Donaldson Europe Document

SUPPLIER PPAP WORKBOOK

CORP SQADOC 004

Prepared by: Ed Van den Enden 0 Rev 0 Book Rev. 15 dd 04/09/2015

PPAP WORKBOOK
DONALDSON EMEA
CORP SQADOC 004 SUPPLIER PPAP WORKBOOK Rev. 15 dd 04/09/2015

Front page
Index
Revision sheet
PPAP Manual

SQAR (Supplier Quality Assurance Requirements)

1.0 Part Submission Warrant Submit
2.0 Appearance approval Report Submit
3.0 Design records Submit
4.0 Authorized change documents Submit
5.0 Part Dimensional approval Submit
6.0 List of checking aids Retention
7.0 Part Material approval Submit
8.0 Process Flow Map Submit
9.0 Process flow example
10.0 Design and or Process FMEA Submit
10.1 Process FMEA scales
10.2 FMEA Requirements
11.0 Control Plan Submit
12.0 Process Capability Study, Cpk Calculation Submit
12.1 Cpk Guidelines
13.0 Measuring System Study, Gage R&R Submit
13.1 Gage R&R Scale
14.0 Sample parts Submit
14.1 Master Sample (If applicable)
Customer Engineering Approval Form
PPAP Level 5 Checklist
PPAP Part Submission Label

CORP SQADOC 004 SUPPLIER PPAP WORKBOOK Book Rev. 15 dd 04/09/2015

9/2015
Rev No Date Description Name

0 14-1-2013 First release EvdE

1 21-1-2013 First check EvdE
2 28-1-2013 Elsmar R&R update EvdE
3 11-Feb-13 Update after check by Ilse Jehoul / release version EvdE
4 19-Mar-13 Update PPAP submission info sheet Evde
5 28-Mar-13 Add Interim Approval to PSW / Reach to Customer IJehoul
Engineering Approval

Edit index sheet. PPAP Label Sheet added. Changed PPAP

6 4-Mar-13 Submission sheet. Changed PSW document EvdE
7
8 3-Jan-14 Higher revision Control Plan IJehoul
9 9-Mar-14 Higher revision FMEA document EvdE
10 23-Sep-14 Inserted revised PUPDOC 033 EvdE
11 5-Feb-15 FMEA sheet and requirements changed EvdE
12 25-Feb-15 FMEA requirements sheet adapted to Industial EvdE
13 26-May-15 Sheet SQAR was named PPAP subm Info EvdE
SQAR sheet: changed Required in Retention for some
14 24-Aug-15 lines EvdE
15 4-Sep-15 Updated hyperlinks to SQAR sheet EvdE
 Book Rev. 15 dd
CORP SQADOC 004 SUPPLIER PPAP WORKBOOK 04/09/2015
 Description
No EN0239211 will be respected

1
Inform you about the PPAP level requested by our purchase department
2
Fix / locate the communication channels. (the Donaldson ppap team)

Check latest revision and communicate always with Donaldson part

3 number including revision number The supplier is fully responsible for
having all documents at the latest revision.
4 Ensure that all required sheets are completed and foreseen with the
Donaldson Partnumber and revision number.

5 Only with all required sheets completed plus ppap approval from the
Donaldson ppap team, you are allowed to supply production parts.
6 All RPN's must be <150. All severities ≥ 8 RPN need to be <100.
All critical dimensions or and key characteristics in notes or dimension
7 should have SPC. You will show evidence in your control plan including
sample quantity.

8 If a measuring system is destructive, please contact the Donaldson ppap

team to determine sample quantity

9 If requirements like Cpk's, tolerances or material spec's can't be met,

please contact the Donaldson ppap team before submitting a ppap.

If material spec's can't be met or you can't give evidence that materials
10 are at spec, you should have raised this shortcoming during the RFQ
process, not at time you have to submit a ppap

11 The supplier is allowed to use his own PPAP document format as long as
these documents are covering the same content as the templates in this
workbook and are in accordance with the AIAG PPAP standard. In all
cases the supplier should respect bullet 12 from this manual.

12 Print the whole workbook as "ONE" pdf document. PPAP documents

should be submitted in an electronic way. Name your ppap document
with the product number plus revision number. Sample: P768764-rev8.
Send ppap WORKBOOK to: ppap.emea@donaldson.com
Info The protected sheets have password : CORP SQADOC 004
CORP SQADOC 004 SUPPLIER PPAP WORKBOOK Rev. 15 dd 04/09/2015
PPAP Submission due date: Planned > Actual >

PPAP status Not submitted

Submission
Reason
Part Name (Donaldson
Part Number (Donaldson)
Revision (Donaldson)
Revision date (Donaldson)
Supplier Part Number (optional)
PPAP Assigned Quality Engineer
Supplier Name
Supplier Number
Street Address
City
Postcode / Zip code
Country
Phone Number
Supplier Contact
Receiving Donaldson Plant EDC, Pathoekeweg 166, B-8000 Brugge,
Belgium
Supplier PPAP LEVEL 3
Remarks Requirements
Part Submission Warrant
If designated appearance part,
appearance compliance will be
Appearance approval Report
identified via a special purchase
order notification.
Design records
Authorized change documents
Part Dimensional approval
List of checking aids
Part Material approval
Process Flow Map
Design and or Process FMEA
Control Plan
Please execute and show
Process Capability Study, Cpk Calculation
evidense of capabillity
Measuring System Study, Gage R&R
Sample parts
Master Sample (If applicable)
Customer Engineering Approval Form

PPAP Level 5 Checklist

CORP SQADOC 004 SUPPLIER PPAP WORKBOOK Book Rev. 15 dd 04/09/2015
 Purchaser name:
Dated and Signed by Donaldson

Submit

Submit

Submit
Submit
Submit
Retention
Submit
Submit
Submit
Submit

Submit

Submit
Submit
dd 04/09/2015
 Donaldson Europe Document
PART SUBMISSION WARRANT
CORP QEHSDOC 018

Prepared by: Ed Van den Enden Rev. 4 dd 23/09/2013

Part Name 0 Part Number:  0

Safety / Government Engineering Drawing
Yes No 0 Dated 30-Dec-99
Regulation Change Level: 
Additional Engineering Changes:  Dated
Shown on Drawing N°:  Purchase Order N°: Weight kg

Checking Aid N°:  Engineering Change Level: Dated

SUPPLIER MANUFACTURING INFORMATION SUBMISSION INFORMATION 

Supplier Name:  0 Statistical ✘ Dimensional ✘ Materials / Function Appearance

Street Address: 0 Customer Name/Division: 
Postal Code/City: 50703, Waterloo, USA Buyer/Buyer Code:
State: Application: 

Does this part contain any restricted or reportable substances? Yes No

Submitted by IMDS or other customer format:
Are plastic parts identified with appropriate ISO Marking codes? Yes No

REASON FOR SUBMISSION 

Initial Submission Change to Optional Construction or Material
Engineering Change(s) Sub-Supplier or Material Source Change
Tooling: transfer, replacement, refurbishment, or additional Change in Part Processing
Correction of Discrepancy Parts produced at Additional Location
Tooling Inactive for more than 1 year Other (please specify):

REQUESTED SUBMISSION LEVEL (check one)

Level 1 - Warrant only (and for designated appearance items, an Appearance Approval Report) submitted to the customer
Level 2 - Warrant with product samples and limited supporting data submitted to the customer
Level 3 - Warrant with product samples and complete supporting data submitted to the customer
✘ Level 4 - Warrant and other requirements as defined by the customer
Level 5 - Warrant with product samples and complete supporting data reviewed at the supplier’s manufacturing location

SUBMISSION RESULTS
The results for: Dimensional measurement Material & Functional tests
Appearance Criteria Statistical Process Package
These results meet all drawing and specifications requirements: Yes No
If “No”, explanation required:
Mold / Cavity / Production Process:

DECLARATION
I affirm that the samples represented by this warrant are representative of our parts, have been made to the applicable drawings and specifications.

I further warrant these samples were produced at the production rate of: / hours (written approval)
I have noted any deviations from this declaration below.
EXPLANATION/COMMENTS:

Name: Title: Phone N°

Supplier Authorized Signature: Date:

FOR CUSTOMER ONLY (if applicable)

Part Warrant Disposition Approved Rejected Interim Approval
Part Functional Approval Approved Rejected Quantity:
Expiry Date:
Customer Name: Customer Signature: Date:
 Donaldson Europe Document
APPEARANCE APPROVAL REPORT
CORP QEHSDOC 019 (replaces old ENGDOC 047)

Prepared by: Ed Van den Enden Rev. 2 dd 11/02/2013

Part Number Drawing Number Application
0 0
Part Name Buyer E/C Level Date
0 0
Supplier Name Manufacturing Location Supplier Code
0 0 0
Reason for Part Submission Warrant Special Sample Re-Submission Other
Submission
Pre Texture First Production Shipment Engineering Change

Appearance Evaluation
Pre-Texture Donaldson Representative
Supplier Sourcing and Texture Information Evaluation signature and Date

Correct and Proceed

Correct and Resubmit

Approved to Texture

Color Evaluation
Color
Color Master Master Material Material Metallic Part
Tristimulus Data Hue Value Chroma Gloss Shipping
Suffix Number Date Type Source Brilliance Disposition
Suffix

DL* Da* Db* DE CMC Red Yel Grn Blu Light Dark Gray CleanHigh Low High Low
Comments:

Supplier Signature Phone No. Date Donaldson Representative Signature Date

 Design Record(s)
The organization shall have the design record for the saleable product / part, including
design records for components or details of the saleable product / part.
Where the design record is in electronic format, e.g., CAD/CAM math data, the
organization shall produce a hard copy like geometric dimensioning & Tolerances
(GD&T) sheets / drawings to identify measurements taken.

Note 1:
For any saleable product, part or component, there will only be one record, regardless
of who has design-responsibility. The design record may reference other documents
making them part of the design record.
Note 2:
A single design record can represent multiple part or assembly configurations, e.g., a
sub-frame assembly with various hole configurations for different applications.
Note 3:
For parts identified as black box, the design record specifies the interface and
performance requirements.
Note 4:
For parts identified as catalog parts, the design record may consist only of a functional
specification or a reference to a recognized industry standard.
Note 5:
For bulk materials, the design record may include identification of raw materials,
formulations, processing steps and parameters, and final product specifications or
acceptance criteria. If dimensional results do not apply, then CAD/CAM requirements
are also not applicable.

CORP SQADOC 004 SUPPLIER PPAP WORKBOOK Book Rev. 15 dd 04/09/2015

 Supplier Product Process
Change Request
PUPDOC 033 REV. 0
Issue Revision
Date:
7/5/2012
Date: Prepared by: Donaldson Purchasing

Product Process Change Request

FORM INCOMPLETE
Proposal Date:

A. SUPPLIER INFORMATION:
Supplier Name:
Supplier City/Country: 0
Donaldson Assigned Supplier Number: 0
Originator Name:

B. SCOPE OF CHANGE:
1. Affected Part Number(s) sold to Donaldson:
Donaldson

2. Name or brief description of part(s):

3. Affected Donaldson Plant(s):

4. Drawing Revision:

C. DETAILED DESCRIPTION OF CHANGE

1. Change Type:
Material Change
POM Change
Supplier Change
Process Change
Design Change
Tooling/Equipment Renewal or Modification
Transfer of Tooling/Equipment
Change in test or test inspection methods
Change in appearance (paint, coating, adhesive..)
Other:

2. Description of Change: Proposed start of production date:

3. Requested PPAP Submission Date:
Note: Planned start of production date must not be less than 12 weeks from dated supplier declaration below.

4. Financial impact details (include cost savings calculations & cost reduction model)

5. Will any Donaldson specifications/drawings be affected by this change?

If yes, list all that will be affected.

6. Is equipment or tooling affected?

Is tooling or equipment Donaldson owned?
7. Is purchase of new tool required?
If YES, who is paying for the tooling?
8. Does the change require relocation of capital equipment?
9. Is the FMEA complete including all effects from the proposed change?

To be filled in by Donaldson Quality

1. PPAP required for this change?
2. Level of PPAP required?
3. Part numbers that suppliers has to submit along with PPAP?

4. PSW released?

Signature Block
Supplier Engineering Manager Plant Engineering Manager
Name Name
Signature Signature

Supplier Quality Manager Plant Quality Manager

Name Name
Signature Signature

Supplier Sales Representative Plant Purchasing Manager

Name Name
Signature Signature
 Supplier Product Process
Change Request
PUPDOC 033 REV. 1
Issue Revision
Date:
7/5/2012
Date:
6/17/2013 Prepared by: Donaldson Purchasing

Product Process Change Request

FORM INCOMPLETE
Proposal Date:

A. SUPPLIER INFORMATION:
Supplier Name: 0
Supplier City/Country: 0
Donaldson Assigned Supplier Number: 0
Originator Name:

B. SCOPE OF CHANGE:
1. Affected Part Number(s) sold to Donaldson:

2. Name or brief description of part(s):

3. Affected Donaldson Plant(s):

4. Drawing Revision:

C. DETAILED DESCRIPTION OF CHANGE

1. Change Type:
Material Change
POM Change
Supplier Change
Process Change
Design Change
Tooling/Equipment Renewal or Modification
Transfer of Tooling/Equipment
Change in test or test inspection methods
Change in appearance (paint, coating, adhesive..)
Other:

2. Description of Change: Proposed start of production date:

3. Requested PPAP Submission Date:
Note: Planned start of production date must not be less than 12 weeks from dated supplier declaration below.

4. Financial impact details (include cost savings calculations & cost reduction model)

5. Will any Donaldson specifications/drawings be affected by this change?

If yes, list all that will be affected.

6. Is equipment or tooling affected?

Is tooling or equipment Donaldson owned?
7. Is purchase of new tool required?
If YES, who is paying for the tooling?
8. Does the change require relocation of capital equipment?
9. Is the FMEA complete including all effects from the proposed change?

To be filled in by Donaldson Quality

1. PPAP required for this change?
2. Level of PPAP required?
3. Part numbers that suppliers has to submit along with PPAP?

4. PSW released?

Signature Block
Supplier Engineering Manager Product Engineering Manager
Name Name
Signature Signature

Supplier Quality Manager Plant Quality Manager

Name Name
Signature Signature

Supplier Sales Representative Corporate Buyer / Plant Buyer*

Name Name
Signature Signature

*for plant managed commodities

YES Level3
NO Level4
 Production Part Approval - Dimensional Results

Part Number
Supplier 0
0
Outside
Laboratory Name Name of Laboratory Part Name
In-
of Laboratory laboratory
house if appl.
0
testing
Type of Spec. Quant
Dimensional specification Supplier Test Results
Test limits tested
Signature Title

CORP SQADOC 004 SUPPLIER PPAP WORKBOOK Book Rev. 15 dd 04/09/2015

Results

Revision Level
0

OK Not OK
 Date

Book Rev. 15 dd 04/09/2015

 List of checking Aids
Part Name: 0 Customer :
Part No: 0 Date:
Rev. No/Date: 0
Availability of Gauge/
Bullet no Gauge / Instrument Calibrated On Calibration Due
Instrument

Prepared By : Approved By :

Signature : Signature :
CORP SQADOC 004 SUPPLIER PPAP WORKBOOK Book Rev. 15 dd 04/09/2015
Calibration Status
Book Rev. 15 dd 04/09/2015
 Production Part Approval - Material Results

Part Number
Supplier 0
0
Outside
Laboratory Name Name of Laboratory Part Name
In-
of Laboratory laboratory
house if appl.
0
testing
Type of Spec. Quant
Specification Supplier Test Results
Test limits tested
Signature Title

CORP SQADOC 004 SUPPLIER PPAP WORKBOOK Book Rev. 15 dd 04/09/2015

sults

Revision Level
0

OK Not OK
 Date

Book Rev. 15 dd 04/09/2015

 Process Flow Map
Part Number: 0 Date:
Rev 0
Part name 0 Prepared By:
Fabrication
Number

Inspect

Item #

Item #
Move
Store Operation Description Key Product Characteristics Key Control Chatacteristics

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53

CORP SQADOC 004 SUPPLIER PPAP WORKBOOK Book Rev. 15 dd 04/09/2015

 Process Flow Map
Part Number: P676767 Date: 14-1-2013
Rev 12
Part name BRACKED LEFT Prepared By: EvdE
Fabrication

Inspect

Item #

Item #
Move
Store

STEP Operation Description Key Product Characteristics Key Control Chatacteristics

1 Incoming inspecion 33GFPA6 1.0 P567677 material spec 33% GF PA6 1.0 Polyprom 33GFPA6 mat sertificate
2 Move
3 Storage 3.0 Standard S1001 2.0 Standard S1001
4 Move
5 Move Tool
6 Install Tool (Mold) 6.0 Cooling, Alignment, Temperature, Pressur6.0 P676767 setup sheet
7 6.1 P676767 checklist
8 Move material P567677 material spec 33% GF PA6 P676767 control sheet
9 F.O.T. sample 9.0 Surface F.O.T. initial sample test
10 Flatness 0.5 P676767 control sheet
11 D=23.7 +/- 0.4
12 L=123 +/- 0.2
13 Release production 13 Surface 13 P676767 control sheet
14 Flatness 0.5
15 D=23.7 +/- 0.4
16 L=123 +/- 0.2
17 Move
18 Inspection last out of tool 18 Surface 18 P676767 control sheet
19 Release for shipping Flatness 0.5
20 D=23.7 +/- 0.4
21 L=123 +/- 0.2
CORP SQADOC 004 SUPPLIER PPAP WORKBOOK Book Rev. 15 dd 04/09/2015
 DONALDSON EUROPE DOCUMENT

FAILURE MODE AND EFFECT ANALYSIS - FMEA

CORP QUALDOC 014
(Replacing CORP QEHSDOC 014)
Prepared by: Ilse Jehoul Rev 11 dd 02/02/2015

DESIGN PROCESS FMEA NUMBER: 0 ORIGINAL DATE: CURRENT REVISION: REVISION DATE:
Subsystem / Name:
Design/Process Responsibility: Suppliers and Plants affected:
Core Team: Model/Part:
Prepared by: Engineering Release Date:
Current Design/ Process Controls Action Results
Special Characteristics Recommended Action

O D
S
c e
e
c t
R Rules: v
u e
i * Continuously work on the e
Item / Process Function Potential Failure Mode Potential Effect(s) of Failure Severity
Potential Cause(s) / Mechanism(s) of Failure Mode
Prevention Occurence
s
Detection Detection
RPN Area/Ind. Responsible
Actions
& Target
TakenCompletion
/ EffectiveDate
Dater r c RPN
reduction of the highest RPN e t
k numbers. i
n i
* Pay special attention to the t
c o
RPNs where the Severity Score y
e n
is ≥ 8, regardless of the total
RPN.

Product Process
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0

* Means change versus previous revision 441756176.xlsx - Page 41 of 84

 Current Design/ Process Controls Action Results
Special Characteristics Recommended Action

O D
S
c e
e
c t
R Rules: v
u e
i * Continuously work on the e
Item / Process Function Potential Failure Mode Potential Effect(s) of Failure Severity
Potential Cause(s) / Mechanism(s) of Failure Mode
Prevention Occurence
s
Detection Detection
RPN Area/Ind. Responsible
Actions
& Target
TakenCompletion
/ EffectiveDate
Dater r c RPN
reduction of the highest RPN e t
k numbers. i
n i
* Pay special attention to the t
c o
RPNs where the Severity Score y
e n
is ≥ 8, regardless of the total
RPN.

Product Process
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0

* Means change versus previous revision 441756176.xlsx - Page 42 of 84

 DONALDSON EUROPE DOCUMENT

FAILURE MODE AND EFFECT ANALYSIS - FMEA

CORP QUALDOC 014
(Replacing CORP QEHSDOC 014)
Prepared by: Ilse Jehoul 0

FMEA - Engine FMEA - Industrial

RISK PRIORITY NUMBER = S x O x D
This value is used to rank the concerns in the design or in the process and prioritize actions.
Within each FMEA shall be continuously worked on the reduction of the highest RPN numbers.
Special attention shall be given to the RPNs where the Severity Score is ≥ 8,
regardless of the total RPN.
RISK PRIORITY NUMBER = S x O x D
This value is used to rank the concerns in the design or in the process and prioritize actions.
Within each FMEA shall be continuously worked on the reduction of the highest RPN numbers.
Special attention shall be given to the RPNs where the Severity Score is ≥ 8,
regardless of the total RPN.

SEVERITY (S) SEVERITY (S)

Effect Ranking Effect Ranking
DESIGN FMEA PROCESS FMEA (Manufacturing/Assembly DESIGN FMEA PROCESS FMEA (Manufacturing/Assembly
PROCESS FMEA (Customer Effect) Effect) PROCESS FMEA (Customer Effect) Effect)
Hazarduous without Potential failure mode effects safe Failure may endanger operator (machine or Hazarduous without Potential failure mode effects safe Failure may endanger operator (machine or
warning operation and/or non-compliance assembly) without warning. warning operation and/or non-compliance assembly) without warning.
with governement regulations. 10 with governement regulations. 10
Failure will occur without warning. Failure will occur without warning.

Hazarduous with Potential failure mode effects safe Failure may endanger operator (machine or Hazarduous with Potential failure mode effects safe Failure may endanger operator (machine or
warning operation and/or non-compliance assembly) with warning. warning operation and/or non-compliance assembly) with warning.
with governement regulations. 9 with governement regulations. 9
Failure will occur with warning. Failure will occur with warning.

Very High Item inoperable (loss of primary Major disruption to production line. Very High Item inoperable (loss of primary Major disruption to production line.
function). 100% of product may function). 100% of product may
have to be scrapped, or repaired with repair 8 have to be scrapped, or repaired with repair 8
time more than 1 hour. time more than 1 hour.

High Item operable but at reduced level of Minor disruption to production line. High Item operable but at reduced level of Minor disruption to production line.
performance. Product may have to performance. Product may have to
Customer very dissatisfied. be sorted, less than 100 % scrap, or reparation 7 Customer very dissatisfied. be sorted, less than 100 % scrap, or 7
with repair time between 0,5h & 1h . reparation with repair time between 0,5h & 1h .

Moderate Item operable but comfort/ Minor disruption to production line. Moderate Item operable but comfort/ Minor disruption to production line.
convenience item(s) inoperable. No sorting, les than convenience item(s) inoperable. No sorting, les than
100% may have to be scrapped or repaired 6 100% may have to be scrapped or repaired 6
Customer dissatisfied. with repair time less than 30 minutes Customer dissatisfied. with repair time less than 30 minutes

Low Item operable but Minor disruption to production line. Low Item operable but Minor disruption to production line.
comfort/convenience operable at 100 % may have to be comfort/convenience operable at 100 % may have to
reduced level of performance. reworked or repaired off-line (not in repair 5 reduced level of performance. be reworked or repaired off-line (not in repair 5
Customer somewhat department). Customer somewhat department).
dissatisfied. dissatisfied.
Very Low Fit & Finish item does not conform. Minor disruption to production line. Very Low Fit & Finish item does not conform. Minor disruption to production line.
Product to be sorted, Product to be sorted,
Defect noticed by most customers. with no scrap, less than 100% to be reworked. 4 Defect noticed by most customers. (> with no scrap, less than 100% to be reworked. 4
(> 75%) 75%)

Minor Fit & Finish item does not conform. Minor disruption to production line. Minor Fit & Finish item does not conform. Minor disruption to production line.
Less than 100% may Less than 100% may
Defect noticed by 50% of customers. have to be reworked, with no scrap, on line but 3 Defect noticed by 50% of customers. have to be reworked, with no scrap, on line but 3
out of station out of station. out of station out of station.

Very Minor Fit & Finish item does not conform. Minor disruption to production line. Very Minor Fit & Finish item does not conform. Minor disruption to production line.
Less than 100% may 2 Less than 100% may 2
Defect noticed by discriminating have to be reworked with no scrap, on-line but Defect noticed by discriminating have to be reworked with no scrap, on-line but
customer (< 25%) in station. customer (< 25%) in station.
None None
Slight inconvenience to operation or operator, Slight inconvenience to operation or operator,
No discernible effect 1 No discernible effect 1
or no effect. or no effect.

* Means change versus previous revision 441756176.xlsx - Page 43 of Pages

 DONALDSON EUROPE DOCUMENT

FAILURE MODE AND EFFECT ANALYSIS - FMEA

CORP QUALDOC 014
(Replacing CORP QEHSDOC 014)
Prepared by: Ilse Jehoul 0

FMEA - Engine FMEA - Industrial

OCCURRENCE (O) OCCURRENCE (O)
Probability of Probability of
Ranking Ranking
Failure DESIGN/PROCESS PROCESS Failure DESIGN / PROCESS PROCESS
Possible failure rates CPK When Possible failure rates CPK When
Very High: Very High:
Persistent Failures >100 per thousand vehicles/items < 0,55 Always 10 Persistent Failures
> 1 per 10 produced If applicable 0.5 Always 10
50 per thousand items >= 0,55 9

High: Frequent High: Frequent

Failures 20 per thousand items >= 0,78 Daily 8 Failures
1 per 40 produced If applicable 0.7 Daily 8
10 per thousand items >= 0,86 7

Moderate: Moderate:
Occasional failures 5 per thousand items >= 0,94 Weekly 6 Occasional failures

2 per thousand items >= 1,00 5 1 per 100 If applicable 1.00 Weekly 5

1 per thousand items >= 1,10 4

Low: Relatively few Very Low: Isolated

failures 0,5 per thousand items >= 1,20 Monthly 3 failures Yearly 2

Very Low: Isolated

failures 0,1 per thousand items >= 1,30 Yearly 2 0.5 per 100 units If applicable 1.33

Remote: Failure is
unlikely < 0,010 per thousand items >= 1,67 Never 1 Never 1

* Means change versus previous revision 441756176.xlsx - Page 44 of Pages


Prepared by: Ilse Jehoul
FMEA - Engine
DETECTION (D)
Probability of
detection
DESIGN
Control will not or can not detect a
Absolutely potential cause and subsequent
Impossible failure mode.Or there is no control.
Current control will probably not
detect potential cause and
Very Remote
subsequent failure mode.
Current control has poor chance of
detection.
Remote
Very low chance current control will
detect potential cause and
Very low
subsequent failure mode.
Low chance current control will
detect potential cause and
Low
subsequent failure mode.
Moderate chance current control will
detect potential cause and
Moderate
subsequent failure mode.
Controls have a good chance to
detect.
Moderately High
High chance current control will
detect potential cause and
High
subsequent failure mode.
Very high chance current control will
detect potential cause and
Very High
subsequent failure mode.
Design control will almost certainly
detect potential cause and
Almost certain
subsequent failure mode.
* Means change versus previous revision
DONALDSON EUROPE DOCUMENT
FAILURE MODE AND EFFECT ANALYSIS - FMEA
CORP QUALDOC 014
(Replacing CORP QEHSDOC 014)
0
FMEA - Industrial
DETECTION (D)
Probability of
PROCESS Ranking PROCESS Ranking
detection
Inspection Type Inspection Type
DESIGN
A B C A B C
Error-Proofed Gauging Manual Insp. Error-Proofed Gauging Manual Insp.
Control will not or can not detect a
X Absolutely potential cause and subsequent X
10 10
Control can not detect or there is no control Impossible failure mode.Or there is no control. Control can not detect or there is no control
Current control will probably not
X detect potential cause and X
9 Very Remote 9
Control is achieved with random checks only subsequent failure mode. . Control is achieved with random checks only
Current control has poor chance of
X detection. X
8 Remote 8
Visual inspection only. Visual inspection only.
Very low chance current control will
X detect potential cause and X
7 Very low 7
Double visual inspection only. subsequent failure mode. Double visual inspection only.
Low chance current control will
X X detect potential cause and X X
6 Low 6
Control is achieved with charting methods subsequent failure mode. Control is achieved with charting methods
(SPC). (SPC).
Moderate chance current control will
X detect potential cause and X
Control is based on variable gauging after 5 Moderate Control is based on variable gauging after 5
subsequent failure mode.
parts have left the station parts have left the station
Controls have a good chance to
X X detect. X X
Error detection in subsequent operations or 4 Moderately High Error detection in subsequent operations or 4
gauging performed on setup & first piece gauging performed on setup & first piece
check. High chance current control will check.
X X detect potential cause and X X
Error detection in-station or in subsequent 3 High Error detection in-station or in subsequent 3
subsequent failure mode.
operations by multiple layers of acceptance. operations by multiple layers of acceptance.
Very high chance current control will
X X detect potential cause and X X
Error detection in station. Automatic gauging. 2 Very High Error detection in station. Automatic gauging. 2
subsequent failure mode.
Cannot pass discrepant part. Cannot pass discrepant part.
Design control will almost certainly
X detect potential cause and X
Discrepant parts cannot be made because 1 Almost certain Discrepant parts cannot be made because 1
subsequent failure mode.
error-proofed by process/product design. error-proofed by process/product design.
441756176.xlsx - Page 45 of Pages
 For Design FMEA
Item / Proces
Enter the items, interfaces or parts which have been identified through block diagrams, P-diagrams, schematics and
other drawings, and other analysis conducted by the team.
The terminology used should be consistent with customer requirements and with those used in other design
development documents and analysis to ensure traceability.

Special Characteristics
Customer specific requirements may identify special product or process characteristic symbols and their usage.

A characteristic designated in the design record as special without an associated design failure mode identified in
the DFME is an indication a a weakness in the design process.

Part / Process F
Enter the function(s) of the item(s) or interface(s) being analyzed which are necessaty to meet the design intent
based on customer requirements and the team's discussion. If the item(s) or interface has more than one function
with different potential modes of failure, it is highly recommended that each of these functions and associated
failure mode(s) islisted separately.

Potential Failur
Potential failure mode is defined as the manner in which a component, subsystem, or system could potentially fail to
meet or deliver the intended function described in the item column.
Identify the potential failure mode(s) associated with the function(s)/requirement(s). Potential failure modes should
be described in technical terms, and not necessarily as a symptom noticeable by the customer.

Each function may have multiple failure modes. A large number of failure modes identified for a single function may
indicate that the requirement is not well defined.
The assumption is made that the failure could occur, but may not necessarily occur, consequently the use of the
word "potential".
Potential failure modes that could occur only under certain operating conditions (i.e., hot, cold, dry, dusty, etc.) and
under certain iusage conditions (i.e., above-average mileage, rough terrain, city driving only, etc.) whould be
considered.

After determining all the failure moders, a validation of the completeness of the analysis can be made through a
review of past things-gone-wrong, concerns, reports, and group brainstrorming.
The potential failure mode may also be the cause of a potential failure mode in a higher level subsystem or system,
or lead to the effect of one in a lower level compoenent.

Potential Effects
Potential effects of failure are defined as the effects of the failure mode, as perceived by the customer(s).
Describe the effects of the failure in terms of what the customer might notice or experience, remembering that the custom
safety or non-compliance to regulations.
The effects should always be stated in terms of the specific system, subsystem, or component being analyzed.
Remember that a hierarchical relationship exists between the component, subsystem, and system levels. For
example, a part could fracture, which may cause the assembly to vibrate, resulting in an intermittend system
operation. The intermittent system operation could cause performance to degrade and ultimately lead to customer
dissatisfaction. The intent is to predict the potential failure effects to the team's level of knowledge.
Typical failure effects should be stated in terms of product or system performance.

Severity
Severity is the value associated with the most serous effect for a given failure code. Severity is a relative ranking within the
The team should agree on evaluation criteria and a ranking system and apply them consistently, even if modified for individ
It is not recommended to modify criteria ranking values of 9 and 10. Failure modes with a rank of severity 1 should not be a

Potential Cause(s)/Mechanis
In the development of the FMEA, the identification of all potential causes of the failure mode is key to subsequent
analysis. Although varied techniques (such as brainstorming) can be used to determine the potential cause(s) of the
failire mode, it is recommended that the team should focus on an understanding of the failure mechanism for each
failure mode.

A failure mechanism is the physical, chemical, electrical, thermal, or other process that results in the failure mode. It
is important to make the distinction that a failure mode is an "observed" or "external" effect so as not to confuse
failure mode with failure mechanism, the actual physical phenomenon behind the failure mode or the process of
degradation or chain of events leading to and resulting in a particular mode.
To the extent possible, list every potential mechanism for each failure mode. The mechanism should be listed as
concisely and completely as possible.
For a system, the failure mechanism is the process of error propagation following a component failure which leads
to a system failure.
A product or a process can have several failure modes which are correlated to each other because of a common
failure mechanism behind them.
Ensure that process effects are considered as part of the DFMEA process.

Potential cause of failure is defined as an indication of how the design process could allow the failure to occur,
described in terms of something that can be corrected or can be controlled. Potential cause of failure may be an
indication of a design weakness, the consequence of which is the failure mode.
Causes ate the ciscumstances that induce or activate a failure mechanism.
In identifying potential causes of failure, use concise descriptions of the specific causes of failures, e.g., specified
bold plating allows for hydrogen embrittlement. Ambiguous phrases such as, poor design of improper design, should
not be used.

Investigation of causes needs to focus on the failure mode and not the effect(s). In determining the cause(s), the
team should assume the existence of the cause under discussion will result in the failure mode (i.e., the failure
mode does not require multiple causes to occur).
Typically, there may be several causes each of which can result in the failure mode. This results in multiple lines
(cause branches) for the failure mode.
To the extent possible, list every potential cause for each failure mode/failure mechanism. The cause should be
listed as concisely and completely as possible. Separating the causes will result in a focused analysis for each cause
and may yield different measurement, controls, and action plans.

In preparing the DFMEA, assume that the design will be manufactured and assembled to the design intent.
Exception can be made at the team's discretion where historical data indicate defifiencies in the manufacturing
process.

Occurren
Occurrence is the likelihood that a specific cause/mechanism will occur resulting in the failure mode within the design life.
The likelihood of the occurrence ranking number has a relative meaning rather than an absolute value.
A consistent occurrence ranking system should be used to ensure continuity. The occurrence number is a relative ranking w
The team should agree on evaluation criteria and a ranking system and apply them consistenly, even if modified for individ
In determining this estimate, questions such as the following should be considered:
* What is the service history and field experience with similar components, subsystems, or systems?
* Is the item a carryover or similar to a previous level item?
* How significant are changes from a previous level item?
* Is the item radically different from a previous level item?
* Is the item completely new?
* What is the application or what are the environmental changes?
* Has an engineering analysis (e.g., reliability) been used to estimate the expected comparable
occurrence rate for the application?
* Have preventive controls been put in place?

Current Design/Pro
Current Design Controls are those activities conducted as part of the design process that have been completed or committ
consideration.
There are two types of design controls to consider:
Prevention: Eliminate (prevent) the cause of the mechanism of failure or the failure mode from occuring, or reduce its rate
Detection: identify (detect) the existence of a cause, the resulting mechanism of failure or the failure mode, either by analy
The preferred approach is to first use prevention controls, if possible. The initial occurrence rankings will be affected by the
Detection control should include identification of those activiteis which detect the failure mode as well as those that detec
The team should consider analysis, testing, reviews, and other activities that will assure the design/process adequacy such
Prevention Controls
* Benchmarking studies
* Fail-safe designs
* Design and Material standards (internal and external)
* Documentation - records of best practices, lessons learned, etc.
* Simulation studies - analysis of concepts to establish design requirements
* Error-proofing
Detection Controls
* Design reviews
* Prototype testing
* Validation testing
* Simulation studies - validation of design
* Desugn of Experiments; including reliability testing
* Mock-up using similar parts
Preventing the causes of the failure mode though a design change or design process change is the only way a reduction in

Detectio
Detection is the rank associated witht the best detection control listed in the Current Design Control Detection column. Wh
as part of the description of the control. Record the lowest ranking value in the Detection column.
A suggested approach to Current Design Control Detection is to assume the failure has occurred and then assess the capab
Do not automatically presume that the detection ranking is low because the occurrence is low. It is important to assess the
in the design release process.
Detection is a relative ranking within the scope of the individual FMEA. In order to achieve a lowe ranking, generally the de
The team should agree on evaluation criteria and a ranking system and apply them consistently, even if modified for individ
Detection
The ranking value of one (1) is reserved for failure prevention through proven design solutions.
The initial focus of the team should be oriented towards failure modes with the highest severity rankings. When the severit
or recommended actions (as documented in FMEA).
For failure modes with severities 8 or below the team should consider causes having higherst occurrence or detaction rank
how to best prioritize the risk reduction efforts that best serve their organization and customers.

Risk Priority Num

RPN = Severity x Occurrence x Detection
Within the scope of the individual FMEA, this value can range between 1 and 1000.
The use of RPN threshold is NOT a recommended practice for determining the need for actions.
Applying thresholds assumes that RPNs are a measure of relative risk (which they often are not) and that continuous impro
Use of the RPN index in the discussions of the team can be a useful tool. The limitations of the use of RPN need to be unde

Recommended
In general, prevention actions (i.e., reducing the occurrence) are preferable to detection actions. An example of this is the u

The intent of recommended actions is to improve the design. Identifying these actions should consider reducing rankings in
* To reduce severity ranking: only a design revision can bring about a reductin in the severity ranking.
For maximum effectiveness and efficiency of this approach, changes to the product and process design should be impleme
* To reduce occurrence ranking: A reduction in the occurrence raning can be accefted by removing or controlling one or m
but not limited to, the following should be considered:
o Error proof the design to eliminate the failure mode
o Revised design geometry and tolerances
o Revised design to lower the stress or replace weak (high failure probability) components
o Add redundancy
o Revised material specification
* To reduce detection ranking: the preferred method is the use of error/mistake proofing. An increase in design validation/
specific part may be required to increase the likelihood of detection (i.e., reduce the ditection ranking). Additionally, the fo
o Desing of Experiments (particularly when multiple or interactive causes of a failure more are present)
o Revised test plan
If the assessment leads to no recommended actions for a specific failure mode/cause/control combination, indicate this by
case of high severity.
For design actions consider using the following:
* Results of DOE or reliability testing
* Design analysis (reliability, structural or physics of failure) that would confirm that the solution is
effective and does not introduce new potential failure modes
* Drawing, schematics, or model to confirm physical change of targeted feature
* Results from a design review
* Changes to a fiven Engineering Standards or Design Guidelines
* Reliability analysis results
 Responsibility & Target
Enter the name of the individual and organization responsible for completing each recommended action including the targ
recommended have been implemented or adequately addressed.

Action Res
This section identifies the results of any completed actions and their effect on Severity, Occurrence and Detection rankings

Action(s) Taken and Co

After the action has been implemented, enter a brief description of the action taken and actual completion date.

Severity, Occurrence, De
After the preventive/corrective action has been completed, determine and record the resulting severity, occurrence, and d
Calculate and record the resulting action RPN.
All revised rankings should be reviewed. Actions alone do not guarantee that the problem was solved (i.e., cause addressed
necessary, repeat the analysis. The focus should always be on continuous improvement.
Item / Process Step

haracteristics (Requirements)

art / Process Function

otential Failure Mode

tential Effects of Failure

g that the customer may be an internal customer as well as the ultimate End User. State clearly if the failure mode could impact

Severity
anking within the scope of the individual FMEA.
odified for individual process analysis.
1 should not be analyzed further.

e(s)/Mechanism(s) of Failure Mode

 Occurrence
in the design life.

relative ranking within the scope of the FMEA and may not reflect the actual likelihood of occurrence.
odified for individual process analysis. Occurrence should be estimated using a 1 to 10 scale.

nt Design/Process Controls
leted or committed to and that will assure the design adequacy for the design functional and reliability requirements under

or reduce its rate of reoccurrence.

de, either by analytical or physical methods, before the item is released for production.
be affected by the prevention controls provided they are integrated as part of the design intent.
s those that detect the cause.
ss adequacy such as:

ay a reduction in the occurrence ranking can be effected.

Detection
 ction column. When more than one control is identified, it is recommended that the detection ranking of each control be included

assess the capabilities of the current design controls to detect this failure mode.
tant to assess the capability of the design controls to detect low frequency failure modes or reduce the risk of them going further

, generally the design control (analysis or verification activities) has to be improved.

odified for individual process analysis. Detection should be estimated using the following table as a guideline:

When the severity is 9 or 10, it is imperative that the team must ensure that the risk is addressed through existing design controls

or detaction rankings. It is the team's responsibility to look at the information identified, decide upon an approach, and determine

k Priority Number (RPN)

continuous improvement is not required (which it is).

N need to be understood. However, th euse of RPN thresholds to determine action priority is not recommended.

ecommended Actions
ple of this is the use of proven design standard or best practice rather than product verification/validation after design freeze.

ducing rankings in the following order: severity, occurrence, and detection.

ould be implemented early in the development process.

ntrolling one or more of the causes of mechanisms of the failure mode though a design revision. Actions such as,

design validation/verification actions should result in a reduction of the detection ranking only. In some cases, a design change to a
dditionally, the following should be considered:

n, indicate this by entering "None" in this column. It may be useful to also include a rationale if "None" is entered, especially in
 ility & Target Completion Date
ncluding the target completion date. The design-responsible engineer/team leader is responsible for ensuring that all actions

Action Results
etection rankings and RPN.

) Taken and Completion Date

on date.

Occurrence, Detection and RPN

ccurrence, and detection rankings.

, cause addressed), thus an appropriate analysis or test should be completed as verification. If further action is considered
 For Process FMEA
em / Process Step
Enter the identification of the process step or operation being analyzed, based on the numbering process and
terminology. Process numbering scheme, sequencing, and terminology used should be consistent with those used in
the process flow diagram to ensure tracibility and relationship to other documents. Repair and repork operations
should also be included.

aracteristics (Requirements)
List the requirements for each process function of the process step or operation being analyzed. Requirements are
thus inputs to the process specified to meet design intent and other customer requirements. If there are multiple
requirements with respect to a given function, each should be aligned on the form with the respective associated
failure modes in order to facilitate the analysis.

t / Process Function

List the process function that corresponds to each process step or operation being analyzed. The process function
describes the purpose or intent of the operation. A risk analysis recommended in order to limit the number of steps
to be included to only those that add value or otherwise are seen as likely to have a negative impact on the product.
If there are multiple process functions being analyzed with respect to a given operation, each should be aligned on
the form with its respective "Requirements" to aid in the development of the associated failure modes.

ential Failure Mode

Potential failure mode is defined as the manner in which the process could potentially fail to meet the process
requirements (including the design intent).
In preparing the FMEA, assume that the incoming parts/materials are correct. Exceptions can be made by the FMEA
team where historical data indicate deficiencies in incoming part quality. The team should also assume that the basic
design of th product is correct; however, if there are design issues which result in process concerns, those issues
should be communicated to the design team for resolution.
List the potential failure mode(s) for the particular operation in terms of the process requirements.

Assume that the failure could occur but may not necessarily occur. Potential failure modes should be described in
technical terms, not as s symptom noticeable by the customer.
If the requirements have been well defined, then the potential failure mode is readily identifiable by determining
the condition when a specific requirement is not met. Each requirement may have multiple failure modes. A large
number of failure modes identified for a single requirement usually indicates that the requirement is not well
defined.
The assumption is made that the failure could occur but may not necessarily occur - consequently the used of the
word "potential".
Verification of completeness of the potential failure modes can be made through a review of past things-gone-
wrong, concerns, reports, and group brainstrorming. Sources for this should also include a comparison of similar
processes and a review of customer (End User and subsequent operation) claims relating to similar components.

ntial Effects of Failure

hat the customer may be an internal customer as well as the ultimate End User. State clearly if the failure mode could impact

The product effects in the PFMEA should be consistent with those in the corresponding DFMEA.
For the End User, the effects should be stated in terms of product or system performance. If the customer is the next
operation or subsequent operation(s)/location(s), the effects should be stated in terms of process/operation
performance.
In order to determine the Potential Effect(s), the following questions should be asked:
1. Does the Potential Failure Mode physically prevent downstream processing or cause potential harm to
equipment or operators? (The location, station or operation at which the effect occures should be identified. If at a
customer's facility, this should be stated).
2. What is the potential impact on the End User?
3. What would happen if an effect was detected prior to reaching the End User?

Severity
king within the scope of the individual FMEA.
ified for individual process analysis.
should not be analyzed further.

s)/Mechanism(s) of Failure Mode

Potential cause of failure mode is defined as an indication of how the failure could occur, and isdescribed in terms of
something that can be corrected or can be controlled. Potential cause of failure may be an identification of a design
or process weakness, the consequence of which is the failure mode.

To the extent possible, identify and document every potential cause for each failure mode. The cause should be
detailed as concisely and completely as possible. Separating the causes will result in a focused analysis for each and
may yield different measurements, controls, and action plans. There may be one or more causes that can result in
the failure mode being analyzed.
In preparing the PFMEA, the team should assume that the incoming part(s)/material(s) are correct.

Exceptions can be made at the team's discretion where historical data indicate deficiencies in incoming part quality.

Only specific errors or malfunctions (e.g., seal not installed or seal installed inverted) should be listed, Ambiguous
phrases (e.g., operator error or seal mis-installed, etc) should not be used.
 Occurrence
the design life.

ative ranking within the scope of the FMEA and may not reflect the actual likelihood of occurrence.
fied for individual process analysis. Occurrence should be estimated using a 1 to 10 scale.

Design/Process Controls
ed or committed to and that will assure the design adequacy for the design functional and reliability requirements under

reduce its rate of reoccurrence.

either by analytical or physical methods, before the item is released for production.
affected by the prevention controls provided they are integrated as part of the design intent.
hose that detect the cause.
adequacy such as:

a reduction in the occurrence ranking can be effected.

Detection
on column. When more than one control is identified, it is recommended that the detection ranking of each control be included

sess the capabilities of the current design controls to detect this failure mode.
nt to assess the capability of the design controls to detect low frequency failure modes or reduce the risk of them going further

enerally the design control (analysis or verification activities) has to be improved.

ified for individual process analysis. Detection should be estimated using the following table as a guideline:

hen the severity is 9 or 10, it is imperative that the team must ensure that the risk is addressed through existing design controls

detaction rankings. It is the team's responsibility to look at the information identified, decide upon an approach, and determine

Priority Number (RPN)

ntinuous improvement is not required (which it is).

eed to be understood. However, th euse of RPN thresholds to determine action priority is not recommended.

ommended Actions
e of this is the use of proven design standard or best practice rather than product verification/validation after design freeze.

cing rankings in the following order: severity, occurrence, and detection.

ld be implemented early in the development process.

olling one or more of the causes of mechanisms of the failure mode though a design revision. Actions such as,

sign validation/verification actions should result in a reduction of the detection ranking only. In some cases, a design change to a
tionally, the following should be considered:

ndicate this by entering "None" in this column. It may be useful to also include a rationale if "None" is entered, especially in
ty & Target Completion Date
luding the target completion date. The design-responsible engineer/team leader is responsible for ensuring that all actions

Action Results
ection rankings and RPN.

aken and Completion Date

date.

currence, Detection and RPN

urrence, and detection rankings.

ause addressed), thus an appropriate analysis or test should be completed as verification. If further action is considered
 Donaldson Europe Document
CONTROL PLAN
CORP QEHSDOC 016 (replaces old QEHSDOC 008)

Prepared by: Ilse Jehoul Rev. 4 dd 03/12/2013

Prototype Pre-Launch Production

Control Plan Number: Team: Original Date: Revision Date:

Part/Process Number *: Revision: Process Owner: Rev. N°:

0 0
Part/Process Name *: Plant/Supplier Approval Date * Customer Approval Date:
0
Plant/Supplier: Supplier Code: Donaldson SQA/Other Approval Date *:
0 0
Characteristics Methods
Machine,
Sample
Device, Special
Part Process Part / Process Evaluation/ Reaction
No Operation Description Jig, Bullet Char. Control
Charac- Charac- Spec / Measurement Respon- Plan
Tools, for No. Class Size Freq. Method
MFG. teristics teristics Tolerance Technique sibility

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20

Page 61 of 84
 Donaldson Europe Document
CONTROL PLAN
CORP QEHSDOC 016 (replaces old QEHSDOC 008)

Prepared by: Ilse Jehoul Rev. 4 dd 03/12/2013

Prototype Pre-Launch Production

Control Plan Number: Team: Original Date: Revision Date:

Part/Process Number *: Revision: Process Owner: Rev. N°:

0 0
Part/Process Name *: Plant/Supplier Approval Date * Customer Approval Date:
0
Plant/Supplier: Supplier Code: Donaldson SQA/Other Approval Date *:
0 0
Characteristics Methods
Machine,
Sample
Device, Special
Part Process Part / Process Evaluation/ Reaction
No Operation Description Jig, Bullet Char. Control
Charac- Charac- Spec / Measurement Respon- Plan
Tools, for No. Class Size Freq. Method
MFG. teristics teristics Tolerance Technique sibility

21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38

Page 62 of 84
 Donaldson Europe Document
CONTROL PLAN
CORP QEHSDOC 016 (replaces old QEHSDOC 008)

Prepared by: Ilse Jehoul Rev. 4 dd 03/12/2013

Prototype Pre-Launch Production

Control Plan Number: Team: Original Date: Revision Date:

Part/Process Number *: Revision: Process Owner: Rev. N°:

0 0
Part/Process Name *: Plant/Supplier Approval Date * Customer Approval Date:
0
Plant/Supplier: Supplier Code: Donaldson SQA/Other Approval Date *:
0 0
Characteristics Methods
Machine,
Sample
Device, Special
Part Process Part / Process Evaluation/ Reaction
No Operation Description Jig, Bullet Char. Control
Charac- Charac- Spec / Measurement Respon- Plan
Tools, for No. Class Size Freq. Method
MFG. teristics teristics Tolerance Technique sibility

39
40
41

Page 63 of 84
 Donaldson Europe Document
CPK CALCULATION
CORP QUALDOC 020
Prepared by: Ed Van den Enden Rev. 0 dd 26/05/2013

Enter Dim number in this field Enter Dim number in this field

Piece Measured 0 Piece Measured 0

1 Average #DIV/0! 1 Average #DIV/0!

2 2
3 Std Dev #DIV/0! 3 Std Dev #DIV/0!
4 4
5 Nominal dim 5 Nominal dim
6 Lower level tol 6 Lower level tol
7 Upper level tol 7 Upper level tol
8 8
9 Cp #DIV/0! 9 Cp #DIV/0!
10 10
11 Cpl #DIV/0! 11 Cpo #DIV/0!
12 Cpu #DIV/0! 12 Cpb #DIV/0!
13 13
14 Cpk #DIV/0! 14 Cpk #DIV/0!
15 15
16 16
17 PPM Over ULT #DIV/0! 17 PPM Over ULT #DIV/0!
18 18
19 PPM Over LLT #DIV/0! 19 PPM Over LLT #DIV/0!
20 20
21 PPM total #DIV/0! 21 PPM total #DIV/0!
22 22
23 23
24 24
25 Only blue cells to fill out 25 Only blue cells to fill out
26 26
27 27
28 28
29 29
30 30
31 31
32 32
33 33
34 34
35 35
36 36
37 37
38 38
39 39
40 40
41 41
42 42
43 43
44 44
45 45
46 46
47 47
48 48
49 49
50 50
 Donaldson Europe Document
CPK CALCULATION
CORP QUALDOC 020
Prepared by: Ed Van den Enden Rev. 0 dd 26/05/2013

Enter Dim number in this field Enter Dim number in this field

Piece Measured 0 Piece Measured 0

1 Average #DIV/0! 1 Average #DIV/0!

2 2
3 Std Dev #DIV/0! 3 Std Dev #DIV/0!
4 4
5 Nominal dim 5 Nominal dim
6 Lower level tol 6 Lower level tol
7 Upper level tol 7 Upper level tol
8 8
9 Cp #DIV/0! 9 Cp #DIV/0!
10 10
11 Cpo #DIV/0! 11 Cpo #DIV/0!
12 Cpb #DIV/0! 12 Cpb #DIV/0!
13 13
14 Cpk #DIV/0! 14 Cpk #DIV/0!
15 15
16 16
17 PPM Over ULT #DIV/0! 17 PPM Over ULT #DIV/0!
18 18
19 PPM Over LLT #DIV/0! 19 PPM Over LLT #DIV/0!
20 20
21 PPM total #DIV/0! 21 PPM total #DIV/0!
22 22
23 23
24 24
25 Only blue cells to fill out 25 Only blue cells to fill out
26 26
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38 38
39 39
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47 47
48 48
49 49
50 50
 Donaldson Europe Document
CPK CALCULATION
CORP QUALDOC 020
Prepared by: Ed Van den Enden Rev. 0 dd 26/05/2013

Enter Dim number in this field Enter Dim number in this field

Piece Measured 0 Piece Measured 0

1 Average #DIV/0! 1 Average #DIV/0!

2 2
3 Std Dev #DIV/0! 3 Std Dev #DIV/0!
4 4
5 Nominal dim 5 Nominal dim
6 Lower level tol 6 Lower level tol
7 Upper level tol 7 Upper level tol
8 8
9 Cp #DIV/0! 9 Cp #DIV/0!
10 10
11 Cpo #DIV/0! 11 Cpo #DIV/0!
12 Cpb #DIV/0! 12 Cpb #DIV/0!
13 13
14 Cpk #DIV/0! 14 Cpk #DIV/0!
15 15
16 16
17 PPM Over ULT #DIV/0! 17 PPM Over ULT #DIV/0!
18 18
19 PPM Over LLT #DIV/0! 19 PPM Over LLT #DIV/0!
20 20
21 PPM total #DIV/0! 21 PPM total #DIV/0!
22 22
23 23
24 24
25 Only blue cells to fill out 25 Only blue cells to fill out
26 26
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 Donaldson Europe Document
CPK CALCULATION
CORP QUALDOC 020
Prepared by: Ed Van den Enden Rev. 0 dd 26/05/2013

Enter Dim number in this field Enter Dim number in this field

Piece Measured 0 Piece Measured 0

1 Average #DIV/0! 1 Average #DIV/0!

2 2
3 Std Dev #DIV/0! 3 Std Dev #DIV/0!
4 4
5 Nominal dim 5 Nominal dim
6 Lower level tol 6 Lower level tol
7 Upper level tol 7 Upper level tol
8 8
9 Cp #DIV/0! 9 Cp #DIV/0!
10 10
11 Cpo #DIV/0! 11 Cpo #DIV/0!
12 Cpb #DIV/0! 12 Cpb #DIV/0!
13 13
14 Cpk #DIV/0! 14 Cpk #DIV/0!
15 15
16 16
17 PPM Over ULT #DIV/0! 17 PPM Over ULT #DIV/0!
18 18
19 PPM Over LLT #DIV/0! 19 PPM Over LLT #DIV/0!
20 20
21 PPM total #DIV/0! 21 PPM total #DIV/0!
22 22
23 23
24 24
25 Only blue cells to fill out 25 Only blue cells to fill out
26 26
27 27
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29 29
30 30
31 31
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36 36
37 37
38 38
39 39
40 40
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45 45
46 46
47 47
48 48
49 49
50 50
 Enter Dim number in this field
Piece Measured 0 Fill in Blue cells

1 Average #DIV/0!
2
3 Std Dev #DIV/0!
4
5 Nominal dim
6 Lower level tol
7 Upper level tol
8
9 Cp #DIV/0!
10
11 Cpo #DIV/0!
12 Cpb #DIV/0!
13
14 Cpk #DIV/0!
15
16
17 PPM Over ULT #DIV/0!
18
19 PPM Over LLT #DIV/0!
20
21 PPM total #DIV/0!
22
23
24
25 Only blue cells to fill out
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50

CORP SQADOC 004 SUPPLIER PPAP WORKBOOK Book Rev. 15 dd 04/09/2015

 DONALDSON
Rev. 0 dd 11/02/2013
CORP QEHSDOC 017
GAGE REPEATABILITY & REPRODUCIBILITY STUDY

GAGE NUMBER PART NUMBER 0

GAGE NAME PART NAME 0

CHARACTERISTIC CONTROL PLAN

SPECIFICATION LSL USL TOL. 0

APPRAISERS TRIALS PARTS

GAGE USAGE FOR (mark) Product Control Process Control

APPRAISER A APPRAISER B APPRAISER C

PARTS
Appraiser/Trial #

AVG'S

Range

AVG'S

Range

AVG'S

Range

Part average

RANGE VARIATION:
Ra No. Trials D4 R x (D4) =
Rb 2 3.267 #N/A =
Rc 3 2.575 Note: LCLR is zero with < 7 trials

R No. Trials A2 X + ( R x A2) =

2 1.880 #N/A =
3 1.023 X - ( R x A2) =
#N/A =

Max X 0.000
Min X 0.000 Note:
X Diff. 0.0000

DATE

STUDY PERFORMED BY

KT.158 Hidria AET d.o.o. junij 2009 file:KT.158_MSA.xls (AQ/11/02) Page 69 of 84

 DONALDSON
Rev. 0 dd 11/02/2013
CORP QEHSDOC 017
GAGE REPEATABILITY & REPRODUCIBILITY STUDY
MEASUREMENT UNIT ANALYSIS % TOTAL VARIATION (TV)

REPEATABILITY - EQUIPMENT VARIATION (EV) % EV = 100 (EV/TV)

EV = R x K1 % EV =
EV = Trail K1
EV = 0 #N/A

REPRODUCIBILITY - APPRAISER VARIATION (AV) % AV= 100(AV/TV)

AV = {(xDIFF x K2) - (EV /nr)} % AV=
2 2 1/2
n=Parts r=Trials
AV =
AV = Appraiser K2
0 #N/A

REPEATABILITY & REPRODUCIBILITY (R&R) % R&R= 100(R&R/TV)

R&R = {(EV + AV )}
2 2 1/2 % R&R= #VALUE!
R&R =
Note: Guidelines for Acceptance of System Based on %GR
R&R = Under10% = Measurement system is acceptable.
10%-30% = May be acceptable based on gauge cost.
Over 30% = Measurement system not acceptable.

PART VARIATION (PV) % PV= 100(PV/TV)

PV = RP x K3 % PV=
PV = Parts K3
PV = 0 #N/A

TOTAL VARIATION (TV) %TV=

TV = {(GRR + PV )}
2 2 1/2

TV =
TV = NUMBER OF DISTINCT CATEGORIES (ndc)
ndc= 1.41(PV/R&R)
ndc= #VALUE!
Note: Guidelines for Acceptance: ndc greater then or equal to 5=

Components of variations

1200%
1000%
800% % TOTAL VARIATION (TV)

600% % TOLERANCE (Tol)

400%
200%
0%
Gage R&R Repeat. Reprod. Part-to-part

Average chart
Average

A pprais er A A pprai s er B A pprai ser C UCL Mean. LC

Range chart

12.000
10.000
Range

8.000
6.000
4.000
2.000
KT.158 Hidria AET d.o.o. junij 2009 file:KT.158_MSA.xls (AQ/11/02) Page 70 of 84
 12.000
10.000
8.000
DONALDSON
6.000
Rev.
CORP
0 dd 11/02/2013 GAGE REPEATABILITY & REPRODUCIBILITY STUDY
4.000QEHSDOC 017
2.000
0.000
1 2 3 4 A5
Appraiser 6 7 8 9 10
Appraiser B 11 12 13 14 15 C 16
Appraiser 17 18 19UCL20 21 22 23 24
Mean 25 26 27 28 29

For information on the theory and constants used in the form see MSA Reference Manual, Third edition.

KT.158 Hidria AET d.o.o. junij 2009 file:KT.158_MSA.xls (AQ/11/02) Page 71 of 84

ATABILITY & REPRODUCIBILITY STUDY

PARTS

Xa
Ra

Xb
Rb

Xc
Rc
X
RP

UCLR

#N/A

UCLX
#N/A
LCLX
#N/A

KT.158 Hidria AET d.o.o. junij 2009 file:KT.158_MSA.xls (AQ/11/02) Page 72 of 84

ATABILITY & REPRODUCIBILITY STUDY
% TOLERANCE (Tol)

100(EV/Tol)

100(AV/Tol)

100(R&R/Tol)
#VALUE!

Note: Guidelines for Acceptance of System Based on %GRR

Under10% = Measurement system is acceptable.
10%-30% = May be acceptable based on gauge cost.
Over 30% = Measurement system not acceptable.

100(PV/Tol)

100(TV/Tol)

NUMBER OF DISTINCT CATEGORIES (ndc)

Note: Guidelines for Acceptance: ndc greater then or equal to 5=OK.

Average chart

A ppr
a is er A A ppr ai s er B A pprai s er C UCL Mean. LCL

Range chart

KT.158 Hidria AET d.o.o. junij 2009 file:KT.158_MSA.xls (AQ/11/02) Page 73 of 84

ATABILITY & REPRODUCIBILITY STUDY

14 15 C 16
Appraiser 17 18 19UCL20 21 22 23 24
Mean 25 26 27 28 29 30

Manual, Third edition.

KT.158 Hidria AET d.o.o. junij 2009 file:KT.158_MSA.xls (AQ/11/02) Page 74 of 84

Gage R&R acceptance criteria
R&R value > 30% - Rejected
R&R value >10% and <=30% - Conditionally acceptable - This instrument should not be used for
critical/Key dimensions
R&R value <= 10% - Acceptable

Important Note:
- Supplier needs to conduct Gage R&R study for any instrument used for validating critical dimensions
and key characteristics addressed in the control plan and submit the same in PPAP

- If same instrument is used for more than one critical or key characteristics, any one R&R study is
adequate for PPAP submission

- For other instruments, supplier can have internal plan for R&R study covering once in a year for each
instrument.

Copy blanc Gage R&R sheet for each instrument in

use

CORP SQADOC 004 SUPPLIER PPAP WORKBOOK ok Rev. 15 dd 04/09/2015

 Engineering Approval Form
Donaldson Engineer:

Part Number: 0 Rev: 0

Description: 0
Supplier Name: 0 Supplier P/N: 0

Annual Usage Product Yearly Volume:

(Optional) Class:
Module: Expected Prod. Buy Date:

ADDITIONAL 1) Has supplier been approved? Yes No N/A

Part Info 2) Is the part RoHS compliant? Yes No N/A
3) Is the product content accepted in the IMDS? Yes No N/A
4) Is the part REACH compliant? Yes No N/A
5) Is the part UL/CSA compliant? Yes No N/A
6) Is the part CE compliant? Yes No N/A

Comments / Justification DR Release #

APPROVALS
Design Name
Engineer: spelled
CORP SQADOC 004 SUPPLIER PPAP WORKBOOK Book Rev. 15 dd 04/09/2015
 MASTER SAMPLE
The organization shall retain a Master Sample for the same period as the production part
approval records, or:
a) Until a new Master Sample is produced for the same customer part number for customer
approval or:
b) where a Master Sample is required by the design record, Control Plan or inspection criteria,
as a reference or standard.
The Master Sample shall be identified as such, and shall show the customer approval date on
the sample.
The organization shall retain a Master Sample for each position of a multiple cavity die, mold,
tool or production process unless otherwise specified by the customer.

Note 1:
When part size, sheer volume of parts, etc. makes it difficult to store master sample, the
sample retention requirements may be modified or waived in a writing by authorized
customer representative.
The purpose of a Master Sample is to assist in defining the production standard, especially
where data is ambiguous or in insufficient detail to fully replicate the part to its original
approved state.

Note 2:
Many bulk materials properties are by their nature time dependent, and if a master sample is
required, it may consist of the manufacturing record, test results, and certificate of analysis of
key ingredients, for the approved submission sample.
CORP SQADOC 004 SUPPLIER PPAP WORKBOOK Book Rev. 15 dd 04/09/2015
 SAMPLE PARTS
The supplier will provide sample products / parts as specified by
Donaldson.
Parts are submitted before or at the same time as the Documents are
submitted.

In all cases please fill out and use the PPAP label you find in this
workbook.
CORP SQADOC 004 SUPPLIER PPAP WORKBOOK Book Rev. 15 dd 04/09/2015
 Level 5 Review Checklist
For Donaldson This sheet has been developed for use during a walk trough
use only for PPAP level 5

When PPAP Level 5 is required the control plan documentation should be checked at the manufacturing site.
The following checklist shows the minimum requirements for this and this must be completed by an Donaldson employee.
PPAP will not be approved while there is disagreement between the Supplier and Donaldson on any of the factors below.
Donaldson
Representative:
Part number: 0 Donaldson part number
Rev: 0 Donaldson part revision number
Date: 0 Revision date

Disagreements Completed
Item Process Comments
Y/N Date
The supplier will walk through the process on the shop floor. From Material receipt to shipment.

Donaldson representative will compare the process as documented to the physical process - noting
Process Flow any differences.
Diagrams
Any area where Donaldson representative believes there to be a quality risk will be noted on the
flow diagram.

Process FMEA will be reviewed to ensure all quality risks identified from the Process Walk Through
and any other source have been documented.

Donaldson representative will review scoring of Failure Modes with the supplier and note any
Process FMEA disagreements.

Donaldson representative will review actions driven from the FMEA and evidence of those actions
being carried out - or planned. Any disagreement about appropriate actions must be recorded.

Control Plan will be reviewed to ensure it addresses all items identified for control in the FMEA.

Control Plan will be reviewed to ensure it addresses any other concern the Donaldson
representative believes it should.
Any disagreement on what is covered in the control plan must be recorded.
Control Plan
Donaldson representative will look for evidence that actions in control plan are in place and will
be/are suitable recorded.
Any disagreement between Donaldson and the Supplier on the execution of the control plan must
be recorded.

All measuring equipment used for PPAP document will be checked for calibration date.

At least one MSA report will be reviewed by the Donaldson representative - with the supporting
document. Where possible the person who carried out the study should talk the Donaldson
representative through the process.
Measurement
System Analysis Donaldson representative will view the measurement of some key dimensions - this will be carried
Studies out by the suppliers normal inspection staff using their standard process. Any disagreement
between the Donaldson representative and the Supplier on how this is done must be recorded.

Any concerns the Donaldson representative has about the equipment, MSA or use of equipment
must be recorded.

Statistic Supplier must provide evidence of capable production processes for all part critical dimensions or
measurements from dimensions the Donaldson SQA representative is asking for.

CORP SQADOC 004 SUPPLIER PPAP WORKBOOK Book Rev. 15 dd 04/09/2015

 EDC, Pathoekeweg 166, B-8000 Brugge,
PPAP sample submission To: Belgium
Shipping date
Shipping quantity
Country of origin
Supplier Name 0
Part Name 0
Part Number 0
Part revision level 0
Sample with PPAP? Yes No
Sample Parts separate submitted Yes No
Shipping Carrier Name
Tracking Number Number

EDC, Pathoekeweg 166, B-8000 Brugge,

PPAP sample submission To: Belgium
Shipping date
Shipping quantity
Country of origin
Supplier Name 0
Part Name 0
Part Number 0
Part revision level 0
Sample with PPAP? Yes No
Sample Parts separate submitted Yes No
Shipping Carrier Name
Tracking Number Number

EDC, Pathoekeweg 166, B-8000 Brugge,

PPAP sample submission To: Belgium
Shipping date
Shipping quantity
Country of origin
Supplier Name 0
Part Name 0
Part Number 0
Part revision level 0
Sample with PPAP? Yes No
Sample Parts separate submitted Yes No
Shipping Carrier Name
Tracking Number Number
CORP SQADOC 004 SUPPLIER PPAP WORKBOOK Book Rev. 15 dd 04/09/2015