Regulatory Compliance & Legal Framework Flashcards

Under ISO 14001, what is the primary purpose of an environmental aspect register?

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.

A Lean leader discovers that a corrective action was implemented without completing a root cause analysis (RCA). What compliance risk does this create?

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.

The Foreign Corrupt Practices Act (FCPA) prohibits U.S. companies from doing which of the following?

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.

In regulated industries, a 'change control' process is used primarily to:

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.

Which U.S. law primarily governs the handling, storage, and disposal of hazardous waste generated during manufacturing operations?

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.

A Lean project reduces work-in-process inventory but inadvertently causes an employee to handle chemicals more frequently. Which compliance obligation is triggered?

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.

Under ISO 9001:2015, what term describes the formal identification and management of processes and their interactions within the quality management system?

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.