Product Genealogy
Product tracking from raw materials to finished product
Manufacturers are often required to track the mixture of raw materials their products are made of including the raw materials, semi-finished product, and finished product so customer service and product engineers can investigate customer complaints, product exceptions, and other related quality conditions.
Product Genealogy is the recording of what goes into their products including:
- Material Name
- Date and time of consumption
- Quantity of consumption
- Lot number of the material
- Serial number of the product
When consumptions are applied at all levels of production throughout the manufacturing process, one can backtrack from the final product all the way back to a specific lot of raw material and its associated paperwork:
- Certificate of Analysis
- Product Specification
- Vendor Specification
- Lab Test Results
This can be a very powerful tool for multiple departments within an organization:
- Customer Service: process complaints
- Production Managers: compare results over time and against a golden standard
- Product Engineers: improve the product
- Quality Engineers: measure conformance to the product specification
- Purchasing Agents: hold vendors accountable to their specifications
- Process Engineers: measure process capability against product specifications
Although one should consider 3rd party off-the-shelf solutions first, custom software can be cost-justified and provide benefits beyond existing solutions:
- Initial prototype
- Competitive advantage
- Special requirements
- Tight specifications/compliance
We work with our customers to make the best choice for their needs and establish metrics based on their business goals to assure success!
Traceability in Practice
Forward and Backward Tracing
- Backward tracing starts from a finished lot or serial number and finds every input: raw material lots, intermediate batches, equipment, operators and process conditions.
- Forward tracing starts from a suspect raw material lot or batch and finds every intermediate, finished lot and customer shipment that used it, which limits the scope of a hold or recall.
Batch Records
An electronic batch record captures what happened during each batch: the recipe and its version, the materials and quantities consumed, set points and actual values, operator actions, sign-offs and exceptions. Linking the batch record with data historian trends shows the process conditions for each lot.
ISA-88 Batch Terminology
The ISA-88 batch control standard provides a common language for batch systems, which makes genealogy data consistent and easier to integrate:
- Physical model: enterprise, site, area, process cell, unit, equipment module and control module.
- Procedural model: procedure, unit procedure, operation and phase.
- Recipes: general, site, master and control recipes.
ISA-95 extends this to the exchange of production, material and quality information between plant systems and business systems such as ERP.
Batch and Genealogy Experts
Automated Results has 30+ years experience with batch processing and product genealogy. One of the owners participated in the development of the ISA-88 (S88) batch control standard and the ISA-95 (S95) enterprise-control system integration standard that defines the framework that software manufacturers and businesses are using to implement product tracking and batch processing.