“You get what you inspect, not what you expect!”
The one process that is the most challenging to medical device companies, regardless of shape and size, is CAPA – Corrective Action and Preventive Action.
You should take corrective actions to limit problems as soon as they are identified. A single occurrence of a non-conformity problem will not compromise your ISO certification, but recurrent problems need corrective actions. A major problem found by the auditor could postpone your certification and leave you struggling to establish a process to fix the issue as quickly as possible.
CAPA is a process which regulators expect companies to follow to detect and resolve compliance issues. As such, it’s a critical point of focus during FDA inspections and ISO QMS audits.
More than just an obligatory requirement, CAPA is the means by which companies can advance their quality system to mitigate risks and avoid issues in the future. With the right tool, a company can get their CAPAs under control and that can help keep information and data organized while prioritizing corrective actions to ensure that the most crucial are addressed first.
The steps necessary to complete and document CAPA efforts successfully are the following:
- CAPA – Identification: defining the possible or real problem, nonconformity or incident, and describing the situation as it currently exists
- CAPA investigation: determining the root cause of the problem, nonconformity or incident which involves collecting relevant data, investigating all possible causes and using the information available to determine the cause of the problem.
- Performing Corrective Action: actions taken to correct the problem.
- Performing Preventive action: actions taken to guarantee the problem will not repeat.
- CAPA Verification: verifying that implementation and completion of all changes, controls and training – ensuring that the actions taken were effective; and adding additional information or comments that may be helpful in understanding CAPA actions.
An effective and compliant CAPA process involves a set of data in order to detect problems, find and implement solutions, and document findings and changes. It’s a process that can impact the entire company, you need a system that can track key activities and provide an audit trail as needed. CAPA process should be dropped into a particular project, thereby triggering a special sequence of events (steps) required to resolve the QMS issue.
The collected information and the following actions that were taken have to be documented and stored in CAPA documentation. If the company regularly performs a risk assessment and CAPA actions after each design and development stage, and as well as when any nonconformance appears, it would significantly decrease the production and post-production costs and additionally contribute to process improvement and product quality.