Quality Risk Management
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1 Quality Risk Management Dr. Tami Greenberg כנס איכות הלכה למעשה.6.2 אורט בראודה
2 The Desired State: A Mutual Goal of Industry, Society, and the Regulators A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces highquality drug products without extensive regulatory oversight. Janet Woodcock, M.D. October 5, 25
3 How do we get to Desired State? ICH Quality Road Map Desired State Quality by Design (Q8/QbD) Quality Risk Management (Q9) Quality Systems (Q/PQS)
4 How Q9 interacts with Q8 and Q High Low Low High Product / Process Risk Using Q9 Quality Risk Management principles continual improvement Risk from Manufacturing site Q Pharm. Quality Systems Q8 Pharmaceutical Development
5 Our vision: The future Pharmaceutical Quality System The Regulatory Quality System Quality Risk Management (Q9) For companies with :. Good design and control strategies 2. Good Risk Management strategies 3. Good Quality Systems Existing GMP Quality by Design (Q8) Quality Systems (Q) Reduced regulatory burden: Reduction of submissions on changes/variations Inspection of quality systems
6 detectability The risk-based approach Parameters for evaluating risks high medium probability low severity risk
7 Definitions Quality Risk Management QRM Degree to which a set of inherent properties of a product, system or process fulfills requirements combination of the probability of occurrence of harm and the severity of that harm Systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle
8 Q9 s Sample Process Initiate QRM Process Risk Assessment Risk Identification Risk Analysis Risk Communication Risk Control Risk Review Risk Evaluation Risk Reduction Risk Acceptance Output / Result of the QRM Process Review Events unacceptable Risk Management Tools
9 Risk Map
10 Step-by-Step Procedure of RM in Chemagis. Risk mapping - total risk profiling across a whole enterprise and identification of Risky Projects. 2. Projects definition and team building. 3. Risk characterization - risk criteria/components and their scales definition, risk components ranking. 4. Prioritization of Risk Drivers - decide what risks to retain and what risks should be treated (risk mitigation/reduction). 5. Risk Control - corrective actions development and implementation. 6. Post-Control Activity - summary, documentation, reporting and communication to all relevant parties, as well as establishing system for risk continuous monitoring & control.
11 TRP implies risk mapping across a whole enterprise from the top down, with a primary focus on strategic risksthreats to business objectives: System Management Marketing, Sales & Customer Support Financial Department Human Resources Purchase and Suppliers Chain Engineering Department (Projects) Logistics R&D Production Facilities & Equipment Maintenance Total Risk Profiling (TRP) Infrastructure Materials Management Regulatory Requirements Safety Environment Quality Quality & Reliability Processes Validation Production Control Laboratory Controls Information System Labeling and Packaging Storage and Shipping, etc.
12 RM in Chemagis is Based on FMEA (Failure Mode Effect Analysis) Implementation FMEA Coverage (Five Dimensional Analysis) Safety & Ecology Problems, % Cost & Schedule Problems, % 2 46 Availability & Serviceability Problems, % Quality & Reliability Problems, % 8 Functionality & Efficiency Problems, %
13 FMEA Performance Team work (Chemagis stuff with ALD support)! Team usually includes usually 6-8 members chosen from: Project Management, R&D Department, Engineering Department, Manufacturing Department, QA Department, Safety/Ecology Department, Equipment Engineering (Maintenance), Purchase and Shipment. 3
14 מיפוי תהלי ך טיפול במוצקים חדר אחסון חדר A שקילה יבוש A סינון A כלי אחסון A ריאקטור הזנה ידנית של חומרי A גלם אחסון ביניים A מנדף B שקילה טחינה B סינון B כלי אחסון B ריאקטור הזנה ידנית של חומרי B גלם אחסון ביניים B
15 Severityהגדרות חומרה דירוג קריטריון זיה ום במ וצר סופ י I Catastrophic זיה ום בחומר ב יני י ם II Critical פגיעה בא יכו ת ה מ וצר III Marginal אין השפע ה IV Negligible
16 Likelihoodהגדרות תדירות Level Descriptive Word Definition A Frequent Likely to occur repeatedly in system life cycle B Probable Likely to occur several times in system life cycle C Occasional Likely to occur sometime in system life cycle D E F Remote Improbable Impossible Not likely to occur repeatedly in system life cycle, but possible So unlikely it can be assumed occurrence but may not be experienced Practically impossible to occur
17 סיכונים Like lihood F E E D D B F D D D D D D C E D D C B Severity Fa ilure Mode שק ית לא סג ורה שימ וש בכ ל ים מזוהמ ים שק ית מזוהמת פ יז ור אבקה בעת פתיחת השקית שפ יכת ח ומר בעת שק י לה ע ל המשק ל וש ו לח ן העב ודה כפפות ו לב וש מזוהם שינ וי בתוכנ ית עב ודה וי יצ ור עם ריאקטור לא נקי בין מ וצר ים ז יהום דרך ו ונט מש ותף כש ל במערכת ספיגה פת יחת ר יאקטור בעב ודה לצ ורך הזנה/דג ימה/בקרה שארי ות במערכת לאחר נ יקו י - תכנ ו ן הנדס י עם כ יס ים ש ל נ וז ל לא מנוקז שי וני בתוכנ ית עב ודה וי יצ ור עם ריאקטור לא נק י בין ש לבים ח וסר תיא ום בהעברת משמרת שימ וש בק ו י נ יק וז גמ ישים מש ותפ ים - ניק ו י לא מספק מדבקה נ ופ לת ס ימו ן לא נכון ש ל ח ומר הזנת ח ומר לא נכו ן - טעות אנ וש הזנה איט ית/בש לבים ס ימו ן בעט ודהי יה/מריחה ש ל הכתב ProcessName שק י לה ר יאקטור אחסו ן ביניים #
18 Risk Analysis at Failure Level Severity Occurrence Detectability S O D Risk Priority Number (RPN) Best Case RPN= S*O*D Worst Case
19 Risk Analysis at Project Level Total Risk Estimate (TRE) TRE Initial = Number RPN of Causes i * * % Where: RPNi - sum of all RPN values, Number of Causes - number of causes (actually number of rows) in the FMEA table Overall Project (System) Criticality Index: BC.% TRE % WC TREacceptable 3 n (5.5) n % 7%
20 יחידה / סיכון Risk סביבתי (מקור חומר) - נזק אוזון אחסון במפעל ביעות קירור ציוד ללא הגדרה מדויקת העדר בקרה בטיחותי (מקור חומרים) -נזק בריאותי ) בטיחותי (מקור ציוד ) בטיחותי (מקור גורם אנושי ) בטיחותי (מקור ניהול ביעות איכות בשלבי ביניים אספקת חו"ג מרכזי שלא במועד הרצוי IQ+OQ פיגור בהשלמת פרוטוקולים ניצולות נמוכה בטיחותי (מקור חומרים) -דליקות בטיחותי (מקור חומרים) -פציצות איכות חו"ג מרכזי -ספק נכשל בהתאמה ל ) מערכת מים להזרקה ) נפח אי יציבות חומרי ביניים אי עמידה בהספקה פסילת חומר סופי ללא אפשרות תיקון שינוי מפרט לחותר סופי בטיחותי (מקור חומרים) -קורוזיבי וריח שילוח ללקוח בתנאים לא מתאימים אספקת ציוד באיחור ביעות בייצור - גימלון מחיר חו"ג מרכזי Overlay Plot Results of Total Risk Profiling Region of Critical Risks Department/Activity/Project R&D, Purchase, Engineering, Production, QA, Storage, Shipment, Safety & Risk=Likelihood*Severity
21 מ יפ ו י ה ס יכ וני ם I Catastrophic II Critical III Marginal IV Negligible Impossible F Improbable E Remote D Occasional C Probable B Frequent A 3 Acceptable Risk Operation permissible 2 Conditionally Acceptable Risk Desirable to reduce risk to lower limits (otherwise operation requires written, time-limited waiver, endorsed by management) Unacceptable Risk Imperative to reduce risk to lower limits
22 Sample FMEA Table Failure Mode End Effect SEV Cause OCC Controls DET RPN Recommended Actions Employee Exposed to ALLYBROMIDE Safety Drops at the end of pipes after filling 9 PPE + Training 8 72 * Change filling method to pressure / Vacuum * Write detailed Instructions for filling Vapors while filling PPE + Training 8 8 * Change filling method to pressure / Vacuum * Periodic check of air changing system Too Little Allylbromide added Product scraped 6 batteries empty during weighing 3 NONE 8 * add marks on filling tank for backup * change batteries periodically Cross contamination - from previous stage Product scraped 6 insufficient cleaning 3 Visual inspectio n 8 44 Temperature too high Product scraped 6 human mistake - improper setting 2 signing the instructio ns 8 96 Temperature too low Neglectable effect human mistake - improper setting 2 signing the instructio ns 8 6
23 Initial Scree Plot RPN = Risk Priority Number Initial TRE = 25.7% Causes Critical Issues
24 Sample Action Table Action Name Respo nsible Target Date Progress Step FM EE S Cause O Controls D R P N Build docking stations for all flexible pipes Perry 3- % 24 contaminatio n Scrap 6 End of pipe contaminate d from surrounding environment 5 NONE 3 New method for adding liquids - including software improvements Rafi % 24 inaccurate water quantities added Scrap 6 L measuring resolution NONE 6 Purchase dedicated refrigerator Perry 5/2 25% 28 mix final product with process materials Regul atory 3 mixed storage NONE 3 New faucet type (engineering) Perry 3- % 7c employee exposure to dangerous materials Safet y Material leftovers in faucet PPE (inefficient ) 9 9
25 FMEA Effectiveness RPN = Risk Priority Number After TRE = 5.6% RPN Before Causes RPN After % IMPROVE= = 39.3% RPN Before Before After
26 THANK YOU
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