Medical Device made Easy Podcast

← Medical Device made Easy Podcast17 sept · 57 min

Why Management Doesn’t Listen to Quality—and How to Change That

Why Management Doesn’t Listen to Quality—and How to Change That17 sept57 min

Quality and Regulatory professionals often find themselves in a frustrating position.

They identify a problem, explain the compliance risk and recommend an action. But instead of being seen as protecting the organization, they can become perceived as the people creating obstacles.

Operations sees a delayed project. Finance sees additional resources. Management sees another problem that needs to be solved.

Over time, this dynamic can leave QA/RA professionals frustrated, isolated and exhausted.

But the problem isn't always management.

Sometimes, the way Quality operates can unintentionally contribute to that isolation.

When Quality Owns Everything

Consider a nonconformity that occurs in Production.

In some organizations, Quality opens the record, writes the description, gathers the evidence, conducts much of the investigation, pushes for the root cause, proposes the corrective action and follows the issue until closure.

The problem happened in Production—but Quality performed almost all the work.

The organization eventually learns a dangerous lesson:

“When something goes wrong, send it to Quality.”