What is FMEA & PPAP During Quality Transformation?

“You don’t learn to walk by following rules. You learn by doing, and by falling over”

Richard Branson

What is FMEA?

FMEA (Failure Mode and Effective Analysis) is a step-by-step approach that uses numerical assignments to find out the risk associated with each input. So, It is a risk assessment tool, that evaluates the severity, occurrence of all possible ways a process or product could fail, and detection of risks to prioritize which ones are the most urgent. Thus, FMEA is a tool that determines potential problems & their impact.

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• Failure modes means the modes, in which anything ought to fail. Failures are any defects or errors, particularly ones that affect the consumer.
• Effect’s analysis indicates eyeing the consequences of those failures.

In other words, FMEA asks & answers:

• What could go wrong?
• Why did the failure occur?
• How likely is this failure?
• What could be the consequences of each failure?

FMEA aims to remove or reduce failures as well as starts with the highest-priority ones. FMEA is an energetic approach that applies early in development to help designers create quality as well as reliable processes from the beginning and continues throughout the life of the product or service.

The two most famous types of FMEAs are Design (DFMEA)and Process (PFMEA).

See Also: 3 Component of Standard Work in Lean Transformation

Criteria for FMEA Analysis

Each category has a scoring matrix with a 1-10 scale.

• A severity of 1 indicates a low risk to the end consumer, and a score of 10 indicates a high risk to the consumer.
• An occurrence of 1 indicates a low probability of the risk happening, and a 10 indicates a very high probability of the risk happening.
• Detection of 1 indicates a process that will likely catch a failure, and a 10 means the process will likely not catch a failure.

When scoring of every category completes for every risk, the 3 scores are multiplied together (Severity x Occurrence x Detection) to find the Risk Priority Number (RPN). Further, The RPNs sorts from largest to smallest, and take actions on the top risks to reduce the complete risk.

Setting FMEA Priorities

After the failure modes have been identified, the team should adjust the FMEA to record failures in descending RPN order which depends on many factors, including industry standards, legal or safety needs, and quality control. But, a beginning point for prioritization is to apply the Pareto rule: typically, 80% of issues are caused by 20% of the potential problems. So, It means teams can concentrate initially on the failures with the top 20% of the highest RPN scores.

Also See- ISO 9001- An enabler for real Quality Transformation

Making FMEA Corrective Actions

When the priorities are clear, one of the team’s final steps is to develop the right corrective actions for decreasing the occurrence of failure modes, or at least for improving their detection. 

Once corrective actions have finished, the team should meet again to reassess and rescore the severity, probability of occurrence & likelihood of detection for the top failure modes. This will enable them to determine the effectiveness of the corrective actions taken during business transformation.

Generally, the severity cannot be reduced, so the team should find ways to reduce the occurrence or increase detection. Hence, After actions are completed, the RPNs are recalculating, and new risks determines. 

Benefits of FMEA

• Cost-effective.
• Failure reduction.
• Shortened lead time.
• Improved communication & Systems.
• Formal risk assessment.
• Improved customer satisfaction

Key Elements of an Effective FMEA

• Timeliness.
• Teamwork.
• Documentation.
• Process/Procedures.
• Structured approach.

Who performs and supports FMEA?

Management’s role (Eng. / Ops.)

• Management is the owner of the FMEA process.
• He ensures the availability of resources (people, time, travel cost, etc.)
• Eliminates roadblocks.
• Demands to use the FMEA properly – not only tolerate its use or use it in each case.

We use FMEA When:

• When an existing process, product, or service modifies.
• When analyzing a new process, design, product, or service.
• When improvement goals are plan for an existing process, product, or service.
• When analyzing failures of an existing process, product, or service.

FMEA Stages

1. Background Stage-

• The FMEA team assembles consisting of relevant cross-functional members.
• Objectives, timelines, and roles are agreed upon.
• Background data is collected for team members to review.

2. Draft Stage-

 The Team Leader drafts the following parts of the FMEA form:

• Item/function/requirements columns,
• Potential failure modes,
• Potential effects of failures,
• Potential causes/mechanisms of failure, and
• Current controls.

The draft is then distributed to the team along with the background data.

3. Team Review Stage-

Team members review the draft FMEA form and:

• Identify additional failure modes, effects, causes, or controls, and
• Provide preliminary rankings for severity, occurrence, and detection.
• Team members submit their drafts to the team leader.
• Team leader adds to team’s comments to the original form as well as creates a composite FMEA.
• Composite copies distributes to team members.

4. FMEA Meeting Stage-

 The team meets to:

1. Review and discuss the composite form,
2. Reach consensus on severity, occurrence, as well as detection,
3. Calculate risk priority numbers (RPNs),
4. Develop recommended actions to eliminate or reduce the risk of failures, and
5. Agree on responsibilities and timing for all recommended actions.

The recorder completes the FMEA form and distributes it to the team members.

5. Implementation Stage-

• Recommended Actions takes to eliminate the cause and/or improve controls.
• Progress is monitored against the plan.
• RPNs revises data based on evidence of reduced risk.

Timing for Standard 5-Step Approach

Most common problems with FMEA-

1. Focus People-

• Not involving all of the right people – executing an FMEA is always Teamwork!
• Lack of involvement as well as commitment.

2. Focus Process-

• Not performing FMEA’s early/timely enough.
• Inadequate linkage to other key activities such as Process Flow, Control Plans and Work Instructions.
• Omitted process steps (material handling, rework, labeling.
• Fail to define the function of the system/sub-system analyze.
• Fail to properly identify the customer.

3. Focus Method-

• Not documenting the results in a proper as well as understandable way.
• Not addressing critical customer/process issues.
• Lack of in-depth analysis of potential failures, effects, as well as root causes.
• Improper/inconsistent ranking.
• Efforts focused on Detection rather than Prevention.
• Confusing failure modes with effects or failure modes with causes.
• Developing recommended actions that are neither actionable nor executable.
• Applying occurrence and detection too optimistically.
• Allowing the Design FMEA to turn into a design review.
• Not separating clearly a Process FMEA from a Design FMEA.

The Design FMEA addresses a design intent and assumes the design will manufacture/assemble to this intent. The Process FMEA focuses on possible failures that happen during the manufacturing process of quality transformation.

PPAP (Production Part Approval Process)

The production part approval process is one of the finest ways of ensuring the quality standards of Components supplied & their production process. Further, PPAP was developed by Automotive Industry & it’s an essential part of the broad Advanced Product Quality Planning (APQP) approach.

This approach is a lengthy package that outlines the methods used for approval of production & service items, comprising bulk materials, and including a part submission warrant. So, It process records the ability of your supplier to meet all customer needs and improve the quality systems. 

PPAP process can also be used to give confidence to your customer that you can meet their requirements.

PPAP Levels

1. Production Warrant and Appearance Approval Report.
2. Production warrant, product samples, as well as dimensional results.
3. Production warrant, product samples, and complete supporting documents.
4. Production warrant and other documents as instructed by the customer.
5. Production warrant, product samples, and other supporting documents. So, At this level, a review is conducted at the supplier’s manufacturing location.

Elements of PPAP

1. Design Record :

It contains the list of all the designs a supplier offers to a particular client.

2. Authorized Engineering Change Document:

Additionally, This documentation usually consists of a copy of the Engineering Change Notice (ECN), which must be approved by the customer engineering department. So, If not yet recorded in the design records, any authorized engineer’s changes in the product or the process of VUCA are mentioned under this heading.

3. Customer Engineering Approval:

Few changes are also termed he “core changes” which need the authorization of the customer. Hence the customer approval documents must collected as well as recorded.

4. FMEA:

It refers to failure modes and effect analysis which are further divided into two parts:

• DFMEA: Design FMEA is a cross-functional activity that examines design risk by exploring the possible failure modes and their effects on the product or customer as well as their probability to occur.
• PFMEA: Process FMEA is in need to make sure the risk of failure is lower in the process, and evidence is needed to be submitted for the same.

5. Process Flow Diagram:

It outlines the complete process for assembling the component. So, The process flow includes incoming material, assembly, test, rework, and shipping. Thus, It creates transparency.

6. Master Sample:

The master sample determined based on the type of product. Thus, If the material is in bulk & unchanging over the passage of time, then, the physical sample is a master sample but if the bulk material changes with time such as fingerprints, the analytical sample is a master sample.

7. Test Results In The Documentation:

A record of material as well as performance test results are conducted to make sure that the material quality and functional requirements satisfy the design record or control plan.

8. Initial Process Capability Study:

These studies reveal that the critical processes are stable, reveal normal variation as well as are running near the intended nominal value in digital transformation.

9. Measurement System Analysis Studies:

These studies will include Gage Repeatability & Reproducibility (GR&R) studies on measurement equipment used during assembly or quality control checks. Further, Calibration records for all gages and measurement equipment must be included.

10. Control Plan:

The control plan is divided into 3 types- Prototype, Prelaunch & production. So, The format of the control plan must comply with IATF 16949:2016 requirements. Thus, The Control Plan lists all product Special Characteristics and inspection methods needed to deliver products that continually meet the customer quality requirements.

11. Part Submission Warrant:

It is the summary of the complete PPAP process. Further, The above observations is in need to submit to the consumer along with the Appearance approval report.

Conclusion

A PPAP summary also makes it very manageable for customers to distinguish issues or defects early in the production process, certainly lessening time and saving costs. So, FMEA can help to observe and eradicate concerns early in the improvement of a process or new service delivery. It is a standardized way to evaluate a process prospectively for apparent ways in which failure can arise, and then redesign the procedures so that the new model eradicates the likelihood of failure.

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Key Takeaways

• FMEA anticipates and addresses potential failures, enhancing product reliability and customer satisfaction.
• PPAP verifies supplier quality, minimizing defects and ensuring consistent product excellence throughout transformation.
• Integrating FMEA and PPAP streamlines quality efforts, fostering a culture of continuous improvement during transformation initiatives.