Regulatory Compliance & Legal Framework Flashcards
7 cards from real LMC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Compliance & Legal Framework flashcards as text
Under the Fair Labor Standards Act (FLSA), which lean workforce practice requires careful legal review to avoid wage and hour violations?
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.
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?
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.
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?
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.
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?
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.
In lean construction projects receiving federal funding, which regulation mandates prevailing wage rates that cannot be reduced through labor efficiency improvements?
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.
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?
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.
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?
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.