1. Right First Time 1 Method 1 on the Shop Floor

2. Right First Time 2 When should we use Method 1? Excellent starting point for most investigations. When something ‘unusual’ happens –This is called a Special Cause.

3. Right First Time 3 How do we do the M1? Who Should be Involved? M1 Investigations are usually performed by a small group (1 to 3). We must include those colleagues who routinely work in the process! Use DMAIC Define Measure Analyze Improve Control

4. Right First Time 4 Example: Bent Needles on a vial washer What?Needles on Line 9 vial washer striking vials causing bent needles and chipped vials. When?Dec 2007 Who?Operations, Maintenance, QA Significance?6902 vials rejected and potential for more in the future if problem is not resolved. Desired StateEliminate the problem of chipped and/or broken vials, needle strikes and bent or broken needles.

5. Right First Time 5 There were 202 needle replacements over the last two years. Of those, 120 (~60%) were outside of scheduled preventative maintenance replacements.

6. Right First Time 6 The group identified several potential causes using brainstorming and Cause & Effect analysis.

7. Right First Time 7 Potential Root Cause Action to confirm Carrier chain stretched.Inspect and measure chain, replace if needed. Too much slop in carrier hole Develop prototype, install & functional test. Needle holes too big due to design update. Review Part and drawing history.

8. Right First Time 8 Confirmed Root Cause Control Plan Carrier chain stretched.Include measurement and replacement in PM. Too much slop in carrier hole New vial carriers implemented. Needle holes too big due to design update. New guide manifold implemented.

9. Right First Time 9 What is a Yellow Belt? A “Yellow Belt” is someone who has demonstrated the use of the RFT Method 1 tools and received certification. Who can apply for certification? All Pfizer Colleagues!!!

10. Right First Time 10 What are the Qualifications? 1.Complete M1 training. 2.Use the M1 tools to solve a problem or perform an investigation. 3.Submit your completed documentation.