1 The assignment What kind of assignment is it? Quality assurance QC / laboratory Validation / CSV R&D / CMC Operations / production management Senior management (CXO, site head) Something else
2 The assignment What best describes the work? A project outcome: a defined deliverable with an end date Specialist expertise we do not have in-house A temporary capacity peak Ongoing, business-as-usual work A structural role in our organisation (a vacancy)
3 Control 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.
The specialist, within the agreed scope Agreed together at milestones Our manager steers the content regularly Our manager assigns tasks day to day
4 Control and embedding Will the specialist manage your permanent staff? No Coordinates a project team for the deliverable only Yes, line management as part of the role
5 Control and embedding How is the specialist’s performance judged? Against deliverables and acceptance criteria In project steering meetings In our HR cycle, like employees
6 Control and embedding How are working hours and presence organised? Own planning; on site when the work requires it Agreed days on site, planned around the work Fixed hours or shifts in our roster
7 Control 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.
Clearly external: a project role under their own company name Uses our systems with a project title Indistinguishable from employees: permanent title in the org chart, counted as team capacity
8 Independence and risk What does the contract describe? Defined deliverables with acceptance criteria Milestones plus hours Hours or days of availability
9 Independence and risk What ends the assignment? Delivery of the agreed outcome A fixed end date Nothing fixed; it is extended while needed
10 Independence and risk If work has to be redone because of the specialist’s own error, who pays? The specialist fixes it at their own cost Agreed case by case We pay the extra hours
11 Also Expected length, including likely extensions? Up to 6 months 6 to 12 months More than 12 months
12 Entrepreneurship How many other clients has the specialist had in the last 12 months? Three or more One or two None: only us We do not know yet
13 Entrepreneurship 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.
Clearly: most of the above Partly Little or none We do not know yet
14 Also Was the specialist employed by you in the last 12 months? No Yes
15 Also Is the hourly rate below €38 excluding VAT? No Yes Not decided yet
See my result How the check works W measures organisational control and embedding (lower is better).
Z measures independent execution and commercial risk (higher is better).
OP measures the person’s entrepreneurship; it supports independence but never overrides W.
Score the design of the engagement, not the person. Following SOPs, training, access and data-integrity rules is part of GMP and does not count as control.