BIOGRAPHY

Nancy L. Pasquan

Principal, Eyes On, Inc., Escondido, CA, USA

Nancy audits full time, focusing on computer systems and data integrity for pharmaceutical and medical device manufacturers.

Audits include ISO 13485:2016 certification audits, supplier assessments, and internal audits across a wide range of manufacturers, laboratories, and service providers.

She has over 30 years’ experience in software systems development, maintenance, and management on pharmaceutical, medical device, clinical, military, and commercial projects.

She spent years providing computer system validation services and training to medical device and pharmaceutical companies. Nancy holds a BS in Computer Science, holds ASQ CSQE and CBA certifications, and is past Treasurer and Secretary of the ASQ Software Division, past treasurer of the ASQ San Diego section (703), and served on the board of the San Diego Society for Software Quality.

Nancy travels whenever the opportunity arises and can otherwise be found wandering around in the San Diego sunshine.

ABSTRACT

Event Logs to Avoid Lost Issues

There are lost, ignored, or simply forgotten quality issues that only become highly evident when viewed cross-functionally. This fact has been very obvious while performing certification and supplier audits across a wide variety of manufacturers. I have noted many instances of information being lost, ignored, or treated as simply ‘not my problem’.

The unique auditor perspective sees across inter functional silos and permits a more global perspective of what is really happening throughout an organization. Observed instances include internal and external audit findings being lost or forgotten, repeated problems with materials, products, and services, repeated complaints from customers not related to product, and a lack of cross- functional examination for trending and analysis. In this presentation I propose a solution in the form of an Event Log (or Issue Log).

In concept, the log is a simple list of all event types that would be frequently reviewed. An event/ event summation from multiple functions would be dispositioned to the appropriate existing process, such as non-conformance reports, corrective actions (CARs), complaints, return material authorization (RMA), etc. The proposed Event Log allows for an at-a-glance review of the state of an organization. The reviews enable cross functional management teams to have insight into activities and issues occurring across the organization and to find true root causes and prevent recurrence more consistently. When viewed individually, they may appear insignificant. From a corporate viewpoint, the organization may be suffering from a thousand cuts.

The content and function of the Event Log will be described in detail along with examples and plenty of time for questions and stories. Stories include real life examples of problems encountered, as well as examples of how the Event Log helped resolve those problems and provide new views into creating better quality. Take aways will include a sample Event Log form, the process description, sample scenarios, and a list of potential benefits.










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