10 Tips for Effective CAPAs

You must accurately describe the problem if you hope to solve it. Document as much as possible in the problem statement. For example:

• Identify the defect, compare the actual measured value or output to the acceptance criteria, and make it clear what specification was not met.
• Identify all affected product and potentially suspect product. Provide a specific time frame during which the problem was known to occur or provide specific lot number(s).
• Bracket suspect lots to be included in the CAPA with appropriate rationale.
• Where known, identify the affected equipment, processes, systems, and/or software.
• Describe the circumstances that led you to recognize the problem and why is it important to investigate the problem.

In addition to the problem statement, the background or introduction of the CAPA record should also explain any known or obvious risks, such as actual or potential harm to patient or user, security issues, compromise to intended use, risk to supply chain, or regulatory risk.

The problem statement should be clear and unambiguous. This is important because the original problem statement will eventually drive the acceptance criteria for determining effectiveness. Verification of effectiveness following implementation of corrective and preventive action is based on demonstrating that the original problem no longer exists. So, defining the problem clearly will facilitate your ability to later demonstrate your actions effectively resolved the problem.

Document everything you know about the problem as this will help you understand the risk associated with the issue. For example:

• Determine how widespread the problem appears to be. Is it an isolated situation or potentially systemic? (This is important in determining Containment strategy.)
• Trend and statically analyze data to understand frequency of occurrence over time.
• Understand any actual harm associated with the event that initiated the CAPA.
• Review and document the predicted severity of event based on the approved Risk Management File (during investigation, it will be important to compare the actual harm and frequency of occurrence against those that were documented in the Risk Management File).

The investigation performed and the priority of the CAPA should be commensurate to risk.  Assign a CAPA risk level (e.g., High/Medium/Low). The CAPA procedures should define the risk levels based on:

• Severity of the event (i.e., potential severity of harm to patient/user, in alignment with severity terms used in the Risk Management procedures),
• Impact to product in distribution, and
• Potential impact to regulatory compliance.

For example: Labeling errors are high risk because they render the product “mislabeled” and subject to regulatory action. Labeling errors often lead to recalls. Similarly, findings associated with regulatory inspections should be considered high risk because they impact compliance and could lead to enforcement action if not addressed swiftly.

Determine how long and often this problem has been occurring. Use appropriate statistical methods to trend applicable populations of data to determine probability of occurrence. If the probability of occurrence of the problem exceeds the predicted probability in the Risk Management File, this would be considered high risk as it means that product in distribution is no longer meeting the acceptable risk level. An isolated event with a high severity could be just as important as a recurring problem with a low severity. Once routine trend analysis of data has identified a signal or an adverse trend, and a preliminary evaluation has confirmed the signal/trend, a CAPA should be initiated regardless of the severity.  Regulators expect that action be taken to correct a product performance problem occurring at a high/unexpected frequency even if the severity of harm is low. A single event such as a complaint identifying a new hazard or a higher degree of harm than anticipated, based on the current Risk Management File, should also escalate to CAPA. Although the event may be isolated it indicates an unknown or unpredicted risk that requires investigation, potential corrective action, and, if appropriate, update of the Risk Management File.

Based on severity of risk, Containment may be necessary. Do not move to root cause investigation without first implementing appropriate containment to:

• Prevent the further distribution of nonconforming or violative product,
• Stop production of nonconforming product, or
• Stop using a process that is not in control.

The CAPA needs to document what is being done in the short-term (immediate time frame).  This might include quarantining the potentially nonconforming product within your control, segregating product in the field to prevent further use, or initiating a recall (including notification of appropriate regulatory authorities).

The CAPA records should include or refer to objective evidence of all containment actions.  The evidence should clearly demonstrate what exact products and quantities were segregated, when the action was done, how, and by whom. Physical segregation of the actual and potential non-conforming product is always the best means for containment.  This can be documented through a material transfer form, or if necessary, by creating a memo to the CAPA file. Physical segregation of nonconforming product is not always possible. Often electronic MRP/ERP systems may be used to lock-out ability to ship certain products. If this is used as one of the means of containment, a record of this action should be included in the CAPA. Even if electronic shipping or transaction holds are put into place, the actual product should still be identified as being on hold or under quarantine using appropriate signage (or other visual means) indicating that personnel should not use or move the product.  

Root Cause determination is the most important part of CAPA. You need to investigate to determine why the problem occurred. There can be many contributing causes, all which may be actionable; but, in addition to these, you need to work hard to determine the true Root Cause. Taking action to address the true or real Root Cause will prevent the problem from occurring again. 

For example, a preliminary CAPA investigation determined that the cause of a product defect was use of an incorrect adhesive during assembly. But this is not the root cause. Further investigation needs to determine why the wrong adhesive was used. Let us say in this case the investigator determined the use of the wrong adhesive was due to a human error during assembly. Is this the true root cause? Not yet! We need to understand WHY the worker selected the wrong adhesive. Was it not clearly labeled? Was it stored in a manner that allowed it to be easily mistaken for another similarly packaged adhesive?

And you must consider why the problem was not identified until after QC release. Was there not an adequate line clearance or supervisor verification of the staged materials? 

Understanding the true root cause will enable us to take an action that will prevent the problem from happening again. Simply retraining a worker is not likely to prevent the error from reoccurring with another worker.

Use tools to help determine root cause and document the investigative process. For example, you may use one or multiple tools to get to root cause, including Pareto Analysis, Ishikawa diagrams (Fish Bones), Is/Is Not, Five Why Analysis, FMECA, and FTA. These tools should be used in addition to forensic analysis, product testing, duplication of the failure mode, interviews with operators involved, and examination and comparison to products from other lots or batches. In some cases, it might be necessary to solicit help from outside laboratories that can perform highly specialized material testing or analysis.

The deeper you look, the more likely you will determine the real Root Cause. Be careful not to mistake a “symptom” of the problem for the root cause. Continue to ask, for each contributing cause, “Why did this happen?” or “What caused this?” to get beyond the symptoms or superficial causes. When multiple contributing causes are found, document each. You will need to take action for each contributing cause, or document why action was not needed. 

When we get to Corrective Action, each identified contributing cause should have a corrective action identified or a rationale where it is determined that no action is warranted. In some cases, if the true root cause is determined and can be eliminated with an effective corrective action, the contributing causes will not manifest, and so, may not require a specific corrective action.

• Ensure you are doing Corrective Actions, as opposed to just Corrections. A Correction returns the nonconforming product or process back to specification. This might mean, for example, adjusting a piece of manufacturing equipment or reworking the nonconforming product or batch. This action is not the Corrective action. A good Corrective Action does something to “prevent reoccurrence”. Some key points:

  • Corrective actions to discipline or re-train an employee is often considered inadequate, as it usually does not address the true root cause of a problem, which may have been an ineffective training program, ambiguous procedures, or insufficient QC oversight of a process.
  • Corrective actions should address some aspect of how the action will prevent the problem from occurring again in the future.
  • Each Contributing Cause and the Root Cause needs its own Corrective Action.
  • Where a particular Contributing Cause will not be addressed, provide rationale for not acting on it.

  A good Corrective Action Plan should discuss the deployment strategy, expected timelines, responsibilities, and what objective evidence is to be collected or documented to support the CAPA record. Do not leave it to the person implementing the action to determine what they should document, make it clear what must be referenced or included within the CAPA record as evidence of the action taken. In addition, start working on the effectiveness plan while you are establishing the corrective action plan.

• Think of verification as testing to provide evidence that the proposed solution works. Where possible, test to confirm that the proposed solution:

  • Results in product that meets approved specifications,
  • Resolves the problem (cancels out the Root Cause), and/or
  • Results in a decrease in the frequency of occurrence of the problem or defect.

  When such testing is not possible, try to create some method to help show the CAPA will eventually be shown to be effective. For example:

  • If providing specialized operator training is one of the Corrective Actions, create a test to confirm the knowledge transfer occurred.
  • If procedural improvements is one of the Corrective Actions, make sure the users of the procedures will understand and follow them with effective and documented training.

  The verification activities will be documented through the Quality Management System depending on what type of corrective action is being taken. If the action is a design change, the action will be documented through the Design History File (DHF); If it is a Supplier Corrective Action Request (SCAR), this will be included in the Supplier’s File, etc. The CAPA record can either include a copy of the evidence, or cross reference to the proper document title, number, and its location. It greatly facilitates audits and inspections to include a copy of the evidence in the CAPA record. It is there when needed. This is easy if the evidence is a drawing revision or an edit to a work instruction. This is not easy, and not recommended, if the evidence consists of a lengthy design verification protocol, supporting data, and a final report. In this case, it is probably best to reference the protocol and final report by the document control number. In many electronic CAPA systems, the software provides ability to link the CAPA directly to the QMS documents that provide objective evidence. This is optimal where the functionality exists. 

Validation is providing evidence that the intended change results in the desired output being consistently met under actual or simulated use. It also helps to demonstrate that the changes made do not introduce new defects or problems. Some degree of validation is required for design changes and process changes. If the original problem was related to usability concerns, and changes were made to increase usability and reduce human induced errors during use, then useability testing may also be warranted. Validation which should be performed in accordance with a pre-approved protocol, will result in data that provides the objective evidence to support the change. As stated earlier regarding design verification data, the CAPA record should refer to the validation protocol and report, including a title, document control number, and document storage location.

The actions taken should be based on the CAPA plan. Implement the planned actions and disseminate information to those who may be impacted in the organization. Make sure the appropriate employees (operators, QC personnel, etc.) are aware of any change and why it is being made. Also, make sure employees are aware of defects or other potential problems they may observe, and that they know how to communicate these to management.   

Consider how the corrective actions will be scheduled and planned to minimize impact to employees, disruption to supply chain, etc. That stated, the priorities and timeliness should be driven by risk.

If any of the planned actions have later been deemed un-necessary, or will not be implemented, provide a rationale for this decision. 

• Create a plan for determining CAPA Effectiveness, often referred to as “Verification of Effectiveness” or VOE. A VOE plan should specify an objective goal or acceptance criteria. It is most helpful if this is measurable (for example, a scrap rate or complaint rate). The plan should also specify a targeted timeframe for performing the VOE check, taking into consideration that it may take some time (often months) for sufficient data to become available for review. This depends on how often the products or processes are put to use to create the opportunity for the original problem to occur (or hopefully not occur!)

  Always design and plan the VOE based on the original problem statement. VOE is not about verifying that a corrective action was taken, but that it is effective at eliminating the original problem. Most often an VOE involves reviewing the rate of occurrence of a failure or defect to determine if the frequency of occurrence has been reduced to an acceptable level (based on risk). The comparison of the before and after CAPA implementation rates of occurrence provides objective evidence to support effectiveness.   

CAPA communication also flows upward in the organization. CAPAs are an important input to Management Reviews and CAPA related metrics should be presented there, including, but not limited to: CAPA aging, number of open CAPAs and their risk levels and current phase, Number of CAPAs initiated out of specific functional areas, CAPA trends based on causes, number of extensions granted, etc.

In many cases CAPAs are generated as a result of management review activities. This is good as it shows the management review processes is healthy, identifying and reacting to quality issues, and providing resources to ensure corrective action.