LMC Regulatory Compliance & Legal Framework 2 — Questions and Answers
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?
- By eliminating all production quotas
- By maintaining organized, hazard-free work areas through Sort, Set, Shine, Standardize, Sustain (Correct answer)
- By requiring employees to sign hazard acknowledgment forms
- By outsourcing dangerous tasks to contractors
Correct 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.
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?
- Implement the change immediately to capture savings
- Halt the process change until a formal design change review is completed per 820.30 (Correct answer)
- Submit a complaint to the FDA about the conflicting regulation
- Apply the change only to non-regulated product lines
Correct 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.
Question 3: Which US federal law establishes whistleblower protections for employees who report safety violations during lean transformation projects in publicly traded companies?
- The Clayton Act
- Sarbanes-Oxley Act (SOX) Section 806 (Correct answer)
- The Robinson-Patman Act
- The Sherman Antitrust Act
Correct answer: Sarbanes-Oxley Act (SOX) Section 806
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?
- Customer satisfaction scores
- HIPAA's required retention periods for protected health information (Correct answer)
- The team leader's authority to approve waste elimination
- ISO 9001 audit schedules
Correct 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.
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?
- APICS CPIM standards
- Generally Accepted Accounting Principles (GAAP) and SEC reporting rules (Correct answer)
- Six Sigma DMAIC documentation requirements
- ISO 14001 environmental standards
Correct 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.
Question 6: 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?
- LEAN SIX SIGMA Body of Knowledge
- COSO Internal Control – Integrated Framework (Correct answer)
- The Toyota Production System manual
- APQC Process Classification Framework
Correct 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.
Question 7: 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?
- Marketing approval from the sales team
- Complete and accurate batch production and control records (Correct answer)
- Voluntary customer feedback forms
- Supplier performance scorecards
Correct 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.
LMC Regulatory Compliance & Legal Framework 2
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?