This is a ready-to-use form for a returned complaint sample, the usual physical evidence in a complaint file, from the moment it arrives to the moment it is destroyed or returned to retention. Replace every <<FILL: ...>> placeholder, set your own document numbers, and route it through your normal document control. A filled specimen follows. Verify your own retention and disposition rules before relying on this as written. This content is educational reference, not legal or regulatory advice.
Document control header
| Field | Entry |
|---|---|
| Document title | Complaint Sample Chain of Custody and Condition on Receipt |
| Document number | <<FILL: FORM-ID, e.g. QA-FRM-061>> |
| Version | <<FILL: version>> |
| Effective date | <<FILL: effective date>> |
| Governing SOP | <<FILL: complaint handling SOP ID>> |
| Complaint number | <<FILL: linked complaint number>> |
1. Purpose
This form creates an unbroken, contemporaneous record of a complaint sample from the moment it reaches the organization to its final disposition, so that a later question about the sample’s condition, identity, or whereabouts can be answered from the file rather than from memory. A gap in this record, not a gap in testing, is usually what turns a defensible complaint investigation into an indefensible one.
2. Scope
Applies to every physical unit returned in connection with a product complaint: the complained-of unit itself, any accompanying packaging, and any accessory (syringe, autoinjector, diluent vial) returned with it. Does not apply to retained or reserve samples pulled from the manufacturer’s own stock, which follow the retained-sample procedure.
3. Instructions
- Complete Section 4 at the moment the sample physically arrives, before it is opened or examined. Do not delay this entry to “do it properly later.”
- Photograph before any handling: the outer shipping container as received, the inner packaging, the product labeling, and the unit itself. Attach or reference the photograph file names in Section 4.
- Confirm identity in Section 5 before any testing begins.
- Log every transfer of custody in Section 6, with no gap between one row’s “received by” and the next row’s “transferred by.”
- Complete the product-type handling note in Section 7 for refrigerated, frozen, or autologous cell and gene therapy product; these categories carry handling risks a standard ambient product does not.
- Record final disposition in Section 8 only after the complaint file is closed and any reporting and appeal period has passed, never before.
4. Receipt and condition on arrival
| Field | Entry |
|---|---|
| Date and time received | <<FILL>> |
| Received by (name, role) | <<FILL>> |
| Shipping method / carrier | <<FILL>> |
| Outer packaging condition on arrival | <<FILL: intact / damaged, describe>> |
| Temperature indicator present and reading (if applicable) | <<FILL: yes/no, reading>> |
| Photograph file references | <<FILL: file names or system IDs>> |
| Quarantine location assigned | <<FILL: physical and system location>> |
5. Identity confirmation
| Check | Result |
|---|---|
| Product name matches company’s product | <<FILL: Y/N>> |
| Lot/batch number legible and plausible (matches a lot this company distributed) | <<FILL: Y/N, lot number>> |
| Presentation / strength matches labeling | <<FILL: Y/N>> |
| Expiry date legible | <<FILL: Y/N, date>> |
| Any indication the unit may not be genuine (see falsified-product branch of the complaint procedure) | <<FILL: Y/N, describe>> |
| Confirmed by (name, date) | <<FILL>> |
6. Custody transfer log
| # | Date / time | Transferred from | Transferred to | Purpose of transfer | Condition noted at transfer | Signature |
|---|---|---|---|---|---|---|
| 1 | <<FILL>> | Complaint intake | <<FILL: e.g. QA complaint coordinator>> | Initial logging | <<FILL>> | <<FILL>> |
| 2 | <<FILL>> | <<FILL>> | <<FILL: e.g. QC laboratory>> | Testing against specification | <<FILL>> | <<FILL>> |
| 3 | <<FILL>> | <<FILL>> | <<FILL: e.g. back to quarantine>> | Post-test storage pending disposition | <<FILL>> | <<FILL>> |
Add rows for every additional transfer, including to an external testing laboratory. No row may be skipped; a sample that cannot be accounted for between two rows is a finding, not an administrative gap.
7. Product-type handling note
Complete only the row(s) that apply.
| Product type | Handling consideration | This sample |
|---|---|---|
| Refrigerated biologic | An excursion during the return journey may itself explain the complaint. Request a temperature indicator with the return where feasible. | <<FILL: temperature history available Y/N, assessment>> |
| Frozen or cryopreserved product | Return may be impossible without destroying the evidence. | <<FILL: returned intact Y/N; if not returnable, document why and what evidence substitutes (retained sample, batch data, shipper record)>> |
| Cell and gene therapy, autologous | The unit is patient-specific and may be unrecoverable or already administered; chain of identity records substitute for a physical retest. | <<FILL: unit available Y/N; if not, which records stand in as evidence>> |
| Reconstituted or compounded at point of care | A variable introduced outside the manufacturer’s control. | <<FILL: preparation details captured at intake>> |
8. Final disposition
| Field | Entry |
|---|---|
| Disposition decision | <<FILL: destroyed / returned to complainant / retained pending litigation / other>> |
| Reporting and appeal period cleared before disposition | <<FILL: Y/N, date confirmed>> |
| Authorized by (name, role, date) | <<FILL>> |
| Disposition method and date | <<FILL>> |
| Witnessed by (if destruction) | <<FILL>> |
9. Record retention
Retain this form with the complaint file for the same period as the complaint record itself. Do not destroy the physical sample, or this form, while the complaint investigation, any associated regulatory report, or an appeal period remains open.
10. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Complaint coordinator (initiator) | <<FILL>> | ||
| QA reviewer | <<FILL>> |
Filled specimen
| Field | Entry |
|---|---|
| Complaint number | CMP-2026-04417 |
| Date and time received | 14 Sep 2026, 10:20 |
| Received by | J. Alvarez, Complaint Intake |
| Shipping method / carrier | Returned via courier, ambient box, no temperature indicator |
| Outer packaging condition on arrival | Intact, one corner crushed, product carton inside undamaged |
| Photograph file references | CMP-2026-04417-PHOTO-01 through 04 |
| Quarantine location assigned | Complaint sample cage, Bay 3, logged in LIMS as quarantined |
Identity confirmation: product, lot (A-2274), presentation, and expiry all matched and were legible; nothing suggested the unit was not genuine. Confirmed by J. Alvarez, 14 Sep 2026.
Custody transfer log: row 1, intake to QA complaint coordinator (M. Diallo), same day, for triage; row 2, QA to QC laboratory (R. Nakamura), 15 Sep 2026, for appearance and crack assessment against specification; row 3, QC back to quarantine, 17 Sep 2026, pending CAPA-linked disposition, test result confirmed a hairline crack consistent with the batch finding already under investigation on lot A-2274.
Product-type handling note: standard solid oral product, no refrigerated, frozen, or autologous considerations applicable.
Final disposition: destroyed by controlled waste process, 02 Dec 2026, after the complaint file closed, the CAPA (CC-1051) was approved, and the 90-day appeal window on the associated recall assessment had passed. Authorized by M. Diallo, witnessed by R. Nakamura.
Common inspection findings this form prevents
- A returned sample is tested but there is no record of its condition on arrival, so a later question about transit damage versus the alleged defect cannot be answered.
- The sample changes hands between intake, the laboratory, and storage with no log, so its whereabouts for part of the investigation cannot be reconstructed.
- A frozen or autologous sample could not be returned intact and the file never states why or what evidence substituted.
- Destruction occurred before the file confirms the investigation, any regulatory report, and the appeal period were all closed.
How to adapt this form
- Set your document number and link it to your complaint-handling SOP.
- Add or remove custody-transfer rows to match your actual workflow (for example, an external contract laboratory leg).
- Tailor Section 7 to the product types your organization actually handles; delete rows that do not apply rather than leaving them blank.
- Confirm your retention period and appeal-window rules with Regulatory Affairs before setting the disposition gate in Section 8.