Many laboratories struggle with developing and implementing a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs. Once accreditation has been achieved many laboratories have difficulty maintaining the QMS as evidenced by the number of non-conformances cited during the subsequent biannual audits.
A review of basic AAA analysis. Will cover the 3 basic types of agreements: Agreement with oneself, Agreement to a peer, Agreement to the standard. Both the "Statistical AAA" and the Kappa value will be reviewed. Confidence levels for the result bands will also be reviewed. Incorporation of AAA into the Control Plan and frequency of "calibration" will be reviewed.
Pre-Control is easier than SPC! With no control limits to calculate and go/no go colored zones, this control tool can rapidly help to reduce process variation. Participants will observe a modeled session that both develops and runs a Pre-Control chart.
If you are constantly struggling to create, manage, and maintain all of the information found in Design Inputs, Design Outputs, and traceability matrices, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.
This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/CAPA system and thorough investigations. The deviation process is explored and evaluated and examples are given to demonstrate the best way to handle deviations and subsequent CAPAs. Attendees will have the opportunity to interact and ask questions about best practices regarding both devotions and the CAPA process. Reasons for having a robust deviation process are given with examples.