SPL FDA ESG Green Belt Project
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The document outlines a green belt project aimed at improving the success rate of SPL submissions from 54.62% to 95% by December 2011, addressing issues with frequent failures at FDA ESG. It includes a detailed analysis of the process capability before and after implementation, showing a significant reduction in defects from 54 to 2, leading to enhanced customer satisfaction and reduced turnaround time. Key milestones and a proposed control plan are also described to ensure ongoing improvements.
SPL FDA ESG Green Belt Project
- 1. Green Belt Project: SPL Conversions Jayprakash
- 2. Define Measure Analyze Improve Control Project Charter BUSINESS CASE ļ¶ This company submitted total 119 Structured Product Labeling documents to FDA ESG from Oct 2009 to Mar 2011, Out of which 65 passed and 54 SPL documents failed the FDA ESG Validation. ļ¶ This higher ratio of failures is affecting the SPL conversion Turnaround time, Productivity, Customer Satisfaction and may result in Loss of Services Contract. PROBLEM STATEMENT ļ¶ The SPL Consulting Team has received numerous grievances from the customer regarding frequent SPL failures at FDA ESG and delayed approvals for their product. ļ¶ Failure to create/convert total compliant SPL ,negatively impacts customer satisfaction and increases cost to both the company business and the customer. GOAL STATEMENT ļ¶ To improve the SPL submission success rate from 54.62% to 95% by Dec 2011 and reduce the SPL conversion Turnaround time to 5 days. SCOPE ļ¶ In Scope ā SPL submissions made by company and Clients (company created SPL documents). ļ¶ Out of Scope - SPL failures due to new FDA guidelines which are not yet implemented and due to invalid information provided by the client . MILESTONES Apr-11 May-11 Timeline Jun-11 Jul-11 Aug-11 04/04 to 08/04 11/04 to 15/04 18/04 to 22/04 25/04 to 29/04 02/05 to 06/05 09/05 to 13/05 16/05 to 20/05 23/05 to 31/05 Define Measure Analyze Improve Control
- 3. Define Measure Analyze Improve Control Capability Analysis PROCESS CAPABILITY AND PERFORMANCE Defect opportunities per Unit O = 1 Number of units processed N = 119 Total number of defects made D = 54 (include defects made and later fixed) Defects Per Opportunity DPO = D/N*O 0.453781513 Yield (1-DPO)*100 54.62 Process Sigma (Short term) Z = 1.6
- 4. Define Measure Analyze Improve Control SPC STATISTICAL PROCESS CONTROL ā SPL DOCUMENT TYPE Before After SPL Document Types SPL Document Types Failed Total Submitted Failed Total Submitted 79 76 41 29 22 14 12 9 4 2 0 0 LCR ERF SPL LCR ERF SPL The number of errors after implementation is reduced
- 5. Define Measure Analyze Improve Control Project Summary PROJECT SUMMARY Define Measure Analyze Improve Control ā¢ Project Charter ā¢ Process Map ā¢ Binomial ā¢ Proposed ā¢ Control Plan ā¢ RACI ā¢ YX Diagram Capability Solution ā¢ Risk ā¢ VOC & CTQs ā¢ FMEA Analysis ā¢ Mistake Proofing Management ā¢ SIPOC ā¢ MSA ā¢ Hypothesis ā¢ Process ā¢ SPC Testing Implementation ā¢ Project ā¢ Project Metrics ā¢ Capability Analysis & ā¢ Vital (X)s Summary ā¢ Project Plan Process Sigma ā¢ 5 WHYs ā¢ Process Capability
- 6. Define Measure Analyze Improve Control Process Capability BINOMIAL CAPABILITY COMPARISON The % of defective items was reduced by 96% from 45.38% to 1.77%.
- 7. Define Measure Analyze Improve Control Process Capability PROCESS CAPABILITY & PERFORMANCE Details Symbols Before After Defect opportunities per Unit O= 1 1 Number of units processed N= 119 113 Total number of defects made D= 54 2 (include defects made and later fixed) Defects Per Opportunity DPO = D/N*O 0.453781513 0.017699 Yield (1-DPO)*100 54.62 98.23 Process Sigma (Short term) Z= 1.6 3.6 By implementing the new proposed solution the process sigma is improved from 1.6 Sigma to 3.6 sigma