LMC Regulatory Compliance & Legal Framework 2

Question 1

Under OSHA's General Duty Clause, employers must provide a workplace free from recognized hazards. How does lean's 5S methodology directly support this legal obligation?

Accepted Answer

By maintaining organized, hazard-free work areas through Sort, Set, Shine, Standardize, Sustain

Answer

5S creates orderly, clean workplaces that reduce slip/trip hazards and improve visibility, directly satisfying OSHA's General Duty Clause requirements.

Question 2

A lean team discovers a process change that reduces waste but may conflict with an existing FDA 21 CFR Part 820 design control requirement. What is the correct course of action?

Accepted Answer

Halt the process change until a formal design change review is completed per 820.30

Answer

FDA 21 CFR Part 820.30 requires formal design change controls; no improvement can bypass this review process in regulated medical device manufacturing.

Question 3

Which US federal law establishes whistleblower protections for employees who report safety violations during lean transformation projects in publicly traded companies?

Accepted Answer

Sarbanes-Oxley Act (SOX) Section 806

Answer

SOX Section 806 protects employees of publicly traded companies who report fraud or safety violations from retaliation.

Question 4

In a lean value stream mapping session, the team identifies that a record retention step adds no customer value. Under HIPAA, what governs whether this step can be eliminated?

Accepted Answer

HIPAA's required retention periods for protected health information

Answer

HIPAA mandates specific retention periods for PHI-related records; lean waste elimination cannot override these legally required retention obligations.

Question 5

A company undergoing lean transformation in its accounting department must ensure changes comply with which set of standards to maintain accurate financial reporting under US law?

Accepted Answer

Generally Accepted Accounting Principles (GAAP) and SEC reporting rules

Answer

US publicly traded companies must comply with GAAP and SEC rules regardless of internal process improvements made during lean transformations.

(LMC) Lean Management Certification Practice Test

(LMC) Lean Management Certification Practice Test

LMC Regulatory Compliance & Legal Framework 2