The short answer
Make quality part of the operations job. Agree clear responsibilities with department heads, build quality objectives into operations targets, give supervisors the tools to make quality decisions on the shift, and train quality champions on the line.
"That's Quality's job." Few phrases frustrate a Quality Director more. When operations sees quality as a service provided by the QA team, every deviation becomes a hand-off, every decision waits for a signature and the QA team becomes a bottleneck. The quality system cannot perform if only one department owns it.
Ownership usually drifts to QA for understandable reasons. Quality teams are the experts, so it is quicker to let them decide. Operations targets focus on output and cost, so quality feels like someone else's measure. And when roles are unclear, responsibility defaults to whoever signs the paperwork.
Regulators see it differently. GMP and ISO standards place responsibility for quality on the people who make the product and on the management who direct them. The QA team oversees the system. It cannot be the system.
“When operations owns quality, QA stops being the bottleneck and starts being the coach.”
Craig Jacobs, Founder and Chief Momentum Officer, Affirm8
Ownership grows fastest when people see that quality makes their day easier. Share the numbers: fewer deviations mean fewer investigations pulling people off the line, less rework means more capacity, and faster batch release means happier customers and fewer planning headaches. Frame quality as a way to hit output targets, not a threat to them.
A shared win on a real problem does more for ownership than any new procedure. Once operations sees a problem solved at source, with less paperwork and fewer delays, the conversation about wider responsibilities becomes much easier. Build from that success, one line or one department at a time.
Everyone. Senior management is accountable for the quality system, operations is responsible for making the product right first time, and QA provides oversight and independent release.
Start with a shared problem that costs operations time, such as a repeat deviation, and solve it together. Early wins build trust faster than new procedures.
Affirm8 helps quality and operations leaders across pharmaceuticals, supplements, medical devices and cosmetics define quality roles, align departments and build high-performing teams where quality is everyone's job. Find out where you stand with the free Always Audit-Ready Diagnostic at affirm8.co.uk.