Standards › Standard 11 › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · PRO-SOP-006 · Version 1.0 · Approved by the ASF Expert Committee
Supports: Standard 11 (Procedure Units), criterion 11.9
At a glance
- Each recall notice is received, logged and checked against stock and against patients treated.
- Each patient who received a recalled batch is contacted within the set time.
- Each adverse reaction is recorded (PRO-FRM-006) and reported where the rule requires.
- The batch register (PRO-REG-001) is the source for tracing patients.
- Stop and get help straight away if: a recalled batch is still in use, or a patient who received it is not contacted.
1. Purpose
To act on recalls and adverse reactions using the batch register (11.9).
2. Scope
| Applies to | Clinical and support staff in the hospital |
| Locations | All wards, clinics and departments of the facility |
| When | Whenever the activity described is carried out |
| Does not apply to | Activities covered by another document listed in section 15 |
3. Definitions
| Term | Meaning |
|---|---|
| Clinical lead | The doctor or nurse in charge of the area at the time |
4. Background
A product recall is only effective if the centre knows which patients received the product. Checking notices against stock and against patients makes the recall reach the people affected.
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Pharmacist or supply lead | Receives recalls and checks stock | Pharmacist |
| Medical director | Contacts patients and reports reactions | Clinician |
6. Materials and equipment
| Item | Requirement | Condition |
|---|---|---|
| Records and forms named in this document | Current version | Checked before use |
7. Safety
- Stop and call for help if a patient is at immediate risk. Do not delay urgent care to complete paperwork.
8. Before you start
- Confirm the forms and equipment named in this document are available and current.
9. Procedure
Step 1. Receive and check.
- Log each recall and check stock and the batch register at once.
Key point: At once.
Step 2. Contact.
- Contact each patient who received a recalled batch within the set time.
Key point: Within the set time.
Step 3. Record and report.
- Record each adverse reaction on PRO-FRM-006 and report it where required.
Key point: Recorded and reported.
10. Decision points
- No decision points in this procedure.
11. Special situations
| Situation | Action |
|---|---|
| Out of hours | Follow the same steps. Use the on-call contact on the wall of the area. |
12. Escalation
- Any serious problem goes to the duty clinical lead at once and to the clinical director the same day.
13. Monitoring
| Measure | Target | Frequency | Owner | If not met |
|---|---|---|---|---|
| Recalls checked against stock within 24 hours | 100% | Each recall | Pharmacist or supply lead | Escalate to medical director |
14. Records
| Record | Kept in | Retention |
|---|---|---|
| Record named in this document | Patient record or the area file | the period set by the facility’s records policy years |
15. Training
- Staff are trained in this document at induction and refreshed each year, with a recorded competency check.
16. Related documents
| ID | Title | Use |
|---|---|---|
| PRO-REG-001 | Product batch register | Register |
| PRO-FRM-006 | Adverse reaction record | Record |
17. Evidence
| Reference | Note |
|---|---|
| E-009 | Based on the ASF Expert Committee consensus and the WHO Guidelines for Safe Surgical Care and Safe Procedures (2009). |
| E-006 | ASF Policy Framework v1.2. Adapted. |
| E-009 | ASF Expert Committee consensus. |
18. Change history
| Version | Date | What changed | Approval |
|---|---|---|---|
| 1.0 | the date of approval | First version | set Expert Committee approval |
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References
- Accréditation Sans Frontières (2026). ASF Policy Framework v1.2. (E-006)
- Accréditation Sans Frontières (2026). ASF Expert Committee consensus on Standard 1. (E-009)