Oriel star a maTRIX Risk Management Process Case Study ‘A groving need has been identified for emphazemciasthmatc support medleaons forthe ambutatory markt. Brest Inc. la star-upsubsidlary dvson ofa lrge producer of gaseous indsral products to a palrachemca, aerospace and miltay customer base. The company’s intial suecesstl venture was the pate ofthe SUVent™ system for recreatonalactve asthmatics. The system proves poral to the recreltonalispors active rcipent ‘ha suffers ftom swings i energy level dopleon of oxygen demand related activty. The company decir to move ts ‘SUVent™ product to the next lave of opportunity by proving @ daca Il product for he mobiyof patios wna ar in ‘ese of presciptonialans for sodatvesimulant corte Design ofan oxygon inhalant devoryeysiem that wil regulate the exchange of inhalant o “iggy istures of eedatve and stimulant based on paont demand. 1k" Hood gas 1 Product prt: ‘Oxygen botialcanstr(ha-gllon) wih special fanny-pack set: ». Delivery of gas is via tubing thts attached by an ear device constuctod ik a sel of CD headshones Regulators @ dual action pot forthe level of exygen and aspensing of drugs that ara in asresot cans of equal volume much tke Fghier fukt-ype canisters nd cip tothe exygen oyincer in he fanny-pec 16. Regulator uses by cata nput trough a palm cevios thal prompts the patient for setings andi also pouehed tothe fanny-pecie 6 The pam devi nas a cerrole nto provide the proper fons af the produ. 2. Amblent conditions fr use 2. Patient has ul prescipve cota! of he eispersing of the crug inhalants brug prescription for patent use isa the ciseroton of the physicien due fo various patent elated indication such as allgos and drug sensitivity, .&Facialtubing constucton comes in vibrant colors with spacial nasl fori deslgn patemed afer the ear form plugs used for noes abatomant 3. Medicinal Canisters for use: 2, "Zp" canisters willbe produced at sister ste that already produces similar containers forthe dispensing of ‘ulane iter fd 'b. The canister production ste has curent FDA cGMP status due to product used for hospital faces inne of gaseous preducts fr patent and laboratory use. SenomlsTarAnATaN, sedgteeneOriel star a matrix PAGE? ‘Aste company Reguatory Manager you have been given the tsk of developing @riskcbasad approach or supporting th approval of this aremarel device. Breath, Ine, has been operating under very adap projet management bul does not have a systematic quelly approach oer than a thorough regulatory compliance! ‘uaity assurance department o support deaign engineering. Process engineering has faarty wan gaseous requatrs ad the assembly of muticonponent médng But net familar wth Grug aerosol producs. You nave fan attending stat physician who consists wih the company in an on-call capacty. Your sister ete Nas @ Instr engineer, 2 roguistarysnicel eka epecelist and aeeos and marketng specail al your isposal forthe development ofthis product. Components ofthe product hat wl be ken nts account for isk seanaios 1. Tho scerais ofthe patent: .Sadertary person and posible senate, », Home ambulatory person end posable scenario Work ambustory person and possible scanao 4, Recreational active petson ard posse sonar. 2. The soenatos ef rodut are: 8, Regulator, canister, tubing, nasal fanny pack, ee Expose (heatolditatontbouncnalsineinae). 4, “The scenarios ofthe environment a. Aacon. b, Theft due to market exposure on drugs. 6. Spatks or open flame (smckar)Oriel stat A matrix Post-Production Assessment ead the case study for Breath, ns combiestion medical deoalpharacoleal product SUVent oxygen inhlant ‘elvery system forecreatloral, active asthmatics and Suageloxs Oxygen System Salelytvormation sheet. Breaths regulatory department has reosived numerous complaints cbout the SUVent oxygen inhalant delvery systom. During complaint investigtion aces, engineers learned of addtonalslely concerns fora compato’s produc! (ie, Swageiok's Onygon System Sefatynlrmation sheet). Subject matter exter have iaentied the same Safely conaérs fr the SUVent onjgen inalardoivary systom. A CAPA waa inated to determine whetha a change fo the SUYent oxygen inhalant detvery system andlor manutactng process ilare required and whothe a product recalls necessary. Using the now data (.., Suagalok’s Oxygen Systom Safely Iermation shel), determine whether any change(s) to {he doviee andlor manuistuing process ilare required and Ihe product shouldbe recaled. Remember to ow Brean’ isk management procedure and use the company’ eeablched and manned risk management mest forme, itany changes fo the device andor manulacuring process isar raquird, alsa revi the sk management plan and ‘sk management records accordingly. + Update the sk management plan, dbFMEA mats, ad rsk management recor. + IGenty each new hazard or falure mode ital describes the matincon or use ero. + Descable new potemtal ham to a person, proper, oF anvrenent «Determine the appronate severity, probable, and detectably to calculate the nia postpeducion sk. «ently any newts recucton measures er canal forthe new hazards or fares + Doscibe hal new veeston or valdaton mth could based to ensure the ak contol llectvaly implement + Calculate Ue new estat isk bases one loentned plemented sk conte Use the General Fisk Anaysis handouts (le, Process FMEA, Design FMEA Ask Analysis verviow, Decision Tree ‘Analysis, FMEA SIPID Rating for PN} for sedional guidance ‘oa STAT AIR Aha