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Corrective Action and Preventive Action

CAPA Form – 15 tips to avoid CAPA failure

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This blog reviews 15 tips for creating an effective CAPA form including source, quality issue description, and the root cause investigation.

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CAPA Form 1024x362 CAPA Form 15 tips to avoid CAPA failure

The reason for creating a “great CAPA form” is to improve the effectiveness of your CAPA process. Anyone in your company could be assigned to a CAPA, but not everyone is a CAPA expert. Therefore, designing an effective CAPA form can reduce errors and improve the effectiveness of the actions taken. You can also purchase our CAPA procedure and CAPA form, which is compliant with ISO 13485:2016.

Corrective and Preventive Action CAPA Procedure CAPA Form 15 tips to avoid CAPA failure
SYS-024 Corrective and Preventive Action (CAPA) Procedure, Form, and Log
Medical Device Academy's newly updated CAPA procedure is a 6-page procedure. Your purchase will also include our CAPA form (FRM-009), our CAPA log (LST-005), and a training webinar. The procedure is compliant with ISO 13485:2016, 21 CFR 820.100, SOR 98/282, and the EU MDR. You will also receive free updates in the future.
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Provide adequate space in CAPA form

The most important feature of a CAPA form is to ensure that there is adequate space for writing a complete response for each section. Having sufficient space is more important than the benefits of a shorter record.

Date your CAPA form was initiated

The date your CAPA form begins to be completed can be used to verify that there was no “undue delay” in the initiation of a CAPA in response to internal audit findings. The date of initiation is also used to calculate the due date for completing the investigation and providing a corrective/preventive action plan.

Include a cross-reference number in your CAPA form

This is typically a sequentially assigned CAPA log number. Ensure the number is prominent on all pages—just in case pages are separated.

CAPA source

The source of a CAPA is useful information when performing data analysis—especially for internal audits where the audit schedule should reflect the results of previous audits. Examples of CAPA sources include:

  • Complaints/Reportable Events
  • Internal, Supplier, and Third-Party Audits
  • Service Work Orders
  • Nonconforming Materials
  • Management Reviews

Description of CAPA issue

I use the word “issue” instead of nonconformity because you need a CAPA form that will work for potential nonconformities (i.e., – preventive actions), as well as nonconformities. Typically, the wording is identical to a customer complaint or an auditor’s text, but the description of the issue identifies the symptoms observed. Specific references to records, locations, times, equipment, products, and personnel involved may be necessary for the root cause investigation.

The investigator assigned and target due date for the plan

In ISO 13485:2016, the only change to the requirements for corrective actions and preventive actions was the clarification that planning is required. Since this was always implied in the standard, your procedure should already comply with clauses 8.5.2 and 8.5.3 in the 2016 version of ISO 13485.

This section of your CAPA form should identify who is going to investigate the root cause of the issue and the date that a corrective/preventive action plan is needed. The FDA requires submitting a corrective action plan for all 483 observations within 15 business days, or it will result in an automatic Warning Letter. Most certification bodies require a plan within 30 days. Your target due date should be risk-based unless there is a specific regulatory requirement. The date will also need to be based upon the date the issue was identified—not necessarily the date the CAPA was initiated.

Documenting the investigation of the root cause is the #1 item in a CAPA form

This section always reminds me of the story about the Ohno Circle. Every company asks if they can close a nonconformity during an audit, and the answer should always be “No.” You can correct a problem, but you cannot perform a root cause investigation and implement an effective corrective action during the same audit. You need to investigate the cause and the investigation documented. Some companies include a specific tool in this section, such as a “Fishbone Diagram.” This is also a mistake because there are many root cause analysis tools, and you need to select the best one for your specific situation. You might even need to use more than one tool.

Is your CAPA form missing containment of nonconforming product?

If the issue requires preventive action, there is nothing to contain. If the issue is specific to a procedure’s deficiency, there is also nothing to contain. If the issue requires corrective action and nonconforming materials or products are involved, then you need to quarantine the affected items. If the affected product has already left the company’s direct control (see 21 CFR 806.2(l) for a definition), then you have a potential recall. Regulators often look for “bracketing” or “bounding” of the upper and lower lot limits for an issue. Therefore, this section is where you document the rationale for why certain lots of products/materials are quarantined, and other lots are not.

Correction(s) – Your CAPA form must separate this from corrective actions

Fixing the immediate problem does not prevent a recurrence, but regulators will verify that each occurrence of the issue identified during the investigation of the root cause has been corrected. You should verify that each of the nonconformities identified in the original finding and the investigation is addressed in this section of your CAPA form. For preventive actions, this section is not applicable.

Corrective Action Plan/Target Due Date for Implementation

These are the steps planned to prevent a recurrence. If the plan changes, then it should be updated. There is no need to delete the old version of the plan, but the new version should include a date when the plan was revised. For preventive actions, this section is not applicable. The target date of implementation should reflect the risk associated with the issue.

Preventive action plan / target due date for implementation

These are the steps planned to prevent the occurrence of nonconformity. If an issue occurred for one product, but not for others, the actions taken for other products can be preventive. In this case, both the corrective action plan and the preventive action plan sections should be completed. The target date of implementation should reflect the risk associated with the issue.

Corrective and preventive actions implemented – Update your CAPA form weekly

This section details what specific actions were performed—both corrective and preventive actions can be documented here. The dates of completing actions should be documented, and reasons for delays and overdue actions should be identified.

How to document your plan for verification of effectiveness – CRITICAL

I recommend filling this section before the plan for corrective and preventive action is developed. This often helps the person developing the plan to ensure that the actions planned are adequate. Whenever possible, this should be quantitative, and it helps to identify a specific date for performing the effectiveness check.

Verification of effectiveness

This section of your CAPA form is where you document verification of effectiveness. Specifically, what verification activities were performed to ensure that the corrective and preventive actions you implemented were effective. The date verification of effectiveness was performed should be documented, and if the actions were not effective, then a new CAPA should be referenced here.

Signature and closure date

Someone needs to review, sign, and date your CAPA form when it is completed. Often, regulators will review only closed records.

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CAPA Case Study

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This blog presents a CAPA training case study related to hundreds of open CAPAs, and how to effectively remediate this issue using a CAPA filter to avoid “death by CAPA.”

Years ago, when I took my first CAPA course, the student sitting next to me explained that he was taking the course as part of a consent decree with the US FDA. Evidently. his company had hundreds of open CAPAs that were not being closed promptly, and the CAPAs were ineffective when the records were finally closed.

Hundreds of open CAPAs?!

I was in total shock. You probably only have five to ten open CAPAs at your company. How could anyone have hundreds open?

He told me that every time a customer asked for technical support, a person was paged. If the page was not answered within three minutes, this was considered a customer complaint, and a new CAPA was opened automatically. The course instructor described the situation as “Death by CAPA.” His company did three things wrong    

1. Overreaction with Microscopic Focus

The company incorrectly identified failure to meet the three-minute target response time as a customer complaint. Also, several complaints related to the same issue should not result in a CAPA specific to each complaint.

2. Lack of Management Oversight

Nobody was tracking how long CAPAs remained open. There were no actions taken when target completion dates were missed. There were no reports to management on the status of CAPAs, and the only time CAPAs were discussed in a meeting was at the annual Management Review meeting.    

3. Failure to Check Effectiveness

Instead of verifying that corrective actions were effective, the company confirmed that corrective actions were implemented. Most of the corrective actions involved “retraining” or “revising the procedure.”

For any process to work correctly, you need to ensure that the process can handle the volume. If one person is responsible for managing hundreds of CAPAs each year, the CAPA process will be ineffective. You need more resources or fewer CAPAs. My recommendation is to use a CAPA filter.

 

Capa funnel photo CAPA Case Study

A CAPA filter does two things. First, it sorts CAPAs into problem categories. For example, all the poor response times to pages should be one problem with one CAPA. Second, a CAPA filter sorts CAPAs according to risk. A response to a page within five minutes instead of three minutes results in a customer waiting longer. A customer receiving no response could have a more severe impact, especially if the customer has diabetes that cannot seem to get their glucose monitoring device to work correctly.

Trend Analysis

Therefore, response rates to pages should be a metric subject to monitoring and measuring—not necessarily a CAPA. You have a positive trend if the number of late responses is declining, and the average delay is steadily shrinking. In this case, there may be no need for a CAPA. You have a negative trend if the number of late responses is increasing, or the average delay is getting longer. In this case, one or two CAPAs may be needed—not one CAPA for each occurrence.

Depending upon the issue, there may be a safety issue associated with extreme limits. In this case, it is recommended to establish alert limits and action limits. Alert limits may increase the frequency of monitoring and measuring, and corrections may also be implemented. However, if the action limit is reached, then a CAPA may be required.

Quality Plan

When I audit a company, it is not uncommon to observe a problem and to quickly identify a root cause. This frequently happens when the issue is familiar to many companies, and the root cause is: 1) inadequate procedures, 2) insufficient training, or 3) inadequate management oversight. If the problem is limited to one area, a CAPA may be entirely appropriate. However, if I observe the same type of problems in several areas, then the root cause is systemic. This can happen in a company where the following problems exist at the same time:

  1. The training procedure does not require demonstrating training effectiveness
  2. Employees are only required to “read and understand” procedures
  3. The top management has put a “freeze” on spending related to training

In a small company, this trifecta of doom is not uncommon. Therefore, in these cases, a CAPA does not address the root cause. Many companies will mistakenly identify the root cause as an “inadequate procedure.” The correction will be to fix the problem caused by the inadequate procedure. The corrective action will be to revise the procedure.

This is only a partial solution because it does not address the root cause. A stronger approach is to identify the root cause as an “ineffective training process.” The correction will be the same. The corrective action, however, will be expanded to include the initiation of a Quality Plan for changing the company training process.

The combined approach of a CAPA plan and a Quality Plan is a better solution because the process change will affect the entire Quality Management System and will require many months to implement fully. This is especially true if resources are constrained.

Here are a couple of upcoming webinars I am doing on CAPA and Complaint Handling:

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