SME
Subject Matter Expert
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 individual with demonstrable expertise in a specific system, process or discipline who leads the technical judgement in a risk-based verification programme — defining requirements, identifying critical aspects, reviewing design, setting the verification strategy and approving acceptance criteria within their area of responsibility.
ASTM E2500 makes the SME role structural rather than advisory: subject matter experts take the lead role in verification within their area of expertise, and the quality unit approves rather than performs the technical assessment. That reallocation is what allows engineering documentation and supplier testing to be leveraged instead of repeated.
The corollary is that SME judgement has to be documented at the time, by a named person with recorded competence. An assessment attributed to "the project team" is not an SME judgement and will not survive inspection as one.
ASTM E2500-25 §6.7 (subject matter experts lead verification within their area of expertise and responsibility); ISPE Baseline Guide Vol. 5 (2nd ed., 2019).
Frequently asked questions
What does SME stand for?
SME stands for Subject Matter Expert.
What is SME?
The individual with demonstrable expertise in a specific system, process or discipline who leads the technical judgement in a risk-based verification programme — defining requirements, identifying critical aspects, reviewing design, setting the verification strategy and approving acceptance criteria within their area of responsibility.
Which regulations cover SME?
ASTM E2500-25 §6.7 (subject matter experts lead verification within their area of expertise and responsibility); ISPE Baseline Guide Vol. 5 (2nd ed., 2019).