RISK REDUCTION PROCESS PROACTIVE RPN REDUCTION PROCESS: Reducing the risk of a POTENTIAL QUALITY FAILURE REACTIVE ERROR PROOFING PAST QUALITY FAILURES

PROCESS FAILURE MODE & EFFECTS ANALYSIS (PFMEA) DEFINITION An analytical technique for each process step that identifies: ways a process may fail to meet requirements. consequences to the internal / external customer (severity). frequency the failure will/could happen (occurrence). effectiveness of current controls (prevention & detection). ranking of causes and effects (risk priority number). A structured procedure for identifying and eliminating process related failure modes. BE BRIEF

PROCESS FAILURE MODE & EFFECTS ANALYSIS (Example) What can go wrong? How does it affect customer? How likely are we to notice if this happens? Use the balloons and stay brief How often does this cause happen? How high is the risk? (AIAG PFMEA Third Edition)

SEVERITY RANKINGS Briefly read the ranking for the example you are using. (AIAG PFMEA Third Edition)

OCCURRENCE RANKING Briefly read the ranking for the example you are using. (AIAG PFMEA Third Edition)

DETECTION RANKINGS Briefly read the ranking for the example you are using. Explain the blue shaded columns. Ask the audience if there are any questions on how to calculate RPN. (Stay on subject.) (AIAG PFMEA Third Edition)

RISK PRIORITY NUMBER (RPN) Severity x Occurrence x Detection = RPN Risk Priority Number (RPN) is the result of Severity, Occurrence and Detection rankings. Severity x Occurrence x Detection = RPN (Example) Read RPN definition then calculate an example. Use the supplier’s PFMEA if available. As you calculate the example move ahead to each of the charts. NOTE TO TRAINER: Remember this is NOT a PFMEA training session! Practice how you are going to present this calculation, it is easy to dwell too long on the charts. It is easy to lose your audience by not pacing this portion to your audience: don’t dwell too long, don’t skim too fast. Stay organized and on subject. Use a dry erase board to help illustrate, if appropriate.

PFMEA’s shall be completed for all manufacturing processes and support functions as required by the Quality Management System. Support functions include: (receiving inspection, material handling, labeling and shipping, etc…) PFMEA’s shall: conform to current AIAG guidelines and customer requirements. be updated on a regular basis (living documents). exist for all product lines / part numbers. include all processes and process steps. be utilized for Continual Improvement. have accurate Severity/Occurrence/Detection ratings. PFMEA Shalls are NOT all inclusive these are the examples to stress

Multi-disciplinary teams shall perform periodic PFMEA Reviews. The frequency and/or number of PFMEA reviews shall be determined by supplier leadership based on: customer expectations (PR/Rs, DDW, Launch activities, etc…) process capability (FTQ, SPC, etc…) changes to the process (Error proofing, Tier 2 changes, etc…) Criteria to prioritize which PFMEA to review include: product from an acquisition, tool move or change in supplier. PFMEA developed without adequate cross-functional involvement. PFMEA for part(s) with history of PR/R, Customer complaints, Warranty or FTQ issues. Occurrence ratings (FTQ, scrap, etc…) have changed significantly. PFMEA with oldest revision dates.

PFMEA Review shall include the following at a minimum: verification that all operations/processes are included and accurate (Paint, Heat Treat, Labeling, etc…). all process controls are included. Detection ratings are accurate . Occurrence ratings are analyzed using data (SPC, FTQ, Quality Gate, C.A.R.E.*, Scrap, Layered Audit* results, etc…). verification that the PFMEA meets customer requirements and expectations (AIAG, PPAP, Launch, DDW, etc…). Upon completion of the review, a list of the highest (RPN) Risk Reduction opportunities is established or revised based on the new data. An action plan or equivalent shall be utilized by the multi-disciplinary team to track progress in reducing the RPN ratings.

RPN TRACKING CHART (Proactive) (Example) Suppliers shall develop an action plan to reduce risk using RPN reduction strategies. If it is a small supplier with a simple process and no quality issues, the list might be a top 5. If the supplier has multiple lines with complex process and parts; the list must be longer.. If the supplier is in Top Focus, Controlled Shipping, or is in Launch, the list may be longer. The number of RPN must be consistent with the status of the supplier and their PFMEAs . The number of RPN on the list is dependent on complexity of parts and process, size of plant, customer feedback, etc…

(Example:) This is an example of a global APQP form. Please caution suppliers to check for latest revisions if they use this format. (This is for reference only; check for latest revision)

REACTIVE RISK REDUCTION: ERROR PROOFING PAST QUALITY FAILURES Multi-disciplinary team(s) shall be utilized to develop a list of the past internal and external quality failures. Team(s) identify true PFMEA Occurrence and Detection Rating for each RPN. Team(s) shall develop an action plan to Error Proof the failures. Recommended Actions are improvements that will prevent or reduce the Failure Mode. When Error Proofing is not feasible, a plan to improve detection shall be established. A team member shall be assigned responsibility for implementing the recommended action. Reasonable target completion dates shall be established. Most suppliers try to error proof past external issues as it is part of the PR/R process. Ask supplier if they know what their highest internal defect are and if they have a plan to error proof them. At minimum, occurrence and detection ratings need to be reviewed And usually revised. Severity may need revision if customer feedback indicates it was previously under estimated.

REACTIVE RISK REDUCTION: ERROR PROOFING PAST QUALITY FAILURES Error proofing shall be verified per the Error Proofing Verification* process. When corrective actions have been implemented, teams shall validate the new Occurrence and Detection rankings and resultant RPN. Teams shall update PFMEA’s with all corrective action measures.

RISK REDUCTION SITE LEADERSHIP: should review the need for PFMEA training at least once per year. shall support RPN reduction activities and provide necessary resources. shall review the RPN reduction tracking charts. shall ensure that formal multi-disciplinary teams are utilized in the preparation and ongoing review of PFMEA’s.

RISK REDUCTION SUMMARY PROACTIVE Leadership shall support RPN reduction activities and provide necessary resources. PFMEA’s shall undergo a complete review. A list of the highest (RPN) Risk Reduction opportunities shall be established. An action plan or equivalent shall be utilized by the multi-disciplinary team to track progress in reducing the RPN ratings. REACTIVE A list of the past internal and external quality failures shall be established. Team(s) shall develop an action plan to Error Proof the failures.