Supplier Quality Management Production Part Approval Process (PPAP

February, 2009 Rev 6 Release
Cooper Industries 600 Travis Suite 5600
Houston, TX 77002
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PPAP Supplier Checklist Externa
Submission Requirements Supplier Checklist
3
Element Order
PPAP Requirements AIAG PPAP Fourth Edition Important: Submit your documents in this order.
Level 1
Level 2
Level 3
Level 4
Level 5
Required Documents
Assigned to
AR
3
5
Can be Cooper FMEA Format or an AIAG compliant DFMEA.
6
Can be Cooper PFMEA Format or an AIAH compliant PFMEA.
8
9
AR
AR
Cooper GRR format or any statistical package format for gage R&R.
10
11
Industry Standard reports or test result formats designated by Cooper Industries.
12
AR
AR
Process Capability Study using any statistical package or Cooper Capability Data Forms.
13
14
16
17
18
a
b
c
IA
IA
IA
IA
e
Required for PPAP submission
Not required
Documents on a case by case basis are marked AR for "As Requested"
IF Applicable
Street Address
Purchasing Representative
Purchasing Office
SOP Date
Does this part utilize Cooper owned tooling? Is it properly identified?
If yes, P.O. #
Does this part contain any restricted substances or require IMDS submission?
Substance(s)?
IMDS Number
Are plastic or polymeric parts identified with appropriate ISO marking codes?
REASON FOR SUBMISSION
New Supplier, New material or new source for existing material
Engineering Change: New/Revised drawing or other specification
Change of supplier, material or non-equivalent materials/services
Tooling: transfer, replacement (new), refurbishment, modified or additional
New process or a change in production process or method
Correction of Non-conformance or discrepancy
Change of manufacturing location, sub-supplier or additional location
Change to optional construction, material or component
Other - please specify
REQUESTED SUBMISSION LEVEL (Check one)
Level 1 - Warrant only submitted to the customer (Applied to non-critical parts and raw bulk material)
Level 2 - Warrant with product samples amd limiting supporting data. (Applied to critical bulk product and simple changes)
Level 3 - Warrant with product samples and complete supporting data. (Applied to new parts on Cooper programs)
DEFAULT COOPER SUBMISSION LEVEL
Level 4 - Warrant and other requirements as defined by Cooper.(Applied only with prior approval from Cooper…special situations only!)
Level 5 - Warrant with product samples and complete supporting data reviewed at supplier's manufacturing location. (Applied to parts requiring onsite review )
SUBMISSION RESULTS
Is this a multicavity tool?
How many Cavities/Spindle (for molds or dies) ?
Number of parts submitted by cavity/spindle
DECLARATION
I affirm that the samples represented by this warrant are representative of our parts, have been made to the applicable Production Part Approval Process Manual 4th Edition
requirements. I further warrant these samples were produced with the specified materials on regular production tooling with no operations other then the regular production
process. The data and samples were produced at the production rate of in on Any deviations to this warrant submission
are noted below in the explanation/comments section.
#parts # hours date
Quality/Supplier Quality
"Yes" is so indicated on part drawing, otherwise "No"
Engineering Revision level on Cooper component level print.
Located either in engineering tittle block or revision matrix on component level print. This is the date the part was revised to the most recent rev level.
List all authorized engineering changes not yet incorporated on the drawing but which are incorporated in the part.
Date you were authorized to incorporate these changes.
Used when the part submitted is on a different drawing then the Cooper component being submitted. The design record that specifies the customer part number being submitted.
Enter this number as found on the first production release purchase order.
Enter the actual weight in kilograms to four decimal places. Must be weight of a completely finished part.
Full Name of Company or Division.
List all locations producing the part for Cooper use.
List all division manufacturing sites that use this part:
Street address of either the primary site of manufacture or origin of submission.
Buyer who has been your primary contact for business with Cooper.
City that Buyer's office is located in.
Please state the ORIGINAL date requested by your buyer representative.
Estimated start of Cooper production or first Cooper production release due date.
Please add the PO # that matches both the part and the revision level being submitted.
List the controlled or restricted substance contained in this part. Please attach additional list or information if required.
Check the appropriate box. Add explanatory details in the "other" section
Identify the submission level requested by your customer and that you are submitting to.
Check the appropriate boxes for dimensional, material tests, performance tests, appearance evaluation, and statistical data if included in the submission. Level 3, 4 and 5 submissions typically require all sections.
Please provide details on the number of molds. cavities or production processes within the overall production of the part reflected on the submission.
Must provide specific detail on the number of parts produced in a given window of time and the date the run was produced.
Provide any explanatory details on the submission results, additional information may be attached as appropriate. Be sure to clearly state any known deviations.
Name of individual responsible for preparing the part submission.
The responsible supplier official, after verifying that the results show conformance to all customer requirements and that all required documentation is available shall approve the declaration and provide title, phone number, fax number and email address.
This section is for Cooper approval only!!
YES
NO
Cooper Division Name Example: Cooper Wiring Devices Cooper Power Systems Cooper Lighting Cooper B-Line Cooper Bussman Cooper Krouse Hinds Cooper Safety
Cooper Part number on the Cooper Part Print
Supplier Vendor number as assigned by your Cooper Division
This section is for Cooper approval only!!
Please record the IMDS number associated with your submission to the MDS Website.
Control Plan
Control Plan
Part Description
Supplier Code
Plant Location
Core Team
Supplier Name
Supplier Plant Approval
PART / PROCESS NUMBER
CHARACTERISTICS
SAMPLE
NO.
PRODUCT
PROCESS
SIZE
FREQ
&L&"Arial,Bold"Note: All part print CTQ's must be clearly identified on this control plan.&R&"Arial,Bold"Page &P of &N
This is the internal document number used to track and control the Control Plan.
This is the key quality person responsible for developing and leading the control plan strategy.
This is the date of original release of the control plan for the part number.
This is the Revision level of the most current CONTROL PLAN release.
Date the current control plan was released or became effective.
Enter the part number and the most current revision level.
Enter the description of the part on the Cooper print.
Supplier code assigned by Cooper division you are supplying.
Location of the current plant.
List all key team members involved in the process and the control plan. List names, numbers and other contact information.
Signature of author or quality approval of control plan.
Customer or Cooper Engineering approval (if required)
Any additional approvals required.
The item number is usually referenced from the process flow chart. If multiple part numbers exist (assembly) list the individual part numbers and their processes accordingly.
All steps in the manufacturing of a system, subsystem or component are described. Identify the process/operation that best describes the activity on each line.
For each operation that is described, identify the processing equipment, machine, device, jig or other tool for manufacturing as appropriate.
A distinguishing feature, dimension or property of a process or it's output on which variable or attribute data can be collected.
Cross reference number from all applicable documents such as FMEAS, process flows etc..
Product characteristics are the features or properties of a part that are described on the drawings or other primary engineering information. The Core Team should identify the special Product Characteristics from all sources. All special characteristics should be listed on the Control Plan.
Process Characteristics are the process variables that have a cause and effect relationship with the identified Product Characteristic. A Process Characteristic can only be measured at the time it occurs. The Core Team should identify Process Characteristics for which variation must be controlled to minimize variation. There could be one or more Process Characteristics listed for each Product Characteristic. In some processes one Process Characteristic may affect several Product Characteristics.
Use the appropriate characteristic as defined by the Cooper Division you are supplying.
Systematic plan for controlling a process.
Specification/tolerance may be obtained from various engineering documents such as drawings, specifications etc..
When sampling is required list the corresponding sample size and frequency.
Brief description of how the operation will be controlled, including procedure numbers where applicable. Should be based on effective analysis of the process. Various methods can be used from additional inspection to SPC or error proofing. The method of control should be clinically evaluated for effectiveness of process control.
The reaction plan specifies the corrective actions necessary to avoid producing nonconforming products or operating out of control. The actions should normally be the responsibility of the people closest to the process.
Full Name of Supplier
Supplier Management signature of the control plan indicating executive level approval of the control plan.
Measurement system being used to check the specification or tolerance. This could include gages, fixtures, tools and or test equipment required to measure the part/process/manufacturing equipment. A measurement system analysis should be done to ensure control of monitoring and measuring devices prior to relying on a measurement system.
Design DFMEA
Potential Failure Modes and Effects Analysis Design FMEA
Please indicate EITHER: 1.) A designated RPN threshold for this process 2.) A target percentage of steps to be addressed. Check One
Print #
&R&"Arial,Bold"Page &P of &N
SEVERITY EFFECT SEVERITY OF EFFECT ON PRODUCT RANK Failure to meet safety Potential failure mode affects safe product operation 10 and/or regulatory and/or involves noncompliance with regulation WITHOUT warning. requirements noncompliance with regulation Potential failure mode affects safe product operation 9 and/or involves noncompliance with warning. Loss or degradation Loss of primary function(product inoperable/does not 8 of primary function. affect safe operation). Degradation of primary function (product operable but 7 at a reduced level of performance). Loss of degradation Loss of secondary function (product operable but comfort 6 of secondary function. convenience functions at a level. Degradation of secondary function (product operable, 5 but comfort convenience functions at a reduced level of performance. Annoyance Appearance or minor issue, product operable, 4 product does not conform and noticed by most customers (>75%). Appearance or minor issue, product does not conform, 3 and noticed by many customers(50%). Appearance or minor issue, product operable, product does not conform and noticed by discriminating customers.(<25%) 2 No effect No discernable effect. 1
Enter a description of each item number here.
In what ways might the product/function potentially fail to meet the part requirements and/or funtion intent? List each potential failure mode. There can be multiple failure modes for each process step.
What is the effect of each failure mode on the outputs and/or customer requirements? The customer could be the next operation, subsequent operations, another division or the end user. Typical failure should be stated in terms of part performance.
How can the failure occur? Describe in terms of something that can be corrected or controlled. Be specific. Try to identify the causes that directly impacts the failure mode, i.e., root causes.
How often does the cause or failure mode occur? RATING LIKELIHOOD OF OCCURRENCE LABEL 10 ≥100 per thousand pieces ≥1 in 10 VERY HIGH 9 50 per thousand pieces 1 in 20 VERY HIGH 8 20 per thousand pieces 1 in 50 HIGH 7 10 per thousand pieces 1 in 100 HIGH 6 2 per thousand pieces 1 in 500 MODERATE 5 .5 per thousand pieces 1 in 2000 MODERATE 4 .1 per thousand pieces 1 in 10,000 MODERATE 3 .01 per thousand pieces 1 in 100,000 LOW 2 ≤.001 per thousand pieces 1 in 1000,000 LOW 1 Failure is eliminated thru preventive VERY LOW control See Chart Page 28 of PPAP Hanbook for further information.
What are the existing controls and procedures (inspection and test) that either prevent failure mode from occurring or detect the failure should it occur? The preferred approach is always prevention!
Estimate how well can you detect cause or failure mode. Do not automatically presume that the detection is low because the occurence is low. Assess the capability of the design controls to detect low frequecy failure modes. Rank Opportunity For Detection Liklihood of Detection by Design Control Liklihood of Detection 10 No Detection Opportunity No current design control: Cannot detect or is not analyzed Almost impossible 9 Not likely to detect at any stage. Design analysis/detection controls have a weak detection Very Remote capabilty; Virtual Analysis is Not Correlated to expected actual operating conditions. 8 Post design freeze and prior to launch Product verification/validation after design freeze and prior to Remote launch with pass/fail testing 7 Post design freeze and prior to launch Product verification/validation after design freeze and prior to Very Low lauch with pass/fail testing 6 Post design freeze and prior to launch Product verification/validation after design freeze and prior to Low laucn with degradation testing. 5 Prior to design freeze Product validation prior to design freeze using pass/fail testing Moderate (reliabilty testing development or validation tests). 4 Prior to design freeze Product validation prior to design freeze using test to failure Moderately High (reliabilty testing development or validation tests) 3 Prior to design freeze Product validation prior to design freeze using degradation testing High (Reliabilty testing development or validation tests). will detect error and prevent processing 2 Virtual Analysis Correlated Design analysis/detection controls have a strong detection capabilty. Very High , Virtual analysis is highly correlated with actual or expected condition prior to a design freeze. 1 Detection not applicable; Error prevention as a result of product Almost Certain Failure prevention. Failure mode cannot occur because it is fully prevented through design solutions (proven design standards, best practice or common material).
What are the actions for reducing the occurrence, or improving detection, or for identifying the root cause if it is unknown? Prevention actions are preferable to detection actions.
SEV x OCC x DET
Enter the name of the person who is responsible for the recommended action and the target date for completion.
List the completed actions that are included in the recalculated RPN. Include the implementation date for any changes.
What is the new severity based on the action applied.
What is the new Occurrence numbers based on the action taken.
What is the new detection ranking based on the action taken. Has the detection improved?
Recompute RPN after actions are complete.
How Severe is the effect to the customer? Identified product characteristics!
Insert FMEA Document Number
Phone number or email of person responsible for completing Information.
Enter the initial due date of the DFMEA which should not exceed start of production.
Company and person responsible for preparing DFMEA
Enter the date the original DFMEA was completed.
Insert date of latest revision to DFMEA
Either a target percentage or RPN threshold is determined by the organization owning the product. A "target percentage" means that regardless of the RPN number, your organization will address a percentage of the highest RPN line item steps in the process WITH ADDITIONAL ACTIONS to reduce overall risk. For example, with a specific product your internal target percentage is to address the top 25% highest RPN values with additional action. This is the Cooper recommended way to address overall risk because it drives improvement regardless of RPN value. Some organizations designate an "RPN threshold" or cutoff value. This means that you will take action beyond a certain value. For example if your RPN threshold value is 50, then any items in the DFMEA that have a calculated RPN at 50 or higher require the "actions taken" section to addressed. Note: Special attention should always be given to any severity 9 or 10 items.
Number for either percentage or threshold.
Eliminate the cause of the mechanism of failure from occuring or reduce its occurrence.
Identify the existence of a cause, the resulting mechanism of failure either by analytical or physical methods before the item is released for production
Enter the requirements of each item/function being analyzed.
Indicate the location city and state of the Cooper manufacturing facility that you are providing parts to.
The item number is may be referenced from the process flow chart or control plan. If multiple part numbers exist (assembly) list the individual part numbers and their functions
Cooper Part Number as stated on Cooper Print.
Name of the System or component for which the process is being analyzed.
Most recent revision off of Cooper Print
Identify the Core Team members for the PFMEA activity.
PLEASE NOTE: ZOOM LEVEL MUST BE AT 100% TO READ LARGE COMMENT FRAMES. Please delete this text box after reading.
Process PFMEA
Potential Failure Modes and Effects Analysis Process FMEA
Print #
&R&"Arial,Bold"Page &P of &N
List the process function that corresponds to each process step or operation being analyzed. .
In what ways might the process potentially fail to meet the process requirements intent? List each potential failure mode. There can be multiple failure modes for each process step.
How Severe is the Effect on the Product SEVERITY EFFECT SEVERITY OF EFFECT ON PRODUCT RANK EFFECT SEVERITY OF EFFECT ON THE PROCESS Failure to meet safety Potential failure mode affects safe product operation 10 Failure to meet Safety May endanger operator (machine/assembly) without warning and/or regulatory and/or involves noncompliance with regulatory standards. Safety and/or regulatory requirements requirments. Potential failure mode affects safe product operation 9 May endanger operator(machine/assembly) without warning and/or involves noncompliance with regulatory standards Loss or degradation Loss of primary function (product inoperable, does not 8 Major Disruption 100% of product may have to be scrapped. Line shutdown of primary function affect safe prodyct operation). or stop shipment. Degradation of primary function (product inoperable, 7 Significant Disruption A portion of production run may have to be scrapped. Deviation but at a reduced level of performance.) from primary process including decreased line speed or added manpower. Loss or degradtion Loss of secondary function(product operable, but 6 Moderate Disruption 100% of production run may have to be reworked off line and of secondary function comfort/convience functions at a reduced level of performance. accepted. Degradation of secondary function (product inoperable, but 5 A portion of the production run may have to be reworked comfort/convience functions at a reducted level. offline and accepted. Annoyance Appearance, noise or minor issue, product operable, item does 4 100% of production run may have to be reworked in station not conform and noticed by most customers (>75%) before it is processed. Appearance, noise or minor issue, product does not conform, 3 A portion of the production run may have to be reworked and noticed by many customers (50%). in station before it is processed. Appearance, noise or minor issue, product does not conform 2 Minor Disruption Slight inconvenience to process, operation or operator and noticed by many customers (<25%). No effect No discernable effect 1 No Effect No discernible effect
What is the effect of each failure mode on the outputs and/or customer requirements? The customer could be the next operation, subsequent operations, another division or the end user.
How can the failure occur? Describe in terms of something that can be corrected or controlled. Be specific. Try identify the causes that directly impacts the failure mode, i.e., root causes.
How often does the cause or failure mode occur? RATING LIKELIHOOD OF OCCURRENCE LABEL 10 ≥ 100 per thousand pieces VERY HIGH 9 ≥ 50 per thousand pieces HIGH 8 ≥ 20 per thousand pieces HIGH 7 ≥ 10 per thousand pieces HIGH 6 ≥ 2 per thousand pieces MODERATE 5 ≥ .5 per thousand pieces MODERATE 4 ≥ .1 per thousand pieces MODERATE 3 ≥ .01 per thousand pieces LOW 2 ≥ .001 per thousand pieces LOW 1 Failure is elimenated through preventative control VERY LOW
What are the existing controls and procedures (inspection and test) that either prevent failure mode from occurring or detect the failure should it occur? The preferred approach is always prevention!
How well can you detect cause or failure mode? RATING CRITERIA Suggested Detection Methods Detection Types 10 No Detection Opportunity Cannot detect or is not checked ALMOST IMPOSSIBLE Manual 9 Not likely to detect at any stage. Error not easily detected indirect VERY REMOTE Manual or random checks. 8 Problem detection post processing Detection by visual/tactile/audible means. REMOTE Manual 7 Problem Detection at Source Attribute Gauging/Post Processing-or Visual VERY LOW Manual 6 Problem Detection Post Processing Control is achieved with charting (SPC) LOW Gauging,Manual 5 Problem Detection at Source Detection is based on 100% gauging on set up MODERATE Gauging Performed on set-up of first piece check up 4 Problem Detection at Post Processing Detection Post Processing that will lock MODERATELY HIGH Error Proof,Gauging part from further processing 3 Pronblem Detection at Source Error detection in station or in HIGH Error Proof, Gauging will detect error and prevent processing 2 Error Detection Problem Prevention Detection in station by controls VERY HIGH Error Proof, that will prevent part from being made 1 Detection not applicable; Error prevention as a result of product . ALMOST CERTAIN Error Proof design. Item has been error proofed.
What are the actions for reducing the occurrence, or improving detection, or for identifying the root cause if it is unknown? Should have actions only on high RPN's or easy fixes.
SEV x OCC x DET
Who is responsible for the recommended action? What is the target completion date.
List the completed actions that are included in the recalculated RPN. Include the implementation date for any changes.
What is the new severity based on the action applied.
What is the new Occurrence numbers based on the action taken.
What is the new detection ranking based on the action taken. Has the detection improved?
Recompute RPN after actions are complete.
How Severe is the effect to the customer? Identified product or process characteristics!
Insert PFMEA Document Number
Phone number or email of person responsible for completing Information.
Enter the initial due date of the PFMEA which should not exceed start of production.
Indicate the location city and state of the Cooper manufacturing facility that you are providing parts to.
Company and person responsible for preparing PFMEA
Enter the date the original PFMEA was compiled.
Insert date of latest revision to PFMEA
Either a target percentage or RPN threshold is determined by the organization owning the process. A "target percentage" means that regardless of the RPN number, your organization will address a percentage of the highest RPN line item steps in the process WITH ADDITIONAL ACTIONS to reduce overall risk. For example, in a specific process your internal target percentage is to address the top 25% highest RPN values with additional action. This is the Cooper recommended way to address overall risk because it drives improvement regardless of RPN value. Some organizations designate an "RPN threshold" or cutoff value. This means that you will take action beyond a certain value. For example if your RPN threshold value is 50, then any items in the PFMEA that have a calculated RPN at 50 or higher require the "actions taken" section to addressed. Note: Special attention should always be given to any severity 9 or 10 items.
Number for either percentage or threshold.
List the methods of detection control that identifythe cause of process failure leading to corrective actions.
List the methods used that eliminate or prevent the cause of failure.
List the requirements for each process/step. Requirements are the inputs to the process specified to meet the design intent. There can be multiple requirements per function.
The item number is may be referenced from the process flow diagrams and/or the control plan. If multiple part numbers exist (assembly) list the individual part numbers and their functions
Identify the Core Team members for the PFMEA activity.
Name of the System or component for which the process is being analyzed.
Cooper Part Number as stated on Cooper Print.
PLEASE NOTE: ZOOM LEVEL MUST BE AT 100% TO READ LARGE COMMENT FRAMES. Please delete this text box after reading.
Cooper Dim Data Sheet
Supplier Representative:
Supplier Signature
Part Name:
Initial submission
Name
Title
New or significantly modified process or routing
Phone Number
OKNI
REQUIREMENT: Description of Check
NOTE: Any out of specification data will require corrective action.
Full Name of Supplier
Drawing Number and Revision listed on accompanying balloon drawing
Revision level on Cooper component level print.:
Located either in engineering title block or revision matrix on component level print. This is the date the part was revised to the most recent rev level
Indicate the reason that the data is being submitted. There may be more than one reason.
Name of Person Completing Report
Title of Person Completing Report
Best Number to Reach Supplier Representative
Supplier Representative Email Address
Date Report Filled Out
Signature of Supplier Representative
V = Variable A = Attribute
Methodology
Measurement system being used to check the specification or tolerance. This Could include gages, fixtures, tools and or test equipment required to measure the part/process/manufacturing equipment. A measurement system analysis should be done to ensure control of monitoring and measuring devices prior to relying on a measurement system.
Nominal Dimension
Maximum acceptable value
Minimum acceptable value
Actual Test Values
Max less Min
If test values do not fall within min and max describe corrective action here
The Corrective Action Required by Cooper Industries, filled out by coordinating Cooper Industries Contact and returned to Supplier
The Action Plan specifies the Corrective Actions necessary to avoid producing nonconforming products or operating out of control. The actions should normally be the responsibility of the people closest to the process:
Supplier Change Request
Supplier Change Request
Supplier Information
Supplier Name
Date of Proposed FUTURE Change
Description of Change (Please describe in detail the nature of the change)
This section is reserved for parts sourced through CES (Cooper Electric Shaghai)
CES Product?
Name of CES SQE
Customer Information: (Please list additional part numbers on a separate sheet if necessary)
Customer Part Number(s) Affected
Customer Location(s) Affected (city,state)
Type of Change
(Note:) You are required to notify and receive approval from Cooper for any of these types.
(Select One)
Designations in ( ) are the recommend PPAP Level submissions for this type of change
1. Change to construction, material or component (L3)
7. Product/process changes on components of the product (L4)
2. New, additional or modified tools (L3)
8. Change in test or inspection method (L4)
3. Upgrade or rearrangement of existing tools (L2)
9. Bulk Material: New source of raw material (L2)
4. Tooling, production or equipment transferred to different site (L3)
10. Change in product appearance attributes (L2)
5. Change of supplier or non-equivalent materials/services (L3)
11. Change in production process or method (L4)
6. Product when tooling has been inactive for 12 months (L2)
12. Change of Sub Supplier or material source (L3)
Reference: Section 3 Table 3.1 on Page 13 of AIAG PPAP 4th edition (May 2006)
ALL Information Below is to be filled out by Cooper Industries.
Cooper Requirements (Plant Quality, Supplier Quality and Puchasing)
Purchasing
Yes
List all locations affected by this proposed change.
This is the proposed date that the change would become effective once you have received approval from Cooper.
This is the date you are sending this request to Cooper
This is the name of the Cooper purchasing representative that you work with.
This is the person that should be contacted at your organization for questions concerning this change.
This is a detailed explanation of the change and the reasons why is is important for your organization.
List all affected part numbers…attach additional list if neccessary
List all Cooper Manufacturing sites affected by this change.
This question is for products sourced through CES ONLY!
This is the name of the designated ASC SQE or SD representative.
These are all of the specific types of changes that Cooper requires approval for prior to implementation. If you are not sure the proposed change you are planning falls into one of these types, contact your Cooper Purchasing repesentative.
No
XXXXX
Required for PPAP
Note: This document must be completed for all Cooper owned tooling.
Complete Supplier Tooling Action Item List to ensure all items are completed.
TOOLING ACTION ITEMS
&RPage &P of &N
Life expectancy of tooling as measured in MAXIMUM number of parts produced before discarding.
Paste digital images into cell. Resize as appropriate. Accepted formats include JPG and TIFF. Maximum width is 4" (100mm), maximum height is 2.25" (57mm)
Should include information such as the part number, tool information, number of cavities etc..
Provide images of the tool from all sides and show Cooper owned tooling information if applicable.
This is based on your own internal procedures.
List responsible individual in your organization.
List actual values and activities for each item.
Due date for when the item is to be completed.
Status of each item which should be complete at the time of PPAP submission. Date complted should also be included.
This number is provided by purchasing and must be included with this document and attched or engraved into the cooper owned tool. This reference number should also be included with the tool tag pictures.
Person responsible for drawings the CAD drawing format the files are created in.
Identify responsible person for costing and list all requested costs. These cost must be consistent with your accepted quote to Cooper.
Brieif description of the tool.
Identify the responsible person for all dimensions and all applicable dimensions.
Identify the press (if applicable) that this tool is scheduled to run on.
Identify the person responsible for developing the tool and the material grade. If this is an outsouce vendor then please list who the vendor is and the primary contact person.
What is the planed capacity for this tool based on your quoted volumes to Cooper.
Supplier Name providing part to Cooper (Not Tool Maker)
This is Level 1-5 based on what Cooper Quality or Supplier Quality has requested.
CHANGES ONLY! If submiiting this document for a change to an exisiting tool, please reference which dimensions are affected by listing the Balloon numbers off of the dimensional report.
Date dcoument created.
Actual PO Part number off of Cooper part print.
Changes Only! This is the actual date a modified tool ran production product.
As listed on the Cooper Part Print.
Manufacturing Facility
Packaging Form
Packaging Form
Supplier Code
Fax Number
Part Description
Supplier Production Facility
Pallet Only
Container (Tare)
DIGITAL IMAGES
PACKAGING MATERIALS
Date packaging design and this document are complete
Overall person responsible for packaging in the event Cooper has a concern or labeling question.
Part number as it appears on the the Cooper Part Print.
Supplier Name
SAP supplier code
Email address for the Packaging Contact.
Description as it appears on the Cooper Part Print.
Please identiy any Hazmat products or packaging materials
Refer to PPAP handbook for divisional specific packaging and testing requirements.
Specification Deviation Form
Specification Deviation Form
Existing Production Deviation
Part Name
Part No:
Expiration Date
Sort
Rework
Repair
Actual Observed Results or Condition
Deviation from Specification to be Allowed
Interim Action
Rework
Approval Signatures
Route To
Approve
Reject
Attach an additional sheet if necessary.
Part name as stated on print.
Actual PO Part number off of Cooper part print.
Expiration date of the deviation request
Date revision was completed
Name of individual requesting the deviation.
Drawing or specification number
Supplier provides data on what the process is currently producing
Specific information to be provided by Cooper as to what is acceptable.
Enter the interim action plan to improve the process.
Summary as to how the interim action will affect cost, quality and delivery
Action item number
Specific action to improve the out of tolerance condition
Person(s) responsible to complete the action item on or before the due date.
Date as to when the improvement action item is completed.
Update as to whether completed or delayed.
PO Number from Cooper division
Select status of interim action from drop down list
Date when interim action will be completed.
GR&R Multiple
X Data
Range Data
j index
Part Average
D4
A2
For use with testing gage systems meant to evaluate features or processes whose output measured numerically, and for which two to three operators are expected to conduct the evaluation. Rev. 11/1/07 Dave Olson
Op 1 X AVG
Range
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0.0000
0.0000
Error
Error
Error
0.0000
0.0000
0.0000
Error
Error
Error
0.000
4
Error
Error
Error
10
0.0000
0.0000
0.0000
0.0000
Error
Error
Error
0.0000
0.0000
0.0000
Error
Error
Error
0.000
5
Error
Error
Error
6
Error
Error
Error
7
Error
Error
Error
8
Error
Error
Error
9
Error
Error
Error
10
Error
Error
Error
* A minimum of six samples for each trial is required for these results to be valid
Gage R&R Summary
Gage R&R Disposition
Total Variation: TV=
10 ≤ GR&RTOL% ≤ 30
% Equipment Variation (EVTV)
%Part Variation (PVTV)
Operator X Values
Part Operator Average Most part averages should be outside the control limits
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Ppk
1
0
1
2
0
2
0
1
0
0
3
0
0
0
0
4
0
1
0
0
5
0
2
2
0
6
0
1
0
0
7
0
0
0
0
8
0
0
0
0
9
0
0
0
0
10
0
0
0
0
UCLr
Bar-R
Process Capability Analysis - Ppk
Use when: (a) You are a new supplier to Cooper that has already been manufacturing the specified part, or (b) you are an existing supplier who has been found to have supplied a large number of nonconforming parts.
Are the Design Characteristics Safety Related, or Functional?
Part Number:
Supplier Name:
Part number as it appears on the Cooper Part Print.
Drawing number listed on balloon drawing.
Most recent revision number taken from Cooper print.
Date revision was completed
Full name of supplier
Name of individual responsible for GR&R study.
Repeatability (Gage precision) The variation in measurements obtained with one gage when used several times by an operator while measuring the identical characteristic on the same part. Referred to as equipment variation in a Gage R&R study.
Reproducibility (Operator precision) The variation in the average of the measurements made by different operators using the same gage when measuring a characteristic on one part. Referred to as Operator Variation in a Gage R&R Study.
Repeatability and Reproductability
Enter the date(s) the data was compiled
Insert the name of the first operator involved in the GR&R study.
Insert the name of the second operator involved in the GR&R study.
Insert the name of the third operator involved in the GR&R study.
Enter type of gage used
Upper Spec Limit
Lower Spec Limit
Grid Location
Name of Process Capabilty Analysis supplier contact person
ID of Equipment
Date of iInstrumentation's last calibration
Gage R&R Is the Percentage of Measurement Variation (Repeatability and Reproducibility) in the Process Under 10%: Acceptable Gage 10% to 30%: May Be Acceptable Over 30%: Unacceptable and Should Be Corrected or Replaced
Upper Spec Level
Cpk Moving Range
Cpk for Subgroups
Use when: (a) new part, (b) part with revised specifications, (c) part in which the materials, processes, manufacturing location, or production equipment have significantly changed, or (d) part in which the material suppliers have changed.
X
X-Bar
LCLx
UCLx
Range
R-Bar
UCLr
USL
USL=
0.000
Cp =
LSL
LSL=
0.000
CpkL =
Mean=
Error
CpkU =
Cpk for Moving Range
Use when: (a) new part, (b) part with revised specifications, (c) part in which the materials, processes, manufacturing location, or production equipment have significantly changed, or (d) part in which the material suppliers have changed AND testing is too expensive to be conducted by subgroups.
Part Number:
Supplier Name:
Cooper Industries
File Attachment
Click on this icon to open the "Cooper Industries PPAP Forms Kit" which is attached to this pdf manual.
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FOREWORD................................................................................................4
SUPPLIER CHANGE REQUEST (SCR) INSTRUCTIONS......................................................... 6
SUBMISSION LEVELS ...................................................................................................... 8
ELECTRONIC SUBMISSION/SUBMISSION METHOD............................................................ 10
ELEMENT 1 PART SUBMISSION WARRANT (PSW)........................................................... 13
ELEMENT 2 DESIGN RECORDS AND BALLOONED DRAWINGS ............................................ 14
ELEMENT 3 APPROVED ENGINEERING CHANGE DOCUMENTATION .................................... 15
ELEMENT 4 CUSTOMER ENGINEERING APPROVALS......................................................... 16
ELEMENT 6 PROCESS FLOW DIAGRAMS......................................................................... 18
ELEMENT 7 PROCESS FMEA (PFMEA)......................................................................... 19
ELEMENT 9 MEASUREMENT SYSTEM ANALYSIS STUDIES (MSA) ...................................... 23
ELEMENT 10 DIMENSIONAL RESULTS............................................................................. 25
ELEMENT 12 INITIAL PROCESS STUDY (CPK, PPK).......................................................... 28
ELEMENT 13 QUALIFIED LABORATORY DOCUMENTATION................................................. 33
ELEMENT 14 APPEARANCE APPROVAL REPORT.............................................................. 34
ELEMENT 17 CHECKING AIDS........................................................................................ 35
APPENDIX C – REVISION HISTORY .......................................................51
Foreword The Quality Assurance staff at Cooper Industries has prepared this handbook for new and existing suppliers of manufacturing based purchased goods to Cooper Industries. Its purpose is to define the approval process of new or revised parts, or parts resulting from new or significantly revised production methods. As a supplier, it is your responsibility to ensure that you ship only parts that have been approved and meet specifications. The procedures outlined in this handbook apply to all Cooper Industries facilities. If you have questions regarding the contents or processes described in this handbook, please contact the Quality Assurance representative of the Cooper Industries location to which your documentation is being submitted. Please note that Green Text in this manual will link to the Definitions Appendix. The requirements in this handbook were drafted to be fully compliant with the Automotive Industry Action Groups (AIAG) Production Part Approval Process (PPAP) standard revision 4 March, 2006. Cooper Industries has specific customer specific requirements and additions to this standard that need to be fully understood before attempting to successfully submit a PPAP to Cooper Industries for review and approval.
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Purpose
The purpose of the Production Part Approval Process (PPAP) is:
To provide the evidence that all customer engineering design record and specification requirements are properly understood and fulfilled by the manufacturing organization.
To demonstrate that the now established manufacturing process has the potential to produce product that consistently meets all requirements during an actual production run at the quoted production rate.
When is PPAP Submission Required?
In general a PPAP is required anytime a new part or a change to an existing part or process is being planned. It is at the discretion of each Cooper Industries Division to determine when and if a PPAP submission will be required. As a supplier you should have the type of quality system that develops all of the requirements of a PPAP submission regardless of whether you have been asked to deliver a submission. In the event a PPAP submission is not requested, Cooper quality reserves the right to request any of these documents at any time during the life of the product. Cooper Quality reserves the right to request a PPAP submission for a variety of reasons including all of the following. New parts, process or suppliers: 1. New part or product 2. New supplier 3. New process or technology
Changes to existing product: 1. Change to construction, material, or component 2. New, additional or modified tools 3. Upgrade or re-arrangement of existing tools 4. Tooling, production, or equipment transferred to a different site 5. Change of supplier or non-equivalent materials/services 6. Product when tooling has been inactive for 12 months 7. Product or process changes on the components of the product 8. Change in test or inspection method 9. Bulk material: New source of raw material 10. Change in product appearance attributes 11. Change in production process or method 12. Change of sub-supplier or material source
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If there are any questions concerning the need for a PPAP Submission, please contact a Cooper Industries Quality or Supplier Quality representative.
Supplier Change Request (SCR) Instructions
Whenever you are planning a change that affects the part or the process making the part you must get approval from Cooper prior to initiating any activity. Included in the PPAP Forms kit is the Supplier Change Request (SCR). This document is used for initiating all supplier changes through all Cooper divisions. The SCR must be approved by both Cooper Industries’ purchasing and quality. Failure to have an approved SCR may affect future business opportunities. Cooper assumes a good faith agreement with you as a supplier with respect to change management. Therefore we rely on the supplier to notify us in good faith of any planned change such as changing the location of manufacture or changing the process that manufactures the part supplied to Cooper. The additional requirements section on the form can be used to document any additional testing, performance data or engineering changes that may be required to make the proposed change a success. Any proposed change to a print requirement from a supplier should be done using the Specification Deviation Form and follow each division’s standard procedure for engineering changes. The SCR should not be used to suggest or initiate print related changes. In addition, the SCR is only for changes that are permanent in nature. Temporary changes or deviations should always follow the Cooper manufacturing site’s process for Temporary Deviations. The SCR identifies several “Types” of changes that require notification. These types are covered in Table 3.1 in the most recent release of the PPAP standard. All of these changes can have significant affect on overall part quality and are therefore identified for customer approval prior to making the change to avoid any unforeseen issues at Cooper facilities or with end user customers. This methodology around change management is consistent with the Customer Notification section in the AIAG PPAP guidelines revision 4. As a supplier to Cooper Industries you are not under any of these circumstances allowed to make a change without prior notification and approval of the SCR form.
Below is the list of Types of changes that require prior notification and approval by Cooper Industries.
Elements of a PPAP Submission
The Cooper Industries PPAP submission requirements are compliant with the existing AIAG standard. One or more of the following elements may be required as part of your formal submission depending upon your assigned submission level: 1. Part Submission Warrant (Cooper Specific Format Required) 2. Design Records & Ballooned Drawings 3. Approved Engineering Change Documents 4. Customer Engineering Approval 5 DFMEA 6. Process Flow Diagram 7. PFMEA 8. Control Plan 9. Measurement Systems Analysis (MSA) 10. Dimensional Results (Cooper Specific Format Required) 11. Material, Performance Test Results 12. Initial Process Study (Cpk) Capability Studies 13. Qualified Laboratory Documentation 14. Appearance Approval Report (AAR) 15. Sample Product Parts 16. Master Sample(s) 17. Checking Aids 18. Cooper-Specific Requirements
A. Tooling information Form B. Packaging Form C. Inspection Plan (Asian Sourcing Center Only) D. Specification Deviation E. Supplier PPAP Worksheet
Cooper industries have many of these forms available to suppliers at no charge as part of our “PPAP kit” which is available on CD. You can use the Cooper supplied forms or
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any AIAG compliant forms with the exception of Element 1 (PSW) and Element 10 (Dimensional Report). Both of these elements must be submitted on the Cooper Industries format.
Submission Levels Submission levels define which elements are required to be submitted. The levels are used for different reasons and applications. The level to be submitted is determined by Cooper Industries, and unless otherwise noted, always defaults to Level 3 which is a full PPAP submission. There are five submission levels listed below, and each is typically applied to the specific areas listed.
Level 1. Warrant only and Appearance Approval Report as requested
submitted to the customer. Applied to: ‘Non-critical’ parts, ‘non critical’ raw/bulk material or catalog/ commodity parts for electrical applications and re-certification of existing parts previously approved by Cooper at levels 3, 4 or 5. Also used for self-certification.
Level 2. Warrant with product samples and limited supporting data
submitted to the customer. Applied to: Critical Bulk products such as Plastic/Paint/Chemicals, critical fasteners, simple material changes, simple revision level only changes or simple print updates not affecting form-fit-function. This level can also be applied to low and medium risk parts within a product family.
Level 3. Warrant with product samples and complete supporting data submitted to customer. Default Cooper Industries Submission Level Applied to: New parts on Cooper programs, changes affecting form-fit-function, reliability, or performance. All products resourced to new suppliers, serial production parts, and existing high risk parts undergoing a part number change.
Level 4. Warrant and other requirements as defined by the customer. This
level is reserved for special applications only. Applied to: This level can only be applied with prior approval from the designated divisional Cooper Quality PPAP representative.
Level 5. Warrant with product samples and complete supporting data reviewed at the supplier’s manufacturing location. Applied to: On site review as requested by each Cooper Division.
Note: A level 4 submission cannot be utilized without the consent of your Cooper Industries Quality or Supplier Quality Representative. Parts sourced in other countries that are delivered to North America must be translated into English and must be Level 3
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submissions. Changes to existing parts will be handled on a case-by-case basis and submissions other than level 3 must have prior approval from your Division level North American Quality or Supplier Quality representative. Supplier PPAP Checklist Cooper Industries has a customer specific requirement that can be used for referencing and organizing a PPAP submission. The Supplier PPAP Checklist lists all of the required elements for each LEVEL option 1 through 5. The level for your PPAP submission is determined by Cooper Industries. If you are not sure what level you are submitting to you should check with your Divisional Cooper Industries Quality or Supplier Quality representative. The Supplier Checklist provides an opportunity to assign responsibilities internally and documents concerns to Cooper about specific areas within the submission. If you have issues or problems with any of the specific elements of a PPAP submission then they should be documented here or on the PSW cover page. For example, if at the time of submission you have not received approval of your packaging material, then this would be the place to document that concern. All concerns must be documented at the time of submission to avoid rejection of the issue at a later time. Below is the top portion of Supplier PPAP Checklist and the full form is in the addendum section of this manual and the PPAP Forms Kit.
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Electronic Submission/Submission Method
Cooper Industries requires that all PPAPs be submitted electronically. There are two preferred methods of submission:
1. Upload to the Cooper Division designated FTP site. (preferred) 2. Email to your quality/supplier quality representative.
Each Cooper division handles delivery of the submission differently so you should check to make sure you are sending your documentation to the correct location. It is preferred that the PPAP be 1 PDF file of the entire submission. If this is not possible then we would request that each element would be in PDF format and not Native format such as MS Excel or Word. Important: The use of a paper or email submission must have prior approval by the authorized Supplier Quality or Quality representative. All submissions must be received prior to the PPAP due date. Significant Production Run
PPAP data must be submitted from a “significant production run”, which is identified by AIAG in the PPAP standard as 300 consecutive pieces sampled randomly. Unless otherwise agreed upon by the Cooper Industries and the supplier, sampling should be taken from no less than 300 pieces from a production run, utilizing production equipment, tooling and production employees operating at production rate. The intent is that all data reflects the actual production process to be used during production. You are required to document the date, time and the actual rate of this run on the Part Submission Warrant.
Submission Status
The review and approval process will be managed by each Cooper division. Subsequently the PPAP submission will be reviewed and dispositioned with one of the following submission statuses:
Approved: A formal acceptance of the submission within the guidelines of any and all criteria set forth by the Cooper division managing the submission.
Rejected: The provision is not acceptable and needs to be resubmitted for approval. (Note: Submission to the wrong revision level or part number will constitute an automatic rejection.)
Interim: An interim approval can occur through an agreement with quality management. The product must be deemed “sellable” by Cooper and the interim
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may only be issued for 90 days. The submission must have an approved Specification Deviation that clearly identifies the corrective action plan to achieve full approval within the 90 day period. The Specification Deviation is in the Cooper Industries’ PPAP Forms kit.
Ongoing Requirements
Cooper Industries reserves the right to request any information you have provided in any data or documented in any element of approval, at any time, including after the approval has been granted. Cooper Industries reserves the right to require recertification at any time. As a supplier to Cooper Industries, the expectation is that you will build your product and processes to be robust not only for the launch of the product but for the life of the product. The expectation is that your system will include verification of the parts and the part requirements on an “on-going basis”. This includes building periodic conformance testing into your overall process such as routine dimensional analysis, functional analysis and process verification. Our recommendation is that you have designated intervals for verifying Critical To Quality (CTQ) characteristics and key process related methods. All of these must be identified on the control plan as part of your ongoing process to verify that your product meets Cooper’s requirements. Cooper reserves the right at any time throughout the life of the product to request evidence of this ongoing conformance.
Critical to Quality (CTQ) Features
CTQ Characteristic Definition:
A critical PART requirement specified on a controlling document (typically an engineering drawing, specification or performance requirements)
A critical PROCESS requirement identified by Customer or Supplier.
Directly represents the safety, regulatory, or primary functional
performance requirements by the end customer or business
Requires verification of part conformance during first production.
Requires documented evidence of process control to maintain part conformance through the life of the product
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Critical to Quality (CTQ) characteristics are those features that most affect the outcome of a product or process. CTQ controls must be designed and implemented as part of your company’s advanced quality planning. Special attention is required during this phase to identify and control variables that affect the conformance of the product. Cooper’s expectation is that you will address all CTQs in the control plan and ensure that you have a robust process for consistently achieving all CTQ requirements as they are defined in the Cooper part print. Each division will have its own CTQ designation methodology. Specific definition per division will be found in Addendum D. Please refer to your division Quality or Supplier Quality Representative with any question concerning. CTQ are typically mandatory for Element 12, the “initial process study” which is sometimes referred to as the capability element. Cooper requires capability studies for all CTQ and any process related characteristics that either you or Cooper identify as critical. This section is mandatory even if there are no CTQs on your part print because there are always critical elements and characteristics of the process that manufactures the part. As a supplier developing product for Cooper, your team may discover process and sometimes additional product characteristics that are critical to part performance. Even if the print does not clearly define any CTQs, Cooper expects that suppliers will identify CTQs for their processes and methods. NOTE: SEE APPENDEX B
PPAP Training
Cooper Industries offers Supplier PPAP training at several levels. You can contact either a member of Cooper Plant Quality or Supplier Quality for more information. The training for suppliers is typically around 4-6 hours and is offered at various times throughout the year both in an on-site format and via Webinar. For these offerings contact your Division Supplier Quality Representative. You can also refer to the AIAG website (www.aiag.org) for additional information, training and materials on the PPAP standard 4th edition as well many of the various elements within the standard. AIAG has developed industry standard publications available for many of the elements that go into specific detail on the concepts and how to plan your approach. In addition you can register for additional AIAG training on these and many other important industry standards.
Instructions for completing a PPAP Submission All submissions must be received prior to the PPAP due date. The review and approval process will be managed by each Cooper division.
Element 1 Part Submission Warrant (PSW)
The purpose of the Part Submission Warrant (PSW) is to document the submission and the approval or rejection of purchased parts prior to production. Cooper Industries has developed its own Submission Warrant document and this form is a required element of PPAP. It must be submitted as part of the PPAP at every submission level. Cooper Industries will not accept the AIAG form or any internal PSW format. Completing the Part Submission Warrant The Part Submission Warrant is included in the forms file in the Cooper Industries’ PPAP Kit. It must be filled out and signed by the supplier. The part number must match the Purchase Order or material agreement that is provided by Cooper Purchasing. The form must be submitted in this format, with the correct part number, revision and submission level. This is 1 of 2 forms that are mandatory for all Cooper submissions. Any fields that do not apply to your submission should be filled in with “N/A” (Not Applicable). It is critical to make sure the PSW is filled out correctly, and contains accurate and legible information. A sample of the Part Submission Warrant described above can be found below. Each field in the Cooper PSW in the forms kit has comments that provide additional clarity on each field.
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Element 2 Design Records and Ballooned Drawings
The purpose of designed records and ballooned drawings is to document and provide a copy of the formal part print and to provide any additional engineering records for reference. Example of a Balloon Drawing A ballooned drawing shows the parts or assemblies in a part print with numbered “balloons” that point to individual dimensions and requirements of the part. The numbers on the ballooned drawing correlate with the numbers found on the Dimensional Data Sheet. A ballooned drawing must be submitted as part of PPAP for every submission level when there are dimensional results.
14
Completing the balloon drawing All part requirements on the Cooper print must be ballooned and numbered for reference and measurement. These may include:
1. Dimensions and tolerances of parts 2. Electrical requirements (performance data, functional tests, etc.) 3. Visual features (color, texture, etc.) 4. Chemical characteristics (cure time, etc.) 5. Physical and mechanical properties (tensile strength, plating thickness,
heat-treat hardness, etc.) 6. Any other specified requirement that you have the capability to measure or
that is described in print notes or referenced specifications.
When dimensions are specified at multiple locations on the drawing, the data for each location should be numbered separately. Dimensional data for Element 10 such as dimensions and tolerances must be addressed on the Cooper Industries Dimensional Data Sheet. Material or Performance data should be included in Element 11 on a format that allows for clear interpretation of the results. For example, material results can be addressed using a material composition report or a certificate of analysis. Either an in-house format or the AIAG formats for material and performance are acceptable.
Element 3 Approved Engineering Change Documentation
This section is used to cover anything that is not addressed in a part print such as emails, Supplier Change Requests (SCR), and Feasibility Studies.
Cooper ECNs must be approved, not pending. Print change submissions must have current prints. Emails can only clarify requirements, not define them Emails cannot re-define a requirement in lieu of a
print change. All supplier initiated changes must have a copy approved Supplier Change
Request (SCR) form. The Supplier Change Request must be approved by both Cooper Purchasing and Quality prior to making any proposed changes. You should not proceed with your change until you have an approved SCR from Cooper.
15
Element 4 Customer Engineering Approvals
Customer Engineering Approvals are used to demonstrate pre-approval by Cooper’s customers of a design. Customer Engineering Approvals are not required for supplier submissions. In the event that this would be required in the future we have maintained a placeholder within the Cooper requirements.
Element 5 Design FMEA (DFMEA)
Design FMEA stands for Design Failure Mode and Effects Analysis (DFMEA) and shows evidence that potential failure modes and their associated risks have been addressed in order to eliminate or minimize their effects through product design changes and improvements. DFMEA is only required when the part is designed by the supplier and must address all Critical to Quality characteristics (CTQs) and any potential voice of the customer inputs identified in the Cooper Project Scope.
The date on the DFMEA should show release prior to print release. Severity, Occurrence and Detection ratings are used when performing FMEA activities. These rating scales must be compliant with the AIAG guidelines for FMEA (4th edition) and definitions are included in the DFMEA worksheet as well as this handbook. Cooper has included a worksheet format in the forms kit. Above is the form and to the right is an example of how the ratings scale for Severity is available in the comments for easy reference. Any potential failure mode not mitigated in the DFMEA should be included in the PFMEA also included on the PPAP worksheet. Any potential failure mode with a severity ranking of 9 or 10 must be addressed with
16
a corrective action plan. Furthermore, potential failure items in the top 25 percent high RPN ranking should have corrective action items addressing the potential failure mode. Organizations that have already developed a DFMEA or PFMEA can submit that as part of their PPAP submission. For organizations without a DFMEA or PFMEA, sample forms have been included in the PPAP kit. The chart below describes the fields in the DFMEA. Completing the DFMEA The DFMEA supports the design process by reducing the risk of failures. The DFMEA should be initiated before the design concept is finalized. Each item/function needs to be addressed. Any potential failure mode of the item/function should be defined as completely as possible. Recommended actions should be recorded. All severities of 9 or 10 must have an associated action plan. Prevention is the preferred method to address the design failure mode. If prevention is not possible, then highlight detection controls. The DFMEA is not meant to be a stand alone document and the results of the DFMEA can be used in the PFMEA. The FMEA Revision 4 tables for Severity, Occurrence and Detection are embedded in the cell comments on Cooper’s FMEA template. The three of these ratings multiplied together produce the initial Risk Priority Number or RPN. Severity x Occurrence x Detection = RPN The use of an RPN Threshold is not 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 improvement is not required (which it is). Cooper Industries recommends that you treat all FMEA activity on a separate case by case basis and that you address the top 25% of your highest RPN values within the FMEA activity you are doing.
PPAP Tools Kit DFMEA Form
17
Example of Guidance Comments within each cell of the DFMEA Form.
Example of Severity, Occurrence and Detection Tables within the cell comments of the DFMEA Form. (per FMEA revision 4).
Element 6 Process Flow Diagrams
The purpose of Process Flow Diagrams is to document and clarify all the steps required in the manufacturing of a part. The Primary process steps must match both the Control plan and the PFMEA. Process flows must include the entire manufacturing process (receiving through shipping).
Raw Goods Receiving
Warehousing Shipping
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The Process Flow Diagram must also include all key steps in the process and all offline activities (such as measurement, inspection and handling). The flow of nonconforming material such as scrap parts, non-conforming parts and rework parts should also be included. The Process Flow can be provided in any format used within an organization. (Examples are available in the training material that is part of the PPAP tool kit.)
Element 7 Process FMEA (PFMEA)
The Process FMEA (PFMEA- Process Failure Mode and Effects Analysis) is used to show evidence that any potential failure modes and risks have been assessed at the manufacturing process level. Process FMEA’s can be submitted in the Cooper format or any AIAG compliant format. Cooper Industries has provided a PFMEA Worksheet in excel format in the PPAP Forms kit. Like the DFMEA it also contains that latest rating definitions for FMEA Revision 4. A PFMEA should be performed for every part, piece of equipment or process involved in manufacturing. PFMEA is a cross-functional activity that is performed internally, updated routinely and reviewed periodically. Severity, occurrence and detection ranking values are included in this handbook, as well as in the PPAP toolkit. Cooper Industries requires that any severity ranking of 9 or 10 be addressed with a corrective action plan. Furthermore, potential failure items in the top 25 percent of the high RPN ranking items must have action items addressing the potential failure mode. This in turn will lower the re-calculated RPN value for that failure mode. Any high RPN process concerns should be carried over and addressed in the control plan. All critical failure modes must be addressed. Completing the PFMEA
The PFMEA worksheet is a tool used to identify and show potential process risks associated with the manufacture of each part. It also highlights the controls associated with each process. Each process step/function should be identified with an action plan to address the process failure mode. All high RPN process concerns should be carried over to the control plan.
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Print # Process Responsibility Item Name Contact Number Rev # Key Date Core Team Customer Manufacturing Site
Prevention Detection Actions Taken S E V
O C C
D E T
R P N
Potential Effects of Failure
Potential Cause(s)/ Failure Mechanisms
Potential Failure Modes and Effects Analysis Process FMEA
The recommended actions in any FMEA should address the initial high RPN numbers to minimize risk in the manufacturing process. The goal is to drive the final RPN number as low as possible. FMEA is a cross-functional activity that can lead to inconsistency particularly when specific team members are not trained. A number of organizations provide good training on both DFMEA ad PFMEA. In addition the AIAG manual (shown to the left) is the industry reference for comprehensive details on FMEA and can be purchased through their website. In addition, AIAG also offers additional training that you or your team can attend. Your Cooper Industries Quality or Supplier Quality
representative can also assist with any questions concerning FMEA. Below is a list of some of the more common mistakes made when performing FMEAs and should be avoided when performing the activity. It is recommended that you review this list with your team prior to performing FMEA.
Examples of common mistakes made on PFMEA
Misapplication of Severity, Occurrence and Detection Redefining Severity, Occurrence and Detection Over estimating the effectiveness of a “Recommended Action” Applying RPN thresholds arbitrarily Not recognizing all potential failures. Failure to properly identify the customer. Misapplication of ranking scales. Confusing Failure Modes with Effects or Failure Modes with Causes. Allowing the PFMEA to turn into a design review.
Element 8 Control Plan
A Control Plan defines the operations, processes, materials, equipment, methodologies, and CTQs (as determined by Cooper and suppliers) for controlling variations in key product or process characteristics integral to the manufacturing process. Its purpose is to communicate the supplier’s decisions during the entire manufacturing process from materials purchase through final shipping. Specifically, the control plan should address the following:
Methods of production Identification of CTQ characteristics’ controls Secondary or outsourced operations
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Materials and their physical and chemical characteristics Types of process equipment at each operation Types of test equipment used to measure each characteristic Specifications, sampling strategy, control and reaction methods used Periodic conformance testing and product verification
All processes must have a control plan that defines all methods used for process control and complies with the customer-specified requirements. The control plan must clearly state each step in the process; the specification & all Critical to Quality (CTQs) must be addressed for product and process. Completing the Control Plan Completing the Control Plan is a fairly straightforward process whereby the supplier simply documents all materials and processes involved in the manufacturing process from start to finish. The process flow diagram and ballooned drawing provide inputs to the Control Plan. All CTQs identified as Process, First-Piece, or Safety Related by the supplier must be listed on the control plan form. Additionally, the supplier will list decisions that are foreseen to affect the outcome of production. Example of Reaction Plan
A control plan should address all testing requirements, inspection and measurement that are required to make a quality product. Suppliers should also include other details they know to be vital in the process. The control plan cannot be excessively dependent on visual inspection and should target prevention techniques wherever possible. The control plan can be submitted on the Cooper Industries supplied format or any AIAG compliant format. The control plan should be developed in stages from proto-type through production. Early planning on the control plan will usually result in a more robust process. Suppliers should develop a pre-launch control plan early in the development of a new product and submit it to their Cooper Industries representative for feedback. This will allow both the supplier and Cooper to troubleshoot and finalize the production level control plan early and avoid unexpected costs or delays. Cooper may also request that you provide specific documents required at PPAP early in the development phase and the most common ones are the PFMEA and a pre-launch Control Plan.
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It is vital the control plan describes the actions required within the manufacturing process flow to ensure that all process outputs are in a state of control and that every step in the process requiring disposition has a defined “Control Method” and “Reaction Plan” outlined on the control plan. This includes all forms of testing, inspection, measurement and process setup. The “Reaction Plan” should clearly define any contingency planning that may need to be addressed during the manufacturing of the product. Finally, the Control Plan should be a living active part of your overall quality system. Cooper Industries prefers that all suppliers develop the Control Plan methodology as part of their everyday practice and Quality system. Control plans should not be developed just for a PPAP submission and in the event of an issue will typically be requested by Cooper. Therefore it is in the best interest of all suppliers to embrace the overall concepts that develop from implementing a robust Control Plan. Cooper Industries may also request that a specific pre-launch Control Plan be developed that minimizes the overall risk of specific product concerns during the launch phase. Unless otherwise requested the control plan for all PPAP submissions is the “production” control plan. The control plan methodology is formally defined in the AIAG APQP guidelines. You must utilize an AIAG compliant format and Cooper has provided one