Predictive indicator model

A predictive indicator tool, comprising:

• analyzing a product manufacturing process to determine each sub-process;
• providing the following 12 questions:
• 1—What is the Level of Patient Risk due to potential failure of this product?
• 2—What is the Level of Regulatory Risk related to this product or process?
• 3—Are product CTQs identified and linked to VOC?
• 4—Is a Product Risk Assessment complete and risk mitigation plan in place?
• 5—Have CTQs flowed down to component/RM level with control plans in place for each component/RM?
• 6—Do Sampling Plans/Control strategies utilize documented statistical rationales?
• 7—Does a Control Plan Exist and identify KPIVs and controls for each CTQ?
• 8—Is an Adequate Test Method control identified for each CTQ?
• 9—What is Critical Defect (3 month average) Process Capability in DPM or Ppk (complete roll-up)?
• 10—Is there an Effective Training Plan defined, followed, and up to date?
• 11—Are Manufacturing Methods and other procedures properly executed (# of human error deviations)?
• 12—Is Process FMEA complete and adequate?
• providing an algorithm and a scoring system for the 12 questions such that the cumulative total will be in the range of 0-100;
• applying each question to each manufacturing sub-process;
• scoring each question and determining a risk score for the process by using the following algorithm:
• PI=Severity*Detection*Occurrence/23328*100, wherein
• Severity=the sum of the scores of Questions 1 and 2,
• Occurrence=the sum of the scores of Questions 3, 4, 5, 7, 9, 10, 11 and 12.
• Detection=the sum of Questions 6 and 8;
• and,
• comparing the risk score to an appropriate alert level, and if the risk score is greater than the alert level, classifying the sub-process as requiring corrective action to eliminate the potential risk identified.