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1、GE Healthcare Supplier Part Quality PlansSupplier Training,Supplier Part Quality Plan Requirements Ref Doc DOC0519115,Training Objectives,Understand the requirements of Supplier Part Quality Plans Understand the individual Elements of Supplier Part Quality Plan Define the responsibilities of Supplie
2、rs to GE Healthcare Define the responsibilities of GE Healthcare Understand the Supplier submission requirements Understand the Suppliers responsibilities for the storage and archival of the plans.,Assist Suppliers to GE Healthcare.,Supplier Part Quality Plans,Training Sections:Supplier Part Quality
3、 Plans-Introduction-ElementsPlan Documentation Responsibilities-Suppliers to GE Healthcare-GE Healthcare,What is a Supplier Part Quality Plan?,The Supplier Part Quality Plan is:,The process by which a Supplier to GE Healthcare demonstrates that they can produce parts,sub-assemblies or high-level ass
4、emblies that meet all GE Healthcare requirements.Demonstrating supplier readiness to manufacture production or service parts using production machinery and tooling at required GE Healthcare quality levels.Part of Initial Part Qualification activity.,Introduction:,Why Do We Need Supplier Part Quality
5、 Plans?,Supplier Part Quality Plans Ensure:,Initial and ongoing production part quality Supplier understanding of GEHC requirements Ability to achieve acceptable supplier quality levels Appropriate test coverage and data correlation to product specifications Manufacturing issues discovered,tracked a
6、nd closed prior to part release.Evaluation and Verification of test and measurement systems prior to production Systems in place to detect or prevent potential failures/defects,Supplier Part Quality Plans,The individual elements of Supplier are based upon and reference Industry Standards such as:Pro
7、duction Part Approval Process(PPAP).,Industry Standard(PPAP)Reference Documents:AIAG-Production Part Approval Process(PPAP)Fourth Edition March 2006 or later.AIAG-Potential Failure Mode and Effects Analysis(FMEA)Reference manual Revision 4 or later.AIAG-Measurement Systems Analysis(MSA)Third Edition
8、 March 2002 or later.AIAG-Advanced Product Quality and Control Plan(APQP)Second Edition July 2008 or later.AIAG Statistical Process Control(SPC)Second Edition,July 2005 or later.Web Site Reference:www.aiag.org,Order of requirements precedence:1.GEHC Drawings/Documentation 2.GEHC Standards/Work Instr
9、uctions 3.Industry Standards,Which GEHC parts or assemblies require a Supplier Part Quality Plan?,Parts and Assemblies will be classified during:New Product Introduction programs,Supplier Transfers Some Engineering Change activity.,Supplier Part Quality Plans will be required for all GE Healthcare c
10、lassified parts.,Supplier Part Quality Plans do not apply to GEHC product software,The minimum requirements of each Supplier Part Quality Plan will differ based on the GEHC defined classifications.At the discretion of GEHC Supplier Quality,additional elements may be required,based upon part complexi
11、ty,supplier quality history,new process requirements,etc.,What are the requirements of a Supplier Part Quality Plan?,GEHC Supplier Quality will forward the formal list of the required elements to the supplier for each part or assembly using the GE Healthcare standard form.(Supplier Part Quality Plan
12、 Requirements Form-DOC0527619).,Refer to the Part Quality Plan Supplier Requirements and Responsibilities(DOC0519115)for a detailed explanation,examples,and instructions for all of the Supplier Part Quality Plan Elements.,The Supplier Part Quality Plan Elements are Design and Requirements Review Pro
13、cess Flow Diagram Process Failure Modes and Effects Analysis(PFMEA)Process Control Plan Gage Repeatability and Reproducibility(Gage R&R)First Article Inspection Process Capability Study Packaging Plan Part Submission Warrant,Elements:,The requirement for any Upon GE Healthcare request elements shall
14、 be determined by Supplier Quality.,Supplier Part Quality Plan Elements,Table No.1,Supplier Part Quality Plan,GE Healthcare will provide a list of which elements will be required for each classified part number.,Example:Supplier Part Quality Plan Requirements Form,Supplier Submission Overview:The su
15、pplier shall submit each required element to GEHC for review and approval.In most cases,standard GEHC templates for each element will be used.The supplier may use some of their own templates with GEHC approval.When a supplier has completed a Supplier Part Quality Plan,the supplier must submit a sign
16、ed Part Submission Warrant form(PSW)-affirming that all GEHC plan requirements have been met.,What are the Supplier requirements of a Supplier Part Quality Plan?,Note:Reference the current revision of theSupplier Part Quality Plan Requirements(DOC0519115)for complete and detailed examples of the Sup
17、plier Part Quality Plan.This document references of all forms and templates with examples of how each of the templates are to be filled out&completed.Available for Suppliers on GEHC Supplier Market Place(SMP)or by request of your assigned GEHC Supplier Quality Engineer.,Supplier Part Quality Plan-El
18、ements,Individual Element Overview,The following section offers a brief description of all of the individual elements of a Supplier Part Quality Plan.,Design and Requirements Review,The Design and Requirements Review is a cross functional,formal meeting held early in the design process,which is cond
19、ucted between GE Healthcare and the supplier to promote clarity and understanding of the part or assembly requirements.It is also the forum for the supplier to offer recommendations of changes to improve process,manufacturability,or quality.,Provides a“two-way”mechanism to ensure Suppliers have an a
20、dequate understanding of GEHC requirements and allows suppliers to provide their suggestions and concerns prior to production.,Cross functional review of the design intent and technical requirements of the part Review of drawings,requirements and applicable specifications Part marking and labeling r
21、equirements Discussion of special design requirements Supplier suggestions on how to improve quality and efficiency Review of packaging qualification and requirements Discussion of supplier manufacturing capabilities,Design and Requirements Review,Typical Content:,The Supplier shall capture all of t
22、he items discussed and implement actions and timelines to address and close those items.GEHC is responsible to make agreed upon design updates to improve quality or manufacturability within an agreed upon timeframe.,Process Flow Diagram,A process flow diagram maps the Suppliers entire process requir
23、ed to produce the GEHC part or assembly,Typical Process Flow Diagram,The Supplier shall detail all of the essential manufacturing,inspection,and test steps required to manufacture the GEHC part or assembly-from incoming receiving inspection on through packaging and final shipping.,Process Failure Mo
24、des and Effects Analysis(PFMEA),PFMEA is a process to identify and evaluate the potential failures and effects of the Suppliers manufacturing process.In addition,the analysis identifies actions that will eliminate or reduce the probability of that failure occurring.,The Supplier will initiate this a
25、nalysis during the pre-production phase,prior to tooling for production.The analysis should account for all primary and secondary manufacturing operations.,For the top 20%of the risks identified,as defined by the Risk Priority Number(RPN)number of severity,the Supplier shall create an action plan to
26、 address each risk or written rationale as to why actions were not taken,Process Control Plan,A process control plan provides a documented description of the methods used to minimize process and product variation.,The Process Control Plan establishes controls for GE Healthcare defined Critical To Qu
27、ality(CTQ)features.These features will be identified within the part documentation(Drawings,Test Specs,Purchase Specifications etc.),As part of the Process Control Plan,the supplier shall identify the overall process controls to be put in place to control the higher risk process steps as identified
28、in the Process Failure Modes and Effects Analysis.,Gage Repeatability and Reproducibility(Gage R&R),The Gage R&R element where the Supplier demonstrates the Repeatability and Reproducibility of the required part measurement system(s)by establishing precision and accuracy of the process.,Why?Evaluate
29、s capability of a measurement system to accurately assess if a measurement device meets certain requirements/specifications Establishes confidence in initial production measurements Provides a level of confidence in trusting reported measurement values reducing both Supplier and GE Healthcare part o
30、r assembly risks Ensures analysis performed on GE Healthcare CTQs,First Article Inspection,A First Article Inspection(FAI)is a complete inspection performed by the supplier of a given part or assembly to evaluate conformance to the documented specifications.,In addition to physical features inspecte
31、d,completion of specified tests(and results),labeling,packaging qualification requirements such as temperature,vibration,and drop testing,are also inspected and verified.,The quantity of parts to be inspected will be determined by GE Healthcare-typically 5 pieces.,Feature identified on the drawing c
32、orrelates to the inspection item number.,For all FAIs,the Supplier shall produce a marked-up Bubble print of the assembly drawing or purchase spec is required tying all important features to an inspection item number in the FAI template.,Process Capability Study,The Process Capability element is the
33、 study of the Suppliers manufacturing process,within defined limits,where the Supplier demonstrates their ability to meet GE Healthcare requirements.,Provides an initial demonstration of suppliers ability to consistently meet specified requirements.,Capability is used as a basis for an indication of
34、 how the process will perform,using statistical data gathered from production parts manufactured by the production process-expressed as a process capability index(i.e.Cpk)First step toward process control via statistical methodology,A statistically significant sample size is required for Process Cap
35、ability Study.GE Healthcare and the Supplier will jointly determine the quantity required.(Typically a 30 piece minimum.),Process Capability Study,Example of a Capability Analysis Graph,Process Capability Index,Packaging Plan,The packaging plan is a documented plan where the Supplier demonstrates th
36、at they can successfully pack and ship the GEHC part or assembly,without any damage or contamination,to its required,global location.,Pictures or drawings of proposed packaging and labelsA“pick list”of defined packaging items,for example,packing foam,static bag,desiccant,etc.Proof of successful comp
37、letion of required package testingProper Labeling Requirements of the container definedFRU(Field Replaceable Unit)vs Line-use packaging requirements met,Typical Content of a complete packaging Plan:,Note:The part or assembly packaging must meet the requirements of the GE Healthcare Global Packaging
38、Requirements Spec-2100268PRE,Part Submission Warrant,A Part Submission Warrant(PSW)is the Suppliers affirmation that the part or assembly samples supplied to GE Healthcare,were made by a process that meets all Supplier Part Quality Plan requirements.,The Supplier will submit a Signed Part Submission
39、 Warrant Form certifying all required elements have been completed.Once reviewed and approved by GE Healthcare Supplier Quality&Design Engineering the SQE will send the PSW back to the Supplier with GE Healthcare approval signatures added.,Once a Supplier Part Quality Plan has been completed by the
40、supplier:,Conditional Part Submission Warrant,A conditional Part Submission Warrant may be submitted to GEHC,where additional data may be required for completion.This requires prior approval from GE Supplier Quality.,Must be clearly defined in the Declaration section of the Part Submission Warrant t
41、emplate.,A strict timeline for closure must be defined.,For example:Additional production parts must be manufactured to obtain the required number of pieces to complete the overall Process Capability Study.,An updated PSW is required to close the conditions.,How are Supplier Part Quality Plans archi
42、ved?,Supplier Part Quality Plans-Introduction-ElementsPlan Documentation Responsibilities-Suppliers to GE Healthcare-GE Healthcare,How are Supplier Part Quality Plans archived?,The Supplier is required to retain all elements of the Supplier Part Quality Plan(per GEHC PMQR)and make the elements avail
43、able to GE Healthcare upon request.,Documentation Responsibilities,GE Healthcare Responsibility:,Per GEHC_GQP_11.01.003_Purchased Material Quality Requirements:“The records required shall be retained until GE Healthcare notifies the Supplier that the product life has ended or for a minimum of fiftee
44、n(15)years,whichever is longer,unless the required records are submitted to GE Healthcare by written agreement or purchase specification.”,GE Healthcare will archive a copy of the approved and mutually signed Part Submission Warrant as a record of the completion of the Supplier Part Quality Plan.,Su
45、pplier Responsibility:,Part Quality Plan Updates,GE Healthcare may require ongoing Supplier Quality Part Plan updates.A request for an update may be based upon a change in suppliers performance,significant increase in demand quantities,age of tooling,etc.If an update is required,the Supplier Quality
46、 Engineer shall submit an updated Supplier Part Quality Plan Required Element form to the Supplier.All execution,submission,and approval responsibilities of the plan shall remain the same as an initial part quality plan submission.In addition,Supplier Part Quality Plan updates may be required as par
47、t of the ECR/ECO(Engineering Change)process as above,GE Healthcare shall provide a Supplier Part Quality Plan Element Requirements form to the Supplier.,Summary,Supplier Part Quality Plans are required for all items categorized as Essential to Safety,Essential to Function,or Minor by GEHC.Element re
48、quirements will vary by part classification.While certain elements are mandatory,additional elements may be required as defined by GEHC Supplier Quality.It is the Suppliers responsibility to perform and submit all of the required elements.The Supplier will provide a signed Part Submission Warrant to
49、 GEHC to affirm they have completed all the Supplier Part Quality Plan requirements.It is GE Healthcares responsibility to review and approve the submission.The Supplier is responsible to retain and archive all element records.The GEHC Supplier Quality Engineer is responsible to archive the mutually
50、 signed Part Submission Warrant.,Thank you!From the GE Healthcare Supplier Quality TeamFor Additional Information:GE Healthcare Procedure:Supplier Part Quality Plan Requirements-DOC0519115Your assigned GE Healthcare Supplier Quality EngineerGESMP-GE Supplier MarketPlace(SMP)at https:/,Supplier Part
