Industry Regulations & Compliance Flashcards

A Functional Safety Assessment (FSA) per IEC 61511 should be conducted at which stage of the safety lifecycle?

Answer: At multiple defined stages including after commissioning

IEC 61511 requires Functional Safety Assessments at multiple stages of the safety lifecycle, including design, installation, commissioning, and after major modifications.

Which document type in the Management of Change (MOC) process formally records the technical basis for approving a modification to an automated control system?

Answer: MOC authorization form with hazard review

An MOC authorization form that includes a hazard review documents the technical basis and approval for changes to control systems before implementation.

In pharmaceutical manufacturing, 21 CFR Part 11 requires that electronic records used in place of paper records must have:

Answer: Audit trails, access controls, and validated software

21 CFR Part 11 requires electronic records to have audit trails capturing who changed what and when, access controls, and validated systems to ensure data integrity.

The concept of 'layer of protection analysis' (LOPA) is used in process safety to:

Answer: Estimate risk reduction provided by independent protection layers

LOPA is a semi-quantitative method used to estimate how much risk reduction is provided by independent protection layers and determine if a Safety Instrumented Function is needed.

For a SIL 2 Safety Instrumented Function using IEC 61511, the required Probability of Failure on Demand (PFDavg) range is:

Answer: ≥ 10⁻³ to < 10⁻²

SIL 2 corresponds to a PFDavg range of 10⁻³ to less than 10⁻², representing between 1-in-1,000 and 1-in-100 probability of failure on demand.

Which body publishes the S84 standard (equivalent to IEC 61511) specifically adopted by the US process industries?

Answer: ISA

ISA (International Society of Automation) publishes ANSI/ISA-84, which is the US adoption of IEC 61511 for safety instrumented systems in the process industries.

Pre-Startup Safety Review (PSSR) under OSHA PSM must be completed before introducing highly hazardous chemicals to a new or modified process. What must the PSSR confirm?

Answer: Construction meets design specs and safety systems are functional

OSHA PSM requires PSSR to confirm that construction matches design specifications, safety systems are functional, procedures are in place, and training is complete before startup.