STATUS: DRAFT — NOT FOR USE. Every critical limit below is marked TBC and must be confirmed against Welsdom’s actual process, equipment capability and supplier data before this plan is approved. Limits taken from a template rather than validated on the line are a finding, not a control.
1. Purpose and scope
This plan identifies food safety hazards in the manufacture of dietary supplements (human) and pet supplements at Welsdom Inc, 11-151 Amber Street, Markham, Ontario, and defines the controls, critical limits, monitoring, corrective actions, verification and records that keep those hazards controlled.
Scope covers all products manufactured on site, own-brand and OEM: gummy, soft chew and biscuit chew, capsule, powder, oil and liquid formats.
2. HACCP team
| Role | Person | Responsibility |
|---|---|---|
| HACCP team leader | Max Cen | Owns the plan, chairs reviews, approves changes |
| Director | Jeremy Chen | Resources, final approval |
| Production Manager | Jian | Process knowledge, CCP monitoring in practice |
| External consultant | IAS | Validation of the plan against cGMP requirements |
3. Product description and intended use
| Attribute | Human supplements | Pet supplements |
|---|---|---|
| Formats | Gummy, capsule, powder, oil, liquid | Soft chew (semi-ball 3 g, bone 5 g, fish 1.5 g), biscuit chew |
| Intended consumer | General adult population; not formulated for children unless the label states it | Dogs and cats |
| Intended use | Oral, as directed on label | Oral, as directed on label |
| Shelf life | TBC per format and stability data | TBC per format and stability data |
| Storage | Ambient unless labelled otherwise; refrigerated items logged | Ambient unless labelled otherwise |
| Known allergens | TBC per formula — declare on label | TBC per formula — declare on label |
| Sensitive populations | Consider pregnancy, medication interaction warnings | Not applicable |
4. Process steps covered
Receiving → quarantine and release → raw material storage → weighing and dispensing → mixing / blending → forming (depositing, encapsulation, tabletting, filling) → drying or curing → cooling → metal detection → primary packaging → labelling → finished goods storage → dispatch.
5. Hazard analysis
B = biological, C = chemical (including allergens), P = physical. “Significant” means reasonably likely to occur and to cause harm if uncontrolled.
| Step | Hazard | Source | Significant | Control measure | Control type (proposed) |
|---|---|---|---|---|---|
| Receiving | C: heavy metals, pesticide residue, undeclared allergen in raw material | Supplier | Yes | Approved supplier programme; COA reviewed and filed against each lot at Incoming Material Inspection | oPRP — candidate CCP if COA review is the only barrier |
| Receiving | B: pathogens in botanical or animal-derived materials | Supplier | Yes | Supplier COA with micro results; specification per material | oPRP |
| Storage | B: growth from temperature or moisture excursion | Storage conditions | Yes for temperature-sensitive items | Temperature Monitoring Log; FIFO/FEFO | PRP |
| Weighing and dispensing | C: wrong active or wrong quantity; allergen cross-contact | Operator error, shared scoops | Yes | Two-person verification of material identity and weight; dedicated or cleaned utensils; allergen sequencing | Candidate CCP |
| Mixing / blending | C: non-uniform distribution of active | Process | Yes | Validated mix time and speed per formula; in-process check | oPRP — CCP where overdose of an active is a safety risk |
| Forming | P: foreign matter from equipment (metal, plastic, gasket) | Equipment wear | Yes | Pre-use equipment inspection; sieving or screening where format allows | PRP feeding CCP1 |
| Drying / curing (gummy, chew) | B: survival or growth of pathogens and moulds at high water activity | Insufficient drying | Yes | Time and temperature control; water activity or moisture check per batch | Candidate CCP |
| Cooling | B: condensation supporting growth | Environment | Possible | Controlled cooling area; environmental swabbing programme | PRP |
| Metal detection | P: ferrous, non-ferrous, stainless fragments | Upstream equipment | Yes | In-line metal detector with reject; test pieces at defined frequency | CCP1 |
| Packaging | P: packaging fragments; B: contamination of open product | Materials, handling | Yes | Approved and inspected packaging materials; line clearance before run | PRP |
| Labelling | C: undeclared allergen, wrong product or wrong expiry on pack | Wrong label applied | Yes | Two-person label verification against Master Label Specification; label reconciliation; first article inspection (SOP-WEL-012) | Candidate CCP |
| Finished goods storage and dispatch | B: growth from temperature excursion; C: mix-up of batches | Storage, picking | Yes | Temperature logging; batch identification on every pallet; FIFO/FEFO | PRP |
6. Proposed CCPs — limits to be confirmed
| CCP | Hazard | Critical limit (TBC) | Monitoring | Corrective action | Record |
|---|---|---|---|---|---|
| CCP1 — Metal detection | P: metal fragments | TBC: detector rejects Fe __ mm, non-Fe __ mm, SS __ mm test pieces; sensitivity set per product and validated | Test pieces at start, every __ hours (TBC) and at end of run; reject mechanism confirmed | Stop line; quarantine all product back to last good check; re-test; investigate | CCP Monitoring Record |
| CCP2 — Drying / water activity (gummy, soft chew) | B: mould and pathogen growth | TBC: water activity ≤ __ or moisture ≤ __ % at end of drying; drying at __ °C for __ minutes | Measure per batch at defined points | Extend drying; re-test; reject batch if limit cannot be met | CCP Monitoring Record + BMR |
| CCP3 — Label and allergen verification | C: undeclared allergen, wrong product or expiry | 100 % match to Master Label Specification, verified independently by two people before the run starts | Every batch at line clearance and first article inspection | Stop packing; segregate affected units; re-verify; reconcile labels | Line Clearance (PKG-01), Batch Packing Record (PKG-02) |
| CCP4 — Raw material acceptance | C/B: contaminated or out-of-spec incoming material | COA present and within specification for every lot; material within expiry; packaging intact | Every delivery | Quarantine; reject to supplier; supplier evaluation review | Incoming Material Inspection |
7. Verification
- Records reviewed by the HACCP team leader within __ days of the batch (TBC).
- Environmental swab programme against the schedule in the swab test records.
- Finished product testing per specification, frequency TBC.
- Metal detector calibration and service by the supplier, at least annually.
- Internal audit of the HACCP system at least annually.
- Mock recall at least annually, traced against BMR and BPR records.
8. Review triggers
The plan is reviewed at least annually and whenever: a new product or format is introduced; a process, equipment or supplier changes; a complaint, deviation or recall indicates a control failure; or regulatory requirements change.
9. Open items before approval
- Confirm which candidate control points are true CCPs — apply the decision tree with IAS; metal detection is the only unambiguous one.
- Set and validate every limit marked TBC from actual process data, not from this template.
- Confirm whether an in-line metal detector exists on each line. If not, CCP1 cannot be claimed and an alternative control is required.
- Confirm allergens handled on site and whether any line is shared between allergen and non-allergen products.
- Confirm shelf life and stability data supporting the expiry dates printed on labels.