Quality control data collection forms

Documentation of data origin is essential. Each completed data collection form needs to contain a file reference number or code to connect it to the documentation sources. This provides an essential trail to audit data quality, to confirm risk or reliability estimates or to investigate data values that appear questionable. Procedures to control data during handling, processing, recording, and reviewing are also necessary to prevent loss of data and to assure that opportunities are not lost to check the content of a form, by... 

Quality assurance programs are designed to serve two functions (1) assessment of collected air quality data and (2) improvement of the data collection process. These two functions form a loop as air quality data are collected, procedures are implemented to determine whether the data are of acceptable precision and accuracy. If they are not, increased quality control procedures are implemented to improve the data collection process. 

In addition, the U.S. Department of Health and Human Services (HHS) and other federal agencies formed the Quality Interagency Coordination Task Force in 2000 and issued an action plan for reducing medical errors. In 2001, former HHS Secretary Tommy G. Thompson announced a Patient Safety Task Force to coordinate a joint effort to improve data collection on patient safety. The lead agencies are the FDA, the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, and the Agency for Healthcare Research and Quality. 

The following discussion will focus on how to apply the previously discussed concepts to the validation of marketed products. To provide a fuller understanding of this procedure, the manufacture of several dosage forms designed for different routes of administration will be examined. For each dosage form, critical process steps and quality control tests will be identified. Useful statistical techniques for examining the assembled data will be illustrated. It is also important to note that not all of the collected information for a product lends itself to this type of analysis. This will become more apparent as we proceed with the evaluation of the five drugs under consideration. 

Subcontractor/supplier performance will be evident from audit reports, surveillance visit reports, and receipt inspections carried out by you or the third party if one has been employed. You need to examine these documents for evidence that the subcontractor s quality system is controlling the quality of the products and services supplied. You can determine the effectiveness of these controls by periodic review of the subcontractor s performance what some firms call vendor rating . By collecting data on the performance of subcontractors/suppliers over a long period you can measure their effectiveness and rate them on a scale from excellent to poor. In such cases you should measure at least three characteristics quality, delivery, and service. Quality would be measured by the ratio of defective conforming products received delivery would be measured by the number of days early or late and service would be measured by the responsiveness to actions requested by you on scale of excellent to poor. The output of these reviews should be in the form of updates to the list of assessed subcontractors/suppliers. 

It takes a lot more than just connecting an IR instrument to a pipe to make the instrument into a process analyzer. The system not only has to be constructed correctly and be capable of flawless operation 24 hours a day, but it also has to be packaged correctly, and be able to access the stream correctly and without any interference from process-related disturbances such as bubbles, water, particulates, etc. Finally, the data acquired from the instrument has to be collected and converted into a meaningful form and then transmitted to the process computer, where the information is used to assess the quality of the product and to report any deviations in the production. Beyond that point, the process computer, typically not the process analyzer, handles any decisions and control issues. There are a few exceptions where robotics are integrated with the analyzer, and good vs. bad product quality are assessed at the point of measurement. The use of... 

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