GHTF Asks Devicemakers to Have a Plan Before QMS Investigations

Before investigating an existing or potential nonconformity, a devicemaker should have a documented plan in place, a final guidance from the Global Harmonization Task Force (GHTF) advises.

The plan should include resources, time frame, a description of activities to be performed, methods and tools, the investigation team and their responsibilities, and the scope of the investigation, which should be in line with the determined risk of the nonconformity. The plan also should describe the nonconformity in a problem statement.

Released by GHTF last month, the quality management system (QMS) guidance finalizes a draft that was released in 2009. The final document makes a few changes to the draft, including the recommendations for the investigation plan.
The GMP Letter