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MEDICAL DEVICE AND LIFE SCIENCES INDUSTRY :
Manufacturing Performance |
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Client: |
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A
major medical device company, designing and producing Class II and
III orthopedic devices, was unable to release products and meet market
demands. |
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Problem: |
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Need
to resolve a product release problem resulting in lot failures from
packaging integrity issues that impaired product sterility. Need to
fully understand the lot failure problem and resolve causes to ensure
product line viability. |
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Approach: |
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Developed
understanding of process flow. Created baseline measurements on key
manufacturing process variables and identified source of variation
coming from the blister packaging operation. Quantified the package
sealing failure rate to be sporadic and intermittent at 3%. Assessed
the process control characteristics of key packaging-related process
variables including raw materials and sealing machine performance.
Isolated source of failure to sealing pressure. Developed a detailed
plan to profile sealing capability and conducted analysis. Determined
that sealing pressure was not uniform and implemented an improvement
strategy to eliminate non-uniformity in sealing capability. Statistically
confirmed that corrective measures were successful. Drove the problem-solving
process through focused on-site consultant support and guidance of
operational teams and management. |
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Results: |
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Salvaged product
line viability and eliminated the source of failure in blister package
sealing operation, ensuring product sterility
Developed an understanding
of the reason for failures and provided a methodology for monitoring
sealing process consistency to ensure packaging reliability
Efficiently
eliminated sealing failures to allow company to release their orthopedic
devices and satisfy critical market demand. |
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