LMC Regulatory Compliance & Legal Framework 3 — Questions and Answers
Question 1: Under the Fair Labor Standards Act (FLSA), which lean workforce practice requires careful legal review to avoid wage and hour violations?
- Cross-training employees on multiple machines
- Requiring non-exempt employees to attend unpaid kaizen events outside scheduled hours (Correct answer)
- Posting visual management boards in work areas
- Using kanban cards to signal replenishment
Correct answer: Requiring non-exempt employees to attend unpaid kaizen events outside scheduled hours
The FLSA requires non-exempt employees to be compensated for all hours worked, including mandatory kaizen or improvement activities outside their regular schedule.
Question 2: An environmental lean project eliminates a chemical cleaning step, reducing solvent use by 80%. Which EPA regulation determines whether this change requires a permit modification?
- Clean Air Act Title V operating permit conditions (Correct answer)
- OSHA Hazard Communication Standard
- EPA Toxic Release Inventory reporting thresholds only
- ANSI Z10 occupational health standards
Correct answer: Clean Air Act Title V operating permit conditions
Clean Air Act Title V permits include specific process and emission limits; changing or eliminating permitted emission sources may trigger a permit revision under 40 CFR Part 70.
Question 3: When a lean team uses error-proofing (poka-yoke) to prevent defects in a consumer product, which federal agency's product safety regulations must the design satisfy?
- Federal Trade Commission (FTC)
- Consumer Product Safety Commission (CPSC) (Correct answer)
- Department of Transportation (DOT)
- Food and Nutrition Service (FNS)
Correct answer: Consumer Product Safety Commission (CPSC)
The CPSC enforces product safety laws under the Consumer Product Safety Act; poka-yoke designs must meet applicable CPSC safety standards for consumer products.
Question 4: A lean practitioner proposes standardizing supplier contracts to reduce administrative waste. Which US law must be considered when including price-fixing or market allocation provisions?
- The Lanham Act
- Sherman Antitrust Act Section 1 (Correct answer)
- The Defend Trade Secrets Act
- Employee Retirement Income Security Act (ERISA)
Correct answer: Sherman Antitrust Act Section 1
Sherman Act Section 1 prohibits contracts, combinations, or conspiracies in restraint of trade; standardized supplier agreements must not contain anticompetitive terms.
Question 5: In lean construction projects receiving federal funding, which regulation mandates prevailing wage rates that cannot be reduced through labor efficiency improvements?
- The Buy American Act
- Davis-Bacon Act (Correct answer)
- Walsh-Healey Public Contracts Act
- Service Contract Act
Correct answer: Davis-Bacon Act
The Davis-Bacon Act requires payment of locally prevailing wages on federal construction contracts regardless of lean-driven productivity gains or labor cost reductions.
Question 6: A lean team wants to implement electronic kanban signals to replace paper records in a medical device company. Which regulation governs the electronic record and signature requirements they must satisfy?
- ISO 45001 occupational health standard
- 21 CFR Part 11 Electronic Records and Electronic Signatures (Correct answer)
- EPA RCRA hazardous waste regulations
- FTC Green Guides
Correct answer: 21 CFR Part 11 Electronic Records and Electronic Signatures
21 CFR Part 11 establishes FDA requirements for electronic records and signatures, including audit trails, access controls, and system validation for regulated industries.
Question 7: During a lean transformation, a company collects employee performance data through IoT sensors. Which emerging US state law framework most directly governs employee data privacy rights in this scenario?
- Uniform Commercial Code (UCC) Article 9
- State-level biometric privacy laws such as Illinois BIPA (Correct answer)
- OSHA's recordkeeping rule 29 CFR 1904
- FCC telecommunications regulations
Correct answer: State-level biometric privacy laws such as Illinois BIPA
Illinois' Biometric Information Privacy Act (BIPA) and similar state laws regulate collection and use of biometric/sensor data from employees, requiring consent and data governance policies.
LMC Regulatory Compliance & Legal Framework 3
Under the Fair Labor Standards Act (FLSA), which lean workforce practice requires careful legal review to avoid wage and hour violations?