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CAPA: Using Risk-Based Decision-Making Toward Closure

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Implementing a risk‐based CAPA process within a QMS is a necessity in the improvement of controls aligned with product and process non-conformances, adverse events, audit findings, complaints, etc. Making decisions concerning scope and extent about these “defectives” is a modern and cost-saving approach to improvement and compliance. Every non-conformity does not force you to open a corrective action. While almost every problematic issue needs at least a correction, the biggest payback is to use corrective actions on systemically-driven problems that are repetitive and recurring.

Applying the methods of determining risk to the device’s complete life cycle will give your company a complete look at all of the device’s risks—including those relative to processes. Manufacturers should be able to justify that they have reduced the risks as far as possible as part of their risk management plan and ongoing corrective and preventive actions.

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CAPA: Using Risk-Based Decision-Making Toward Closure

  1. 1. The Corrective & Preventive Action (CAPA) Process “Why Is My CAPA Process Not Working?” …..and I even asked “why” five times….. John Gagliardi MidWest Process Innovation, LLC JGAGL777@One.Net www.midwestprocessinnovation.com
  2. 2. What are the symptoms of an ineffective CAPA system? - __________________ - __________________ - __________________ - __________________ - __________________ - __________________ - __________________ Do these symptoms sound familiar!
  3. 3. The CAPA Process Supporting:  Identification of the Problem  Root Cause Analysis  CAPA Planning  Corrective and Preventive Action  Verification/Validation…to establish effectiveness  Making management aware …we need to get better results with 1. Better root cause analysis 2. Development of better corrective actions based on the root causes of the problems 3. Corrective actions that provide the strongest safeguards to future errors ©Copyright, 2016 MPI, LLC www.midwestprocessinnovation.com 3
  4. 4. Y Y Y Y Y SIMPLE TECHNIQUE: 5-Whys I’ve probably heard more “experts” talk about 5-Whys than any other root cause tool. Why? Because it is simple. Simple to teach and simple to use. All you have to do to find root causes is ask “Why?” five times. Here are five reasons why the five whys can fail:  Tendency for investigators to stop at symptoms rather than going on to lower-level root causes.  Inability to go beyond the investigator's current knowledge - cannot find causes that they do not already know.  Lack of support to help the investigator ask the right "why" questions.  Results are not repeatable - different people using 5 Whys come up with different causes for the same problem.  Tendency to isolate a single root cause, whereas each question could elicit many different root causes. ©Copyright, 2016, MPI, LLC www.midwestprocessinnovation.com 4
  5. 5. The vehicle will not start. (the problem) Why? - The battery is dead. (first why) Why? - The alternator is not functioning. (second why) Why? - The alternator belt has broken. (third why) Why? - The alternator belt was well beyond its useful service life and not replaced. (fourth why) Why? - The vehicle was not maintained according to the recommended service schedule. (fifth why, a root cause)  The questioning for this example could be taken further to a sixth, seventh, or higher level, but five iterations of asking why is generally sufficient to get to a root cause.  Note that, in this example, the fifth why suggests a broken process or an alterable behavior, which is indicative of reaching the root-cause level.  It is interesting to note that the last answer points to a process. This is one of the most important aspects in the 5 Why approach - the real root cause should point toward a process that is not working well or does not exist.  Untrained facilitators will often observe that answers seem to point towards classical answers such as not enough time, not enough investments, or not enough person power. These answers may be true, but they are out of our control. Therefore, instead of asking the question why?, ask why did the process fail? ©Copyright, 2016, MPI, LLC www.midwestprocessinnovation.com 5
  6. 6. A key phrase to keep in mind in any 5 Why exercise is, “People do not fail, processes do." ©Copyright, 2016, MPI, LLC www.midwestprocessinnovation.com 6
  7. 7. It starts with…(I know that this sounds simple) • Understanding the Problem (UTP) • Finding the (root) cause…..the real one! There’s no magic formula… UTP + Root Cause(s) + C/A Plan + C/A = We’re Done ©Copyright, 2015, MPI, LLC www.midwestprocessinnovation.com 7
  8. 8. …...every company I go to (to one degree or another)…..  Management doesn’t have patience for long (lasting) CAPAs  They forget where they are (in the process) when solving problems  They don’t follow-up and follow-through  “CAPAs are such a pain”  They close them out too soon…..cleaning up the books feels good  Do you mean that “we can’t fix this today with a fire truck and a white horse”?  “Isn’t there an APP for this mess”! ©Copyright, 2016, MPI, LLC www.midwestprocessinnovation.com 8
  9. 9. This is (also) the last slide of this session….. 1. Your root cause analysis is only as good as the info you collect. 2. Your knowledge (or lack of it) can get in the way of a good root cause analysis. 3. You have to understand what happened before you can understand why it happened. 4. Interviews are NOT about asking questions. 5. You can’t solve all human performance problems with discipline, training, and procedures. 6. Often, people can’t see effective corrective actions even if they can find the root causes. 7. All investigations do NOT need to be created equal (but some investigation steps can’t be skipped). Y Y Y Y Y 9
  10. 10. CAPA FDA 483 Items An informal review by the authors of recent FDA 483 Items issued to medical device companies revealed that approximately 30% of the cites were concerned with the firm’s CAPA system. As evidenced by the significant number of warning letter cites on the topic, firms face many challenges in making the CAPA system work as intended.
  11. 11. Failure Investigation - Decisions All non-conformities do not require a risk analysis, failure investigation, and corrective action (every time)… The preamble to the October 7, 1996 Quality System regulation provides insight into FDA’s position on these matters. In comment 159 of the preamble which relates to the degree of corrective or preventive actions, FDA states “FDA cannot dictate in a regulation the degree of action that should be taken because each circumstance will be different, but FDA does expect the manufacturer to develop procedures for assessing the risk, the actions that need to be taken for different levels of risk, and how to correct or prevent the problem from recurring, depending on that risk assessment.” A CAPA system should provide mechanisms to assess risk throughout the process.
  12. 12. Establishing the Root Cause (Causes) is more than just doing the “Five Whys” If you’re going to use the “Five Whys” there are foundations that must be built and used …..not just educated guesses….. …..children ask the “whys” all of the time….. ©Copyright, 2016, MPI, LLC www.midwestprocessinnovation.com 12
  13. 13. Background Information ©Copyright, 2016, MPI, LLC www.midwestprocessinnovation.com 13
  14. 14. …..as a reminder Correction – action to eliminate a detected nonconformity. Corrections typically are one-time fixes, but they may be done in concert with a corrective action if the problem recurs or otherwise persists. A correction is an immediate and sometimes temporary solution while a corrective action may be required to permanently address the issue. Corrective action – action to eliminate the cause(s) of a detected nonconformity or other undesirable situation. The corrective action should eliminate the recurrence of the issue. Preventive action – action to eliminate the cause of a potential nonconformity or other undesirable potential situation. The preventive action should eliminate or prevent the occurrence of the potential issue. ©Copyright, 2016, MPI, LLC www.midwestprocessinnovation.com
  15. 15. Failure Investigation - Decisions Nonconformities should be evaluated as to their potential risk to patients and users. This evaluation should be supported by a documented product risk assessment performed under design controls or subsequently generated at the time the nonconformity is identified. The determination whether or not to pursue failure investigation and/or corrective action is based in part on the magnitude of the problem and any related risk, and should be made by properly trained and qualified individuals. The determination and, if appropriate, the rationale for not pursuing corrective action should be documented in accordance with criteria defined in written procedures.
  16. 16. FDA’s August 1999 “Guide to Inspections of Quality Systems” (the QSIT manual) states, “The purpose of the corrective and preventive action subsystem is to: - collect information - analyze information - identify and investigate product and quality issues - take appropriate and effective corrective and/or preventive action to prevent recurrence - verifying or validating corrective and preventive actions, communicating - corrective and preventive action activities to responsible people, providing - relevant information for management review, and documenting these - activities are essential in dealing effectively with product and quality issues, - preventing their recurrence, and preventing or minimizing device failures.”
  17. 17. CAPA Is a World-Wide Concept The concept of CAPA is not restricted to the QS regulation or QSIT, but is a widely accepted concept in most quality systems, whether based on GMP, ISO, or some other standard or guideline. Since most modern quality systems strive to improve quality, there must be mechanisms in place to recognize existing or potential quality issues, take the appropriate steps necessary to investigate and resolve those issues, and, finally, make sure the same issues do not recur. CAPA process issues are basically the same world-wide
  18. 18. CAPA is Not Just About Product Defectives The CAPA system must look beyond product issues and consider other quality issues, including problems associated with systems and processes. During failure investigation or root cause analysis, firms will occasionally conclude their investigation when the nonconforming part or material is identified and corrected. However it is important to note that an important element of the CAPA system is to address processes and procedures. In many instances, if a given process were working appropriately, it would be less likely for nonconformities to be introduced into the system. Where practical, processes and procedures should be reviewed and considered as potential root causes for product or quality issues.
  19. 19. Risk Management Plays a Major Role Concerning CAPA RISK ANALYSIS • Identification of intended use, purpose of product/service • Identification of process hazards • Estimation of risk (occurrence/severity and detection) RISK EVALUATION • Decisions as to risk acceptability RISK CONTROL • Option analysis • Implementation • Residual risk evaluation • Overall risk acceptance POST- PRODUCTION INFORMATION  Post-production experience  Review of risk management experience RISK MANAGEMENT RISK ASSESSMENT 19
  20. 20. The Quality Review Board (QRB) Overview Cross-functional decision-making Realization of Trends Use of Quality Data Team Approach
  21. 21. QRB - Risk Management Process Documentation: - Policy and Procedures toward Implementation - Strong Linkage to Design Controls and Manufacturing - Risk Management Files - Hazards and Failure Modes Analysis - Risk Controls - Management Review Correction Corrective Action Preventive Action
  22. 22. The Reach of the QRB Risk Management System Management Responsibility Audit Results Complaints N/C Products Reports…corrections & removals Medical Device Reports Records, Documents & Change Control Quality Review Board Medical Device Tracking Service Reports Sterilization Process Issues Customer Feedback 22
  23. 23. Quality Review Board - Authority and Logistics Responsibility and authority necessary for the QRB in the Quality Management System… - Cross Functional Team - Pre and Post-market Inputs (as well as internal inputs) - Risk-based Decision-Making - Feedback to Management - Feedback to Management Review - Linkages to the CAPA Process - Initialize Internal Investigations - Trends in product and process performance - Process effectiveness - Product safety and functionality - Supplier performance - Success of performance improvement objectives - Necessity for re-design - Necessity for re-validation (process) 23
  24. 24. The CAPA Process Is Data Driven – Intro….. the QRB The “Five Whys” should be information-driven CAPA systems are (should be) inherently data driven. This means that without adequate, relevant data, it can be difficult to draw definitive conclusions about product or quality issues. There is an increasing reliance on technology to help gather and sort data. One of the challenges facing many firms is the proliferation of small, uncontrolled data repositories within the organization. Departments or individuals now have the ability to create and manage databases that house important quality information that is invisible to the rest of the organization. Where practical, firms should seek out and use tools that allow for the collection of that information in a more centralized manner, while still allowing those same departments and individuals to do their respective jobs.
  25. 25. An important aspect of the CAPA system is that the data coming into the system are complete, accurate and timely. Your QRB should implement procedures that describe: - What the sources of product and quality data are - How the data are to be captured - How the data is to be analyzed, including the method of analysis - When the data is to be analyzed - What steps are taken after analysis QRB should also be able to demonstrate that the activities described above actually occurred. Data that is Complete, Accurate and Timely …..toward understanding root cause…..
  26. 26. Input into the Management Review Output from Management Review Visibility Evidence to show an FDA investigator that CAPA information is an integral part of the management review process might include: - Procedures for management reviews that contain standard agendas with headings that discuss the review of corrective and preventive actions. - Agendas relating to the management review of the quality system including corrective and preventive actions, and certification that reviews were conducted. - Completed or closed corrective and preventive actions that resulted from the management reviews. - Schedules of management reviews (past and future) - CAPA analysis reports submitted for Management Review. - Top – level visibility
  27. 27. Quality Data and Records “Foundation”
  28. 28. Sources of Quality Data – to make decisions - Acceptance activity records relating to component, in process, and device testing - Complaints - Medical Device Reports (MDRs) and Vigilance Reports - FDA 483s and Warning Letters - Reports of system, process or product nonconformities - Process monitoring data (e.g., statistical control charts, trends, run charts, etc.) - Calibration and maintenance records - Scrap, rework and “Use As Is” (UAI) records - Clinical adverse events - Internal, external, supplier and third party audits - Returned products analysis - Installation and/or repair reports - Spare parts usage - Customer and/or technical service requests - Field service and/or warranty reports - Customer feedback (e.g., surveys, polls, etc.) - Historical records from previous corrections - Corrective and preventive actions - Lawsuits and other legal actions - Published literature - Reports from employees www.midwestprocessinnovation.com intelligent Y Y Y Y Y
  29. 29. Statistical methods can also be useful when they are applied across different data sources to analyze comparable issues. For example, by comparing manufacturing Non-conformances across multiple manufacturing sites, information regarding common suppliers, or complaint information against customer service reports, the firm can achieve a more complete perspective of the entire organization. Although statistical techniques are powerful tools for analyzing product and quality issues, they should not be the only mechanism used by firms. 29 Trending is an Important Statistical Tool
  30. 30. Non-statistical techniques provide an opportunity to rely on corporate knowledge and expertise to recognize issues sometimes before there is an observable trend. These techniques include (in part): - Management reviews - Quality and/or material review boards - Safety committees (internal or external) - CAPA Disposition Meetings - Employee suggestion programs - Individual clinical, product or engineering expertise - Other internal reviews 30 Non-statistical Techniques…..also an important tool
  31. 31. 31 Closed Loop Process “Foundation”
  32. 32. 32 5.1 Measure and 5.2 Analyse coordination / linkage of data / data sources / “horizontal analysis” 5.0 Phase II Measurement and Analysis within and across Data Sources 6.0 Phase III Improvement 4.0 Phase I Planning 4.1 Plan for Measurement, Analysis and Improvement Processes 7.0 Phase IV Input to Management 7.1 Report to Management and 7.2 Management Review Examples of defined Data Sources Within each data source 4.2 Establish Data Sources and Criteria Feedback Complaints ServiceReports Sparepartsusage QualityAudits (internal/external) Supplier Performance/Controls ProcessControls ReturnedProduct Market/customer survey Improvement 6.1 Investigate 6.2 Identify Root Cause 6.3 Identify Actions 6.4 Verify identified Actions6.5 Implement Actions 6.6 Determine Effectiveness of Implemented Actions
  33. 33. A compliant CAPA system “closes the loop” on many of the documented issues by directly providing input into the design control requirements of its quality system. For example, trending is realized from non-conforming product reports and this information is relayed to the QRB for purposes of decision-making. The risks are evaluated, the product non-conformity is investigated and the QRB decides that this is a design issue and not merely a manufacturing non- conformance. 33 Closed Loop Process
  34. 34. (part of) Failure Investigation …..and you ask Why?..... FIVE TIMES 34
  35. 35. SIMPLE TECHNIQUE: 5-Whys I’ve probably heard more “experts” talk about 5-Whys than any other root cause tool. Why? Because it is simple. Simple to teach and simple to use. All you have to do to find root causes is ask “Why?” five times. Here’s an example of the technique from the technique’s creator, Tailchi Ohno: 1. “Why did the robot stop?” The circuit has overloaded, causing a fuse to blow. 2. “Why is the circuit overloaded?” There was insufficient lubrication on the bearings, so they locked up. 3. “Why was there insufficient lubrication on the bearings?” The oil pump on the robot is not circulating sufficient oil. 4. “Why is the pump not circulating sufficient oil?” The pump intake is clogged with metal shavings. 5. “Why is the intake clogged with metal shavings?” Because there is no filter on the pump. 35
  36. 36. What do you think? Is “NO FILTER ON THE PUMP” a root cause? I think this example is a perfect example of what is WRONG with 5-Whys. First, they missed a whole line of questioning. Why didn’t the loss of lube oil pressure trigger an alarm or an automatic shutdown? Another line of questioning that was missed was “Where did the metal shavings come from?” After all, metal shavings are not normally found in a well-maintained machine. And finally, ”Why was there no filter on the pump?” Did maintenance forget to install it? Did the designer fail to include it? Was it removed because it kept getting clogged? All of these questions need to be answered but the ultimate expert, Tailchi Ohno, didn’t ask them because he thought he already had the answer. 36
  37. 37. Y Y Y Y Y Problem Statement: You are on your way home from work and your car stops in the middle of the road. 1. Why did your car stop? – Because it ran out of gas. 2. Why did it run out of gas? – Because I didn’t buy any gas on my way to work. 3. Why didn’t you buy any gas this morning? – Because I didn’t have any money. 4. Why didn’t you have any money? – Because I lost it all last night in a poker game. 5. Why did you lose your money in last night’s poker game? – Because I’m not very good at “bluffing” when I don’t have a good hand. Is the root cause about not be very good at bluffing? The five whys are based upon a strong foundation…..not like children asking about why the sky is blue. ©Copyright, 2016, MPI, LLC www.midwestprocessinnovation.com 37
  38. 38. Inexperienced investigators…..They can’t find what they don’t know. Many “experts” have little or no training or understanding of the psychology behind human error. They search for familiar patterns and disregard counter evidence. (The technical name for this phenomenon is “confirmation bias.”) But many investigators, and some root cause tools, start by asking “Why?” when they should be trying to understand “What happened?” Starting by asking “Why” is jumping to conclusions. And this can lead the investigator to find causes that they have jumped to because they didn’t first seek to understand. The “Why” question turns off the “remembering” trail that we want the brain to go down and turns on the “justification” trail. After all, isn’t the purpose of an interview to collect information (not justification)? If you look at most industrial accident/incident investigations, you find three standard corrective actions: 1. Discipline. Which starts with the common corrective action: “Counsel the employee to be more careful when …”. 2. Training. This may be the most used (and misused) corrective action of all. 3. Procedures. If you don’t have one, write one. If you already have one, make it longer. The misuse of these three standard corrective actions is the reason that so many accident investigations don’t really cause performance to improve. They don’t solve the real problems. 38
  39. 39. Failure investigation procedures might include provisions for: - Establishing who is responsible for evaluating product or quality issues and determining if a failure investigation is necessary. - Maintaining a record when no failure investigation is made, including the reason and the name of the individual responsible for the decision. - Describing how investigations are conducted and what records are maintained. - Defining the content and format of the failure investigation report. - Identifying the failure modes…..FMEA - Determining the significance and risk of each failure mode. - Determining the depth to which a failure investigation is to be carried out including when an investigation should include root cause analysis. - Requiring review and approval of the failure investigation, risk analysis, conclusions and any required actions. - Feeding information into FMEA (Failure Effects and Modes Analysis) and tying back to the risk analysis originally performed during the design phase. 39
  40. 40. Often, people can’t see effective corrective actions even if they can find the root causes. Why? Because they have performed the work the same way for so long that they can’t imagine another way to do it. It’s true that some investigations may take too long and cost too much. But that doesn’t mean that every root cause analysis needs to take too long and cost too much. Root cause analysis should be scaled to the size of the problem and the risk of future accidents with similar causes. Small risk = small investigation. Big risk= ___________ 40
  41. 41. 1.Your root cause analysis is only as good as the info you collect. 2. Your knowledge (or lack of it) can get in the way of a good root cause analysis. 3. You have to understand what happened before you can understand why it happened. 4. Interviews are NOT about asking questions. 5. You can’t solve all human performance problems with discipline, training, and procedures. 6. Often, people can’t see effective corrective actions even if they can find the root causes. 7. All investigations do NOT need to be created equal (but some investigation steps can’t be skipped). 41
  42. 42. Failure Investigation – Basic Expectations The comprehensiveness and depth of failure investigations should be commensurate with the magnitude of the issue, and the potential risk the issue presents to the patient and/or end user. Typically, the failure investigation should include: - Problem identification and definition – Once identified, the issue must be characterized and defined in order to understand the potential scope and impact. This characterization should include the documented risk analysis. - Investigation – The issue is investigated and documented, including results of analyses (data, process, operations and/or other sources of information) and identification of failure modes and conclusions regarding root cause(s). - Rationale – If a failure investigation or analysis is not performed, the record should include the reason no investigation was performed and the individual responsible for the decision. - Action Plan – A thorough failure investigation might include information and other data that can be useful in crafting an action plan to address the issue.
  43. 43. Significance of the Issue – Risk-related rationale Typically, the following factors are taken into consideration in determining if a product or quality issue is significant: - Is there potential for user or patient safety issue? – Likelihood that the issue may result in a death or serious injury, even if the cause is determined to be user error. - What is the classification of the device? – Class II and III products tend to have higher risks associated with them than Class I products. - Is there a reliability issue? – Does the nonconformance or product issue affect the product’s reliability? - Did the product meet its specifications? – Does the nonconformance or product issue cause the product to fall outside of established specifications? - Was the product labeling involved? – Does the nonconformance or product issue cause the product to be misbranded, adulterated, or otherwise not properly identified? - Has the frequency of occurrence for a known issue changed? – Is the nonconformance or product issue occurring at a higher rate than expected over a given period? - Is the issue difficult to detect? – A nonconformance or product issue that is difficult to detect is less likely to be identified and corrected prior to causing a problem.
  44. 44. Is Your CAPA Process Really Working ?
  45. 45. Evidence to show an FDA investigator that the CAPA system is functioning properly Evidence to show an FDA investigator that the CAPA system is functioning properly might include: - CAPA inputs – Sources of product and quality data are routinely reviewed. - Analysis – Documentation demonstrating that data were analyzed for possible unfavorable trends or other indicators of product or quality issues. - Investigations – Documentation demonstrating that qualified personnel have investigated unfavorable trends, non-conformances, and product issues. - Action records – Corrective or preventive action plans and other records demonstrating action start and end dates. - Effectiveness checks – “Before” and “After” product or process quality trend reports or other analyses. These checks should establish that the action effectively prevented the recurrence (or initial occurrence) of the non-conformance.
  46. 46. Evidence to show an FDA investigator that the CAPA system is functioning properly Evidence to show an FDA investigator that the CAPA system is functioning properly might include: - Verification checks – Engineering change orders (ECOs) or other control forms for initiating a change to a product or process. - Validation checks – Design verification, design validation, and process validation protocols, and summary reports to ensure the actions were effective and that they do not adversely affect the device. - Control checks – Training records, product tracking information, segregation, reprocessing, rework or final product disposition records with appropriate authorizations. - Timeliness checks – Tracking mechanisms to demonstrate that actions are conducted in a timely manner. - Management checks – Management review agendas and schedules, corrective/preventive action status, aging and closeout reports.
  47. 47. Remember….. 1. Your root cause analysis is only as good as the info you collect. 2. Your knowledge (or lack of it) can get in the way of a good root cause analysis. 3. You have to understand what happened before you can understand why it happened. 4. Interviews are NOT about asking questions. 5. You can’t solve all human performance problems with discipline, training, and procedures. 6. Often, people can’t see effective corrective actions even if they can find the root causes. 7. All investigations do NOT need to be created equal (but some investigation steps can’t be skipped). Y Y Y Y Y 47
  48. 48. Case Study 48
  49. 49. Thank you John Gagliardi MidWest Process Innovation, LLC 7736 Woodside Court, Maineville, OH 45039 www.MPILLC.co www.midwestprocessinnovation.com JGAGL777@One.Net Cellular Telephone: 513-315-9820 49

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