What is FMEA? The full form of FMEA – FMEA is known as failure mode and effect analysis. This blog post helps you to understand the concept of FMEA, FMEA meaning, FMEA template, FMEA analysis, benefits of FMEA, and application of FMEA.
Is FMEA a quality tool?
Yes FMEA is a quality tool. The purpose of FMEA is an early estimation & elimination of failure mode involved in the product system, design, and manufacturing process. FMEA helps to deliver a quality product to customers on time. FMEA method helps in deriving potential failure modes in the process or product. This tool helps to minimize or eliminate failure mode in product design / manufacturing processes and improve quality.
To understand what is Failure mode effect analysis & FMEA process, please watch the following short video.
Why FMEA is so important?
Early estimation and controlling of potential failure mode in design/process helps to ,
- to avoid product recall.
- to avoid customer dissatisfaction
- to avoid loss of market share
- to avoid loss of reputation
- to avoid legal action
- to mitigate risk (risk management)
To read more about risk management, please click the link (risk management word)
Benefits of FMEA
- On-time delivery of the Quality product to a customer.
- Higher accuracy in designing & manufacturing of products.
- Better control of verification and validation of design.
- Better co-ordination between design, manufacturing engineering, supplier, quality team.
- Less rework in the design phase.
- No/very low risk of product failure in the market.
- Less rework and repair in the pre-production phase.
- Better customer satisfaction & better market reputation.
What are the types of FMEA?
This type of FMEA mainly conducted to detect potential failure modes within the system due to the interaction of different components. This FMEA is commonly known as S-FMEA.
- S-FMEA of a fuel injection system of a new engine to meet new emission norms.
- S-FMEA of a new car’s drive system to cross-check torque & speed rating.
- S-FMEA of disc brake
What Is Design FMEA?
Design FMEA mostly used in new product development. Design FMEA helps in detecting potential failure mode in the product. Design FMEA is also known as D-FMEA.
- D-FMEA of a new fuel injector.
- D-FMEA of a new car tire.
- D-FMEA of brake pad
The application of this FMEA type is to detect potential failure modes in the manufacturing/assembly process. This FMEA type is commonly known as P-FMEA.
- P-FMEA of the newly developed manufacturing process of a fuel injector.
- P-FMEA of the newly developed manufacturing process of a tire.
- P-FMEA of brake pad manufacturing and assembly
Content in FMEA
- Process Step No (in S-FMEA / D-FMEA tool process step can be replaced as Engineering Change Notice)
- Process Step / Flowchart step Description (in S-FMEA / D-FMEA tool process step can be replaced as components / parts description)
- Potential Failure Mode:
- Effects of Failure Mode:
- Severity rating
- Causes of Failure (Root cause analysis)
- Occurrence rating
- Current Potential Prevention / Detection control (Refer CAPA)
- Detection rating
- RPN (Risk Priority Number)
When to deploy FMEA?
The following ideal scenarios can be considered for FMEA implementation?
- New product development (from concept design to serial production).
- Enhancement in the existing product.
When should FMEA be updated?
- On-going engineering changes in the product
- Increased customer complaints
- Change in the manufacturing process
- Changes in the raw material, specification
- Localization of existing products in the new market and at a new manufacturing site.
- Changes in the product to meet statutory and regulatory requirements in the country of sale.
- Change in the manufacturing location
- Product recall
- To meet improved Quality goals / KPI.
- Migration from manual work to automation or vice versa.
Confused about how to implement FMEA for a new product?
What are the steps of the FMEA process?
Don’t worry, please follow simple steps for FMEA implementation.
- Shortlist a product line or process based on the project charter. Priority should go for a product or process which requires high lead time for design and development.
- Team formation: This is an important step to form the right team members for the effective implementation of FEMA. Team members must comprise of design engineer, process engineer, product quality engineer, supplier quality engineer, production engineer, and other stakeholders eg. maintenance team, logistics team, procurement team.
- Data Collection: Before you start with drafting FMEA, it’s better to collect data from different stakeholders like design specification, drawings, warranty data of the previous product line, draft SOP (standard operating process), draft design data, draft manufacturing process flow diagram, product & process key characteristics.
- FMEA Lead: Ideally FMEA should be driven by the Quality assurance team. The quality assurance team should lead to FMEA activities for better control and monitoring of risk analysis. FMEA lead must schedule a brainstorming session, action items in FMEA meeting
- FMEA Brainstorming Session 1: With the presence of the cross-functional team (design engineer, process engineer, production engineer, industrial engineering, procurement) identify potential failure modes in the system/design or the manufacturing process. List down all essential potential failure modes, effects of each potential failure mode. In this session, focus on potential failure mode and it’s an effect.
- FMEA Brainstorming Session 2: In this section focus on severity level, causes of failure, occurrence level, of each effect of failure, current potential prevention action, and current prevention control and detection control and detection rating.
- Severity Rating, Occurrence Rating & Detection Rating Guideline: If your organization is the first time deploying FMEA, drafting severity, occurrence, and detection rating need another brainstorming session. If guidelines for severity, occurrence, and detection rating is already defined, FMEA lead should use this guideline and draft the FMEA.
- RPN: Risk Priority Number is the product of Severity, Occurrence & detection. RPN = Severity X Occurrence X Detection. Most of the organization define RPN threshold to initiate action to reduce occurrence and detection level. It’s a common practice to initiate actions if RPN is greater than 100.
- Action Items & risk mitigation: Considering RPN greater than 100, the cross-function team should focus on reducing the risk level by implementing following prevention and detection control (example). FMEA action items must be tracked for effective implementation of FMEA.
|Prevention Control||Detection Control|
|Design mistake proofing||Product testing after final assembly|
|Poka-Yoke / Error proofing in process||Inspection of parts before assembly|
|Nut / screw tightening by programmed DC Nut runner||Nut / screw tightening by|
|Automation – Programmed robotic welding||Manual welding inspection by laser detector.|
What is RPN formula?
RPN = Severity x Occurrence x Detection
What is FMEA explain with example?
Do watch YouTube video about Design-FMEA of brake system.
How is FMEA effectiveness measured?
FMEA will not be effective without preventive and detection action implementation. Prevention and detection actions mandatory in order to mitigate the risk involved in the design or process. Regular follow-up with stakeholders is very essential for the on-time implementation of prevention or detection action items. Revised RPN shall be calculated based on the implementation of prevention and detection action. Revised RPN must be documented with revision control and FMEA implementation effective date and stake holders sign off.
Is FMEA a living document?
Yes, FMEA is a live document. Whether it’s system, design, or process FMEA, FMEA will remain as a live document until the production & end of the life of the product. Once the product is phased out, FMEA documents are still retained as reference & legal documents.
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