Production%20Certification%20Process%20Status

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Production Certification Process Status

Jack Fowler
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Process Certification Steps

• Process control
• Approved written procedures in EDMS
• Approved testing of product
• Approved drawings in EDMS
• Personnel training
• Record keeping and database implementation
• Process can support the production rate
• Process yields reproducible and consistent
  results
• Tooling is adequate and in place
• All processes are safe to operate
• All equipment as necessary is calibrated

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Process Status
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EDMS Status

• Most procedures have been submitted to EDMS in
  draft form
• Meeting held to get agreement on Core Steps for
  module production
• Currently revising procedures and checklists
  based on meeting results
• CCB will convene at workshop to approve final
  procedures

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Database Status at Duke

• Current database is installed
• Receiving information entered
• Production data is being entered for current
  module
• Previous modules will be added once checklists
  have been updated
• All necessary data for previous modules is
  available for entry into database
• Database to be online in June 01

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Audit Follow Up

• Finalize written procedures and submit to EDMS
• Get procedures and checklists updated in database
• Finalize tooling list and obtain sufficient
  spares
• Finalize safety, calibration and training
  documents