Quality System Vision

Presentation Abstract

In regulated industries, an effective Quality System with clear, concise, consistent procedures, work instructions and processes is critical to avoid risk, legal, and compliance issues. Creating new Quality System documentation, managing changes, or making updates requires thorough knowledge of users and linked processes. Even with an effective Quality System in place, some new and seasoned users do not know how to use documentation tools or how to navigate document control systems. Additionally, some users do not know how to find the information needed to do their work, or how to identify linked processes affecting their work.

Our organization is a Class I and II Medical Device Division performing Design and Manufacturing activities. The organization is comprised of engineers and support staff at varying levels of experience. Users specific to the Quality System include: Quality System Analysts, Technical Writers, Subject Matter Experts, Document Owners, and End Users.

Two years ago, we created a Quality System Vision. The Quality System Vision represents a three to five year phased plan addressing two main issues: proactively transitioning into a new Product Lifecycle Management System, used for Document and Record Control; and, the converting the Quality System into XML/DITA to address user needs. To create the Quality System vision we identified system and process requirements. Then, to address user needs and the use of XML/DITA, we embarked on a series of time studies, user surveys, process mapping sessions, cost analysis, user stories, and case studies.

The Quality System Vision phased plan was presented and accepted in 2015. The presentation prompted reorganization efforts to combine two teams and three functions into one Content Management team. The teams combined included: Quality System, Document Control, and Technical Publications. The Technical Publication Writers have been using XML/DITA since 2012. The Quality System Vision phased plan is currently in the first of four phases.

Upon completion of the fourth phase, end users will be able to use keyword searching to identify Quality System elements in the Product Lifecycle Management system. End users will also be able to use the Organization’s Intranet to access shape data enhanced work flows, built from Quality System process audits and a custom template, ensuring they know each step of their work and that they produce consistent documentation. Quality System Analysts and Subject Matter Experts will be able to quickly query the Product Lifecycle Management system document libraries to identify linked processes improving project management and reducing project documentation costs. Technical Writers will be able to make universal changes in an XML authoring system using DITA maps reducing costs, ensuring efficient translation processes, and reducing delivery times.

What can attendees expect to learn?

This presentation will benefit an audience, especially those from heavily regulated industries, seeking additional ways to: engage users, understand user experience, and develop tools to glean better information from users. The presentation will also outline how to implement user experience/needs improvements into a phased approach.

Meet the Presenter

Kirsten Peterson currently works as the Sr. Quality System Analyst for Stryker Medical, a Division of Stryker, in Portage, MI. In 2006, Kirsten earned a MLIS from Simmons College (Boston, MA), where she focused on International Librarianship, Preservation, and Information Access. Previous to her current position, Kirsten worked as an Acquisitions Librarian, a Requirements Analyst, and a Manager. She has 16 years experience in Medical Device, Legal, Information, Publishing, and Government organizations.


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