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 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?
Answer: By maintaining organized, hazard-free work areas through Sort, Set, Shine, Standardize, Sustain
5S creates orderly, clean workplaces that reduce slip/trip hazards and improve visibility, directly satisfying OSHA's General Duty Clause requirements.
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?
Answer: Halt the process change until a formal design change review is completed per 820.30
FDA 21 CFR Part 820.30 requires formal design change controls; no improvement can bypass this review process in regulated medical device manufacturing.
Which US federal law establishes whistleblower protections for employees who report safety violations during lean transformation projects in publicly traded companies?
Answer: Sarbanes-Oxley Act (SOX) Section 806
SOX Section 806 protects employees of publicly traded companies who report fraud or safety violations from retaliation.
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?
Answer: HIPAA's required retention periods for protected health information
HIPAA mandates specific retention periods for PHI-related records; lean waste elimination cannot override these legally required retention obligations.
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?
Answer: Generally Accepted Accounting Principles (GAAP) and SEC reporting rules
US publicly traded companies must comply with GAAP and SEC rules regardless of internal process improvements made during lean transformations.
During a kaizen event, a team proposes eliminating a dual-approval step for purchase orders. Which internal control framework should be consulted to assess whether this violates segregation of duties requirements?
Answer: COSO Internal Control – Integrated Framework
The COSO framework defines segregation of duties as a key internal control; eliminating dual approvals may create fraud risk and violate SOX compliance requirements.
A lean project in a pharmaceutical plant aims to reduce batch documentation time. Under 21 CFR Part 211, what must be preserved even after process simplification?
Answer: Complete and accurate batch production and control records
21 CFR Part 211 requires complete batch records as a GMP requirement; lean simplification cannot reduce the completeness or accuracy of these mandated records.