Summary
In short
- Test the decision, not just the trace. A mock recall that starts from a given batch code has skipped the hardest step, which is deciding to act on ambiguous information.
- Name the decision authority and a deputy, and make both reachable outside working hours. Recalls are not usually discovered on a Tuesday morning.
- Under FSMA, a facility with a hazard requiring a preventive control must have a written recall plan covering notification, public warning where necessary, effectiveness checks and disposition.
- The reportable food registry obligation in the US requires submission within 24 hours of determining that a food is reportable, which is a separate clock from the recall itself.
- Time to complete a trace is a useful measure and is not the constraint in a real recall. The constraint is usually the decision and the contact list.
- Test with rework in the batch. A trace through a clean batch tests the easy path and every real recall involves the complicated one.
What it is
What it is
What is a recall plan?
A documented plan setting out who decides a recall, on what basis, how affected product is identified and located, who is notified and within what timescales, how product is recovered and reconciled, and how the recall is closed and reviewed.
What is the difference between a recall and a withdrawal?
A withdrawal removes product from the supply chain before it reaches consumers. A recall extends to product that may already be with consumers and generally involves public notification. The distinction affects the notification obligations and the speed required, and the decision between them is one the plan should address explicitly.
When to use it
When to use it, and when not to
The plan covers the whole response. Several supporting capabilities are separate and are what the plan depends on.
Use it for
- Defining the decision authority, escalation and out-of-hours reachability
- Setting out classification, notification obligations and timescales by jurisdiction and customer
- Documenting how affected product is identified, located, recovered and reconciled
- Planning and recording mock recalls and traceability exercises
- Reviewing after a real event, a mock exercise or a change in customers, markets or products
Not for
- The traceability system itself, which the plan relies on and which is tested separately
- Crisis communications and media handling, which is broader and sits alongside
- The complaint and incident processes that may trigger a recall
- Product disposition and destruction records, generated during the response
- Insurance and legal notification, which follows its own requirements
Standards
What it is built against
Recall obligations combine a written plan requirement, reporting duties with their own clocks, and scheme testing expectations.
| Clause | Requirement | Where it lands |
|---|---|---|
| 21 CFR 117.139 | Written recall plan where a hazard requires a preventive control, with notification, public warning, effectiveness checks and disposition | Header |
| 21 CFR 1.900 series | Reportable Food Registry submission within 24 hours of determining a food is reportable | Classification and decision |
| FSMA section 206 | FDA mandatory recall authority where a responsible party fails to voluntarily recall | Classification and decision |
| 21 CFR 1 Subpart S | Additional traceability records for foods on the Food Traceability List | Traceability and notification |
| 9 CFR 418 | Recall procedures and notification requirements for meat and poultry establishments | Recovery and closure |
| SQF Edition 9 cl.2.6 | Product trace, withdrawal and recall with testing at defined frequency | Testing |
| BRCGS Issue 9 cl.3.11 | Product withdrawal and recall procedures tested at least annually | Testing |
| EU Reg 178/2002 art.19 | Withdrawal and recall obligations and notification of competent authorities | Traceability and notification |
What it does not cover
- The traceability system, which the plan depends on and which is exercised separately.
- Crisis communications, which is broader and includes media, customers and staff.
- Complaint and incident processes, which may generate the trigger.
- Disposition and destruction records, generated during a response.
- Insurance and legal notification, following its own requirements and timescales.
Filling it in
Filling it in well
Name who decides, rehearse the decision, and test the trace on a batch that is difficult.
One named person with authority to initiate, a named deputy, and contact details that work at 11pm on a Sunday. Recalls are discovered outside office hours more often than inside them, and a plan naming a job title rather than a person with a mobile number has not answered the question.
Construct a scenario with partial information, commercial pressure and a plausible case for waiting. Give it to the actual decision maker with the actual data available at that point. This is the step that fails in real events, and it is almost never exercised because mock recalls begin after the decision has been made for them.
Choose a batch involving rework, blending, partial shipment or repacking. Clean batches test the straightforward path, and the complicated cases are where lineage breaks and where a real recall will land. Set a time limit and observe how the answer is assembled.
Customers, distributors, authorities, laboratories, the certification body and internal escalation. Contact lists decay faster than any other part of a recall plan, and the discovery that a key number is three years out of date happens during the event. Verify them on the same cycle as the test.
Audit findings
Common audit findings
Recall findings concentrate on what the testing did not cover.
| Finding | Clause | What fixes it |
|---|---|---|
| Mock recall begins from a supplied batch code, skipping the decision. | SQF 2.6 | Rehearse the decision with ambiguous information and commercial pressure. |
| Decision authority named by job title with no out-of-hours contact. | 21 CFR 117.139 | Name people and numbers that work at night and at weekends. |
| Traceability exercises always performed on clean batches. | BRCGS 3.11 | Test with rework, blending or partial shipment in the batch. |
| Contact lists not verified between exercises. | 21 CFR 117.139 | Verify on the same cycle as the test; lists decay faster than procedures. |
| Reportable Food Registry obligation not built into the response. | 21 CFR 1.900 series | The 24-hour clock runs from determining the food is reportable and is separate from the recall. |
| No effectiveness checks defined for recovery. | 21 CFR 117.139 | Define how you confirm that customers received and acted on the notification. |
| Mass balance not reconciled at the end of the exercise. | SQF 2.6 | Reconcile quantities; an unreconciled trace has not established the boundary. |
| Plan not updated after a change of customers, markets or distribution. | BRCGS 3.11 | New markets bring different notification obligations and different timescales. |
| Exercise conducted during the working day only. | SQF 2.6 | Test out of hours at least once; that is when real events start. |
| Foods on the Food Traceability List without the additional records required. | 21 CFR 1 Subpart S | Check whether products are listed; the record requirements are additional and specific. |
Worked case
Case in point: the exercise that started too late
A manufacturer ran two mock recalls a year, both completed within the four-hour target. The exercises began with a batch code supplied by the quality manager and ended when quantities reconciled. Results were reported to management and to the certification body as evidence of a robust system.
A real event began on a Friday evening with a customer reporting a complaint that might have indicated a process failure, or might have been a single damaged pack. The named decision maker was on leave, the deputy was not listed with a mobile number, and the information available did not clearly support either recalling or not recalling.
Product moved for a further eleven hours while the site sought more information. The traceability system, when eventually used, produced the answer in under two hours exactly as the exercises had shown.
Definitions
Definitions and key terms
- Recall
- Removal of product from the market, extending to product that may have reached consumers, generally involving public notification.
- Withdrawal
- Removal of product from the supply chain before it reaches consumers, with narrower notification requirements.
- Reportable food
- Food for which there is a reasonable probability of serious adverse health consequences, triggering a 24-hour registry submission in the US.
- Mock recall
- A rehearsal of the recall process, usually testing traceability and rarely testing the decision.
- Effectiveness check
- Confirmation that those notified received the notification and took the required action.
- Mass balance
- Reconciliation of quantities produced, shipped, held and recovered, which establishes whether the trace is complete.
- Food Traceability List
- The FDA list of foods subject to additional traceability record requirements under 21 CFR 1 Subpart S.
- Decision authority
- The named individual empowered to initiate a recall, with a named deputy and out-of-hours contact.
FAQ
Frequently asked questions
What does a mock recall usually fail to test?+
The decision. Exercises typically begin with a batch code supplied by the organiser and measure how long reconciliation takes, which tests the traceability system. Real events begin with ambiguous information arriving at an inconvenient time with commercial consequences attached, and that is the step where product continues to move while the organisation seeks more certainty.
How should we make the exercise more realistic?+
Give the actual decision maker a scenario with partial information and a plausible argument for waiting, out of hours, and observe what happens. Separately, run traceability tests on batches involving rework, blending or partial shipment rather than clean ones, because the complicated cases are where lineage breaks and where a real event will land.
What does FSMA require in a recall plan?+
Where a hazard requires a preventive control, a written recall plan with procedures to notify direct consignees, notify the public where necessary to protect public health, conduct effectiveness checks, and appropriately dispose of recalled food. Separately, the Reportable Food Registry requires submission within 24 hours of determining that a food is reportable, which is a distinct clock.
How often should we test?+
At least annually under most schemes, and more frequently where products, customers, markets or distribution change. Frequency matters less than variety: several exercises of the same type demonstrate the same thing repeatedly, while varying the trigger, the batch complexity and the time of day tests different failure points.
What decays fastest in a recall plan?+
Contact lists. Customers, distributors, authorities, laboratories and internal escalation contacts all change, and the discovery that a critical number is years out of date reliably happens during a real event. Verifying the list should be part of every exercise rather than an annual administrative task.
The agents
What the agents do with it
The plan governs a response nobody wants to run. What fails is the decision nobody rehearsed and the contact list nobody checked.
Holds the plan with named decision authority and deputy, runs exercises including decision scenarios, and verifies contact lists on each cycle.
Executes the trace across shipments and distribution, including rework and partial consignments where lineage is hardest.
Watches complaints and out-of-specification results for patterns that should trigger the decision earlier than a single report would.
Tracks notification obligations and timescales by jurisdiction and customer, including registry submissions with their own clocks.
This template lives in KnowQuality — quality and food safety. HACCP, nonconformance, traceability, laboratory and customer complaints.
Sources
Sources
- 21 CFR 117.139, recall plan, FDA
- 21 CFR Part 1 Subpart H and the Reportable Food Registry requirements, FDA
- 21 CFR Part 1 Subpart S, additional traceability records for foods on the Food Traceability List, FDA
- 9 CFR Part 418, recalls, USDA FSIS
- SQF Edition 9 clause 2.6 and BRCGS Food Safety Issue 9 clause 3.11