Quality Management is a process to take into account in all the activities of every organization. Every action performed, every product or service provided, campaign, practice, … will be benefited if quality processes are implemented for its control and continuous improvement.
Notwithstanding, and based on the goal of each of the goals of the quality processes, we can distinguish four main blocks:
- Quality in engineering
- Quality assurance and control
- Quality improvement
- Change management
QUALITY IN ENGINEERING
The main function of engineering or products design, is to incorporate in them the characteristics required by customers. But, at the same time, to do it in a way that they will be manufactured in the most efficient way and avoid as far as possible the generation of defects during the process of manufacturing or service.
For this function, it is necessary to have the strategies, processes, and tools from the start. Quality in engineering provides the functions and tools required for the design and introduction of new products, focusing on “Quality through Design”, rather than on “Quality through tests”.
The process of quality in engineering starts with creating a project, that can include defined deliverables, milestones, and stability studies. Next, it will follow an iterative process of closed cycle of tests, in which the different results during the product development will be analyzed and adequate corrective actions taken with the goal of improving the quality of the design. This iterative process will continue until the initial milestones are achieved, and the new product or service is launched.
Therefore, these ones will be the steps of this important function in quality:
1. TO DEFINE THE DEVELOPMENT PROJECT
Adequate management of the project is critical for the success of the introduction of new products. Establishing from the start adequate deliverables, milestones and if necessary, stability studies, will contribute to defining the scope and avoid wandering without focusing on the real goals.
2. MASTER DATA AND INSPECTION PLANS MANAGEMENT
As in the rest of SAP S/4 HANA functionalities, having updated and completed master data will ease all the rest of the tasks. Due to the closed integration of quality management with the rest of modules, this requirement is also needed in these other modules to guarantee the quality in the design process.
3. TO EXECUTE AND REGISTER THE RESULTS OF THE ITERATIVE CLOSED CYCLES DEFINED FOR THE DESIGN
For this task, it will be required close collaboration with the rest of the involved areas. But we also must consider that a good design based on the feedback of these other areas will also bring benefits to their operations in the end. Thus, improving the prototypes sent by vendors, or the in-house manufacturing, will improve the standard processes once the product is launched, avoiding disgusting surprises.
4. TO PLAN AND EXECUTE THE STABILITY STUDIES
The stability studies allow the evaluation of the products in different phases of the life cycle under specific environmental conditions and during defined periods of time. For instance, they can be used for calculating the expiration time based on different parameters such as the temperature, humidity, atmospheric pressure, light exposure, … they also allow, for instance, to analyze the best compositions of products, or the best ways of packaging.
5. TO CREATE AND MAINTAIN THE REQUIRED QUALITY DOCUMENTATION
They can be technical procedures or results, but all the information collected during the design process will be very important for posterior quality management.
2. QUALITY ASSURANCE AND CONTROL
Once, the new product or service has been launched, even having designed it based on its quality, it will be necessary to monitor its manufacturing and execution. This process will be critical, both for ensuring that it follows the expected quality standards and also for implementing a process of continuous improvement that will take us to offer better products and services with each passing day.
Quality assurance and control processes contain general quality processes such us the request of quality certificates to our vendors in the moment of receiving the purchase orders, inspection tests in the different moments of the manufacturing process, release of manufactured products, … as well as implementing the required corrective actions for fixing the detected defects and for improving the process avoiding them in the future.
Quality inspections are a key element in this block, as they are the input for the analysis and decision taking.
In this area, we can distinguish the following phases:
We must decide and configure in the system in which moments a sample must be taken, or a test must be performed.
These triggers can be defined by the step in the manufacturing or procurement process, but they can also be restricted to specific materials or conditions. They can be random samples, and in some cases, they can be triggered manually. Therefore, they can be planned or unplanned tests.
2. TEST REQUEST
Once the conditions have been met for triggering an inspection test, the system will create an inspection lot with the sample to take and the instructions for performing that test.
The test can be a simple visual inspection or include complex laboratory analysis. In any case, we will need to enter in the system the relevant results for quality.
Additionally, we must enter the found defects, if any.
4. USAGE DECISION
Finally, with all the collected information, we need to indicate to the system if the tested products can be used.
Normally, we will use batches to group quantities of the same materials manufactured in the same way or procured with the same purchase order. The result of the usage decision will be applied to the whole batch, even if only a sample is tested, and the necessary posterior processes will be triggered in order to identify both physically and in the system those batches that are not eligible for being used so that we can ensure they are not employed by error.
Other important functionalities in this process are the following:
– INTERFACES WITH TEST EQUIPMENT TOOLS
In order to automatize as far as possible the processes of data collection from tests, SAP S/4 HANA offers an interface for data interchange with the inspection tools.
– PROCESS STATISTICAL CONTROL
For the analysis process, it is also important to use the right statistical tools. In this way, we can make studies of different types (Six Sigma, Pareto, trends analysis, exceptions, …).
– LABORATORY INFORMATION SYSTEM
For those industries in that extensive laboratory tests are required, it is also important to take into account the provided functionality for sample management.
– GXP COMPLIANCE
In all the processes performed in the system, we must try to comply with the recognized quality standards (Good Practices). For instance, in the relevant industries and processes, we must consider functionalities provided for FDA documentation control, electronic signature, audit trails, batch traceability of electronic batch records.
3. QUALITY IMPROVEMENT
Apart from preventing us from sending products with insufficient quality to our customers, the information collected from the performed tests or of any other quality process will be very useful for another crucial function, Quality Improvement.
For this function, SAP S/4 HANA provides the functionality of Quality Notifications.
This process contains the following steps:
1. QUALITY NOTIFICATION ENTRY
Through Quality Notifications, we can register different types of problems. These problems can be due to insufficient quality in the received materials or detected in our internal manufacturing processes.
2. ANÁLISIS DE LOS AVISOS DE CALIDAD
Once detected, every quality notification must be analyzed, in some cases by specialized technicians. The main goal is to categorize them and find the common causes of them.
3. ASIGNACIÓN DE ACCIONES CORRECTORAS O PREVENTIVAS
Once the causes have been found, adequate corrective actions must be planned, and if possible process reengineering must be considered to avoid new defects of the same kind. It is crucial to determine the right cause, but also those departments or personnel which can influence these causes in order to avoid them in the future.
5. CORRECTIVE ACTIONS EXECUTIONS
Through the Worklist, the different responsibles of the corrective actions to take will be able to check what they have to do and the status of their tasks.
6. ACTIONS AND PROBLEMS MONITORING
Once the corrective actions have been performed, we must enter the confirmation in the system, and the Quality Notification can be closed.
For analyzing Quality Notifications, SAP S/4 HANA offers different reports and analysis tools
4. CHANGE MANAGEMENT
During the life of a product, it might be required to make specific changes to it, both in its composition (components or raw materials that uses), and in the way of manufacturing it (operations or phases).
Actually, change management is another step in the product lifecycle, as it was its launch, so it should follow similar processes.
In the PLM module, it is possible to manage these changes, and again, the great advantage of using an ERP as SAP S/4 HANA is that we can plan and configure in the same system the multiple interactions that each change has with the rest of the logistics processes.