Seven Steps to Effective CAPA

							      Seven Steps to Effective CAPA
      When manufacturers capitalize on CAPA processes, they see vast improvements
      in process performance. An effective CAPA system is not only vital to compliance
      with regulations like the FDA’s QSR and ISO 13485 – it is a key practice in
      achieving good product quality. Yet corrective and preventive action failures are
      the most frequently cited problem by FDA officials for medical device companies,
      accounting for 21% of all observations noted during inspections in 2005. And with
      industry giants receiving FDA injunctions for their inadequate CAPA processes, it
      seems that no one is invulnerable. By implementing these key strategies, your
      company can avoid regulatory sanctions and reap the benefits of a streamlined
      CAPA system.
      1) Analyze quality data. When you continually analyze your business processes
      and records, you can identify potential and existing quality problems.
      Consistently monitor information from a range of data sources, such as:
      customer complaints, MDRs, calibration and maintenance records, lawsuits, and
      employee reports. Use trending analysis so that you can quickly identify any
      irregularities. Record all data in a central, secure location – auditors want to see
      thorough documentation of all CAPA processes.
      2) Get to the root of the problem. In order to resolve existing quality issues,
      you need to pinpoint the root cause. Regulatory bodies require detailed
      documentation through every step of the CAPA process, so write a clear
      investigation plan before you begin. Review all circumstances related to the
      problem, including design, materials, procedures, employee training, and
      external factors. Document all possible causes. Often there are several
      contributing factors involved, so make sure you can account for all of them.
      3) Identify the appropriate actions. Once you have established the root cause
      of the problem, you should identify the appropriate actions for correcting or
      preventing it. Consider the potential impact of the problem, and the risks it poses
      to your company and/or your customers. The action you take should correspond
      with the magnitude of the repercussions. Outline a clear, step-by-step plan for
      your corrective or preventive action.
      4) Verify or validate corrective and preventive actions. After you have
      performed a preventive or corrective action, you should evaluate whether the
      steps you took were appropriate and successful. You should have a monitoring
      system in place that keeps track of the effectiveness of your processes. You can
      often use the same data sources as you did when you were identifying problems,
      and look for changes that have occurred as a result of your CARs and PARs.
      5) Adjust CAPA processes according to your findings. If your analysis shows
      that the actions taken were not effective, you should rethink those processes.
      Make sure your actions, findings – and any resulting changes in the SOPs for
      corrective actions – are thoroughly documented.
      6) Disseminate CAPA information. Distribute information about the CARs and
      PARs to the appropriate personnel, including those responsible for product


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      quality. Outline any changes in policies and procedures that will affect
      employees, and have them acknowledge that they understand the changes.
      7) Submit CARs and PARs for management review. The FDA requires that
      senior management stay informed about quality issues. Your SOPs should detail
      which members of management are required to sign off on CARs and PARs.
      Before closing a CAR or PAR, submit a detailed account of the problem and the
      actions for this party’s review. Document the reviews, so that there is evidence
      they occurred.




IBS America, Inc • 125 Hartwell Avenue • Lexington, MA 02421 • Tel: (781) 862-9002 Fax: (781) 862-9003 • www.ibs-us.com