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A1 - DESIGN FMEA CHECKLIST

Customer or internal part number:_________________________ Revision level:_________________________

Person Due
Question Yes No N/A Comment / Action Required Responsible Date
Was the DFMEA prepared using the Chrysler, Ford and
General Motors Potential Failure Mode and Effects
Analysis (FMEA) reference manual and applicable
1 customer requirements?
Have historical campaign and warrant data been
2 reviewed?
Have best practices and lessons learned from similar
3 parts DFMEAS been considered?
4 Does the DFMEA identify Special Characteristics?

Have pass-through characteristics been identified and


reviewed with affected suppliers for FMEA alignment
5 and appropriate controls in the supply base?
Have special characteristics designated by the
customer or organisation been reviewed with affected
6 suppliers to ensure FMEA alignment?
Have design characteristics that affect high risk priority
7 failure modes been identified?
Have appropriate corrective actions been assigned to
8 high risk priority numbers?
Have appropriate corrective actions been assigned to
9 high severity numbers?
Have risk priorities been revised when corrective
10 actions have been completed and verified?

Revision Date

Prepared by:
A2 - DESIGN INFORMATION CHECKLIST
Customer or internal part number:_________________________ Revision level:_________________________

Person Due
Question Yes No N/A Comment / Action Required Responsible Date
A. General
1 Does the design require:
a - New materials?
b - Special tooling
c - New technology or process?
Has assembly build variation analysis been
2
considered?
3 Has Design of Experiments been considered?
4 Is there a plan for prototypes in place?
5 Has a DFMEA been completed?
Has a DFMA (Design for Manufacturing and Assembly)
6
been completed?
Have service and maintenance issues been
7
considered?
8 Has the Design Verification Plan been completed?
9 If yes, was it by a cross-functional team?
As all specified tests, methods, equipment and
10
acceptance criteria clearly defined and understood?
11 Have Special Characteristics been selected?
12 Is Bill of Materials complete?
13 Are Special Characteristics properly documented?
A2 - DESIGN INFORMATION CHECKLIST - CONTINUED
Customer or internal part number:_________________________ Revision level:_________________________

Person Due
Question Yes No N/A Comment / Action Required Responsible Date
B. Engineering Drawings
Are reference dimensions identified to minimise
14
inspection layout time?
Are sufficient control points and datum surfaces
15
identified to design functional gauges?
Are tolerances compatible with accepted manufacturing
16
standards?
Can existing and available inspection technology
17
measure all design requirements?
Is the customer designated engineering change
18 management process used to manage engineering
changes?
C. Engineering Performance Specifications
19 Have all Special Characteristics been identified?

20 Are test parameters sufficient to address required use


conditions i.e. production validation and end use?
Have parts manufactured at minimum and maximum
21
specifications been tested?
22 Will all product testing be done in-house?
23 If not, is it done by an approved subcontractor?
Is the specified in-process performance test sampling
24 size and/or frequency consistent with manufacturing
volumes?
Has customer approval been obtained e.g. for testing
25
and documentation, as required?
A2 - DESIGN INFORMATION CHECKLIST - CONTINUED
Customer or internal part number:_________________________ Revision level:_________________________

Person Due
Question Yes No N/A Comment / Action Required Responsible Date
D. Material Specification
26 Are special material characteristics identified?
Where the organisation is design responsible, are
27 specified materials, heat treat and surface treatments
compatible with the durability requirements in the
identified environment?
Where required, are the intended material suppliers on
28
the customer approved list?
Has the organisation developed and implemented a
29
process to control incoming material quality?
Have material characteristics requiring inspection been
30
identified? If so:
a - Will characteristics be checked in-house?
b - If checked in-house, is test equipment available?
- If checked in-house, are competent people available
c
to assure accurate testing?
A2 - DESIGN INFORMATION CHECKLIST - CONTINUED
Customer or internal part number:_________________________ Revision level:_________________________

Person Due
Question Yes No N/A Comment / Action Required Responsible Date
D. Material Specification - continued
31 Will outside laboratories be used?

- Does the laboratory have a process in place to


a assure laboratory competency such as accreditation?
NOTE. Competency needs to be assured, regardless of
the organisation's relationship with the laboratory.
Have the following material requirements been
32
considered?
a - Handling, including environmental aspects?
b - Storage, including environmental aspects?
- Have the materials/substance composition been
reported in accordance with customer requirements i.e.
c IMDS?
- Have polymeric parts been identified/marked as per
d customer requirements?

Revision Date

Prepared by:
A3 - NEW EQUIPMENT, TOOLING AND TEST EQUIPMENT CHECKLIST
Customer or internal part number:_________________________ Revision level:_________________________

Person Due
Question Yes No N/A Comment / Action Required Responsible Date
1 Does the design require:
a - New materials?
b - Quick change?
c - Volume fluctuations?
d - Mistake proofing?
2 Have lists been prepared identifying:
a - New equipment?
b - New tooling?
c - New test equipment (including checking aids)?
3 Have acceptance criteria been agreed upon for: (include all suppliers)
a - New equipment?
b - New tooling?
c - New test equipment (including checking aids)?
Will a preliminary capability study be conducted at the
4
tooling and/or equipment manufacturer?
Has test equipment feasibility and accuracy been
5
established?
Is a preventative maintenance plan complete for
6
equipment and tooling?
A3 - NEW EQUIPMENT, TOOLING AND TEST EQUIPMENT CHECKLIST - CONTINUED
Customer or internal part number:_________________________ Revision level:_________________________

Person Due
Question Yes No N/A Comment / Action Required Responsible Date
Are set up instructions for new equipment and tooling
7
complete and understandable?
Will capable gauges be available to run preliminary
8 process capability studies at the equipment supplier's
facility?
Will preliminary process capability studies be run at the
9
producing plant?
Have process characteristics that affect special product
10
characteristics been identified?
Were special product characteristics used in
11
determining acceptance criteria?
Does the manufacturing equipment have sufficient
12 capacity to handle forecasted production and service
volumes?
Is testing capacity sufficient to provide adequate
13
testing?
Has the measurement equipment been verified and
14 documented showing qualification for the required
scope of measuring and testing?

Revision date:

Prepared by:
A4 - PRODUCT / PROCESS QUALITY CHECKLIST
Customer or internal part number:_________________________ Revision level:_________________________

Person Due
Question Yes No N/A Comment / Action Required Responsible Date
Is customer assistance or approval required for the
1
development of the control plan?
Has the organisation identified who will be the quality
2
liaison with the customer?
Has the organisation identified who will be the quality
3
liaison with its suppliers?
Has the quality system been reviewed and approved
4
per customer specific requirements?
5 Are there sufficient personnel identified to cover:
a - Control Plan requirements?
b - Layout Inspection?
c - Engineering Performance Testing?
d - Problem reaction and resolution analysis?
6 Is there a documented training program that:
a - Includes all employees?
b - Lists who's been trained?
c - Provides a training schedule?
7 Has training been completed for:
a - Statistical process control?
b - Capability Studies?
c - Problem solving?
d - Mistake proofing?
e - Reaction plans?
f - Other topics as identified?
Is each operation provided with process instructions
8
that are keyed to the control plan?
A4 - PRODUCT / PROCESS QUALITY CHECKLIST - CONTINUED
Customer or internal part number:_________________________ Revision level:_________________________

Person Due
Question Yes No N/A Comment / Action Required Responsible Date
Are standard operator instructions accessible at each
9
operation?

10
Do operator instructions include pictures and diagrams?
Were operator/team leaders involved in developing
11
standard operator instructions?
12 Do inspection instructions include:
- Easily understood engineering performance
a
specifications?
b - Test frequencies?
c - Sample sizes?
d - Reaction plans?
e - Documentations?
13 Are visual aids:
a - Appropriate, easily understood and legible?
b - Available?
c - Accessible?
d - Approved?
e - Dated and current?

14 Is there a procedure to implement, maintain and


establish reaction plans for issues such as out of
control conditions based on statistical process control?
Is there an identified problem solving process that
15
includes root cause analysis?
Are the latest drawings and specifications available for
16 the operator, in particular at the points of the
inspection?
- Have engineering tests (dimensional, material,
a appearance and performance) been completed and
documented as required in accordance with customer
requirements?:
A4 - PRODUCT / PROCESS QUALITY CHECKLIST - CONTINUED
Customer or internal part number:_________________________ Revision level:_________________________

Person Due
Question Yes No N/A Comment / Action Required Responsible Date
Are forms/logs available for appropriate personnel to
17
record inspection results?
Are the following available and placed at the
18
appropriate points of the operation?
a - Inspection gauges?
b - Gauge instructions?
c - Reference samples?
d - Inspection logs?
Have provisions been made to certify and calibrate
19 gauges and test equipment at a defined frequency that
is appropriate?
Have required measurement system capability studies
20
been:
a - Completed?
b - Accepted?
Have initial process capability studies been conducted
21
as per customer requirements?
Are layout inspect equipment and facilities adequate to
22 provide initial and ongoing layout of all details and
components in accordance with customer
requirements?
Is there a procedure for controlling incoming product
23
that identifies:
a - Characteristics to be inspected?
b - Frequency of inspection?
c - Sample size?
d - Designated location for approved product?
e - Disposition of nonconforming products?
Have sample production parts been provided as per
24
customer requirements?

A4 - PRODUCT / PROCESS QUALITY CHECKLIST - CONTINUED


Customer or internal part number:_________________________ Revision level:_________________________

Person Due
Question Yes No N/A Comment / Action Required Responsible Date

25 Is there a procedure to identify, segregate and control


nonconforming products to prevent shipment?
Are rework/repair procedures available to assure
26
conforming product?
Is there a procedure to re-qualify repaired rework
27
material?
Has a master sample, if required, been retained as part
28
of the approval process?
29 Is there an appropriate Lot Traceability procedure?
Are periodic audits of outgoing products planned and
30
implemented?
Are periodic assessments of the quality system planned
31
and implemented?
Has the customer approved the packaging and the
32
packaging specification?

Revision date:

Prepared by:
A5 - FLOOR PLAN CHECKLIST
Customer or internal part number:_________________________ Revision level:_________________________

Person Due
Question Yes No N/A Comment / Action Required Responsible Date
Have lean concepts been applied in considering
1
material flow?
Does the floor plan identify all required process and
2
inspection points?
Have clearly marked areas for all material, tools and
3
equipment at each operation been considered?

4
Has sufficient space been allocated for all equipment?
5 Are process and inspection areas:
a - Of adequate size?
b - Properly lit?
Do inspection areas contain necessary equipment and
6
record storage?
7 Are there adequate:
a - Staging areas?
b - Impound areas?
Are inspection points located to prevent shipment of
8
nonconforming product?
Are there controls for each process to eliminate
9
contamination or inappropriate mixing of product?
Is material protected from overhead or air handling
10
systems contamination?
11 Have facilities been provided for final product audit?
Are facilities adequate to control movement of
12
nonconforming incoming material?

Revision Date:

Prepared by:
A6 - PROCESS FLOW CHART CHECKLIST
Customer or internal part number:_________________________ Revision level:_________________________

Person Due
Question Yes No N/A Comment / Action Required Responsible Date
Does the flow chart illustrate the entire process from
1 receiving through shipping, including outside processes
and services?
In development of the process flow chart, was the
2 DFMEA used, if available, to identify special
characteristics that may be critical?
Is the flow chart keyed to product and process checks
3
in the control plan and PFMEA?
Does the flow chart describe how the product will move
4
i.e. roller conveyer, slide containers etc?
Has the pull system / optimisation been considered for
5
this process?
Have provisions been made to identify and inspect
6
reworked product before being used?
Are material controls for movement and staging of
product, including appropriate identification properly
7 defined and implemented? The controls should address
incoming supplier product as well as subcontracted
processes.

Revision Date:

Prepared by:
A7 - PROCESS FMEA CHECKLIST
Customer or internal part number:_________________________ Revision level:_________________________

Person Due
Question Yes No N/A Comment / Action Required Responsible Date

Was the process FMEA prepared by a cross functional


1 team? Has the team taken into account all customer
specific requirements including FMEA methodologies
as shown in the current edition OF FMEA?

2 Have all operations including subcontracted or


outsourced processes and services been considered?

3 Have all operations affecting customer requirements


including fit, function, durability, government regulations
and safety been identified and listed sequentially?
4 Were similar part/process FMEAs considered?
Have historical campaign and warranty data been
5
reviewed and used in the analysis?
Have you applied the appropriate controls to address
6
all of the identified failure modes?
Were severity, detection and occurrence revised when
7
corrective action was completed?
Do the effects consider the customer in terms of the
8
subsequent operation, assembly and product?
Were customer plant problems used as an aid in
9
developing the process FMEA?
Have the causes been described in terms of something
10
that can be fixed or controlled?

11 Have provisions been made to control the cause of the


failure mode prior to subsequent or the next operation?

Revision Date:

Prepared by:
A8 - CONTROL PLAN CHECKLIST
Customer or internal part number:_________________________ Revision level:_________________________

Person Due
Question Yes No N/A Comment / Action Required Responsible Date
Was the control plan developed according to the
1 methodology described in chapter 6 of the A.P.Q.P.
manual?
Have all the controls identified in the PFMEA been
2
included in the control plan?
Are all special product/process characteristics included
3
in the control plan?
Were DFMEA and PFMEA used to prepare the control
4
plan?
Are material specifications requiring inspection
5
identified?
Does the control plan address incoming
6 (material/components) through processing/assembly
including packaging?
Are engineering performance testing and dimensional
7
requirements identified?
Are gauges and test equipment available as required
8
by the control plan?
If required, have the customer approved the control
9
plan?
Are the gauge methodology and compatibility
10
appropriate to meet customer requirements?

11 Have measurement systems analysis been completed


in accordance with customer requirements?
Are sample sizes based upon industry standards,
12 statistical sampling plan tables, or other statistical
process control methods or techniques?

Revision Date:

Prepared by:
TEAM FEASIBILITY COMMITMENT
Customer: Date:

Part number: Part Name:

Revision level:

Feasibility Considerations:
Our product quality planning team has considered the following questions.
The drawings and/or specifications provided have been used as a basis for analysisng the organisation's ability to meet all specified
requirements. All 'no' answers are supported with attached comments identifying our concerns and/or proposed changes to enable the
organisation to meet the specified requirements.

Yes No Consideration
Is product adequately defined (application requirements etc.) to enable feasibility evaluation?
Can Engineering Performance Specifications be met as written?
Can product be manufactured to tolerances specified on drawing?
Can product be manufactured with process capability that meet requirements?
Is there adequate capacity to produce product?
Does the design allow the use of efficient material handling techniques?
Can the product be manufactured within normal cost parameters? Abnormal cost considerations may include:
- Costs for capital equipment?
- Costs for tooling?
- Alternative manufacturing methods?
Is statistical process control required on product?
Is statistical process control presently used on similar products?
Where statistical process control is used on similar products:
- Are the processes in control and stable?
- Does process capability meet customer requirements?

Conclusion

Feasible Product can be produced as specified with no revisions.


Feasible Changes recommended (see attached).
Not Feasible Design revision required to produce product within the specified requirements.

Approval

Team member / Title / Date Team member / Title / Date

Team member / Title / Date Team member / Title / Date

Team member / Title / Date Team member / Title / Date


PRODUCT QUALITY PLANNING SUMMARY AND APPROVALS
Date:

Product name: Part no./Rev.

Customer: Manufacturing plant:

1. Preliminary Process Capability Study Quantity


REQUIRED ACCEPTABLE PENDING*
Ppk Special Characteristics

2. Control Plan Approval (if required) Approved (Yes/No)* Date approved:

3. Initial Production Samples


Characteristic Category Quantity
CHARACTERISTIC
REQUIRED S PER SAMPLE ACCEPTABLE PENDING*
Dimensional
Visual
Laboratory
Performance

4. Gauge and Test Equipment


Measurement System Analysis Quantity
REQUIRED ACCEPTABLE PENDING*
Special Characteristic

5. Process Monitoring Quantity


REQUIRED ACCEPTABLE PENDING*
Process Monitoring Instructions
Process Sheets
Visual Aids

6. Packaging/Shipping Quantity
REQUIRED ACCEPTABLE PENDING*
Packaging Approval
Shipping Trials

7. Approvals

Team member / Title / Date Team member / Title / Date * Requires


preparation of

Team member / Title / Date Team member / Title / Date an action plan to
track progress.
Team member / Title / Date Team member / Title / Date

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