CPS Industry Regulations & Compliance 2 — Questions and Answers
Question 1: 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?
- The chemical exceeds its flash point at ambient temperature
- The quantity on-site meets or exceeds the listed threshold quantity in Appendix A (Correct answer)
- The chemical is used in a continuous rather than batch process
- The facility employs more than 50 workers handling the chemical
Correct 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.
Question 2: Which regulatory framework governs the prevention of accidental chemical releases that may affect surrounding communities, complementing OSHA's PSM standard?
- FDA 21 CFR Part 211
- EPA Risk Management Program (RMP) under Clean Air Act Section 112(r) (Correct answer)
- DOT 49 CFR Part 173
- NFPA 70E electrical safety standard
Correct 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.
Question 3: 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?
- Document the event only if a chemical release actually occurred
- Report it to OSHA within 8 hours as a recordable incident
- Investigate it through the incident investigation procedure as a near-miss event (Correct answer)
- Replace the valve and resume operations without formal documentation
Correct 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.
Question 4: ISO 9001:2015 uses a 'risk-based thinking' approach primarily to replace which older quality management concept?
- Statistical process control charts
- Preventive action as a standalone clause requirement (Correct answer)
- Customer satisfaction surveys
- Management review meetings
Correct 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.
Question 5: Which element of OSHA's PSM standard requires employers to document that process equipment complies with recognized and generally accepted good engineering practices (RAGAGEP)?
- Process Hazard Analysis (PHA)
- Mechanical Integrity (Correct answer)
- Management of Change (MOC)
- Pre-Startup Safety Review (PSSR)
Correct answer: Mechanical Integrity
The Mechanical Integrity element of PSM requires inspection, testing, and documentation verifying that equipment meets RAGAGEP standards throughout its lifecycle.
Question 6: Under FDA 21 CFR Part 820 (Quality System Regulation for medical devices), a 'design validation' differs from 'design verification' in that validation:
- Confirms design outputs meet design input requirements through testing
- Confirms the device meets user needs and intended uses under actual or simulated conditions (Correct answer)
- Reviews design documents for completeness and accuracy
- Ensures manufacturing processes are capable of producing conforming devices
Correct 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.
Question 7: The Sarbanes-Oxley Act (SOX) Section 404 primarily requires publicly traded companies to do which of the following related to process compliance?
- Implement ISO 9001-certified quality management systems
- Assess and report on the effectiveness of internal controls over financial reporting (Correct answer)
- Conduct annual process hazard analyses for all manufacturing processes
- Register all chemical processes with the SEC before operation
Correct 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.
CPS Industry Regulations & Compliance 2
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?