LABELING, DOCUMENTATION, AND SOP
Ability to follow an SOP and evaluate a batch record.
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.
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.
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
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
Follow established policies and procedures
Record information according to established procedures
Exercise proper document control
Recognize and address nonconformances