Expert: Increase Quality Staff When Outsourcing

Although manufacturers often look at outsourcing as a reason to shrink their quality assurance (QA) staff, they should do exactly the opposite, an expert recommends.

Martin Browning, president of EduQuest, an FDA-compliance consulting firm, said when companies outsource, the QA department should expand so it can monitor outsourcing activities.
 
Hiring more QA staff is “not an unusual thing, but it typically, unfortunately, occurs as a result of a correction or a corrective action — after a problem has occurred,” Browning said during an FDAnews audioconference.

“All too often … we outsource some process, and we think, ‘Well now we don’t need those three or four quality assurance people to handle that for us because our outsource partner is doing that,’” he said.

He cited a recent case in which a devicemaker was fined $2.2 million for GMP violations involving outsourcing.

Browning said firms can expect the FDA to look harder at how outsource companies are evaluated, how they’re selected and how auditing and monitoring processes are carried out by the manufacturer.