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Background: The implementation of competency-based medical education requires postgraduate medical training programs to adjust their assessment strategies. A criterion-referenced competency assessment tool (C-CAT) was developed based on content-validated milestones, but the response process had to be validated before implementation. Objectives: To evaluate the C-CAT response process and to identify difficulties encountered by users that could bias the assessment. Methods: Qualitative study involving 10 volunteer clinical teachers. Data was collected during individual interviews using the think-aloud protocol. Three researchers independently carried out a content analysis of the verbatim responses, hence data were triangulated. The coding structure consists of four themes: comprehension, information recall, judgment and response selection. Results: Comprehension and information retrieval generally did not cause any problem. Difficulties at the judgment (heterogeneous indicators and normative evaluation) and response selection (inadequate response scale) stages were identified. Discussion and conclusion: This study validated the C-CAT response process, which proved adequate for comprehension and information retrieval, but required improvements for judgment and response selection. Based on these results, the C-CAT was revised before implementation. The ongoing evaluation of the internal structure, relations with other variables and consequences of testing will complete the validation process. [ABSTRACT FROM AUTHOR]