FMEA_Preparation_Guide_060302
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FMEA_Preparation_Guide_060302


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Doc # 10901 FMEA Preparation Guide 060302.doc Revision Date: 6/3/2002 
 
Facilitators\u2019 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 
 
Facilitators\u2019 Guide for Product FMEA Workshop 
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. 
aCCredo Corp. Page 2 of 12 © 1998-2002, aCCredo Corp. 
Doc # 10901 FMEA Preparation Guide 060302.doc Revision Date: 6/3/2002 
 
Facilitators\u2019 Guide for Product FMEA Workshop 
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 
aCCredo Corp. Page 3 of 12 © 1998-2002, aCCredo Corp. 
Doc # 10901 FMEA Preparation Guide 060302.doc Revision Date: 6/3/2002 
 
Facilitators\u2019 Guide for Product FMEA Workshop 
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. 
\u2022 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. 
\u2022 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 
\u2022 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). 
\u2022 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. 
\u2022 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. 
\u2022 Select appropriate participants (use participant guidelines). 
aCCredo Corp. Page 4 of 12 © 1998-2002, aCCredo Corp. 
Doc # 10901 FMEA Preparation Guide 060302.doc Revision Date: 6/3/2002 
 
Facilitators\u2019 Guide for Product FMEA Workshop 
Leader/Facilitator pre-meeting (continued): 
\u2022 Describe roles and responsibilities of the Leader, co-leaders and participants (see 
roles and responsibilities section). 
\u2022 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. 
\u2022 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. 
\u2022 Review FMEA process by briefly stepping though the session instruction guide. 
\u2022 Schedule meetings with one week between Sessions 1 and 2 if possible. 
\u2022 Identify conference room to be used and assure it has the appropriate layout and 
features. (use Conference Room Selection guidelines).