The Corrective Action Preventive Action Plan Documentation And Procedures In SAP ERP Systems For Manufacturing Industries

INTRODUCTION SAP CORRECTIVE AND PREVENTIVE ACTION Across the globe, companies are under constant pressure to be compliant to regulation from various regulatory bodies, customers and governments. Managing non-conformities, process deviations and critical observations in accordance with Quality guidelines across business function in an organization is an integral part of being regulatory compliant. Corrective action and preventive action (CAPA) is one such process which can be used for categorizing the various types of issues faced during the operations of a company, documenting it, monitoring the progress and impact of the actions taken and implementing the findings to prevent reoccurrence of the major cause of the complaint and improving product and process quality. Root cause analysis deals with ascertaining the source of problem, defect or non conformity by identifying reasons for failure of product or inconsistency in process operations and to implement corrective or preventive action to address the issue. Generally, most of the organizations use only the Defect reporting functionality in SAP, while still using the manual or non integrated system for managing or tracking corrective actions. The Defect Reporting can never ensure the non - reoccurrence of the defect/issue. SAP ERP provides a standard Quality Notification functionality where various types of incident or defects can be recorded and processed. SAP Quality Notification can be configured for an effective CAPA solution. The issues can get quick resolution as task can be defined and assigned to concerned persons who need to process the task for defect resolution. Defect Analysis can also be done to identify likely sources where most of the defects are originating. The corrective actions can be monitored using SAP business workflow to track follow up actions. Catalogs can be defined to efficiently classify the defects. Integration with SAP BI can be done for optimized reporting. Standard workflow can be used to keep track of approvals and actions taken to address the issue. The SAP based solution mostly addresses the key elements for an integrated corrective / preventive action system, which on a high level includes:-

Continuous monitoring based on documented procedures Prioritization and risk management

Verification & validation Well defined procedures

Implementing SAP Quality Notification based solution enables the organization to manage defect reporting across all business processes and functions, define workflows to monitor and track actions, leverage reporting capabilities of SAP and above all enable integration with all other major business processes of the organization. THE SAP CAPA PROCEDURES Incident Identification: This is nonconformity incidents, which are generally deviations from processes and procedures that get detected during audits (internal Quality audits). It can also be complaints from Operators. The source of the incident must also be recorded. Following are the features that a incident exists Action Type i.e. Corrective action/Preventive action ) Form Number This number should be created sequentially the system when a new record is started) Part Number(s) This is the specific equipment/machine number component Initiated By The person who initiated the action should be noted eg. Initiated by: Abc Date the date the action was started is recorded, while the default is the current date

Incident Evaluation: The incident that was actually identified should be evaluated, to determine the need for action and level of action required. As a result of this evaluation, the level of risk that is associated with the problem. Incident Investigation: A proper written procedures for conducting an investigation into the problem. This written plan helps to assure that the investigation will be good and is left out, this procedure includes; the objectives for the action that will be taken, the procedures to be followed, the personnel that will be responsible and other anticipated resources needed. Incident Analysis: This is primarily to determine the root cause of the problem described through the investigation report documented. It is very important to distinguish between the observed symptoms of a problem and the fundamental (root) cause of the problem. 3

Action Plan (Correction Action): From previous investigation and analysis result , the optimum method

for correcting the situation (or preventing a future occurrence) is determined and an action plan developed. The plan should include, as appropriate: the items to be completed, document changes, any process, procedure, or system changes required, employee training, and any monitors or controls necessary to prevent the problem or a recurrence of the problem. Action plan items may also include the due date and identify the person(s) responsible for completing each task.

Follow Up: The most fundamental steps in the CAPA process is an evaluation of the actions that were taken. Several key questions must be answered: Have all recommended changes been completed and verified? Has appropriate communications and training been implemented to assure that all relevant employees understand the situation and the changes that have been made? Have all of the objectives of this CAPA been met? Is there any chance that the actions taken may have had any additional adverse effect on the product or service? Was the action effective?

Completion: When the Follow up is complete, the CAPA can be checked as complete, dated, and

signed by authorized personnel. Note: approval authorization must be set for specific users with the manager users tool.