Corrective action simply comprises of improvement steps that can be implied to an organization process of action to eradicate the causes of non-desirable situations. The CAPA management basically is the heart of the QMS and it keeps on indicating that how effective and reliable your Quality Management System is working. In this regard, it is always get audited by the respective bodies and mostly audited in a supplier one. This process holds its importance by itself and the fact is that the CAPA process is still one of the leading when it comes to the third-party references that further leads to the critical changes.
The issue still arises for the medical device companies relating to the warning letters and the observations of the FDA is a major concern. It is a clear image now that all the companies have to sit together at a point and make tactics to deal with the CAPA Management System. We will try to put a drop of light to the darkest side of this audit. Getting deep into the conversation of this we will elaborate the prime importance of CAPA and the way that how you can implement an effective prevention system.
If you are already familiar with the system and running a CAPA system in your organization we will provide you with some of the checklist options to look ahead and fulfill your gaps before the auditor does it. You should be clearly verified about the whole system requirements that their quality regulations are defined and up-to-date. Having the knowledge of all the current sources related to the product and its quality issues as an input in the system. Deviation Management process of reviewing the data which is coming is up to the mark with complete and accurate timely.
The current era of Covid-19 has also made forced decisions of our digital transformation and make the environment much quicker than we have expected. We had to come out of our comfort zone to get along with the significant changes related to the work routine of our everyday life. In this period, a slight change in Deviation Management has seen in the field of medical industry in terms of its effective control on its processes and Supplier Quality Management. Before this, we are used to with the Supplier audits and right after that we have to go through QMS of the supplier.
Performing a site audit is a little bit time consuming nowadays. It normally takes between one or two days for an audit depending on the working ethics of the suppliers and their commitment towards it. Travel restrictions has also forced some of the changes in control processes and the suppliers with an outer audit is limited. The availability and management of such of these tasks and the critical Supplier Quality Management has been compromised. The real fact is that all the solutions of these problems have been shifted remotely and the industries are still not familiar with it.