As a Medical Device company, you are required to investigate the cause of quality failures or production problems. Surprisingly though, “Failure to thoroughly investigate…” is a common finding from quality (management) system inspections and audits against FDA 21 CFR Part 820 and ISO 13485.
To conduct effective failure investigations and perform root cause analysis you must ensure that you have a structured investigation process driven by your corrective and preventive action (CAPA) system.
Despite CAPA being a well known and mature concept with many regulatory and guidance publications for the medical device industry, CAPA failures continue to disrupt companies from a compliance and efficiency perspective.
To make the most of your CAPA system and improve your business, you must:
- Understand the language of investigation, problem solving and CAPA
- Identify regulatory requirements and expectations related to failure investigation, root cause analysis (RCA) and CAPA
- Know when to use risk assessment
- Outline the steps in a common failure investigation and root cause analysis process
- Understand when and where to apply problem solving methods and tools
- Document failure investigation and root cause analysis process activities
- List the essential features of effective CAPA systems
- Ensure your CAPA process is efficient and effective
Contact us for advice on how to get more value from your CAPA system and address concerns with quality or production of your medical device(s). We can help you eliminate causes of non-conformities and prevent their occurrence or recurrence. You may also be interested in our CAPA training course.
