Regulatory Compliance Flashcards
7 cards from real COM 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 flashcards as text
What distinguishes a 'willful' OSHA violation from a 'serious' violation?
Answer: A willful violation is one where the employer intentionally disregards or is plainly indifferent to OSHA requirements, carrying significantly higher penalties
OSHA classifies a violation as willful when evidence shows intentional disregard or plain indifference to the law, resulting in penalties up to $156,259 per violation versus up to $15,625 for serious violations.
A company operating internationally must comply with the Foreign Corrupt Practices Act (FCPA). What does the FCPA primarily prohibit?
Answer: Bribing foreign government officials to obtain or retain business
The FCPA prohibits U.S. persons and companies (and foreign companies listed on U.S. exchanges) from paying bribes to foreign officials to gain a business advantage.
Which element is most critical when documenting a compliance training program for regulatory defense purposes?
Answer: Records of who attended, what was covered, when training occurred, and assessment results
Defensible compliance training documentation must show which employees completed training, the specific topics covered, dates, and assessment outcomes to demonstrate due diligence.
Under the Resource Conservation and Recovery Act (RCRA), how are hazardous wastes tracked from generation to final disposal?
Answer: Through a manifest system that documents the waste's movement from generator to transporter to treatment, storage, or disposal facility
RCRA's cradle-to-grave manifest system requires a paper trail accompanying hazardous waste shipments through every transfer until final disposition is confirmed.
An operations manager is reviewing a corrective and preventive action (CAPA) process triggered by a compliance audit finding. What should CAPA documentation include?
Answer: Root cause analysis, specific corrective steps, responsible owners, timelines, and effectiveness verification
Effective CAPA documentation must capture root cause analysis, defined actions with owners and deadlines, and a follow-up verification step to confirm the fix was effective.
What is the significance of the 'statute of limitations' in regulatory compliance enforcement?
Answer: It defines the maximum time period within which a regulatory agency can bring an enforcement action for a violation
The statute of limitations sets the window after a violation occurs during which a regulatory agency may initiate legal or administrative enforcement proceedings.
Which approach best supports a 'culture of compliance' in an organization?
Answer: Leadership visibly modeling compliance behaviors, combined with training, open reporting channels, and no-retaliation policies
A genuine compliance culture requires tone-at-the-top leadership modeling, accessible reporting mechanisms, employee education, and protection for those who raise concerns.