CLL Regulatory Compliance & Legal Framework 2 — Questions and Answers
Question 1: Under OSHA's General Duty Clause, employers are required to provide a workplace free from which type of hazard?
- Recognized hazards likely to cause death or serious physical harm (Correct answer)
- All hazards regardless of likelihood
- Only chemical and biological hazards
- Hazards reported by employees in writing
Correct answer: Recognized hazards likely to cause death or serious physical harm
The OSHA General Duty Clause (Section 5(a)(1)) requires employers to keep workplaces free from recognized hazards that cause or are likely to cause death or serious physical harm.
Question 2: Which U.S. regulation requires manufacturers to maintain Safety Data Sheets (SDS) for hazardous chemicals in the workplace?
- EPA Clean Air Act
- OSHA Hazard Communication Standard (HazCom) (Correct answer)
- FDA 21 CFR Part 11
- DOT HMR 49 CFR
Correct answer: OSHA Hazard Communication Standard (HazCom)
OSHA's Hazard Communication Standard (29 CFR 1910.1200) mandates that chemical manufacturers and employers maintain and provide Safety Data Sheets for hazardous substances.
Question 3: A Lean team identifies a process change that may affect a product's FDA 510(k) clearance. What must the organization do before implementing the change?
- Implement the change immediately and notify FDA afterward
- Conduct a substantial equivalence review and potentially submit a new 510(k) (Correct answer)
- Notify customers only
- File a CAPA and proceed with the change
Correct answer: Conduct a substantial equivalence review and potentially submit a new 510(k)
Changes that affect safety, effectiveness, or substantial equivalence of a 510(k)-cleared device may require a new premarket notification submission to the FDA.
Question 4: In the context of Lean and regulatory compliance, what does 'design freeze' typically refer to in a regulated industry?
- A temporary halt to all manufacturing due to a quality defect
- The point at which product specifications are locked and documented for regulatory submission (Correct answer)
- A software update lockout during a compliance audit
- Freezing headcount in the engineering department
Correct answer: The point at which product specifications are locked and documented for regulatory submission
Design freeze is the formal milestone where product specifications are finalized and controlled, forming the basis for regulatory submissions and design validation.
Question 5: Under Sarbanes-Oxley (SOX) Section 404, what are public companies required to do?
- Certify annual environmental impact reports
- Assess and report on the effectiveness of internal controls over financial reporting (Correct answer)
- Submit Lean improvement plans to the SEC annually
- Disclose all supplier contracts to shareholders
Correct answer: Assess and report on the effectiveness of internal controls over financial reporting
SOX Section 404 requires management and external auditors to report on the adequacy of internal controls over financial reporting each fiscal year.
Question 6: Which principle in Lean directly supports regulatory traceability requirements by ensuring every item can be tracked through the value stream?
- Jidoka (autonomation)
- Visual management
- Lot traceability and serialization (Correct answer)
- Takt time calculation
Correct answer: Lot traceability and serialization
Lot traceability and serialization enable organizations to track materials and products through each process step, satisfying regulatory requirements in industries such as medical devices, food, and aerospace.
Question 7: When a Lean improvement project in a pharmaceutical facility reduces batch cycle time, which regulatory body's guidelines most likely govern validation of the new process?
- OSHA
- EPA
- FDA (21 CFR Parts 210/211) (Correct answer)
- FTC
Correct answer: FDA (21 CFR Parts 210/211)
FDA regulations under 21 CFR Parts 210 and 211 (Current Good Manufacturing Practice) govern pharmaceutical manufacturing processes and require validation of any process changes.
CLL Regulatory Compliance & Legal Framework 2
Under OSHA's General Duty Clause, employers are required to provide a workplace free from which type of hazard?