Medical Device Link.

Originally Published MX March/April 2004

GOVERNMENTAL & LEGAL AFFAIRS

To tabulate a compliance index score for each of the four principal data sources involves collecting and weighting specific data from each source according to their importance in the company's overall compliance picture. For example, one portion of the metric requires the collection of data through employee interviews. The metric should include criteria for the selection of interviewees. Sample criteria might include the following.

• A certain minimum number of employees should be interviewed.
• The regulatory and quality departments should be represented in equal balance.
• All compliance personnel should be included.
• At least one employee from every other corporate operating division should be included in addition to those from regulatory and quality affairs.

Both written questionnaires and oral interviews should be used as information sources. Following administration of the written questions, the oral interview can delve deeper into issues raised by the questionnaire answers.

The interview agenda of general topical areas should be weighted by relative importance, as suggested by the following.

• Known or suspected compliance shortcomings (50%).
• Adoption of best practices (20%).
• Compliance culture (20%).
• Status of FDA relationship (10%).

Not only would these overarching subjects be weighted but so would the individual questions in the questionnaire. Indeed, each question should be given a numerical value based formulaically upon the answer a respondent selects. A truly comprehensive questionnaire would have questions crafted to allow interviewees to choose from a scale of answers ranging from "strongly agree" to "strongly disagree" rather than simply "yes" or "no."

The oral interviewer should ask a variety of questions pertaining to the four topics itemized above, exploring any compliance issues raised in the written questionnaire. The candor of the respondent should be assessed numerically as part of the formula, and factored into the score.

Finally, the written and oral interview scores should be combined by formula to produce the company interview subscore, which would be weighted as 25% of the overall, or base, score.

Copyright ©2004 MX