Tracking & Tracing
HYDRA Tracking & Tracing
Complete Product Documentation (Traceability)
To comply with consumer safety standards, most companies need to have a complete and current overview and documentation of all products and materials throughout the entire production to ensure traceability of finished products and to provide source and disposition lists pertaining to raw materials in the event of complaints. International standards, such
as FDA standard 21CFR11 or EU standard 178, leave little leeway for the pharmaceutical and food industries. Similar regulations apply to manufacturers of packing material and suppliers of safety related parts, e.g. in the automotive sector. The HYDRA “Tracking & Tracing” module (TRT) forms the basis for batch management and comprehensive product
documentation (traceability), which can be used for single-level or complex processes as well as intricate and multi-level processes.
Integration with other HYDRA modules
If required, information from other HYDRA applications may be integrated. The module allows the user to specify individual details, including which details shall be printed and which data is to be included in the product certificate. For example, the following data may be saved for generated batches:
• Descriptive batch attributes, such as weight or date of manufacture
• Operating materials used
• Machines used
• Recorded process data
• Persons involved in the production process
• Tools used
• Maintenance data pertaining to machines and tools
• Quality-relevant data, such as measurement readings, test equipment, and so forth
Increased safety in the process chain
The Tracking & Tracing module not only documents the production process of an item, it also helps to make the production process safer. Therefore, functions can intervene in the process chain by actively monitoring production processes and stopping these processes in the event of failures.
For example, HYDRA can check the weight values of raw materials and compare them to the default values included in the component list. Once raw materials have been mixed,
a unique batch number and batch label are generated for the intermediate product. If this product is used in further production steps, HYDRA will perform validation checks based on the master data of this order. The next production phase will only be started if the result of the validation is positive.
Internal material flow
In addition, HYDRA assists in the internal material flow management accurately identifying and assigning products or batches within a multi-level production process. RFID tags
or container labels including bar-codes are used to identify products that might be stored in WIP (“work in progress”) warehouses.
Batch data collection
Batch data is directly entered at shop floor terminals located on the production floor. Validation checks prevent the manual input of erroneous data. Bar-code or RFID readers are recommended to ensure accurate data input and to prevent errors common to manual data entries. If required, batches can also be reclassified manually via the terminal (e.g. classifying batches as “failed” and / or posting them to “inventory on hold“ storage areas).
Functions for batch tracing
The batch overview shows all batches included in the system, irrespective of whether they have been generated in HYDRA or copied from ERP systems. Typical batch information stored and displayed includes details on the status, date of manufacture and expiration, storage location (material buffer), quantities, characteristics, specific batch data, and so forth.
The batch history includes all processes recorded for a batch in chronological order.
The “batch tracing” function provides a tabular presentation of the product manufacturing process.
The graphic batch tracing generates a “batch tree,” which documents the creation of a product graphically. It may be used to view the process from the raw material stage to the finished product and vice versa (traceability). If a consumer detects a damaged product, it can be determined which input batches (raw material or semi-finished articles) were used
in the finished product. Then, other processes are checked which might include the same input batches. Therefore, it can be determined which finished products have to be recalled and replaced or repaired.
Dialog box of the terminal: Information relating to machines and orders is displayed at the top.
Data pertaining to batches is displayed on the bottom. This dialog shows produced output batches.
Dialog box for changing input batches if, for example, one container of raw material is empty and a new batch is used in a new container.
