ISA CAP Industry Regulations & Compliance 3 — Questions and Answers
Question 1: A Functional Safety Assessment (FSA) per IEC 61511 should be conducted at which stage of the safety lifecycle?
- Only during initial design before installation
- At multiple defined stages including after commissioning (Correct answer)
- Only after the SIS has been in operation for one year
- Exclusively by the original equipment manufacturer
Correct 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.
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?
- Field change notice
- Pre-startup safety review checklist
- MOC authorization form with hazard review (Correct answer)
- Corrective maintenance work order
Correct 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.
Question 3: In pharmaceutical manufacturing, 21 CFR Part 11 requires that electronic records used in place of paper records must have:
- Dual-redundant storage on separate servers
- Audit trails, access controls, and validated software (Correct answer)
- Printed backups stored in a fireproof safe
- Daily exports to an FDA-approved database
Correct 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.
Question 4: The concept of 'layer of protection analysis' (LOPA) is used in process safety to:
- Determine the thickness of physical containment barriers
- Estimate risk reduction provided by independent protection layers (Correct answer)
- Calculate the number of emergency responders needed on-site
- Design the physical layout of control room consoles
Correct 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.
Question 5: For a SIL 2 Safety Instrumented Function using IEC 61511, the required Probability of Failure on Demand (PFDavg) range is:
- ≥ 10⁻¹ to < 10⁰
- ≥ 10⁻³ to < 10⁻² (Correct answer)
- ≥ 10⁻² to < 10⁻¹
- ≥ 10⁻⁴ to < 10⁻³
Correct 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.
Question 6: Which body publishes the S84 standard (equivalent to IEC 61511) specifically adopted by the US process industries?
- ASME
- ISA (Correct answer)
- NFPA
- API
Correct 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.
Question 7: 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?
- All employees have completed annual safety training
- Construction meets design specs and safety systems are functional (Correct answer)
- Insurance coverage is current for the process unit
- Environmental impact assessment has been filed with the EPA
Correct 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.
ISA CAP Industry Regulations & Compliance 3
A Functional Safety Assessment (FSA) per IEC 61511 should be conducted at which stage of the safety lifecycle?