SFMEA Check List

A-1Design FMEA Checklist
QSE QSE
QUALITY SYSTEMS ENGINEERING INC.
MEETING THE REQUIREMENTS - OVERVIEW OF QSE FMEA / APQP APPLICATION
Customer or Internal Part No. TYPE YOUR PROJECT AND/OR TEAM NAME
Person Due
Question Yes No Comment/Action Required Responsible Date
Was the SFMEA and / or DFMEA prepared using the Chrysler, QSE FMEA/APQP application has copyright permission from
Sandra
1 Ford and General Motors Potential Failure Mode and Effects X AIAG - and reflects the most recent 3rd edition. Severity, Werwega
07/07/02
Analysis (FMEA) reference manual? Occurrence and Detection scales are user defined.
This information can be tracked using the Team Tracking
2 Have historical campaign and warranty data been reviewed? X attachment that is included in the QSE FMEA/APQP
Application. Historical data can be linked to full page report.
QSE FMEA/APQP application can be saved and renamed for
3 Have similar part DFMEAs been considered? X similar part FMEA’s. Making templates from past FMEA’s as
groups or part files using the “save as” function.
All Characteristics and their requirements are identified in the
4 Does the SFMEA and /or DFMEA identify Special characteristics? X Process Flow and are linked to other documents: Char Wksht,
Control Plan, Work Instructions, Audit sheets and more.
Automatic and user defined sorting and reporting high risk
Have design characteristics that affect high risk priority failure
5 X characteristics are color coded High-Red, Avg-Green
modes been identified?
Low-Yellow. User as choice of many automatic reports.
QSE FMEA/APQP provides a full page Action Plan per
Have appropriate corrective actions been assigned to high risk
6 X Characteristic, includes picture box for graphic presentation of
priority numbers?
high risk and/or operation function.
High severity numbers can be reported on separately as well as
Have appropriate corrective actions been assigned to high severity
7 X grouped per users choice. Actions Plans in four layouts per
numbers?
characteristic are automatic, or see QSE Concern Application
Drop down tables for easy editing of RPN’s. Risk Management
Have risk priorities been revised when corrective actions have been
8 X report with initial and final RPN’s next to each other for easy
completed and verified?
editing. See QSE Concerns application for tracking verification.
Title User Define Title User Define Original Date: Status: Revision Level: Revision Date:
Printed on: 08/01/02 www.qseprocess.com © 1996/2002 All Rights Reserved - QSE Inc. Toll Free +1 866-871-7301 Prepared By: Sandra Werwega Pg. 1 of 1
QSE A-2 Design FMEA Information Checklist
QSE
Person Due
A. General
Does the design require:
1 > New Materials? X User Defined
2 > Special tooling? X User Defined
3 Has assembly build variation analysis been considered? X User Defined
4 Has Design of Experiments been considered? User Defined
5 Is there a plan for prototypes in place? User Defined
6 Has a DFMEA been completed? X QSE FMEA/APQP application supplies a DFMEA layout.
7 Has a DFMA been completed? User Defined
8 Has service and maintenance issues been considered? User Defined
9 Has the Design Verification Plan been completed? X QSE FMEA/APQP application supplies a DVP&R layout .
QSE FMEA/APQP cross functional team information can be

10 If yes, was it completed by a cross functional team?
tracked using the Team Tracking attachment.
Are all specified tests, methods, equipment and acceptance criteria

11 QSE FMEA/APQP application supplies a DVP&R layout .
clearly defined and understood?
Are identified in the QSE FMEA/APQP application using the

12 Have Special Characteristics been selected?
class dropdown or the class copy and paste symbols.
QSE
Person Due
A. General
13 Is bill of material complete? User Defined
Special Characteristics are identified using the class symbol

14 Are Special Characteristics properly documented?
attachment.
B. Engineering Drawings
Customers CAD drawing program will address the Engineering
15 Have dimensions that affect fit, function and durability been identified?
Drawings questions.
QSE FMEA/APQP applications have picture field layouts, link
16 Are reference dimensions identified to minimize inspection layout time?
to any drawing program for view of drawing.
Are sufficient control points and datum surfaces identified to design When linked changes in one changes the drawing in both
17 functional gages?
applications.
18 Are tolerances compatible with accepted manufacturing standards?
Are there any requirements specified that cannot be evaluated using known
19 inspection techniques?
C. Engineering Performance Specifications

QSE application encourages small simple steps (operation
20 Have all special characteristics been identified?
description) so each characteristic is identified.
Is test loading sufficient to provide all conditions, i.e., production validation
21 and end use? User Defined
Have parts manufactured at minimum and maximum specifications been

22
tested?
User Defined
Can additional samples be tested when a reaction plan requires it, and still
23 conduct regularly scheduled in-process tests? User Defined
24 Will all product testing be done in-house? User Defined
25 If not, is it done by an approved subcontractor? User Defined
QSE A-2 Design FMEA Information Checklist QSE
Person Due
26 Is the specified test sampling size and/or frequency feasible? Feasibility is addressed in QSE PPAP Package application.
If required, has customer approval been obtained for test

27 User Defined
equipment?
D. Material Specification
28 Are special material characteristics identified? User Defined
Are specified materials, heat treat and surface treatments

29 compatible with the durability requirements in the identified User Defined
environment?
30 Are the intended material suppliers on the customer approved list? User Defined
Will material suppliers be required to provide certification with each

31 User Defined
shipment?
Have material characteristics requiring inspection been identified?

32 User Defined
If so,
33 > will characteristics be checked in-house? User Defined
34 > Is test equipment available? User Defined
35 > Will training be required to assure accurate results? User Defined
36 > Are all laboratories used accredited (if required)? User Defined
QSE
Person Due
D. Material Specification - Continued
Have the following material requirements been considered:
These should be included in the operation steps and the related
38 > Handling? X characteristics will be the requirements to be met.
39 > Storage? X characteristics will be the requirements to be met.
40 > Environmental? X characteristics will be the requirements to be met.
QSE A-3 New Equipment, Tooling and Test Equipment Checklist
QSE
Person Due
Has tool and equipment design provided for:
1 > Flexible system, e.g. cell mfg? X User defined
2 > Quick change? X User defined
User defined
3 > Volume fluctuations?
4 > Mistake proofing? User defined
Have lists been prepared identifying:

User defined
5 > New equipment? X
User defined
6 > New tooling? X
User defined
7 > New test equipment?
Has acceptance criteria been agreed upon for:

User defined
8 > New equipment? X
User defined
9 > New tooling?
User defined
10 > New test equipment?
Will a preliminary capability study be conducted at the tooling and/or User defined
11
equipment manufacturer?
User defined
12 Has test equipment feasibility and accuracy been established?
Is a preventive maintenance plan complete for equipment and User defined

13
tooling?
Are setup instructions for new equipment and tooling complete and User defined
14
understandable?
QSE A-3 New Equipment, Tooling and Test Equipment Checklist - Continued QSE
Person Due
Will capable gages be available to run preliminary process capability studies User defined
15 at the equipment supplier’s facility
X
User defined
16 Will preliminary process capability studies be run at the producing plant?
Have process characteristics that affect special product characteristics been User defined
17 identified?
Were special product characteristics used in determining acceptance User defined
18 criteria?
Does the manufacturing equipment have sufficient capacity to handle User defined
19 forecasted production and service volumes?
User defined
20 Is testing capacity sufficient to provide adequate testing?
QSE A-4 Product/Process Quality Checklist QSE
Person Due
Is the assistance of the customer’s quality assurance or product engineering

1 activity needed to develop or concur to the control plan?
User defined
2 Has the supplier identified who will be the quality liaison with the customer? User defined
3 Has the supplier identified who will be the quality liaison with its suppliers? User defined
Has the quality system been reviewed using the Chrysler, Ford, and General
4 Motors Quality System Assessment?
User defined
Are there sufficient personnel identified to cover:
5 > Control plan requirements? User defined
6 > Layout inspection? User defined
7 > Engineering performance testing? User defined
8 > Problem resolution analysis?
Is there a documented training program that:
9 > Includes all employees? User defined
10 > Lists whose been trained? User defined
11 > Provides a training schedule? User defined
Has training been completed for:
12 > Statistical process control? User defined
Person Due
Has training been completed for: - Continued
A 30 pc XBar and RBar input data attachment is included in the
13 > Capability studies? X
QSE FMEA/APQP application gives user Cpk.
14 > Problem solving? X QSE Concern Applciation
Error Proofing linked layout is included in the QSE FMEA/APQP

15 > Mistake proofing X
applcation.
16 > Other topics as identified? User defined
Is each operation provided with process instructions that are keyed to the
17 control plan?
X QSE FMEA/APQP provides linked S.W.I. per each operation.
QSE FMEA/APQP provides linked S.W.I. per each operation,

18 Are standard operator instructions available at each operation? X
these can be printed and include pictures per operation.
Were operator/team leaders involved in developing standard operator Team member can be tracked in the QSE FMEA/APQP
19 instructions?
X
Application
Do inspection instructions include:
20 > Easily understood engineering performance specifications? X These can be created in the full picture control plan layout.
21 > Test frequencies? X Is included per characteristic in the control plan.
22 > Sample sizes? X These can be created in the full picture control plan layout.
23 > Reaction plans? X Reaction plan attachment per control plan is included
Standard Work Instructions are linked to Control plan data,
24 > Documentation’s? X
have user defined text box and include linked picture field.
Are visual aids:
Standard Work Instructions are linked to Control plan data,
25 > Easily understood? X
have user defined text box and include linked picture field.
Standard Work Instructions are full page per four steps-large
26 > Available? X
enough to post at work stations.
Person Due
Are Visual aids: - Continued
The S.W.I. included in the QSE FMEA/APQP is large enough so Sandra

27 > Accessible X
operators can see what should be posted per station. Werwega
07/31/02
Each document has Revision Status field in footer that is linked

28 > Approved? X
to revision summary page.
QSE includes S.W.I. that are linked to the Control Plan, Original
29 > Dated and current? X
dates and Reivsion date are included.
Is there a procedure to implement, maintain, and establish reaction
30 plans for statistical control charts? X Full page Reaction Plan is included in the QSE FMEA/APQP.
QSE FMEA/APQP Applciation provides a Preventive Analysis

31 Is there an effective root cause analysis system in place? X
for finding Root Cause.
Have provisions been made to place the latest drawings and Full Page Picture Sheets, Process Flow, Process Control Plan
32 specifications at the point of inspection? X
and Processs Overview.
Are forms/logs available for appropriate personnel to record Logs and Forms should be identified on the Control Plan. Audit
33 inspection results? X Sheet that is linked to the Control Plan
Have provisions been made to place the following at the monitored operation:
34 > Inspection gages? X Linked Gage Plans are included per characterisitc.
35 > Gage instructions? QSE Instructions application is available.
36 > Reference samples? User defined
Full Page Audit Sheet that is linked to the Control Plan

37 > Inspection logs? X
Characteristic is included.
Have provisions been made to certify and routinely calibrate gages QSE FMEA/APQP application includes linked Gage plan that
38 and test equipment? X
tracks total variance, Gage R&R frequency and dates.
Have required measurement system capability studies been:
QSE FMEA/APQP includes a XBar and RBar Sample data entry
39 > Completed? X that automatically calculates Cpk.
Person Due
Have required measurement system capability studies been: - Continued
40 > Acceptable? User Defined
Are layout inspection equipment and facilities adequate to provide

41 initial and ongoing layout of all details and components? User Defined
Is there a procedure for controlling incoming products that identifies:
42 > Characteristics to be inspected? X This is identifiied on the Control Plan
43 > Frequency of inspection? X This is identifiied on the Control Plan
44 > Sample size? X This is identifiied on the Control Plan
45 > Designated location for approved product? X This should be identified on the Reaction Plans
46 > Disposition of non conforming products? X This should be identified on the Reaction Plans
Is there a procedure to identify, segregate and control non

47 conforming product to prevent shipment? This should be identified on the Reaction Plans
48 Are rework/repair procedures available? User Defined
49 Is there a procedure to requalify repaired/reworked material? User Defined
50 Is there an appropriate Lot Traceability system? User Defined
51 Are periodic audits of outgoing products planned and implemented? User Defined
Are periodic surveys of the quality system planned and

52 implemented? User Defined
53 Has the customer approved the packaging specification? User Defined
QSE A-5 Floor Plan Checklist QSE
Person Due
Does the floor plan identify all required process and inspection
1 User Defined
points?
Have clearly marked areas for all material, tools, and equipment at
2 User Defined
each operation been considered?
3 Has sufficient space been allocated for all equipment? User Defined
Are process and inspection areas:
4 > Of adequate size? User Defined
5 > Properly lighted? User Defined
6 Do inspection areas contain necessary equipment and files? User Defined
Are there adequate:
7 > Staging areas? User Defined
8 > Impound areas? User Defined
Are inspection points logically located to prevent shipment of

9 These are identified on the Process Flow Diagram
nonconforming products?
Have controls been established to eliminate the potential for an

10 operation, including outside processing, to contaminate or mix This should be identified in the Reaction Plan
similar products?
Is material protected from overhead or air handling systems

11 User Defined
contamination?
QSE A-5 Floor Plan Checklist QSE
Person Due
12 Have final audit facilities been provided? User Defined
Are controls adequate to prevent movement of nonconforming

13 User Defined
incoming material to storage or point of use?
QSE A-6 Process Flow Chart Checklist QSE
Person Due
Does the flow chart illustrate the sequence of production and Flow symbols are user defined. The QSE systems encourages
1
inspection stations? small simple steps of each operations including inspection.
Were all the appropriate FMEAs (SFMEA, DFMEA) available and

2 User Defined
used as aids to develop the process flow chart?
Is the flow chart keyed to the product and process checks in the In the QSE application All information in the Flow chart is linked
3
control plan? to the Process Control Plan.
Flow symbols are user defined. The QSE systems encourages

Does the flow chart describe how the product will move, i.e., roller
4 small simple steps of each operations including the transferring
conveyor, slide containers, etc.?
of parts.
5 Has the pull system/optimization been considered for this process? User Defined
Have provisions been made to identify and inspect reworked The QSE FMEA APQP system has a reaction plan attachment
6
products before being used? this can be identified with a letter on the Process Control Plan.
Corrective Actions and Action plans can be created in the QSE

Have potential quality problems due to handling and outside
7 FMEA/ APQP full picture views . See QSE Concerns application
processing been identified and corrected?
for more detail of 8D’s, Concern Resolutions etc.
QSE A-7 Process FMEA Checklist QSE
Person Due
Was the Process FMEA prepared using the Chrysler, Ford, and QSE FMEA /APQP application has copyright permission from
1 X
General Motors guidelines? AIAG - and reflects the most recent 3rd edition.
Have all operations affecting fit, function, durability, governmental QSE includes class symbol drop down and paste functions for
2 X
regulations and safety been identified and listed sequentially? identifing special characterisitcs.
QSE FMEA/APQP makes it easy to save FMEA information for
3 Were similar part FMEAs considered?
similar part and/or family files.
This is mentioned in Phase I of the QSE Manual. The team
4 Have historical campaign and warranty data been reviewed?
uses this in the FMEA meetings.
Have appropriate corrective actions been planned or taken for high High Risk Priority Numbers are automatically and user defined
5
risk priority numbers? sorted in the QSE FMEA/APQP Application.
Have appropriate corrective actions been planned or taken for high Corrective Actions and Action Plans can be identified per
6
severity numbers? characteristic in the full page picture view of the FMEA .
Were risk priorities numbers revised when corrective action was Automatic calculation / This is simplified in the Risk
7
completed? Management - initial and final RPN numbers by side.
Were high severity numbers revised when a design change was This is mentioned in Phase I of the QSE Manual. The team
8
completed? uses this in the FMEA meetings.
Do the effects consider the customer in terms of the subsequent Add effect/cause feature makes it easy to add. Effects
9
operation, assembly and product? explained in Phase II of the QSE FMEA / APQP manual.
Was warranty information used as an aid in developing the Process This is mentioned and in Phase I of the QSE Manual. This
10
FMEA? information can be tracked in the team tracking attachment.
Were customer plant problems used as an aid in developing the This is mentioned and in Phase I of the QSE Manual. This
11
Process FMEA? information can be tracked in the team tracking attachment.
Have the causes been described in terms of something that can be Add effect/cause feature makes it easy to add. Causes are
12
fixed or controlled? explained in Phase II of the QSE FMEA / APQP manual.
Where detection is the major factor, have provisions been made to Detection and Preventive controls are identified with “P” and “D”
13
control the cause prior to the next operation? in the QSE FMEA / APQP application.
Printed on: 07/27/02 www.qseprocess.com © 1996/2002 All Rights Reserved - QSE Inc. Toll Free +1 866-871-7301 Prepared By: Sandra Werwega Pg.1 of 1
QSE A-8 Control Plan Checklist QSE
Person Due
Was the control plan methodology referenced in Section 6 used in QSE FMEA / APQP application enables user to follow the the
1
preparing the control plan? control plan methodology referenced in Section 6.
Corrective Actions and Action plans can be created in the full

Have all known customer concerns been identified to facilitate the
2 picture views . See QSE Concerns application for more detail of
selection of special product/process characteristics?
8D’s, Concern Resolutions etc.
Are all special product/process characteristics included in the control Easy to use drop down electronic symbol or copy/paste symbol
3
plan? attachment.
Were SFMEA, DFMEA, and PFMEA used to prepare the control This is mentioned in Phase I of the QSE Manual. The team
4
plan? uses this in the FMEA meetings.
QSE system specifications must be identified per characteristic,

5 Are material specifications requiring inspection identified?
it is up to the user to include inspection specifications.
The QSE systems encourages small simple steps of each

Does the control plan address incoming (material/components)
6 operations including transferring material from one operation to
through processing/assembly including packaging?
another.
QSE application includes DVP&R and an easy to use fishbone

7 Are engineering performance testing requirements identified?
diagram for this information.
Are gages and test equipment available as required by the control Gage Plans and test equipment is linked to the control plan
8
plan? evaluation methods in the QSE FMEA/APQP application.
Required Approval of all documents can be tracked and

9 If required, has the customer approved the control plan?
identified in the Summary Revision layout.
In the QSE FMEA/APQP application multiple gage plans can be

10 Are gage methods compatible between supplier and customer?
opened at the same time and compared.

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A-1Design FMEA Checklist

1 > New Materials? X User Defined

2 > Special tooling? X User Defined

3 Has assembly build variation analysis been considered? X User Defined

4 Has Design of Experiments been considered? User Defined

5 Is there a plan for prototypes in place? User Defined

7 Has a DFMA been completed? User Defined

8 Has service and maintenance issues been considered? User Defined

QSE FMEA/APQP cross functional team information can be

Are all specified tests, methods, equipment and acceptance criteria

Are identified in the QSE FMEA/APQP application using the

Special Characteristics are identified using the class symbol

18 Are tolerances compatible with accepted manufacturing standards?

C. Engineering Performance Specifications

Have parts manufactured at minimum and maximum specifications been

24 Will all product testing be done in-house? User Defined

25 If not, is it done by an approved subcontractor? User Defined

If required, has customer approval been obtained for test

28 Are special material characteristics identified? User Defined

Are specified materials, heat treat and surface treatments

Will material suppliers be required to provide certification with each

Have material characteristics requiring inspection been identified?

33 > will characteristics be checked in-house? User Defined

34 > Is test equipment available? User Defined

35 > Will training be required to assure accurate results? User Defined

1 > Flexible system, e.g. cell mfg? X User defined

2 > Quick change? X User defined

4 > Mistake proofing? User defined

Have lists been prepared identifying:

Has acceptance criteria been agreed upon for:

Is a preventive maintenance plan complete for equipment and User defined

Is the assistance of the customer’s quality assurance or product engineering

Are there sufficient personnel identified to cover:

5 > Control plan requirements? User defined

6 > Layout inspection? User defined

7 > Engineering performance testing? User defined

8 > Problem resolution analysis?

Is there a documented training program that:

9 > Includes all employees? User defined

10 > Lists whose been trained? User defined

11 > Provides a training schedule? User defined

Has training been completed for:

12 > Statistical process control? User defined

14 > Problem solving? X QSE Concern Applciation

Error Proofing linked layout is included in the QSE FMEA/APQP

16 > Other topics as identified? User defined

QSE FMEA/APQP provides linked S.W.I. per each operation,

21 > Test frequencies? X Is included per characteristic in the control plan.

The S.W.I. included in the QSE FMEA/APQP is large enough so Sandra

Each document has Revision Status field in footer that is linked

QSE FMEA/APQP Applciation provides a Preventive Analysis

35 > Gage instructions? QSE Instructions application is available.

36 > Reference samples? User defined

Full Page Audit Sheet that is linked to the Control Plan

40 > Acceptable? User Defined

Are layout inspection equipment and facilities adequate to provide

Is there a procedure for controlling incoming products that identifies:

42 > Characteristics to be inspected? X This is identifiied on the Control Plan

43 > Frequency of inspection? X This is identifiied on the Control Plan

44 > Sample size? X This is identifiied on the Control Plan