Product Risk Practice
A productized, repeatable service line helping manufacturers identify product risk early, audit evidence and workflows across the product lifecycle, and embed practical controls to keep decisions defensible without slowing the business down.
Designed for the North American market, where product risk is driven by claims scrutiny, liability exposure, and transparency expectations as much as by compliance requirements.
The Situation Manufacturers are Responding to
Across manufacturers, the same patterns recur:
Unknowns in formulations, articles, and supply chains
Supplier information that is incomplete or difficult to defend
Decisions made without a consistent audit trail
Claims that evolve faster than the underlying evidence
Workflows that surface risk too late to avoid cost, disruption, or rework
Managing risk “by regulation” creates reactive cycles. Yordas helps clients run product risk as a disciplined business process with clear ownership, minimum evidence standards, and control points that hold under pressure.
What Clients Gain
Earlier visibility of exposure and blind spots
Audit-ready evidence and clearer traceability
Cleaner decision flow with defined sign-offs and escalation triggers
Faster responses to customer scrutiny, audits, and legal review
A realistic plan to reduce risk through sequenced, practical remediation
Pick-and-mix pillars, defined by client need
Clients select the pillars they need. Delivery remains consistent and leaves behind reusable internal artifacts.
Exposure Baseline (Diagnostic)
Baseline risk view and evidence readiness review.
Control Design (Operating Model)
Control points, decision flow, sign-offs, escalation triggers, minimum evidence standards.
Claims Defensibility (Assurance)
Claims substantiation review and minimum viable evidence definition for scrutiny events.
Risk Governance (Run)
Cadence of reassessment, targeted deep dives, issue tracking and remediation pattern.
External Validation Pathway (Trust Marks)
Readiness mapping and sequencing for credible external validation routes.
Market Activation (Commercial Signal)
Technical assurance to support responsible customer assurance and external messaging.
The Enduring Legacy
This Practice is designed to leave behind artifacts clients can reuse internally so product risk management becomes an internal capability.
Faster customer assurance and procurement responses
How Engagements Typically Start
Most North America engagements begin with Pillar 1: Exposure Baseline (Diagnostic), then expand into Control Design and Claims Defensibility, where the business needs stronger decision discipline. Ongoing governance is added where risk and scrutiny are persistent.
Reduced rework through standardized evidence expectations
Stronger audit readiness and accountability
Improved defensibility under scrutiny
Get in touch
Request a free consultation for your team.
“As scrutiny increases across the North American market, product risk is now at the forefront of all decisions. We help manufacturers move from reactive compliance to disciplined, defensible decision-making, so when questions come, the evidence is ready and the business keeps moving.”
Giselle Vincett
VP - North America
Yordas Group
