Achieving greater quality in manufacturing, you need a means to implement improvements to an organization’s processes so that they eliminate causes of non-conformities or other undesirable situations. This process is commonly referred to as CAPA or Corrective and Preventive Actions. One cannot achieve compliance to ISO 9001, ISO 13485, GMP and myriad other quality standards without a strong, consistent CAPA process. The consequences of CAPA noncompliance are costly and significant, resulting in damaged brand reputation and , potentially, a company’s long-term profitability. Effective CAPA management is more than just a regulatory requirement. It’s a good business practice that can reduce company liability and warranty claims and increase customer satisfaction.
CAPA, as the term indicates has 2 parts to the process. Corrective Action and Preventive Action. Corrective actions are implemented in response to customer complaints, unacceptable levels of product non-conformance, issues identified during an internal audit, or adverse or unstable trends in product and process monitoring. Preventive actions are implemented in response to the identification of potential sources of non-conformity to prevent reoccurrence. CAPA implementation and effectiveness verification are leading indicators of the overall quality system effectiveness.
The CAPA process has the following key phases:
- Problem Definition: In-take of the issue and finding all the required information so that the detailed analysis can be conducted. This step also includes identifying and including the relevant personnel from the company or outside of the company who can help address the issue at hand. Not all source inputs to potential nonconformances are always identified. Information is typically is not measured, monitored or shared across different product lines or business units. Trending data are not always visible to the appropriate level in the organization. Companies tend to look at product and material issues and correcting them and neglect to look beyond into the processes and procedures of their quality system.
- Analysis: Thorough analysis of the issue that has been summarized from step 1. The analysis may include scanning the entire system to determine if issues of similar nature have occurred. Conducting risk assessment to determine the severity and the potential impact the issue at hand will have on the company’s key stakeholders and principal/values.
- Investigation: You will need t identify everything from problems that may occur from partner sites through final manufacturing, labeling/packaging and distribution lifecycle to any possible customer complaints. Key to recording problems is to drive to the root cause and focus on prevention and correction actions. Locate and document the root cause(s) of the identified non-conformity. Use the various investigation tools such as 5 Why’s, Pareto Analysis, Fishbone Diagram, etc. to be sure that the root cause investigation was done using scientific methods. The more knowledge you have, the faster you can react. Without n integrated system, identifying root causes is little more than guesswork. Assumptions are made based on rumor and conjecture, rather than accurate, reliable data. Islands of information created by multiple data streams lead to inconsistencies and waste. Immediate data and real measuring tools enable managers to determine precisely where and when mistakes are occurring and why.
- Action Plans: Create and document the required action plans that will mitigate the identified root causes. Care should be taken to be address the corrective action to address the non-conformity at hand and at the same time take preventive actions to be certain that the issues of similar kind does not occur in the future. The actions may require initiating change control to address all the required changes to be addressed including procedural or documentation changes. Such changes should be communicated to those directly involved – making sure everyone is aware of the changes, understands the changes, and implements the changes. Once source error information is correctly captures, many companies escalate these immediately to CAPAs to begin the investigation process. Everything becomes a CAPA! This behavior may lead to an overload of data that doesn’t inherently provide the important impacts of what’s failing across the organization. With a volume of CAPAs, companies cannot always assure 100% effectiveness of its corrective/preventive action plans; what the trending really is tell you and, if the information provided back to the product design is really going anywhere – there’s just too many.
- Verification or validation of effectiveness of the actions: Did the changes have their desired effect and did they have any adverse effects? Effectiveness checks are a critical part of the CAPA process to be sure that effectiveness checks are done in a systematic manner and the information collected through this process is documented for why the information as accepted or not. The CAPA process should be tied to a company’s overall change management strategy to more effectively response to issues as they arise.
- Review at the management level – make management aware of and ensure they are on board with all the activities.
- Document everything – provide that “audit trail” or “evidence” of everything done.
To accomplish the above processes of what a good CAPA process requires for a company to manage their need the following QMS solutions:
- Nonconformance Management: Identify and capture any product or process related nonconformities including customer complaints. Capturing events that happen at the source is a critical part of an effective CAPA system
- CAPA Management: A good CAPA management tool provides an effective problem resolution management platform that allows to choreograph the above identified elements by supporting the processes within it or by working with other parts of the integrated EQMS solution framework.
- Change Management: Many a times, action plans proposed may need to be spun off as change projects whether they be replacing machines, re-validating a specific process or equipment, changing documents, creation of new documents or ensuring that knowledge is properly propagated, a change management tool is essential to carry out the complete CAPA action plan objective.
- Document Control: We know information is knowledge and no process change can be complete without the supporting information in documents are revised and thus aligned with the improvement to the processes that are being worked on.
5. Training Management: Knowledge dissemination due to the changes or creation of new content requires that the resources who should be informed and knowledge transferred and assessed are all important part of the effectiveness of how well a CAPA got implemented.
So as you see, for a good CAPA process to work, a company needs to have 5 core solutions, if not more. The purpose of a highly integrated EQMS solution is to support such choreographed processes and thus ensuring the company achieves a high degree of required business process automation resulting in reduction in cost and improvement in brand loyalty.