Experts: Quality Culture a Difficult But Necessary Metric to Measure

In the next few years, drugmakers will have to collect quality metrics data for FDA investigators to use in determining a facility’s quality status. Metrics being bandied about include batch failure rates, CAPA rates, complaints and right-first-time rates.

One key indicator of quality, however, may be much harder to measure: a facility’s culture and approach to quality.

“There are no one or two things,” says Steven Niedelman, lead quality systems and compliance consultant for King & Spalding’s FDA and life sciences practice team. A quality culture “should be something that goes beyond meeting the minimum requirements.”

The FDA will publish draft guidance this year outlining the quality metrics it wants durgmakers to collect. The agency has flirted with including quality culture metrics on the list, but no firm choices have been made.

Quality culture is an important area to measure. “It is persistently cited by companies as one of the leading contributors to quality and compliance risk,” according to a quality metrics report from the consulting firm McKinsey & Company.

McKinsey recommends companies measure five areas to get a good pulse on a facility’s quality culture: leadership, mind-set, governance, capabilities and risk attitude.

Each would have a specific set of dimensions that could be measured. For example, the leadership metric could include dimensions such as whether the leader prioritizes quality issues when taking business decisions and communicates the importance of quality to employees.

These dimensions could be measured through a standard employee survey on an annual or biannual basis, the report says.

Pharma companies can also look to other industries for quality culture tips. The automotive industry, for instance, conducts daily quality reviews where participants on the manufacturing floor review defects that occurred over the previous 24 hours, analyze one “easy to fix” problem, derive a single lesson learned and define a countermeasure.

“This approach instills a new way of solving quality problems and establishes the routine of fixing at least one problem day after day,” McKinsey says.

The FDA has hinted that it will measure quality culture in some form or another. However, officials haven’t specified which indicators the agency could use.

One such indicator is whether employees feel they can tell managers of a quality problem without being reprimanded, says Mary Malarkey, director of CBER’s Office of Compliance and Biologics Quality.

Other culture metrics floated by the agency include how a company decides to launch a CAPA and the seniority of the executive who signs off on an annual product review.

Stay up to date on quality stories like this one by subscribing to Drug GMP Report. For over 20 years, drug manufacturers have relied on DGR for the latest on FDA’s interpretation and enforcement of cGMPs and the Quality Systems Regulation — information you need to stay in compliance.