ISA CAP Industry Regulations & Compliance 3

Question 1

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

Accepted Answer

At multiple defined stages including after commissioning

Answer

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

Question 2

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

Accepted Answer

MOC authorization form with hazard review

Answer

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

Question 3

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

Accepted Answer

Audit trails, access controls, and validated software

Answer

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.

Question 4

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

Accepted Answer

Estimate risk reduction provided by independent protection layers

Answer

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.

Question 5

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

Accepted Answer

≥ 10⁻³ to < 10⁻²

Answer

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.

(ISA CAP) ISA Certified Automation Professional Practice Test

(ISA CAP) ISA Certified Automation Professional Practice Test

ISA CAP Industry Regulations & Compliance 3