10007152Making Biotechnology Products in a Quality Environment
Course Information
Description
The course reviews and illustrates the importance of quality in a laboratory environment, with special emphasis on how a quality system directly impacts laboratory scientists. The laboratory revolves around the creation of a product to be used in other courses in the biotechnology curriculum. Students will create the product, as well as monitor the quality of the process.
Total Credits
2
Course Competencies
  1. Analyze the concept of quality
    Assessment Strategies
    Case Study
    Criteria
    Identify quality characteristics
    Identify how to measure quality in a product
    Describe features in a quality product for consumption
    Discuss ways to measure “quality”
    Identify ways to add quality to a product Introduce role of FDA in ensuring quality in foods

  2. Examine the development of quality management systems in the United States
    Assessment Strategies
    Written Product
    Criteria
    Describe the evolution of regulations that the FDA enforces
    Illustrate how the quality of products increases as the regulations evolve
    Describe the events that shaped the quality management movement in the United States
    Identify failures or loopholes lead to improved regulation
    Identify the major milestones that have resulted in quality regulation by the FDA
    Define the scope of FDA regulation (what it does and does not govern)

  3. Compare and contrast regulated and voluntary quality systems
    Assessment Strategies
    Written Product
    Criteria
    Describe the similarities between regulated and voluntary quality systems with regard to purpose
    Contrast regulated and voluntary quality systems with respect to scope
    Contrast regulated and voluntary quality systems with respect to oversight
    Describe the purpose, scope and oversight of the code of federal regulations current good manufacturing practices
    Describe the purpose, scope and oversight of ISO

  4. Define key concepts relating to quality
    Assessment Strategies
    Study Guide
    Criteria
    You achieve at least 80% accuracy according to the standards of the supplied rubric
    Describe the difference between requirements and standards
    Define “best practices”
    Discuss the relationship between error management and quality systems

  5. Evaluate how quality management systems control quality throughout all aspects of a business
    Assessment Strategies
    Process Map
    Criteria
    You achieves at least 80% accuracy according to the standards of the supplied rubric
    Describe the role of quality planning within a company
    Define the role of quality control (QC) within a company
    Define the role of quality assurance (QA) within a company

  6. Explain the role of auditing in assuring the quality of a product
    Assessment Strategies
    Study Guide
    Criteria
    You achieve at least 80% accuracy according to the standards of the supplied rubric
    Explain the roles of audits
    Identify the types of audits
    Describe the sections of a classic audit report
    Define three reasons auditors check for conformance to quality standards

  7. Explain basic statistical measures used to evaluate the quality of products
    Assessment Strategies
    Case Study
    Criteria
    Define the type of sample selected
    Describe how an Ishikawa diagram can optimize quality
    Describe how an Ishikawa diagram relates to Pareto optimization
    Explain the relationship between samples and populations
    Discuss the use of normal curves and standard deviation in quality optimization
    Illustrate the use of Ishikawa diagrams for the elimination of process errors
    Describe Pareto optimization theory
    Explain the elements of a quality control chart

  8. Describe the basic principles of the ISO 9000 quality standards
    Assessment Strategies
    Study Guide
    Criteria
    You achieve at least 80% accuracy according to the standards of the supplied rubric
    Explain how adopting quality standards adds value to products
    Describe the basic elements of ISO 9000
    Define the ISO 9000 certification process
    Discuss the pros and cons of ISO 9000

  9. Map the Six Sigma methodology (DMAIC)
    Assessment Strategies
    Study Guide
    Criteria
    You achieve at least 80% accuracy according to the standards of the supplied rubric
    Describe the history of Six Sigma
    Define the principles of Six Sigma
    Define the components of Six Sigma

  10. Describe the basic principles of Lean (JIT) Manufacturing
    Assessment Strategies
    Study Guide
    Criteria
    You achieve at least 80% accuracy according to the standards of the supplied rubric
    Describe the history of Lean (JIT) Manufacturing
    Define the principles of Lean (JIT) Manufacturing
    Define the components of Lean (JIT) Manufacturing

  11. Follow required professional safety protocols
    Assessment Strategies
    Practical Assessment
    Criteria
    You achieve at least 80% accuracy according to the standards of the supplied rubric
    Demonstrate laboratory safety by following safety protocols
    Dispose of hazardous materials properly

  12. Describe the structure of a biotechnology company
    Assessment Strategies
    Written Product
    Criteria
    You achieve at least 80% accuracy according to the standards of the supplied rubric
    Identify the units of a biotechnology company
    Illustrate how each unit contributes to the financial viability of the production process

  13. Test raw materials for use in a production process
    Assessment Strategies
    Raw materials training documents
    Raw materials approval documents
    Group meeting minutes log
    Criteria
    All documents are completely and accurately filled in, signed and witnessed
    Explain the importance of raw materials testing
    Train on SOPs used in raw materials testing
    Perform quality control measures on raw materials
    Complete raw materials testing documentation
    Release raw materials to production unit

  14. Make a biotechnology product in a quality environment
    Assessment Strategies
    Production training documents
    Production quality control documents
    Group meeting minutes log
    Criteria
    All documents are completely and accurately filled in, signed and witnessed
    Train on SOPs used in production
    Perform quality control measures on product
    Complete production documentation
    Transfer product for stability testing

  15. Perform stability testing on a biotechnology product
    Assessment Strategies
    Stability testing training documents
    Stability testing quality control documents
    Group meeting minutes log
    Criteria
    All documents are completely and accurately filled in, signed and witnessed
    Train on SOPs used in stability testing
    Perform stability testing measures on product
    Complete stability testing documentation

  16. Complete a performance review
    Assessment Strategies
    Performance
    Criteria
    The performance review is completed, discussed and signed.
    Analyze the importance of a performance review
    Objectively review individual performance
    Identify professional strengths
    Identify areas for professional improvement

  17. Complete a self-audit
    Assessment Strategies
    Written Product
    Criteria
    The audit documentation is complete, witnessed and signed
    Analyze the importance of an audit
    Complete an internal audit
    Create an audit report