Suzanne Clark, Ken Block Consulting
CAPA Corner

Considering CAPA: Maybe It’s Not a Monster After All

By Suzanne E. Clark
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Suzanne Clark, Ken Block Consulting

It’s time to consider CAPAs as opportunities rather than just other issues to tackle.

For many people working in medical devices, or a similarly regulation-laden industry, CAPA (Corrective Actions and Preventive Actions) is a dreaded term. These tasks are typically considered a burden on all other necessary daily business objectives—like everyday routine work, any process “fires” that have suddenly arisen, or back-to-back meetings.

Sound familiar? Perhaps it is time to consider CAPAs as opportunities rather than just other issues to tackle. Let’s not sugarcoat this. CAPA initiatives are time-consuming and will take you away from your busy schedules, but these tasks need to be completed in an appropriate time frame to ensure that the same issues do not unduly continue to impact your production. Additionally, CAPA can reduce the frequency of seemingly standard problems that arise during the work day and allow for other work processes to become more streamlined, those previously mentioned “fires” to shrink or disappear, meetings to be held less frequently, and employee time and collaboration to be more efficiently organized.

CAPA processes can have a positive impact on daily business interactions because these tasks typically involve several people, and often they can cover several departments and products. The lead employee on a CAPA initiative will likely need to solicit the involvement of an expert to understand the current processes and the adjustments needed to properly address any issues. Once the corrective or preventive actions have been implemented, these improved processes will greatly benefit the overall productivity of a company.

No one wants to get backlogged with work because of machinery that continues to malfunction or be required to repeat processes that typically do not work effectively on the initial run. In fact, these grievances only lower the rate of productivity and cause frustration. Often they will also weaken the quality of outputs, which can lead to business demise. But once a company commits to a strong CAPA process, the typical issues fade, and there is an unwritten appreciation and ease for improved processes.

The following are some basic guidelines to follow to ensure that your CAPA is valid and can be used as an effective tool to easily assess new issues. When assessing an issue, it is important to know whether this is a new concern or if this same issue has occurred in the past; whether the root cause was found, or if the CAPA only fixed a symptom; whether the issue affects other processes and products; and how the issue arose in the first place. For instance, was it ineffective training, faulty equipment, inadequate raw materials, or something else? Ensuring your CAPA tackles all these concerns will provide the necessary information to prepare for follow up reviews and investigations in the future.

The CAPA Checklist

  1. Establish a problem statement: Precisely identify the issue by answering the What, Where, and When. But leave the Why and Who for later, as these two questions require investigation.
  2. Include all identifiers: Lot number, part number, machine number, procedure number, location, date, time, etc.
  3. Identify the extent of the issue and the location of the affected process, and place the affected lot(s) on hold.
  4. Explain the process with a workflow or diagram to describe how it is supposed to function.
  5. List all possible causes of the issue, rather than just jumping to what is believed to be the cause.
  6. Utilize a standard root cause analysis tool to determine the actual root cause.
  7.  Review data history to determine if this issue or a similar issue has occurred before.
  8. Develop a corrective action plan to resolve the root cause(s). Yes, there can be more than one root cause to an issue. Ensure the plan affects only the issue and does not impede on other parts and processes, and address how the action will prevent the issue from recurring.
  9. After the action(s) have been implemented, allow some time to pass. Then, review the part and process data to determine if the issue has recurred. Ideally, it has not! But if the issue has recurred, then the correct root cause was not successfully found.
  10. Document everything. Keep all associated data collected, during the CAPA process, organized and accessible so that a review can occur as needed. The CAPA should remain a complete story for a more efficient future review.
    In addition to correcting problems that have already occurred, think about ways to prevent them from happening at all. Preventive actions are just as important to the health of a company as corrective actions. Think about ways to improve your processes before a problem arises. For example, when a regulatory body revises a compliance standard, perform a gap analysis throughout your quality system to ensure your current procedures address all the revised or new elements. Schedule and perform re-validations on equipment and processes. Any risk to product is mitigated greatly when potential issues are addressed before non-conformances or breakdowns occur.

Corrective and preventative initiatives can become welcomed tasks, although laborious and likely time-consuming. However, if done well, the seemingly “standard” issues that used to take away from your busy schedules will lessen or disappear completely. This is the ultimate purpose of CAPA. In other words, the goal of CAPA is to create a long-term solution that will improve the efficiency of all your business processes and help prepare for problems in the future, rather than just finding a temporary fix. CAPA improvements can be observed in production turn-around times, employee productivity and organization, product quality, unused material and waste reduction, and a variety of other company benefits.

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Suzanne Clark, Ken Block Consulting

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