CLL Regulatory Compliance & Legal Framework 2

Question 1

Under OSHA's General Duty Clause, employers are required to provide a workplace free from which type of hazard?

Accepted Answer

Recognized hazards likely to cause death or serious physical harm

Answer

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?

Accepted Answer

OSHA Hazard Communication Standard (HazCom)

Answer

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?

Accepted Answer

Conduct a substantial equivalence review and potentially submit a new 510(k)

Answer

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?

Accepted Answer

The point at which product specifications are locked and documented for regulatory submission

Answer

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?

Accepted Answer

Assess and report on the effectiveness of internal controls over financial reporting

Answer

SOX Section 404 requires management and external auditors to report on the adequacy of internal controls over financial reporting each fiscal year.

(CLL) Certified Lean Leader Practice Test

(CLL) Certified Lean Leader Practice Test

CLL Regulatory Compliance & Legal Framework 2