Assignment 1 Due Week 7 (During your midterm)
You are a Quality Consultant for Diagnostic company X
1. Critically explain the role of Statistical Process Control in maintaining quality, quality improvement and determining process capability. Give examples of the types of control charts that can be used to monitor process stability. (20%)
2. Critically assess the role of validation within good Manufacturing Practice Outlining the stages of Validation and parameters required in a validation Report. (20%)
3000 Words
• Incorporate a clear structure
• Use Harvard System referencing (10%)
• Use Arial or Calibri
• Font – size 12 with 1.5 spacing
Outline
Introduction: c. 1000 words
• Brief overview of SPC &Validation
• Why & When to use apply SPC &Validation
• Brief overview of Types of Control Charts used in SPC &(Sampling plans used in validation, risk assessment tools and examples of validation guideline– Red text will cover in Lecture 2 & 3)
Body(Must include a hypothetical example of how to apply SPC in Validation of a process) c. 2000 words
Conclusion: c. 1000 words
? Softcopy Due 11.59 on Sunday31st October 2021
? Upload via Turnitin on Moodle
? Check Moodle for this assignment
