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DOCUMENTATION AND SOP

Ability to follow an SOP and evaluate a batch record.

Objective Measured:

  • Communicate the answers to prompts about specific parts of an SOP.

  • Evaluate an SOP for compliance with good documentation practice.

  • Complete a batch record accurately.

Performance Assessed

  • Student will be provided with an SOP and asked specific questions about the components.

  • Student will be given an SOP with multiple errors that must be identified.

  • Student will be asked to perform a simple task following an SOP to prepare a one ingredient solution.   Upon completion of the task, student will be asked to fill out a batch record documenting the work completed.

Credential Alignment

Washington Biotechnology/Biomedical Skill Standards

  • D3. Enter and manage laboratory information electronically

    • Data is entered accurately.

    • Data is correctly cross-referenced and aligns with the linear progression of the work and the experiment methodologies and outcomes.

  • C3. Review data and reports for compliance Data forms are complete, accurate, and legible and are completed in a timely manner.  Standard operating procedures and guidelines are correctly documented.


Texas Biomanufacturing Skill Standards

1.1 Follow Standard Operating Procedures (SOPs)

1.2 Fill out batch records

1.3 Document and analyze data


BACE

Skills Category: Workplace Safety and Behavior
• Follow practices associated with regulatory compliance
• Demonstrate good documentation practices, including following Standard Operating Procedures (SOPs)
• Properly label items, including solutions, buffers, Petri plates, samples, and products


Core Skill Standards for Bioscience Technicians

Critical Work Function: Comply with applicable regulations and standards 

Key Activities 

  • Follow established policies and procedures 

  • Record information according to established procedures 

  • Exercise proper document control

  • Recognize and address nonconformances

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