Investigation System Assessment and Improvement

  • Overview
  • Benefits
  • Why Work With NSF?

Investigation system assessment may be required to determine underlying weaknesses in the procedures and methods followed to triage incidents, conduct thorough investigations, and identify and close out CAPAs. Our quality systems experts have years of experience evaluating investigation and CAPA programs for companies, so you can trust us to get the job done right. Our objective is not to burden you with an overly complex investigation and CAPA program, but to right-size the program so that the system facilitates quality improvement for your company.

Our approach is tailored to your company size and technology. The needs of a large company seeking to improve or remediate an investigation program are typically very different from the needs of a smaller company. The nature of the product and process, and ultimately patient risk, varies depending on the product, dosage form and manufacturing process. Our investigation assessment takes these factors into consideration to design a risk-based program that keeps patient safety in focus.

Benefits

Our team of former U.S. FDA employees and industry executives brings unique and well-versed understanding of investigations and CAPAs to the pharmaceutical, biologics and biotechnology industries. We communicate our recommendations for improving your investigation and CAPA program in a way that ensures the changes can be implemented in the context of your company. We do not simply turn over a summary report, but are available to help implement the improvements if requested.

Why Work With NSF?

This case study illustrates the benefits of working with NSF. A state agency responsible for blood collection and production was facing a national crisis in collection levels and risking not being able to meet hospital demand for blood. NSF was asked to facilitate a problem-solving process involving experts in departments across the client’s organization including Quality, Donor Relations, Marketing, Human Resources, Finance and Legal.

Objectives

The project team’s objective was to analyze the national and local trends across the various collection channels and identify short- and long-term actions to increase donations and meet hospital demand for blood. Subteams were formed to implement immediate actions and measure the effectiveness of each workstream. NSF’s role was to facilitate the sub team activity using an investigation and CAPA process.

Approach/Methodology

We used analysis tools to identify potential root causes for the trends observed across the blood collection channels. We helped organize the subteams to use a multi-voting process to prioritize the contributing factors to the national blood collection problem and to develop action plans to address the primary contributing factors. Following endorsement by senior leadership, the subteams began implementation and tracking of the immediate actions.

Outcomes/Benefits to Client (ROI)

The immediate actions we led to implement averted a national appeal for blood collection and helped to re-establish blood supplies to a normal level. Our problem-solving process identified longer-term actions to improve marketing, communications and operations at customer service centers and collection centers, which all indirectly contribute to the blood collection levels. Our investigation and CAPA process confirmed the value of a methodical and inclusive approach to troubleshooting a large-scale issue involving experts across the organization.

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