WorkflowSuppliers & Contract Manufacturing

OEM Customer Audit Preparation for Contract Manufacturers

Customer audit preparation for contract manufacturers that pulls each agenda slot's records, runs the auditor's checks before the auditor does, strips other customers out, and leaves what is shared to the site quality manager's signature.

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Follow the 14:00 slot from weak spot to signature ↓

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The problem

The auditor finds the lapsed training date before your own team does

The agenda arrives about ten days out. Then a customer quality manager spends days working out what each item will sample, and pulling the records by hand: batch records and travelers from the ERP, corrective actions and nonconformances from the quality system, training, calibration and document control. Each record gets checked the way the auditor will check it, if there is time.

Shared lines make it worse. Equipment logs, site-wide corrective actions, schedule boards and training matrices all carry other customers' parts and lots, and one name on a printout is a breach of the quality agreement. Whatever gets promised at the closing meeting tends to live in someone's email.

Built forCustomer quality managersSite quality managersProduction supervisorsTraining coordinatorsQuality release leads

The Problem Today

Each customer audit means pulling records by hand from five systems, then removing other customers' data.

48: Customer audits a year at a four-site contract manufacturer our estimate

Pulled and checked by hand today

Batch files
Actions
Training
Calibration

Weak spots surface lateA lapsed date is found in front of the auditor
Promises get lostCommitments made at the closing live in email

The Solution

Agenda read into slotsEach agenda item becomes a slot holding what the auditor will sample
Checked like an auditorTraining dates, corrective action clocks, look-backs and change notices
Other customers removedAnother customer's name, part or lot becomes a redacted copy
Shared on a signed sampleThe site quality manager opens a stated sample and signs each slot

Built-in controls

A signer opens each sample item first
Agents never share, sign or dismiss
Dismissals and extensions need a second person

What You Get

Quality teams answer each audit from records already checked, with the fixes under way before the visit.

$69K: A year of quality time at four sites, half the preparation saved our estimate

Weak spots before the visitEach one placed on the slot where it would surface
No other customer's dataShared and site-wide records go as redacted copies
Commitments kept per customerEach finding answered on the agreement's own clock

Five days before the audit

Customer audit preparation for a catheter line, one slot at a time

A device customer's supplier auditor arrives for two days to audit the catheter subassembly line. The agenda has eleven slots, and the 14:00 one samples five batch records.

demoThe plant, the customer, the people, the lots and the figures are sample data.

01Morning
Eleven agenda slots over two days, nothing pulled yet
Customer quality manager
The agenda letter has been read into a timetable: opening, corrective actions, the line tour, nonconformances, batch record sampling and validation on day one, then suppliers, training, calibration, changes and the closing. Each slot shows what the auditor will sample. She starts the run from this screen.
0210:03
186 records pulled into the slots; six weak spots marked where they surface
Customer quality manager
The agents pull from five systems and run fourteen checks an auditor would run. Each slot now carries its record count, a chip for records that hold another customer's data, and any weak spot. The 14:00 batch record slot holds 25 records and one weak spot. Nine records will go out only as redacted copies.
0310:04
Operator 11 signed the crimping step two days before training on it
Customer quality manager
The weak spot names the check, the rule and the two records to open. The new crimping work instruction took effect the day before the signature, and the operator's training record on it came two days later. Of 31 step entries by 9 operators since the change, this is the only one. Training was a finding last audit.
0410:05
She opens the traveler and the training record herself
Customer quality manager
Each record must stay open long enough to be read before it counts. She reads the traveler, then the training record with its signature date. Nothing on this weak spot can be confirmed or dismissed until both are opened by the person who decides.
0510:07
Confirmed: the lot goes on hold and a corrective action opens at once
Customer quality manager
She confirms with her own user ID and password. The 120-unit lot comes off Monday's shipment on a hold, a re-check of ring diameters goes to the line supervisor, and a corrective action opens. A disclosure note is drafted from the records for the customer, in plain words she can change.
0610:09
Her sample for the slot is six items, and only two were drawn at random
Site quality manager
The slot comes to her with a stated sample: the flagged traveler, the training record it cites, the redacted pull tester log, the disclosure note, and two records drawn at random from the other 23. She cannot sign until she has opened each one for its reading time.
0710:11
The pull tester's log lists another customer's lot, so it goes out redacted
Site quality manager
The tester's printout for that day holds 11 runs, including another customer's lot and test program. The copy the auditor will see keeps only the 8 pull-off runs of this lot, with 3 other rows removed and the reason shown. She reads it as the auditor will, which is the point of opening it.
0810:17
25 records approved for the customer, with the weak spot disclosed as drafted
Site quality manager
With all six items opened, she signs for this one slot: share the 25 records, one as the redacted copy, with the weak spot disclosed in the words shown. One signature covers one slot. Reopening the slot later would clear it and take it out of the auditor's view.
0910:18
The auditor's view holds one slot, its redacted log and the disclosure
Supplier auditor
Logged in as a guest, the customer's supplier auditor sees only the slots that have been approved. Today that is the 14:00 slot: the batch records, the redacted run log and the disclosure note. No other customer's part, lot or program is on this screen, and nothing can be edited.

Where the six weak spots sit on the agenda, and what each check found

Each one is placed on the agenda slot where the auditor would have found it.

Weak spot	Slot	What the check found
Crimping step signed before training	14:00, day one	1 of 31 step entries since the change
Corrective action effectiveness check	09:30, day one	7 days past due, 14 of 20 lots done
Ring diameter gauge out of tolerance	11:30, day two	+0.009 mm against ±0.003 mm, no look-back on 23 lots
Leak test revalidation	15:30, day one	69 days past due, protocol approved
Adhesive dispenser change	13:30, day two	No change notice found under the agreement
Nonconformance report	13:00, day one	Open 41 days against a 30-day target

demoSample data, from the working solution. For the dispenser change the agent says plainly that finding no notice does not prove none was sent.

Around the audit

Sharing, training, the line tour and follow-up for supplier audit preparation

What the quality team, the line and the training coordinator open in the days around the visit.

Sharing overview for a customer audit: each slot's status and the records shared only as redacted copies — **Sharing**Each slot's sharing state, the nine records that go out only as redacted copies, and what still waits for the site quality manager.

Training check for crimp-qualified operators, comparing each training date with the first batch record entry under the new instruction — **Training**The nine crimp-qualified operators, with each one's training on the new instruction against their first step entry under it.

Line tour readiness page with checks for the production line, the upcoming shipment and the correction form — **Line tour**Eight readiness checks for the line, the next shipment with the held lot taken off it, and the correction form.

Audit agenda letter, quality agreement clauses on audit rights and confidentiality, and the previous audit's findings — **Agenda and agreement**The audit plan letter, the eight clauses of the quality agreement that apply, and the last audit with training marked as a repeat topic.

Follow-up list of audit commitments by customer with due dates from the quality agreement and the upcoming audits — **Follow-up**Each commitment per customer with its clock from the agreement, and the next audits on the calendar.

Audit trail of the audit preparation with each confirmation, reading, approval and signature meaning by session — **Audit trail**Who confirmed, sent, opened and signed, with the reason, the signature meaning and the session. The evidence set exports approved slots only.

demoSample data, from the working solution.

Who settles a weak spot, who shares, and who releases a lot

The person who sends a slot is never the one who approves it.

Customer quality manager

Sees: The timetable, each weak spot and its two records
Signs: Confirms or dismisses weak spots and sends slots for approval

Site quality manager

Sees: A stated sample per slot, opened item by item
Signs: What each customer sees, dismissals and extensions

Production supervisor

Sees: Tour readiness and the corrections on the line
Signs: Records each re-check on the floor

Training coordinator

Sees: Training against each operator's first entry
Signs: Effectiveness checks on training

Quality release lead

Sees: Holds set during the preparation
Signs: Releases lots, in the quality system, never here

Supplier auditor

Sees: Approved slots only, with redacted copies
Signs: Nothing; reads and asks for records

Who pulls the records

Seven agents before the visit, and none of them shares a record

They read, pull, check and draft. People confirm, approve and sign.

Agenda reader

Reads the audit plan letter into slots and what each will sample.

Never guesses a slot the letter does not name

Agreement and history reader

Quotes the clauses that apply and marks repeat topics from the last audit.

Never paraphrases a clause
Never reads complaint records

Record puller

Pulls each slot's records from five systems.

Read only; never edits a record

Segregation checker

Finds other customers' names, parts, lots and programs and proposes redacted copies.

Never shares anything

Pre-audit checker

Runs fourteen auditor-style checks and drafts the disclosure.

Never closes, dismisses or hides a weak spot
Never calls a record fine when it was not found

Request runner

During the audit, finds what the auditor asks for and its slot.

Never sends

Commitment keeper

Tracks commitments per customer on the agreement's clock and reminds owners.

Never marks a commitment closed

What stays with the quality team during a customer audit

The agents prepare the visit. Named people make these calls.

A weak spot is never dismissed by an agentThe customer quality manager confirms or dismisses it, and a dismissal waits for the site quality manager.

Holds and corrective actions start at onceThe safer action needs no second signature. Lifting a hold is the quality release lead's job, in the quality system.

Complaint records stay out of every slotComplaints the customer passes on go to the plant's named complaint contact under the agreement. Text that reads like a product problem is set aside unread.

Reopening a slot unsigns itThe slot leaves the auditor's view and the evidence export is blocked until it is approved again.

What contract manufacturers ask about customer audit preparation

What is customer audit preparation for a contract manufacturer?

Customer audit preparation is the work between the agenda arriving and the auditor walking in: pulling what each agenda item will sample, checking it, and removing other customers' information. Here agents do the pulling and checking per slot, and the site quality manager signs what each customer sees.

How are other customers' records kept out?

The segregation checker reads each record for other customers' names, parts, lots and programs. Shared and site-wide records go out only as redacted copies, and the auditor's guest view shows approved slots only.

Does it decide what gets disclosed to the customer?

No. It drafts a disclosure note from the records. The customer quality manager edits it, and the site quality manager approves the words with the slot. Edited words are marked for a person to read in full.

Can a weak spot be hidden from the auditor?

Not by an agent. A weak spot is confirmed or dismissed by a person, a dismissal needs a second signature, and every step lands in the audit trail.

Does it read complaints the customer sends us?

No. Complaints belong to the customer and go to the plant's named complaint contact under the quality agreement. No complaint record is pulled into a slot.

Does it replace our quality management system or ERP?

No. It reads them, along with training, calibration and document control. Holds and releases still happen in the quality system, and records are never changed from here.

Suppliers & Contract Manufacturing

Send us one audit agenda
and your quality agreement.

We will fill each slot with its records and show you the weak spots first.

Book a demo Browse solutions

OEM Customer Audit Preparation for Contract Manufacturers

The auditor finds the lapsed training date before your own team does

The Problem Today

The Solution

What You Get

Customer audit preparation for a catheter line, one slot at a time

Eleven agenda slots over two days, nothing pulled yet

186 records pulled into the slots; six weak spots marked where they surface

Operator 11 signed the crimping step two days before training on it

She opens the traveler and the training record herself

Confirmed: the lot goes on hold and a corrective action opens at once

Her sample for the slot is six items, and only two were drawn at random

The pull tester's log lists another customer's lot, so it goes out redacted

25 records approved for the customer, with the weak spot disclosed as drafted

The auditor's view holds one slot, its redacted log and the disclosure