A post from Cogiscan that is very near-and-dear to my heart crossed my feed recently. It discusses traceability information in the automotive industry’s electronics manufacturing environment. The avionics industry that I work in has similar requirements, albeit even more stringent.
Part of the post lists out six categories of traceability (in bold), and I’ll expand on how my organization has used each of those information:
1. Who touched the product. We’ve had operators who violated process and were terminated as a result. We needed to review all units that they worked on to determine whether rework was required.
2. When was it in process. We’ve seen defects increase during rapid environmental fluctuation. Identifying the units with work in progress at that time helped us focus closer inspection on the subset of units at risk.
3. What operations and equipment it went through. If we determine a particular piece of test equipment is malfunctioning, we can determine the assemblies which it processed and pull them back for re-test.
An additional aspect that’s closely related is being able to show whether the equipment is being properly maintained at the time it touched products, that the equipment was validated after installation, and is suitable for the requirements of the task. (i.e. That it can do what we’re using it for, within the tolerances we need.)
4. How that process transpired. Traceability data doesn’t have much impact upon this, but we have excellent proof of process. We strictly enforce that all of our production processes are documented in compliance with design docs and equipment usage. Our documents must be approved prior to use, all changes are tracked via coded revisions, and when we need physical documents their distribution is tightly controlled. Our operators are trained and re-trained when needed, on a process-specific frequency, and we retain ongoing records of their training.
Further, our assemblies are all individually tested upon product-specific test equipment and processes that are as stringently-controlled as our production processes – arguably, under even tighter control due to its governance by the Quality department.
5. What materials were used. Each assembly we build is tracked with a unique serial number. Raw materials and component parts are tracked via lot batch, which indicates their source. When materials are replaced, the old data is retained and can be queried. We’ve needed to identify all lot batches used for a component of a particular part during failure analysis. We’ve also needed to identify all units that include a particular lot batch of a component.
6. Where those materials came from. A raw material or component lot batch tracks back to our ERP ordering system. We can identify the unique receipt line of a shipment against a purchase order. It identifies the source organization, when it was received, where it was stocked, etc– generally, the same traceability information as tracked by our production systems.