PROCESS FAILURE MODE and EFFECTS ANALYSIS AIAG&VDA FMEA HANDBOOK-June 2019-1.Version

PROCESS FAILURE MODE and EFFECTS ANALYSIS
AIAG&VDA FMEA HANDBOOK-June 2019-1.Version

FMEA handbook is used by the automotive sectors. FMEA studies should have complied when the customer’s requirements. FMEA is divided into 2 types. These are Design FMEA and Process FMEA.

The cause of the FMEA’s Handbook publishing:

1.OEM expects high quality,

2.The cost optimization on the processes and the products,

3. The types of different process arise due to high part’s production,

4. The production requirements are with local/legal regulations.

The FMEA method can be studied in systematic perspectives, group studies, analytic approaches, and qualitative and quantitative approaches.

The goal of FMEA’s studies are;

1. To assess the potential risks in terms of the technical at the products and processes,

2. To analyze the effects and causes of the errors can be occurred from the potential risks,

3. To find and prevent the errors, activities should be documented,

4. To decrease the risks prevent actions should be recommended.

If FMEA has in the customer’s requirements, FMEA analysis should be studied in every start of the production. During processes, if there has a new application or revision, FMEA should be revised. If the FMEA revisions can affect other similar processes, it should be revised. On the other hand, If the revisions come from engineering, FMEA should be revised in the existing processes or products.

Before the FMEA studies should have a project meeting. To make plans should be described at the following steps:

1.FMEA Intent,

2.FMEA Timing,

3.FMEA Team,

4.FMEA Task,

5.FMEA Tool.

The FMEA team should be reviewed at least 1 in a year. The FMEA team should be established and the team includes team leadership, engineers, customer representatives, quality and safety engineers. On the other hand, if the organization has a broad scope, the team should be built and added bigger such as maintenance engineers, Project managers, design engineers, service engineers, operators, purchasing, quality and safety engineers, customer representatives.

APQP (Advanced Product Quality Planning):

1.The task planning and definition,

2. Recalls, assessments and corrective actions,

3. Verification of product design and development,

4. Process Design and development verification,

5. Validation of products and production.

The FMEA is 7 steps. All 7 steps have defined in the original FMEA Handbook. The analysis form has been standardized in the FMEA Handbook.

STEP 1-PLANNING and PREPARING:

When the PFMEA Project starts, all processes and products should be defined in the first step. The Project Plan should be prepared that should be included the goals, the times, the teams, the duties, and the vehicles. Also, analytical methods should be defined.

To define the PFMEA’s limits can help criteria. These are;

The PFMEA criteria are the legal requirements, the technical requirements, the customer’s requirements/needs, the diagrams, the schemas, the risk analysis,  the previous PFMEA’s from the same products, the error-proofing regulations, the assembly and manufacturing for design, the quality functions.

The PFMEA analysis can include all processes definitions from the incoming part check to the logistic steps.

The identification of the PFMEA’s Scope should be careful criteria that are;

There are some technologies, history of the quality and validity, design complexities, personal and security systems, cyber securities, local/legal regulations, catalogs, and standards.

To make sure using that the PFMEA’s final scope has some criteria that should be implemented:

New developing products or processes, product and process changes, operational changes, legal/local regulation or customer requirement changes, manufacturing topics, the high risk of the processes, continuous improvement activities.

In the first step, All PFMEA studies should be recorded and sustained in the lessons learned and these activities should be defined in the basic PFMEA. After all, when all necessary activities are completed, go to the next step.

STEP 2- STRUCTURE ANALYSIS:

The first step comes as input in the second step.  Structure analysis uses the process flow diagram. The process flow diagram should be defined for all the product’s processes step by step. The flow diagram titles should be included the operator name, the operation number, and the operation name. After all, when all necessary activities are completed, go to the next step.

STEP 3-FUNCTIONAL ANALYSIS:

The previous step comes as input in the next step.  When making the functional analysis, there are some essential key points that are defined such as the function of the process, the process name, the special product characteristics, the operator name and the function of the product characteristics.

Requirements/Characteristics: One product has special characteristics that can be measurable and distinguishing.

Product/Proses Characteristics: Product characteristics can be defined in the technical drawing and specifications. These requirements come up after the process functions. The definition of the requirements and characteristics should be identified in the technical drawing or the specification. After the manufacturing, special characteristics should be measured in the process steps. Also, the process characteristics should be checked by the process and product quality controller.

Local/Legal Regulations: Local and Legal regulations have some expectations to comply with the environmental management system and occupational health and safety management systems.

Customer Requirements: According to the customer requirements, they expect that one part should be produced for the specifications.

The main and essential goal is that the product should have differed in whole function steps in terms of the requirements or regulations. That's why All steps should be explained in detail.

At the functional analysis with outputs, The engineering team should be worked together and they should be done the functional visual instructions, the process flow diagrams that these are connected with the requirements or characteristics. After all, when activities are completed, go to the next step.

STEP 4-ERROR ANALYSIS:

The previous step comes as input in the next step.  The fault analysis studies should consist of the fault effect, the fault type, and the fault cause. To assess the risks, the fault analysis should be defined in detail. To make a true analysis, the fault types should be defined. After that according to the results, it should be studied on the effects and causes. To see the whole analysis, the fault chain should be the outcome of the fault chain activities. The effects of the faults and types should be identified. In addition to this, first, the causes of the process faults should be determined with the fishbone method. Second, The relation between the customer and the supplier should be observed with the fault effect activity. At the end of the studies, the FMEA form should be standardized as a basic risk analysis.

The Effects of the Error: The negative effects of the safety and the inconsistency causes of the regulation should be defined clearly. The potential error effect analysis is included the external and internal sides, the legal and local regulations or requirements and the last users that are calculated and found a severity score.

The Error Type: The error types are defined in some of the bad situations when the product cannot reach the goals of the output. During production, it should be thought that it might occur a bad situation or negative effects. The error types are expressed and shown with the technical drawings. To analyze the error types correctly should be taken support in the lessons learned, the past quality problems, the rejection and scrap results, the similar proses activities, the customer recalls and etc.

The Causes of the Error: The causes of the error should be identified and noted down in a clear way. After all, when all necessary activities are completed, go to the next step.

STEP 5-RISK ANALYSIS:

The previous step comes as input in the next step. The main goal of the risk analysis is that the risk of the error is eliminated. The risk analysis results come up with the severity, probability, and detectability. The purposes of the risk analysis are included all control definitions, preventive action definitions, to determine the detection checks for the causes of the errors and types, to determine the severity, probability and detectability scores for every error chain, to assess the activity priorities.

There are two control groups. These are preventive checks and detection checks.

1.           The Preventive Checks: To decrease high risks or probability of the risks with preventive studies can prevent negative results or situations such as Poke-Yoke, maintenances, instructions, visual alerts, first piece approvals, machine controls, etc.

2.           The Detection Checks: Before the dispatch of the part to the customers, final controls are so important to find the failure part and causes of the error. The detection checks are such as camera systems/controls, visual controls, final controls, final control checklists, interprocess controls, measurement tools, and types of equipment, random inspections or controls and etc.

Risk analysis has 3 criteria. These are;

1.SEVERITY: The most serious score is the error type and detectability and probability are calculated independently for the severity. To check and analyze the scores, the severity table is used. The severity table has been standardized in the FMEA Handbook.

2.PROBABILITY: The probability score is defined in with the preventive controls and the possibility of the error mistakes. As the probability score is determined, the cause of the error from the detection controls are assessed the possibility of emerging independently. During the assessment, the probability table is used. This table has been standardized in the FMEA Handbook.

3.DETECTABILITY: As the detectability score are determined, should be used the detectability table wherein the FMEA Handbook. With the current situation and controls, the rate of catching the error is detectable.

According to the result of the scores, the risk analysis table is defined as a high, low and medium priority. In accordance with the risk analysis table, to decrease the risks, high and medium priority scores should be found. And, to take preventive actions should be included at least the continuous improvement activities such as setting up the team, corrective, and preventive controls, making plans, dates, and records. During the severity scores, If the scores are the high and medium priority (max. 9-10 scores), should be made plans and taken actions. All improvements should be implemented and continued and followed regularly because the severity scores are the most important analysis. The severity level is not changed and the severity’s risk is always there. After all, when all necessary activities are completed, go to the next step.

STEP 6- OPTIMIZATION:

The previous step comes as input in the next step. The optimization includes the preventive activities, the detectable actions, the responsible persons, the project deadlines, the status, the evidence and the completed dates of the activities. The main goal is that to decrease the risk, should be built the FMEA team with all internal and external stakeholders and should be focused on potential faults. After all, when all necessary activities are completed, go to the next step.

STEP 6- DOCUMENTATION OF RESULTS:

The previous step comes as input in the next step. The last step is the documentation of results. The FMEA documentation should not be a lack. The result of the activity steps, the risk assessment report and the risk analysis results should be shared with related the employees, the customers, and sub-suppliers.