{"id":43449,"date":"2021-09-23T09:53:00","date_gmt":"2021-09-23T09:53:00","guid":{"rendered":"https:\/\/kepner-tregoe.com\/about\/case-studies\/a-systematic-approach-to-investigations-yields-rapid-results\/"},"modified":"2026-03-18T10:09:53","modified_gmt":"2026-03-18T10:09:53","slug":"a-systematic-approach-to-investigations-yields-rapid-results","status":"publish","type":"client-success-story","link":"https:\/\/kepner-tregoe.com\/zh-hans\/about\/client-success-stories\/a-systematic-approach-to-investigations-yields-rapid-results\/","title":{"rendered":"Improving root cause investigation efficiency in pharma manufacturing"},"content":{"rendered":"\n

A leading global biopharmaceutical manufacturer sought to improve its root cause analysis and deviation investigation process<\/strong> to achieve greater manufacturing excellence<\/strong>. By implementing the Kepner-Tregoe investigation methodology<\/strong>, the site standardized its approach to problem solving and CAPA investigations<\/strong>, trained cross-functional teams, and achieved a 33% reduction in total investigations within one year.<\/em><\/p>\n\n\n\n

Client<\/h2>\n\n\n\n

This global biopharmaceutical company manufactures prescription pharmaceuticals in several therapeutic areas. The plant implementing this initiative produces solid and injectable pharmaceutical products.<\/p>\n\n\n\n

Challenge: lack of a standardized root cause investigation methodology<\/h2>\n\n\n\n

In a continuous quest to achieve manufacturing excellence, site managers explored opportunities to reduce the number of investigations as well as the number of days required to close their investigations. The plant did not have a standard, systematic approach to finding the root cause of manufacturing deviations. <\/p>\n\n\n\n

In fact, engineers and scientists often relied on trial-and-error approaches that delayed investigations and allowed deviations to recur, since the true cause was not found and corrected. <\/p>\n\n\n\n

Site managers believed that by adopting a formal methodology to ensure faster time to closure on investigations, they would be able to reduce the number of investigations and improve results.<\/p>\n\n\n\n

Response: Implementing a systematic root cause analysis approach<\/h2>\n\n\n\n

After a rigorous evaluation, a decision was made to implement the Kepner-Tregoe root cause investigation methodology. Site managers developed implementation plans around four major actions:<\/p>\n\n\n\n