The first person you pay

The first hire in a supplement business is usually somebody to fill, seal and pack, and the act of hiring forces documentation the rule already expected you to have.

What to hand over

Filling, sealing, labeling, packing and clean-down. Repetitive, dusty, and the bulk of a production day.

Clean-down in particular deserves to be handed over properly rather than left as the leftover task, because cross-contamination between products with different allergens and actives is a real risk in a dusty craft.

The quality unit question

This is specific to 21 CFR 111. The rule expects a quality unit that reviews and approves, and the intent is that it is independent of production.

In a one-person business that is impossible and the practical answer is a documented separation of the activity: the review is a distinct step, done against written specifications, recorded and signed.

The first hire is an opportunity to make that separation real, and it is worth thinking about which role does the making and which does the approving rather than defaulting.

What arrives with an employee

You become an employer with ordinary wage and hour obligations, hours and earnings records, and injury reporting. Supplement manufacturing is not agricultural, so agricultural exemptions do not apply.

Record family help too. Unpaid labor hides the true cost per unit.

Training for a documented craft

Two things a new person must understand. That the written process is the product: blend time, pre-blend steps and sampling points are not guidance, and shortening a blend produces a batch that may not meet specification.

And that recording as you go is part of the work rather than paperwork afterwards, because a record written from memory at the end of the day is not the record the rule expects.

Write the process for somebody competent but unfamiliar, watch them follow it once, and fix the places where it was ambiguous. It always is.

References