CPS Industry Regulations & Compliance 3 — Questions and Answers
Question 1: When a company acquires a new facility that falls under OSHA PSM, the Management of Change (MOC) procedure would be LEAST applicable to which scenario?
- Replacing a pump with a larger-capacity model of a different type
- Replacing a pump with an identical model from the same manufacturer (Correct answer)
- Changing the operating pressure of a covered process
- Introducing a new chemical substitute in an existing process
Correct answer: Replacing a pump with an identical model from the same manufacturer
Replacement-in-kind (RIK) — substituting equipment with an identical item — is exempt from formal MOC procedures, unlike changes that alter design intent or specifications.
Question 2: GMP (Good Manufacturing Practice) regulations under 21 CFR Part 211 require that drug product containers and closures be qualified through which type of testing to confirm they do not interact harmfully with the product?
- Accelerated stability testing only
- Extractables and leachables (E&L) testing (Correct answer)
- Sterility testing under USP <71>
- Bioburden testing per USP <61>
Correct answer: Extractables and leachables (E&L) testing
Extractables and leachables testing evaluates whether container-closure systems release substances that could contaminate or react with pharmaceutical products.
Question 3: A CPS practitioner is auditing a process and finds that the last Pre-Startup Safety Review (PSSR) was conducted but did not verify that all action items from the previous PHA were resolved. This gap violates which PSM element?
- Employee Participation
- Pre-Startup Safety Review (Correct answer)
- Process Hazard Analysis
- Compliance Audits
Correct answer: Pre-Startup Safety Review
The PSSR element requires confirmation that recommendations and action items from PHAs and other safety reviews have been addressed before startup of new or modified processes.
Question 4: Under EPA's Risk Management Program (RMP), a Program 3 process differs from a Program 1 process primarily because Program 3:
- Has never had an accidental release causing off-site impacts
- Is subject to OSHA PSM and requires a full prevention program including PHA and MOC (Correct answer)
- Stores chemicals below 10% of the threshold quantity
- Is located more than one mile from the nearest public receptor
Correct answer: Is subject to OSHA PSM and requires a full prevention program including PHA and MOC
Program 3 processes are those subject to OSHA PSM and require the most comprehensive RMP prevention program elements, including PHAs, MOC, and mechanical integrity programs.
Question 5: In ISO 14001:2015 environmental management, the concept of 'life cycle perspective' when identifying significant environmental aspects means an organization must consider:
- Only direct environmental impacts from its own manufacturing operations
- Environmental impacts upstream and downstream, including raw material acquisition and end-of-life disposal (Correct answer)
- The expected useful life of its pollution control equipment
- Annual environmental impact trends over a 10-year period
Correct answer: Environmental impacts upstream and downstream, including raw material acquisition and end-of-life disposal
ISO 14001:2015 requires organizations to consider the life cycle stages — from raw material extraction through end-of-life — when identifying and evaluating environmental aspects.
Question 6: Which NFPA standard specifically governs electrical safety work practices and defines requirements for establishing an electrically safe work condition (ESWC) before working on de-energized equipment?
- NFPA 70 (National Electrical Code)
- NFPA 70E (Standard for Electrical Safety in the Workplace) (Correct answer)
- NFPA 72 (National Fire Alarm Code)
- NFPA 101 (Life Safety Code)
Correct answer: NFPA 70E (Standard for Electrical Safety in the Workplace)
NFPA 70E defines the requirements for establishing an electrically safe work condition, including lockout/tagout steps and verification testing before electrical work begins.
Question 7: A process facility must retain P&IDs (Piping and Instrumentation Diagrams) that reflect current installed conditions. This requirement falls under which PSM element?
- Mechanical Integrity
- Operating Procedures
- Process Safety Information (PSI) (Correct answer)
- Process Hazard Analysis
Correct answer: Process Safety Information (PSI)
Process Safety Information must include up-to-date P&IDs that accurately reflect the current state of the process, as required by the PSI element of PSM.
CPS Industry Regulations & Compliance 3
When a company acquires a new facility that falls under OSHA PSM, the Management of Change (MOC) procedure would be LEAST applicable to which scenario?