practical design control training
Post on 08-Apr-2022
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• RevisionoftheGMP’stoaddressdesign• TheISOequivalenceistheISO13,485
• FrameworkacompanyMUSTbuildupontocreatetheirownspecificprocedure
• DesignInputs=User/Customer/Design/DeviceRequirements• DesignRequirements(DI)aredevelopedintoDesignSpecifications(DO)
• Requirementsbeforedesigns
• TransformUsersNeedsintoEngineeringlevelrequirements(“Strongholdingforce”intofivepoundsoftensilestrength)
• Designrequirementsinputsaretheendresult,notthestartingpoint.
• Prototypestestlimitsofperformanceandgapsinknowledge,tothenrefineDesignInputs.
• Priortosolutions
• Solution-freerequirementsallowsfordifferentdisciplinestodevelopsolutionsfromanewanduniqueperspective
Exercise: Using Solution-Free Requirements From Current Product to New Design User Needs:
• Body elevated above solid surface below
• Torso and back supported in upright natural position • Head positioned to look forward and around • Legs not fully supporting weight
• Arms free to move about
• Comfortable due to cushioned body interface
• One size fits all
• Usable for work or leisure
• Ifaprojecttakes18monthstocomplete,itwouldtake6monthstorefinetherequirementsbeforeidentifyinganysolutions.
• “Wemadethepartright”• SpecificationsmeetRequirements
• DifferenceinDesignValidationandProcessValidation(IQ/OQ/PQ)
• Verification(andValidation)cannotoccurinparts• Youshouldconductpre-verificationandpre-validationactivitiesthroughouteachstage.• Atrueverificationandvalidationmustoccurwhenproductionequivalentdevicesareavailable
• Thedesignspecificationsbecometheprocessrequirementsforthemanufacturertocreateproductionspecifications
• Consideredthesebelow
• Notyourtypicalproductionspecs,butyoumustfullydefinetheproduct.
• Whentransferringyourdesignoutputtothemanufacturesyoumustincorporatemethodsforvalidation
• ThekeytaskofDeignTransfer
• Allchangesmustbetracedanddocumented• Whataboutprototypes?Whatisthepurposeofaprototype?Trackingprototypechangesisimportant
• PriortoandpostDesignTransfer
• Designreviewsmustoccurtoensurethatthetradeoffsareresolved.• Howdoyouanalyzedesigntradeoffs?ByRisk!
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