FAILURE INVESTIGATION AND ROOT CAUSE ANALYSIS

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1 FAILURE INVESTIGATION AND ROOT CAUSE ANALYSIS Presented By Clay Anselmo, R.A.C. President and C.O.O. Reglera L.L.C. Denver, CO

2 Learning Objectives Understand the Definitions of Failure Investigation and Root Cause Analysis (RCA) Introduce a common Failure Investigation and RCA Process Define 1271 Regulatory Requirements Related to Failure Investigation and RCA Understand When and Where to Apply Methods and Tools Tool Introduction and Purpose Best Practices Provide Guidance on Documentation of Activities Page 2

3 Definitions Failure Investigation - The process of understanding the key attributes of a particular failure and identifying the likely causes of failure. Root Cause Analysis The process of conducting an analysis to identify the physical, human, and latent causes of a particular undesirable event. Root causes are specific underlying causes Root causes are those that can reasonably be identified Root causes are those that are controllable and fixable Root causes are those where prevention is possible Page 3

4 Regulatory Requirements When is it REQUIRED to formally investigate (and perform root cause analysis)? (b)(2) Ensuring that procedures exist for receiving, investigating, evaluating, and documenting information related to core CGTP requirements, including complaints (b)(3) Ensuring that appropriate corrective actions relating to core CGTP requirements Documentation must include, where appropriate; (ii) The nature of the problem requiring corrective action; (b)(6) Investigating and documenting HCT/P Deviations and trends of HCT/P deviations relating to core CGTP requirements (a) Procedures. You must establish and maintain procedures for review, evaluation and documentation of complaints and the investigation of complaints as appropriate (b) Complaint File. The complaint file must contain sufficient information about each complaint for proper review and for determining whether the complaint is an isolated event or represents a trend. Page 4

5 Regulatory Requirements When is it REQUIRED to formally investigate (and perform root cause analysis)? (c) Review and evaluation of complaints. As soon as practical, you must review, evaluate, and investigate each complaint that represents an event required to be reported to FDA You must review and evaluate a complaint relation to core CGTP requirements that does not represent an event required to be reported to determine whether and investigation is necessary When no investigation is made, you must maintain a record that includes the reason no investigation was made (a) Adverse reaction reports. (1) You must investigate and adverse reaction involving a communicable disease related to an HCT/P that you made available for distribution (a)(3) You must, as soon as possible investigate all adverse reactions that are the subject of these 15-day reports (b) Reports of HCT/P deviations. (1) You must investigate all HCT/P deviations related to a distributed HCT/P for which you performed a manufacturing step. Page 5

6 Process Overview Key Process Steps General Problem Identification Gather / Create Samples Failure Investigation and Experimentation Examination / Dissection / Physical Testing Causal Factor Identification Brainstorming Use of tools (fishbone, causal factor chart) Hypothesis Development Linking Analysis Data to Causal Factors Hypothesis Testing DOE / ANOVA / Simple Verification Statistically Based Methodology Root Cause Identification Root Cause Map Page 6

7 Process Flow Chart Start Revise / Clarify Problem Statement to be Specific General Problem Identification and Basic Problem Statement Gather / Create Evaluation Sample(s) Failure Investigation and Experimentation Outcome Consistent with Problem Statement Causal Factor Identification Hypothesis Development Hypothesis Testing and Verification Data Analysis Data Consistent w/ Hypothesis Final Root Cause Identification Revise Hypothesis Page 7

8 Failure Investigation Common Tools / Activities Sample Dissection Representative / Worst Case Sample Creation Physical, Chemical, Human Factors Testing and Analysis Environmental Stress Screening Process Characterization Procedural Review Page 8

9 Root Cause Analysis Common Tools / Analysis Fishbone Diagrams Pareto Charts, Run Charts, other Control Chart Methods ANOVA and Design of Experiments Causal Factor Charting Root Cause Map Page 9

10 Basic Points Use common sense Use tools when they support a comprehensive analysis, not just because they are available. Right-Size the Investigation / Analysis be sure not to make the problem more complicated than necessary Avoid ANALYSIS PARALYSIS Analyze the likely causes FIRST Use feedback loops to refine problem statement and causal analysis Most problems have more than one root cause Don t be afraid to ignore the instructions Use the tools in a way that make sense for the problem. Tools are generic and may need to be modified to fit your situation. The problem dictates the tools, not the other way around Page 10

11 Problem Identification Draft Problem Statement Begin the process with a simple statement of the problem. Do not define the cause in the problem statement. Keep an open mind. Create / Gather Samples Gather evidence showing the existence of the problem. Product Returns Collecting Documents Creation of discrepant samples Page 11

12 Problem Identification Sample Evaluation Samples may be tissue products, packaging, test results, records, etc. Product Review Sample Dissection Physical Testing Chemical Microbial Physical Functional Records Review Dates Changes Relationship to other relevant records Chronology / History Interviews Duplicates in other locations Page 12

13 Problem Identification Problem Statement Revision Inspection / Testing / Review Are results consistent with Initial Problem Statement? Updated Problem Statement Change Scope Expand Scope Reduce Scope BE SPECIFIC based on observable data Page 13

14 Identify Likely Causes Utilize Analysis Tools Cause and Effect (Fishbone) Diagram Causal Factor Chart Process Flow Chart Brainstorm Do not rule out causes or assess likelihood Look at all elements of the process When in doubt start with 5 standard categories Process Environment Materials Human Factors Equipment Page 14

15 Cause / Effect Diagram Process Environment Lack of Procedure Detail Writing Skills Valiation Particulate Filters Doors Not Calibrated Humidity No Procedure Late De-humidifier Source Air Cleaning Temperature Contamination Environment Storage Wrong Thickness Wrong Material Supplier Error Process Cleaning Materials No Procedure Spec Error Mixup Design Heating Element Installation Maintenance Reliability Chemical Air Pressure Not Executed Controller Failure Wrong Procedure Pressure Control Electrical Supply Equipment HVAC Complexity Setup Environment Distraction Other Src. Workload Overtime Training Operator Operation Cirriculum Human Factors Bag Seal Failure Page 15

16 Hypothesis Development / Testing Causal Analysis Identify list of most likely causes (top 3 to 5) Develop / utilize a rating scale or rating scheme (i.e. hazards evaluation) Be specific so that the contribution of each cause can be evaluated Hypothesis Development Develop one or more scenarios to describe the failure based on the failure investigation data and the causal analysis Must be able to be evaluated / tested Hypothesis Testing / Evaluation Simple Inspection / Review of Data Experimental Design Worst Case Analysis ANOVA DOE Page 16

17 Hypothesis Development / Testing Data Analysis Appropriate Statistical Methods Does the Data Support the Hypothesis? Yes Continue to Corrective / Preventive Action No Revise Hypothesis or Causal Analysis Maybe Further Experimentation is necessary Hypothesis Revision Revise Causal Analysis based on Experimental Results Revise Hypothesis Statement Retest as Necessary Page 17

18 Pareto Charts Calibration Errors Normalized Quantity January February March April May June Month Page 18

19 Control Chart Average Production Hours Hours UCL Mean LCL Week Number Page 19

20 Misc. Charts Bar Temperature by Position Temperature (C) Position Page 20

21 Root Cause Identification Summarize Results of Hypothesis Evaluation Identify all root causes that significantly contribute to failure Identify significant interactions between root causes Prioritize root causes based on impact Develop recommendations for: Corrective Action (remedial action to correct items / units / tissues already exhibiting failure) Preventive Action (action to prevent recurrence of the problem) Formally Document the Results Page 21

22 Root Cause Summary Table Bag Seal Failure Root Cause Analysis Summary Table Root Cause ID Description 1 Temperature Variation on Sealer Bar H 2 Sealer Cycle Time H 3 Material Thickness M 4 Accuracy of Calibration M Impact (H/M/L) Siginificant Interactions Recommendations Temperature variability increases dramatically with decreased sealing Replace sealer bar, increase calibration cycle time frequency, perform validation Decreasing cycle time increases temperature variation on sealer bar Specify minimum cycle time as 30s in SOP Lower end of current specification does not seal correctly at highest temperature Revise specification, implement thickness seen on sealer bar measurement at RI Revise instrumentation specifications for Calibration variation accounts for 20% use during sealer calibration. Improve of overall bar temperature variation instrument accuracy to 1:10 ratio Page 22

23 Documentation Failure Analysis / Root Cause Analysis can be included in: Complaints / Adverse Reactions / HCT/P Deviations Internal Deviations (Errors, Incidents, Accidents) Validation Failures Inspection Failures / Non-Conforming Product Other Corrective / Preventive Action Projects Key Elements of Documentation Specific Problem Statement Traceability / Tracking Information Failures Test Samples Page 23

24 Documentation Key Elements of Documentation (cont.) Failure Investigation Observational / Inspection Data Test Information Protocol Data Analysis Results Conclusions Causal Factor Identification Hypothesis Hypothesis Testing and Verification Protocol Data Analysis Results Conclusions Root Cause Summary (report, table, etc.) Page 24

25 Documentation Points to Consider How detailed do I need to be in my documentation? Detailed enough so that someone from the outside can follow your logic and could replicate your results. Detailed enough to meet specific regulatory requirements (i.e. complaints, adverse reactions, HCT/P deviation) Do some areas need to be more detailed than others? If so, what areas should I emphasize? Yes: Problem Description Traceability Failure Investigation Root Cause Summary Page 25

26 Documentation Points to Consider Do I have to go through every step for every investigation? No, use common sense and right-size the activities for the project. Wherever the term investigation is used in a regulation or standard, a certain level of rigor is implied. Again, focus on: Problem Description Traceability Failure Investigation Root Cause Summary For Complaints (not reportable to FDA), when can I avoid doing an Investigation and Root Cause Analysis? When a similar complaint has been fully investigated and you can refer to such an investigation. When the event, based on documented data analysis, is an isolated event and does not represent a trend (this does not relieve requirements for review and evaluation for complaints related to core CGTP requirements.) Page 26

27 Documentation Points to Consider When in doubt, write it down! If you were an Auditor, what would you want to see to ensure activities were done correctly? If CAPA is done by another group or person, what will they need to complete the project? If I were gone, would someone be able to follow my process and reach the same conclusion? Page 27

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