In today’s competitive environment, a majority of industries are facing increasing pressure from regulatory bodies, big players in their respective industries, the latest customer mandates, and internal quality initiatives to take a proactive and automated approach for managing non-conformity, process deviations, and critical observations in relation to the defined quality procedures across their supply chains.

Corrective action and preventive action (CAPA) is one such process that has become a formal requirement by regulatory authorities for categorizing the various types of issues a company may encounter. The CAPA process I describe is based on the define, measure, analyze, improve, and control (DMAIC) framework, which can improve supply chain performance considerably by containing critical-to-quality problems, including: 

• Nonconformity incidents, which are deviations from processes and procedures that get detected during audits ( audits can be conducted internally or by external regulatory bodies)
• Process-related incidents resulting from an internal or external audit at a supplier premise
• Complaints from customers

CAPA can help organizations identify, record, investigate, and resolve nonconformity issues across the supply chain. Apart from resolving incidents within the organization with regards to process inconsistencies reported by customers or any other internal process issue, the CAPA process based on the DMAIC framework can also help assess supplier process compliance during delivery of goods and services.

The CAPA process requires companies to document the issues, monitor the progress and impact of the actions taken, and implement the findings to prevent reoccurrence of the major cause of the complaint and to improve process quality. Companies can then use these findings to conduct largely error-free operations and to make more consistent decisions, resulting in higher quality and more reliable supply chain operations. You can apply CAPA to any industry. 

For instance, companies can initiate CAPA with an investigation to identify the root cause of the nonconformance. Root cause analysis centers on ascertaining the source of a problem, defect, or nonconformity, by identifying the reasons for a product failure or inconsistency in process operations. From there, you implement corrective or preventive action to address the issue. CAPA can identify various solutions to reported incidents or nonconformities (e.g., new training, redesigned business processes, or added risk management steps).

A software solution that automates the process can be instrumental in managing and tracking a corrective and preventive process. The next section describes the use of SAP quality notification functionality within SAP quality management (SAP QM) for implementing CAPA solutions based on the DMAIC framework.

Implementing an SAP QM-based CAPA Solution

SAP ERP provides a standard notification functionality that can record and process various types of incidents or defects. The issues are quickly resolved because a task can be defined and assigned to designated persons who process the task for defect resolution. Also, defect analysis can identify likely sources from which most of the defects originate. You can monitor the corrective actions using business workflow functions to track follow up actions. You can define catalogs to efficiently classify the defects. Some examples of process defects include:

• While performing a lab test standard, a customer does not follow operating procedures, which leads to inaccurate results or safety risks for the people involved
• A customer complains that delivery timelines are not met
• A supplier audit finding by an external agency indicates that a vendor did not meet proper quality guidelines

In the past, many organizations used defect reporting functionality in SAP, while still using a manual or nonintegrated system for managing or tracking corrective actions. However, this functionality did not ensure that defects did not occur repeatedly. 

Now the SAP-based CAPA solution is based on SAP QM functionality and incorporates the five phases of DMAIC (Figure 1). The key roles within the SAP CAPA solution are incident reporter, incident approver, incident analyst, and task processor. 

Figure 1

CAPA using the DMAIC framework for managing and tracking defect reporting

The main steps of an SAP QM-based CAPA process are as follows.

Phase 1 – Define

In this stage a process defect is reported. Let’s use an example in which an operator at a work center does not follow standard operating procedures while working on a repair order, which can happen if the operator is new to the job. An internal departmental audit discovers the problem. The auditor (i.e., incident reporter) is the person who identifies the incident and enters the incident details into the system. Any business user who notes a problem regarding processes not being followed can report an incident. Using transaction IQS21, which creates a quality notification, the incident reporter enters the following (Figure 2):

• Notification type based on origin of defect
• Coding to further classify the defect
• Incident description (e.g., “Standard operating procedure not followed during repair of product”)
• Incident location
• Incident priority (e.g., high)
• Incident approver details (an incident approver can be a department or an individual in the department who is responsible for verifying the details of the incident and confirming its validity)

Figure 2

Create Notification screen

Change the Set User Status to 02 REL Released for processing to trigger a workflow and then click the checkmark pencil icon next to the status fields (Figure 3). This is a system step and is required to trigger the workflow process, so that, in turn, the approver receives a workflow task to verify details of the incident and take further action.

Figure 3

Select the status of the notification

Save the incident report by clicking on the save icon above the Create Notification header (not shown in Figure 3). The workflow is triggered and a workflow task is sent to the SAP inbox of the incident approver (Figure 4).

Figure 4

Incident report in the SAP inbox of the incident approver

Phase 2 – Measure

The incident approver makes the decision to approve or reject the incident based on the analysis of the business impact and the priority of the defect. The incident approver clicks the workflow task, opens the defect in change mode, and checks the defect details in order to determine if there was a deviation from a process or standard operating procedure. Again using our example of an operator not following standard operating procedures while working on a repair order, the incident approver finds this to be a valid incident worthy of further action.

The incident approver can approve or reject the defect using the accept or reject icons . If the incident approver rejects the incident, an information item is sent to the incident reporter and the incident is closed. In our example of an operator not following standard operating procedures while working on a repair order, the incident approver can reject the incident if he or she finds that the problem is not a true deviation from standard operating procedures. If the incident approver approves the incident, he or she enters the details from the incident analyst in the notification, changes the status to 03 ANA Analyze, and saves the incident. This triggers another workflow, and the workflow task goes to the SAP inbox of the incident analyst.

Phase 3 – Analyze

The incident analyst is a person from the quality department assigned by the incident approver to analyze the incident, identify the root cause, and suggest appropriate corrective actions. In our example, the incident analyst contacts the operator and auditor and investigates the reasons for deviating from the standard operating procedures. The incident analyst:

• Clicks the workflow task to open the incident in change mode or uses transaction QM02.
• Identifies the root cause of the incident after a detailed investigation. In our example, the incident analyst concludes that the operator is not properly trained for certain tasks. The incident analyst then updates the root cause by clicking the Items tab and then the Causes tab, and then entering the root cause information under Causes for Item (Figure 5).

Figure 5

An incident updated with a root cause

Phase 4 – Improve

In this stage, the incident analyst takes steps to address the root cause and, based on the root cause, determines corrective tasks required to resolve the issue. The corrective tasks then are assigned to a task processor. In our example, the incident analyst finds it compulsory that the operator attends required training under a specialized trainer. The trainer in this case acts as the task processor, who ensures that the operator completes the training (Figure 6).

Figure 6

Training task for operator is assigned to a trainer (i.e., the task processor)

The task processor:

• Enters the task processor details in the Responsible field
• Releases the task by clicking the release task flag icon  and changes the user status at item level to 02 REL
• Changes the header status to 04 IMP – Improvement and saves the notification. The process to change a status is the same as shown in Figure 3. This triggers the workflow and a task item is sent to the SAP inbox of the task processor.

From there, the task processor performs the following activities:

• Opens the task by clicking the SAP inbox item.
• Updates the corrective action taken in the summary page (Figure 7).
• Changes the status of the item task to 03 CTRL – Control by pressing the checkmark pencil icon in Figure 7 and saves the tasks. This triggers the workflow and a processing item is sent back to the incident analyst. 

Figure 7

Update of corrective action by the task processor

Phase 5 – Control

In this stage the incident analyst evaluates the task performed and takes the appropriate closure steps. Upon receiving the updated task from the task processor, the incident analyst can either accept the comments written by the task processor or reject them. To reject them, the incident analyst changes the item status to 02 – REL and sends the task back to the task processor with explanatory remarks.

To accept the comments, the incident analyst marks the task by clicking the complete icon  and the successful icon  at the item level, changes the header status to 05 CTRL - Control, and clicks the complete icon  at the header level.

This completes the quality notification process and an information item is sent to the incident reporter noting that the issue is resolved. There are standard reports available in SAP QM to view reported and closed incidents based on notification types.

Implementing the SAP quality notification-based solution enables an 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, to ensure integration with all other major business processes of the company.

Divyanshu Shekhar

Divyanshu Shekhar is a lead consultant in the SAP Practice at Infosys, Ltd. He has more than eight years of professional experience, most of it coming from SAP implementations, project management, and consulting engagements. He currently works as part of the SAP Energy Practice at Infosys.

You may contact the author at divyanshu_shekhar@infosys.com.

If you have comments about this article or publication, or would like to submit an article idea, please contact the editor.

Vineet Pandey

Vineet Pandey is a lead consultant in the SAP Practice at Infosys, Ltd. He has more than nine years of SAP consulting experience. He has expertise in SAP supply chain functional areas (purchasing, material management, quality management) for oil field services and the natural gas industry.

 

You may contact the author at vineet_pandey@infosys.com.

If you have comments about this article or publication, or would like to submit an article idea, please contact the editor.