Apqp la

Advanced Product Quality PlanningAPQP

ISO TS 16949:2002 Lead Auditor Course

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Course Objectives

• By the end of the course the participant should be able to;– Audit APQP both internally and externally– Understand the need for a APQP program– Identify the 5 phases of APQP – Develop and add value to an APQP

program

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The 5 Phases of APQP

1.Plan and Define the Program

2.Product Design and Development

3.Process Design and Development

4.Product and Process Validation

5.Feedback, Assessment and

Corrective Action

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An APQP overview

ConceptConceptInitiation/ApprovalInitiation/Approval

ProgramProgramApprovalApproval PrototypePrototype PilotPilot LaunchLaunch

Planning

Product Design and Dev.

Process Design and Development

Product and Process Validation

Production

Planning

Feedback Assessment and Corrective Action

Plan andPlan andDefineDefine

ProgramProgram

ProductProductDesign andDesign and

DevelopmentDevelopmentVerificationVerification

ProductProductand Processand Process

ValidationValidation

ProcessProcessDesign andDesign and


FeedbackFeedbackAssessment andAssessment andCorrective ActionCorrective Action

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1.0 Plan and Define Program



Planning



ProgramProgram



ProductProductand Processand ProcessValidationValidation



FeedbackFeedbackAssessment andAssessment and

Corrective ActionCorrective Action

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Phase 1Plan and define the program

• Form a cross functional team– The first step in planning the program is to define

who will make up the cross functional team. Cross functional team does not mean one(1) person doing everything!

– Typical members of a cross functional team may include:

• Engineering, Production, Quality, Sales,Costing, Manufacturing, Marketing, Purchasing etc..

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Plan and define the program

• ISO TS requires that personnel within the design activity should be qualified in the following skills as appropriate– Geometric Dimensioning and tolerancing (GD&T)– Quality Function Deployment (QFD)– Design for Manufacture/Assembly (DFM/DFA)– Value Engineering (VE)– Design of Experiments (Taguchi & Classical)– Failure Mode and Effects Analysis - Design and

Process

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– Finite Element Methods (FEM)– Solid Modelling– Simulation techniques– Computer Aided Design/Engineering

(CAD/CAE)– Reliability Engineering plans

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• Determine customer requirements

Customer requirements are typically determined by any or all of the following;– Market research– Warranty history from similar products– Supplier Quality Reports– Team Experience

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• Business plan The Business plan is a formal

requirement of ISO TS. It is a strategic document which may place some constraints on the development of the proposed product.Examples of Constraints:Project timing, cost of investment in technology, machinery and human resources, quality requirements, manufacturing capabilities, government regulations

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• Benchmark data - Process & Product

At this stage of the program Benchmark data should be obtained for the process and product as appropriate.

Benchmark data may be used to establish the “GAP” between your current product or process and that of the “World Best”.

Corrective action plans should be developed to close the “GAP” with the focus on becoming “World Best”.

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• Product and Process assumptions

List all of the current product and process assumptions.

Examples may be:– Material Characteristics and Performance– Reliability assessments– Machine capabilities– Management Structure

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• Product Reliability studiesThis area relates to identifying the frequency of repair or replacement of components over periods of time.

Examples are:– Service every 30,000 miles– Replacement after 2 years– Service after 1,000,000 cycles

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• At the completion of this stage the following aspects should be defined;

• Design goals• Reliability goals• Quality targets

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• Preliminary Bill of Material (BOM)• Preliminary process flow chart• Preliminary listing of special characteristics• Any governmental, environmental or safety

regulations

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Example(Typical output at completion of phase 1 - Plan and define the program)

Supplier Name: World Class Pty Ltd

Part Name: Boot Carpet trimPart Number: 1234-1 Drawing date: 19 FEB ‘99

Brief description of part:

The Boot carpet trim is a carpet that is vacuum formed onto a polypropylene substrate. It is then trimmed by a water jet cutter into shape, followed by an assembly operation where six (6) spacers are located.

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• Design Goals– Zero Carpet folds– Acceptable color match between carpet and mating

components– No peeling of carpet from polypropylene substrate

• Reliability Goals– Zero customer returns for carpet wear

Note: reliability goals are typically set for mechanical and/or electrical components.

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• Quality Targets– PpK of all special characteristics >1.67– Cpk of all special characteristics >1.33– Reject rate < 0.5% for 1st 12 months

< 0.35% for 2nd 12 months– Color tolerance for carpet Delta E <0.5 units

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• Preliminary Bill Of Material (BOM)

Name Location Name Location

Vacuum Former #4 Production Fixture 1234-1 Store F23

Steel frame 1800x1200 mm Store E24 Packaging 50/crate Store F10

Poly propylene 1850x1250 Store B16 Spacers 6/unit Store A17

Carpet 1850x1250 Store B21 Mounting Fixture 1234-2 Store F24

Water Jet cutter #1 Production Labels 1/unit Store F22

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• Preliminary Process Flow Chart

Receive material and locate in store

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Vacuum forming operation

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Trim carpet to correct shape using

water jet cutter

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Assemble 6

spacers to each

unit

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Pack in stillage

5

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• Preliminary Listing of Special characteristics ie KPC– Color of carpet - Delta E < 0.5 units– Hole locations +/- 1.0 mm– Hole Dimensions +/- 0.5mm

• Government, Safety or Environmental regulations– Substrate of Polypropylene to be identified for recycling

purposes

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Plan & Define the program

Document a once sentence summary

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2.0 Product Design & Development



Planning




ProgramProgram








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Phase 2Product Design and Development

The Product Design and Development phase begins with the generation of a Design FMEA

• Design Failure Mode and Effects Analysis

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Product Design and Development

• ISO TS requires that design output shall be the result of a process that includes the following;– Efforts to simplify, optimise, innovate and reduce waste

with methods such as;

• Quality Function Deployment (QFD)• Design for Manufacture/Assembly

(DFM/DFA)• Value Engineering (VE)• Design of Experiment• Tolerance studies (GD&T)• Response surface methodology

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• Analysis of costs/performance/risks trade offs

• Use of feedback from testing, production and the field

• Use of Design FMEA’s

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• Design verification at appropriate stages of design

The purpose of the design verification is to ensure that the design output is meeting the planned design input as defined in phase 1, Plan and Define the program.

Example:

Phase 1: Design Input - Hole locations +/- 1.0 mm

Phase 2: Design Output - Engineering Drawings stipulating the Hole locations at the tolerance of +/- 1.0 mm

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• Design reviews (formal documented review)Design reviews are conducted to monitor the progress of the project relative to customer requirements. The reviews are conducted by a cross functional team and the results of each review must be documented.Typically, the Design reviews might cover; Design FMEA’s, Design verification progress, reliability tests and studies, computer simulation results, benchmark data and overall progress relative to time constraints

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• Prototype build control plan

A prototype build control plan should be developed for a product when required by the customer. This control plan will detail the results from a dimensional analysis, material and functional tests, engineering and reliability tests.

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• Finalisation of;– Engineering drawings including CAD data– Engineering specifications– Material specifications

At this stage the cross functional team should have reviewed and approved all drawings, engineering specifications and material specifications.

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• New equipment, tooling and facilities

During the design review the cross functional team may determine that new equipment, tooling and facilities will be required. These details must be addressed and included in the overall timing plan. Emphasis must be placed on ensuring that new equipment, tooling and facilities are completed on time.

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• Finalisation of special characteristics

At this stage the majority of technical information is known and as a consequence the special characteristics should be agreed upon by the cross functional team and finalised.

The Control Plan should denote the finalised special characteristics.


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• Any new inspection, measuring and test equipment device

Based on all the information generated, in particular, the characteristics which need to be measured the cross functional team should determine whether any new inspection, measuring and test equipment is required.

If the equipment is required, this should be recorded into the overall timing plan and progress towards the acquisition be monitored.


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• Team Feasibility statement (This is a compulsory requirement of ISO TS 16949:2002

At this time the cross functional team must be satisfied that the proposed design can be manufactured to the customer’s requirements.

Once satisfied, the cross functional team members must sign off the Team Feasibility Statement.


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Product Design & Development


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3.0 Process Design & Development



Planning





ProgramProgram








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Phase 3Process Design and Development

The Process Design and Development phase requires the following aspects to be defined and/or documented;

• Customer packaging and labelling standards

Generally, the customer will provide documented packaging and labelling guidelines. These documents should be followed. When no guidelines are available, the cross functional team is responsible for developing guidelines to ensure integrity of the packaged product.

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• Review of the current Quality Management System to ensure its suitability for the prospective product and associated processesThe cross functional team should review the manufacturing sites Quality Manual to ensure the current Quality Management System addresses all of the requirements to design and manufacture the product under consideration.Any additional controls and/or procedural changes should be used to improve the Quality Management System in operation

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• Finalisation of the process flow chart

The finalized process flow chart is a schematic representation of the process flow. This chart is used to detect any potential bottlenecks, such as, material flow problems and manpower.

This chart also serves as a starting point when conducting the Process Failure Mode and Effects Analysis.

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• Floor plan layout with an emphasis on minimising material travel

The floor plan should be developed to determine the acceptability of inspection points, control chart locations, visual aid locations, rework area(s) and storage areas.

When developing the process and subsequent floor plan an emphasis must be placed on utilising floor space for value added activities.

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• Completion of the Process Failure Mode and Effects Analysis (FMEA)

The Process FMEA should be conducted prior to production commencing.

The process FMEA is a structured and detailed study performed by a cross functional team on a process to determine how potential external and internal factors could impact a process. Once

potential problems are established, preventive actions are developed to control all such problems.

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• Completion of the Pre-launch Control Plan

The Pre-Launch control plan provides a description of the dimensional measurements and functional test that occur after prototype and prior to full production. The pre-launch control plan typically includes additional product/process controls until the production process is validated.

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• Measurement systems analysis plan to encompass all of the inspection measuring and test equipment designated on the control plan

All inspection, measuring and test equipment utilised to measure product or process characteristics as defined in the Control plan must under go a Measurement Systems Analysis. The analysis should not be just restricted to Gauge Repeatability and Reproducibility but should also include studies on, linearity, and accuracy, as appropriate.

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• Process Monitoring and Operator Instructions - these shall typically include or reference as follows;– Operation Name and number keyed to process flow

chart– Part Name and Number– Current Engineering level/date– Required tools, gages and other equipment– Material identification and disposition instructions– Customer and supplier designated special

characteristics– SPC requirements– Relevant Engineering and manufacturing standards

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– Inspection and test instructions– Corrective action instructions– Revision date and approvals– Visual aids– Tool change intervals and set up instructions

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• Preventative maintenance The cross functional should identify key process equipment and develop an preventative maintenance system. At a minimum the system must include;– A procedure that describes planned maintenance

activities– Scheduled maintenance activities– Predictive maintenance methods

• Review of Manufacturers recommendations• Tool wear• Fluid Analysis• Vibration Analysis

– Availability of replacement parts for key manufacturing equipment

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• Preliminary process capability requirements

If no requirements have been specified a Ppk value greater than or equal to 1.67 should be achieved for preliminary results (less than 30 production days)

• If process is unstable refer to customer

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Process Design & Development


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4.0 Product & Process Validation



Planning






ProgramProgram








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The Product and Process validation phase requires the following aspects to be defined and/or documented;

• Production trial run as stipulated in the Control Plan - typically the results from this trial production run are used for;

• Preliminary process capability studies• Measurement systems analysis (Gauge R&R)• Process review• Product validation testing (Functional fit)

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• Production Part Approval• Packing evaluation• Quality Planning signoff• Finalisation of Production Control Plan

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• Measurement Systems Evaluation

Validating that all measuring devices used for product and process validation have been evaluated for Measurement error, typically Gauge Repeatability and Reproducibility studies.

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• Preliminary Process Capability study

Ensuring that preliminary process capability studies have been conducted on all characteristics identified on the Control Plan

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• Production Part Approval

Production Part Approval is required to validate that the product manufactured meets all customer requirements.

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• Production Validation Testing

Production Validation testing refers to Engineering tests that validate the production process as meeting all of the customer requirements, particularly, Engineering requirements.

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• Packaging Evaluation

Validating the packaging to ensure product is protected to the point of delivery is an integral phase of Product and Process Validation.

In addition the cross functional team representatives should ensure that the type of packaging will allow the end user to handle the product in a safe and efficient manner.

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• Production Control Plan

The production control plan describes the systems for controlling the entire process. The production control plan is a living document that must reflect the current flow of production. Any addition or deletions of process, inspection activities etc.. must be reflected in the control plan.

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• Quality Planning Sign-off

The Quality planning sign off is typically is typically conducted by the cross functional team once the control plan accurately reflects the entire process, process instructions are satisfactory, FMEA’s are complete and Measurement System Studies have been completed.

The form which is typically used for sign off is referred to as the Product Quality Planning Summary and Sign Off Report.

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Product & Process Validation


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5.0 Feedback, Assessment & Corrective ActionConceptConcept

Initiation/ApprovalInitiation/ApprovalProgramProgramApprovalApproval PrototypePrototype PilotPilot LaunchLaunch

Planning




Production

Planning



ProgramProgram








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Feedback, Assessment and Corrective Action

• Based on the output of phase 4, more specifically the;– Production trial run– Measurement Systems Analysis– Preliminary process capability study– Production part approval– Production validation testing– Packaging Evaluation– Customer concerns

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the results(feedback) are assessed and corrective action is instigated with a focus on;

CONTINUOUS IMPROVEMENT

QS 9000

Feedback, Assessment and Corrective Action

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Feedback, Assessment & Corrective Action


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Auditing APQP

1. How does the organisation select a cross functional team?

2. Are cross functional teams used for APQP?3. How does the organisation determine customer

requirements and integrate them into Phase 1 – Plan and define the program

4. Are key dates extracted from the customer and how are these communicated to the organisation's cross functional team

5. Does the organisation have a defined APQP program and is it followed

6. How is this APQP process measured

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Auditing APQP

7. What actions are taken when milestones are not achieved?

8. How does the organisation monitor supplier APQP9. Examine the mechanism that the organisations has in

place to communicate information to the supplier, and changes to these requirements

10. Does the organisation sign off the team feasibility and commitment form?

11. Is it signed off by a cross functional team?12. Do the team members who sign off this document

understand why the are signing the document?13. How does the organisation transition into production

from APQP?

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