INTOPLANE RISK ASSESMENT

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INTO-PLANERISK ASSESMENT

• DESC QM Conference
• Lee Oppenheim
• 18 Nov 2003

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RISK ASSESSMENT

• Background
• DCMC wanted to eliminate the six month mandatory
• Industry questioned frequency
• DESC/DCMC/AF worked on guidance
• Audit list developed first
• Risk assessment then developed
• DCMC Homestead was test location
• DESC/AF approved 1997, DCMA changed

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RISK ASSESSMENT

• DESC assumes QA role
• Re-institutes risk assessment as tested and
  approved
• Requires QAR to perform audit of facility
• Risk assessment rates processes
• Gives overall score
• Score used to determine frequency of visit

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RISK ASSESSMENT

• Process Areas
• Product
• Safety
• Facilities
• Documentation Records
• Personnel
• Operational Consideration

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RISK ASSESSMENT

• FACTORS
• Four items have Inherent, Past and Future ratings
• Documentation/Records and Personnel have only
  Past and Future

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RISK ASSESSMENT

• ISSUE
• Use of Risk assessment requires manager
  intervention
• QAR skews to medium risk
• QM needs to review and make sure assessment being
  used correctly
• Need to modify assessment when you feel medium is
  misused, redirect QAR

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RISK ASSESSMENT

• ISSUE
• Difficult to produce a low risk facility
• Is there another way to do risk assessment
• DESC-AM proposed using
• Likelihood of Occurrence
• Consequence of Occurrence
• Numerical rating and formula
• ?

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Risk Assessment
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RISK ASSESSMENT

• LIKELIHOOD
• Numerical rating from near certainty to remote
• Subjective

• CONSEQUENCE
• If goes wrong what will the effect be
• Numerical rating 1 5 corresponding to complete
  failure to no impact
• Can we get more specific in order to use

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RISK ASSESSMENT

• Should we look at using likelihood/consequence
  vice inherent/past/future?
• Are there other issues that need to be addressed
  in the into-plane risk assessment?

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