Pet supplement compliance risks can hide between audits

An SGS quality expert outlined how animal supplement companies can use supplier, testing and complaint data to build on certification and catch problems before an auditor, retailer or regulator does.

2 Lisa Selfie December 2020 Headshot
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An audit is a snapshot, but the business keeps moving. Companies that use quality data between audits can catch risks before they become problems.
Lisa Cleaver | DALL-E

Pet supplement certification audits provide a quality foundation but only capture a single moment in time, while compliance risks can build in the months between audits. Companies should implement continuous risk-based oversight, gap assessments, and targeted fixes rather than relying solely on periodic audits to strengthen their quality programs and stay compliant with evolving regulatory expectations.

  • Audits are snapshots: Certification captures only one moment, and business changes—supplier shifts, label updates, reformulations—can introduce compliance gaps between audits.
  • Common gap areas: Unapproved supplier changes, misaligned product specifications, new regulatory guidance, claims management delays, and traceability failures often surface after clean audits.
  • Risk-based oversight: Companies should prioritize supplier monitoring based on ingredient potency, contamination history, supplier reliability, country of origin, and product complexity rather than treating all suppliers equally.
  • Targeted solutions: Gap assessments, mock audits, traceability exercises, specification alignment, and role-specific training close specific weaknesses without replacing existing quality systems.
  • Continuous model: Replace audit-driven preparation cycles with ongoing data collection, risk assessment, and verification to catch issues early and prevent costly complaints, recalls, or regulatory action.

Certification gives animal supplement companies an important quality foundation, but an audit captures only a single moment, and risk can build in the months between audits, according to Jennifer Lott, senior director of Tailored Solutions at SGS, a NASC Preferred Supplier.

Lott spoke during a webinar hosted by National Animal Supplement Council (NASC), “Beyond Certification: Closing the Gaps in Animal Supplement Quality and Compliance,” where she outlined how companies can use supplier, testing, complaint, audit and regulatory information to strengthen existing certified programs rather than replace them.

“I want to be very clear that this is not a criticism of certification,” Lott said. “Certification is valuable. It provides structure, discipline, documentation and expectations. But an audit is a snapshot. It looks at a moment in time, and the business keeps moving.”

At SGS, Lott leads the development and delivery of customized food safety, quality, regulatory and supply chain assurance programs. She has worked with food, beverage, packaging, pet food and dietary supplement organizations on management systems, certification preparation, supplier oversight and emerging regulatory requirements.

Expectations rising on several fronts

Lott said regulators are increasing scrutiny of label claims, good manufacturing practices (GMPs) and product documentation, while retailers often require documented quality systems and third-party verification before accepting products. Certification programs, including NASC and GMP requirements, also continue to evolve and become more stringent.

Consumers are raising the bar as well.

“Pet owners often think about animal supplements the same way they think about human health products,” Lott said. “They expect transparency, traceability and confidence that what is on the label is what is in the product.”

Those expectations rarely line up with a company’s audit schedule, she said.

“A retailer may come next week. A supplier change may happen quietly. A new regulatory expectation may affect your claims or documentation,” Lott said. “This is why companies need a system that can respond between the audits.”

Where gaps develop

Lott identified several areas where risk commonly builds after a clean audit. An approved supplier may change an ingredient source, process or subsupplier without notifying its customer. Finished product specifications, raw material specifications and certificate of analysis (COA) review criteria may not fully align, creating confusion during product release or investigations. New guidance, import alerts or state-level requirements may emerge after the last audit.

Claims and change management are another weak point, she said. A marketing team may add a claim, update a label, reformulate a product or move to a new contract manufacturer before the quality review process catches up. Traceability can also fall short under real conditions.

“A mock recall may pass on paper, but under real pressure, the team may struggle to retrieve complete records quickly or connect a complaint to the right lot,” Lott said.

She said these gaps do not necessarily mean a company has a poor program.

“Growth often exposes gaps that were not visible when the company was smaller or less complex,” Lott said. “None of these gaps require a failed audit to cause a real problem.”

Such issues can surface later as customer complaints, import holds, retailer delistings, warning letters or costly internal investigations, she said.

Prioritizing oversight by risk

Because quality resources are limited, Lott recommended moving from a flat approved supplier list to a risk-based oversight model.

“Not all ingredients, suppliers and products carry the same risk,” she said. “A simple, stable ingredient from a long-term supplier with strong documentation does not need the same level of oversight as a complex botanical sourced internationally through a supplier with inconsistent certificates of analysis or repeated delays.”

Risk factors she listed included ingredient potency concerns, contamination history, botanical complexity and known adulteration; supplier audit findings, deviations, responsiveness and corrective action effectiveness; country of origin; product complexity, including multi-ingredient formulas, sensitive delivery forms and novel ingredients; complaint trends and adverse event reports; and testing history, such as out-of-specification results, retests and COA discrepancies.

Lott said companies should also weigh repeat audit findings, new FDA guidance, import alerts, new dietary ingredient questions and business criticality, such as top-revenue products, strategic customers or hard-to-replace suppliers.

“A repeat finding usually tells us that the first corrective action didn’t fully address the root cause,” she said.

Under the approach Lott described, suppliers that pose high risk with low reliability call for immediate action, high-risk suppliers with high reliability call for verification, and low-risk suppliers can be monitored. Companies gather data, score risk, prioritize actions, then verify and adjust.

“It doesn’t have to be complicated,” Lott said. “Even a quarterly review of the right data can help you see trends earlier and avoid treating each issue as an isolated event.”

Targeted fixes, not new programs

Lott said the tools to close those gaps include gap assessments, supplier risk reviews, standard operating procedure development, mock audits, traceability exercises, regulatory readiness reviews, specification alignment, risk-based testing, corrective and preventive action (CAPA) support and role-specific training.

“We are not talking about adding another program on top of NASC, GMP or your existing quality system,” she said. “Most companies already have enough procedures, forms and requirements. What they need is help closing specific gaps.”

Traceability exercises should test actual records, not just written procedures, and a risk-based testing strategy should define what to test, how often and what threshold triggers action, Lott said.

“A CAPA should not just be a paperwork response,” she said. “It should identify root cause, define corrective and preventive actions, assign ownership and verify effectiveness.”

On training, Lott said, “Many gaps are not caused by lack of commitment. They happen because people are unclear about expectations or how to execute them.”

A continuous model

Lott urged companies to replace audit-driven cycles of preparation with a continuous loop: certification as the baseline, followed by data collection, risk assessment, targeted action, verification and improvement.

She said new products, suppliers, markets and customers should prompt a reassessment.

“One of the mistakes companies make is treating these changes as business events only,” Lott said. “They are quality events too.”

“The strongest programs do not just pass audits,” she said. “They use information between the audits to become stronger.”

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