CAPA Solutions for Manufacturing: How to Resolve Backlogged CAPAs in ISO 13485 Regulated Environments

In the manufacturing of medical devices that adhere to the ISO 13485:2016 standard and 21 CFR Part 820 regulations, corrective actions/preventative actions (CAPAs) often fail and result in extensive backlogs and extensions. This is due to inefficient and unorganized processes and/or a lack of or insufficient knowledge about CAPA processes, training, and investigation processes. The 80/20 rule generally means 80% of the responsibility and work is shouldered by only 20% of employees. Many medical device organizations often have numerous issues and bottlenecks with CAPAs. What are some reasons for this?

Common CAPA Management Pitfalls

1. Lack of Effectiveness Checks:

   Corrective action is considered effective if it can avoid the recurrence of the cause. There is often confusion about what exactly is an effective check. Some organizations document that the action was implemented, rather than provide evidence that the action worked as intended. Effectiveness checks fail due to two reasons: 1) No follow-up 2) Lack of measuring of the output of the closed CAPA.

2. Lack of Accountability and Responsibility:

   Internal stakeholders are not held accountable for their CAPAs.

3. Lack of Proper Investigation:

   Investigations are not conducted properly.

4. Lack of Understanding of the CAPA Process:

   No concrete knowledge of the fundamentals of the CAPA process.

5. No Metrics and/or Disregard for Metrics:

   No metrics for closure and no metrics to measure CAPA management effectiveness (outputs).

6. Problem Statements:

   Lack of training and knowledge to understand how to write a concise problem statement.

What are some effective tools to remove these bottlenecks?

Improve Root Cause Investigations

Root cause analysis is a problem-solving approach to identify, analyze, and resolve the cause of a problem. A robust quality management system (QMS) must monitor its processes continually to identify existing or potential sources of nonconformities. The overall CAPA process entails investigations that are performed to find the root causes of any nonconformities.

Root Cause Analysis Framework

1. Preventative Action: Proactive means of assessing processes for potential risk and putting controls in place.
2. Containment: The action of defining how big or extensive the problem might be.
3. CAPA: A retrospective and proactive risk management tool.
4. Root Cause Analysis: A problem-solving approach aimed at identifying, analyzing, and resolving the core issue.
5. Correction: The activities conducted to bring the nonconforming parts back into compliance.

Root Cause Analysis Containment Process

Containment is comprised of four different phases:

1. Prevent: It prevents certain process steps from being done by certain workers.
2. Check: It checks and purges inventory work in progress.
3. Remove: Removing bad equipment, gauges, or tools.
4. Inspect: Inspect work at the source to catch the problem early.

Use Cause and Effect Diagrams

6M Process

An effective 6M process (outlined below) may have many potential causes. The diagram is used to identify all the contributing root causes likely to be causing a problem. This methodology can be used on any type of problem and can be tailored by the user to fit the circumstances. This tool is most effective when used in a team or group setting and includes the following elements:

• Man: Competencies, training, inadequate staffing, discipline, and experience.
• Machine: Centrifuges, label equipment, and lyophilizers.
• Material: Shelf life, suppliers, variability, status
• Method: Adherence, validation, not documented, etc.
• Mother Nature (environmental): Temperature, humidity dryness, other environmental factors.
• Measurement: Sample size, measurement source, bias, equipment

Participants in the 6M process should write the problem to be solved (the effect) as descriptively as possible.

Fishbone Diagram

Fishbone diagrams are used to represent factors that might contribute to an observed effect. It clearly shows interrelationships among possible. They are an effective way to generate and organize the causes of observed events or conditions since they display causal information in structured way.

Company Culture and Stakeholders

Corporate culture is an implied social order of an organization. It constitutes the beliefs and behaviors of the leadership and employees. An organizational structure is a hierarchical relationship system that maps how activities are directed to achieve the goals of an organization. These activities can include process, policies, roles, and responsibilities. Organizational structure also determines how information flows between levels within the company. All stakeholders have responsibility for the CAPA process.

• Satellite Stakeholders: They provide input to the project but are not directly responsible for being actively involved in project success, i.e., regulatory bodies and subject matter experts (SMEs).
• External Stakeholders: Upper-level management suppliers and customers.
• Internal Stakeholders: Process owners.
• Owners: Individuals responsible for CAPA management.
• Experts/SMEs: Experts in their responsible work arena/area.

Sampling Plans

Systems are usually measured by a primary metric that is easy to digest, such as profitability. Process metrics and measurements provide team members and process leaders with trends to monitor processes or performance.

A process capability index expresses a numerical relationship between the process capability and the specification limits. A process capability index (Cpk) of 1 or greater means that the process is capable at a level of at least 99.73% conforming, which is the limit associated with an X and R chart run chart. Cpk is a measure of long-term capability.

Once a CAPA is closed out, it is important to do an effectiveness check by looking at the outputs and determining if the actions have been implemented effectively. Run charts are very good use for this process. A statistically sound sampling plan can provide an adequate confidence level regarding their effectiveness. Measurements that consider performance improvements can provide a benchmark for CAPA process effectiveness.

Training Effectiveness

Quality managers or CAPA managers should conduct regular CAPA training on the CAPA processes, and this training should be measured. Measuring training effectiveness, however, is not a task that many organizations perform, which is a common reason for the CAPA bottlenecks.

Create Concise Problem Statements

The first step to creating a problem statement for the CAPA is to meet with the process owner of the CAPA to understand what the problem is. This can also be conducted at CAPA review board (CRB) meetings with the impacted cross-functional departments.

Problem statements consist of five elements: who, what, where, when, and how.

• Who: Write who is affected by the problem. Is it a certain group of people? If so, identify them.
• What: Stating what the problem is. Be specific as possible.
• When: Time when this problem occurred. Was it on a specific shift or day of the week? Is there a specific seasonal trend that is occurring?
• Where: Where did the problem occur?
• When: When did the problem occur?
• How: How long the problem has been going on?

Impact is another key element of the problem statement. It defines the impact on the organization and how widespread it is. It also describes what happens to the customer or internal department, the process, and the equality of the product because of the problem. It helps answer questions such as: Who is the focus of the problem? What is wrong? Where can you find the problem? When did the problem start? What is the size of the problem?

Recommendations

1. Establish a CAPA review board. A CRB is a cross-functional team of managers that help all stakeholders maintain an effective CAPA process. The CRB should have bi-weekly meetings so stakeholders can apply best practices for situation analysis of CAPA documents. This will ensure effective feedback regarding reviews for documents.
2. Create annual and quarterly trainings so internal stakeholders can understand the fundamentals of the CAPA processes.
3. Create effective problem statements.
4. For those who use collaboration tools like Slack, create bots (Slackbots) so all stakeholders can stay up to date with meetings and updates. Customize the CAPA management workspaces/workstreams for quicker response time via direct messages (DMs). This works great for remote workers.
5. Establish sampling plans with 95%-99.73% confidence levels to measure effectiveness of CAPAs.
6. Implement purpose-built CAPA software to automate CAPA processes like routing, notification, escalation, and approvals. Modern CAPA software solutions help organizations avoid bottlenecks and expedite issue resolution.

Conclusion

Assessing and streamlining the effectiveness of their CAPA processes will ensure organizations can identify and eliminate causes of problems in a timely manner. CAPA management improvements not only help organizations prevent or minimize the risk of adverse events and product failures, but they also simplify compliance with the regulatory expectations outlined in ISO 13485:2016 and 21 CFR Part 820.