots inside it and earlier service visits in one lookup.
Service engineers write repair notes, replace parts and recalibrate on site. Those notes feed the same record. A pattern, such as three hinge failures from one steel lot, only appears when complaint, lot and service data share a key.
Without that key, each department sees one small fault. With it, you see the cause. That is the whole point.
Test it with a mock recall
Before choosing any system, run a drill. Pick one lot of raw material and ask for every finished serial number that used it, every customer who holds one and every open complaint on those units. Time the answer.
If your present setup needs a full day and four people, write that down. It becomes your acceptance test. Ask each vendor to repeat the drill on a sample of your own records, not on a polished demo.
Finish by deciding who owns each part of the record. Quality owns the rules, operations owns the entries, and one named person owns the gaps between them.
Device record readiness sheet
This worksheet has six rows: device history, material lots, inspection, calibration, complaints and service. Across each row, note where the data lives today, who owns it, whether it carries the serial or lot number, and how many minutes a lookup takes. The last line holds the time your mock recall drill took.
Open a blank worksheet to printQuestions owners ask
What is a device history record?
It is the file proving that a particular device or lot was built to its approved routing. It shows the operations signed, the materials used, the inspections passed and the final release. Good software builds it as work progresses.
Do we need separate systems for quality and production?
Not always. What matters is a shared key, the serial or lot number, across both. Separate tools can work if they exchange that key without anyone retyping it.
Can a small maker manage with spreadsheets?
For a handful of products, often yes. Trouble starts when one lot of material feeds many orders and a complaint needs a quick reverse search.