Quality Management System Record Control QP2

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Quality Management SystemRecord Control (QP-2)
Quality

• Prepared by CPHST Quality Management Unit
• August 2006

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Purpose

• Defines the controls needed for
  identification, storage, protection, retrieval,
  retention time and disposal of CPHST records.

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Scope

• All CPHST quality and technical records are
  covered by this procedure.

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What is a Record?

• Record A written body of information that
  provides chronological objective evidence that
  CPHST activities have been conducted according to
  quality procedures, technical procedures, or work
  instructions.

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Technical vs Quality Records

• Technical Records provide evidence that CPHST
  work was produced in accordance to documented
  requirements.
• Examples include worksheets, laboratory
  notebooks, laboratory reports, instrument
  notebooks, etc.

• Quality Records provide evidence of
• Effective operation of the quality system
• Capability of key personnel, processes, or
  suppliers
• Controlled operation of processes that affect
  quality
• Examples include audit reports, Reports of
  Nonconforming Work, Document Change Forms,
  training records, document disposition records,
  etc.

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General Record Requirements

• Records are
• Secured and stored to prevent deterioration and
  damage
• Indexed, clearly marked and grouped for expedient
  retrieval
• Considered confidential but retrievable for use
  and are made available for review as allowed by
  law or regulation when requested by auditors or
  customers
• Traceable to the laboratory work performed
• Maintained to avoid loss or damage of original
  data

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What about Mistakes?

• Each mistake in a written record will be crossed
  out using a single line (Do not Erase or Delete
  the Mistake!!)
• Enter the correction alongside the error.
• Sign or initial the correction.
• Maintenance of Electronic Records is discussed in
  QP-20.

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Quality Records

• CPHST Quality Records are maintained by the CPHST
  Quality Management Unit (QMU).
• Each laboratory will have a work instruction
• documenting specific Record Control procedures.
• These work instructions will consist of
• record collection and identification procedures
• record indexing, access, filing, storage,
  maintenance and security procedures

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Technical Records

• Technical records will contain information on
  factors affecting the data uncertainty and will
  enable repetitions of the laboratory work under
  conditions as close as possible to the original
  work.
• Technical records will also include the identity
  of each person involved in the laboratory work

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Technical Records

• Each laboratory will have a work instruction
• documenting specific Record Control procedures
  for all technical records. This includes (as
  applicable)
• records of original observation
• Derived data and sufficient information to
  establish an audit trail
• Laboratory reports
• Calibration and standardization records
• This work instruction(s) must address
• record collection and identification procedures
• record indexing, access, filing, storage,
  maintenance and security procedures

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Record Retention

• CPHST records are maintained for the length of
• time as specified in the table on the
  following slide.

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Record Retention

• If any CPHST laboratory is required by
  regulations or law to maintain records other than
  those listed in the preceding table, the
  laboratory will develop a work instruction to
  document their record retention requirements.

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Records Disposal

• CPHST disposes of hard copy records that exceed
  their retention dates (as shown in
  preceding table) by
• Shredding
• burial in a secure sanitary landfill or
• Incineration
• The destruction of records will be witnessed and
  a memo to file will be prepared to include the
  records disposed of and a statement that the
  disposal was witnessed.

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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