How to audit a supplement factory in one visit

Most factory visits are theatre. You are met at reception, walked a route that has been walked a hundred times, shown certificates in a frame, and driven back to your hotel having learned nothing useful.

The difference between that and a real audit is not access. It is what you ask to see, and in what order. This checklist is written for use on any supplement manufacturer, including this one; where it describes how Organix does something, treat that as a thing to verify rather than accept.

Before you travel

Request these in writing. How a plant responds is itself information, and costs nothing to learn from your desk.

• The facility licence or national listing, with its issue date
• Each certificate as a document, not a logo: issuing body, scope, site, expiry
• Which dosage forms the facility is approved for
• An organisation chart showing who the quality function reports to
• A blank batch manufacturing record for a product like yours
• A list of export markets shipped, with dates

Then ask for three harder things: a visit on a production day rather than a quiet one, a scheduled meeting with the quality manager by name, and permission to choose which batch records you inspect once there.

A plant that agrees to all three before you arrive has told you most of what you came to find out.

Walk the material flow, not the tour route

Ask to follow a material from the gate to the pallet, in sequence. Factories are designed around that flow, and problems live where it breaks.

Goods-in and quarantine. Is incoming material separated and status-labelled — quarantined, approved, rejected? Look for a rejected-material area. A plant that never rejects anything is either very lucky with suppliers or not testing properly.

Dispensing. Where is material weighed out for a batch? It is a cross-contamination point and a dose-accuracy point at once, so expect a dedicated space rather than a corner of the warehouse.

Production. Watch gowning actually happen, including for the people escorting you. Ask which way air moves between zones, what else that room runs, and what the changeover procedure is.

In-process control. Ask where the IPC lab sits and how samples reach it. A lab at the far end of the site produces results after the fact.

Packing. Ask for the line clearance record for the current run and how batch coding is verified. Mislabelling is one of the most common recall causes in this industry.

Finished goods. Is released stock separated from stock awaiting release, and who controls that boundary?

The four record pulls that reveal the truth

An audit is a document exercise with a factory attached, so pick the records yourself.

1. In-process control records for a batch run last week. Not a template, not a pack prepared for visitors. Look at timestamps. Entries clustered at identical intervals in identical handwriting are not a record of a shift, they are a reconstruction.

2. A raw material that failed. Ask for the last incoming rejection and follow it through: test result, decision, what happened to the material, and what happened to that supplier. The follow-up is the real answer. Organix has had a material arrive with perfect paperwork and testing find it non-conforming, which is why incoming testing matters however good a certificate of analysis looks.

3. A traceability exercise. Hand them a finished pack and ask them to trace it back: raw material lots, batch record, the cleaning record for the equipment used, who ran it. Then look at your watch. Under thirty minutes is a system. Half a day is a filing cabinet.

4. Deviations, complaints and corrective actions. Ask for the last three of each, including one still open. A deviation log with no entries is not a clean factory, it is an unused one.

Who is allowed to stop a batch

This question decides everything else, because every other control depends on someone being able to enforce it.

Ask it three times: of the commercial contact, of the quality manager, and if you can, of an operator. You are listening for whether the answers match, and whether people name a person or recite a policy.

Then ask the harder half: who can overrule that person, and has it ever happened?

At Organix the quality department outranks the owner on quality decisions — a deal struck on day one, in the chairman's description: full authority to the quality team in exchange for zero defects, stated publicly and in front of staff. Do not take our word for it. Ask someone on a line who stops a batch and see whether the answer matches.

The test is identical in any factory: find out what happens when a quality decision and a delivery date disagree, and who wins. If the answer is the commercial director, you have learned something.

Finished-unit inspection, and what it costs

Ask precisely how finished units are checked. Expect three layers: machine rejection on the line, periodic checks during the run — on a capsule line, units pulled onto a precision balance at intervals, since unit weight is a proxy for dose — and a final inspection before packing, where the question is whether it covers a sample or the whole batch.

Organix sorts capsules visually, one by one before packing, on top of machine rejection and periodic weight checks — slow, labour-heavy, and a cost a factory only carries if it has decided to. We set out what that looks like in what quality control actually looks like on a capsule line. Whatever a plant tells you, ask the follow-up: who pays for that sorting labour, and has anyone proposed reducing it?

The spend nobody ever asks about

Ask what the plant spends on quality consumables — alcohol, sanitiser, gowns, masks, hairnets, overshoes, cleaning agents — and whether that line has ever been cut.

Nobody asks this, which is why the answer is informative: it is a cost with no visible product, no marketing value and no customer demanding it. At Organix, alcohol alone runs close to EGP 80,000 a month.

Two questions in the same spirit: who calibrates the balances and instruments, and what spare parts are held in stock. Supplement lines are rarely made locally, so a plant without a spares buffer and preventive maintenance will eventually explain a delay to you as bad luck.

What a visit cannot tell you

A day on site cannot tell you true available capacity, how a plant behaves when it is late, whether your batch gets prioritised over a larger order, or whether the company is solvent. Those come from references: ask for a client who stayed for years, and one who had a serious problem. The second request distinguishes a confident manufacturer from a nervous one.

Red flags

• Certificates shown as images, with documents "available later"
• No rejected-material area, and no recent rejections
• A quality manager who is unavailable, or who answers through the sales lead
• Reluctance to let you choose which records to inspect
• A lead time noticeably shorter than everyone else's, with no explanation
• Nobody can name a rule change in the last three years that affected them

A short scorecard

If you audit us

Use this list unchanged. Ask for the White List listing and its date, the seven certificates with their scopes, which of the 13 dosage forms are approved, and the in-process records for whichever batch you pick. Ask our quality manager who may overrule her, and check the answer against what the chairman says publicly.

Then run the same visit at two other factories and compare. A manufacturer confident in its plant should be recommending that. One who discourages it has already answered your most important question.