Digital Fire Fighting with a Quality Management System

The act of “putting out a fire” is associated with resolving an urgent problem. Afterward, we worry about the cause, the consequences, and what knowledge we can gain, or so we believe. Quite frequently, this next step is replaced by handling and putting out the next fire. The digital factory provides us the ability to prioritize quality “hot-spots” that require handling. However, in world-class organizations, we must ensure that we complete the additional step and do more than extinguish the flames.

If we compared assembly manufacturing to a brain, the “bi-polar” region would be quality management. Quality first is the most important today, even for the most straightforward products. Since practically everything we use relies on electronics in some way, the importance of quality and safety is no longer limited to explicitly defined mission-critical applications. The standard manufacturing management directive is that the operation should not compromise when it comes to product quality. Managing quality has always been extremely costly, and you could make the case that there is no direct benefit from any quality activity. If production would do it “right the first time,” then there would be no need for test and inspection processes, including AOI, ICT incoming material inspection, quality assurance reviews, sampling on machines and in finished products, etc. This would, in many instances, save as much as 50% of manufacturing cost if precise manufacturing could be guaranteed.

Due to this conflict, efforts have been made to rethink quality management in manufacturing over the years. In place of inspecting all materials that are received, reliable supplier programs developed that offer a sufficient amount of assurance. Moving possible problems “up-stream,” managing and regulating the cause allows quality assurance to be more economical, is a less damaging and therefore suitable option. Likewise, as an alternative to testing and inspecting every Printed Circuit Board after every vital process, we can utilize our digitized factory data to pinpoint which Printed Circuit Boards have been produced with any form of exception. In the end, defects originate from these exceptions. If a Printed Circuit Board has been built exactly the same way as the one before, without any variations such as a machine stop, a change in material, an interruption, a human touch etc., then any test result is expected to be exactly like the prior Printed Circuit Board, so, the significance of this test lessens. Could we reliably presume the outcome and not got through the trouble of testing?

Gathering data in the digital factory is turning out to be a necessary quality tool. Having a one of a kind defect in a work-order of a thousand units was once a huge problem that was unable to be corrected. It would create uncertainty in the process, not knowing if or how other products may have similar flaws. Currently, we use our digital factory data to determine what exactly took place during the manufacturing of this faulty unit. We can see the multifaceted circumstances that were the reasons for the unique defect. Here also is the verification that other production units in the work-order did not experience similar circumstances, and it is okay to ship them. An excellent tool for quality is the digital traceability build record. Since the manufacturing data -is being delivered in real-time, this process creates an extremely efficient alert system. Should any defect recur, an alarm can go off as a notification of a potentially widespread problem, to initiate immediate action before any other similar defects happen. Generating traceability data from the digital factory process costs very little, requires less manpower, shortens inspection and testing times, all of which can save money once quality is under digital control. Based on this, it seems as if the digital factory embodies the newest form of quality management in manufacturing.

Sadly, that is not the case. Fire-fighters do more than extinguish fires. They uncover risk, educate people, recommend fire-resistant materials in high-risk areas, and create procedures that reduce or eliminate the risk of fire. Comparable tools have existed for quite some time in manufacturing, which do similar things for quality hot-spots, the most common are CAPA (Corrective and Preventive Action) and FRACAS (Failure Reporting, Analysis, and Corrective Action System), though there are numerous variations with similar names. Every one of these methods delivers a very detailed analysis of a defect event or exception occurrence to guarantee that triggers, measurements, causes, actions, and precautionary steps are all accurately outlined, ordered, completed, documented, and certainly, not forgotten. In digital factories nowadays, the data for nearly all recorded exceptions and defects is stored within the digital factory management system. It is then logical to have CAPA / FRACAS management incorporated into the digital factory platform. Digital links and tags can be created and substituted with the CAPA / FRACAS procedures, which will safeguard that both facets of quality management are associated and synchronize. Having a completely outlined and followed CAPA / FRACAS procedure established, it is likely that new or revised operational guidelines and policies are defined, which in many instances will then be added into the digital manufacturing operation configuration, thereby stopping defects from recurring, no matter if they are a one-off kind where unique circumstances need to be avoided, or, the right process to prevent a widespread problem from happening. CAPA / FRACAS cases can affect all aspects of manufacturing, including the supply chain, engineering, and manufacturing execution.

To describe a factory that is fully “fire-proof” is to digitalize the whole plant, ensuring that the full digital traceability record is collected in accordance with level 4 of the IPC-1782 traceability specification. To accomplish this, all data should be gathered from processes automatically, for instance, using the IPC-CFX requirement. The comprehension of the digital product design should be completed using IPC-2581. Combining all of these, on a digitalized modern platform designed for this new technology, forms the environment where digital CAPA / FRACAS and quality management software can be entirely incorporated.