FMEA Preparation Guide

Doc # 10901 FMEA Preparation Guide 060302.
doc Revision Date: 6/3/2002

Facilitators Guide for Product FMEA Workshop
Failure Mode & Effect Analysis
(FMEA) Application Workshop
Preparation Guide

aCCredo Corp.
13267 SW Bull Mountain Rd.
Tigard, OR 97224

Ed Metzler -- President

503-624-2124
503-805-7758 (cell)
503-624-5723 (fax)
emetzler@accredo.com
aCCredo Corp. Page 1 of 12 1998-2002, aCCredo Corp.
Doc # 10901 FMEA Preparation Guide 060302.doc Revision Date: 6/3/2002

Background -- Failure Mode and Effect Analysis
Introduction:
Failure Mode and Effects Analysis (FMEA) is a brainstorming, prioritization, and
action item definition risk assessment process performed by a multi-disciplined
team from design, manufacturing, quality and field engineering. The goal of
FMEA is to assure that the most critical failure modes of a system, product
design, process or security approach have been identified and addressed before
they occur. FMEA is, therefore, an anticipatory process utilized to reduce overall
costs and improve customer satisfaction.
For years, FMEA has been an integral part of product development and has
grown to be one of the most powerful and practical process control, reliability and
risk assessment tools for manufacturing environments. Most notably, the
automotive industry has adopted FMEAs for evaluating risk in the design and
manufacturing of automobiles. The American Society for Quality (ASQ) and the
Automotive Industry Action Group (AIAG) chartered the ASQ/AIAG Task Force to
standardize FMEA reference manuals, procedures, reporting formats and
technical nomenclature. These resources are used for FMEA by Chrysler, Ford,
and General Motors internally and in their respective supplier Quality systems.
FMEA is a requirement for companies subscribing to QS-9000.
The US Military (i.e., Air Force, Navy) require FMEAs for all systems to ensure
safety as well as reliability. And, for the most part, FMEA has become an
indispensable tool for the aerospace industries. Sematech references FMEA in
their FMEA Guide for Continuous Improvement for the Semiconductor Equipment
Industry (Sematech 92020963A). The European Union (EU) ISO 9004 quality
standard identifies FMEA as an effective tool for insuring quality product design
and manufacture. The FDA has issued a quality planning bulletin (FDA 90-4236)
urging implementation of FMEA during pre-production phases.
Although there are several types of FMEAs (e.g. system, product, design,
process, materials, automation, security, etc.) and approach varies from site to
site, one common factor has remained through the years -- resolving potential
problems (risks) before they occur.

Table of Contents

BACKGROUND -- FAILURE MODE AND EFFECT ANALYSIS.....................................................................................2
FMEA PLANNING....................................................................................................................................................................4
FMEA PLANNING CHECKLIST...........................................................................................................................................6
FMEA PARTICIPANT SELECTION.....................................................................................................................................7
FMEA WORKSHOP MATERIALS LISTS..........................................................................................................................11
FMEA CONFERENCE ROOM SELECTION.....................................................................................................................12

FMEA Planning
Leader/Facilitator pre-meeting:
Note: use the FMEA Planning Checklist for documenting agreement
The Facilitator should conduct a pre-meeting with the FMEA session Leader and one or two
key session participants (co-leaders) prior to first session announcement. A checklist is
included at the end of this section to document the meeting outcomes.
Select the target product or process for which the FMEA will be conducted. Usually this
product or process is known prior to the pre-meeting.
Define scope of the FMEA (i.e. match level of detail and complexity with available time).
For example, rather than selecting an system assembly, focus instead on the sub-
system. The purpose of limiting the scope is to assure that closure can be attained on
specific action items rather than being overwhelmed by complexity. A model, in either
drawing or physical form, is necessary to provide boundaries to keep the FMEA
workshop on track. This model should be presented by the Leader at each session
Identify target customers to consider when brainstorming failure modes. These
customers may be internal or external. For example, the customers for a new Pen
design might be the actual end-user who installs it in their printer. In that case failure
modes considered would be established from their point of view. An example of an
internal customer might be the production organization in the case of a new
manufacturing process. It is usually necessary to select only a single customer (e.g. the
external end-user) or class of customers (e.g. internal users of an automation system or
new process).
Define the level of detail and sources of ideas that will be considered as failure modes.
For example, it may be more important to deal with interfaces between processes rather
than the detail of an individual process step. We call this stratification -- segmenting
the problem into manageable chunks. Facilitator note: a good break point is 200 failure
modes. More than 200 are extremely difficult to manage with an affinity diagram.
Define the baseline on which failure severity, frequency of occurrence and detectability
should be related. Should brainstorming and risk assessment be based on results from
prototype builds, prior comparable products, or field failure analysis? Setting a baseline
is very critical since a product or process development effort usually follows a plan of
record; with multiple steps until final release.
Select appropriate participants (use participant guidelines).

Leader/Facilitator pre-meeting (continued):
Describe roles and responsibilities of the Leader, co-leaders and participants (see
roles and responsibilities section).
Set expectations for time involved (usually two 4-5 hour FMEA sessions). Assure
commitment for Leader and co-leaders to actively participate in both sessions. If unable
to attend both sessions, assure alternate Leader is assigned or reschedule.
Agree on an approach for follow-up to assure action items are completed and the
solutions re-evaluated with the FMEA matrix. A database is usually required to enter,
track and follow-up on issues resulting from the FMEA sessions. We recommend
eRoom.
Review FMEA process by briefly stepping though the session instruction guide.
Schedule meetings with one week between Sessions 1 and 2 if possible.
Identify conference room to be used and assure it has the appropriate layout and
features. (use Conference Room Selection guidelines).
Finalize Leader and co-leader identification for the session.
Request that the Leader send out invitation two weeks prior to the session.

FMEA Planning Checklist
Facilitator/Leader Checklist:
1. Target product or process:
2. Leader and co-leader identification:
3. Customers:
4. Perspective (point-of-view):
5. Scope:
6. Stratification or level of detail:
7. Baseline:
8. Roles and responsibilities (see write-up):
9. Participant selection:
10. Workshop process clarification:
11. Schedule (Date, Time and location):
12. Invitations:
13. Handouts:
14. Action Item follow-up methodology:

FMEA Participant Selection
Selection Guidelines:
The following are suggestions for the membership of FMEA teams. Team size should be
between 6 and 12 participants with 10 being optimal.
Product FMEA
Design/Project Manager -- Leader
Designer(s) -- Product Design
Manufacturing Development Engineer(s) -- Process Design
Production Engineer(s) -- Process Capability
Quality/Customer Engineer(s) -- End User
Product Engineer(s) -- End User
Procurement Engineer(s) -- Supplier Relationship
Supplier Engineer(s) -- Outsourced Design
Process FMEA
Manufacturing Development Engineering Manager -- Leader
Manufacturing Development Engineer(s) -- Process Design
Designer(s) -- Product Design
Supplier Engineer(s) -- Outsourced Process Equipment/Processing
Materials Specialist/Chemist(s) -- Material Selection
Technician(s) -- Equipment
Process Operator(s) Operations


Selection Guidelines (cont.):
Material FMEA
Materials Specialist/Chemist Manager -- Leader
Materials Specialist/Chemist(s) -- Material Selection
Procurement Engineer/Buyer(s) -- Supplier Relationship
Supplier Engineer(s) -- Outsourced Materials
Process Operator(s) -- Operations
Automation FMEA
Automation Systems Design Manager -- Leader
Automation Design Engineer(s) -- Software/Hardware Design
MIS Engineer(s) -- Software Design
Process Operator(s) -- Operations
Facilities Engineer(s) -- Production Area Design
Supplier Engineer(s) -- Outsourced Automation Equipment

FMEA Roles and Responsibilities
Facilitator:
The Facilitator shall have a working knowledge of the ACCREDO FMEA process.
Experience with statistical methods and good facilitation skills are required. A
background with high-tech product and process design is highly desired. The
Facilitator should feel comfortable relating other experiences with FMEA and in
answering technical and application questions that arise. The Facilitator must:
Guide the pre-meeting and provide FMEA introductory training for the Leader and
ad-hoc leaders.
Provide set-up and tear-down of facility work aides (e.g. posters, affinity diagram,
etc.).
Provide a stimulating environment for drawing ideas from all participants during the
FMEA sessions. Assure a balancing of views.
Keep the session on track and on time.
Provide FMEA Workshop process expertise and assure that the process follows
these Facilitator Guidelines (or change the guidelines if they do not work).
Document the Affinity Diagram, Tree Diagram and FMEA Matrices based on
workshop outcomes.
Cooperate with and support the Leader to assure workshop success.
Leader:
The organizational level of the Leader is typically peer-plus-one in order to
provide control and discipline of the meeting. The Leader should provide an
environment for exposing of failure modes without blame and for assuring that
there is full and broad representation in the FMEA sessions. The Leader should:
Provide and present introductory comments on: Why are we here? What do we
hope to gain? How does this fit with other activities? Clarification of the target
product, scope (model), customers, perspective, stratification, participant selection
and baseline.
Lead by actively participating without overwhelming or dominating other participants.
Support the facilitator in following the FMEA process
Provide real-time direction when dealing with controversial issues.
After consensus on action items reached in workshop, assure support, tracking and
progress reporting.
Assure that room arrangements are made and meeting announcements are sent out
two weeks prior to the initial session.

Roles and Responsibilities(cont.):
Participants
Participants are chosen based on their knowledge of the issue being examined.
They should be the experts that will provide illumination of failure modes -- their
severity, frequency of occurrence and detectability. Finally, they should be
empowered to recommend action items for resolution. All Participants should:
Attend all FMEA sessions
Provide an assessment of failure modes and their seriousness
Actively participate and support the FMEA process (i.e. be patient enough to stick
with it and recommend improvements)
Follow up and report on Action Items
Re-evaluate FMEA rating after Action Items (solutions) are implemented
Other Setup suggestions:
Minimum workshop size = 6 people. Maximum workshop size = 12 people.
Schedule both FMEA sessions for when people would be most alert. Generally,
reserving 8:00 am to 1:00 p.m. works well. Always end before or on time.
Be sure to time breaks consistent with recommendations in the Facilitators Guide.
However, be flexible. Plan breaks with Leader and participants.
Be sure to get the critical contributors to attend the session. If not present, assure
that the Leader understands the risk and makes an informed decision.
Set up the room ahead of time. Be sure to schedule the room to allow at least a 1/2
hour for setup and another 1/2 hour for tear down. Assure that at least a 15 foot
wide clear area is available in front of the plotter paper to ameliorate the crowded
feeling when constructing the affinity diagram. Put up FMEA Matrix posters only for
session 2.
The blank surface for the affinity diagram and tree diagram should be prepared by
placing three ~ 20 x 3 pieces of plotter paper on the wall so that the edges just
overlap. Secure corners and middle with tape so that movement of post-it notes will
not pull the paper away from the wall. TAPE THE PLOTTER PAPER ON THE
WALL BEFORE BOTH SESSIONS.

FMEA Workshop Materials Lists
List of participant materials:
Each participant attending the FMEA Workshop should be provided with a:
Copy of FMEA Workshop PowerPoint slides in paper handout form
Name tent
Pad of paper
Felt tip marking pen (use the aromatically pleasing variety)
One pack of 3 x 5 post-it notepads

List of facilitator materials:
FACILITATORS MATERIALS consist of:
The Facilitators Guide document
FMEA Workshop PowerPoint slides
Blank plotter paper rolls and masking tape (for affinity and tree diagrams)
Blank FMEA Table poster (for placement on wall)
Brainstorming guidelines & Action Required [examples] poster (for placement on wall)
Severity, Occurrence and Detection Ranking posters
(set of 3 posters for placement on wall)
Participants sign-in sheet
Multi-media projector
Several extra 3 x 5 Post-it notepads and aromatically pleasing marking pens
Flip charts (2)
Box of foam balls for entertainment during session

FMEA Conference Room Selection
Conference Room requirements:
The conference room needs to have sufficient blank wall space on which to place posters and
plotter paper. There must be room for construction of the Affinity and Tree Diagrams during
which the entire team will be adjacent to the BLANK WALL area. An ideal conference room
layout is shown in Figure 1 below:
20 FEET
BLANK WALL SPACE
P
B
L
A
N
K
O
S
T
E
R

W
A
L
L
S
30

S
P
A
C
E
FEET
RE
FRESH
MEN

LOC
ATION
FLIP
CHART
PROJECTOR
WHITEBOARD / SCREEN
DOOR

Figure 1 -- FMEA Workshop (Ideal Room Requirements)

FMEA Preparation Guide

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Doc # 10901 FMEA Preparation Guide 060302.

doc Revision Date: 6/3/2002

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