Your Controls Look Fine on Paper.
The RCEI Measures What Actually Happens.
The Regulatory Risk and Control Effectiveness Index is a scored executive diagnostic that measures whether your controls actually operate under real conditions. Not whether they are written down.
6
Control Domains Assessed
5-8 min
Estimated Completion
12
Scored Questions
Plans Developed For
Most Compliance Failures Do Not Start With a Missing Policy
They start with execution. The policy exists. The training was logged. The form was filled out. But the process ran differently than written, the record does not reflect what actually happened, and no one caught it.
Controls that exist on paper but are not followed in practice
Accountability gaps where no one owns the outcome
Documentation that reflects what should have happened, not what did
Process drift that accumulates quietly until it becomes a finding
Regulators and certification auditors have become highly effective at identifying exactly this gap. When they find it, the result is not a minor correction. It is evidence of a systemic control failure.
Regulatory Risk Is Costing Organizations More Than They Realize
Most FDA Warning Letters
cite control execution failures, not missing procedures (FDA Enforcement Data)
$1M+ Average
cost of a voluntary product recall in regulated manufacturing, excluding downstream liability (Stericycle Recall Index)
Process Drift
is the leading root cause identified across CAPA systems in FDA-inspected facilities (Industry QMS Benchmarking Reports)
60-90 Days
is the typical window between a control gap forming and it producing a recordable finding or customer complaint (Operational Risk Research)
What the Diagnostic Actually Measures
The RCEI assesses 6 critical control domains across two dimensions: how controls are designed versus how they are actually executed. The gap between those two is where regulatory exposure lives.
Regulatory Exposure
Whether your control environment reflects current regulatory expectations, not just historical audit results.
Documentation Integrity
Whether your records reflect what actually happened, and whether they would survive a records review during an inspection.
Control Design vs. Execution
Where your documented procedures and your actual operational behavior diverge. This gap is what regulators find.
CAPA and Deviation Effectiveness
Whether your corrective action process is closing root causes or just closing tickets. A key indicator of systemic risk.
Audit and Evidence Readiness
Whether your organization could produce clear, contemporaneous evidence of control operation on short notice.
Accountability and Governance
Whether ownership of control outcomes is defined, enforced, and visible to leadership before a regulator asks.
A Scored, Leadership-Ready View of Your Actual Exposure
Every output is designed to be actionable at the executive level. No raw data dumps. No vague summaries. Clear findings, scored by severity, with a prioritized path forward.
Overall RCEI Score
A single composite index reflecting your organization's regulatory and control risk across all assessed domains.
Category-Level Scores
Scored results for each control domain, showing exactly where risk is concentrated and where controls are performing.
Critical, Moderate, and Minor Findings
Exposure findings ranked by severity, with supporting observations tied to specific control failures.
Design vs. Execution Gap Analysis
Where your documented controls do not match operational reality. This is the gap that regulatory enforcement actions are built on.
Prioritized Remediation Plan
Immediate, Short-term, and Long-term actions, sequenced by risk impact, not complexity.
Built for Operators Who Need Answers, Not More Documentation
Owners and CEOs
Who need a clear, honest picture of operational and regulatory risk before a board meeting, an audit, or a transaction.
COOs and Operations Leaders
Managing multi-site or high-throughput environments where process drift and accountability gaps accumulate silently.
CFOs and Risk Officers
Quantifying exposure for insurance, lending, M&A due diligence, or investor reporting.
Quality and Compliance Leaders
Who need external validation of their control environment before a regulatory inspection or certification audit.
Built From Investigative and Operational Risk Experience, Not Frameworks
The RCEI was developed from direct, field-level experience conducting operational risk assessments, quality system investigations, and control effectiveness reviews across regulated industries.
It is not built from generic compliance frameworks or theoretical risk models. It is built from the patterns observed when controls fail in real operations: what breaks, where accountability dissolves, and what organizations wish they had caught earlier.
The diagnostic asks the same questions a competent external auditor would. The difference is that you see the answers first.
Investigative Methodology
Built on real-world operational risk and control failure patterns
Regulated Industry Experience
Medical devices, pharmaceuticals, food safety, aerospace, manufacturing
Execution-Focused
Every question targets what happens operationally, not what policy says
Know Where Your Controls
Actually Stand
The RCEI takes under 10 minutes.
The exposure it surfaces can take months to close if you find it late.