Square footage and years in business are the easiest things to compare between kit suppliers and the least predictive of whether a specimen kit program actually runs correctly. What predicts it is whether the provider builds and releases regulated product under its own quality system, and how long it has done that for accredited labs.
Below is the criteria sheet we hand to companies evaluating us. Our column is filled in. The right column is blank on purpose. Send the same list to your current supplier and to anyone else you are considering, then compare the answers side by side.
If a provider cannot answer a line, that is the answer.
The criteria sheet
| Criterion | Supera Fulfillment | Your current or prospective supplier |
|---|---|---|
| Company | ||
| Years in business | 6 | |
| Years running specimen kit programs | 6 | |
| Regulatory standing | ||
| ISO 13485:2016 certified | Yes, certified by NSF-ISR | |
| FDA registration type | Registered kitting facility, 21 CFR Part 820 | |
| Registrant responsibility for your kit | Supera, if you want it there | |
| Device history records maintained by | Supera | |
| Lab and program experience | ||
| Active kit programs in production today | Approximately 35 | |
| CLIA or CAP accredited labs supported today | 15 | |
| Longest running lab program | 5 years | |
| Regulated return logistics under UN3373 | Daily, including international lanes | |
| Quality system in practice | ||
| Controlled assembly SOP for each program | Yes, with revision history | |
| Defined QC stages in the build | Five | |
| Inspection level and sampling plan set by | The program SOP, its AQL, and client requirements, applied on every lot | |
| Lot-level release before shipment | Yes, QC sign-off per lot | |
| QC records and certificates retrievable by lot | Yes | |
| Documented CAPA and nonconformance handling | Yes | |
| Client may pull any SOP, QC record, or certificate | Yes | |
| Capacity | ||
| Pallet positions available to your program today | Quoted per program | |
| Additional positions, and how soon | Quoted per program | |
| Cleanroom | ISO Class 7 on site | |
| Controlled temperature storage | Yes | |
| The people on your program | ||
| Named program owners | Quality, production, operations, IT | |
| Average tenure of those leads | 5 years | |
| Executive owner for specimen management | 25 years in the field | |
| Accounts carried by your day-to-day owner | One. Dedicated project manager at steady state. |
Every item in our column can be verified on site or in documents we provide on request. We are glad to be measured against anyone else on the same list.
Why these lines and not the usual ones
Most supplier comparisons collect facts that are easy to gather. Warehouse size. Headcount. Number of shipments per day. Years since founding. None of those tell you whether a kit will be built correctly, whether anyone will notice if it is not, or whether the record will exist when you need it.
The lines above test four things instead:
- Does the provider hold the regulated role, or push it back to you? Registrant responsibility and device history records are the two lines that reveal this. A provider that will not hold either is asking you to carry the regulatory weight of an operation you do not control.
- Is there a release gate? Lot-level release with a QC sign-off is the difference between manufacturing and packing. Without it, nothing was ever declared fit to ship.
- Can records be produced on demand, by lot, without a project? Not “do you keep records.” Can you pull one while I wait.
- Who actually owns your program, and how many others do they own? A coordinator carrying eleven accounts will not know your kit. That shows up first as slow answers and later as a mis-kit.
Know what a bad answer costs
The gaps in that list are not paperwork problems. Each one has a failure mode that reaches a laboratory and a patient.
| The gap | What it looks like when it fails |
|---|---|
| Bad barcode or label | The specimen arrives and will not scan, so it is held. Or worse, it scans into the wrong patient record. Either way you are issuing a redraw request, delaying a result, and opening a complaint investigation on a kit you did not build. |
| No identity verification at assembly | Two kits are labeled with each other’s identifiers. Two patients receive each other’s results. That is a patient safety event before it is anything else. |
| No component lot traceability | A tube manufacturer recalls a lot. You cannot tell which of your kits received it, so you cannot target the recall. You recall everything you shipped that quarter. |
| No release record | An investigator asks who decided this lot could ship. Nobody can answer, because no one made the decision. |
| No disposition authority on returns | A consumer-handled kit goes back into sellable inventory because nobody was named as the person who decides. |
| Improvised complaint handling | A consumer calls the shipper, the shipper sends a replacement and discards the original. The evidence you were required to preserve is in a dumpster. |
| Expired kits in the field | Nobody was tracking component expiration through to the finished kit, so a patient collects into a tube whose stabilizer is out of date and the sample is invalid on arrival. |
Every one of those costs money. Replacement kits, expedited reships, lab time on invalid samples, staff hours on an investigation, and in the recall case a quarter of shipped inventory. But the money is the smaller half of it.
How to run the comparison
- Send the list as a list. Not as part of a broader RFP where it can be answered in a paragraph of marketing copy. One line, one answer.
- Ask for the evidence behind three answers of your choosing. The certificate with its scope line. One kit history record from last month. One nonconformance with its disposition.
- Time a trace. Give the provider one component lot number and ask which finished kits and recipients it reached. Note how long the answer takes. A slow answer today is an unmanageable recall later.
- Audit the floor that will do the work. Receiving, segregation, labeling, the assembly stations, controlled storage, the records. Not the corporate office.
- Compare the columns, not the pitch. Where a column has a blank, ask why once. If the second answer is also vague, you have your comparison.
Why we hold this standard
We publish our column because we would rather be measured than described. If a competitor fills the same sheet out better than we do, you should hire them. That is what a real comparison is for.
But the reason we get exacting about barcodes and release records and expiration tracking is not the audit.
At the end of every kit is a person. A patient. A son, a daughter, a mother, a father. That is why we have to get it right every time. It is not a kit. It is a person.
A mis-labeled tube is a wrong result on a real chart. A held specimen is a person waiting longer for an answer they are already frightened of. An invalid sample is a second blood draw for someone who did not want the first one. That is what is on the other end of a work instruction, and it is why the work instruction exists.
Supera Fulfillment builds specimen collection and at-home test kits under an ISO 13485 certified quality system in Houston, Texas, and holds registrant responsibility for client kits where clients want it there. See our approach as a specimen collection kit contract manufacturer, our at-home test kit manufacturing and fulfillment programs, what our ISO 13485 certification covers, and our medical kitting services. To request the criteria sheet with our column filled in, or to put us on your list, get in touch.
FDA establishment registration is a listing obligation. It is not clearance and it is not approval, and nothing above should be read as a claim that any kit or client product has been reviewed, cleared, or approved by FDA.
