Is Your CAPA System Effective?

A corrective and preventive actions (CAPA) system is an essential component of any quality management system, and is an approach intended to correct and prevent problems from recurring or prevent them from ever happening. This article describes key components of a CAPA system, highlights key elements of a CAPA report, and reviews some methods for root cause analysis. Also discussed is the need for implementing a risk-based approach when reviewing CAPAs, and the benefits of setting up a CAPA program.

Some Terminology

A corrective action (CA) includes steps taken to eliminate the cause of an actual problem, which should prevent the problem from recurring. Corrective actions are easier to develop than preventive actions. Per ISO 9000:2015, a CA is defined as an “action to eliminate the cause of a nonconformity and to prevent recurrence.”1

A preventive action (PA) includes steps taken to prevent the occurrence from ever happening. Therefore, a CA is a reactive measure, and a PA is a proactive approach. ISO 9000:2015 states that a PA is “action to eliminate the cause of a potential nonconformity or other potential undesirable situation.”1

Having PAs is highly desirable in terms of reducing costs when compared to spending time and money to fix (“react to”) a problem; in short, preventing problems up front is where organizational leaders should strive to spend their resources.

Components of CAPA

Writing the CAPA report can be a step-by-step process (see Table 1*), including the problem statement, a root cause analysis, a proposed solution, details on the implementation of the solution, and an effectiveness check.

Where Do the Data Come From?

Data for CAPAs can come from many places. Most data can be acquired from internal sources; however, there are several external sources that can be beneficial for a CAPA program. For example, internal and external audits can provide valuable information for opportunities for improvement.

In addition, consider observations from a regulatory inspection to be entered into the CAPA program. Customer feedback, especially critical complaints, can contain valuable information for a CAPA with nonconforming work products or services.

Any issue can move into a CAPA program via management direction. Observations from staff are very important because they are the closest to the task at hand and can provide invaluable information, which should not be overlooked.

Remember that all CAPA data need routine analysis from the key players. One widely used approach is the Pareto analysis technique developed by Joseph Juran.2 This technique is used to identify, evaluate, and prioritize nonconformities. Pareto analysis can summarize many data such as impact, error, defect, delays, and cost.

The outcome of a Pareto analysis is typically in a chart. A Pareto chart allows a team to count the number of times (frequency) each category occurs (see Figure 1*). This arrangement allows the most significant problems (categories) to be identified quickly. The ability to organize data helps to focus and handle one issue at a time. Also, the organized data suggest to stakeholders where resources must be used.

Once an issue is resolved, the organization can apply resources to the next unresolved root cause.

Setting CAPA Triggers

Regarding data analysis, there are a few things to consider. Review the data on a routine basis and define the frequency and volume of data, so trending can be performed at appropriate intervals. Regarding data trending, include the organization’s audit schedule and scope to eliminate redundancy in data review and trending efforts.

The goals of data analysis are to capture a baseline of the data and help in establishing action limits (thresholds). This helps to justify the data, and identify when data are truly outliers so the item of concern can move into the CAPA process, but not overburden the CAPA program.

For data trending, use appropriate methods to ensure the data can be analyzed properly. Consider tools such as scatter diagrams, histograms, and the Pareto analysis to help in reviewing data.

Remember not all CAPAs are created equal. Therefore, it is necessary to establish a method for categorizing CAPAs based on risk level (e.g., critical, major, and minor). Using a risk-based approach filters and prioritizes CAPAs, which can communicate a sense of urgency to management.

Each department should work to identify its critical processes (areas of interest), and consider evaluating any processes which are high-risk or have critical vulnerabilities (such as regulatory file management). Focus on the “vital few, not the trivial many.”4 Work to set tolerance levels by asking how much down time can the department withstand if something happened. If a tolerance level is met, this will trigger the need to create a CAPA.

In addition, management can use its discretion and request a CAPA for any high-risk failure. It is imperative that problems with greater potential impact, such as issues related to regulatory compliance and human subject protection, receive appropriate attention.

Repeat failures can be interpreted as a lack of due diligence for how to design, produce, and deliver reliable products and/or services. To reduce any confusion and uncertainty, ensure CAPA risk levels are well-defined and included within the appropriate standard operating procedures.

The Rigors of Root Cause Analysis

The root cause analysis step involves investigating the cause and determining the problem. Root cause analysis aids in determining whether the problem is, for example, a process issue, procedural issue, or human error. There are countless approaches and quality tools available for root cause analysis.”

Consider developing a flowchart to document a new process or to further analyze a current process. Flowcharting provides a visual depiction of any potential bottlenecks, weaknesses, or other concerns with the process using various symbols. Keep the beginning narrow, internal, logical, and focused with clear boundaries to avoid scope creep. Avoid going outside the organization, and do not assign blame.

Once boundaries are established, a flowchart can be created for better understanding of the process. Flowcharts can identify who should or should not be involved in the process. Also, flowcharts demonstrate steps that may have contributed to the problem, help identify data collection points, and help show drilldown points.

Brainstorming techniques such as the “Five Whys” and “Cause and Effect,” discussed in more detail below, are two other root cause analysis tools to consider.

Brainstorming provides no root cause, but is useful in combination with other problem identification tools. Brainstorming is used in a small, controlled group to explore many possibilities of the root cause; the effectiveness depends on the group and its leader.

Having a leader help guide the team through a nonbiased discussion will help identify many potential causes to the problem. A leader should not try to interject his or her own opinions or desires, but guide the discussion in a healthy manner. If the session becomes stagnate, the leader serves as a facilitator to move the conversation along.

Brainstorming will not solve the problem, but encourages open thinking and generates ideas. Toward this goal, “Five Whys” is an easy and quick analysis tool for use with a small team when causes might be confusing and when a team prefers a visual tool. Visual tools might also include flip charts, post-it notes, or a computer. Ask “Why” at least five times to make sure a fundamental answer has been reached. When used properly, the “Five Whys” can uncover the root cause.2

The “Cause and Effect” diagram, also known as a Fishbone diagram, is another helpful tool for root cause analysis with a small group. It is a highly visual technique that aids the process of defining the elements of a problem or event and determining how it probably occurred.6 Such diagrams capture the use of manpower, machines, materials, environment, and methods that could cause the problem (see Figure 2*). The problem or effect is placed in the box on the right side of the diagram, and the potential major causes are inserted in the boxes directing to the main problem.

Figure 2* has been populated with an example scenario. The diagram focuses on defining the problem and can be used for preventive action analysis.

Elements of an Effectiveness Check

The effectiveness check should be completed at least 30 days after the proposed solution has been implemented, to allow adequate time for the change to take effect. The check is documented as the final step on the CAPA report before the CAPA is closed.

Sometimes, 30 days may not be enough time for a solution to deliver results, depending upon the process (i.e., equipment not frequently used). Effectiveness checks can also deem the attempted solution has failed for several reasons, including: the CAPA plan was not specific to the root cause, an incorrect root cause was targeted, or inappropriate data were used during the assessment phase.

If an effectiveness check fails, leave the CAPA open and re-investigate the problem; improper resolution means the problem will return over time, so it is better to spend the time up front resolving the issue. Further, if a CAPA will be open for an extended period, strive to document periodic “check-ins” and document the progress of the work to show if a regulatory inspection occurs.

An effectiveness check can be performed in a variety of ways, such as during a routine internal audit, remote audit, or a separate verification review. Make sure the process is flexible enough to allow the effectiveness check to be made by a variety of methods, so it is not a burden to staff and other resources.7

When All is Said and Done

Finally, make sure the CAPA report is complete. The CAPA report is a key component of a CAPA system and captures all relevant information in one place. There are key elements that a CAPA report should contain: a unique report number, a problem statement, a risk level, investigation methods, description of items/documents reviewed, results, an implementation plan, names and dates of the CAPA review team, and effectiveness check results.

Two other key components of a CAPA system are procedure(s) on the CAPA process and CAPA trending. Procedures on the CAPA process should cover documentation practices and the process, in terms of how to define the problem, categorize risk, identify root cause, determine the solution that is appropriate to the risk and root cause, and define implementation and completion of an effectiveness check.

Further, at a minimum it is essential to trend CAPAs annually. Trending CAPAs allows for a representation of any repeat problems, reoccurring tendencies in the same area, etc. Trending CAPAs may reveal another PA, which shows continuous improvement and forward thinking.

Challenges and Benefits of CAPA Programs

Some challenges may arise from staff rushing to close the CAPA prematurely, poor documentation of the root cause, overuse of the CAPA system (putting every problem into the system), lack of follow-up to closure, gradual obsolescence of the CAPA system, and use of multiple CAPA systems.

A clear sign the CAPA program is not working properly is when the same issues occur over and over. The team is constantly putting out the same fires.

The benefits to having an effective CAPA system include, but are not limited to reducing overall cost, meeting regulatory requirements, focusing on patient safety, having more efficient processes and procedures, and focusing on continuous improvement rather than on a reactive approach.

Remember, it takes time to establish a CAPA program that properly resolves the true root cause to serious problems. However, when implemented correctly, a CAPA program can be beneficial to every organization.

PEER REVIEWED

References

  1. BS EN ISO 9000:2015, Quality Management Systems Fundamentals and Vocabulary. www.iso.org/iso/home/standards/management-standards/iso_9000.htm
  2. Andersen B and Fagerhaug T. Root Cause Analysis, ASQ Quality Press, Milwaukee, Wis., 2000.
  3. Gano D. Apollo Root Cause Analysis, Apollonian Publications, LLC, Richland, Wash., 2007.
  4. Juran J. Juran on Leadership Quality, New York, The Free Press, 1989
  5. Okes D. Root Cause Analysis, ASQ Quality Press, Milwaukee, Wis., 2009.
  6. Wilson P, Dell L, and Anderson G. Root Cause Analysis, ASQ Quality Press, Milwaukee, Wis., 1993.
  7. Tague N. The Quality Toolbox, ASQ Quality Press, Milwaukee, Wis., 1995.

For Further Reading

Ketola J and Roberts K. Correct! Prevent! Improve!, ASQ Quality Press, Milwaukee, Wis., 2003.

Susan Muhr Leister, BS, MBA, PhD, CQA, CSSBB, (smmuhr@gmail.com) serves as the director of quality assurance at Technical Resources International Inc., and as faculty for both graduate and undergraduate studies at the University of Phoenix. She also serves the ASQ Section 509 Executive Committee as the Chair Elect, and has been serving for the past four years as a Maryland Performance Excellence Award Examiner.

[DOI: 10.14524/CR-15-0020]

*To see all figures and/or tables published originally in this article, please visit the full-issue PDF of the February 2016 Clinical Researcher.