ISPE & PDA Create Guide to Improving Quality Culture in Pharmaceutical Industry

07 October, 2019
Quality Culture - man calibrating pharma equipment


Root Cause Analysis guideThe Parenteral Drug Association (PDA) and the International Society for Pharmaceutical Engineering (ISPE) today announce the joint publication of a guide for Root Cause Analysis (RCA) to help the pharmaceutical industry improve quality culture by providing recommendations for tools, techniques, and processes.

The organizations also announced today that they have signed a Memorandum of Understanding (MOU) confirming their plans to continue to advance practical approaches for quality culture. The first product of this collaboration is the Root Cause Analysis guide, which will assist the pharmaceutical industry in evolving and identifying best practices, tools and appropriate references for root cause analysis. The Memorandum of Understanding leaves open the possibility that the organizations could directly collaborate on additional topics in the future.

The organizations selected Root Cause Analysis as the first topic in this undertaking as root cause analysis forms a significant part of any organization’s continuous improvement program. The lack of rigor applied to identifying the true root cause of failure events often leads to situations where the causal factors or effects of a given failure are identified and corrected, rather than the underlying cause. These symptoms of failure are often more visible and easily reported, while the actual root cause(s) of the problem may go unaddressed. This practical guide identifies a range of RCA tools along with recommendations for their application in the search for true root cause.

Please review the Root Cause Analysis guide and the Parenteral Drug Association.