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Engagement-design check for external specialists (Wet DBA)

Most DBA problems in life sciences come from how a role is designed, not from bad intent. This check scores the design of one engagement on the three lenses used in our guide: organisational control and embedding, independent execution and commercial risk, and personal entrepreneurship. It takes about four minutes. It is a diagnostic, not a legal test.

1The assignment
What kind of assignment is it?
2The assignment
What best describes the work?
3Control and embedding
Who decides how the work is done?

Following your SOPs, QMS, safety and data-integrity rules does not count as steering; GMP requires it.

4Control and embedding
Will the specialist manage your permanent staff?
5Control and embedding
How is the specialist’s performance judged?
6Control and embedding
How are working hours and presence organised?
7Control and embedding
How visible is the specialist as part of your organisation?

A badge, system access and a company email address are normal on a GMP site.

8Independence and risk
What does the contract describe?
9Independence and risk
What ends the assignment?
10Independence and risk
If work has to be redone because of the specialist’s own error, who pays?
11Also
Expected length, including likely extensions?
12Entrepreneurship
How many other clients has the specialist had in the last 12 months?
13Entrepreneurship
How visible is the specialist as a business?

Own company and KvK registration, liability insurance, a website or other marketing, investment in their own training and tools.

14Also
Was the specialist employed by you in the last 12 months?
15Also
Is the hourly rate below €38 excluding VAT?