After enough years of getting calls from clients when an internal project has gone sideways or an audit has uncovered a problem, you start to hear the same sentence
“I thought they had it.”
It is almost never about a careless person. It is what happens when responsibility changes hands and no one confirms the catch.
Quality assumed Operations had the next step. The sponsor assumed the CDMO was handling it. The site assumed the project team still owned it. The internal team assumed the project lead would carry it across.
Everyone was doing their part. The part between them was the part nobody owned.
That is where real work disappears. Not in a dramatic failure, but in a quiet gap that looks harmless for weeks: a missing approval, a validation decision left open, a supplier commitment nobody verified, or a CAPA action that changed hands but was never formally accepted.
It stays invisible until it gets expensive: rework, a late release, an overdue commitment, a 483 observation, a warning letter, or an inspection question the team cannot answer without reconstructing who was supposed to do what.
A handoff is not finished because someone sent an email or held a meeting. Sending is not the same as receiving.
A handoff is finished when four things are true:
Someone owns the next action, by name.
The required decision or deliverable is defined.
Everyone agrees what evidence will demonstrate completion.
The receiving side confirms it has accepted the work.
That holds whether work is moving between two departments, a company and its consultant, a site and a supplier, or a sponsor and its CDMO. The seam is where the risk hides.
A lot of what we do at MEDVACON LIFE SCIENCES, LLC is make those seams visible before they turn into remediation. Whether the handoff sits inside a CAPA, a validation program, a technology transfer, a supplier relationship, or a sponsor-CDMO model, we identify where responsibility changes hands, clarify decision rights, define the evidence required, and establish escalation paths so ownership does not disappear when the work moves.
Because “I thought they had it” is not a root cause. It is a sign the structure was never clear enough to begin with.
Where have you seen handoffs create the most avoidable risk in regulated work?