Fmea Alignment Aiag and Vda
Fmea Alignment Aiag and Vda
Fmea Alignment Aiag and Vda
504H0004, Issue 7
Identification and Documentation Content Approved: 2015-07-09
of Special Characteristics New Format Implemented 2016-01-15
Strategic Owner: Content owner: Approved by:
Jeff Baldus Global Engineering Product Technology Leadership (PTL) / Author: Jeff Jeff Herrin
Baldus
2 PURPOSE
The purpose of this standard is to define the Danfoss Power Solutions system for classifying
the characteristics most important for our customer’s safety and satisfaction as special
characteristics.
The classification system ensures extra attention and manufacturing process controls are
focused on those “vital few” characteristics during the product and process design, PPAP
Validation, and on-going production.
3 DEFINITIONS
The special characteristic designations to be used as part of the Danfoss Power Solutions
system are:
Safety Characteristics - Safety characteristics are those characteristics/features which have
the potential to affect safety.
When defining safety characteristics the safety of all personnel involved in the manufacture,
test, commissioning, and end use of the product need to be considered.
Safety characteristics are best controlled through well-understood and maintained design
margins coupled with manufacturing error-proofs that prevent or detect abnormal process
variations which could significantly reduce operating margins.
Safety critical items will be identified on the engineering drawing with a pentagon with an
‘S’ inside it.
Key Characteristics - Key characteristics are defined to be those characteristics for which
the normally expected process variation affects product function/customer satisfaction.
Stated another way, the end customer can distinguish product differences due to the
variation of a key characteristic within specification. The customer’s satisfaction is
increased when these characteristics are maintained on target with minimum variation.
Key Characteristics will be identified on the engineering drawing with a pentagon with a ‘K’
inside it.
504H0004, Issue: 7 , Approved: 2015-07-09 Available to: Danfoss Power Solutions and Suppliers 1/14
Process Characteristics - Process Characteristics are characteristics which do not directly
affect the function of a product but are important for success of downstream manufacturing
processes such as an automated assembly.
Process characteristics will be identified on the engineering drawing with a pentagon with a
‘P’ inside it.
Characteristics with Multiple Designations - In rare cases characteristics could be both
“Safety” and “Key”. This would designate that the feature needs to be statistically
maintained “on target with minimum variation” for customer satisfaction as well as being
error-proofed to ensure the prevention or detection of any abnormal process variations
which could significantly reduce operating margins.
4 RESPONSIBILITY
Product Engineering is responsible for classifying Safety and Key special characteristics.
Process characteristics, if required, are to be classified by Process Engineering and
communicated to Product Engineering for inclusion on the drawing/specification.
Product Engineering managers in the individual areas shall be responsible for ensuring
compliance with the requirements contained in this standard.
Efforts should be taken by Product Engineering to minimize the number of special
characteristics through design activities focused on reducing the severity and/or occurrence
rankings from the Design FMEA (DFMEA).
Typically, this can be achieved by making design changes that eliminate failure modes with
high severity rankings, by adopting a design that has a large design margin, or by improving
the engineering organization’s fundamental knowledge of the causes of failure.
5 GENERAL
Characteristics are divided into four classifications (Safety, Key, Process, Standard) based
on a Design FMEA assessment of failure mode severity and occurrence ratings and/or a
Quality Loss Function Analysis.
Each classification has process capability and control requirements and also serves to
indicate to the process/service operators the level of importance of the operation they are
performing.
504H0004, Issue: 7, Approved: 2015-07-09 Available to: Danfoss Power Solutions and Suppliers 2/14
6 IDENTIFICATION AND CLASSIFICATION METHOD
Potential Special Characteristics shall be determined by the DFMEA occurrence and severity
rankings as shown in Table 1.
The Occurrence and Severity rankings shall originate from a Design FMEA conducted per
the Danfoss Power Solutions standard, 504H0002.
If the severity is ≥ 9, then the characteristic is a safety characteristic, independent of its
status as a key characteristic. Any severity ≥ 9 occurring in the product, which cannot be
reduced through re-design, requires steps to mitigate the risk in the manufacturing process.
If severity is ≥ 5 and occurrence ≥ 4, the characteristic is classified as a key characteristic.
Characteristics may be classified with more than one special characteristic. For example,
characteristics with a severity of ≥ 9 and the occurrence ≥ 4 are classified as Safety and Key
characteristics.
Table 1
504H0004, Issue: 7, Approved: 2015-07-09 Available to: Danfoss Power Solutions and Suppliers 3/14
Reference 504H0002 for Design FMEA Occurrence and Severity descriptions.
In addition to the use of DFMEA Severity and Occurrence, Key characteristics can be
determined using the quality loss function logic defined in Appendix ‘C’.
Quality Loss Function logic can be an effective way to assess “border” cases from the “S x
O” method (i.e. Occurrences of 5 & 6 and Severities of 5 and 6) to determine if classification
as a “Key” characteristic is really warranted.
504H0004, Issue: 7, Approved: 2015-07-09 Available to: Danfoss Power Solutions and Suppliers 4/14
DOCUMENTATION REQUIREMENTS
Product Engineering is responsible for recording on the technical document (e.g. drawing,
assembly specification, test specification, material specification etc.) any special
characteristics.
A pentagon with an ‘S” for Safety, a pentagon with a “K” for Key, a pentagon with a “P” for
Process shall be placed on the technical document by each characteristic designated as a
special characteristic. See Figure 1.
Figure 1
Figure 2
504H0004, Issue: 7, Approved: 2015-07-09 Available to: Danfoss Power Solutions and Suppliers 5/14
In cases where a characteristic is both a safety and a key, the special characteristics are to
be designated as shown in Fig 3. The order (K first or S first) is not important.
Figure 3.
Product Engineering shall include on all drawings and relevant specifications, as early as
possible in the design process, a Customer Importance Table (CIT) summarizing special
characteristics.
Standard Characteristics may also be included, but they are not required in the CIT unless
deemed necessary by the team during the Design for Manufacturability/Assembly/Test
(DFM/A/T) process.
Typical drawing and specification CIT formats, as well as guidelines for completing the CIT,
can be found in Appendix A. The Customer Importance Table is always located on the first
sheet.
It is optional to include a table indicating the location and quantity of special characteristics
placed on the drawing (see Appendix A).
Technical documentation that has undergone an FMEA process with no resulting special
characteristics identified, must either include a blank CIT (see Appendix A), or the text
“Special Characteristics per 504H0004” must be shown in the drawing/specification
indicating the process for identifying special characteristics has been completed but no
special characteristics were found.
Special Characteristics can also for other reasons be denoted in the documentation even
though the FMEA process did not identify any Characteristics per Table 1.
504H0004, Issue: 7, Approved: 2015-07-09 Available to: Danfoss Power Solutions and Suppliers 6/14
6.1 Danfoss Power Solutions drawings and specifications created prior to 504H0004Rev E
Special characteristics created prior to 504H0004 Rev. E followed a different classification
system. The system defined Quality Characteristics as Critical and Key characteristics and
did not have Safety or Process characteristics. Critical and Key characteristics (prior to
revision E) are to be interpreted as Key Characteristics under the New System.
Characteristic Type 504H0004 Before Rev E 504H0004 Rev E & After
Safety Characteristic
Safety Not Part of Standard
Key Characteristic
Critical
Quality
Key
Process Characteristic
Process Not Part of Standard
504H0004, Issue: 7, Approved: 2015-07-09 Available to: Danfoss Power Solutions and Suppliers 7/14
Table 2
Minimum Cp Minimum Cpk Equivalent
Classification
Requirement Requirement PPM Level
Safety Error Proof
Key 1.83 1.33 32
Process 1.0 1.0 2700
Safety + Key 1.83 1.33 Error Proof
Standard 1.0 1.0 2700
Process capability studies shall be completed for Key and Process characteristics and
submitted as part of the PPAP process. Reference Danfoss Power Solutions standard
504H0007.
If the process capability requirements are not met, then Product and Process Engineering
must work to resolve the issue.
Typically, resolution can be achieved by changing the design concept, testing/analysis to
determine if design tolerance can be increased, and/or implementing process
improvements.
In the cases where these activities do not achieve the desired capability a more restrictive
control plan such as 100% inspection to reduced limits can be used.
Measurement
Production Gauging shall be selected for each special characteristic per Table 3.
Table 3
Classification Gauging GR&R
Safety Error Proof Not Applicable
Key Variable ≤20% Required
Safety + Key Error Proof + Variable ≤20% Required
Process Variable or Attribute ≤30% is recommended for all
Standard Variable or Attribute measurement systems
Key Characteristics must have Gage Repeatability and Reproducibility (GR&R) studies
completed and submitted as part of the PPAP process. Reference Danfoss Power Solutions
standard 504H0010.
If GR&R requirements are not met, work must be done to resolve the issue.
For key characteristics with DFMEA occurrences ≥8 continuing efforts to achieve ≤ 20%
GR&R should be undertaken.
504H0004, Issue: 7, Approved: 2015-07-09 Available to: Danfoss Power Solutions and Suppliers 8/14
For key characteristics with DFMEA occurrences ≤ 7 more restrictive control plans such
guard banding (reducing tolerance by the GR&R) or attribute gauging can be employed to
mitigate a GR&R > 20%.
Control Plan
The production control plan shall identify each special characteristic (S, K, or P) and define
the production process controls. Reference Danfoss Power Solutions standard 504H0012.
The production process control method for special characteristics shall be selected for each
special characteristic per Table 4.
Table 4
Production Control
Classification Examples for Reference Only
Method
Safety Error Proof Poke-Yoke
Statistical Process Control with Cpk>1.33
Statistically based
Key Pre-Control at 50% Green Zone
charted method
Other Statistically Proven Controls
Error Proof +
Poke-Yoke plus Pre-Control at 50% Green
Safety + Key Statistically based
Zone
charted method
Process Samples to Print Check 1/10 to print limits
8 References:
Danfoss Power Solutions Global Standards:
o Design FMEA 504H0002
o Capability Study 504H0007
o Gage R&R 504H0010
o Control Plan Requirements 504H0012
504H0004, Issue: 7, Approved: 2015-07-09 Available to: Danfoss Power Solutions and Suppliers 9/14
CHANGE HISTORY:
504H0004, Issue: 7, Approved: 2015-07-09 Available to: Danfoss Power Solutions and Suppliers 10/14
APPENDIX A
Pentagon – with identification for Safety, Key, or Process characteristics, referring to the CIT.
Cpk – Process capability index adjusted for process off center. Reference 504H0007
Key Cpk1.33
Tolerance required for process
Process
not function
The "Zone" column will indicate quantity of "⌂S's" or , "⌂K's" or “⌂P’s” with a "(number)X" prefix to the zone
(Example: 2X 12H ).
It is not necessary to indicate quantity when there is only one critical in a zone.
504H0004, Issue: 7, Approved: 2015-07-09 Available to: Danfoss Power Solutions and Suppliers 11/14
APPENDIX B
It is not appropriate to put “K” on a material specification because the design margin would be low if the
producer uses the wrong material or a required heat treatment is omitted.
The special characteristics must be assigned to something that is measurable (hardness, case depth,
tensile strength, etc.) and not to the entire specification.
Production Part Approval Process activities should focus activities on the material/heat treatment Process
FMEA and the Production Control plan.
The control plan should define samples representing both the “Within” variation due to position in
Basket/Oven or order (First, Middle, Last) as well as the “Between” variation due to different batches or
runs.
Capability and Gage R&R studies should be replaced by studies to understand and implement the best
sampling methodologies.
In addition to the recommendations above the Capability and GR&R activities should be completed.
504H0004, Issue: 7, Approved: 2015-07-09 Available to: Danfoss Power Solutions and Suppliers 12/14
APPENDIX C
Determining Key Characteristics Using a Quality Loss Function
Quality Loss Functions may also be used for determining “Key” Characteristics. It is not
appropriate for “Safety” characteristics which must come from DFMEA Severity ratings.
Use of the Quality Loss Function does not replace/negate the requirement for completing a
DFMEA! It is only a different method for determining “Key” characteristics. Reference 504H0002
for DFMEA requirements.
If Quality Loss Function methodology is used, it should be completed by a panel of Product
Engineering experts representing the body of knowledge of the entire engineering department
and be facilitated by someone with expert knowledge of loss functions. The figures below
summarize determining Key characteristics through loss functions.
No
n Continuous Loss Function Key Margin
Small
n Low Margin Loss Function May be Key Margin
– Losses When “Just Outside of Specification”
– Small Margin
Large
n High Margin Loss Function Not Key Margin
504H0004, Issue: 7, Approved: 2015-07-09 Available to: Danfoss Power Solutions and Suppliers 13/14
LOSS FUNCTION
Specification IN Out
Loss occurs Inside or Outside of Specification
Slope
Of the Loss Function Steep Shallow Steep Shallow Steep Shallow
504H0004, Issue: 7, Approved: 2015-07-09 Available to: Danfoss Power Solutions and Suppliers 14/14