Practice Test Geeks(CPS) Certified Process Specialist Practice Test
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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

  1. Under 21 CFR Part 11, which combination of controls makes an electronic signature legally equivalent to a handwritten signature for FDA-regulated records?

    Answer: At least two distinct identification components (e.g., ID code + password) with a binding statement linking the signature to the record

    21 CFR Part 11 requires electronic signatures to consist of at least two distinct identification components and be linked to the associated electronic record via a binding statement.

  2. REACH regulation (EC 1907/2006) primarily affects process industries by requiring:

    Answer: Registration, evaluation, and authorization of chemical substances manufactured or imported into the EU above threshold quantities

    REACH requires manufacturers and importers of chemical substances in the EU to register substances above 1 tonne/year and demonstrate safe use through chemical safety assessments.

  3. In the context of IEC 61511 (Functional Safety for process industry SIS), a Safety Instrumented Function (SIF) must achieve a target Safety Integrity Level (SIL). Which metric is used to express the SIL requirement for a low-demand mode SIF?

    Answer: Probability of Failure on Demand (PFDavg)

    For low-demand mode SIFs, SIL is expressed as a Probability of Failure on Demand average (PFDavg), with SIL 1 through SIL 4 corresponding to decreasing PFDavg ranges.

  4. A pharmaceutical company is inspected and FDA investigators find batch records missing required data entries. Under 21 CFR Part 211, the MOST appropriate corrective action framework to prevent recurrence is:

    Answer: Implement a CAPA that includes root cause analysis, corrective actions, effectiveness check, and timely closure

    cGMP requires a robust CAPA system with documented root cause analysis, implemented corrections, and verified effectiveness to prevent recurrence of documentation deficiencies.

  5. The Globally Harmonized System (GHS) of Classification and Labelling of Chemicals standardizes Safety Data Sheets (SDS) into how many sections?

    Answer: 16 sections

    GHS standardizes SDSs into 16 sections covering chemical identity, hazard identification, composition, first aid, firefighting, handling, storage, exposure controls, physical properties, and more.

  6. Under EPA's RCRA (Resource Conservation and Recovery Act), a facility that generates more than 1,000 kg of hazardous waste per month is classified as a:

    Answer: Large Quantity Generator (LQG)

    RCRA classifies generators producing more than 1,000 kg/month of hazardous waste as Large Quantity Generators, subject to the most stringent storage time limits and regulatory requirements.

  7. During a compliance audit, an auditor finds that the facility's written operating procedures have not been reviewed or certified as accurate within the past year, violating which PSM element?

    Answer: Operating Procedures

    PSM's Operating Procedures element requires that procedures be reviewed as often as necessary and certified annually as current and accurate.