Breakout Session Abstracts
This page will be updated as the abstracts are received. Check back often.
- Validation or Performance Check – What is Really Necessary? (Richard Remy)
- Root Cause Analysis (Think Reliability)
- Horizontal and Vertical Auditing (Cindy Moran)
- Investigating Complaints (Kris Cano & Lt. Matt Evans)
- Correction vs Corrective Action (Erin Henry)
- Quality System Above and Beyond (Lori Nix & Anastacia Melendy)
Whether it is receiving new instrumentation, creating a new method or modifying an already existing method laboratory personnel sometimes have the confusing job of determining what is required so that an instrument or method can be used on casework. Do you need to perform only a performance check or do you need to do a full blown validation? If you need to do a full blown validation what should you include in that validation? Questions such as these will be answered in this workshop. Attendees of this workshop will learn about the requirements for a Performance Check and Validation. Attendees will also work with peers to learn about and develop a validation plan and then implement that plan to do their own validation. This workshop will use a combination of lecture and hands on training to prepare anyone interested on how to perform exceptional validations and performance checks.
Auditing is a time consuming and difficult task, but it is one of the most important items we do to ensure that we have a good Quality Assurance program. How can we cover everything and not become overwhelmed? How can we ensure that we have consistency between the different disciplines? This session will include discussion on how to incorporate horizontal and vertical auditing. A portion of the session will include participation from attendees on tips and tricks they have learned over time.
There are times when an internal investigation into a quality issue can result in the need for further investigation. We are all familiar with root cause analysis, corrective actions, and preventative actions, but what do you do when there is a question of integrity or negligence? This presentation will provide tools on how to conduct a proper internal investigation using resources inside and outside of the laboratory. An unbiased approach can be used to determine the significance and merit of the compliant based on compliance or violation of established policies. A laboratory and police perspective will be presented with the advantages of partnering with other resources to provide objectivity to your investigation. The presentation will also focus on when the issue becomes a personnel issue and the use of your agency’s human resources department.
This break-out session will be focused on how to avoid making mountains out of mole hills while ensuring that mole hills don’t grow to become mountains. The session will explain the difference between correction and corrective action and when each is appropriate. The session will also include a review and discussion of relevant ISO/IEC requirements (17025 sections 4.9 and 4.11 and 17020 section 8.7). Finally, the session will conclude with Q&A, including a facilitated opportunity for attendees to discuss the policies/procedures in place for correction/corrective action at their own laboratories.
As part of a Quality program, labs regularly require actions that are in excess of legal or accreditation requirements. We will be discussing some common extra requirements implemented by laboratories and the potential pros/cons of requirements above the standard. The goal of this session is to share information as well as spark a dialogue regarding these actions and their benefits/pitfalls.