What is traceability in manufacturing? When done wrongly, it is one of the most expensive, confusing, distracting, valueless wastes of time that manufacturing is ever required to do, but when done properly, it can be the one thing that saves the life of a manufacturing business, which can happen in several different ways. Traceability, in this new age of digital manufacturing, has never been so inexpensive, and with the recently increasing ingress of counterfeit materials, never more important.
What Is Traceability Data? Definition of Traceability
In itself, traceability data concept and definition is quite simple, being the build record of all events that have occurred and have had an effect on a product. Like a video-tape, the data is gathered throughout the time-line of production, recording materials added, tools used, process steps executed, test results and readings. A common issue with traceability is the difficulty to agree exactly what data needs to be collected. IPC-1782 is the first traceability data specification standard for the whole of the electronics industry, containing a clear specification of the parameters that should be recorded, as applicable to product classification and risk assessment. The use of the standard avoids the frequent and somewhat painful experience, where customers and suppliers argue about what data is required, what is cost-effective, how it should be collected, reported and stored. Having different expectations across in the market is very confusing and often leads to scenarios where the expected data was not in fact captured correctly, resulting in a lot of wasted time and effort, zero value, disappointed customers, and potential liabilities.
How To Collect Traceability Data - Traceability Requirements
Even today, it is very common to see traceability data being collected and compiled manually. Compliance and conformance still seem to be focused on “paper trails” of responsibility. Any data collection operation that includes a human to create or manipulate the data leads to doubt. People make mistakes and create variable results; we are not automatons. There is also the cost element to consider, as people in manufacturing who should be focused solely on adding value in manufacturing and not distracted with data recording and processing. The IPC-1782 standard encourages the automated collection of data where possible. There are two elements to this, the first of which is to connect to automated machine processes electronically through an interface to gather data, such as test results, readings and measurements, materials used and actions that have occurred. Automated data collection however has been one of the greatest challenges in the manufacturing industry. No-one designing automated machines in the past really thought about how machines need to work together across functional and competitive barriers to provide information needed by customers. New technologies such as the IPC Connected Factory Exchange (CFX) are now in play to bring long overdue neutral data formats, with defined content, and true plug and play infrastructure for the industry, such that for any application, machine, MES solution etc., there need only be one standard interface for manufacturing data. Digital product traceability benefits greatly from the direct capture of data from automated processes, as the data is accurate and timely, and, when using CFX, consistent between all machines. In addition, CFX supports the operational events of manufacturing, including things such as material flow, work-order assignments, tool management, energy usage etc., so that critical information that is external to automated processes can also be digitally captured. Having this digital data capture as part of the operation means that complete digital build records of production events across all products can be created continuously, with almost zero net cost for data collection. This digital build record is of the highest order of quality, easily satisfying the highest need for traceability, and potential for value creation.
The Values Of Traceability: Active Quality Management
Rather than consider first the more well-known value of traceability supporting product recall scenarios that we never want to have happen, we can look into the arguably more important value of traceability data as an excellent everyday quality management tool. Consider the case where, in a batch of a thousand products, there is a single defect recorded. Normally, the cause of such one-off defects are almost impossible to locate with any certainty, as different defect occurrences seem to just come and go at random. With dependable and detailed traceability data, analysis can be done to discover the exact unique combination of circumstances and events that lead to the occurrence of the defect. As part of the best digital Quality Management Systems which feature integrated administrative quality functions, such as corrective action management, procedures can be defined and put into place to ensure that the unique combination of factors is never allowed to reoccur, thus avoiding such defects in the future. The scope of the corrective action components can include other products in similar processes so as to widen the benefit gained. In addition, the knowledge and understanding of the unique circumstances behind the defect means that the other products in the lot or work-order in which the defect was found can be trusted not to have the same defect, and so can be shipped without reinspection once the single failure has been rectified. Digital traceability used in this way together with integrated administrative quality functions represents a continuous value towards a true zero-defect factory operation.
The Value of Traceability: Conformance
As electronics has become a critical part of so many areas of manufacturing, especially medical, automotive, aerospace products etc., the reliability of electronic products is critical. This can even be said of the most humble of electronic products, the USB device, which many people are using today as critical backup devices. It is a fact of life however that products will fail in the market, sometimes due to a fault or weakness, but also due to use or treatment beyond their design intent. As a result, there are cases where critical failures occur, where the responsibility for the failure needs to be quickly assessed. The manufacturer is often seen as a likely source of a hidden defect, as this is where almost all actions were taken for the creation of the product. Conformance and compliance to agreed rules and procedures are there to protect the manufacturer in this regard, to prove that there was no mistake or deviation in the manufacture of a defective product that they were responsible for. This can include the use of only designated materials and confirmed processes. The traceability data within the digital build record can immediately satisfy such requirements, as every action that was performed as part of the conformance or compliance procedure was recorded. Responsibility for any defects can then be sought elsewhere, protecting the manufacturer from costly legal proceedings, as well as protecting the company image.
The Value of Traceability: Counterfeit Materials
The ingress of counterfeit materials has today reached a point where they can be found quite commonly in manufacturing. The reason for this is that there is no real accountability whenever a counterfeit material is detected, so the people responsible for the counterfeits continuously get away with it without a real risk of detection or prosecution. An effective deterrent has to be created, proof that a specific carrier of material purchased, contained counterfeit material before responsibility can be passed to the supplier. In terms of manufacturing costs, counterfeit materials are really bad news. Where suppliers have become trusted over many years, now with the likelihood of receiving counterfeit materials growing, costly incoming inspection procedures need to be reinstated. The counterfeiters are also very clever, in that they know how to package materials so as to defeat simple sampling procedures. To quickly reinstate Incoming Quality Control (IQC) processes as a part of a modern digital MES solution is already an essential tool to minimize effect and risk of existing counterfeit materials in the supply-chain. Without this, detection is often only made when the failure of a product occurs in manufacturing, or even in the market.
Having the full traceability digital build record means that even though significant time may have passed since the material was used, the responsibility for exactly where a counterfeit material came from can be clearly tracked back. In addition, any other product, either in the factory or shipped, that also used materials from the identified carrier can be identified and necessary action taken ahead of potential failure. Any liability for the recall of products is minimized as specific serial numbers and potentially owners, can be contacted directly, resulting in a very significantly reduced impact to both the company that owns the logo on the product as well as the manufacturer. Material suppliers must in turn create their own secure traceability, as part of a trusted digital supply-chain control, in order to avoid liability for counterfeit materials. As soon as the responsibility can be traced back far enough to expose the source of ingress, the automated policing of the supply chain will be complete, such that the creation of counterfeit materials will become too risky, and so be deterred.
The good news about digital traceability in manufacturing, even in terms of just the values illustrated here, clearly exceed the remnants of any costs associated with traceability data collection by orders of magnitude. The digital build record, as an integrated part of a modern digital MES designed with IoT, is the essential solution to reduce the costs and risks of day to day manufacturing operation risk, a must for the successful companies of the future.
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