Six Questions That Separate a Manufacturer From a Repackager

The change happened without a letter. Same product code, same bag design, same certificate format. The only difference was that set time went from 70 seconds to just over four minutes, and it took a care group two months and eleven complaints to work out why. The supplier had switched polymer grade to protect a margin, and nobody had asked the one question that would have caught it.

Auditing a supplier in this category is not complicated, but the questions that matter are not the ones on a standard vendor form.

Question one: what do you test with?

Absorbency figures quoted in deionised water are meaningless for urine. A polymer can show 300 g/g in pure water and 30 g/g in real urine, because the ionic load suppresses the osmotic drive. Ask for the test medium. If the answer is deionised water, sodium chloride at 0.9 percent, or “standard test fluid”, the number tells you about the polymer and nothing about your application.

A supplier who tests in synthetic urine, or better in pooled real urine at a stated pH and specific gravity, is telling you they understand the application. Ask for the method as well as the result: absorbency under load at 0.5 psi is a much more useful figure than free swell, because a gel under the weight of 600 ml in a bag is under load.

Question two: what is on the certificate, per lot?

A certificate of analysis that repeats a specification is not a certificate of analysis. It should carry measured values for the lot: moisture or loss on drying, pH of a 0.9 percent dispersion, absorbency, residual monomer, particle size distribution, and the lot number that matches the bag.

Ask how long lot records are kept and whether retained samples are held. A supplier who can produce a retained sample of the lot you bought eighteen months ago, and test it against the current one, is a manufacturer or a very well organised converter. A supplier who cannot is a trader.

Question three: what is the change notification policy?

This is the question that would have prevented the two months of complaints. Grades change. Suppliers change polymer source, cross-link density, surface treatment, even the anti-caking agent, and every one of those changes alters set time or capacity by 10 to 30 percent.

Ask for a written commitment: no change to formulation, polymer source or plant without prior notification, and a sample of the new material before the first commercial delivery. Put a notification period in the contract — 30 days is common, 60 is better for a hospital — and a right to reject a changed lot at the supplier’s cost.

Question four: net weight and fill tolerance

Declared net weight is a legal requirement in most markets and a useful audit point. Ask what the fill tolerance is and how it is verified. A 25 kg bag that runs 2 percent light across a year is 6 kg on 300 kg, and nobody notices because nobody weighs.

Weigh three bags from a delivery at random, on a calibrated scale, and record the results. If they are consistently 1 to 4 percent over, ask about moisture.

Question five: what does the dust data say?

Powder handling in a sluice is dusty, and the dust is a respiratory irritant as well as a slipping hazard on a wet floor. Ask for the safety data sheet and for any respirable dust or dustiness classification the supplier holds. Ask whether the grade is treated for dust suppression and whether that treatment affects wetting rate — some anti-dust oils slow the initial uptake noticeably.

Question six: capacity, lead time and a second source

Ask what the monthly plant capacity is, what share of it you would represent, and what happens if the line goes down. A supplier whose entire output goes through one line and who holds no finished stock is a single point of failure for a hospital contract. Ask for the stockholding policy and the lead time on a repeat order, not on the first one.

What the audit looks like in practice

Two hours, a sample of the current lot, a jar of urine, and a scale. Run the sample at your own dose and check the set at two minutes and at thirty. Compare it with the retained sample from last year’s lot, if you have one. That single side-by-side test tells you more about a supplier than a folder of certificates.

Ask the questions in writing and keep the answers with the contract. When a batch behaves differently in eighteen months, the paper trail is what turns a complaint into a replacement delivery rather than an argument about whether anything changed.

None of this requires a laboratory. It requires a buyer who knows that the number on the certificate and the behaviour in the pan are two different things, and who asks which test produced which. The technical data for SAP grades is the document to hold against a supplier’s own certificate, line by line.