Samples and pilot runs are the gates where a medical charger program proves itself: the sample validates the configuration and the documents together, the golden sample becomes the written reference, and the pilot confirms that production can reproduce it. Each gate has a pass condition written in advance, and each result stays in the project file. This guide covers the sample types, how to build a sample test plan, the golden sample as a written gate, pilot run checks and how to keep reorders aligned with the sample.
Key takeaways
- The sample validates hardware and documents together, not hardware alone.
- The golden sample is a written reference: sealed, numbered and documented.
- Reorders stay aligned through batch records and the golden sample.
Content updated: August 2026 — confirm current standards editions and model-specific details before ordering.
Scope note: This guide is industry information, not regulatory, legal or certification advice; standards applicability is confirmed per configuration.
Sample Types and What Each Validates
Not all samples are the same, and each type validates a different part of the program:
| Sample type | What it validates |
|---|---|
| Engineering sample | The configuration works electrically |
| Documentation sample | The certificate and report match the configuration |
| Golden sample | The physical and documented reference for production |
| Pilot units | Production can reproduce the golden sample |
The engineering sample proves the design; the documentation sample proves the evidence; the golden sample fixes both; the pilot proves the factory. A program that skips a type discovers the gap at the next gate.
The sample types also have a natural order. Engineering first, documentation in parallel, golden at approval, pilot before volume. The order keeps each gate's evidence ready for the next.
The sample count is also a planning input. A single sample proves one unit; the program may need multiple units for simultaneous tests — device compatibility, thermal behavior and document review can run in parallel on separate units. The sample plan names the quantity and the purpose of each unit, so the test matrix is complete rather than improvised.
The sample stage is also where the program's assumptions surface. The duty cycle, the environment and the pass conditions are tested against reality, and a sample that fails reveals an assumption that was wrong. The failure is information, and the test plan is designed to capture it rather than hide it.
Building a Sample Test Plan
The test plan is written before the sample arrives:
- Functional check — output matches the profile table.
- Real-device test — the device behaves at the duty cycle.
- Thermal check — behavior in the expected environment.
- Document match — certificate and report name the sample configuration.
Each check has a pass condition stated in advance, and the environment and measurement points are recorded. A plan written in advance states what is required; one written after states what happened.
The test plan also records the assumptions: the starting state of charge, the ambient temperature and the duty cycle. The same sample can pass at 20°C and fail at 35°C, and the plan says which one was tested.
The test plan should also state who runs each check and what the record looks like. A plan with named owners and defined records produces evidence; one without them produces opinions. The evidence is what the next gate reads, and the plan is what makes the evidence comparable.
The document check belongs in the same plan as the hardware checks. The certificate and report arrive with the sample and are verified against the configuration — a sample that works but arrives with mismatched documents has failed the gate. Hardware and documents are validated together because they ship together.
The Golden Sample as a Written Gate
The golden sample is the approved reference that production and reorders are measured against — physically and in documentation. It deserves its own record: a sealed reference unit with a serial number, a storage location, the approver's name and date, and a note of which documents it represents.
The golden sample is a written gate because approval means more than "it worked." The approval records the configuration, the documents and the pass conditions, and it is the standard every later unit is compared with. A program without a golden sample reference is a program measuring production against memory.
The golden sample is also protected. It is stored where it cannot be modified, logged when it is handled and replaced only through a documented process. The reference has to stay the reference, because every reorder check reads from it.
The golden sample's documentation is equally protected. The approval record names the configuration, the standard edition and the pass conditions, and it is versioned like any other document. When the configuration changes, the golden sample is re-approved or replaced through the change process, and the file shows the sequence.
The golden sample also serves the field-issue story. When a unit in service misbehaves, the comparison against the golden sample separates a design problem from a batch problem. The reference is not just a production tool; it is the program's diagnostic baseline.
Pilot Run Checks Before Volume
The pilot run is the bridge between the sample and volume. It validates that production can reproduce the approved sample — same output, same appearance, same documents — at a meaningful quantity.
The pilot checks:
- Units match the golden sample in output and appearance.
- Batch records exist and name the configuration.
- Packaging and labeling match the approved documents.
- The certificate-to-configuration match survives the production flow.
The pilot is also the moment to resolve drift before the volume order. A difference found at pilot costs a correction; the same difference found at volume costs a recall.
The pilot run is also where the commercial terms are tested. The inspection scope, the batch records and the shipping documentation are exercised at pilot scale, so the volume order runs on a proven process rather than a first attempt. The pilot is the rehearsal for the production run.
The pilot result is a written gate. The units are inspected against the golden sample, the records are filed and the approval is dated, and the volume order is released on that evidence. A pilot that is not gated is a pilot that did not happen.
Keeping Reorders Aligned With the Sample
Reorders stay aligned through the golden sample and the batch records. Each reorder carries its own records, and the receipt check compares the shipped configuration with the golden sample reference and the certificate.
The reorder conversation is evidence-based: batch records from the last order, a confirmation that the configuration matches the golden sample, and a review of any change since the approval. A reorder without its own evidence is a new gamble, not a repeat.
Change management closes the loop. Any change after approval triggers the documented review — the change notification — which re-checks the certificate and test coverage before the change ships. The golden sample, the batch records and the change process together keep the program aligned across every order.
The reorder review also includes the commercial layer. The MOQ, the lead time and the terms are re-confirmed against the current configuration, and the reorder file records the confirmation. The alignment between the sample, the documents and the commercial terms is what makes the reorder a repeat rather than a new project.
The sample and pilot discipline closes where the program's other processes close: with a complete project file. The test plan, the golden sample record, the pilot approval and the reorder evidence are one versioned record, and every review reads from it. Programs that maintain the file as they go find that the gates become faster with each order — the evidence is already there, and the question is confirmation rather than reconstruction.
The WEP Series GaN Chargers at WECENT are the fixed-plug platform for single-region medical-adjacent lines, and the Quality Control page describes the production test flow and records. To run the sample and pilot gates for a configuration, submit the device list and requirements to WECENT's project engineering team — the review returns the sample plan, golden sample process and pilot gate sequence for the program.
Frequently Asked Questions
What is the difference between a sample and a golden sample?
A sample validates the configuration; the golden sample is the approved reference that production and reorders are measured against, sealed, numbered and documented.
What should the sample test plan include?
Functional check, real-device test at the duty cycle, thermal check in the environment and document match. Each check has a pass condition written in advance.
Why does the golden sample need a serial number and storage location?
Because it is the reference for every later comparison. A logged, sealed reference stays the reference; an unlogged one drifts into memory.
What is the pilot run for?
It validates that production can reproduce the golden sample at a meaningful quantity, including batch records, packaging and the certificate-to-configuration match.
How do reorders stay aligned with the sample?
Through batch records, the golden sample reference and a change review. Each reorder carries its own evidence and is checked against the approved configuration.