‘Follow Pharma Broadcast Annex I: Methods & Tools era ANSE Annex 1.4 Fault Tree Analysis (FTA) eo Sone TS ATE OR SO A OT PTT GERAnnex I: Methods & Tools 1.4: Fault Tree Analysis (FTA) (IEC 61025) e Assumes failure of the functionality of a product or process Identifies all potential root causes of an assumed failure or problem that it is thought to be important to prevent e Evaluates system (or sub-system) failures one at a time Can combine multiple causes by identifying causal chains ‘repares by some embers ofthe IH OB EWG for exaple ony, nor an Tl pale igudance RT OG>Annex I: Methods & Tools 1.4: Fault Tree Analysis (FTA) How to perform? Results are represented pictorially in the form of a tree of fault modes At each level in the tree, combinations of fault modes are described with logical operators (AND, OR, etc.) a © © A ht tt /Avww.sverdrup com/safety/tta. pdf ‘repares by some embers ofthe IH OB EWG for exaple ony, nor an Tl pale igudance usp ye?Annex I: Methods & Tools Q9 QUALITY | 1.4: Fault Tree Analysis (FTA) « Basic symbols: Basic Flow ¢ Fault in a box indicates FAULT that it is a result of previous faults « Connects preceding fault OR with a subsequent fault that could cause a failure * Connects two or more faults AND that must occur simultaneously to cause the preceding fault Source: Overview of Risk Management Techniques. Robert C. Mensan, PhD (2004) ‘repae3 by some embers ote TON GB EWG Ter example any, naan oT paiguence ‘iy 2005 setAnnex I: Methods & Tools 1.4: Fault Tree Analysis (FTA) « Basic symbols: End Points & Connector ¢ Root cause (= basic fault) (e.g. part failure, software error, human error) e Fault to be further analyzed with more time or information if needed /\ /\ ¢ Transfer-in and transfer-out events Source: Overview of Risk Management Techniques. Robert C. Mensan, PhD (2004) ‘repae3 by some embers ote TON GB EWG Ter example any, naan oT paiguence Root cause iy 2006 adeAnnex I: Methods & Tools 1.4: Fault Tree Analysis (FTA) « Additional Symbols « Exclusive OR Gate: C © Fault occurs if only one of the input faults occurs « Priority AND Gate: Fault occurs if all inputs occur in a certain order e Voting OR Gate: (mC Fault occurs if “m” or more out of “n” input faults occurs Source: Overview of Risk Management Techniques. Robert C. Mensan, PhD (2004) iy 2006 se 6 ‘repae3 by some embers ote TON GB EWG Ter example any, naan oT paiguenceAnnex I: Methods & Tools era ANSE 1.4: Fault Tree Analysis (FTA) Potential Areas of Use(s) e Establish the pathway to the root cause of the failure « While investigating complaints or deviations to fully understand their root cause « Ensure that intended improvements will fully resolve the issue and not lead to other issues « Evaluating how multiple factors affect a given issue ICH Qo ‘repae3 by some embers ote TON GB EWG Ter example any, naan oT paiguence “iy 2005, 31067Annex I: Methods & Tools 1.4: Fault Tree Analysis (FTA) ¢ Investigation of laboratory failures Prono fom ater pone catraton Out speciicaion or [ Laberroe or LL rac of ieraces ores fost ronson fos ber ‘repae3 by some embers ote TON GB EWG Ter example any, naan oT paiguence “iy 2005, heAnnex I: Methods & Tools 1.4: Fault Tree Analysis (FTA Hard to open rey a Cer eT Ea ecru] eee] Change closing torque and calibrate periodically “Takayoshi Matsurira, Eisai Co Grape ame mambo ee GD EWG To Bae OB et ORR PTSIRNTARE {uy 206 ste Supply pce coking ClosedAnnex I: Methods & Tools era ANSE 1.4: Fault Tree Analysis (FTA) Experiences ¢ Better as a retrospective tool « Visually focused: aid for showing linkages * Limitations > Only as good as input > Time and resource consuming (needs FMEA as a complement ) > Need skilled leader to focus on what is really important > Need significant amount of information > Human errors may be difficult to predict > Many potential fault trees for a system - Some more useful than others - Need to evaluate contribution ‘repares by some embers ofthe IH OB EWG for exaple ony, nor an Tl pale igudance “hy 2005, seAnnex I: Methods & Tools 1.2: Failure Mode Effects Analysis (FMEA) 1.4: Fault Tree Analysis (FTA) FTA FMEA e Assumes * Assumes failure of the component failure functionality of a product ¢ Identifies the root cause ¢ Identifies functional failure of functional failure as a result of component failure ° Top down ¢ Bottom up ‘repae3 by some embers ote TON GB EWG Ter example any, naan oT paiguence “iy 2005, 027