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Successfully Achieving And Delivering Results Through Rigorous Project Selection Tools 10th Iqpc Lss Conference
1. Successfully Achieving and Delivering Results through Rigorous Project Selection Tools 10 th Lean Six Sigma for Pharmaceuticals and Biotech and Medical Device Excellence Conference Jeff Cisneros, PT Biologics OE Manager Shawn L. Carner, Oceanside OE Manager July 26-28, 2010
12. Page Page Portfolio Management Process Detail A3 methodology
13. The 2x2 Project Type Selection Map Page NARROW ENGAGEMENT NEEDED BROAD LOW COMPLEXITY/RISK HIGH EXPERT STUDY PROJECTS Break the log jam on complex problems by verifying causes and solutions through statistical analysis (FCT and DMAIC Project) Functional Core Teams (FCT) Projects requiring longer than a week to complete, functional in nature but may require coordination with supporting functions like engineering, automation, QA etc.. Scope sheet needed. BREAKTHROUGH PROJECTS Redesign core processes and systems by engaging cross-stakeholder teams in the application of lean and innovation principles (IMPACT and DMAIC Project) Projects requiring longer than a week to complete, Highly cross-functional in nature, may require Capital allocation , Scope sheet prioritized through the FCT teams. LEADERSHIP DECISIONS Generate momentum and maintain motivation by taking "Just-Do-It" decisions off of the waiting list (Management Decision) RAPID ACTION PROJECTS Improve operating performance by engaging employees closest to the action with a disciplined approach to tapping existing know-how and experience (Kaizen) When is it appropriate to apply Kaizen? Projects to be completed within 1 week – significant pre-work may be needed. Process has an observable cycle time -Process occurs frequently – Kaizen particularly useful when a step change is needed in a process .
18. Rank the solutions or projects Page Page Project Example Recommended Remediation V--xxxx Root Cause Best Practice / robustness (preventative) Return to validated state Easy Cheap High profile concern CAPA or Quality requirement Cosmetic No Impact to Actemra project Rank ( Highest = Best Solution) crack remediation (DCI) 10 10 10 10 5 10 10 1 10 9.7 Standardize Steam trap internals 1 5 1 5 5 1 10 1 10 3.4 Correct slope issues 8 10 10 10 5 7 1 1 10 8.0 Modify pressure hold boundries and procedure 4 10 1 1 10 7 1 1 10 5.0 Remove atomizer XV-071 6 7 1 1 5 10 1 1 10 5.3 Add TE to atomizer trap line (CIPS header low point drain) 1 5 1 1 5 1 1 1 10 2.5 Replace antifoam addition line 1 1 1 1 5 10 1 1 10 2.7 Antifoam subsurface to surface 1 1 1 5 5 1 1 1 10 2.1 Replace feed and batch media filter bases (improve tolerance) 2 10 1 1 5 5 1 1 10 3.9 Upgrade feed/batch media filter bases to tapered tabs 1 10 1 1 1 5 1 1 10 3.5 Obtain and use (plastic?) filter stabilizers 1 10 1 10 10 5 1 1 10 4.2 Pressurize gas filters post SIP 1 10 1 1 10 1 1 1 10 3.4 Change cool down ramp of jacket temperature 1 1 1 5 10 1 1 1 10 1.4 Change WFI flush liquid filter drain path 5 10 1 1 10 1 1 1 10 4.8 Close XV-63 during media filter SIP 1 10 1 5 10 1 1 1 10 3.6 Add double block and bleed on CIP supply header 1 10 1 1 1 1 1 1 5 2.7 Post vessel SIP flag sample lines as clean not steamed 1 10 1 5 10 1 1 1 10 3.6
19. How are Operational Excellence projects selected Page 1. VSM 2. Brainstorm 3. Criteria-Based Ranking Activities with highest NVA time or wastes or directly to the areas that will benefit specific goals 4. Cost/Benefit Matrix FTE in Kaizen week
SLIDE The 4-Box Project Map, highlights four improvement project domains each with different outputs, inputs and processing requirements.
Show example filled in? Your team will need to brainstorm its own list of criteria. As a starting point, here is a checklist of common criteria used to evaluate proposed changes or solutions. Which root causes are attacked, and to what extent? What is the cost? What are the potential benefits? How easy will this be to implement? What are the potential problems? How easy will it be to prevent or remedy side effects ?
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