CAPA is undoubtedly at the heart of a Quality System. Hence, it is expected that this system has to be dependable and solid, if not perfect. It is both these; yet, there are numerous challenges as to its implementation.
Although a good CAPA implementation is the most desirable outcome of a Quality System audit; it cannot be denied that Quality professionals face a major issue when it comes to some aspects of CAPA. Some of the most important of these are listed here:
- It looks at what is wrong, and not why it is wrong. This makes the system shaky at its very foundation. In other words, it addresses the symptoms, not the cause.
- Ambiguity and subjectivity is another root problem of CAPA. It is the kind of system that allows for multiple and vague interpretations of many aspects of the system, making it something that can be bent at will.
- CAPA documentation rarely reflects current status. The level of documentation is almost never proportionate to the work CAPA documentation performs.
- CAPA is very rigid in its implementation. It requires multiple approvals, several signatures, many of which may ultimately never be used; and formation of too many CAPA committees.
- Another very important problem with CAPA is that alignment with Quality Policy, Quality Objectives and Business Objectives is absent, making it somewhat of an asynchronous documentation.
1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801