Lesson 5

The Form: Issue Resolution Section

5-1
 Lesson 5 - Objectives

Upon completion of this lesson, you will be able to:

Understand the purpose of the Issue Resolution section.

Determine appropriate entries and complete the Issue

Resolution section.
• Recommended Action(s)
• Responsibility
• Target Completion Date
• Actions Taken
• Revised Severity
• Revised Occurrence
• Revised Detection
• Revised SOD

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 The Issue Resolution Section

The Issue Resolution section requires answers to questions such as:

• What should be done to reduce the potential risk?

• By whom and when will the actions be done?

• What were the results of the actions?

• How do the actions taken affect the risk?

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 Issue Resolution Overview
What is the revised What is the
Occurrence rating? revised
Detectability
rating?

What should be Who is responsible for When What was the result
done to reduce the recommendation? is it of the The combination of
the risk? going recommendation? the revised Severity,
Reduce either to be Can refer to lab Occurrence, and
Severity, done? reports, print Detection.
Occurrence, or specifications, or
Detection. PHM, etc.

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 Risk Assessment
Each row in an FMEA represents an issue (or a
potential issue).

Discipline must be exercised in documenting a

method of resolution for issues.

All critical Design and Process Failure Modes/Causes

must be resolved prior to Production Release.

Critical issues must be determined before

Recommended Actions can be identified.

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 Risk Assessment
Review the SOD and determine areas requiring
additional work.

• If the risk is too high, based on SOD, determine additional

actions to reduce the Occurrence and Detection.

• If the risk is considered low, then simply carry out the

prevention / detection plans to validate the SOD.

• The validation can be done through the test plan (Product

Approval Plan), control plan, development testing, analysis,
design changes, customer studies, etc., as defined in the
Prevention and/or Detection Columns.

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 Risk Assessment for
Safety Issues
Safety related hazards (Severity ‘9’) identified in the FMEA are to
be addressed through the Corporate Product Safety System:
• The list of hazards are to be shared & reviewed in the Product Safety Audit.

• Closure of a safety related item in the FMEA requires the following:

• The Safety Audit process will drive/help define the appropriate Prevention /
Detection / Recommended Actions.
• Safety risk assessment for safety items must be completed and show an
acceptable risk level for Product Approval or First Part Approval.
• Process FMEAs can and may identify the need for PHMs related to design
and design changes.

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 Recommended Actions
The Recommended Actions column is used to document action
plans to reduce risk (Severity, Occurrence & Detection). Risk
reduction can be accomplished by actions such as:
Changing the Design or Process
Improving the Prevention Method
Improving the Evaluation Method(s)
More than one action may be entered.

Note: It is assumed that the Design Controls will

What should be be carried out. The Recommended Actions
done to reduce column represents additional actions, over and
the risk? above the Design Controls.
Reduce either
Severity,
Occurrence, or If a design/process change is made, the
Detection. team needs to review the change to insure
it does not introduce any new Failure
Modes/Causes.

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 Recommended Action
Examples
When Severity, Occurrence & Detection values are low, simply state
the reason your team opted to not continue to populate the row.
When the initial Severity, Occurrence & Detection are high, you need
to document what steps you plan to take to lower the SOD.

Plan #1 Subsequent Plans

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 Responsibility/
Target Completion
The Responsibility and Target Completion Date columns identify
who ‘owns’ the Recommended Action and the targeted
completion date.
Enter the name of the:
• Organization Responsible and/or
• the Individual(s) Responsible

Enter the expected completion date

Who is responsible When

for the is it
recommendation going
to be
done?

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 Exercise 8
Risk Assessment

For each Cause of Failure, determine if the risk associated with the
SOD is acceptable. Then fill in the Recommended Actions,
Responsibility & Target Date columns.

Discuss the FMEA content and its relevance to the CET TDP tollgate.

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 Actions Taken

The Actions Taken column is used to document a brief

description of the results of the Recommended Actions.

Actions Taken is intended to justify any changes made to

the revised Severity, Occurrence and Detection ratings.

The information in the Actions Taken column can include

reference to other documentation such as a specific
control plan, maintenance schedule, lab report #, Product
Hazard Management documents, etc.
What was the result
of the Never leave the Actions Taken column blank for rows
recommendation? where the Severity = ‘9’. At a minimum, ‘Not Applicable’
Can refer to lab should be entered in the Actions Taken column.
reports, print
specifications, or For safety related items, the Actions Taken column
PHM, etc.
should:
• reference the safety analysis documents or the actions
following the safety hierarchy, and

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 Reassessment of Risk / SOD
The final columns in the FMEA are used
to document the team’s reassessment of
Severity, Occurrence, Detection and SOD
based on the results of the
Recommended Actions / Actions Taken.

These final columns show, quantitatively,

that critical issues have been resolved.

What if the final SOD is too high?

If the risk reflected in these final columns is not
acceptable, a new row should be added to the
Reassessment
FMEA and additional Recommended Actions
should be defined.

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 Line Item Closure
Line item closure can be obtained by either:

• Providing documented evidence that the Failure

Mode/Cause/Design Control combination is not significant
and does not require further action (for example: A low
S,O,D rating).

• Providing documented evidence that the presumed risks are

adequately addressed and are therefore insignificant (for
example: Actions Taken reduce the S,O,D ratings to an
acceptable risk level).

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 Closing Rows in an FMEA
When the initial Severity, Occurrence & Detection are high, you
need to document what steps you took to lower the SOD.

More than
one action
may be
required.
Simply add
a row in
the FMEA.

Plan #1 Subsequent Production

Estimate
Plans

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 Closing Rows in an FMEA
We are fast approaching production release and there are some
SOD values that my team cannot reduce. What do I do?

If the decision is to proceed to production, as is, note in this box:

For Severity ‘9’:

Refer to the safety criteria on the next slide.

For Severity of ‘7’ or less:

1) Actions Taken to reduce SOD, if applicable, AND
2) Describe the business / technical case for proceeding, (and/or see the Letter of Finding.)
3) Note the plans to address the issue post-production (e.g., Corrective Action number).

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 Reassessment of Safety Issues
In the FMEA, safety items are given a Severity of ‘9’. In order to illustrate
closure of a safety related item in an FMEA, the Occurrence and Detection must
be 0, 0. (SOD = 900)

Before a 0,0 can be assigned to Occurrence & Detection (in the Issue
Resolution section) the following requirements need to have been met . . .

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 Reassessment of Safety Issues

‘0’ is only to be
used in the
Issue Resolution
section of the
FMEA.

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 Reassessment of Safety Issues

‘0’ is only to be
used in the
Issue Resolution
section of the
FMEA.

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 Validation of the Design/Process
Changes
In the late 1980s, IBM determined that 80% of all
Engineering Change Notices (ECN) were directly the
result of previous ECN!

Lesson Learned at IBM’s expense:

• When making a change to the design (process), verify
through testing that the design change does not introduce
other failures elsewhere in the design.

• Consider the plans for verifications and implementation as

additional Recommended Actions in the FMEA.

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 Exercise 9
Risk Assessment

For each Cause of Failure, fill in the Action Taken. Reassess the SOD
and determine if additional actions are needed. Fill in the FMEA form
appropriately based on your risk assessment.

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 Whirlpool’s Product Quality System
WPQS Guidelines:
FMEA documentation must be at an approved and released
level for each Technical Design Preview (TDP) tollgate, Product
Approval (PA) and First Part Approval (FPA).

For Product Approval or First Part Approval, safety risk

assessment for safety items must be complete and show an
acceptable risk level.

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 Issue Resolution and TDP
At the Business Evaluation Tollgate (BET)/Design Release Milestone
(DRM), teams should have completed the Issue Resolution section of the
FMEA.

• DFMEAs updated through Actions Taken, and updated SODs are meeting
project requirements.

• Production approval test plans finalized.

• PFMEAs updated through SOD, prioritized, and associated action plans

developed.

How does this impact your project?

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 Issue Resolution Summary
Completion of the Issue Resolution section provides:
• Design/Process issues that have been OR are being ________.

• A Product Approval Plan is _________.

• A ________ Plan is developed.

• Control Plans address ________ ________ of the line.

• The Customer Focus & Engineering Focus sections helped ________

________ issues. The Issues Resolution section provides
_______________ that these issues have been ____________.

Answer Choices:
documentation resolved critical
issues identify critical
addressed Control developed

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 Lesson 5 - Summary

In this lesson you learned to:

Understand the purpose of the Issue Resolution section.

Determine appropriate entries and complete the Issue

Resolution section.
• Recommended Action(s)
• Responsibility
• Target Completion Date
• Actions Taken
• Revised Severity
• Revised Occurrence
• Revised Detection
• Revised SOD

July 2006 Version 1.0 Copyright 2005-2006 Whirlpool Corporation 5-25