Process Development and Manufacturing Strategy

1. © John Glenning 2008© John Glenning 2008
John Glenning's ProcessJohn Glenning's Process
Development-Development-
Manufacturing StrategyManufacturing Strategy
John GlenningJohn Glenning
December 2, 2008December 2, 2008

2. © John Glenning 2008© John Glenning 2008
Process Development-ManufacturingProcess Development-Manufacturing
StrategyStrategy
Process Development Philosophy:
1. Resolve critical problems
Eliminate all problems that cause the product to fail during the manufacturing
process or prevent the product from operating functionally
2. Meet product specifications
Successfully build early hardware for the down stream processes and allow for
product testing
3. Eliminate precision problems
Minimize variability in the incoming material and the manufacturing processes in
space and time
4. Optimize the manufacturing process using Designed Experiment
• Optimized Conditions (eliminate accuracy problems)
• SPC
Measure all process parameters and mid-stream product parameters to
identify product variables to control chart and the process variables to adjust

3. © John Glenning 2008© John Glenning 2008
Process Development-ManufacturingProcess Development-Manufacturing
StrategyStrategy
Process Development Philosophy:
5. Develop High Manufacturing Capability
Improve the Cp & Cpk for all final product variables at all locations to 2.0 or
greater
6. High Yields
Cp & Cpk for all final product variables at all locations to 2.0 or greater directly
lead to high yields.
7. Eliminate Mass Inspection
Cp & Cpk for all final product variables at all locations to 2.0 or greater allows for
eliminating mass inspection and replace with sample inspection
8. Qualify the manufacturing process
Stress the manufacturing line by building more product to tighter standards over
a shorter period of time. This will identify manufacturing problems that may
occur during full scale manufacturing

4. © John Glenning 2008© John Glenning 2008
Process Development-ManufacturingProcess Development-Manufacturing
StrategyStrategy
Process Development Philosophy:
9. Reduce Cycle Time
Find sources in process set-up, manufacturing operations and process
breakdown & clean-up that hurt capacity utilization
10.Improve Equipment Up-time
Develop a preventive maintenance plan that addresses sources of equipment
crashes and be prepared to do preventive maintenance during unplanned
downtime
11.Reduce Manufacturing Costs
Identify and qualify alternative incoming materials that maybe used, adjust the
processes to allow for increased manufacturing speed without sacrificing quality
and look for opportunities to reduce the manpower to operate the equipment

5. © John Glenning 2008© John Glenning 2008
Process Development-ManufacturingProcess Development-Manufacturing
StrategyStrategy
Process Development Philosophy:
• Consistently track key manufacturing metrics
• Capability (Quality)
• Cycle time
• Equipment up-time
• Total Manufacturing Cost
Incoming material, capital depreciation, labor, maintenance and
engineering support
• It cost 10 times more to solve problems in manufacturing than in
development and it cost 10 times more to solve problems in development
than in research
The earlier problems are identified and resolved, the less it costs the
business

6. © John Glenning 2008© John Glenning 2008
Process Development-ManufacturingProcess Development-Manufacturing
StrategyStrategy
Process Development Philosophy:
• Capability is the standard to determine the ability of the manufacturing
process to build the product so it consistently meets customer
specification. This needs to be done for all specified product features by
location
• Cp = (USL – LSL)/6σ & Cpk = lesser of (USL - µ)/3σ and
(µ- LSL)/3σ
• Cp & Cpk < 1.00: Process is “Not Capable”
• Cp & Cpk ≥ 1.00 for features at all locations: Process is “Capable”
• Cp & Cpk ≥ 2.00 for features at all locations: Elimination of mass
inspection
• Cp & Cpk ≥ 3.00 for features at all locations: World Class
Manufacturer

7. © John Glenning 2008© John Glenning 2008
Process Development-ManufacturingProcess Development-Manufacturing
StrategyStrategy
Process Development Philosophy:
• Repeatability Studies for both product and process measurement systems: Is the
measurement error significantly less than the differences you are trying to detect?
• When problems are identified, determine if they are accuracy or precision
problems. This is critical because the solutions are different.
Accurate but not precise Precise but not accurate
• Cp & Cpk will help to identify the accuracy & precision problems
• First solve the precision problems because they can mask accuracy problems
• Consistent incoming material in space & time
• Minimize process variability in space & time
• Designed experiments are excellent at solving accuracy problems

8. © John Glenning 2008© John Glenning 2008
Process Development-ManufacturingProcess Development-Manufacturing
StrategyStrategy
Process Development Philosophy:
• Understanding Manufacturing Processes
• Hold your suppliers to meet your material specifications in space & time
• Track & identify incoming material lots to your product
• Retain samples of incoming material for future analysis
• Capture time-stamped processing data in a database
• Time stamp product when run in each process
• Measure product mid-stream
• Correlate incoming material lots & processing data to interim and final
product attributes
• This does not demonstrate cause & effect
• Cause & effect is demonstrated when the problems can be created at will

9. © John Glenning 2008© John Glenning 2008
Process Development-ManufacturingProcess Development-Manufacturing
StrategyStrategy
Process Development Philosophy:
• Yield Improvement Plans
• Do not develop yield improvement plans based on
inspection reports
• Inspection is “First Defect Found”
• First Defect Found-finds the easiest defect to inspect for,
not the most common defect
• Yield improvement plans need to be based on defect
unlayering
• Start from end of the process-biggest impact on costs

10. © John Glenning 2008© John Glenning 2008
Process Development-ManufacturingProcess Development-Manufacturing
StrategyStrategy
Process Development Philosophy:
• Cycle Time
• Minimize Cycle Time
• Eliminate or minimize “non-value added process” like set-up
• Find the slowest step and work on it until it is no longer the
slowest step
• Low variability in cycle time
• Requires more starts to ensure customer shipments are not
missed
• Inventory unneeded finished products
• Adds significant costs
• “Tail chasing sessions”-attack the “problem of the day”

11. © John Glenning 2008© John Glenning 2008
Process Development-ManufacturingProcess Development-Manufacturing
StrategyStrategy
Process Development Philosophy:
• Improve Equipment Up-time
• Product Change-overs
• Keep required tools & materials at the equipment
• Planned downtime-maintenance & upgrades
• Unplanned downtime-machine crashes
• Plan for unplanned downtime
• Be prepared to do maintenance
• Cost
• Track on a continual basis
• If costs are highly variable, profitability cannot be assured
• Difficult to reduce manufacturing costs

12. © John Glenning 2008© John Glenning 2008
Process Development-ManufacturingProcess Development-Manufacturing
StrategyStrategy
End of Presentation