Regulatory Compliance & Legal Framework Flashcards

A lean practitioner implements a new digital training record system. Under OSHA's hazardous energy control standard (29 CFR 1910.147), what training documentation must be maintained?

Answer: Records demonstrating that each authorized and affected employee has been trained in lockout/tagout procedures

29 CFR 1910.147 requires employers to certify that employee training on lockout/tagout has occurred, including employee names, dates, and the subject of training.

Which federal statute creates legal liability for lean teams that knowingly submit false cost savings claims to obtain government contracts or grants?

Answer: The False Claims Act (FCA), 31 U.S.C. § 3729

The False Claims Act imposes treble damages and civil penalties on anyone who knowingly submits false or fraudulent claims for payment to the federal government, including inflated lean savings claims.

A lean team reduces chemical inventory as part of waste elimination. At what threshold does the EPA's Risk Management Program (RMP) under Clean Air Act Section 112(r) impose planning and reporting requirements?

Answer: When regulated substances are held at or above specified threshold quantities at a stationary source

EPA RMP regulations apply when a regulated substance is present at or above threshold quantities; lean inventory reductions may bring a facility below the threshold, potentially eliminating RMP obligations.

In a lean transformation project for a financial services firm, which regulation requires that process changes affecting anti-money laundering (AML) controls be validated before deployment?

Answer: Bank Secrecy Act (BSA) and FinCEN guidance requiring maintenance of effective AML program controls

The BSA requires financial institutions to maintain effective AML programs; process changes that affect suspicious activity monitoring or reporting controls must be validated to preserve regulatory compliance.

A lean project reduces product testing frequency based on statistical process control data. In an FDA-regulated environment, which regulatory pathway allows for this type of reduced testing approach?

Answer: Process Analytical Technology (PAT) framework under FDA's 21st Century initiative for pharmaceutical manufacturing

FDA's PAT framework allows pharmaceutical manufacturers to use real-time data and statistical controls to reduce end-product testing when process understanding is sufficiently demonstrated.

When a lean team implements visual performance boards displaying individual employee productivity data in a healthcare setting, which federal privacy law must be assessed?

Answer: HIPAA's employee health information protections and state employee privacy laws

Publicly displaying individual performance data in healthcare may implicate HIPAA if data reveals health-related information, and state privacy laws may further restrict employee performance data display.

A lean practitioner in a food manufacturing facility wants to combine two HACCP critical control points to reduce inspection time. What regulatory consequence could result from this change without proper validation?

Answer: Violation of 21 CFR Part 120 or Part 123 HACCP regulations and potential FDA enforcement action

FDA HACCP regulations (21 CFR Parts 120/123) require that each critical control point be maintained with validated monitoring procedures; combining CCPs without scientific validation and reapproval violates these regulations.