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Risk management using FMEA in pharma

The document discusses risk management in the pharmaceutical industry using Failure Mode and Effects Analysis (FMEA) as a key tool. It outlines a four-step risk management process according to ICH Q9, focusing on identifying potential failures and their impacts while providing practical examples like the coffee-making process. FMEA is presented as a systematic approach for evaluating risks, prioritizing them, and implementing controls to enhance product quality and compliance.

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Risk Management in Pharma using FMEA @ Sandeep.LeanSixSigma Sandeep.LeanSixSigma
What we do in Pharma? PRODUCTS & SERVICES Sandeep.LeanSixSigma
Every Process has... Probability of Failure or Loss or Exposure to Danger Sandeep.LeanSixSigma
Quality Issues Compliance Customer Satisfaction Product Functionality Business and Profits This processes have RISK of Failures.. Sandeep.LeanSixSigma
Measure Risk Manage Risk We Can’t totally avoid RISK RISK GUARANTEED & Sandeep.LeanSixSigma
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH - Q9 ICH Defines the Standard of Quality Risk Management ICH Defines the Standard of Quality Risk Management Sandeep.LeanSixSigma
Managing Risk 4 STEPS of Risk management as per ICH Q9 RISK COMMUNICATION RISK ASSESSMENT RISK REVIEW RISK CONTROL Risk Analysis Risk Evaluation Risk Reduction Risk Acceptance Step 1 Step 2 Step 3 Step 4 Risk Identification Sandeep.LeanSixSigma
Risk reviewRisk review Risk controlRisk control Risk AssessmentRisk Assessment QRM Process - ICH Q9 Initiate QRM process Risk identificationRisk identification Output / result of QRM process Risk analysisRisk analysis Risk evaluationRisk evaluation Risk reductionRisk reduction Risk acceptanceRisk acceptance Review eventsReview events Unacceptable Riskmanagementtools Riskcommunication Sandeep.LeanSixSigma
ICH Q9 vs ISO 14971(medical devices) Sandeep.LeanSixSigma Risk Review RiskCommunication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process RiskManagementtools
Risk Management Scope Risk Management Preventive Maintenance Preventive Maintenance IPC sampling / testing IPC sampling / testing QualificationQualification ValidationValidation Out of SpecOut of Spec Change controlChange control Environmental. Monitoring. Environmental. Monitoring. DeviationsDeviations Equipment. cleaning Equipment. cleaning CalibrationCalibration Sandeep.LeanSixSigma
Risk Management ToolsRisk Management Tools There are many tools of Risk Management. We will learn FMEA in this training Sandeep.LeanSixSigma
FMEA Sandeep.LeanSixSigma
What you will Learn • What is FMEA? • Why is an FMEA important • How to identify Risk • How to mitigate Risk using FMEA • Live Example of FMEA • Do it your self Sandeep.LeanSixSigma
What is FMEA Failure Mode Effect Analysis Analysis Mode Failure Effect Types , Ways Possibilities Potential Negative Effect on process under study Study RISK and Reduce it What can go WRONG in your process or product Sandeep.LeanSixSigma
FMEA a Tool and a process to Identify Potential Failures, its Effects and Risks in your Process and Product Design and then Eliminate or Reduce them. Process Step Key Process Input Potential Failure Mode Potential Failure Effect S e v Potential Causes O c c Current Controls D e t R P N Actions Recommended S e v O c c D e t R P N What is FMEA Failure Mode Effect Analysis Sandeep.LeanSixSigma
History of FMEA Sandeep.LeanSixSigma
Application of FMEA in Pharma Sandeep.LeanSixSigma
DesignDesign • Parts • Components • Sub Comp • Parts • Components • Sub Comp ProcessProcess • Man • Method • Material • Machine • Procedures • Man • Method • Material • Machine • Procedures OthersOthers • Service FMEA • System FMEA • Concept FMEA • Service FMEA • System FMEA • Concept FMEA Types of FMEA Sandeep.LeanSixSigma
Application of FMEA Implementing FMEA at early stage reduce the Cost of error Sandeep.LeanSixSigma
• Get it right the first time • Indentifies any inadequacies in the development of the product • Tests and trials may be limited to a few products • Regulatory reasons • Continuous improvement • Preventive approach • Team building • Required procedures The Reasons for FMEA Sandeep.LeanSixSigma
Creating an FMEA Sandeep.LeanSixSigma
Risk Assessment - Creating FMEA The FMEA process begins by identifying “Failure Modes,” the ways in which a product, service or process could fail wrt Customer Requirement. A project team examines every element of a service, starting from the inputs and working through to the output delivered to the customer. Sandeep.LeanSixSigma
Risk Assessment - Creating FMEA At each step, the team ASK ONE QESTION ?” WHAT CAN GO WRONG HERE Sandeep.LeanSixSigma
What is Customer Requirements? Critical To Customer Analyze how your process can fail to deliver CTC Sandeep.LeanSixSigma
Risk Assessment - Creating FMEA List down the Process Steps in the system under analysis ?List down the Process Steps in the system under analysis ? Sandeep.LeanSixSigma
Let us make Coffee for our Customer CTQ 1. Taste, 2. Strength 3. TemperatureSandeep.LeanSixSigma
Input Output Mapping MATERIAL Man Method Machine Product or Output Inputs Outputs Every process has Processing Let us do the process flow map of Coffee making process Sandeep.LeanSixSigma
Coffee Process Map Inputs OutputsInputs Outputs Filter Maker w/Filter Fresh Coffee Dosing Scoop Maker w/Filter & Coffee Brewing Coffee Maker with water Maker w/Filter Maker w/Filter & Coffee Operating Maker Heat Brewed Coffee Hot Coffee Customer Order Size Specification Complete Order Hot Coffee Cup Filled Cup Customer Cream Sugar Amount Desired Complete Order Money Coffee Delivery Complete Order Filled Cup Customer Reply Amount Specified Complete Order Make Change Temperature Taste Strength Smile Happy Customer Pour Coffee into Cup Pour Coffee into Cup Offer Cream & Sugar Offer Cream & Sugar Complete Transaction Complete Transaction Say Thank YouSay Thank You Receive Coffee Order Receive Coffee Order Pour Water into Maker Pour Water into Maker Place Filter in MakerPlace Filter in Maker Put Coffee in Filter Put Coffee in Filter Select Temperature Setting Select Temperature Setting Turn Maker OnTurn Maker On Process Map for making Coffee Water Maker Maker with water Sandeep.LeanSixSigma
Risk Assessment - Creating FMEA Pour Water in the Maker Let us take the First process step of Coffee making. Sandeep.LeanSixSigma
Risk Assessment - Creating FMEA Raw Material / Information SOP / WI / Checklist Equipment / Infrastructure Process Control / Method / Policy Utilities Environment / Regulation Human Resources Measurement List various ways how the Process can fail to deliver at various aspects of CTQ.List various ways how the Process can fail to deliver at various aspects of CTQ. We can use the following Key Process Inputs to identify failures. Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker This are the potential Failure Modes for step of pouring water This are the potential Failure Modes for step of pouring water Sandeep.LeanSixSigma
Risk Assessment - Creating FMEA How the product can fail to deliver satisfaction to customer if the failure mode occurs? How the product can fail to deliver satisfaction to customer if the failure mode occurs? Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker This are the potential Failure effects of the Failure mode - “Wrong amount of water” This are the potential Failure effects of the Failure mode - “Wrong amount of water” Sandeep.LeanSixSigma
Risk Assessment - Creating FMEA Numerically rate what is the Severity of this Failure Effect on the CustomerNumerically rate what is the Severity of this Failure Effect on the Customer Example Which consequence is more severe? 1. A fire in an open area where no one was present. 2. A fire in a house with 3 people affected. 3. A fire in a factory with 30 employees affected Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee Most Severe Sandeep.LeanSixSigma
Severity Ratings 10 Dangerous ly High Failure could lead to death or permanent injury to the customer. Financial: >1,00,00,000 INR 9 Extremel y high Failure could lead to injury to the customer. Failure would create non- compliance with registered specifications. Failure likely to lead to recall. Financial: 1,00,00,000 INR 8 Very High Failure could lead to adverse reaction for customer. Failure would create noncompliance with GMP regulations or product registrations. Failure possible to lead to recall. Financial: 50,00,000 INR 7 High Failure leads to customer percept ion of safety issue. Failure renders individual unit(s) unusable. Failure causes a high degree of customer dissatisfaction. Recall for business reasons possible but Authority required recall unlikely. Financial: 10,00,000 INR 6 Moderate Failure causes a high degree of customer dissatisfaction and numerous complaints. Failure unlikely to lead to recall. Financial: 5,00,000 INR 5 Low Failure likely to cause isolated customer complaints. Financial: 1,00,000 INR 4 Very Low Failure relates to non-dosage form issues (like minor packaging problems) and can be easily overcome by the customer. Financial: 50,000 INR 3 Minor Failure could be noticed by the customer but is unlikely to be perceived as significant enough to warrant a complaint. Financial 10,000 INR 2 Very Minor Failure not readily apparent to the customer. Financial: <$1,000 1 None Failure would not be noticeable to the customer. Financial: none
Risk Assessment - Creating FMEA Numerically rate what is the Severity of this Failure Effect on the Customer with reference to the Scale Numerically rate what is the Severity of this Failure Effect on the Customer with reference to the Scale Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Sandeep.LeanSixSigma
Risk Assessment - Creating FMEA Brainstorm among process experts what are the causes of failure in the systemBrainstorm among process experts what are the causes of failure in the system Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Faded level marks on Maker Person not attentive Person with No knowledgeNow we have to find the CAUSEs of the Failure ModesNow we have to find the CAUSEs of the Failure Modes Sandeep.LeanSixSigma
Risk Assessment - Creating FMEA Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Faded level marks on Maker Person not attentive Person with No knowledge Ask WHY? Why Wrong amount of WaterWhy Wrong amount of Water Because of Faded level marks on JarBecause of Faded level marks on Jar BrainstormBrainstorm Sandeep.LeanSixSigma
Risk Assessment - Creating FMEA Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Faded level marks on Maker Person not attentive Coffee maker not washed properly Person with No knowledge Coffee maker not Stored properly Person with No knowledge Failure Mode 1 Effect 1 Effect 2 Causes 1 Causes 2 Causes 1 Causes 2 Causes 3 One failure mode can have more then 1 Effects Each effect can have more then one Causes Sandeep.LeanSixSigma
Risk Assessment - Creating FMEA Which probability is more? 1. Chances of rain in the month of July. 2. Chances of rain in the month of January. 3. Chances of rain in the month of September Numerically rate what is the Occurrence of this Failure CauseNumerically rate what is the Occurrence of this Failure Cause Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Faded level marks on Maker Person not attentive Person with No knowledge Most Certain Sandeep.LeanSixSigma
Probability Ratings 10 Very High: Failure is almost inevitable 1 per Day or > 3 in 10 Units More than one occurrence per day or a probability of more than three occurrences in 10 units. 9 1 per 3 to 4 Days or = 3 in 10 Units One occurrence every three to four days or a probability of three occurrences in 10 units. 8 High: Repeated failures 1 per Week or = 5 in 100 Units One occurrence per week or a probability of 5 occurrences in 100. 7 1 per Month or = 1 in 100 Units One occurrence every month or one occurrence in 100 units. 6 Moderate: Occasional Failures 1 per 3 Months or = 3 in 1000 Units One occurrence every three months or three occurrences in 1,000 units. 5 1 per 6 Month to 1 Year or = 1 in 10,000 Units One occurrence every six months to one year or one occurrence in 10,000 units. 4 1 per Year or = 6 in 100,000 Units One occurrence per year or six occurrences in 100,000 units. 3 Low: Relatively few Failures 1 per 1 to 3 Years or = 6 in 10,000,000 Units One occurrence every one to three years or six occurrences in 10,000,000 units. 2 1 per 3 to 5 Years or = 2 in 1,000,000,000 Units One occurrence every three to five years or 2 occurrences in 1,000,000,000 units. 1 Remote: Failure is unlikely 1 per >5 Years or < 2 in 1,000,000,000 Units One occurrence in greater than five years or less than two occurrences in 1,000,000,000 units.
Risk Assessment - Creating FMEA Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Person not attentive Person with No knowledge 3 8 4 Let us give the Occurrence Ratings for the Causes based on Probability Chart Faded level marks on Maker Evaluate how often this Cause has occurred in the past Evaluate how often this Cause has occurred in the past Based on: 1. Past Data 2. Trends 3. Experience Based on: 1. Past Data 2. Trends 3. Experience Faded level marks on Maker 10 – Event Will Occur most Probably10 – Event Will Occur most Probably 1 – Event Will Not Occur1 – Event Will Not Occur Sandeep.LeanSixSigma
Risk Assessment - Creating FMEA Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Faded level marks on Maker Person not attentive Person with No knowledge 3 8 4 What are Present Controls to Detect that this Causes have occurredWhat are Present Controls to Detect that this Causes have occurred Visual Inspection None Trainings Sandeep.LeanSixSigma
Risk Assessment - Creating FMEA Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Faded level marks on Maker Person not attentive Person with No knowledge 3 8 4 Visual Inspection None Trainings Which Detection is the best is more? 1. Manual Check by operator for Defects 2. Machines give alarm if defects occurs 3. Machine stops if defect occurs Numerically rate what is the Present Control Detection 10 -- Most Difficult to Detect and 1 – Most easy to detect Numerically rate what is the Present Control Detection 10 -- Most Difficult to Detect and 1 – Most easy to detect Best Detection Sandeep.LeanSixSigma
Detection Ratings 10 Impossible to detect The product is not inspected or the defect caused by the failure is not detectable. 9 Very Remote Product is sampled, inspected, and released based on Acceptable Quality Level (AQL) sampling plans. 8 Remote Product is accepted based on no defects in a sample. 7 Very Low Product is accepted based on double inspecting and no defects in a sample. 6 Low Product is 100% manually inspected in the process. 5 Moderate Product is 100% manually inspected using go/no-go or other mistake-proofing gauges. 4 Moderately High Some Statistical Process Control (SPC) is used in the process and product is final inspected off-line. 3 High SPC is used and there is immediate reaction to out-of-control conditions. 2 Very High All product is 100% automatically inspected. 1 Almost Certain The defect is obvious and there is 100% automatic inspection with regular calibration and preventive maintenance of the inspection equipment.
Risk Assessment - Creating FMEA Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Faded level marks on Maker Person not attentive Person with No knowledge 3 8 4 Visual Inspection None Trainings 10 -- Most Difficult to Detect10 -- Most Difficult to Detect 4 8 5HOW GOOD IS MY TECTION SYSTEM? Rate it NUMERICALLY 1 – Most Easy to Detect1 – Most Easy to Detect Sandeep.LeanSixSigma
Risk Assessment - Creating FMEA Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Faded level marks on Maker Person not attentive Person with No knowledge 3 8 4 Visual Inspection None Trainings 4 8 5 RPN = Severity X Occurrence X Detection Risk Priority Number 96 640 140 8 3 4X X = 96 Sandeep.LeanSixSigma
By Getting RPN for failure mode we Complete the stage 1 of FMEA Stage 2 is RISK Mitigation RISK ASSESSMENT Sandeep.LeanSixSigma
Risk Control – Acting on FMEA Action D E T R P N Recommend ed Action(s) Responsi bility TCD Potential Failure Mode (How the X fails?) S E V O C C RPN Should be as low as possible 1 10 1 10 1 10 1 1000 Min = ?? Max = ?? So Acceptable = ?? Min Max Sandeep.LeanSixSigma
Risk Control – Acting on FMEA RPN To 125 Occ Det Reduce the Occurrences of Failure by Act on the Root Causes, fix the problem. Improve Controls to Detect failure modes Sev Severity can’t be changed, it remains the same.= Actions Taken O C C D E T R P N Action ResultsD E T R P N Recommend ed Action(s) Responsi bility TCD Potential Failure Mode (How the X fails?) S E V O C C Actions Taken O C C D E T R P N Action ResultsD E T R P N Recommend ed Action(s) Responsi bility TCD Potential Failure Mode (How the X fails?) S E V O C C Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder 8 10 7 3 8 4 96 640 140 4 8 5 So we have to reduce Severity Occurrence Detection So to mitigate or reduce RISK Sandeep.LeanSixSigma
Risk Control – Acting on FMEA Sandeep.LeanSixSigma
Risk Control – Acting on FMEA RPN To 125 Occ Det Sev= Actions Taken O C C D E T R P N Action ResultsD E T R P N Recommend ed Action(s) Responsi bility TCD Potential Failure Mode (How the X fails?) S E V O C C Actions Taken O C C D E T R P N Action ResultsD E T R P N Recommend ed Action(s) Responsi bility TCD Potential Failure Mode (How the X fails?) S E V O C C Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder 8 10 7 3 8 4 96 640 140 4 8 5 Replace Coffee maker Ram 10 July 14 Storage & Inspection Standards Krishna 10 July 14 2 3 3 48 120 63 3 4 3Std measurements Hari 10 July 14 Back to our coffee making example We recommend some actions to reduce Occurrence and increase Detection After the action completion Occurrence will reduce and rating will come down to 3 from 8 After the action completion Occurrence will reduce and rating will come down to 3 from 8 Sandeep.LeanSixSigma
Specific Cases and Thumb Rules 2 10 10 200 10 2 10 200 10 10 2 200 10 4 2 80 3 10 4 120 2 8 10 160 Failure Mode 1 Which Failure Mode would you take to Top Priority. All are having same RPN of 200 Failure Mode 2 Failure Mode 3 Failure Mode 1 Failure Mode 2 Failure Mode 3 Which Failure Mode would you take to Top Priority Sandeep.LeanSixSigma
Specific Cases and Thumb Rules 2 10 10 200 10 2 10 200 10 10 2 200 10 4 2 80 3 10 4 120 2 8 10 160 Failure Mode 1 Failure Mode 2 Failure Mode 3 Failure Mode 1 Failure Mode 2 Failure Mode 3 Higher the SEVERITY more should the priority 1st 2nd Higher the SEVERITY more should the priority Sandeep.LeanSixSigma
Examples Source : Bio Pharm International Volume 24, Issue 3, pp. 44-48 Sandeep.LeanSixSigma
Recipe in FMEA What can Go Wrong in Process – Failure Mode Potential Failure Effect on Product Quantify Severity of Effect on Product Potential Cause of the Failure Mode Quantify Occurrence of Cause Present Controls to detect of cause Failure Mode Quantify Detection of Cause Calculate RPN (Risk Priority Number) RPN = Severity x Occurrence x Detection Act and Control High RPN CausesSandeep.LeanSixSigma
Ranking Severity (S) Probability (P) Detection (D) 10 Death More than once a day Impossible to detect 9 ↓ 3 – 4 times a day Remote 8 Permanent injury Once a week Very slight 7 ↓ Once a month Slight 6 Temporary injury Once in three month Low 5 ↓ Once in half – one year Medium 4 Reported/ dissatisfied Once a year Moderately high 3 ↓ Once in 1 – 3 years High 2 Notice/ no report Once in 3 – 5 years Very High 1 ↓ Less than once in 5 years Virtually certain FMEA Ratings – SPD simplified Sandeep.LeanSixSigma
FMEA – Template Identify failure modes and their effects Identify causes of the failure modes and controls Prioritize Determine and assess actions Sandeep.LeanSixSigma
Now complete one FMEA on your OWN And you will learn things that I have NOT thought you. Sandeep.LeanSixSigma
Hope it helps Sandeep.LeanSixSigma
Disclaimer Sandeep.LeanSixSigma The opinions expressed in this presentation and are solely those of the presenter and not necessarily those of in line with regulatory or other guidelines. Use this presentation only for the purpose of reference. The author does not guarantee the accuracy or reliability of the information provided herein.
References 1. ICH, Q7A Good Manufacturing Practice Guideline 2. ISO 14971 Guidelines 3. Failure Mode and Effect Analysis : FMEA from Theory to Execution, 2nd Edition by D H Stamatis. 4. Pharmamanufacturing Journal 5. Pharmmirror Journal 6. Bio Pharma International Journal 6. www.stockfreeimages.com Sandeep.LeanSixSigma
@ the author is a Business Excellence Consultant a Lean Six Sigma Black Belt an Engineer with MBA in Operations a Decade of experience in Manufacturing and Pharma stays in Goa, India. Email : sandeep.leansixsigma@gmail.com : www.slideshare.net/sandeepleansixsigma : www.youtube.com/user/sandeepleansixsigma Sandeep.LeanSixSigma Sandeep U Naik Do Get in touch
Thank You Please comment below Sandeep.LeanSixSigma

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Risk management using FMEA in pharma

  • 1.
    Risk Management inPharma using FMEA @ Sandeep.LeanSixSigma Sandeep.LeanSixSigma
  • 2.
    What we doin Pharma? PRODUCTS & SERVICES Sandeep.LeanSixSigma
  • 3.
    Every Process has... Probabilityof Failure or Loss or Exposure to Danger Sandeep.LeanSixSigma
  • 4.
    Quality Issues Compliance Customer Satisfaction ProductFunctionality Business and Profits This processes have RISK of Failures.. Sandeep.LeanSixSigma
  • 5.
    Measure Risk ManageRisk We Can’t totally avoid RISK RISK GUARANTEED & Sandeep.LeanSixSigma
  • 6.
    International Conference on Harmonisationof Technical Requirements for Registration of Pharmaceuticals for Human Use International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH - Q9 ICH Defines the Standard of Quality Risk Management ICH Defines the Standard of Quality Risk Management Sandeep.LeanSixSigma
  • 7.
    Managing Risk 4 STEPSof Risk management as per ICH Q9 RISK COMMUNICATION RISK ASSESSMENT RISK REVIEW RISK CONTROL Risk Analysis Risk Evaluation Risk Reduction Risk Acceptance Step 1 Step 2 Step 3 Step 4 Risk Identification Sandeep.LeanSixSigma
  • 8.
    Risk reviewRisk review RiskcontrolRisk control Risk AssessmentRisk Assessment QRM Process - ICH Q9 Initiate QRM process Risk identificationRisk identification Output / result of QRM process Risk analysisRisk analysis Risk evaluationRisk evaluation Risk reductionRisk reduction Risk acceptanceRisk acceptance Review eventsReview events Unacceptable Riskmanagementtools Riskcommunication Sandeep.LeanSixSigma
  • 9.
    ICH Q9 vsISO 14971(medical devices) Sandeep.LeanSixSigma Risk Review RiskCommunication Risk Assessment Risk Evaluation unacceptable Risk Control Risk Analysis Risk Reduction Risk Identification Review Events Risk Acceptance Initiate Quality Risk Management Process Output / Result of the Quality Risk Management Process RiskManagementtools
  • 10.
    Risk Management Scope RiskManagement Preventive Maintenance Preventive Maintenance IPC sampling / testing IPC sampling / testing QualificationQualification ValidationValidation Out of SpecOut of Spec Change controlChange control Environmental. Monitoring. Environmental. Monitoring. DeviationsDeviations Equipment. cleaning Equipment. cleaning CalibrationCalibration Sandeep.LeanSixSigma
  • 11.
    Risk Management ToolsRiskManagement Tools There are many tools of Risk Management. We will learn FMEA in this training Sandeep.LeanSixSigma
  • 12.
  • 13.
    What you willLearn • What is FMEA? • Why is an FMEA important • How to identify Risk • How to mitigate Risk using FMEA • Live Example of FMEA • Do it your self Sandeep.LeanSixSigma
  • 14.
    What is FMEA FailureMode Effect Analysis Analysis Mode Failure Effect Types , Ways Possibilities Potential Negative Effect on process under study Study RISK and Reduce it What can go WRONG in your process or product Sandeep.LeanSixSigma
  • 15.
    FMEA a Tool anda process to Identify Potential Failures, its Effects and Risks in your Process and Product Design and then Eliminate or Reduce them. Process Step Key Process Input Potential Failure Mode Potential Failure Effect S e v Potential Causes O c c Current Controls D e t R P N Actions Recommended S e v O c c D e t R P N What is FMEA Failure Mode Effect Analysis Sandeep.LeanSixSigma
  • 16.
  • 17.
    Application of FMEAin Pharma Sandeep.LeanSixSigma
  • 18.
    DesignDesign • Parts • Components •Sub Comp • Parts • Components • Sub Comp ProcessProcess • Man • Method • Material • Machine • Procedures • Man • Method • Material • Machine • Procedures OthersOthers • Service FMEA • System FMEA • Concept FMEA • Service FMEA • System FMEA • Concept FMEA Types of FMEA Sandeep.LeanSixSigma
  • 19.
    Application of FMEA Implementing FMEAat early stage reduce the Cost of error Sandeep.LeanSixSigma
  • 20.
    • Get itright the first time • Indentifies any inadequacies in the development of the product • Tests and trials may be limited to a few products • Regulatory reasons • Continuous improvement • Preventive approach • Team building • Required procedures The Reasons for FMEA Sandeep.LeanSixSigma
  • 21.
  • 22.
    Risk Assessment -Creating FMEA The FMEA process begins by identifying “Failure Modes,” the ways in which a product, service or process could fail wrt Customer Requirement. A project team examines every element of a service, starting from the inputs and working through to the output delivered to the customer. Sandeep.LeanSixSigma
  • 23.
    Risk Assessment -Creating FMEA At each step, the team ASK ONE QESTION ?” WHAT CAN GO WRONG HERE Sandeep.LeanSixSigma
  • 24.
    What is CustomerRequirements? Critical To Customer Analyze how your process can fail to deliver CTC Sandeep.LeanSixSigma
  • 25.
    Risk Assessment -Creating FMEA List down the Process Steps in the system under analysis ?List down the Process Steps in the system under analysis ? Sandeep.LeanSixSigma
  • 26.
    Let us makeCoffee for our Customer CTQ 1. Taste, 2. Strength 3. TemperatureSandeep.LeanSixSigma
  • 27.
    Input Output Mapping MATERIAL Man Method Machine Productor Output Inputs Outputs Every process has Processing Let us do the process flow map of Coffee making process Sandeep.LeanSixSigma
  • 28.
    Coffee Process Map InputsOutputsInputs Outputs Filter Maker w/Filter Fresh Coffee Dosing Scoop Maker w/Filter & Coffee Brewing Coffee Maker with water Maker w/Filter Maker w/Filter & Coffee Operating Maker Heat Brewed Coffee Hot Coffee Customer Order Size Specification Complete Order Hot Coffee Cup Filled Cup Customer Cream Sugar Amount Desired Complete Order Money Coffee Delivery Complete Order Filled Cup Customer Reply Amount Specified Complete Order Make Change Temperature Taste Strength Smile Happy Customer Pour Coffee into Cup Pour Coffee into Cup Offer Cream & Sugar Offer Cream & Sugar Complete Transaction Complete Transaction Say Thank YouSay Thank You Receive Coffee Order Receive Coffee Order Pour Water into Maker Pour Water into Maker Place Filter in MakerPlace Filter in Maker Put Coffee in Filter Put Coffee in Filter Select Temperature Setting Select Temperature Setting Turn Maker OnTurn Maker On Process Map for making Coffee Water Maker Maker with water Sandeep.LeanSixSigma
  • 29.
    Risk Assessment -Creating FMEA Pour Water in the Maker Let us take the First process step of Coffee making. Sandeep.LeanSixSigma
  • 30.
    Risk Assessment -Creating FMEA Raw Material / Information SOP / WI / Checklist Equipment / Infrastructure Process Control / Method / Policy Utilities Environment / Regulation Human Resources Measurement List various ways how the Process can fail to deliver at various aspects of CTQ.List various ways how the Process can fail to deliver at various aspects of CTQ. We can use the following Key Process Inputs to identify failures. Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker This are the potential Failure Modes for step of pouring water This are the potential Failure Modes for step of pouring water Sandeep.LeanSixSigma
  • 31.
    Risk Assessment -Creating FMEA How the product can fail to deliver satisfaction to customer if the failure mode occurs? How the product can fail to deliver satisfaction to customer if the failure mode occurs? Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker This are the potential Failure effects of the Failure mode - “Wrong amount of water” This are the potential Failure effects of the Failure mode - “Wrong amount of water” Sandeep.LeanSixSigma
  • 32.
    Risk Assessment -Creating FMEA Numerically rate what is the Severity of this Failure Effect on the CustomerNumerically rate what is the Severity of this Failure Effect on the Customer Example Which consequence is more severe? 1. A fire in an open area where no one was present. 2. A fire in a house with 3 people affected. 3. A fire in a factory with 30 employees affected Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee Most Severe Sandeep.LeanSixSigma
  • 33.
    Severity Ratings 10 Dangerous lyHigh Failure could lead to death or permanent injury to the customer. Financial: >1,00,00,000 INR 9 Extremel y high Failure could lead to injury to the customer. Failure would create non- compliance with registered specifications. Failure likely to lead to recall. Financial: 1,00,00,000 INR 8 Very High Failure could lead to adverse reaction for customer. Failure would create noncompliance with GMP regulations or product registrations. Failure possible to lead to recall. Financial: 50,00,000 INR 7 High Failure leads to customer percept ion of safety issue. Failure renders individual unit(s) unusable. Failure causes a high degree of customer dissatisfaction. Recall for business reasons possible but Authority required recall unlikely. Financial: 10,00,000 INR 6 Moderate Failure causes a high degree of customer dissatisfaction and numerous complaints. Failure unlikely to lead to recall. Financial: 5,00,000 INR 5 Low Failure likely to cause isolated customer complaints. Financial: 1,00,000 INR 4 Very Low Failure relates to non-dosage form issues (like minor packaging problems) and can be easily overcome by the customer. Financial: 50,000 INR 3 Minor Failure could be noticed by the customer but is unlikely to be perceived as significant enough to warrant a complaint. Financial 10,000 INR 2 Very Minor Failure not readily apparent to the customer. Financial: <$1,000 1 None Failure would not be noticeable to the customer. Financial: none
  • 34.
    Risk Assessment -Creating FMEA Numerically rate what is the Severity of this Failure Effect on the Customer with reference to the Scale Numerically rate what is the Severity of this Failure Effect on the Customer with reference to the Scale Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Sandeep.LeanSixSigma
  • 35.
    Risk Assessment -Creating FMEA Brainstorm among process experts what are the causes of failure in the systemBrainstorm among process experts what are the causes of failure in the system Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Faded level marks on Maker Person not attentive Person with No knowledgeNow we have to find the CAUSEs of the Failure ModesNow we have to find the CAUSEs of the Failure Modes Sandeep.LeanSixSigma
  • 36.
    Risk Assessment -Creating FMEA Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Faded level marks on Maker Person not attentive Person with No knowledge Ask WHY? Why Wrong amount of WaterWhy Wrong amount of Water Because of Faded level marks on JarBecause of Faded level marks on Jar BrainstormBrainstorm Sandeep.LeanSixSigma
  • 37.
    Risk Assessment -Creating FMEA Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Faded level marks on Maker Person not attentive Coffee maker not washed properly Person with No knowledge Coffee maker not Stored properly Person with No knowledge Failure Mode 1 Effect 1 Effect 2 Causes 1 Causes 2 Causes 1 Causes 2 Causes 3 One failure mode can have more then 1 Effects Each effect can have more then one Causes Sandeep.LeanSixSigma
  • 38.
    Risk Assessment -Creating FMEA Which probability is more? 1. Chances of rain in the month of July. 2. Chances of rain in the month of January. 3. Chances of rain in the month of September Numerically rate what is the Occurrence of this Failure CauseNumerically rate what is the Occurrence of this Failure Cause Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Faded level marks on Maker Person not attentive Person with No knowledge Most Certain Sandeep.LeanSixSigma
  • 39.
    Probability Ratings 10 VeryHigh: Failure is almost inevitable 1 per Day or > 3 in 10 Units More than one occurrence per day or a probability of more than three occurrences in 10 units. 9 1 per 3 to 4 Days or = 3 in 10 Units One occurrence every three to four days or a probability of three occurrences in 10 units. 8 High: Repeated failures 1 per Week or = 5 in 100 Units One occurrence per week or a probability of 5 occurrences in 100. 7 1 per Month or = 1 in 100 Units One occurrence every month or one occurrence in 100 units. 6 Moderate: Occasional Failures 1 per 3 Months or = 3 in 1000 Units One occurrence every three months or three occurrences in 1,000 units. 5 1 per 6 Month to 1 Year or = 1 in 10,000 Units One occurrence every six months to one year or one occurrence in 10,000 units. 4 1 per Year or = 6 in 100,000 Units One occurrence per year or six occurrences in 100,000 units. 3 Low: Relatively few Failures 1 per 1 to 3 Years or = 6 in 10,000,000 Units One occurrence every one to three years or six occurrences in 10,000,000 units. 2 1 per 3 to 5 Years or = 2 in 1,000,000,000 Units One occurrence every three to five years or 2 occurrences in 1,000,000,000 units. 1 Remote: Failure is unlikely 1 per >5 Years or < 2 in 1,000,000,000 Units One occurrence in greater than five years or less than two occurrences in 1,000,000,000 units.
  • 40.
    Risk Assessment -Creating FMEA Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Person not attentive Person with No knowledge 3 8 4 Let us give the Occurrence Ratings for the Causes based on Probability Chart Faded level marks on Maker Evaluate how often this Cause has occurred in the past Evaluate how often this Cause has occurred in the past Based on: 1. Past Data 2. Trends 3. Experience Based on: 1. Past Data 2. Trends 3. Experience Faded level marks on Maker 10 – Event Will Occur most Probably10 – Event Will Occur most Probably 1 – Event Will Not Occur1 – Event Will Not Occur Sandeep.LeanSixSigma
  • 41.
    Risk Assessment -Creating FMEA Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Faded level marks on Maker Person not attentive Person with No knowledge 3 8 4 What are Present Controls to Detect that this Causes have occurredWhat are Present Controls to Detect that this Causes have occurred Visual Inspection None Trainings Sandeep.LeanSixSigma
  • 42.
    Risk Assessment -Creating FMEA Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Faded level marks on Maker Person not attentive Person with No knowledge 3 8 4 Visual Inspection None Trainings Which Detection is the best is more? 1. Manual Check by operator for Defects 2. Machines give alarm if defects occurs 3. Machine stops if defect occurs Numerically rate what is the Present Control Detection 10 -- Most Difficult to Detect and 1 – Most easy to detect Numerically rate what is the Present Control Detection 10 -- Most Difficult to Detect and 1 – Most easy to detect Best Detection Sandeep.LeanSixSigma
  • 43.
    Detection Ratings 10 Impossible todetect The product is not inspected or the defect caused by the failure is not detectable. 9 Very Remote Product is sampled, inspected, and released based on Acceptable Quality Level (AQL) sampling plans. 8 Remote Product is accepted based on no defects in a sample. 7 Very Low Product is accepted based on double inspecting and no defects in a sample. 6 Low Product is 100% manually inspected in the process. 5 Moderate Product is 100% manually inspected using go/no-go or other mistake-proofing gauges. 4 Moderately High Some Statistical Process Control (SPC) is used in the process and product is final inspected off-line. 3 High SPC is used and there is immediate reaction to out-of-control conditions. 2 Very High All product is 100% automatically inspected. 1 Almost Certain The defect is obvious and there is 100% automatic inspection with regular calibration and preventive maintenance of the inspection equipment.
  • 44.
    Risk Assessment -Creating FMEA Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Faded level marks on Maker Person not attentive Person with No knowledge 3 8 4 Visual Inspection None Trainings 10 -- Most Difficult to Detect10 -- Most Difficult to Detect 4 8 5HOW GOOD IS MY TECTION SYSTEM? Rate it NUMERICALLY 1 – Most Easy to Detect1 – Most Easy to Detect Sandeep.LeanSixSigma
  • 45.
    Risk Assessment -Creating FMEA Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder Pour Water in the Maker Coffee too Strong or weak Contamination of Coffee Change in Taste of Coffee 8 10 7 Faded level marks on Maker Person not attentive Person with No knowledge 3 8 4 Visual Inspection None Trainings 4 8 5 RPN = Severity X Occurrence X Detection Risk Priority Number 96 640 140 8 3 4X X = 96 Sandeep.LeanSixSigma
  • 46.
    By Getting RPNfor failure mode we Complete the stage 1 of FMEA Stage 2 is RISK Mitigation RISK ASSESSMENT Sandeep.LeanSixSigma
  • 47.
    Risk Control –Acting on FMEA Action D E T R P N Recommend ed Action(s) Responsi bility TCD Potential Failure Mode (How the X fails?) S E V O C C RPN Should be as low as possible 1 10 1 10 1 10 1 1000 Min = ?? Max = ?? So Acceptable = ?? Min Max Sandeep.LeanSixSigma
  • 48.
    Risk Control –Acting on FMEA RPN To 125 Occ Det Reduce the Occurrences of Failure by Act on the Root Causes, fix the problem. Improve Controls to Detect failure modes Sev Severity can’t be changed, it remains the same.= Actions Taken O C C D E T R P N Action ResultsD E T R P N Recommend ed Action(s) Responsi bility TCD Potential Failure Mode (How the X fails?) S E V O C C Actions Taken O C C D E T R P N Action ResultsD E T R P N Recommend ed Action(s) Responsi bility TCD Potential Failure Mode (How the X fails?) S E V O C C Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder 8 10 7 3 8 4 96 640 140 4 8 5 So we have to reduce Severity Occurrence Detection So to mitigate or reduce RISK Sandeep.LeanSixSigma
  • 49.
    Risk Control –Acting on FMEA Sandeep.LeanSixSigma
  • 50.
    Risk Control –Acting on FMEA RPN To 125 Occ Det Sev= Actions Taken O C C D E T R P N Action ResultsD E T R P N Recommend ed Action(s) Responsi bility TCD Potential Failure Mode (How the X fails?) S E V O C C Actions Taken O C C D E T R P N Action ResultsD E T R P N Recommend ed Action(s) Responsi bility TCD Potential Failure Mode (How the X fails?) S E V O C C Wrong amount of water Coffee Maker not Clean More or less Sugar or Coffee powder 8 10 7 3 8 4 96 640 140 4 8 5 Replace Coffee maker Ram 10 July 14 Storage & Inspection Standards Krishna 10 July 14 2 3 3 48 120 63 3 4 3Std measurements Hari 10 July 14 Back to our coffee making example We recommend some actions to reduce Occurrence and increase Detection After the action completion Occurrence will reduce and rating will come down to 3 from 8 After the action completion Occurrence will reduce and rating will come down to 3 from 8 Sandeep.LeanSixSigma
  • 51.
    Specific Cases andThumb Rules 2 10 10 200 10 2 10 200 10 10 2 200 10 4 2 80 3 10 4 120 2 8 10 160 Failure Mode 1 Which Failure Mode would you take to Top Priority. All are having same RPN of 200 Failure Mode 2 Failure Mode 3 Failure Mode 1 Failure Mode 2 Failure Mode 3 Which Failure Mode would you take to Top Priority Sandeep.LeanSixSigma
  • 52.
    Specific Cases andThumb Rules 2 10 10 200 10 2 10 200 10 10 2 200 10 4 2 80 3 10 4 120 2 8 10 160 Failure Mode 1 Failure Mode 2 Failure Mode 3 Failure Mode 1 Failure Mode 2 Failure Mode 3 Higher the SEVERITY more should the priority 1st 2nd Higher the SEVERITY more should the priority Sandeep.LeanSixSigma
  • 53.
    Examples Source : BioPharm International Volume 24, Issue 3, pp. 44-48 Sandeep.LeanSixSigma
  • 56.
    Recipe in FMEA Whatcan Go Wrong in Process – Failure Mode Potential Failure Effect on Product Quantify Severity of Effect on Product Potential Cause of the Failure Mode Quantify Occurrence of Cause Present Controls to detect of cause Failure Mode Quantify Detection of Cause Calculate RPN (Risk Priority Number) RPN = Severity x Occurrence x Detection Act and Control High RPN CausesSandeep.LeanSixSigma
  • 57.
    Ranking Severity (S)Probability (P) Detection (D) 10 Death More than once a day Impossible to detect 9 ↓ 3 – 4 times a day Remote 8 Permanent injury Once a week Very slight 7 ↓ Once a month Slight 6 Temporary injury Once in three month Low 5 ↓ Once in half – one year Medium 4 Reported/ dissatisfied Once a year Moderately high 3 ↓ Once in 1 – 3 years High 2 Notice/ no report Once in 3 – 5 years Very High 1 ↓ Less than once in 5 years Virtually certain FMEA Ratings – SPD simplified Sandeep.LeanSixSigma
  • 58.
    FMEA – Template Identifyfailure modes and their effects Identify causes of the failure modes and controls Prioritize Determine and assess actions Sandeep.LeanSixSigma
  • 59.
    Now complete oneFMEA on your OWN And you will learn things that I have NOT thought you. Sandeep.LeanSixSigma
  • 60.
  • 61.
    Disclaimer Sandeep.LeanSixSigma The opinions expressedin this presentation and are solely those of the presenter and not necessarily those of in line with regulatory or other guidelines. Use this presentation only for the purpose of reference. The author does not guarantee the accuracy or reliability of the information provided herein.
  • 62.
    References 1. ICH, Q7AGood Manufacturing Practice Guideline 2. ISO 14971 Guidelines 3. Failure Mode and Effect Analysis : FMEA from Theory to Execution, 2nd Edition by D H Stamatis. 4. Pharmamanufacturing Journal 5. Pharmmirror Journal 6. Bio Pharma International Journal 6. www.stockfreeimages.com Sandeep.LeanSixSigma
  • 63.
    @ the author isa Business Excellence Consultant a Lean Six Sigma Black Belt an Engineer with MBA in Operations a Decade of experience in Manufacturing and Pharma stays in Goa, India. Email : sandeep.leansixsigma@gmail.com : www.slideshare.net/sandeepleansixsigma : www.youtube.com/user/sandeepleansixsigma Sandeep.LeanSixSigma Sandeep U Naik Do Get in touch
  • 64.
    Thank You Please commentbelow Sandeep.LeanSixSigma