The table below provides some examples of analyses and follow-up actions from real practices. Your team, stakeholders and patients will be eager to learn more about your successes. Write up a brief summary of the quality improvement initiative and its results. Present a summary of the report during a lunch time meeting and celebrate your successes.
QAI performs the following duties: Maintain the master schedule of in-house studies. Maintain a QAU file of all studies, with a copy of the protocol and of all audit reports. Review all protocols before approval. Perform all in-phase inspections, data audits, and report audits for all studies performed by the laboratory.
Issue the QAU statements. Assure distribution of audit reports to study directors and testing facility management, when appropriate. Maintain all personnel training files. Maintain the electronic database from which all electronic SOPs are accessible.
Advise laboratory personnel in improving data collection forms, substances, reagents, and solution databases, report presentation, etc. Perform specialized GLP training of laboratory personnel. It needs an in-house Quality Assurance Unit, but does not expect to be able to keep a person occupied full time.
QAI is generally on-site at this company three days per week, but only as long as needed to assure the functions of the QAU. Revise the entire SOP manual.
Review and revise other SOPs as needed. Improve data collection forms. Maintain the QAU study files, including a copy of the protocol, a master inspection log for each study, and all inspection reports.
Conduct protocol reviews, in-phase inspections, data and report audits for all studies performed by the laboratory. Signs the QAU statement in study reports. Review equipment qualification data; advise on appropriate design of qualification testing. Advise management and scientists on improvements needed to the Quality System.
Establish archive for study data. Train the designated archivist.Quality Associates - QA provides consulting services in the area of Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) to regulated companies and government agencies. It specializes in quality assurance, and also provides scientific support for the conduct of regulatory studies.
Essay about Case Problem Quality Associates, Inc. Words Apr 6th, 3 Pages. Show More. Critical Case Study Assignment Maurine Shaughnessy GEN/ Paul C. Moretti, M.B.A. September 12, I am the newly hired Vice President of Organizational Development.
My responsibilities include creating the Organizational Development Department. About Us We help our clients perform better Established in the year , KS Madhavan & Associates was started with a focus to add value to the industry through continuous improvement in systems, work processes and people abilities contributing to the organisational growth.
Case Studies. Some real-world examples of how manufacturers are using quality tools and processes to improve their work and the bottom line. Supply Chain Techniques Applied to Six Sigma Saves SeaDek Marine Products $, Scribd is the world's largest social reading and publishing site.
Case Studies SOP Development. The Department of Pharmacology of this University had used the services of Quality Associates for GLP training several years in a row.