CLL Regulatory Compliance & Legal Framework 3 — Questions and Answers
Question 1: Under ISO 14001, what is the primary purpose of an environmental aspect register?
- To list all suppliers contributing to waste
- To identify environmental aspects and evaluate their potential impacts (Correct answer)
- To document regulatory fines paid by the organization
- To assign environmental tasks to employees
Correct answer: To identify environmental aspects and evaluate their potential impacts
An environmental aspect register catalogues activities, products, and services that interact with the environment and evaluates which impacts are significant, forming the basis for ISO 14001 objectives.
Question 2: A Lean leader discovers that a corrective action was implemented without completing a root cause analysis (RCA). What compliance risk does this create?
- It triggers an automatic ISO audit
- The corrective action may not address the true cause, leading to recurrence and audit findings (Correct answer)
- It voids all previous quality certifications
- It requires immediate regulatory shutdown
Correct answer: The corrective action may not address the true cause, leading to recurrence and audit findings
Skipping RCA means the correction targets a symptom rather than the root cause, risking recurrence and a nonconformance finding during third-party or regulatory audits.
Question 3: The Foreign Corrupt Practices Act (FCPA) prohibits U.S. companies from doing which of the following?
- Importing goods from sanctioned countries
- Bribing foreign government officials to obtain or retain business (Correct answer)
- Hiring foreign nationals without work authorization
- Exporting technology without an EAR license
Correct answer: Bribing foreign government officials to obtain or retain business
The FCPA makes it unlawful for U.S. persons and entities to bribe foreign government officials to gain or keep business advantages abroad.
Question 4: In regulated industries, a 'change control' process is used primarily to:
- Limit the number of Lean projects allowed per quarter
- Ensure that changes to products, processes, or systems are evaluated and approved before implementation (Correct answer)
- Notify unions about operational changes
- Track budget variances in improvement projects
Correct answer: Ensure that changes to products, processes, or systems are evaluated and approved before implementation
Change control is a formal process to review, approve, document, and validate changes before they are implemented, protecting product quality and regulatory compliance.
Question 5: Which U.S. law primarily governs the handling, storage, and disposal of hazardous waste generated during manufacturing operations?
- Clean Water Act (CWA)
- Resource Conservation and Recovery Act (RCRA) (Correct answer)
- Toxic Substances Control Act (TSCA)
- Safe Drinking Water Act (SDWA)
Correct answer: Resource Conservation and Recovery Act (RCRA)
RCRA establishes the framework for proper management of hazardous and non-hazardous solid waste, including generation, storage, transportation, and disposal.
Question 6: A Lean project reduces work-in-process inventory but inadvertently causes an employee to handle chemicals more frequently. Which compliance obligation is triggered?
- EEOC reporting
- OSHA Hazard Communication and potential ergonomic risk review (Correct answer)
- FTC marketing disclosure
- SEC material change filing
Correct answer: OSHA Hazard Communication and potential ergonomic risk review
Increased frequency of chemical handling triggers OSHA HazCom requirements for updated training and exposure risk assessment, plus potential ergonomic evaluation.
Question 7: Under ISO 9001:2015, what term describes the formal identification and management of processes and their interactions within the quality management system?
- Value stream mapping
- Process approach (Correct answer)
- Hoshin planning
- Plan-Do-Check-Act
Correct answer: Process approach
ISO 9001:2015 explicitly requires a 'process approach,' which means identifying processes, their sequences, interactions, and the resources and criteria needed to manage them effectively.
CLL Regulatory Compliance & Legal Framework 3
Under ISO 14001, what is the primary purpose of an environmental aspect register?