Quality Management System Corrective Action QP5

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Quality Management SystemCorrective Action (QP-5)
Quality

• Prepared by CPHST Quality Management Unit
• August 2006

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Purpose

• Describes the steps followed to initiate,
  execute, and document corrective action requests.

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Scope

• This corrective action
• procedure applies to all of
• CPHST

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When Should a Corrective Action Request be
Submitted?

• Any time a condition having an impact on quality
  is identified. These conditions may include
• Defect rates
• Productivity rates
• Customer complaints
• Nonconforming work

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Conditions are observed through

• Employee observations
• Examination of statistical data
• Audit observations
• Management reviews
• Customer complaints

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

• To initiate a corrective action request, use
  Form 5-1

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(No Transcript)
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Corrective Action Request Resolution Panel

• This Panel is appointed by CPHST QMU or
  Laboratory Director, as necessary, to
• conduct meetings and experiments to determine the
  root cause of the nonconformance or problem.
• Collect raw data, perform data analysis and
  prepare summary of findings
• Maintain minutes of their meetings

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Presentation of Root Cause/Proposed Corrective
Action

• The results will be reported in writing to the
  CPHST Director of Quality Management or to the
  Laboratory Director on or before the assigned due
  date. The accepted corrective action will be
  documented on the Corrective Action Request Form

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Monitoring of Corrective Actions

• Once approved and implemented, the CPHST
  Director of Quality Management or the laboratory
  Quality Manager will ensure that the action taken
  is monitored through auditing

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Records

• Form 5-1 Corrective Action Request
• Corrective Action log
• Minutes of Corrective Action Request Resolution
  Panel meetings
• Experimental data and analysis
• Summary of experimental findings

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Laboratory Work Instructions Needed

• No laboratory specific work instructions are
  needed for this quality procedure
• CAR 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