A lot finishes final pack on Tuesday and ships on Friday. Nothing was wrong with the product. Three days went into finding a signature, re-keying a torque value and reconciling a traveler. (Illustrative.)
This is a familiar problem in medical-device production. The product is finished, but the record that proves how it was made is not.
Until that record is complete and reviewed, the lot cannot be released through the plant's normal process.
The delay often starts much earlier than final inspection. It starts wherever information leaves the production process and must be carried, copied, or entered somewhere else.
Consider a typical device production line. Material moves through receiving, kitting, assembly, inspection, packaging, and release.
At each stage, someone needs to record what happened.
When that information is captured on paper or re-entered into another system, there is a chance it will be missed, mistyped, or delayed.
Here are eight common points where that happens.
Materials arrive with supplier lot information and a certificate of conformance (CoC).
Someone checks the documents and types the details into the enterprise resource planning (ERP) system.
A typing error can make it harder to connect the material received with the material later used in production.
A pick list tells the operator which components to gather.
The operator checks the parts, then writes down the lot numbers.
If a number is missed or hard to read, someone may need to reconstruct that information later.
A paper traveler accompanies the product through assembly.
Operators complete steps and add signatures as they go.
If a signature is missing, the record may need follow-up even though the physical work is finished.
A torque tool or fixture displays a process value.
The operator reads it and enters it on the traveler or another form.
The value may be correct, but the act of copying it creates another chance for error.
An inspector measures a feature and records the result.
That result is then typed into a spreadsheet or another system.
The inspection is complete, but the production record depends on a second entry being correct.
An inspector finds an issue and sends an email.
A nonconformance record is opened later in the quality system.
That delay can leave the production record without a clear link to the issue and its disposition.
Packaging staff verify printed labels and reconcile them against the production documents.
This helps prevent mismatches, but manual reconciliation adds another task before the lot is ready for review.
Quality gathers the traveler, inspection results, signatures, and other required evidence.
Missing items must be found before review can finish.
The product may have been ready for days. The record was not.
|
Receiving
1
|
→ |
Kitting
2
|
→ |
Assembly
3 · 4
|
→ |
Inspection
5 · 6
|
→ |
Packaging
7
|
→ |
Release
8
|
Each orange marker identifies a manual handoff explained above.
It is tempting to treat incomplete records as an administrative issue.
Add a checklist. Ask operators to write more clearly. Give Quality more time to prepare the record.
These actions may help, but they do not remove the reason the record falls behind the product.
The problem is that production and recordkeeping are happening as separate tasks.
A device moves forward even when its supporting information is waiting to be entered, checked, or transferred.
Each manual transfer creates three risks:
The more handoffs a line has, the more places there are for the record to fall behind.
A better approach is to make recording the work part of doing the work.
When an operator completes a production step, the required information should be captured at that step.
When equipment produces a result, that result should be linked to the correct unit or lot.
When an inspection finds an issue, the issue should be recorded with the inspection that found it.
This changes when the record gets built. Instead of being assembled after manufacturing, it develops as production moves forward.
Each of the eight handoffs has a practical electronic alternative.
| Manual handoff | What closes the gap |
|---|---|
| Supplier information typed at receiving | Scan at receipt and link the lot to material genealogy |
| Paper kit list and handwritten lot numbers | Verify the kit against the bill of materials (BOM) at the step |
| Paper assembly traveler | Use electronic routing to enforce production step order |
| Equipment values copied by hand | Capture readings from connected equipment automatically |
| Inspection results re-keyed | Record measurements with their limits at the inspection step |
| Nonconformance raised by email | Open the nonconformance directly from the production step |
| Packaging labels reconciled manually | Generate labels using information already in the production record |
| Device record assembled at release | Keep the record current and support review by exception |
These changes do more than replace paper with screens.
They help make sure the right information is present before work moves forward.
For example, an electronic route can require a completed sign-off before the next operation starts. A connected torque tool can send its result directly to the production record, reducing the need for manual entry.
The goal is not to remove people from the process. It is to remove avoidable copying, searching, and reconciliation.
This is the role of a manufacturing execution system, or MES.
An MES guides production steps, captures evidence as work takes place, and maintains traceability between products, materials, equipment, and operations.
Connected Manufacturing implements and supports Siemens Opcenter MES for medical-device manufacturers.
Closing every manual handoff across an entire factory is a large undertaking.
A more practical approach is to start where incomplete records cause the most disruption.
Step 1: Map one production line.
Follow a representative lot from receiving to release. Identify where information is written, copied, emailed, or entered again.
Step 2: Select the three most costly handoffs.
Look for recurring missing signatures, duplicate data entry, or frequent record reconciliation. Ask operators, supervisors, and Quality which issues create the most follow-up work.
Step 3: Close those gaps at the source.
Introduce electronic checks, routing, or equipment capture where they address the selected problems.
Step 4: Prove the process works.
Check record completeness, exception counts, and the time between final pack and record readiness. Compare results using a defined period before and after the change.
Step 5: Expand to another line.
Use what the first line taught the team. Keep the effective controls and adjust what did not work.
For regulated manufacturers, system validation is part of this work. Requirements, testing, and evidence must match the intended use of the system and the manufacturer's quality process.
Connected Manufacturing supports validation as part of its implementation projects.
A finished product should not have to wait for someone to reconstruct its history.
When lot identity, assembly steps, equipment readings, inspection results, and packaging evidence are captured during production, the record is easier to review at release.
That does not remove Quality review or release controls. It gives the people performing those tasks a more complete record to work with.
The key question for any device plant is simple:
Where does the product move forward while its record gets left behind?
Those are the handoffs worth closing first.
See all eight on one page, and how MES closes each one.
Request the free two-page brief, Where MES removes manual handoffs in medical-device production.
Any new system is validated before use. Starting with one line keeps the initial validation scope smaller, and Connected Manufacturing supports validation as part of the project. The exact work depends on the system's intended use and the manufacturer's validation requirements.
No. The MES records production as it happens and passes that record to the quality system you already run. The quality management system continues to support its existing quality processes.
Related knowledge topic: Pick the decision, then the agent: choosing your first manufacturing agent