Industry Regulations & Compliance Flashcards
7 cards from real CPS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Industry Regulations & Compliance flashcards as text
Under OSHA's Process Safety Management (PSM) standard 29 CFR 1910.119, what is the primary threshold quantity trigger for coverage of a highly hazardous chemical?
Answer: The quantity on-site meets or exceeds the listed threshold quantity in Appendix A
PSM coverage is triggered when a highly hazardous chemical is present in a quantity at or above its specific threshold quantity listed in 29 CFR 1910.119 Appendix A.
Which regulatory framework governs the prevention of accidental chemical releases that may affect surrounding communities, complementing OSHA's PSM standard?
Answer: EPA Risk Management Program (RMP) under Clean Air Act Section 112(r)
EPA's RMP rule under CAA Section 112(r) requires facilities with listed chemicals above threshold quantities to develop and register risk management plans addressing off-site consequences.
A process engineer discovers a 'near miss' incident where a safety valve failed to open but no release occurred. Under good compliance practice, what is the MOST appropriate immediate action?
Answer: Investigate it through the incident investigation procedure as a near-miss event
Near-miss events must be investigated under PSM's incident investigation element to identify root causes and prevent future incidents, even when no actual release or injury occurred.
ISO 9001:2015 uses a 'risk-based thinking' approach primarily to replace which older quality management concept?
Answer: Preventive action as a standalone clause requirement
ISO 9001:2015 embedded risk-based thinking throughout the standard to replace the prescriptive preventive action clause that existed in ISO 9001:2008.
Which element of OSHA's PSM standard requires employers to document that process equipment complies with recognized and generally accepted good engineering practices (RAGAGEP)?
Answer: Mechanical Integrity
The Mechanical Integrity element of PSM requires inspection, testing, and documentation verifying that equipment meets RAGAGEP standards throughout its lifecycle.
Under FDA 21 CFR Part 820 (Quality System Regulation for medical devices), a 'design validation' differs from 'design verification' in that validation:
Answer: Confirms the device meets user needs and intended uses under actual or simulated conditions
Design validation confirms the finished device meets intended user needs and uses, while verification confirms design outputs meet specified design input requirements.
The Sarbanes-Oxley Act (SOX) Section 404 primarily requires publicly traded companies to do which of the following related to process compliance?
Answer: Assess and report on the effectiveness of internal controls over financial reporting
SOX Section 404 mandates that management assess and report on the effectiveness of internal controls over financial reporting, with external auditor attestation.