Hot-Link Gary Stanley Workshop September 2012

Purpose Provide Users with information on MRL criteria and why it is important Provide Users with information on MRL criteria and why it is important To address users’ requests for more help/ information on criteria definitions and meaning To address users’ requests for more help/ information on criteria definitions and meaning Provide insight into systemic/significant problems being seen in this area Provide insight into systemic/significant problems being seen in this area Share Lessons Learned in achieving this criteria Share Lessons Learned in achieving this criteria Help users implement MRLs and perform assessments of manufacturing risk and readiness

Operational Guide The user will click on an individual cell of the Matrix The user will click on an individual cell of the Matrix Clicking on a cell will activate a mega-data sheet pop-up window with pertinent information Clicking on a cell will activate a mega-data sheet pop-up window with pertinent information The mega-data sheets will be under MRL Working Group control The mega-data sheets will be under MRL Working Group control Content Content Configuration Configuration

Mega-Data Proposed Format Identification of the MRL Cell with text Identification of the MRL Cell with text Background Background Goal Goal Rationale for the requirement Rationale for the requirement Definitions (if applicable) Definitions (if applicable) Sources of Information Sources of Information Questions from MRL questionnaire (plus other pertinent questions derived from lessons learned) Questions from MRL questionnaire (plus other pertinent questions derived from lessons learned) Lessons Learned Lessons Learned

Today’s Objective Provide Feedback/Recommendations Provide Feedback/Recommendations The merit of this approach and capture issues/concerns The merit of this approach and capture issues/concerns Adequacy of the format/content Adequacy of the format/content Reach a agreement on way forward Reach a agreement on way forward

Proposed Implementation Schedule Agree upon format – Target Today Agree upon format – Target Today Populate as many cells as possible before the DMC Populate as many cells as possible before the DMC Demonstrate at DMC Demonstrate at DMC Place on Web Site in October Place on Web Site in October Propose to release in increments Propose to release in increments Configuration control maintained by version designator (e.g., V , , etc) Configuration control maintained by version designator (e.g., V , , etc) Finishing/Improving Hot-Link will be a focus area for MRL working group 2013 Finishing/Improving Hot-Link will be a focus area for MRL working group 2013

Summary Today Today Capture issues/concerns Capture issues/concerns Agree upon format Agree upon format MRL Working Group will Assign OPRs to prepare draft mega-data MRL Working Group will Assign OPRs to prepare draft mega-data The mega-data sheets will be under MRL Working Group control The mega-data sheets will be under MRL Working Group control Content Content Configuration Configuration Inputs/changes/issues to mega data worked through Service/Industry Focal points on MRL Working Group Inputs/changes/issues to mega data worked through Service/Industry Focal points on MRL Working Group

Art - Demonstrate Tool