# VM3COP06.01 — Failed Calibrated Equipment Procedure

**Draft Date:** 2026-06-09
**Status:** DRAFT — For review
**Linked VOP:** VOP 06 — Measurement Control, Calibration, QA Stock
**Applicable to:** Viamed Ltd & VST / Vandagraph Sensor Technologies

---

## 1. Purpose

This procedure defines the steps to be taken when any item of calibrated test equipment is found to be out of calibration, has failed calibration, or is suspected of giving inaccurate readings. It covers two distinct scenarios:

- **Scenario A:** Equipment fails when sent away for external calibration (ACAS or equivalent calibration house).
- **Scenario B:** Equipment fails or is suspected of failure during normal use (dropped, damaged, won't turn on, gives inconsistent readings within the calibration period).

---

## 2. Responsibilities

| Role | Responsibility |
|------|---------------|
| **User / Operator** | Immediately stop using equipment. Complete the Equipment Failure Notification (Section 6) and report to line manager. |
| **Line Manager / Warehouse Controller** | Receive notification. Quarantine equipment. Escalate to Managing Director. |
| **Managing Director** | Assess impact on previously tested products. Decide on customer notification or recall. Determine if a QC21 Non-Conformance is required. |
| **ISO Controller** | Ensure the procedure is followed and all records are filed in Intrastats Document Index. |

---

## 3. Scenario A: Equipment Fails External Calibration (ACAS or Similar)

### Trigger
Equipment has been sent away for re-calibration. The calibration house (ACAS / subcontractor) reports that the equipment **cannot be calibrated** — i.e. it fails to meet its specification tolerances even after adjustment.

### Procedure

1. **Notification** — The calibration house returns the equipment with a Failure Report (or failed calibration certificate). The Warehouse Controller receives the report.

2. **Log the Failure** — Complete the Equipment Failure Notification form (Section 6). Include the calibration house report reference.

3. **Quarantine Equipment** — Tag the equipment as **FAILED / OUT OF CALIBRATION** using a quarantine label. Move it to the Quarantine / Hold area. Do not use until resolved.

4. **Assess Historical Impact** — The Managing Director reviews:
   - What product was tested with this equipment since its **last valid calibration date**.
   - Which customers received that product.
   - Whether the test results could have been affected by the equipment's out-of-tolerance condition.

5. **Decision Point — Recall / Notification** — If product tested with the failed equipment is suspect:
   - Inform the customer(s) that they may have received suspect product.
   - Initiate a recall if necessary (recorded via Intrastats).

6. **QC21 Form** — If the failure constitutes a Non-Conformance (i.e. suspect product was shipped), raise a QC21 form in line with VOP 10 (Non Conformance, Corrective & Preventive Actions).

7. **Equipment Disposition** — The Managing Director decides whether the equipment is:
   - Sent for repair (and re-calibrated on return).
   - Scrapped / replaced if irreparable.

8. **Documentation** — Upload the failure report, QC21 (if raised), and all decisions to Intrastats Document Index under the equipment's CE reference.

---

## 4. Scenario B: Equipment Fails or Is Suspected of Failure During Normal Use (Within Calibration Period)

### Trigger
A user notices one of the following during normal operation:
- Equipment was **dropped or physically damaged**.
- Equipment **fails to power on**.
- Equipment gives **inconsistent or clearly incorrect readings**.
- Equipment has been **subject to environmental damage** (liquid, extreme temperature, etc.).

### Procedure

1. **Immediately Stop Using** — The user must stop using the equipment and isolate it. Do not use it for any further testing.

2. **Complete Equipment Failure Notification** — See Section 6. Provide as much detail as possible about what happened and what was observed.

3. **Escalate to Line Manager** — User informs their line manager / Warehouse Controller of the suspected failure.

4. **Quarantine Equipment** — Tag the equipment as **SUSPECT / UNDER INVESTIGATION** using a quarantine label. Move to Quarantine / Hold area.

5. **Impact Assessment (by Managing Director)**

   - **If equipment was dropped / physically damaged / failed suddenly (e.g. won't turn on):**
     - Product tested *immediately before the incident* was almost certainly tested with a working, in-calibration unit.
     - **No recall action typically required** unless the equipment was producing incorrect readings *before* the incident became obvious.
     - The Managing Director reviews the last test records for that equipment to confirm no anomalies.

   - **If equipment was producing incorrect readings (e.g. drifts, inconsistent results):**
     - ALL product tested with this equipment since its **last valid calibration date** is potentially suspect.
     - The Managing Director identifies which product and which customers are affected.
     - Follow the same recall / customer notification process as Scenario A (steps 5–7).

6. **Repair Path** — Send the equipment for assessment / repair:
   - If repaired and re-calibrated: update the calibration record in Intrastats with the new calibration date.
   - If irreparable: scrap and replace. Update the Calibration Index to mark the equipment as withdrawn.

7. **QC21 Form** — If suspect product was shipped, raise a QC21 in line with VOP 10.

8. **Documentation** — All forms, decisions, and repair reports uploaded to Intrastats Document Index.

---

## 5. Key Rules Summary

| Scenario | Immediate Action | Historical Impact? | QC21 Required? | Customer Notification? |
|----------|-----------------|-------------------|----------------|----------------------|
| **A — Failed external calibration** | Quarantine, log failure | Yes — assess all product tested since last valid cal | If suspect product shipped | If product affected |
| **B — Dropped / sudden failure** | Quarantine, log failure | Low risk — assess last tests | Only if evidence of prior drift | Only if evidence of prior drift |
| **B — Suspect readings / drift** | Quarantine, log failure | Yes — assess all product since last valid cal | If suspect product shipped | If product affected |

---

## 6. Equipment Failure Notification Form (Template)

This form should be completed by the user who discovers the failure and submitted to the line manager / Managing Director within one working day.

```
================================================================================
              EQUIPMENT FAILURE NOTIFICATION — VM3COP06.01
================================================================================

1. EQUIPMENT DETAILS
   CE Reference:     _______________________
   Barcode/Serial:   _______________________
   Description:      _______________________
   Location:         _______________________

2. FAILURE DETAILS
   Date Discovered:  ____/____/________
   Discovered By:    _______________________
   
   Failure Type (tick one):
   [ ] Failed external calibration (ACAS / subcontractor)
   [ ] Dropped / physical damage
   [ ] Will not power on
   [ ] Inconsistent / suspect readings
   [ ] Environmental damage (liquid, heat, etc.)
   [ ] Other: _________________________

   Description of incident / observations:
   ____________________________________________
   ____________________________________________
   ____________________________________________

3. IMMEDIATE ACTIONS TAKEN
   [ ] Equipment quarantined / tagged
   [ ] Intrastats calibration record updated to "SUSPECT"
   [ ] Line manager notified

4. TESTED PRODUCT HISTORY (to be assessed by Managing Director)
   Last valid calibration date: ____/____/________
   Products tested since last calibration using this equipment:
   ____________________________________________
   ____________________________________________
   Customers potentially affected:
   ____________________________________________
   ____________________________________________

5. MANAGING DIRECTOR DECISION
   [ ] No recall action required
   [ ] Customer notification issued
   [ ] Product recall initiated (reference: _________ )
   [ ] QC21 raised (reference: _________ )
   [ ] Equipment sent for repair
   [ ] Equipment scrapped / replaced

   MD Signature: ___________________  Date: ____/____/________

6. DOCUMENTATION UPLOADED TO INTRASTATS
   [ ] Failure report / calibration house report
   [ ] QC21 (if applicable)
   [ ] MD decision record
   [ ] Repair report / scrap record

================================================================================
```

---

## 7. Related Documents

| Document | Reference |
|----------|-----------|
| VOP 06 — Measurement Control, Calibration, QA Stock | [VOP 06 PDF] |
| VOP 05 — Supplier Control (returns / supplier returns) | [VOP 05 PDF] |
| VOP 10 — Non Conformance, Corrective & Preventive Actions | [VOP 10 PDF] |
| VOP 19 — Feedback, Customer Complaints, Vigilance | [VOP 19 PDF] |
| QC21 Form | Intrastats Non-Conformance Module |
| Calibration Index | Intrastats ISO Calibration Index |
| ACAS / Subcontractor Calibration Report | Per-equipment in Document Index |

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**END OF DOCUMENT**

*This is a DRAFT document and has not been formally approved. It is intended for review by the Managing Director and ISO Controller before introduction into the QMS.*