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GullySystem
A practical guide

Material certificates filed apart from the job: how it goes wrong

Ganesh HSStrategy and Technology, GullySystem
Practical advice · 5 min read

In this guide 6 sections
The short answer

A material certificate filed apart from the work order breaks traceability because nobody can prove which lot went into which surgical instrument. In an audit or recall you must guess, quarantine far too much stock, or miss affected units that already sit in a hospital drawer. Link the certificate to the lot. Link the lot to the job.

What the gap looks like on the floor

A steel bar arrives with its certificate. Stores staff stamp it received and drop it in a folder named after the supplier, then move the bar to the saw and the CNC lathe. The work order never names the heat.

Weeks later a finished pair of forceps sits in a tray, and its paperwork shows a drawing, a routing and an inspector’s stamp. It does not show the steel. Everyone assumes the folder will answer. It rarely does. A folder sorted by supplier and month cannot tell a polished cobalt chrome bar from one that sat in the rack for a quarter.

  • Certificate filed by supplier, not by lot
  • Work order without a heat or batch field
  • Offcuts returned to the rack unmarked
  • Two lots of the same grade mixed in one bin

How it fails during an audit

The auditor picks one serial number and asks for the material certificate, so you open the supplier folder and find three certificates for that grade from the same month. Which one applies? Without a heat number on the work order, you can only offer a likely answer, and the auditor has not asked for likely answers.

A likely answer is not evidence. The auditor records a finding. Then the sample widens. One missing link turns a ten-minute check into a half-day review of every record held for that product family, while the shop waits for answers.

How it fails during a recall

Suppose the supplier reports a chemistry deviation on one heat of steel or one lot of polymer resin, and you need every finished unit made from it, quickly. With the heat number only in a folder, you search work orders by date, guess at the saw logs and hope the offcut bins were labelled.

Hope leads to two outcomes. Either you recall too many units and lose stock, time and goodwill, or a device with suspect material stays in a hospital drawer for another year.

  • List work orders that consumed the lot
  • List serial numbers produced from those orders
  • List customers and ship dates for each serial
  • List unused stock to quarantine at once

What a connected record changes

The fix is small and strict. Receiving records the lot, attaches the certificate to it and checks the chemistry or resin grade against the purchase specification before the bar is cut or the drum opened. The lot then gets a barcode label.

Issue to the floor requires scanning that label against the work order, so the job carries the lot from the first cut to the final inspection record. A reverse search takes seconds. Offcuts return under the same label. The trail never breaks at the saw.

Receiving also rejects any certificate whose grade differs from the purchase order, and it does so before the bar reaches the saw or the resin reaches the dryer. A wrong grade caught at the dock costs a phone call to the supplier, while the same grade found in a finished clamp costs a recall.

Fix it in one week

Pick your most critical product. Take its last ten work orders and try to find the certificate for each one, timing every search with the stores clerk watching the clock. Count the misses. That count is your baseline. It is also your argument for change.

Then add a mandatory lot field to the work order and a lot label at receiving, so that no bar leaves stores without a number written on it. Even before any software, a paper traveller with a lot box filled by the operator and checked by the inspector closes most of the gap. Compare the two counts.

Certificate trace test

Ten rows, one per recent work order, carry columns for serial number, lot found, certificate found yes or no, minutes taken and who located it. A summary box counts full traces.

Open a blank worksheet to print

Questions owners ask

Why not file certificates by purchase order?

One purchase order can contain several heats or batches, and the certificate describes a lot, so the link must sit at lot level. Otherwise the lot question stays open. Filing by purchase order also breaks when a partial delivery arrives, because two certificates then share one order number and one folder.

Do polymer and resin lots need the same control as steel?

Yes, whenever the lot can affect a device that reaches a patient, whether it is a steel bar, a resin pellet or a rubber compound. Resin grade, batch and drying records matter as much as a steel heat number, since moisture in the pellets can change the moulded part.

Is a scanned PDF enough?

A scan helps only if it is linked to the lot record and retrievable from the work order in a few clicks, without searching by file name. A loose PDF is still filed apart. Name the file with the heat number at minimum, so a search for the number finds it even when the link is missing.

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