"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.

Why ownership sits in the wrong place

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.

Six steps to shared ownership

1. Map responsibilities clearly. Use a simple RACI to set out who is responsible, accountable, consulted and informed for each quality activity, from line clearance to deviation reporting.
2. Agree it, don't impose it. Build the RACI with department heads in a workshop. People own what they help create.
3. Put quality in operations targets. Add measures such as right-first-time and deviations raised on time to operations managers' objectives and appraisals.
4. Equip the shift. Give supervisors clear escalation rules, short visual standards and the authority to stop the line when something looks wrong.
5. Train quality champions. Select respected people on each shift, train them in basic problem solving and make them the first point of contact for quality questions.
6. Recognise the right behaviour. Thank people who raise issues early and fix problems at source. What gets recognised gets repeated.

“When operations owns quality, QA stops being the bottleneck and starts being the coach.”

Craig Jacobs, Founder and Chief Momentum Officer, Affirm8

Show operations what's in it for them

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.

Common mistakes to avoid

• Writing roles nobody reads. A RACI stored in a controlled document and never discussed will be ignored.
• Handing over without support. Moving responsibility without training or tools sets people up to fail.
• Keeping QA as the safety net. If QA quietly fixes everything, operations never has to own anything.

Where to start this week

1. Choose one recurring deviation that costs operations time and frustration.
2. Run a short problem-solving session with the supervisors and operators involved, and let them lead the fix.
3. Agree who owns each quality activity on that line, write it on one page and review it together after a month.

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.

Frequently asked questions

Who is responsible for quality in a manufacturing company?

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.

How do I get buy-in when operations resists?

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.

How Affirm8 can help

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.

Related reading

• How do you get leadership to see quality as a value driver?
• What quality KPIs should a life sciences manufacturer track?