Assignment task: You are the Quality Director for a small startup device company. Production Dept notified the Supply Chain Manager that they would like to order a major component from a new vendor. The components will be used inside an ISO 7 clean room. The Supply Chain Manager, who just started, notifies you since they are not on the Approved Supplier List.
What steps would you implement to ensure that they can use the part supplied by the vendor? What must be done to be able to accept the component into the building and eventually into the clean room and used by production?
Think about all phases of the supplier evaluation program. What will your supplier evaluation program look like? Will major components be treated differently from less critical ones? What steps will the supplier have to go through? Will the supplier immediately be placed on the approved list? What will happen when the part is delivered to receiving? What will quality have to do at receiving? What will quality check the component against? How will you ensure that the component is traceable after is gets to production?
Could you please suggest a product and help in preparing a PP training presentation to show your quality team the steps you would take to be able to use this new vendor. It can be up to 12 slides. Please cite any references as needed.
I have already done the outline.
Slide 1: Introduction
- This presentation outlines the steps we will take to ensure that a new vendor can be used for a major component in our ISO 7 clean room.
Slide 2: Supplier Evaluation Program Overview
- All suppliers must go through our evaluation program before being used.
- Major components will be treated differently from less critical ones.
- The supplier will not be immediately placed on the approved list.
Slide 3: Supplier Evaluation Program Steps
1. Initial screening
2. On-site audit
3. Quality system evaluation
4. Performance monitoring
Slide 4: Initial Screening
- Gather basic information about the supplier.
- Check for any red flags such as quality or regulatory issues.
- Determine if the supplier meets our minimum requirements.
Slide 5: On-Site Audit
- Conduct a detailed on-site audit of the supplier's facilities.
- Verify that the supplier has the necessary resources and controls in place to manufacture the component.
- Confirm that the supplier is following all applicable regulations and standards.
Slide 6: Quality System Evaluation
- Evaluate the supplier's quality system to ensure that they have appropriate processes and procedures in place.
- Verify that the supplier has a robust quality management system that includes documentation, change control, and corrective actions.
Slide 7: Performance Monitoring
- Monitor the supplier's performance over time.
- Use metrics such as on-time delivery, quality, and customer complaints to evaluate the supplier's performance.
- Address any issues with the supplier in a timely manner.
Slide 8: Major Components
- Major components will require additional scrutiny.
- A failure of a major component can have serious consequences.
- Major components may require additional testing and validation.
Slide 9: Receiving Inspection
- Quality will perform an inspection of the component when it arrives at our facility.
- Inspect the component for damage or defects.
- Confirm that the component meets all specifications.
Slide 10: Traceability
- All components must be traceable to the supplier.
- Quality will ensure that the component is properly identified and labeled.
- Any necessary documentation must accompany the component.
Slide 11: Approval
- If the component passes all inspections and meets all specifications, it will be approved for use.
- The supplier will be added to the approved supplier list.
- The component will be used in production.
Slide 12: Conclusion
- Our supplier evaluation program ensures that all suppliers meet our high standards.
- Major components will require additional scrutiny.
- All components must be properly inspected and traceable.
- Our goal is to ensure that our products meet the highest quality standards.
References:
- ISO 9001:2015, Quality management systems - Requirements
- ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes.
Could you please provide 2 to 3 additional points for my each side headings?