RAM Industry Regulations & Compliance 2 — Questions and Answers
Question 1: Which MIL-HDBK-217 revision is most commonly referenced for electronic parts reliability prediction in US defense contracts?
- MIL-HDBK-217A
- MIL-HDBK-217F Notice 2 (Correct answer)
- MIL-HDBK-217C
- MIL-HDBK-217D
Correct answer: MIL-HDBK-217F Notice 2
MIL-HDBK-217F Notice 2 is the most widely cited revision for electronic reliability prediction in defense procurement.
Question 2: Under FDA 21 CFR Part 820, what is the primary purpose of a Design History File (DHF)?
- To document production yields and defect rates
- To record all design and development history of a finished device (Correct answer)
- To track supplier qualification records
- To store post-market surveillance data
Correct answer: To record all design and development history of a finished device
A DHF contains the records that demonstrate the design was developed in accordance with the approved design plan and regulatory requirements.
Question 3: Which IECEE scheme provides a globally recognized path for demonstrating compliance with IEC standards for electrical and electronic equipment?
- CB Scheme (Correct answer)
- ATEX Directive
- CE Marking
- UL Listing
Correct answer: CB Scheme
The IECEE CB Scheme enables manufacturers to obtain a single test report accepted by member countries to reduce duplicative testing.
Question 4: What does the 'safe-life' design philosophy require, as regulated in aviation under FAA AC 25.571?
- Components must be inspectable at each maintenance interval
- Components are retired before they can reach their endurance limit (Correct answer)
- Redundant systems must operate if the primary fails
- Damage tolerance testing replaces scheduled retirement
Correct answer: Components are retired before they can reach their endurance limit
Safe-life design mandates that a component is removed from service before it is statistically likely to fail from fatigue.
Question 5: ISO 13849-1 classifies safety function performance using Performance Levels (PL). Which PL corresponds to the highest reliability requirement?
- PL a
- PL c
- PL d
- PL e (Correct answer)
Correct answer: PL e
PL e is the highest category in ISO 13849-1, associated with a probability of dangerous failure per hour (PFHd) below 10⁻⁸.
Question 6: Which regulatory framework governs reliability and airworthiness requirements for civil aircraft systems in the United States?
- FAR Part 25 (Correct answer)
- MIL-STD-882E
- OSHA 1910.147
- NFPA 70B
Correct answer: FAR Part 25
FAR Part 25 (14 CFR Part 25) sets airworthiness standards for transport category aircraft, including reliability and safety system requirements.
Question 7: Under IEC 61511, what is the role of a Safety Requirements Specification (SRS) in compliance with functional safety standards?
- It defines the hardware proof-test intervals only
- It documents the safety functions and integrity levels required for the Safety Instrumented System (Correct answer)
- It replaces the need for a hazard and risk assessment
- It specifies maintenance schedules for all plant equipment
Correct answer: It documents the safety functions and integrity levels required for the Safety Instrumented System
The SRS captures all safety functions, their required Safety Integrity Levels (SIL), and performance requirements that the SIS must achieve.
RAM Industry Regulations & Compliance 2
Which MIL-HDBK-217 revision is most commonly referenced for electronic parts reliability prediction in US defense contracts?