Template issue date 2019DEC12

Design Failure Mode and Effects Analysis

Company/Organization Name: Export Control Classification:

Company/Organization Location: Other Restrictions:

Design Information DFMEA Information

Program/Project: Supporting Information (Scope): DFMEA Number & Revision:
System Subsystem Component

Part/Dwg Number(s): Product Owner & E-mail: Date (Original):

Part/Dwg Revision(s): DFMEA Facilitator & E-mail: Date (Revision):

Part/Dwg Name(s) or Family Name: Cross Functional Team Members & Function:

Classification
Action
Actual Action
Doc (Line) SEV * Target OCCResultsResults
Item Function Requirement Potential Failure Mode Potential Effect(s) of Failure SEV Potential Cause(s) of Failure Current Prevention Controls OCC Current Detection Controls DET RPN Recommended Action(s) Responsibility Actions Taken & Results Completion Action Results
Action
SEVResults
Action DET Results
# OCC Date SEV *
Date RPN
OCC

1 0 0 0 0
2 0 0 0 0
3 0 0 0 0
4 0 0 0 0
5 0 0 0 0
6 0 0 0 0
7 0 0 0 0
8 0 0 0 0
9 0 0 0 0
10 0 0 0 0
11 0 0 0 0
12 0 0 0 0
13 0 0 0 0
14 0 0 0 0
15 0 0 0 0
16 0 0 0 0
17 0 0 0 0
18 0 0 0 0
19 0 0 0 0
20 0 0 0 0
21 0 0 0 0
22 0 0 0 0
23 0 0 0 0
24 0 0 0 0
25 0 0 0 0
26 0 0 0 0
27 0 0 0 0
28 0 0 0 0
29 0 0 0 0
30 0 0 0 0
31 0 0 0 0
32 0 0 0 0
33 0 0 0 0
34 0 0 0 0
35 0 0 0 0
36 0 0 0 0
37 0 0 0 0
38 0 0 0 0
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40 0 0 0 0
41 0 0 0 0
42 0 0 0 0
43 0 0 0 0
44 0 0 0 0
45 0 0 0 0
46 0 0 0 0
47 0 0 0 0
48 0 0 0 0
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51 0 0 0 0
52 0 0 0 0
53 0 0 0 0
54 0 0 0 0
55 0 0 0 0
56 0 0 0 0
57 0 0 0 0
58 0 0 0 0
59 0 0 0 0
© 2020 IAQG  The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)

07:13:15 07/12/2021 1 of 11
 Template issue date 2019DEC12

DFMEA Revision History

Date Rev Revision Summary Approval

© 2019 IAQG  The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev.
ope and the Asia Pacific Region (Rev. 08-2015)
 Template issue date 2019DEC12

Design Failure Mode and Effects Analysis Guidance & Best Practices

Classification
✘

Actual
Current Detection Action Results
Doc (Line) # Item Function Requirement Potential Failure Mode Potential Effect(s) of Failure SEV Potential Cause(s) of Failure Current Prevention Controls OCC DET SEV * OCC RPN Recommended Action(s) Responsibility Target Date Actions Taken & Results Completion Action Results SEV
Action Results OCC
Action Results DET
Controls RPN
Date

This column Enter the item or part used for scope. Enter the intent/functionality of the Enter the requirement(s) for each A failure mode is the manner in which an List effect(s) for each potential failure 1-10, 10 being A failure cause is an indication of why List all current activities used to 1-10, 10 being most Current detection 1-10, 10 Multiply SEV x OCC RPN = Enter a unique ID for List action(s) from the cross functional team to reduce Person responsible for Enter targeted Enter description of the action(s) that was Enter the 1-10, 10 being 1-10, 10 being 1-10, 10 being New RPN =
should be "item" being assessed. The function is item/function being assessed. item could potentially fail to meet or mode as experienced by the customer. most severe. the failure mode could occur. prevent the cause of the failure. severe. Click link to D- controls detect the being most SEV x OCC x DET special requirements RPN. recommended actions completion date for implemented. Provide document references actual date the most severe. most severe. most severe. New SEV x
updated anytime If using this template for documenting the “Verb – Noun” that describes what Requirements include, but not deliver the intended function or The customers may be internal/external. Click link to D- List the cause(s) for each potential (e.g. design and material standards, OCC tab. existence of a failure severe. Click such as a Key recommended action. for evidence resulting from actions. actions were Click link to D- Click link to D- Click link to D- New OCC x
additional rows a Design Risk Analysis performed by the item does. There may be many limited to the voice of the customer, requirements. All the effects are listed in the same cell. SEV tab. failure mode. error proofing, conformance to best Take into cause or mode before link to D-DET Characteristic (KC), completed SEV tab. OCC tab. DET tab. New DET
are added or an alternative means, enter the functions for any one item. voice of engineering, design Describe failure modes in technical Key point: As a team, identify what is If there are multiple causes separate practices) consideration the the item is released for tab. Critical Items (CI), or
deleted. identified risk here. parameters and functional terms, not symptoms noticed by the the worst effect for ranking severity. them into individual rows. current design production. items requiring
Use for sorting If using this template for documenting requirements and non-functional customer. prevention control, List all current activities additional design or
purpose only. a Design Risk Analysis performed by performance requirements (see Consider the 5 types of failure modes: If using this template for documenting a If documenting the Design Risk services, customer used to identify the process controls.
an alternative means, enter any guidance). • Loss of function (i.e. inoperable, etc.) Design Risk Analysis performed by an Analysis, enter the source of the failure probability cause of the failure.
functions associated with the identified • Under/over function (i.e. performance alternative means, list the potential design risk. (internal/external) to (e.g. design reviews,
risk, if applicable. loss, etc.) effects if the design risk listed in column determine the design of experiments,
If using this template for • Intermittent function (i.e. operation C is realized. appropriate rating. validation testing,
Guidance documenting a Design Risk Analysis starts/stops/starts often as a result of simulation studies)
performed by an alternative means, moisture, temperature, etc.)
enter any requirements associated • Degradation (i.e. performance loss
with the identified risk, if applicable. over time, etc.)
• Unintended function (i.e. operation at
the wrong time, unintended direction,
etc.)

If using this template for documenting a

If documenting a separate Design
Risk Analysis within the DFMEA,
preface the item with the term "DRA"
or similar to designate the DRA input. First list all the known items and
Also include a description of the type in any gaps.
of DRA performed (e.g. variation
analysis, monte carlo, P-diagram,
etc.)
Best Practices
Design Risk Analysis performed by an
alternative means, enter a description of
the identifed design risk.
If an item has more than one function There may be many failure modes for
list all of the functions separately. any 1 requirement. If there are multiple
failure modes then separate them into
individual rows for each requirement.
functions then briefly brainstorm to fill
The potential failure mode may be the
cause of a potential failure mode in a
Complete the item name and item higher level subsystem or system.
function columns as completely as Alternatively the potential failure mode
possible before moving on to failure may be the effect of a lower level LRU
modes. component.
Move critical functions to the top of the Failure modes that only occur during
list certain operating conditions should also allowable deflection. The System
be considered.
Failure mode definition sometimes
uncovers additional requirements not
previously considered. Those
requirements should then be included in alloable. The deflection continues until
the requirements list.
Precede the local, next level, and end
effects with (L), (N), or (E) to
differentiate between the effects.
For each potenttial effect, the
associated severity rating can be placed
in parenthases following the effect
description.
Example:
Bracket deflection exceeds maximum
allowable. The LRU performance
degrades as bracket exceeds maximum
degradation associated with LRU
degradation results in a minor effect on
operability. (4)
Bracket deflection exceeds maximum
bracket contacts and damages an
adjacent LRU which is a pressurized
accumulator. Damage increases the risk
of breach of the pressure vessel
resulting in the loss of a primary system
(8)
What is the The potential cause is the root cause
severity of the of the Failure Mode, not the failure
worst case effect. Do not fall into the trap of
effect? defining causes for the failure effect.
Example: The failure causes are addressing the
8 design process errors which may lead
to the failure mode rather than to the
physical failure of the item. Examples
of failure causes:
- Incorrect material specified
- Incorrect design life assumption
- Part/component overstressed
- Incorrect torque specified
- Tolerance stack up incorrect
Mechanisms can be added to the
causes if it clarifies the analysis.
Consider adding phrases such as
"resulting in" or "due to", such as
"Material yield due to incorrect material
specified".
For each failure mode the prevention What is the
controls should be typed into the
same cell.
The prevention controls can only be error from occurring?
included if the prevention control
activity is included in the planning for
this project.
The occurrence ranking is assigned
based on an evaluation of the
effectiveness of the collective controls
in preventing the design error from
occurring.
If the Occurrence ranking is high
consideration should be given to
implementing additional preventative
controls as a recommended action.
Preference should always be given to
definition of preventative controls
rather than reliance on detection
controls.
For each failure mode What is the The SEV*OCC result, The RPN is used to Use of the The objective of recommended actions is to reduce or Each action shall be assigned Each action shall be As a result of the completed actions taken, re- Enter the
effectiveness of the the detection controls best (i.e. also known as the facilitate Classification column mitigate the risk of the failure (Severity). This is to a responsible individual as assigned a target rate severity, occurrence and detection based actual date the
collective controls in should be typed into the lowest) criticality number, communication of for KC and CI accomplished by reducing the likelihood of the failure defined by the team. completion date. The on any changes to the end effect, likelihood of actions were
preventing the design same cell. detection highlights the impact risk and provides an tracking ensures (Occurrence) and/or improving the ability to detect Alternately the action may be actions and target occurrrence, and the likelihood of the actions completed.
ranking? of severity and indicator of potential
traceability across failures prior to production release (Detection). When assigned a a separate team completion dates taken + design controls to detect the failure When date is
Each detection control occurrence when improvement that DFMEA, Process considering recommended actions emphasis should who will in turn assign a should be mechanism. input the
should be ranked in RPN may be equal. reduces any one Flow Diagram, be placed on preventing rather than detecting failures. responsible individual. It is the communicated to the projected
parenthesis, and only the S/O/D factor. PFMEA and Control responsibility of the responsible Project Manager if he or If further action is considered necessary, the SEV, OCC,
lowest, or best, ranking The use of the Plan which supports The severity ranking cannot be changed without individual or team to she is not already analysis is repeated. DET, and
should be typed into the criticality number is RPN thresholds (as the AS/EN/JSIQ9145 eliminating the failure mode and its effect. Only a communicate and coordinate participating in the RPN are then
"DET" column. optional. a decision criteria) traceability design revision can bring about a reduction in he with those responsible for DFMEA. If this field is blank the projected improvement updated to
should not be requirement. severity ranking. When a severity is ranked as a 9 or resource management on the to SEV, OCC, or DET may be entered into the actual values.
implemented. 10, the potential risk must be reviewed regardless of project. "Action Results SEV", "Action Results OCC",
the RPN. and "Action Results DET" fields to support the
recommended actions discussion based on
The occurrence ranking can only be reduced by the projected improved RPN. Once the
removing or controlling the cause(s) of the failure actions are completed the actual changes to
mode through a design revenge. SEV, OCC, or DET must be entered.
The detection ranking can be reduced only through an
increase in the design validation/verification actions.
Increasing the validation/verification actions is a less
desirable action since it does not address the severity
or occurrence of the failure mode and typically occurs
late in the design cycle.

© 2020 IAQG  The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)

07:13:15 07/12/2021 7 of 11
 7.2.6 APQP Phase 3 Checklist Rev 1 May 2017
3.04 Process Failure Mode and Effects Analysis (PFMEA) www.iaqg.org/scmh Section 7.2

# Question Y* N N/A RYG Evidence

Was the DFMEA created by a cross-functional team
1 including Design Engineering, Manufacturing Engineering,
Was one of the team members trained in DFMEA
2 methodology?
Have historical part data been reviewed? (Example :
3 Nonconformances, Field Failures, Yields, etc.)
Have similar DFMEAs been reviewed?
4
Have subcontracting activities been considered (if
5 applicable)?
Have Design Risk Analyses (DRA) been documented within
6 the DFMEA?
Have all potential failure modes been properly evaluated
7 considering Severity, Occurence and Detection for the initial
RPN calculation?
Has the scoring been consistent using a methodology based
8 on industry guidance for ranking rules?
Have Key Characteristics and Critical Items been considered
and highlighted in the DFMEA in order to identify and
9 ultimately minimize variation where applicable?

Have appropriate corrective actions been assigned to high

10 severity numbers?

Do the corrective actions for high severity numbers

11 change the design to eliminate the risk?

If the design can not be changed, then do the corrective

actions include risk mitigation measures for controlling
12 key processes or key process parameters?

If the key processes or key process parameters are not

in control, then do the corrective actions include
measures to detect the risk as soon as possible in the
13 process and/or prevent the risk from passing to the next
step in the process?

Is the DFMEA up to date reflecting the latest information?

14
Have RPNs been reassessed following the implementation
of identified actions and evaluation of the effectiveness of
15 the action?

Have any remaining CIs or KCs been transferred to the

16 PFMEA?

Have any additional risks including mitigation plans been

17 identified that may affect this deliverable?

X 25% N/A Deliverable RYG Rating

IP 50%
 7.2.6 APQP Phase 3 Checklist Rev 1 May 2017
3.04 Process Failure Mode and Effects Analysis (PFMEA) www.iaqg.org/scmh Section 7.2

# Question Y* N N/A RYG Evidence

Red: Some questions have a negative answer and no recovery plan is in place or the plans
25% - Action Identified 50% - Owner Identified identified will have an impact in program timing. Support is required. When an item is highlighted
Status (%): 75% R
75% - Action in Progress 100% - Action Closed Red an assessment on the impact to the WP timing needs to be provided.
Yellow: Some questions have a negative answer but a recovery plan is in place which will
100% Y prevent impact on timing
Green: All questions have a positive answer (Y) and are ongoing normal program development
G
© 2020 IAQG  The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
 7.2.6 APQP Phase 3 Checklist Rev 1 May 2017
3.04 Process Failure Mode and Effects Analysis (PFMEA) www.iaqg.org/scmh Section 7.2

Open Due Status Actual End

# Question Actions Required Responsible Date Date % Date
Was the DFMEA created by a cross-functional team
1 including Design Engineering, Manufacturing Engineering,
Was one of the team members trained in DFMEA
2 methodology?
Have historical part data been reviewed? (Example :
3 Nonconformances, Field Failures, Yields, etc.)
Have similar DFMEAs been reviewed?
4
Have subcontracting activities been considered (if
5 applicable)?
Have Design Risk Analyses (DRA) been documented within
6 the DFMEA?
Have all potential failure modes been properly evaluated
7 considering Severity, Occurence and Detection for the initial
RPN calculation?
Has the scoring been consistent using a methodology based
8 on industry guidance for ranking rules?
Have Key Characteristics and Critical Items been considered
and highlighted in the DFMEA in order to identify and
9 ultimately minimize variation where applicable?

Have appropriate corrective actions been assigned to high

10 severity numbers?

Do the corrective actions for high severity numbers

11 change the design to eliminate the risk?

If the design can not be changed, then do the corrective

actions include risk mitigation measures for controlling
12 key processes or key process parameters?

If the key processes or key process parameters are not

in control, then do the corrective actions include
measures to detect the risk as soon as possible in the
13 process and/or prevent the risk from passing to the next
step in the process?

Is the DFMEA up to date reflecting the latest information?

14
Have RPNs been reassessed following the implementation
of identified actions and evaluation of the effectiveness of
15 the action?

Have any remaining CIs or KCs been transferred to the

16 PFMEA?

Have any additional risks including mitigation plans been

17 identified that may affect this deliverable?

X
IP Location: / Site:
 7.2.6 APQP Phase 3 Checklist Rev 1 May 2017
3.04 Process Failure Mode and Effects Analysis (PFMEA) www.iaqg.org/scmh Section 7.2

Open Due Status Actual End

# Question Actions Required Responsible Date Date % Date

25% - Action Identified 50% - Owner Identified

Status (%):
75% - Action in Progress 100% - Action Closed
Reviewed by:

Reviewed with:

Date :
© 2020 IAQG  The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)