Why Supply Chain Controls Are Critical to FSMA Readiness

No food facility operates in a vacuum. From raw ingredients to packaging materials, the safety of your finished product often depends on external suppliers. That’s why Supply Chain Controls are one of the four core types of preventive controls required under 21 CFR §117.135(c)(4). When a supplier’s product introduces a hazard requiring a preventive control, the Preventive Controls Qualified Individual (PCQI) is responsible for ensuring those risks are managed through preventive controls identified in the hazard analysis.

Done right, supply chain controls reduce the risk of contamination, allergen mismanagement, and adulteration—while also strengthening relationships with vendors and making FSMA inspections more efficient.

Step 1: Determine When Supply Chain Controls Are Required

The PCQI and food safety team must first determine whether supply chain controls are needed. These are required when a supplier controls a hazard that affects your product, and your facility does not further mitigate that hazard.

Examples of such hazards include:

• Pathogens in raw flour, leafy greens, or dairy
• Undeclared allergens in blended spices
• Chemical residues in imported ingredients

Actionable Tip: Ensure that all ingredients are included in hazard analysis and consider both ingredient-related hazards and the supplier’s process and facility-related hazards.

Step 2: Approve Suppliers Based on Risk and Performance

Not all suppliers require the same level of scrutiny. If the ingredient requires a supply chain preventive control, the hazard is managed through the food safety plan. However, it is also industry standard practice to approve all suppliers based on risk and performance.

• Conduct a risk-based evaluation of each supplier (ingredient type, country of origin, past compliance history)
• Review supplier food safety plans, third-party audits, or FDA inspection results
• Require certifications for high-risk ingredients (e.g., GFSI-recognized audits, USDA Organic, etc.)

Actionable Tip: Use a supplier approval checklist that includes risk category, audit frequency, certifications, and corrective action history.

Step 3: Establish and Implement a Written Verification Program

Establish a formal Supply Chain Verification Program (SCVP) be documented Documentation requirements for each supplier (e.g., COAs, HACCP plans, lab results). Your facility may choose to have the PCQI responsible for the verification program.

• Methods of verification such as onsite audits, sampling/testing, or supplier questionnaires
• Frequency of verification activities, based on the ingredient’s risk profile
• Corrective action protocols for supplier non-compliance

Actionable Tip: Build an annual calendar of supplier verification activities to avoid lapses or audit surprises.

Step 4: Monitor Incoming Goods and Maintain Traceability

Even with approved suppliers, routine monitoring is essential. The PCQI should ensure that receiving protocols include:

• Visual inspections of incoming shipments for damage, temperature, or tampering
• Review of Certificates of Analysis (COAs) and matching lot codes
• Verification of allergen declarations and ingredient labels

Traceability systems should allow for quick identification of:

• Affected finished products if an ingredient is later found to be compromised
• Supplier lot history and where materials were used in production

Actionable Tip: Implement barcode scanning and digital logging for all inbound materials to streamline traceability.

Step 5: Handle Supplier Non-Conformance Swiftly and Strategically

When a supplier fails to meet requirements, the PCQI must act quickly to mitigate risk. Steps include:

• Placing the supplier on probation or temporary suspension
• Requesting corrective action documentation with timelines
• Re-testing or quarantining product until resolved
• Re-evaluating supplier approval status

Actionable Tip: Develop a supplier scorecard that factors in audit scores, responsiveness, and incident history to guide procurement decisions.

Avoiding Common Pitfalls in Supply Chain Control Programs

• Over-reliance on one supplier → Diversify sourcing for high-risk ingredients.
• Failure to act on poor audit results → Don’t approve suppliers based on convenience.
• No formal verification plan → FSMA requires documentation, not just good intentions.
• Lack of traceability for specific lots → Improve internal tracking systems and label reconciliation.

Actionable Tip: Review your SCVP quarterly and update it as ingredient sources, risks, or regulations change.

Strong Supply Chains Start with PCQI Oversight

A weak link in your supply chain is a liability—but a well-managed one can become a competitive advantage. The PCQI plays a central role in selecting, verifying, and monitoring suppliers to ensure that upstream hazards don’t compromise downstream safety.

Registrar Corp offers PCQI training and supply chain consulting to help food facilities build robust, audit-ready supplier control programs.