For effective food safety management system in an organization it is important to have deep knowledge on the problems by identifying its root cause to fight it. Corrective action and preventive action (CAPA) is an investigative process for determining the proper disposal of problems by identifying the root cause of problem and taking preventive action against it to prevent its recurrence.
Purpose of CAPA is to take appropriate, effective, and comprehensive corrective and/or preventive actions. CAPA helps in identify and investigate existing and potential product and quality problems. It works by collecting and analyzing information based on appropriate statistical methodology as necessary to detect recurring quality problems. CAPA ensures that problems are detected and resolved without its recurrence. It is also linked to various other requirements such as complaint files, non-conforming product, acceptance activities, servicing, audits, reports of correction and removal (recall)
How to Implement CAPA
Two approach for implementing CAPA is corrective action and preventive action, both of which deals with long term goal of achieving problem free process. Once a problem is detected, before going for long term solution it is important to address the problem immediately. For which comes correction that involves repair, rework, or adjustment and relates to the disposition of an existing nonconformity.
Corrective Action: Initiation of systematic set of activities as soon as problem is communicated. It involves describing of problem so as to reach the root cause of problem. It is a long term approach which generally comes up after studying which tells more specifically about the root cause of problem. It is important to validate and verify the corrective action.
Preventive Action: Preventive action recognizes the value of the information and actions taken during the corrective action function. Once a root cause has been physically described, it is easy to define the problem being in system, policies, procedures or in any other step.
Elements of CAPA system
- Data Analysis: Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify nonconforming product, or other quality problems. Appropriate statistical methodology should be employed where necessary to detect recurring quality problems and establishing the data resources.
Common Statistical Techniques for data analysis are pareto charts, run charts, control charts, mean and standard deviation, Graphical methods (fish bone diagrams, histograms, scatter plots spreadsheets) etc.
- Investigate Cause: Investigating the cause of nonconformities relating to product, process, and the quality system is a must. Investigation steps to be followed are
- Identify the problem and characterize
- Determine scope and impact
- Investigate data, process, operations and other sources of information
- Determine root cause if possible
- Possible root causes: It can be in system, manufacturing procedure, training, design, management policies, change control, purchasing/ Supplier quality, documentation, maintenance etc.
- Root cause analysis tools: Commonly used tools -Fish bone diagrams, 5“why’s” and fault tree analysis.
- Identify Action: Action(s) needed to correct and prevent recurrence of non-conforming product and other quality problems should be timely identified.
After identifying action, take action by
- Identifying Solutions
- Develop action plan for corrective action/ preventive action
- Consider the risk posed by the problems as not all problems require the same level of investigation and action.
- Verify/ Validate Effectiveness: Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished product which can be checked by ensuring that the proposed solution works perfectly or by checking it solution has created other potential non conformances. All verification/validation protocols should be established and data should be reviewed against the activities.