The key points to review in a PFMEA

Creating a robust Process Failure Modes and Effects Analysis (PFMEA) can be a daunting challenge even for experienced SQEs, especially when facing the many intricacies of the Production Part Approval Process (PPAP). This is a high stakes job —PFMEA plays a critical role in identifying potential process failures and ensuring quality improvement.

SQE’s often face several hurdles that need solving before they can impact production, customer satisfaction or non-compliance with industry regulations. So, you can think of a PFMEA as a trusty ally that shows you potential risks in your supply chain and helps you understand the causes of mishappenings when they occur to prevent them in the future. 

Learn about the implementation of PFMEA and corrective actions in quality management with this article. Read more to reinforce your leadership as an SQE. 

What is a Process Failure Modes and Effects Analysis (PFMEA)?

A Process Failure Modes and Effects Analysis (PFMEA) is a structured approach to identifying and mitigating potential failure modes within a manufacturing or business process. It’s a critical tool to proactively address issues before they lead to costly defects or problems. 

A PFMEA’s objective is to identify and mitigate risks in fabrication processes across industries where precision and reliability are paramount, such as electronics, medical parts, and automotive manufacturing. The systematic analysis of potential failure modes and effects helps organizations to prioritize quality improvement and customer satisfaction.

Key points to review in a PFMEA

In order to develop a thorough PFMEA, it’s important to account for a full-scope process evaluation. From the implementation of corrective actions to integration with QMS, such as IATF, VDA 6.3, ISO 9001 and IAQG/AS9145, here are fundamental aspects to consider:

1. Rev level: Part number and revision level match the drawing’s rev level.
2. Process steps: List all the steps in the analyzed process. This forms the basis for alignment and consistency throughout the rest of the analysis. Make sure the PFMEA matches the PFD and Control Plan —in other words, verify the risks identified in the PFMEA are fully reflected in the process steps shown in the PFD, and that the Control Plan includes controls specifically designed to address those risks.
3. Failure modes: Identify potential failure modes for each process step. A failure mode is a specific way the process can go wrong.
4. Severity (S): Evaluate the severity of each failure mode. This is typically rated on a scale from 1 to 10, with 1 being the least severe (minor impact) and 10 being the most potent (significant impact). This rating considers the potential consequences of the failure on the product or the customer.
5. Occurrence (O): Assess each failure mode’s likelihood or occurrence frequency. Use a scale from 1 to 10, with one being highly unlikely and ten being very likely. This rating considers how often the failure is expected to occur.
6. Detection (D): Evaluate the ability of the current process controls to detect or prevent each failure mode before it reaches the customer. Again, use a scale from 1 to 10, with 1 indicating excellent detection and 10 indicating poor or no detection.
7. Compliance with AIAG/VDA (if applicable): Severity, Occurrence and Detection ratings match the latest AIAG/VDA Requirements
8. Risk Priority Number (RPN): Calculate the RPN for each failure mode by multiplying the Severity (S), Occurrence (O), and Detection (D) ratings (RPN = S x O x D). Higher RPN values indicate higher risks and should be prioritized for action.
9. Recommended actions: Prioritize which failure modes to address based on the RPN values. Develop recommended corrective actions for each high-priority failure mode to reduce malfunction risk.
10. Responsibilities: Assign responsibility for implementing the recommended actions to specific team members or departments. Ensure accountability.
11. Action plans: Develop detailed action plans for addressing each high-priority failure mode. These plans should include what, when, and how the actions will be implemented.
12. Verification: Establish methods for verifying the effectiveness of the corrective actions. This could involve testing, monitoring, or other validation processes.
13. Documentation: Keep comprehensive records of the PFMEA process, including the identified failure modes, severity, occurrence, detection ratings, RPN values, recommended corrective actions, responsible parties, and action plans.
14. Review and update: Regularly review and update the PFMEA as processes change or new information becomes available. This ensures that it remains a dynamic tool for continuous improvement.
15. Cross-functional collaboration: Involve cross-functional teams from various departments in the PFMEA process. Different perspectives can lead to more comprehensive analyses.
16. Training: Ensure personnel involved are trained in the PFMEA methodology and understand their roles in its execution.
17. Integration with quality management systems: Integrate the PFMEA into your organization’s broader quality management systems, such as ISO 9001, to ensure alignment with quality objectives.
18. Risk reduction: Focus on reducing the RPN values over time by successfully implementing corrective actions. The goal is to reduce the risk of process failures.
19. Communication: Maintain open lines of communication regarding PFMEA results, progress on corrective actions, and any emerging issues.
20. Continuous improvement: Use the lessons learned from PFMEA to drive a culture of constant improvement within the organization.

Master PFMEA for quality improvement with PPAP Manager

Remember that PFMEA is an iterative process. It should be regularly revisited and refined to ensure its effectiveness in preventing non-compliances and improving quality assurance. 

A PPAP manager software can significantly aid in streamlining the PFMEA documentation and approval process. This tool allows quality engineers to easily create, organize and manage the detailed analyses required for precision manufacturing industries, ensuring that all potential failure modes and effects are thoroughly documented and assessed. 

By providing real-time metrics and reports, along with the ability to track corrective and preventive actions (CAPA) a PPAP manager allows for SQE’s informed decision making and alignment with industry best practices for PFMEA and quality management. 

While a PPAP manager software doesn’t replace the judgment of an experienced quality engineer, it does help to enhance efficiency and accuracy while saving time and money. Avoid unnecessary stress, maintain consistency and meet critical deadlines: manage your supplier quality processes with Kiuey’s cloud-based PPAP management solution.