Step by step instructions on navigating your Corrective Action & Preventive Action (CAPA) for FDA.
Corrective Action & Preventive Action (CAPA) ensures continuous improvement measures on your company's processes, allowing it to stay in operation. CAPA impacts every aspect of your day-to-day business and is a critical component of any FDA inspection.
CAPAs establish a precedent for dealing with issues even before your medical device makes it to market. Prior to any incident, you want to make sure your organization has taken note of all your processes to assemble an efficient risk management plan.
In this blog, we will discuss:
- Defining CAPA
- Right Step Towards Risk Management
- 10 Steps to Achieve a Successful CAPA Process
- How Can I Achieve Compliance and Credibility
Defining CAPA
Before we dive into the 10 easy steps to CAPA, we define a few important terms to help better understand the steps to writing a CAPA.
- Nonconforming Material or Process: Any material or process that does not meet its required specifications or documented procedure.
- Correction: Refers to repairs, reworks, or adjustments and relates to the disposition of an existing nonconformity.
- Corrective Action: To identify and eliminate the causes of existing nonconforming products and other quality problems.
- Preventive Action: To identify and eliminate the causes of potential nonconforming product and other quality problems.
Learn the purpose of Corrective and Preventive Actions (CAPAs) for Medical Device Development.
Corrective and Preventive Actions (CAPAs)
Misunderstandings about the CAPA process can lead to clogged processes that make it difficult to report across some or all departments- Advantages:
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- Provides a structured platform with capacity to investigate and identify systemic issues
- Offers a means by which to develop a permanent corrective action, thereby reducing the propensity adversities
- Provides documentation that further improves effectiveness of corrective actions
- Disadvantages:
- Can be tedious and exhausting to manage
- Cost of quality may be difficult to track or monitor when disorganization is present
- Poor management can lead to inconsistent data, confusion, non-compliance, and hesitancy in taking action when needed
Right Step Towards Risk Management
Startups often overlook CAPA at the beginning of their product's development due to efforts put into fundraising and development. CAPA can help establish an audit trail for your organization making issues linked to the entire organization easily identifiable.The FDA doesn't offer the best guidance when it comes to implementing a CAPA system with options to mitigate necessary risk.
As one of the main triggers for 21 CFR Part 820, CAPA is a main component of your overall quality program and will help leverage your product's level of quality against FDA inspections and audits.
10 Steps to Achieve a Successful CAPA Process
The table below includes a step-by-step summary version of the CAPA Process.
| Steps | Descriptions |
| 1) Identify Personnel | Elect a quality manager or set of managers, or Review Board, to oversee the process from start to finish. (size dependent on the number of CAPAs) |
| 2) Assign ID for CAPA Process | After CAPA submission is approved, assign an identification number to monitor the process and record-keeping. |
| 3) Label Problem Source | Label how the problem was identified -- i.e. Audit, Non-conformity, or Complaint. |
| 4) Assess Affected Products and Processes | Assess the products and processes this problem is affecting to identify the resources and actions needed to resolve the issue -- such as a product recall. |
| 5) Outline Potential Impacts | Outline the potential risks your customers and company may face if the problem is not resolved. |
| 6) Conduct a Procedural Investigation | Conduct a procedural investigation that includes a detailed document outlining the clear objective, personnel in charge, and resources needed to be successful. |
| 7) Create an Action Plan | Create a plan to not only correct, but prevent the problem to avoid future repeats. |
| 8) Record and Verify Actions | Record any actions completed, such as system changes, employee trainings, or monitors/controls. |
| 9) Evaluate and Implement | Evaluate every action that has been documented and taken in the investigatory process to implement any changes, controls, and training. |
| 10) Verify CAPA Resolution | Verify that any corrective actions taken were either effective or ineffective so that the proper controls can be instituted for preventive measures. |
Click here to download an infographic of the 10 Easy Steps to CAPA!
How Can I Achieve Compliance and Credibility
The main takeaway when conducting a process like CAPA is to document every single action taken from start to finish. This reassures FDA that your business is able to not only identify quality issues, but also assess and correct them with a well-defined script.
CAPA gives your Life Science, Medical Device, or BioTech company the credibility needed to operate within this industry. Proper CAPA documentation demonstrates that your company's employees can maintain quality system in an effective and efficient manner through corrective and preventive action.
Over-flooding of CAPAs
Is your organization searching for a better way to manage your CAPA process in order to prevent some of these disadvantages? Are you tired of wasted manpower, resources, and erroneous data?
Chances are your company is already buried in paperwork and there isn't room for any more CAPA documents. Documenting every action of every step can be a burden and achieving full traceability of records when the FDA comes knocking on your door can be the ultimate stressor.
Here at Sierra Labs, we help companies like yours have any document or record available at their fingertips! With our Quality Management System, Sierra QMS, your company won't have to dig through endless files, giving you more time to ensure your CAPA processes are progressing in the right direction, while simultaneously providing beginning-to-end traceability.
Want to breeze through FDA regulations with zero stress?
Check out Sierra QMS today!
