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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
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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)
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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