Regulatory Compliance & Legal Framework Flashcards

A lean team in a defense contractor facility wants to reduce inspection steps. Which federal acquisition regulation framework requires that quality management system changes be pre-approved by the government customer?

Answer: Federal Acquisition Regulation (FAR) Subpart 46.202 and DFARS quality clauses

FAR Subpart 46.202 and DFARS quality clauses require defense contractors to obtain government approval before reducing or modifying inspection requirements on covered contracts.

Which legal doctrine holds that lean practitioners who identify a compliance gap during a process improvement project may be held liable if they fail to escalate or correct it?

Answer: The responsible corporate officer (Dotterweich) doctrine

The responsible corporate officer doctrine (from US v. Dotterweich) holds that individuals in positions of authority can be liable for regulatory violations they had power to prevent.

A lean event reduces machine guarding to improve operator access. Under OSHA 29 CFR 1910.212, what is the legal standard the employer must meet?

Answer: Machine guarding must protect operators from contact with dangerous parts at all times during operation

OSHA 29 CFR 1910.212 requires that all machines be guarded to protect operators and other employees from machine hazards; no lean improvement justifies removing required guards.

When lean practitioners implement standard work that affects job duties for unionized workers, which federal law governs the employer's obligation to bargain before implementing changes?

Answer: National Labor Relations Act (NLRA) Section 8(a)(5) duty to bargain

NLRA Section 8(a)(5) requires employers to bargain in good faith with unions over mandatory subjects including wages, hours, and working conditions before implementing standard work changes.

Under the Americans with Disabilities Act (ADA), what must a lean team consider when redesigning workstations to eliminate ergonomic waste?

Answer: Redesigned workstations must remain accessible or provide reasonable accommodations for employees with disabilities

The ADA requires employers to provide reasonable accommodations; workstation redesigns must not inadvertently eliminate accessibility features or create new barriers for employees with disabilities.

A lean value stream map reveals that a company ships products internationally. Which US export control framework must be reviewed before sharing lean process documentation with foreign employees or partners?

Answer: Export Administration Regulations (EAR) and ITAR

The EAR (Bureau of Industry and Security) and ITAR (State Department) control the export of technical data and processes; sharing manufacturing documentation with foreign nationals may require a license.

During a lean supply chain audit, a team discovers a tier-2 supplier uses materials that may trigger Dodd-Frank Act Section 1502 reporting obligations. What is the compliance requirement?

Answer: Conduct due diligence and file a Conflict Minerals Report with the SEC if the materials are necessary to product functionality

Dodd-Frank Section 1502 requires SEC-reporting companies to conduct supply chain due diligence and file a Conflict Minerals Report if covered minerals are used in manufactured products.