CPS Industry Regulations & Compliance 3

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?

Accepted Answer

Replacing a pump with an identical model from the same manufacturer

Answer

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?

Accepted Answer

Extractables and leachables (E&L) testing

Answer

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?

Accepted Answer

Pre-Startup Safety Review

Answer

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:

Accepted Answer

Is subject to OSHA PSM and requires a full prevention program including PHA and MOC

Answer

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:

Accepted Answer

Environmental impacts upstream and downstream, including raw material acquisition and end-of-life disposal

Answer

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.

(CPS) Certified Process Specialist Practice Test

(CPS) Certified Process Specialist Practice Test

CPS Industry Regulations & Compliance 3