Quality Management System Preventive Action QP6

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Quality Management SystemPreventive Action (QP-6)
Quality

• Prepared by CPHST Quality Management Unit
• August 2006

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Purpose

• This Quality Procedure describes the steps
  followed to initiate, complete, and document
  preventive action

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Scope

• This Preventive
• Action Procedure
• applies to all CPHST
• employees

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When Should a Preventive Action Request be
Submitted?

• Any time a need for improvement or a potential
  source of nonconformance is identified.

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Sources Used to Identify Preventive Actions

• Employee suggestion
• Examination of statistical data
• Audit observation
• Defect rates
• Productivity rates
• Management reviews
• Customer observation

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Who is Responsible for Submitting Preventive
Action Requests?
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Initiation of Preventive Action Request

• To initiate a preventive action request, complete
  Form 6-1

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(No Transcript)
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Preventive Action Request is Reviewed

• The CPHST Director of Quality Management or the
  Laboratory Director or Quality Manager will
  review the preventive action request. One of
  three determinations will be made
• The request is valid and should be implemented,
• The request requires more detailed analysis,
• The request will not provide the proposed
  preventative measure and is Not approved.

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• If the CPHST Director of Quality Management or
  the Laboratory Director or designee determines
  that a more detailed review is required, a
  meeting will be scheduled to include the
  appropriate personnel are present for the
  presentation of additional information.
• At this time, one of two determinations will
  be made
• The request is valid and should be implemented,
• The request will not provide the proposed
  preventive measure and is not approved

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Laboratory Work Instructions Needed

• No laboratory specific work instructions are
  needed for this quality procedure
• PAR Log is required to be maintained by CPHST QMU
  and laboratory Quality Managers

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Questions or Comments

• Please Contact CPHST Quality Management Unit
• John Gallagher, CPHST Director of Quality
  Management
• [phone]
• john.b.gallagher_at_aphis.usda.gov
• Or
• Kathy Burch, CPHST Senior Quality Auditor
• [phone] or [phone]
• katherine.j.burch_at_aphis.usda.gov