Do you have a robust and compliant CAPA system? Pharma biotech companies around the globe are struggling to juggle numerous priorities and challenges. One of their biggest struggles is to effectively manage CAPAs.
Let’s find out
- Do you use a scored risk assessment process to determine the need for an investigation and CAPA?
- Do fewer than 10% of your investigations conclude human error as the root cause?
- Do you maintain and use metrics on how your CAPA system is performing?
- Do you perform effectiveness checks that include objective and measurable criteria?
- Do fewer than 25% of your CAPAs need extensions?
Unless you answered YES to all of the questions, your CAPA system may not be as robust and compliant as you think.
Symptoms of an ineffective CAPA system
Pharma biotech companies that lack robust and compliant CAPA systems may be struggling with one or more of the following common problems:
- employees focus on closing the CAPA to release the batch rather than applying a systemic approach to resolve and remediate the problem and prevent it from happening again
- CAPA actions address symptoms but do not fix the underlying root causes
- lack of expertise in developing, implementing and maintaining (and sometimes enhancing) a CAPA system that integrates compliance into business practices and quality systems
- the CAPA system may be good but personnel do not use, or do not have the knowledge and expertise on to effectively use, the CAPA system to improve profitability by decreasing the cost of quality
- the CAPA system doesn’t use effective checks and thereby results in unintended consequences
- the CAPA actions add unnecessary complexity and inevitably lead to non-compliance with local procedures.
