Pharmaceutical Processing - July 2008 - cResults - (Page 3) July 2008 3 managing efficiency, the QA operation presents a real challenge. QC is closer to a manufacturing function that basically produces test results. However, for many years QA was predominately a compliance organization; its existence was associated with the cost of doing business. Although QA is intended to be independent as per the FDA requirement, that independence should not prevent them from improving efficiency and reducing cost. In fact, improving QA efficiency by removing waste and removing non value added activities can be used not only for cost reduction but perhaps more importantly to enhance the quality standards by providing more resources that formerly performed nonvalue added activities and focus their effort on areas presenting a greater compliance risk. The project team has taken a slightly different approach than with the QC laboratories and selected to establish a software tool to obtain the information which then can be analyzed and used for improvements. This approach was mainly chosen due to the lack of visibility and information availability on the daily activities and output of the QA Group. While manufacturing, packaging and QC information usually are captured in the ERP/LIMS or other home grown systems, QA information is relatively limited. Par, with assistance from cResults and ERD software, implemented a software tool called Compliance Manage Efficiency (cME). This tool provides the platform to manage all QA activities such as audits, inspections, clearances, batch record release, equipment, swabs, and QA standards. The innovative approach supported by cME begins with (1) identifying specific activities performed by QA techs (i.e., batch record review, audit, clearance, and general activities), then (2) associate an expected duration for each of the defined activities. Once the activity is performed, QA techs record the information leveraging tablet PC/desktop and compare the actual duration to its standards. With the information available from cME, the project team is now able to measure QA efficiency and cycle time and provide the needed visibility to its management. Developing trends and inefficiency root causes by various events/incidents are recorded and reported on a regular basis. With the information now available, the operational excellence team has the ability to: * Identify and quantify opportunities for lean six sigma projects by measuring deviation from standard and trends/differences/variability in actual performance. * Continuously measure the impact of ongoing six sigma and lean projects, so benefits can be measured an d corrective actions can be taken. The batch record release was identified as one of the first areas to focus on as it affects the overall supply chain cycle time. The improvement team focused on data collection leading to the following areas: * What is the Right First Time (RFT) (by area/ product)? Figure 3: Building Blocks for an Optimized Batch Record Release Figure 4: Right First Time by Area * What is the QA review cycle time? * What is the Mfg./Pkg. response time to correct documentation errors? * What are the main delays/pending issues causing Batch Record delays? * What is the impact of investigations/CAPA closure on the Batch Record release time? * What is my reviewer’s efficiency? * What is the RFT by QA tech, and what leads to the variability between QA techs? * What are the causes for time losses for my reviewers? * What are the value added reviews/stages throughout the release process? * What is the breakdown of the documentation errors? In addition, the building blocks for an optimized batch record release were identified (Figure 3), and with the use of cME platform, the team has managed to address the root causes for documentation errors, delays such as investigation/Corrective and Preventive Actions (CAPA), waiting for QC results, communication issues, inefficiencies. The improvement team effectively made the needed enhancements in the areas of training, visibility, ownership and accountability by both manufacturing/packaging and quality and increased overall awareness to improve the overall batch record release. A key improvement in manufacturing and packaging response time for documentation correction was the printing and providing a formal docu-
Table of Contents Feed for the Digital Edition of Pharmaceutical Processing - July 2008 - cResults Pharmaceutical Processing - July 2008 - cResults Pharmaceutical Processing - July 2008 - cResults - (Page 1) Pharmaceutical Processing - July 2008 - cResults - (Page 2) Pharmaceutical Processing - July 2008 - cResults - (Page 3) Pharmaceutical Processing - July 2008 - cResults - (Page 4) Pharmaceutical Processing - July 2008 - cResults - (Page 5) Pharmaceutical Processing - July 2008 - cResults - (Page 6)
For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.