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A territory budget audit is a one-day test of three written promises, not a tour of a factory floor. The promises are annual capacity for the two or three SKUs a dealer will stock, spare-parts fill rate, and service response time. Each promise needs a record behind the answer, because a spoken number cannot be re-read in month nine. The three promises are the only numbers a dealer can price, and each one either survives a document or becomes a contract clause.

According to ISO 19011:2026, audit conclusions rest on verifiable evidence collected through records and interviews rather than on impressions. A single day provides roughly eight usable hours, and 100% of the value sits in which files get pulled.

The method is falsification. Name the number which would make the answer wrong, then ask for the document holding the true number. Dealers who arrive with a one-page request leave with copies; dealers who arrive with a ninety-line checklist leave with catalogues.

Why Is a Factory Visit an Underwriting Problem Rather Than a Scorecard?

A factory visit is an underwriting exercise because the budget is exposed to three specific failures: no capacity when the tender lands, no part when a machine stops, and no engineer when a hospital calls. A scorecard rates the supplier, while underwriting prices the risk.

According to ISO 13485:2016 clause 7.2, customer-related processes cover communication on enquiries, contracts and feedback, so a compliant factory already keeps the channels where these answers live.

Practical consequence: three questions carry more weight than forty checklist lines, and each question needs one written answer plus one record. In practice, dealers who arrive with a single-page request leave with photocopies; dealers who arrive with a ninety-line checklist leave with brochures.

The clock is the constraint. Two hours in a showroom consumes 25% of an eight-hour day, and the showroom answers none of the three questions.

Promise One: Which Capacity Number Should the Budget Rest On?

Annual capacity for a dealer territory is the monthly line rate for the exact SKUs on the opening order, multiplied by the months the factory will allocate, not the total plant output printed in a brochure.

According to ISO 13485:2016 clause 7.5.1, production control requires documented information describing product characteristics and the equipment used, so a line rate is a recorded figure rather than an estimate.

Factory load test of a stainless steel medical trolley with a weighted test platform and force gauge in the production hall
A recorded load test is the kind of line-level evidence a capacity claim has to rest on, not a brochure figure.

Ask for three items during the visit: the production plan showing your model, the planned month of your first batch, and the changeover record between your model and the neighbouring one. Changeover time is where 100% of schedule slippage hides on mixed lines.

For example, a factory quoting forty units a month may run your model in one week of four, which is 25% of the month, and the defensible capacity is ten units.

Promise Two: What Does a Spare-Parts Fill Rate Have to Prove?

A spare-parts fill rate is the percentage of part lines which ship from stock on the day of request, not the percentage of parts a factory can eventually manufacture. The distinction decides whether a machine returns to service in days or in a quarter.

According to ISO 13485:2016 clause 7.4, purchasing controls cover components bought for production, and those supplier records reveal which parts carry long lead times before the first order arrives.

Demand the shipping log for the last twelve months at 100% of lines, with four columns: part number, date requested, date shipped, and source. A fill rate quoted as 95% without a line list is a claim rather than a rate.

Then ask which three part numbers missed the rate most often, because a critical spares first kit built from that list beats a stocked shelf built from a catalogue. Second question: which parts ship from the factory floor instead of the warehouse, because a part pulled from a live line delays somebody else’s order.

Promise Three: How Do You Test a Service Response Time Before You Sign?

A service response time is the interval between the moment a fault is reported and the moment a qualified person begins diagnosis. The interval is measurable only when both ends carry a timestamp.

According to Regulation (EU) 2017/745 Article 87, manufacturers report serious incidents on clocks of 2, 10 and 15 days, so an importer’s own reporting duty begins when the factory starts the clock. A vague forty-eight-hour promise moves 100% of the regulatory risk onto the importer.

Ask for the complaint log covering the last twenty events with four fields: date opened, date of first technical contact, date closed, and fault code, the same code set a fault-code sheet fixes before the first failure. Median close time answers the budget question better than any service clause.

For example, a log with twenty entries and three closures is an intake record, not a response record, and no contract wording repairs a missing column.

Where Do the Three Promises Sit in the Factory’s Records?

A record map is a one-page list pairing each promise with the document able to prove or break the claim, so the visit becomes a document pull rather than a tour. Three documents carry the whole weight, and a compliant quality system already holds all three.

According to ISO 13485:2016 clause 8.4, analysis of data must include input from feedback, product conformity and suppliers, which means the raw material for all three answers is already being collected.

One rule governs the day: never accept a procedure where a record exists. A procedure describes what should happen 100% of the time; a record shows what happened on named dates. Procedures are written for auditors, while records are written by the work itself, which is why a written record survives the second question and a procedure rarely does.

The Record Map: Three Promises, Three Documents

The record map below pairs each promise with the one document able to settle it, plus the question which ends the conversation and moves the day forward.

Promise Document that settles it What to ask for in the room
Capacity for your SKUs Production plan with your model on a dated line The week which carries my first batch
Spare-parts fill rate Shipping log, twelve months, every line The three part numbers missed most often
Service response time Complaint log with four date fields The median close time in days

How Should You Read the Record Map in the Room?

Reading the record map in the room means opening each file beside the person who owns the number, then asking which line would make that person’s own answer false. A number nobody can falsify is marketing.

According to ISO 19011:2026, findings rest on verifiable evidence, and evidence sampled from records outweighs statements gathered in conversation. Sampling discipline: ask for 100% of the last twelve events, never a curated example chosen before the meeting.

Sequence matters. Capacity file first, at the production office rather than the showroom. Parts log second, in the warehouse with the storekeeper. Complaint log third, with the service manager alone and no sales colleague in the room.

In practice, the third file changes decisions most often, because no brochure quotes a complaint log, and the complaint log is the only file which prices the first week after a failure.

What Can a One-Day Visit Never Show You?

A single day cannot show three things: long-term reliability, real complaint handling speed under pressure, and consistency after the production ramp. Eight hours of observation produces a snapshot, while reliability is a curve measured across years and hundreds of units inside a warranty period.

According to the FDA Quality Management System Regulation, in force since 2 February 2026, complaint and servicing records form part of the device record set, so the historical curve already exists as data even when the curve cannot be watched directly.

The honest position: the visit prices the promises and the contract collects the rest. Request the reliability figure with a denominator, meaning 100% of units shipped rather than only the units which came back. The gap is not a factory defect; the gap is a measurement limit.

For example, two failures in five hundred units and two failures with no denominator describe different machines.

Which Three Clauses Turn a Blind Spot Into a Commitment?

A blind spot is a claim the day cannot test, and three clauses close the gap. Each clause names a trigger, a deliverable and a clock, so the promise becomes auditable after signature.

1. Reliability: a warranty annex requiring the factory to report failures per quarter with 100% of shipped units as the denominator.

2. Complaint speed: a fault-code sheet plus an escalation clock, so a report arrives with a code the factory already recognises rather than a description negotiated by email.

3. Consistency: a revision lock, so the second batch carries the same configuration code as the first.

According to ISO 13485:2016 clause 8.5.2, corrective action must address causes rather than symptoms, and a clause without a clock produces letters instead of actions.

The test for each clause: a lawyer should accept the wording and an engineer should accept the number.

What Does a Realistic One-Day Agenda Look Like?

A one-day audit agenda is a timed list of document pulls rather than a sequence of rooms, which keeps the showroom short and the records long. The order matters more than the hour count, since each file sets the question for the next one.

Start at 08:30 with the capacity file and the production plan, in the planning office rather than the reception area.

Step 2, at 10:30, walk the line for your own model only and stop at the changeover station.

Step 3, after lunch, open the parts warehouse and pull the twelve-month shipping log at 100% of lines.

Finally, at 15:00, meet the service manager alone with the complaint log.

According to ISO 19011:2026, audit time should follow the importance of the subject, and three records outrank a complete building tour.

Reserve the final hour for copies, signatures and a written list of every request which was refused.

When Should You Walk Away From the Visit?

A refusal is a data point rather than a dead end, and the pattern of refusals prices the deal. Walk away when a record is refused twice, when the person who owns a number is not in the building, or when two managers give different figures for the same number in the same room.

According to ISO 13485:2016 clause 4.2.5, records must be retained for a defined period, so a certified factory can produce a complaint log unless internal policy forbids release to customers.

Distinguish three refusals. A redacted customer name is normal, and 100% of European dealers accept redaction. A missing file is an organisation problem. A different figure from two managers is a control problem, and a control problem travels to every future shipment.

For example, capacity of forty units a month from sales and twenty-five from planning is not a communication issue; the planning number is the real number plus a sales margin.

What Should You Carry Home From the Day?

A productive visit ends with three signed pages and one written list of gaps, not with a folder of catalogues. The pages are the production plan for your own SKUs, the parts shipping log, and the complaint log; the gaps become clauses.

According to ISO 13485:2016 clause 7.2.3, the manufacturer communicates with customers on enquiries, contracts, feedback and advisory notices, so written answers inside a dealer territory agreement sit inside normal practice rather than outside it.

The arithmetic which genuinely matters: with three SKUs on the opening order and records for one, 33% of the budget rests on evidence and 67% rests on trust.

Trust is acceptable when priced. Price the remaining 67% into the warranty annex, the first-batch hold point and the parts opening stock, then revisit the whole arrangement after twelve months of your own complaint data.

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