Corrective and Preventive Action Software

CAPA is the immune system of all companies. It is a system by which you can identify deviations, invest them and implement corrective and preventive actions to bring improvements in the organization. CAPA processes are mainly used in industries such as medical device, life science, food processing, aerospace, automotive etc.

Corrective action eliminates the issue that has caused nonconformity and prevents repetition. It also helps to move products, processes, projects and products back to baselines. Corrective actions process differs from one organization to another and there are several steps taken in order to solve an undesired event. Few of them are mentioned below:

·         Recognize and acknowledge the nonconformance

·         Conduct root cause analysis

·         Execute a plan in order to correct the action

·         Plan for preventing its reoccurrence so that it is not repeated in the future

·         Investigate gaps in quality management system in order to reduce the risk of similar nonconformances

·         Evaluate that corrective action has worked and nonconformance hasn’t repeated.

Preventive action determines prevention of potential occurrences in the future. It means identifying not only the issues that has caused but also opportunities to improve the same in the coming days. With the changes which is being implemented, controls should be included to prevent and check for possible nonconformities.  It can also be used to improve the effectiveness of a process. Preventive action processes include:

·         Identify nonconformance or the area where improvement is required from trending analysis, customer recommendation or internal discussions.

·         Develop plan and implement preventive action

·         Evaluate the efficiency of preventive action

·         Verify that preventive action has worked and nonconformance has been resolved and process improvement has been realized

Hence, the approach of CAPA is to target the root cause and eliminate the same. Conducting manual process takes lot of time as well as efforts. So it is recommended to make use of CAPA Management software. Qualityze is one of the effective Corrective andPreventive action software used by many professionals to manage quality issues in many industries such as healthcare, FMCG, pharmaceuticals, life sciences, aerospace, automotive etc. Using Qualityze, you can improve the efficiency of your CAPA Management system from initiation to closure and enable users to approve and review changes. Along with CAPA management, it comes with other quality management system such as Nonconformance management software, Change management software, customer complaints management software, supplier quality management software, audit management software, document management software and Training Management software.

It is simple to use and intuitive dashboard clearly explains you all the steps that has to be carried out. Also, it will take your minimal time to carry out the process of CAPA Management. You, as a CAPA owner has the access to make the determination whether the CAPA was effective in eliminating the cause of the quality issues based on the objective evidence collected in the review task. Using Qualityze, you can meet global compliance and management systems which needs to manage issues and enhance your organizational performance. Request for demo today to understand more about Qualityze CAPA Management

Nononformance in Quality Management

In the competitive and challenging trading environment we operate today, businesses find effective ways to ensure conformity to process and define company as well as customer requirements. As your business become more complex, the lack of policy and process conformity might result in a number of issues affecting the business like decrease in the product quality, increase in waste, increase in customer complaints as well as cost, decrease in efficiencies which might result in loss of market share.

Nonconformance might lead you to rework when a product does not meet defined specifications or industry regulation and standards. It will negatively affect your company in terms of cost, reputation, efficiency and effectiveness. So, nonconformance management is required to quickly identify issues within the organization. Nonconformance management is a process wherein the organization manages nonconformances so that they are identified, documented, investigated and dispositioned as per standards and regulations. Effectively managing nonconformances is an integral part of an organization and it will result in fewer defective products and more loyal and satisfied customers.

Management review can identify and correct any issues before they might reveal by an audit or incident. Routinely reviewing the organization’s process helps in continuous improvement. A proper system should be in place for implementing any plan or verifying the effectiveness. Another important thing is, customer satisfaction. Customer complaints should be recorded and actioned as it plays a vital role in improving and minimizing nonconformance. Customer feedback and suggestions might prevent any issues from being occurring in the future. It might be negative or positive both are valuable and it helps to look into the cause of the issue which may not always be obvious.

Nothing is perfect so problems with the system i.e. nonconformance will occur, and the aim is to resolve the same as quickly as possible to prevent from recurrence. A nonconformance management software offers a set of features which allows you to control and manage the products from identification, tracking, reporting, CAPA resolution and closure. Nonconformance software is necessary in assisting and managing all steps in the nonconformance process thereby allowing you to generate corrective and preventive actions that are linked to the original nonconformance.  

Qualityze is one of the effective nonconformance software to ensure that the regulatory and standards compliance are met at all times.  This software is helpful in all the industries that rely on sensitive documents. It is simple to use nonconformance application which enables organizations to perform comprehensive risk assessment across multiple sites as well as dimensions. It is built on salesforce platform which makes it easy to tailor, extend and integrate process for related areas. The software automatically adjust workflows for critical products and also provides trend analysis to help you monitor low-risk defect before they become critical. You will get detailed documentation on the outcome of the analysis including investigations for each nonconformance record. Further, you can access Nonconformance solution on the go, anywhere anytime and from any device. It supports Quality management system in different industries such as manufacturing, life science, pharmaceutical. Healthcare, aerospace, automotive etc.