right first time 1 method 1 on the shop floor. right first time 2 when should we use method 1?...
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Method 1 onthe Shop Floor
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When should we use Method 1?
• Excellent starting point for most investigations.
• When something ‘unusual’ happens– This is called a Special Cause.
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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
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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 State Eliminate the problem of chipped and/or broken vials, needle strikes and bent or
broken needles.
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Number of Needles Replaced Jan 2006 - Dec 2007
05
101520253035404550
1/1/2006 4/11/2006 7/20/2006 10/28/2006 2/5/2007 5/16/2007 8/24/2007 12/2/2007
Date
Nu
mb
er o
f N
eed
les
There were 202 needle replacements over the last two years. Of those, 120 (~60%) were outside of scheduled preventative maintenance replacements.
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The group identified several potential causes using brainstorming and Cause & Effect analysis.
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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.
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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.
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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!!!
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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.