I've spent the last month writing about quality systems. A CAPA that sat unfixed for three years. A machine guard that was never installed. A supplier inspection that caught a defect in four cars before anyone got hurt.
Every one of those stories came down to one thing. Whether a person did their job or didn't.
That's the part nobody talks about. Your quality system isn't a set of documents. It's a person. Usually one person. Sometimes that person also covers safety. Sometimes they also cover environmental. Sometimes they're also the one who handles customer complaints, manages the document control system, runs internal audits, preps for external audits, trains new hires on procedures, and still gets pulled into production meetings because they're the only one who knows where the data lives.
A recent study found that manufacturing professionals spend up to 20 hours a week just on data activities. Finding information. Chasing down records. Reconciling numbers across systems that don't talk to each other. Twenty hours. That's half a work week before the real work starts.
Forty-one percent of procurement professionals, 50% of engineering professionals, and 54% of sales professionals spend one to two hours every day just tracking down critical information. Some spend more than four.
These numbers don't even capture what happens inside a quality department. Your quality manager is doing all of that plus maintaining the QMS, plus responding to nonconformances, plus running root cause analyses, plus keeping the CAPA log from falling apart.
And here's the risk nobody puts on their risk register. What happens when that person quits?
Not if. When.
I talked to a shop owner earlier this year who told me his quality manager had been in the role for eleven years. Knew every customer spec by memory. Knew which operators needed extra oversight. Knew where every document lived. Then she left. Took a job closer to home. Two weeks notice.
It took them four months to hire a replacement. During those four months, three customer complaints went unresolved for weeks because nobody knew the process. An internal audit got postponed. A CAPA that was supposed to close in January was still open in May because nobody could find the supporting documentation.
The quality system didn't fail because of bad procedures. It failed because the entire system lived inside one person's head.
This is a single point of failure. In engineering, we would never design a system that depends entirely on one component with no redundancy. But that's exactly how most shops run their quality programs.
If your quality manager got hit by a bus tomorrow, how long would it take someone else to run an internal audit? To close a CAPA? To pull the records for a customer audit? To even find the current revision of your quality manual?
If the answer is "I don't know," that's not a staffing problem. That's a systems problem. And it belongs on your risk register right next to your critical equipment and your key suppliers.
One Thing to Try This Week
Pick one thing only your quality manager knows how to do. Just one. The one that would cause the most pain if they were out for two weeks. Document it. Not a 30-page procedure. A one-page checklist that someone else could follow. If you can't write it down in under a page, the process is too dependent on tribal knowledge.
What I'm Reading
Sedgwick's 2026 State of the Nation report found that 858 million defective units were recalled across U.S. industries in 2025. That's up 26% from 681 million the year before. Consumer products hit their highest recall count in 18 years. The interesting number for quality teams: the consumer products sector recorded 414 recall events, the most in over a decade. The regulatory environment is getting tighter, not looser. If your documentation and traceability systems depend on one person's memory instead of an actual system, you're carrying more exposure than you think.