SRA
System Risk Assessment
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The documented assessment that determines which aspects of a system are critical to product quality and patient safety, and therefore how much qualification effort each part of the system warrants. It is the mechanism that lets a risk-based C&Q programme test some things hard and others not at all.
The SRA is the successor to the older System Impact Assessment and Component Criticality Assessment pairing. Where those classified whole systems as direct, indirect or no impact and then walked the component list, the SRA works from process understanding to critical aspects and then to the design elements that control them.
A qualification protocol that tests everything to the same depth has not been risk-assessed — it has been written to avoid making a judgement. The point of the assessment is that the judgement is documented, made by subject matter experts, and approved by the quality unit.
ISPE Baseline Guide Vol. 5, Commissioning and Qualification (2nd ed., 2019); ICH Q9(R1) for the quality risk management principles it applies; ASTM E2500-25.
Frequently asked questions
What does SRA stand for?
SRA stands for System Risk Assessment.
What is SRA?
The documented assessment that determines which aspects of a system are critical to product quality and patient safety, and therefore how much qualification effort each part of the system warrants. It is the mechanism that lets a risk-based C&Q programme test some things hard and others not at all.
Which regulations cover SRA?
ISPE Baseline Guide Vol. 5, Commissioning and Qualification (2nd ed., 2019); ICH Q9(R1) for the quality risk management principles it applies; ASTM E2500-25.