Difference between Planning and Preparation (Step 1: FMEA-1st Edition) and Planning (FMEA-4th Edition)

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Ethics is knowing the difference between what you have the right to do and what is right to do: Potter Stewart

Introduction

As per the Deming cycle (PDCA: Plan, Do, Check, Action), the key for an effective PDCA cycle is P (Planning). If a person or an organization is doing effective planning, the possibility of success enhances. 

Objective

Failure Mode and Effects Analysis (FMEA) is a well-established method in the manufacturing industry, commonly applied to optimize product/process reliability and cost. It requires cross-functional teams to identify and evaluate the product/process functions, to continuously improve them to reduce risks. The FMEA is a living document and is re-evaluated many times during its lifecycle.

The purpose of the Planning & Preparation (Step 1 as per FMEA Handbook: AIAG & VDA 1st Edition 2019) is aimed at facilitating complete understanding of the Product/Process by using different inputs like a lesson learned, baseline FMEA, customer requirements, Parameter (P) chart, Process Flow chart and Block diagram.  

Detailed Information

FMEA (Failure Mode & Effect Analysis) is a team-oriented, systematic, qualitative and analytical method to identify, analyze and mitigate the technical risks related to the ‘product and manufacturing process design.

The FMEA is the ‘Before the Event’ and not the ‘After the Event’ exercise.

7 Step Process:

  1. Planning & Preparation: Objectives, Project identification, plan boundaries
  2. Structure Analysis: Process Item, Process step, process work element
  3. Function Analysis: Intended Function/Requirement
  4. Failure Analysis: Failure Effect, Failure Mode, Failure Cause
  5. Risk Analysis: Prevention and Detection Control, Severity/Occurrence/Detection
  6. Optimization: Recommended Actions, Responsibility, target date, revised S, O, D
  7. Result Documentation

Planning & Preparation (Step 1: FMEA 1st Edition)

There are 5 key steps through which we can clearly understand the Planning & Preparation

  1. Project identification and boundaries
  2. Project plan (5T): InTent, Timing, Team, Task, Tools
  3. Analysis boundaries: what needs to be included and excluded
  4. Identification of baseline FMEA with the lesson learned
  5. The basis for step 2 (Structure Analysis)

 

  1. Project Identification and Boundaries

Identification of key points: It helps the organization to assure consistent direction, commitment and focus.

  1. What needs to be evaluated
  2. Type of FMEA needed for the customer program
  3. What to include and exclude?
  4. Any new requirements
  5. If FMEA is needed by the customer or the organization?
  6. If the organization is Product Design responsible or only Process Design responsible?
  7. If there is a need for system/subsystem/component/any other level of analysis?

Boundaries:

  1. Legal requirements
  2. Customer requirements and expectations like error proofing, QFD, field return, warranty policy etc.
  3. Requirement for Drawing, 3D data, Boundary diagram, Parameter diagram, Bill of Material (BOM) etc.
  4. Previous FMEA
  5. Novelty of technology
  6. Complexity of design
  7. Safety requirements
  8. Cyber security
  9. Processes that can impact the product quality like incoming inspection, production process, rework/repair process, packaging, labelling, storage etc.

 

  1. Project Planning: The plan for the FMEA helps the organization to be proactive in starting the FMEA early by using the 7-step process. Following are the 5 T’s which are useful in effective planning   
  1. InTent: Why are we doing FMEA?
  2. Timing: When it is due?
  3. Team: Who needs to be in the Team?
  4. Task: What work needs to be done?
  5. Tool: How do we conduct the analysis?
  1. Baseline FMEA:   
  1. Knowing what information is already available
  2. Like foundation FMEA, Family FMEA, similar FMEA

 

  1. FMEA Header: The header includes the basic information about the FMEA like Company name, customer name, Model, FMEA start date, revision number, CFT.

 

  1. The basis for structure analysis (Step 2)

Planning: FMEA 4th Edition (Old)

  • Understand the process intent
  • Process flow chart, Block diagram, P diagram
  • Preliminary risk assessment using the Process Flow chart
  • Identification of product effect from DFMEA
  • Understanding of the manufacturing process
  • Establish the scope of the analysis during FMEA
  • Identification of the relevant cross-functional team
  • Drawing, Bill of material, interrelationship matrix
  • Historical data, Lesson learned
  • Deciding Header for the PFMEA form

Present Challenges

  • How often the cross-functional team is clear about the requirements of step 1 and plan and prepare themselves accordingly?
  • How often are inputs like a lesson learned, customer warranty policy, cyber security, safety etc. are considered before preparing the FMEA?

References:

IATF 16949: 2016

FMEA Handbook (AIAG-VDA 1st Edition June 2019)

FMEA 4th Edition (AIAG- 2008)

Industry Experts

 

This is the 127th article of this Quality Management series. Every weekend, you will find useful information that will make your Management System journey Productive. Please share it with your colleagues too.

In the words of Albert Einstein, “The important thing is never to stop questioning.” I invite you to ask anything about the above subject. Questions and answers are the lifeblood of learning, and we are all learning. I will answer all questions to the best of my ability and promise to keep personal information confidential.

Your genuine feedback and response are extremely valuable. Please suggest topics for the coming weeks.

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Rameshwar Mall

Thanks again sir I’m studying all your blog and it’s a very useful because you are sharing your experience .Thanks for this and salute to you.

Sir please can you make a video on any type of trial if we doing for customer complaints what should we do before starting trial.