Click to edit Master title style 1 Business Confidential & Proprietary Information Rev: 00 Watts Waters Technologies PPAP Requirements

Click to edit Master title style

1Business Confidential & Proprietary Information Rev: 00

Watts Waters TechnologiesPPAP Requirements



What’s PPAP?


3

What is PPAP ?

•Production Part Approval Process

•Standard used to formally reduce risks prior to product or service release, in a team oriented manner using well established tools and techniques.

• Initially developed by AIAG (Auto Industry Action Group) in 1993 with input from the Big 3 - Ford, Chrysler, and GM.

•AIAG’s 4th edition effective June 1, 2006 is the most recent version as of this print.

•PPAP has now spread to many different industries beyond automotive, this is now becoming a standard in the Water industry.

Business Confidential & Proprietary Information Rev: 00


4

Purpose of PPAP


Provide evidence that all customer engineering design record and specification requirements are properly understood by the organization.

To demonstrate that the manufacturing process has the potential to produce product that consistently meets ALL requirements during an actual production run at the quoted production rate.

PPAP manages change and ensures product conformance!


5

Watts Required Notification of Changesfor PPAP Consideration:

Change of other construction or material than was previously approved.

Production from new or modified tools , dies, molds, patterns, etc. including additional or replacement tooling. (except perishables).

Change in part processing (upgrade or rearrangement of tooling).

Production from tooling and equipment transferred to different plant site or from an additional plant location.

Change of suppliers for parts, or material source changes or services.

Tooling inactive greater than one year.

Product & Process changes related to components of the production product manufactured internally or manufactured by suppliers. e.g. (form, fit, function, performance, durability).

Changes in test/inspection methods – equivalent and (no affect on acceptance criteria).

Bulk materials – new source of raw materials from new or existing supplier.

Bulk materials - Change in product appearance attributes.

New part or product, or color not previously supplied.

Correction of discrepancy on previously submitted parts.

Engineering change to design records specifications or materials for production product/part numbers.

New process technology new to the organization not previously used for the product (bulk material).


Supplier notification to Watts is required for any planned changes to the design, process or site.


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Benefits of PPAP Submissions

• Helps to maintain design integrity

• Identifies issues early for resolution

• Reduces warranty charges and prevents cost of poor quality

• Assists with managing supplier changes

• Prevents use of unapproved and nonconforming parts

• Identifies suppliers that need more development

• Improves the overall quality of the product & customer satisfaction



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Production Run

PPAP data must be submitted from a production run using:

Production equipment and tooling Production employees Production rate Production process


All data reflects the actual production process to be used at start-up!


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Production Run Rate

• The purpose of a Production Run Rate is to verify the supplier’s manufacturing process is capable of producing components that meet Watts quality requirements, at quoted tooling capacity, for a specified period of time.

• Verification of the Run Rate will be at the Supplier Quality Engineer’s (SQE) discretion. The supplier will be notified of the need to perform a Run Rate as early in the process as possible.

• The number of components to be produced during the Run Rate should be sufficient to demonstrate process capability and will be predetermined by the SQE and the supplier. Factors such as product complexity, shelf life, storage, cost

and single shift vs. multiple shift operations will be taken into consideration.



9

Official PPAP Requirements

1. Design Records (Necessary part drawings, specification used to produce the product).

2. Authorized Engineering Change Documents

3. Customer Engineering Approval, (if required)

4. Design Failure Modes and Effects Analysis (DFMEA) applied in special situations

5. Process Flow Diagram

6. Process Failure Modes and Effects Analysis (PFMEA)

7. Control Plan

8. Measurement Systems Analysis (MSA) – [Gage R & R]

9. Dimensional Results

10. Records of Material / Performance Test Results

11. Initial Process Studies

12. Qualified Laboratory Documentation

13. Appearance Approval Report

14. Sample Production Parts

15. Master Sample (Master Part Retained on Site)

16. Checking Aids

17. Customer-Specific Requirements

18. Part Submission Warrant (PSW)



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Watts PPAP Requirements


1. Design Records * 2. Authorized Engineering Change Documents3. Team Feasibility Commitment (HQMS)4. Customer Engineering Approval, (if required)5. PPAP Report (Watts Requirements Checklist)6. Design Failure Modes and Effects Analysis (DFMEA) applied in special

situations*7. Process Flow Diagram8. Process Failure Modes and Effects Analysis (PFMEA)9. Control Plan10. Measurement Systems Analysis (MSA)11. Dimensional Results (HQMS)12. Records of Material / Performance Test Results (HQMS)13. Initial Process Studies*14. Qualified Laboratory Documentation15. Appearance Approval Report (HQMS)16. Sample Production Parts17. Master Sample*18. Checking aids (drawings)*19. Watts -Specific Requirements*20. Part Submission Warrant (PSW) – “Production Warrant21. Packaging Requirements

Supplier shall retain these *6 items at

appropriate locations, and make readily

available upon request.


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PPAP Submission Levels

Level 1 Production Warrant and Appearance Approval Report

(if applicable) submitted to Watts.

Level 2 Production Warrant, product samples and dimensional results submitted to Watts.

Level 3 Production Warrant, product samples and complete supporting data submitted to Watts.

Level 4 Production Warrant, and other requirements as defined by Watts.

Level 5 Production Warrant, product samples and complete supporting data (review will be at the organizations location).



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PPAP Submission Level Table


* = Supplier shall retain at appropriate

locations, and submit to Watts upon request.

Watts will identify what is needed for submission.

R = Supplier shall retain at appropriate locations and make readily available to Watts upon request.


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Definitions of Risk

High Risk

Parts associated with multiple critical features, complex design, or high end technology that is not yet established in the general manufacturing environment.

Supplier’s quality system and/or quality performance is not to Watt’s satisfaction.

Medium Risk

Parts that have at least one critical feature.

Low Risk

Parts that have no critical features and can be manufactured by any manufacturer in the commodity category.

Supplier’s quality system and quality performance are acceptable.



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Submission Level Requirements

New Parts Level 3 is required for all New Part Numbers.

Part Changes Level 3 is required for Parts produced at a new or additional

locations and is the default level for Watts products. Review PPAP 4th edition requirements for further defined details

for notification of changes and PPAP requirements.


Watts reserves the right to redefine the submission level required.


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PPAP Status

Approved

The part meets all Watts requirements. Supplier is authorized to ship production quantities of the part.

Deviation

Permits shipment of part on a limited time or piece quantity basis under deviation.

Rejected

The part does not meet Watts requirements, based on the production lot from which it was taken and/or accompanying documentation.


Production quantities may not be shipped before Watts Approval


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Electronic Submission Requirements

Watts requests that all PPAPs be submitted electronically via Watts HQMS. (Harrington Quality Management System).

Use of paper submission must have prior approval by the Watts.

Submission must be received on or prior to the PPAP due date.

Review and Approval Process: Watts will review and provide feedback within 10 business days.



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Watt’s PPAP Documents

What are Watt’s PPAP Documents? An Excel spreadsheet containing labels & templates of the documents

suppliers are required to submit to Watts. These PPAP documents can be found on our supplier website: www.wattswater.com/Suppliers

Why use the Watt’s PPAP Documents? Simplifies the process for suppliers by serving as a “checklist” of

what needs to be submitted to Watts. Reduces the number of files to manage. Enables the engineer or commodity manager to quickly see if

anything is missing.



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Part Submission Warrant



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Part Submission Warrant (PSW)


What is it?• Documents required for all newly tooled

or revised products in which the supplier confirms that inspections and tests on production parts show conformance to Watts requirements.

• Used to:Document part approvalProvide key informationDeclare that the parts meet specification.

Objective or purpose

When to use it• Prior to shipping production parts.


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Part Submission Warrant (PSW)

Supplier’s Checklist

Must be completely filled out

Must be signed by the supplier

P/N must match the PO

Submitted at the correct revision level

Submitted at the correct submission level

Specify the reason for submission



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Authorized Engineering Change Documents



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Authorized Engineering Change Notice

The supplier shall provide authorized change documents as required below but not limited to that affects the PPAP:

Specifications

Deviations

MA–Manufacturing Alerts/ECN (must be approved, not pending)

Feasibility studies (Team Feasibility Commitment next page)

Supplier change requests

Sub-assembly drawings

Life or reliability testing requirements



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Team Feasibility Commitment


What is it?• Review required for all new or revised

product, tooling etc. in which the supplier confirms that processes, controls, specifications, tests, equipment and costs on production parts meet Watts requirements.

• Used to:Identify controls are in place and being met.Declare that the parts meet specifications and requirements.


When to use it• Prior to shipping production parts.

Attention: Watts Water Technologies

Supplier Name

供应商名称:

Part / Item Number

生产件 /项目号:

Dwg. Revision Level

图纸修订级别:Part Name / Desc.

生产件名称 /描述:

Our product quality planning team has considered the following questions, not intended to be all-inclusive, in performing a feasibility evaluation. The drawings and / or specifications provided have been used as a basis for analyzing the abilityto meet all specified requirements. All "no" answers are supported with attached comments identifying our concernsand / or proposed changes to enable us to meet the specified requirements.

我们的产品质量规划团队已经在进行可行性评估的过程中考虑了如下问题（但无意囊括一切问题）。所提供的图纸和 /或详细说明书均已用来作为分析是否能够满足一切明确规定要求的依据。凡是答案为“否”的问题均附有说明，以表示我们的忧虑和 /或为了使我们能够满足明确规定的要求而建议进行的更改。

Yes No N/A(不适用)

Conclusion:Feasible.可行 Product can be produced as specified with no revisions. 产品可以按照明确规定的要求（无须修订）生产。Feasible.可行 Changes recommended (see attached). 建议进行更改（参见随附文件）。Not Feasible不可行 . Design review required to produce product within the specified requirements. 要求进行设计复查以便在明确规定的要求范围之内生产产品。

Sign-Off签字同意：:

Team Member / Title / Date团队成员/职衔/ 日期 Team Member / Title / Date团队成员/职衔/ 日期



Where statistical process control is used on similar products:

在哪里对类似的产品使用了统计过程控制？

Watts Form Number 沃茨表格编号: WW-PPAP-112

Are the processes in control and stable?

这些过程是否在控制范围内而且稳定？

Can Engineering Performance Specifications be met as written?

能否满足所写的工程性能技术要求？

Can the product be manufactured without incurring any unusual:

制造该产品是否能够不招致如下的任何异常情况的发生？

Form Revision Date

表格修订日期:3/20/2014

Are Cpk's greater than 1.67?

这些过程是否在控制范围内而且稳定？

Has Watts supplied samples?

沃茨公司是否已经提供了样品？

If sample is available, does it meet Engineering specification and print?

如果有样品可供使用，则它是否符合工程技术规格与打印材料？

Can product be manufactured to tolerances specified on drawings?

产品是否能够按照图纸上明确规定的公差制造？

Is statistical process control required on product?

是否要求对产品进行统计过程控制？

Is statistical process control presently used on similar products?

目前是否对类似的产品使用了统计过程控制？

TEAM FEASIBILITY COMMITMENT (小组可行性承诺书)

Cost for capital equipment?

资本设备的成本？

Cost for tooling?

工装的成本？

Alternative manufacturing methods?

替代制造方法？

Considerations(考虑因素)

Is product adequately defined (application requirements, etc.) to enable feasibility evaluation?

是否对产品作了充分的规定（应用要求等）以便能够进行可行性评估？

Can product be manufactured with Cpk's that meet requirements?

产品是否能够以符合要求的cpk制造？

Is there adequate capacity to produce product?

是否有足够的产能生产产品？


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Process Flow Diagram



25

Process Flow Diagram


What is it?• A visual diagram of the entire

process from receiving through shipping, including outside processes and services.

To help people “see” the real process. Process maps can be used to understand the following characteristics of a process:• Set-by-step process linkage• Offline activities (measurement, inspection, handling)• Rework, scrap.


When to use it• To understand how a process

flows.• Prior to completing the PFMEA.


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Process Flow Diagrams


Date:

ECL:

Prepared By:

STEP

Fa

bric

atio

n

Mov

e

Sto

re

Insp

ect

Operation

Description Item

#

Item

#Control Methods

1

2

3

4

5

6

7

8

9

10

11

12

PROCESS FLOW DIAGRAM

Part Description:

Part Number:

Product and

Process

Characteristics The process flow example diagram utilizes symbols to

clearly identify each step in the process.


27

Process Flow Diagram Example


:800-3253535 : :

: : :

Deburring & Cleaning

Despatch

Incoming Inspection

- INSPECTION - PROCESS- SUPPLIER END OPERATION

CNC Sliding Machining

Final Inspection

APPROVED BY & DATE Rose 12-09-87

Pre delivery Inspection

PREPARED BY & DATE Rbru 10-11-87

Oiling, Packing & Preservation

Pre shipment audit

- PATROL INSPECTION

Layout Inspection

- MOVEMENT - STORAGE

PROCESS FLOW DIAGRAM

Rev. No. / Date 1 of 1 Rev A 10-11-89Part Name : Page Sample part

xyz12364Part No. Customer Name Horton Doc. No.

**RM receiving Insp. report

Inspection per AAB

If Rejected

Return to supplier

** Inspection as per Operation layout

Not ok , Rejected

If rework possible Rework

Scrap

100% Re-inspection

Next operation

Not ok Ok

Note : Tags to be provided for OK, Rework, Inspection

& Rejection

05 10

3040

Pre shipment audit report

60

Self Inspection Report

Layout Inspection Report

5070

20

Final Inspection register

Patrol Insp. report

Not ok , Rejected

15


28

Process Flow Diagrams

Suppliers Checklist

Process Flow must identify each step in the process.

Should include abnormal handling processes.

• Scrap

• Rework

Process Flow must include all phases of the process.

• Receiving of raw material

• Part manufacturing

• Offline inspections and checks

• Assembly

• Shipping



29

Process FMEA



30

Process FMEA ( PFMEA)


What is it?• A tool used to identify and

prioritize risk areas and their mitigation plans.

Objective or purpose• Identifies potential failure modes,

causes, and effects. Inputs come from the process flow diagram.

• Identifies key inputs which positively or negatively affect quality, reliability and safety of a product or process. A proactive approach used to manage risk.

When to use it• After completion of the process

flow diagram.• Prior to tooling for production.

FMEA No. (FMEA 编号):

Prepared By 编制人:

Page 第页Of 共页

Action Taken

采取的措施

Sev.严重度

Occ.频度

Det.

探测度

RPN

风险顺序系数

WW-PPAP-102

3/20/2014

PROCESS FMEA (潜在失效模式及后果分析/过程FMEA)

Action Results 措施结果

Part/Item Number

零件号/项目号:

Part Name 零件名称:

Analysis Team

分析团队:

Process Resp.过程责任:

Date(Orig.)

日期(编制):Drawing Rev.图纸版本:

Date (Rev.)

日期(修订):

Process Functions / Requirements

过程功能 /要求

Potential Failure Mode

潜在失效模式

Potential Effect(s) of Failure

潜在失效后果

Sev.

严重度(S)Recommended Action建议措施

Responsibility & Target

Completion Date

责任及目标完成日期

Class

级别

Occur.

频度(O)

Current Process Controls

现行过程控制(探测)


现行过程控制(预防)

Potential Causes(s) /

Mechanism(s) of Failure

潜在失效起因 /机理

Watts Form Number (沃茨公司表格号):

Form Revision Date (表格修订日期):

Process Stages

工序

Line Number

行号

Detect

探测度(D)RPN

风险顺序数


31

PFMEA Example Steps 1and 2


Spray head clogged: - Viscosity too high- Temp too low- Pressure too low

5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads

5 175

Detect

R.P.N

.

Class

Potential Cause(s)/


Occur


Process StepPotential Failure

Mode

Potential Effect(s) of

Failure

Sev

280Allows integrity breach of inner

door panel

Corroded interior lower door

panels

Deteriorated life of door leading

to: - Unsatisfactory appearance due to rust through paint over time

- Impaired function of

interior door hardware

Insufficient wax coverage over

specified surface

Op 70: Manual application of

wax inside door panel

7 Manually inserted spray

head not inserter far

enough

Variables check for film

thickness; Visual check for coverage

58

1. There should be at least one potential failure mode for each process step.2. There should be at least one failure effects for each potential failure mode.

Effects should be specific, clear, and leave no doubt to the uninformed reviewer.

1 2


32

PFMEA Example Steps 3 and 4




5 175

De

tec

R.P

.N.

Cla

ss

Potential Cause(s)/


Occu

r



Mode


Failure

Se

v


door panel


panels






specified surface





enough



58

3. There should be at least one potential cause for each failure mode.4. This step in the FMEA begins to identify initial shortcomings or gaps in the current control plan. If a procedure exists, enter the document number. If no current control exists, leave block as a “NONE.”

3 4


33

PFMEA Step 5




5 175

De

tec

R.P

.N.

Cla

ss

Potential Cause(s)/


Occu

r



Mode


Failure

Se

v


door panel


panels






specified surface





enough



58

Assign Severity, Occurrence, and Detection ratings

5. Severity, Occurrence and Detection rating details on next slide.

5 55


34

PFMEA - Definition of Terms


Severity (of Effect) - Severity of the effect on the customer and other stakeholders (Higher Value = Higher Severity).

Occurence (of Cause) - Frequency with which a given failure occurs and creates failure mode (Higher Value = Higher Probability of Occurrence).

Detection (Capability of Current Controls) - Ability of current control scheme to detect the cause before creating the failure mode and/or the failure mode before suffering the effect. (Higher Value = Lower Ability to Detect).

Notice the scale difference for Detection on the next page.



An Example of Rating Definitions

Rating

High 10

Low 1

*If No Controls Exist, Detection = 10

Create a rating system that makes sense for the defects you are trying to prevent.


36

PFMEA - Step 6




5 175

De

tec

R.P

.N.

Cla

ss

Potential Cause(s)/


Occu

r



Mode


Failure

Se

v


door panel


panels






specified surface





enough



58

6. The RPN is used to prioritize the most critical risks identified in the first half of the FMEA.

High RPNs are flags to take efforts to reduce the calculated risk.

Regardless of RPN, high severity scores (9 or 10) should be given special attention.

Calculate the Risk Priority Number (RPN)RPN = Severity x Occurrence x Detection

6


37

Analyzing the PFMEA


Sort by RPN to determinethe most significant failure modes

Once the RPN numbers are determined, they can be used to prioritize the most significant failure modes.

Sort the FMEA by the RPN numbers. Graphical and statistical tools can help the team select a “cut-off” RPN for the next steps.

Others490

150 75 9350 70 50 25 30250

300 15

3 2 2 2 2 4 4 4 4 6 8 910

5 3 3 3 3 7 7 7 710131517

100 95 92 88 85 82 75 68 62 55 45 32 17

60

50

40

30

20

10

0

100

80

60

40

20

0

Defect

CountPercentCum %

Per

cent

Co

unt

Pareto Chart for RPN

RPN ThresholdsWhen using an RPN threshold, DO NOT forget to address high scores.


38

PFMEA – Remediation Guidelines


Severity – Can only be improved by a design change to the product or process.

Occurrence – Can only be reduced by a change which removes or controls a cause. Examples are redundancy, substituting a more reliable component or function or mistake-proofing.

Detection – Can be reduced by improving detection. Examples are mistake-proofing, simplification and statistically sound monitoring.


39

PFMEA – Step 7


Determine Actions Recommended to reduce High RPNs

Actions Taken

Sev

Occ

Det

R.P

.N.

Add positive depth stop to sprayer

Mfg. Eng. By 5/10/10

Stop added, sprayer checked on-line

Automate spraying


Rejected due to complexity of different doors on the same line

175 Use DOE on viscosity vs. temp vs. pressure


Temp and press limits were determined and limit controls have been installed - Control charts show process is in control Cpk = 1.85

7 1 5 35

Action Results

R.P

.N.

Recommended Actions

Responsibility & Target Date


Mode


Failure


door panel


panels






specified surface



7 2 5 70

7. The higher RPN’s need to be reviewed for determined actions.

7


40

Actions TakenS

ev

Occ

De

t

R.P

.N.

Add positive depth stop to sprayer


Stop added, sprayer checked on-line

Automate spraying


Rejected due to complexity of different doors on the same line

175 Use DOE on viscosity vs. temp vs. pressure


Temp and press limits were determined and limit controls have been installed - Control charts show process is in control Cpk = 1.85

7 1 5 35

Action Results

R.P

.N.

Recommended Actions

Responsibility & Target Date


Mode


Failure


door panel


panels






specified surface



7 2 5 70

FMEA – Steps 8,9 and 10


89

8. Responsibility - Assign a specific person who will be responsible for the recommended actions.

9. As actions are completed, document it in the Actions Completed column.

SEV, OCC, DET, RPN – As actions are complete reassess the Severity, Occurrence and Detection and recalculate RPN. Continue RPNs until all risks (are below 100).

Now recalculate your RPNs based on mitigation plans.



Summary Steps To Complete a FMEA1. For each process input, determine the ways in which the process

step can potentially fail. These are (failure modes).2. For each failure mode associated with the inputs, determine effects

on the outputs.3. Identify the potential causes of each failure mode.4. List the current ccontrols for each cause.5. Assign severity, occurrence and detection ratings after creating a

ratings key appropriate for your project.6. Calculate RPN.7. Determine the recommended actions to reduce High RPNs.8. Take appropriate actions and ddocument the issue.9. Recalculate RPNs.10. Revisit steps 7 and 8 until all the significant RPNs have been

addressed.A FMEA is living document that must be reviewed

and updated as processes changeA FMEA is living document that must be reviewed

and updated as processes change


42

Control Plan



43

Control Plan


What is it?

Objective or purpose• Primary reference source for

minimizing process and product variation.

• Description of how teams should react to out-of-control situations.

When to use It

• Implementation of new process.• Following a process change.

A control plan is considered a living document as processes are expected to be continuously updated and improved.

• A document that describes how to control the critical inputs to continue to meet Watts expectations of the new output.


44

Control Plan


Process StepsProcess Steps

New/Revised Process Steps

New/Revised Process Steps

New/Revised

Process Steps

New/Revised

Process Steps

Process Steps

Process StepsRis

k Prio

ritize

d

Proce

ss S

teps

Risk P

riorit

ized

Proce

ss S

teps

Impro

ved

Contr

ols

Impro

ved

Contr

ols

Control Plan

Process FMEAProcess Flow chart

Interaction of Tools


45

Control Plan


A Control Plan addresses the areas below:

Three Distinct Phases – prototype, pre-launch and production.

Administrative section – Identifies part numbers and descriptions, supplier, required approvals, signature and dates.

Part/Process requirements, characteristics of product or process, machine /tools that are used in the manufacturing process.

Specifications/tolerances, measurement technique, sample size and frequency.

Control methods, and reaction plans.


46

Control Plan


Suppliers Checklist

Use process flow diagram and PFMEA to build the control plan; keep them aligned.

Controls must be used to be effective. Keep it simple.

Ensure that the control plan is in the document control system of the business.

Good control plans address:

All testing requirements - dimensional, material, and performance.

All product and process characteristics at every step throughout the process.

The control method should be based on an effective analysis of the process.

Such as SPC, Inspection, Sampling Plan.

Control plans should reference other documentation.

Specifications, tooling, etc.


47

Measurement System Analysis (MSA)



48



An MSA is a statistical tool used to determine if a measurement system is capable of precise measurement.

What is it?

When to use itOn the critical inputs and outputs prior to collecting data for analysis.• For any new or modified process in

order to ensure the quality of the data.

Who should be involved

• Everyone that measures and makes decisions about these measurements should be involved in the MSA.

Objective or purpose• To determine how much error is in

the measurement due to the measurement process itself.

• Quantifies the variability added by the measurement system.

• Applicable to attribute data and variable data.

Measurement System Analysis is an analysis of the process, not an analysis of the people!

IMPORTANT!


49

Types of Data -Attribute and Variable MSA


Attribute Data Examples:

Count, pass/fail, yes/no, red/green/yellow, timekeeping buckets

Variable Data Examples:

Physical measurement (length, width, area, …)

Physical conditions (temperature, pressure…)

Physical properties (strength, load, strain…)

Continuous or non-ending

Unless approved by Watts attribute data is not acceptable for PPAP submission

Unless approved by Watts attribute data is not acceptable for PPAP submission


50



The observed variation in process output measurements is not simply the variation in the process itself; it is the variation in the process plus the variation in measurement that results from an inadequate measurement system.


51



Observed Variation

The output of the process measured by:

• Cycle time• Dimensional data• Number of defects and others


52



Process VariationProcess Variation Calibration addresses accuracy


53



Process VariationProcess Variation

Accuracy(Central Location)

LinearityLinearity

Bias

Stability

Let’s take a closer look at Precision


54



Error in ResolutionThe inability to detect small changes.

Possible Cause Wrong measurement device selected - divisions on scale not fine enough to detect changes.

Resolution


55



Equipment Variation

Error in RepeatabilityThe inability to get the same answer from repeated measurements made of the same item under absolutely identical conditions.

Possible Cause Lack of standard operating procedures (SOP), lack of training, measuring system variability.


56



Error in ReproducibilityThe inability to get the same answer from repeated measurements made under various conditions from different inspectors.

Possible Cause Lack of SOP, lack of training.

Reproducibility

Appraiser Variation


57

Variable MSA – Gage R&R Study


• Gage R&R is the combined estimate of measurement system Repeatability and Reproducibility.

• Typically, a 3-person study is performed Each person randomly measures 10 marked parts

per trial. Each person can perform up to 3 trials.

• There are 3 key indicators: EV or Equipment Variation AV or Appraiser Variation Overall % GRR


58

Variable MSA – Example Gage R&R Form


Suppliers shall use their own Gage R & R forms to address the requirements for Measurement System Analysis (MSA).


59

Variable MSA – Gage R&R Steps


Step 1 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Step 10Step 2

1. Select 10 items that represent the full range of long-term process variation.

2. Identify the appraisers.

3. If appropriate, calibrate the gage or verify that the last calibration date is valid

4. Have your Gage R & R form available to record data.

5. Have each appraiser assess each part 3 times (trials – first in order, second in reverse order, third random).

6. Input data into the Gage R&R worksheet.

7. Enter the number of operators, trials, samples and specification limits

8. Analyze data in the Gage R&R worksheet.

9. Assess MSA trust level. ( > 30% fail) (10-30% marginal) ( <10% pass)

10. Take actions for improvement if necessary.


60

Tips and Lessons Learned


Important: An MSA is an analysis of the process, not an analysis of the people. If an MSA fails, the process failed.

A Variable MSA provides more analysis capability than an Attribute MSA. For this and other reasons, always use variable data if possible.

The involvement of people is the key to success.

Involve the people that actually work the processInvolve the supervisionInvolve the suppliers and customers of the process

An MSA primarily addresses precision with limited accuracy information.


61

MSA Review

Supplier’s Checklist


If the gage/inspection affects quality and used for product acceptance, then conduct a Gage R&R.

Make sure the study is recent - less than 1 year.

Compare the control plan gages against the Gage R&Rs.

If you question that gage, then;Question the technique and part sampling.Ask for additional studies.


62

Dimensional Results



63

Dimensional Results


What is it?

Objective or purpose• To show conformance to the

customer part print on dimensions and all other noted requirements.

When to use it

• For each unique manufacturing process (e.g., cells or production lines and all molds, patterns, or dies.

• Evidence that dimensional verifications have been completed and results indicate compliance with specified requirements.

Item

项目号

Test Date

测试日期

QtyTested

测试数量

Measurement Method

测量方法

OK

合格

Not OK

不合格

DIMENSIONAL TEST / RESULTS (尺寸报告)

WW-PPAP-104

Inspection Facility 检验机构:

Supplier/Vendor Code供应商/卖主代码:

Part Name / Desc.

零件名称/描述:

Sample Date Code/Lot Number 样品日期代码/批号:

Supplier to Watts

沃茨直接供应商:

Draw ing Revision 图纸版本:

Engineering Change Documents

工程更改文件:

Part / Item Number


DATE 日期：

Dimension/Specif ication 尺寸/规格

TITLE 职衔：


Form Revision Date (表格修订日期): 3/20/2014

Specif ication / Limits

规格/限制

Supplier Measurement Results (Data)

供应商测量结果(数据)

SIGNATURE 签字：

Blanket statements of conformance are unacceptable for any test results.

笼统地说“合格”,对于任何测试结果来说都是不可接受的。


64

Dimensional Requirements

The Supplier shall provide the number of sample parts as specified on the PPAP. The specific sample size will be determined based on factors such as component size, complexity, projected volume, etc.

Take or make samples from actual production tooling and /or processes unless otherwise approved in writing. Where multiple production molds, cavities, dies, machines, etc., are utilized, samples are required from each. For any questions consult Watts for data requirements.

Complete a Dimensional report for five parts. The dimensional report is a comprehensive inspection report of the part being qualified. It is considered a full part layout and must accompany all samples submitted. It includes measurement and verification of all dimensions, drawing notes, engineering specifications and quality standards. This is sometimes referred to as a First Article Inspection (FAI).

Actual variable data must be provided in terms of measurements, not attribute (pass / fail; go / no go; etc.) data. All results must be traceable to the specific samples from which obtained.

The sample parts must be shipped with a copy of the dimensional report work sheet. These parts when shipped need to be identified as PPAP samples using the Watts PPAP sample label that can be obtained on the Watts supplier website. www.wattswater.com/Suppliers from the (PPAP) link.



65

Dimensional Checklist


A Watts determined quantity of parts are required for part qualification. These initial production parts must be identified when shipped for the first time.

Five of these parts must be shipped to Watts for verification of form, fit, and function and properly labeled.

The same five parts will be used to verify both critical and non-critical dimensions.

Supplier must clearly identify the production sample parts that are being shipped with Watts PPAP sample label.

Supplier should make every effort to ship five parts that represent both the low and high ends of the specifications for dimensions.



Records of Material / Performance Test

Results


67

Records of Material Test Results


Test Date

测试日期

Qty. Tested

测试数量

OK

合格Not OK

不合格

Purchase Order

订单号EDP Number EDP号:

Form Revision Date (表格修订日期): 3/20/2014




SIGNATURE 签字: TITLE 职衔: DATE 日期: WW-PPAP-105

Material Specif ication /Chemicals Comp/Physical

材料规格/化学成分/物理特性

Specif ication Limits

规格/限制Test Results

测试结果

MATERIAL TEST RESULTS (材料试验报告)

Draw ing Revision 图纸版本:

Engineering Change Documents

工程更改文件:

Material Supplier

原材料供应商:

Supplier to Watts 沃茨直接供应商:

Supplier/Vendor Code

供应商/卖主代码:

Part / Item Number


Part Name / Desc.

零件名称/描述:

*Customer Specified Supplier/Vendor Code

客户指定的供应商/卖主代码:

Name of Laboratory 实验室名称:

Lot/Batch ID 批号:

*If source approval is req'd, include the Supplier (Source) & Customer assigned

code.如果要求审批供应商货源，则包括供应商（货源）与客户指定代码

Records of Material Test Results

Material Test Results• The supplier shall perform tests for

all parts and product materials when chemical, physical, or metallurgical requirements are specified by the design record or control plan and list the tests performed on the form.

• The supplier shall have records of material test results for the correct raw material/grade as specified on the design record or control plan.

Material Specification /Chemicals

Comp/Physical 材料规格 /化学成分 /物理

特性

Specification Limits 规格 /限制

Test Date测试日期

Qty. Tested 测试数量

Test Results 测试结果

OK 合格

Not OK 不合格

DOW CONTINUUM DGDA-2490 BK

1/1/12 1 provided material cert x

Example


68

Records of Performance Test Results


Test Date

测试日期Qty. Tested

测试数量OK

合格Not OK

不合格

Name of Laboratory

实验室名称:

Test Specif ication / Rev / Date

测试规格/版本/日期

Specif ication / Limits

规格/限制

*Customer Specified Supplier/Vendor Code

*客户指定的供应商/卖主代码:

Supplier to Watts

沃茨直接供应商:

PERFORMANCE TEST RESULTS (性能试验报告)Part / Item Number零件号/项目号:

Supplier Code

供应商代码:Part Name / Desc.零件名称/描述:

Supplier Test Results (Data) / Test Conditions

供应商测试结果(数据)/测试条件

*If source approval is req'd, include the Supplier (Source) & Customer assigned

code.如果要求审批供应商货源，则包括供应商（货源）与客户指定代码

3/20/2014

Watts Form Number (沃茨表格编号):

SIGNATURE 签字: TITLE 职衔: DATE 日期: WW-PPAP-106

Form Revision Date: (表格修订日期):



Draw ing Revision

图纸版本:

Engineering Change Documents 工程更改文件:

Records of Performance Test Results

Performance Test Results

• The supplier shall have records of performance test results for tests specified by the design record or control plan.

• The supplier shall perform tests for all part(s) or product material(s) when performance or functional requirements are specified by the design record or control plan.

Test Specification / Rev / Date 测试规格 /版本 /日期

Specification / Limits

规格 /限制

Test Date测试日期

Qty. Tested测试数量

Supplier Test Results (Data) / Test Conditions 供应商测试结果 (数据 )/测试

条件

OK 合格

Not OK 不合格

temp 10C to 85C 10c 85c 4/2/14 1 Test report provided x

Example


69

Material/ Performance Review


Reviewers Checklist

For products with Watts-developed material specifications and or an Watts-approved supplier list, the supplier shall procure materials and or services from suppliers on that list.

Supplier shall address all areas on the Watts form(s) to meet the PPAP requirements for both Material and Performance requirements.



Initial Process Study




S = Supplier shall submit to Watts a copy of the records or documented items at appropriate locations.


72



What is it?• A set of tools used to understand

process capability.

Objective or purpose• To evaluate the performance of

your process as compared to specification limits.

• To determine if the production process is likely to produce product that will meet customer requirements.

When to use it• To establish base line capability.• To validate process improvements.


73

Steps for Determining Process Capability


1. Decide on the product or process characteristic to be assessed (required or all critical characteristics).

2. Validate the specification limits ( through customers, suppliers, controlling agencies).

3. Validate the measurement system through appropriate (MSA).

4. Collect data

Short term data:

»Free of special causes

»Collected across a narrow inference space i.e. one shift, one machine, one operator, etc..

Long term data:

»Subjected to the effects of both random and special cause variation.

»Collected across a broad inference space i.e. multiple shifts, machines, operators, etc.

Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7


74

Steps for Determining Process Capability


Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7

5. Assess Data characteristics - Is it what you would expect? If not, investigate.

6. *Assess Process stability - Assess process stability in order to understand how your process behaves over time. Control charts are the recommended tool.

7. Calculate process capability - Calculate the appropriate statistical metrics in order to determine how the “Voice of the Process” compares to the “Voice of the Customer.”

Example: Capability Metrics: PPM, DPMO, Cp, Cpk, Pp, & Ppk ; Sigma Levels (Z

Scores)

*Capability is only valid when the process being studied is stable!


75

Focus on Variable Data


The initial process study should be focused on variable, not attribute data.Assembly errors, test failures, and surface defects are examples of attribute data, which is important to understand, but is not covered in this initial study.

To understand the performance of characteristics monitored by attribute data will require more data collected over time.Unless approved by an authorized Watts representative, attribute data are not acceptable for PPAP submission.

Focus on variable data


76

Capability Indices – Cpk & Ppk


Cpk predicts capability: Based on short term within subgroup variation. Does not include the effect of process variability between subgroups.

Cpk should be used when: Developing new parts. Revising specifications on a part. Materials, processes, manufacturing location, or equipment have significantly

changed. Material suppliers have changed (include certificate of analysis).

Ppk indicates past performance: Based on long term total variation. Unlike Cpk, Ppk is not limited to variation within subgroups. However, Ppk cannot isolate within subgroup variation from between subgroup variation. When calculated from the same data set, Cpk and Ppk can be compared to analyze the sources of process variation.

Ppk should be used when: The supplier is new to Watts, but has already been manufacturing a part. The supplier is existing, but has produced a number of nonconforming parts.


77

Acceptance Criteria


Capability acceptance criteria for characteristics

For Watts products based on short term capability a 1.33 Cpk or greater is required and for Ppk a 1.67 or greater is required.

For Long Term capability for Watts products the Cpk must be 1.33 or greater for key characteristics.

Suppliers shall ensure that the results are acceptable, and that the process is stable and capable of producing a quality part to watts Requirements.



Qualified Laboratory Documentation


79

Qualified Laboratory Documentation


•Inspection and testing for PPAP shall be performed by a qualified laboratory as defined by Watts requirements (e.g., an accredited laboratory). •The qualified laboratory (internal or external to the supplier) shall have a laboratory scope and documentation showing that the laboratory is qualified for the type of measurements or tests conducted.

When an external laboratory is used, the supplier shall submit the test results on the laboratory letterhead or the normal laboratory report format.

The name of the laboratory that performed the tests, the date(s) of the tests, and the standards used to run the tests shall be identified.



Appearance Approval Report


81

Appearance Approval Report


Application 应用:

PART SUBMISSION WARRANT生产件提交保证表 SPECIAL SAMPLE特殊样品 RE-SUBMISSION重新提交

PRE TEXTURE纹饰预处理 FIRST PRODUCTION SHIPMENT首批产品发运 ENGINEERING CHANGE工程更改

RED红 YEL黄 GRN绿 BLU兰 LIGHT浅 DARK深 GRAY灰暗 CLEAN明亮 HIGH高 LOW低 HIGH高 LOW低

(Product Name 产品名称)

COMMENTS

说明

PHONE NUMBER

照片编号EMAIL

电子邮箱

Paint 油漆

Draw ing Revision

图纸版本:

Buyer Code

买方代码:

E/C Level

本次提交的工程更改等级:

Date

日期:

Chroma

色度

Correct & Resubmit

纠正并重新提交

Approved to Texture

对纹理加工签批

Part Dispositon

零件处理状况

DATE 日期

Metallic Brilliance

金属光泽度

Material Type

材料类型

Watts Form Number Form Revision Date WW-PPAP-107 3/20/2014

AUTHORIZED CUSTOMER REPRESENTATIVE SIGNATURE

客户全权代表签字

Grain 粒度

Plating

电镀

Hue 色调

Material Source(MFG)

材料来源(制造)

Coating 涂层

Color 颜色

APPEARANCE APPROVAL REPORT (外观批准报告)

Watts Part /Item Number

沃茨l零件号/项目号:

Watts Supplier Sourcing & Texture Information 沃茨供应商来源与纹理加工信息

APPEARANCE EVALUATION 外观评价

Reason for Submission 提交理由:

Watts Part Name/Desc.

沃茨零件名称/描述:

Manufacturing Location

制造场所:

Supplier Code

供应商代码:Supplier Name

供应商名称:

Correct & Proceed

纠正并继续进行

Other 其他:

Authorized Customer Representative Signature & Date

客户全权代表签字与日期

Pre-Texture Evaluation

预处理表面评估

Gloss 光泽

FINISH/COLOR EVALUATION 整饰/颜色评价

Value 色值

SUPPLIER SIGNATURE/DATE

供应商签字/日期

When to use it• Prior to tooling for production.

What is it?• A report completed by the supplier

concerning areas such as paint, plating, appearance, color, grain etc.. that have criteria for these areas.

• To demonstrate that the part has met the appearance requirements on the design record.

Typically applies for parts with color, grain,

or surface appearance requirements.

IMPORTANT!




PPAP Sample Productions Parts


83

PPAP Sample Production Parts


What is it?

Objective or purpose• Confirm dimensional, cosmetic or

functional part approval.

When to use it

• Sample parts should be delivered with the PPAP submission.

• Actual samples that reflect the parts documented in the PPAP.


84



• The sample parts provided shall be the same parts measured for the dimensional results.

• Where multiple production molds, cavities, dies, machines, etc., are utilized, samples are required from each.

• Default quantity for all submissions is 5 parts unless otherwise requested.


85


PPAP sample production parts MUST be properly identified.

At a minimum the following information is required on the PPAP sample label:

• Part/Item number

• Engineering Change level

• Part Name

• Supplier Name

• Supplier Code

• Quantity


See Watts sample part label on the next slide.


86

PPAP Samples Label


1

2

3

4

5

6

Supplier Name

供应商名称：:

Quantity

数量:

Quantity 数量：

Supplier Name for the product in approval.已批准产品的供应商名称.

Supplier Code assigned by Watts (see Purchase Order). 沃茨指定的供应商代码（见采购定单）.

Supplier Code 供应商代码：

Supplier Code

供应商代码:

PPAP SAMPLES Label (PPAP样品标签)

PPAP SAMPLES (生产件批准程序/PPAP样品)

Part / Item Number 零件号/项目号：

Engineering Change Level 工程更改级别：

Part Name 零件名称：

Part/Item Number 零件号/项目号：Engineering Change Level 工程更改级别：Part Name 零件名称：

Enter Watts part numbers

填入沃茨的零件号.

Engineering Change Level of the part number

该零件的工程更改级别.

Form Revision Date

表格修订日期:3/20/2014

Supplier Name 供应商名称：

Part Name / Description.

零件名称/描述.

Sample size sent for evaluation.

送交评估的样品数量.

Watts Form Number

沃茨表格编号: WW-PPAP-110

ATTACH THIS LABEL TO THE "PPAP SAMPLES"

将此标签贴在“生产件审批程序/PPAP样品”上

PPAP Label:• Upper half is informational

and lower half is the label portion used for identification of shipment.



First Shipment Label for Production Parts


88

First Shipment Production Parts

First shipment production parts MUST be properly identified.

– Include the following information on the part label:

• New Product – (Mark if this is the first shipment for a new product)

• Process Change - (Mark if this is the first shipment after a process change)

• Design Change - (Mark if this is the first shipment after a design change)

• Watts part number

• Engineering Change level

• Part Name

• Supplier Name

• Supplier Code

• Quantity


See Watts First Shipment label on the next slide


89

First Shipment Production Parts


First Shipment Label:• Upper half is informational

and lower half is the label portion used for identification of shipment.

1

2

3

4

5

6

7

8

9

Part / Item Number零件号/项目号:

FIRST SHIPMENT(首批发运）

Part Name 零件名称:

Supplier Name 供应商名称：

Quantity 数量:

ATTACH THIS LABEL TO THE FIRST SHIPMENT

将此标签贴在首批发运产品上

Supplier Name

供应商名称：Supplier Name for the product in approval.

该产品的供应商名称.

Supplier Code

供应商代码：Supplier Code assigned by Watts. 沃茨指定的供应商代码.

Quantity

数量：Sample size sent for evaluation. 送交评估的样品数量.

Design Change 设计更改

Mark if this is the first shipment after a design change.标示这是否是设计更改后的首批发运.

Supplier Code 供应商代码:

Part / Item Number 零件号/项目号

Enter Watts part number(s). 填入沃茨的零件号.

Engineering Change Level

工程更改级别：Engineering Change Level of the part number.

该零件的工程更改级别.

Part Name

零件名称：

NEW PRODUCT新产品: ________ PROCESS CHANGE过程改变: ____________ DESIGN CHANGE设计更改: ______________

Engineering Change Level 工程更改级别：

Watts Form Number

沃茨表格编号: WW-PPAP-111

Form Revision Date

表格修订日期:3/20/2014

Part Name and part description. 零件名称与零件描述.

FIRST SHIPMENT LABEL (首批发运标签)

New Product

新产品Mark if this is the first shipment for a new product.

标示这是否是新产品的首批发运.

Process Change 过程改变

Mark if this is the first shipment after a process change.

标示这是否是过程改变后的首批发运.


90

Packaging Requirements


What is it?• A form that is to be completed by the

supplier to identify all areas related to the packaging of the part that is being shipped.

• To detail how a part is packaged for review and acceptance by the Watts.


When to use it• Prior to first initial shipment of

product to the customer.

Part Name / Desc.:

零件号/零件描述

EDP Number EDP号

Contact Person:联系人

Address:地址 Phone:电话

E-Mail:邮箱

Country 村

Phone:电话

Item 序号

Total parts per box

每盒零件数Parts per Bag if applicable

每包零件数（如果适用）Bags per Box if applicable

每盒中包数（如果适用）Qty of Boxes per master carton每大箱中的纸盒数

1

Weight of Master Carton

外箱重量Weight of Inner Carton

内箱重量

2

Master Carton

外箱Inner Carton

内箱Layer Count - Master

外箱中层数Layer Count - Inner

内箱中层数

3please supply pictures

请提供图片please supply pictures

请提供图片If applicable 如果适用

If applicable 如果适用

Single / Double / Triple Wall

单层/双层/三层壁Card board

纸板Plastic or Wood

塑料或木头Other

其他

4

Master Carton Box

Dimensions外箱尺寸Inner Carton Box Dimensions

内盒尺寸

5

Date Code - M.7.1.D

日期编码-M.7.1.DDomestic Packaging M.75.A.1

国内包装-M.75.A.1Import Packaging - M.75.A3

进口包装-M.75.A3

6

Maximum Height

最大重量

7

External Packaging Color

外包装颜色

8

Lead Free - Yes or No

无铅产品- 是或不是

9

Recyclable Packaging 可回收的包装

10

Master Carton pass

外箱合格Inner Carton Pass

内箱合格

11

Approved

接受 Rejected

拒收Date:

日期

WW-PPAP-113

Is all packaging being used recyclable? Yes or No

是不是所有的包装可循环使用？

Identify Box Material Dimensions

识别箱子材料尺寸

Form Revision Date

表格修订日期:

Packaging approval: 包装批准

Has supplier meet Watts requirements for date code, labels & packaging. Place an X in areas that have been met. (Samples required)

供应商提供的日期编码，标贴及包装符合沃茨要求吗？符“合的在对应区域打 X"。（需要样品）

3/20/2014

Are all packaging materials used free of the element LEAD? 是不是所有的包装材料都不含铅？

Has packaging for external color/ print consistency been addressed and verified. Enter Yes or No

包装的外部颜色/打印一致性是否已确定和验证，输入对或错。

Watts Form Number

沃茨表格编号:

Does packaging used for product provide sufficient protection to prevent damage of product during transportation?Place a Yes or No in the appropriate box(s)

所用包装是否足够保护产品在运输中不被损坏？在相应箱子填对或错

Supplier to Identify Max. height of shipment allowed to prevent product damage.供应商确定允许装运的最大重量以防止产品损坏。

Packaging Requirements for Shipment of Product包装要求(WATTS OR SUPPLIER) 沃茨或供应商

Part / Item Number:

生产件号/项目号

Required Packaging Information要求的包装信息

Supplier Name:

供应商名称

Quantity of parts in box (Select appropriate formats) 纸盒中的零件数（选择合适的格式）

Open box fully Packaged - pictures required

打开装满的箱子-要求图片

Identify Box Type (material construction)

识别箱子类型（构造材料）

Packaging Check list:包装检查清单

City, State, Zip

省，市，邮编

Weight of Master and Inner carton

外箱和内箱的重量



THANK YOU