国际型供应商管理

1、1 / 29ge healthcare10/24/2021ge healthcare supplier part quality planssupplier training supplier part quality plan requirements ref doc doc0519115 2 / 29ge healthcare10/24/2021training objectives understand the requirements of supplier part quality plans understand the individual elements of supplie

2、r part quality plan define the responsibilities of suppliers 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 .3 / 29ge

3、healthcare10/24/2021supplier part quality plans 4 / 29ge healthcare10/24/2021what 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 assemblies that meet all ge h

4、ealthcare 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.5 / 29ge healthcare10/24/2021why do we need supplier part quality plans?sup

5、plier 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 and closed

6、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 6 / 29ge healthcare10/24/2021supplier part quality plansthe individual elements of supplier are based upon and reference industry

7、 standards such as: production 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 - measurem

8、ent systems analysis (msa) third edition 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 : order of requirements precedence: 1. ge

9、hc drawings/documentation 2. gehc standards / work instructions 3. industry standards 7 / 29ge healthcare10/24/2021which gehc parts or assemblies require a supplier part quality plan? parts and assemblies will be classified during:new product introduction programs, supplier transfers some engineerin

10、g change activity. supplier part quality plans will be required for all ge healthcare classified parts. supplier part quality plans do not apply to gehc product software 8 / 29ge healthcare10/24/2021the minimum requirements of each supplier part quality plan will differ based on the gehc defined cla

11、ssifications. at the discretion of gehc supplier quality, additional elements may be required, based upon part complexity, 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 requ

12、ired elements to the supplier for each part or assembly using the ge healthcare standard form. (supplier part quality plan requirements form - doc0527619). 9 / 29ge healthcare10/24/2021refer to the part quality plan supplier requirements and responsibilities (doc0519115) for a detailed explanation,

13、examples, and instructions for all of the supplier part quality plan elements. the supplier part quality plan elements are design and requirements review process flow diagram process failure modes and effects analysis (pfmea) process control plan gage repeatability and reproducibility (gage r&r) fir

14、st article inspection process capability study packaging plan part submission warrant10 / 29ge healthcare10/24/2021design & requirements review required required upon ge healthcare request process flow diagram required required upon ge healthcare request process failure modes & effects analysis (pfm

15、ea) upon ge healthcare request upon ge healthcare request upon ge healthcare request process control plan upon ge healthcare request upon ge healthcare request upon ge healthcare request gage repeatability & reproducibility (gr&r) upon ge healthcare request upon ge healthcare request upon ge healthc

16、are request first article inspection required required required process capability study required upon ge healthcare request upon ge healthcare request packaging plan upon ge healthcare request upon ge healthcare request upon ge healthcare request part submission warrant required required required q

17、uality plan elementspart essential classificationessential to safety essential to function minorthe requirement for any upon ge healthcare request elements shall be determined by supplier quality.supplier part quality plan elementstable no. 111 / 29ge healthcare10/24/2021supplier part quality plange

18、 healthcare will provide a list of which elements will be required for each classified part number.example: supplier part quality plan requirements form12 / 29ge healthcare10/24/2021supplier submission overview: the supplier shall submit each required element to gehc for review and approval. in most

19、 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 signed part submission warrant form (psw) - affirming that all gehc plan requirem

20、ents have been met.what are the supplier requirements of a supplier part quality plan? 13 / 29ge healthcare10/24/2021note: reference the current revision of thesupplier part quality plan requirements (doc0519115 ) for complete and detailed examples of the supplier part quality plan. this document re

21、ferences 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 - elements individual element overview

22、the following section offers a brief description of all of the individual elements of a supplier part quality plan.14 / 29ge healthcare10/24/2021 design and requirements review the design and requirements review is a cross functional, formal meeting held early in the design process, which is conduct

23、ed 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

24、 adequate understanding of gehc requirements and allows suppliers to provide their suggestions and concerns prior to production. 15 / 29ge healthcare10/24/2021 cross functional review of the design intent and technical requirements of the part review of drawings, requirements and applicable specific

25、ations part marking and labeling requirements 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 reviewtypical content:the

26、 supplier shall capture all of the 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.16 / 29ge healthcare10/24/2021 process flow diagrama

27、 process flow diagram maps the suppliers entire process required to produce the gehc part or assemblytypical process flow diagramthe supplier shall detail all of the essential manufacturing, inspection, and test steps required to manufacture the gehc part or assembly - from incoming receiving inspec

28、tion on through packaging and final shipping. 17 / 29ge healthcare10/24/2021process failure modes 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

29、eliminate or reduce the probability of that failure occurring. the supplier will initiate this analysis 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 def

30、ined by the risk priority number (rpn ) number of severity, the supplier shall create an action plan to address each risk or written rationale as to why actions were not taken18 / 29ge healthcare10/24/2021process control plana process control plan provides a documented description of the methods use

31、d to minimize process and product variation. the process control plan establishes controls for ge healthcare defined critical to quality (ctq) features. these features will be identified within the part documentation (drawings, test specs, purchase specifications etc.)as part of the process control

32、plan, the supplier shall identify the overall process controls to be put in place to control the higher risk process steps as identified in the process failure modes and effects analysis. 19 / 29ge healthcare10/24/2021gage repeatability and reproducibility (gage r&r)the gage r&r element where the su

33、pplier demonstrates the repeatability and reproducibility of the required part measurement system(s) by establishing precision and accuracy of the process. why ? evaluates capability of a measurement system to accurately assess if a measurement device meets certain requirements/specifications establ

34、ishes confidence in initial production measurements provides a level of confidence in trusting reported measurement values reducing both supplier and ge healthcare part or assembly risks ensures analysis performed on ge healthcare ctqs20 / 29ge healthcare10/24/2021first article inspectiona first art

35、icle 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 inspected, completion of specified tests (and results) , labeling, packaging qualification requirements such

36、 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.21 / 29ge healthcare10/24/2021feature identified on the drawing correlates to the inspection item number.for all fais, the sup

37、plier 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. 22 / 29ge healthcare10/24/2021process capability studythe process capability element is the study of the suppliers manufact

38、uring 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 how the process will perform,

39、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 methodologya statistically significant sample size is required for process capability study. ge healthca

40、re and the supplier will jointly determine the quantity required. (typically a 30 piece minimum.)23 / 29ge healthcare10/24/2021process capability studyexample of a capability analysis graph-4-3-2-101234lsluslprocess capability analysis for averageusltargetlslmeansample nstdev (st)stdev (lt)cpcpucplc

41、pkcpmppppupplppkppm uslppm totalppm uslppm totalppm uslppm total 4.00000 *-4.00000-0.275312560.8910780.8614751.501.601.391.39 *1.551.651.441.44 0.00 0.00 0.0014.58 0.8015.38 7.67 0.35 8.02process datapotential (st) capabilityoverall (lt) capabilityobserved performanceexpected st performanceexpected

42、lt performancestltprocess capability index24 / 29ge healthcare10/24/2021packaging planthe packaging plan is a documented plan where the supplier demonstrates that they can successfully pack and ship the gehc part or assembly, without any damage or contamination, to its required, global location.1.pi

43、ctures or drawings of proposed packaging and labels2.a “pick list” of defined packaging items, for example, packing foam, static bag, desiccant, etc.3.proof of successful completion of required package testing4.proper labeling requirements of the container defined5.fru (field replaceable unit) vs li

44、ne-use packaging requirements mettypical content of a complete packaging plan:note: the part or assembly packaging must meet the requirements of the ge healthcare global packaging requirements spec - 2100268pre 25 / 29ge healthcare10/24/2021part submission warranta part submission warrant (psw) is t

45、he 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 warrant form certifying all required elements have been completed.once reviewed and a

46、pproved 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 supplier: 26 / 29ge healthcare10/24/2021conditional part submission warranta conditi

47、onal 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 template. a strict timeline for closure must be defin

48、ed. 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. 27 / 29ge healthcare10/24/2021how are supplier part quality plans archived?supplier part qua

49、lity planssupplier part quality planssupplier part quality plans - introduction - introduction - introduction - elements - elements - elements28 / 29ge healthcare10/24/2021how are supplier part quality plans archived?the supplier is required to retain all elements of the supplier part quality plan (

50、per gehc pmqr) and make the elements available to ge healthcare upon request.documentation responsibilitiesge 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

51、life has ended or for a minimum of fifteen (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 comp

52、letion of the supplier part quality plan.supplier responsibility :29 / 29ge healthcare10/24/2021part 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

53、quantities, age of tooling, etc. if an update is required, the supplier quality 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 pla

54、n submission. in addition, supplier part quality plan updates may be required as part of the ecr/eco (engineering change) process as above, ge healthcare shall provide a supplier part quality plan element requirements form to the supplier.30 / 29ge healthcare10/24/2021summary supplier part quality p

55、lans are required for all items categorized as essential to safety, essential to function, or minor by gehc. element requirements 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 respo

56、nsibility to perform and submit all of the required elements.the supplier will provide a signed part submission warrant to 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 signed part submission warrant. 31 / 29ge healthcare10/24/2021thank you!from the ge healthcare supplier quality teamfor additional information: ge healthcare proce