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Job 03 · Receiving and quality

// Chemical distributors · Incoming COA checks

Incoming COA checks: every producer certificate read before the lot is allocated.

A tote of solvent pulls in with the producer's certificate of analysis. Before it fills an order, someone checks that certificate against your purchase order, your purchase spec and the limits of each customer waiting on that product. In a free AI proof of concept, AI repeats that check on copies of 20 to 30 lots you already received, listing every miss for the person who releases the lot. Your reviewer, the person on your team who knows your receiving and quality files best, sets each check beside what your team decided. The AI never releases, holds or rejects a lot.

Book a proof-of-concept call30 minutes with Rob
Lots tested
20 to 30, already received
Lots released or rejected by AI
None
First step
An NDA, then copies

// The one job

From a producer's certificate to a check sheet for the person who releases lots

The certificate shows up by email ahead of the truck, in a sleeve taped to a drum, or in a producer's portal days later. Someone ties it to the purchase order and the receipt, reads every result against your item spec, then pulls up the open orders for that product and reads the same results against each customer's spec. A lot that suits one account and misses another has to be allocated with care, or held.

For the test, AI reads copies of those certificates with the POs, receiving records and specs behind them and writes one check sheet per lot: what matched, what didn't, which waiting customers the results fit and which they miss. It allocates nothing and clears nothing. A value it couldn't read or a document it couldn't match goes on the sheet for a person, with the reason.

Producer COAArrives with the lot
Product and grade
Producer batch
Retest or expiry
Released by
TestMethodResult
Made-up example certificate
Checked against
PO, spec and open orders
Lot check sheetFor release review
PO and receipt
Item spec
Customers it fits
Misses
TestLimit sourceStatus
Made-up example check sheet

// The hard parts

Why a genuine certificate can still hold up a lot

Some customers can lean only on a certificate that shows its work. FDA's rule for dietary supplement makers lets them rely on a supplier's certificate of analysis to confirm a component other than a dietary ingredient only if the certificate describes the test methods, the limits and the actual results, the supplier was first qualified by confirming its results, the certificate is re-confirmed from time to time, and quality control approves the basis. Drug makers meet a similar bar in 21 CFR 211.84: a supplier's report of analysis stands in for full testing only with at least one specific identity test of their own and periodic validation of the supplier's results. A certificate that prints "conforms" beside a test, with no number and no method, gives those accounts nothing to lean on, so the sheet marks each such result and names the customers whose specs want numbers.

Dates are part of the result. A certificate may carry an expiry date, a retest date or only a date of manufacture. ICH Q7, the GMP guide for active pharmaceutical ingredients, says a retest date is the common practice there rather than an expiration date, and that a repacker moving material into a different type of container should run stability studies to support the date it assigns. Some products change on the shelf: one producer's published sheet for acrylic acid gives its dimer limit ex works, warns that dimer keeps forming in storage at room temperature, and says the product stays within specification for one month after delivery. The check sheet sets each lot's dates against the ship dates of the orders waiting on it and marks any lot that would age past a limit before it leaves.

A certificate you reissue carries the producer's with it. When you repack or retest a lot and issue your own certificate, the trail has to show where each number came from. ICH Q7 asks that a certificate reissued by a repacker, agent or broker give the name, address and phone number of the laboratory that ran the analysis, refer to the original manufacturer and its batch certificate, and attach a copy of that certificate. It also expects every certificate to be dated and signed by authorized quality staff. Its chapter for distributors has them keep the PO, bill of lading, receipt, manufacturer's batch number and every authentic certificate. The sheet keeps the producer's batch number beside your own lot number and marks any reissued certificate that has lost the link.

A grade on the PO is a spec of its own. An order for ACS reagent grade points at the American Chemical Society's Reagent Chemicals: a product may be labeled and sold as ACS Reagent Grade only when it meets those purity specifications by ACS-approved methods, ACS has said the monographs are updated twice a year, and the online edition is the version of record. A customer may also want an outside lab's result, and a lab accredited to ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, reports under that standard. The sheet compares the grade and the methods printed on the certificate with what the PO and each customer's spec name, and treats a near match as a miss.

What your reviewer watches for. Usually the quality manager or whoever releases lots today. They check that each sheet tied the certificate to the right PO, receipt and producer batch, that every limit came from the right spec revision, yours or a customer's, that a less-than value was judged honestly against its limit, and that no lot was shown as fit for a customer whose spec it misses.

// What you send

Copies from receiving and the quality file

Copies only
No ERP or portal login
01

20 to 30 received lots

Producer certificates for lots already in, each with its PO, the receiving record or bill of lading, and what your team did: released, held, retested or sent back. Add a bulk load and a lot that sat past its retest date.

02

The specs that applied then

Your item or purchase specs, plus the specs of the customers who had open orders for those products at the time, at the revision in force on the day each lot arrived.

03

Your release rules

Who may release a lot, which missing items always mean a hold, which producers you still spot-test, and how a lot that suits only some customers gets allocated.

04

An NDA, then copies

The NDA is signed before any certificate moves. We never sign in to your ERP, your quality system or a producer's portal. Customer names can be masked, and records that can't leave the building become look-alikes built with your reviewer.

// Before it starts

Agreed in writing before the first certificate is copied

A lot cleared by mistake ends up in a customer's tank, so the owner sets these terms first.

COA check test termsOwner signs off
Your reviewer
Named by the owner, often the quality manager or whoever releases lots
Checks in scope
PO and receipt match, item spec, customer specs, dates and signer, or a subset
Success criteria
Written and agreed, including how a missed or a needless mark is scored
Sample
Picked by your reviewer, with a held lot and a reissued certificate in it
Release and allocation
Stay with your people, during the test and live
Price
A range for running the checks live

// How it's judged

Each check sheet beside what your team decided

Lot by lot
Every result traced to a limit
On the same 20 to 30 lotsWhat your team decidedThe AI check sheet
Certificate tied to the PO, the receipt and the producer batchMarked on your lotsMarked on your lots
Grade and test methods compared with the PO and the specsMarked on your lotsMarked on your lots
Every result read against your item specMarked on your lotsMarked on your lots
Waiting customers the lot fits, and the ones it missesMarked on your lotsMarked on your lots
Expiry, retest and manufacture dates set against waiting ordersMarked on your lotsMarked on your lots
Signer, issuing lab and any reissued certificate traced to the producerMarked on your lotsMarked on your lots
Lots marked for a person, and whyMarked on your lotsMarked on your lots
No marks before your lots. Every cell stays open until certificates from your own receipts have been checked.Your reviewer's marks decide it.

// After a yes

About 30 days on lots as they arrive

When your reviewer says yes against the success criteria, every certificate that comes in gets a check sheet for about 30 days.

Your quality lead still releases every lot and makes every allocation, and a lot the sheet marks stays where your rules put it until a person clears it. A customer's revised spec joins the checks only after your team approves it.

Whatever comes after is a separate decision with a separate price.

// What could come next

Possible next jobs, in order

Ideas to weigh with you
One at a time
  1. 01

    SDS, COA and statement requests

    Customer document requests answered from your approved files, with the certificate for the lot that actually shipped.

    Next
  2. 02

    Missing certificate follow-ups

    Lots still waiting on a certificate or a corrected one, listed each morning with a request drafted for your buyer to send.

    Then
  3. 03

    Customer quality questionnaires

    Supplier surveys drafted from your approved policies and documents, for your quality manager to finish and sign.

    After that

// One hard limit

The AI never releases, holds or rejects a lot.

Its check sheet lists what matched and what didn't, and stops there. Releasing, holding, rejecting or allocating a lot, signing or sending a certificate, deciding whether a material meets a rule, and asking a producer or telling a customer anything all stay with qualified people on your team. The test works only from copies of lots already received, and nothing on this page is legal or regulatory advice.

Incoming COA checks are priced as a job of their own: a range before the proof of concept, a fixed price before you sign.

What moves the range: how many lots you receive a month, how many producers and grades they come from, and how many customer specs each lot is read against.

// Questions

What receiving and quality teams ask

Will it release lots for us?
No. It writes a check sheet for each lot and marks every miss with the spec it came from. Releasing, holding and allocating stay with the person who does that today.
Our certificates arrive as scans, portal downloads and emailed PDFs. Does that matter?
Send them as they came, a poor scan or two included. The sheet names the file each value was read from, and a value it can't read is marked for your team instead of guessed.
Can it handle a lot that suits one customer and not another?
Yes, that is the point of the check. The sheet lists each customer with an open order for the product and whether the lot's results fit that customer's spec. Who gets the lot stays your team's decision.
Do we still need to test lots ourselves?
That stays with your quality staff and your customers' terms, and the sheet follows the spot-test rules you send. For drug ingredients, ICH Q7 suggests full analysis on at least three batches before a buyer cuts back its own testing, then full analysis at intervals, compared with the certificates.
Is this regulatory advice on what our customers' rules require?
No. When a check sheet cites a rule such as 21 CFR 111.75, it is there so your reviewer can follow the reasoning. Your quality staff, your customers and your counsel decide what each rule asks of your business.
Rob Eason

Rob Eason, founder

// Book a call with Rob

Bring the last lot you had to hold.

A 30-minute call with Rob: your company and role, whether incoming checks are the right first job, and about how many lots arrive each month. Hold certificates and specs back until the NDA is signed.

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