PARTNER FOCUS
compliance due to risk taking significantly increases. This of course
brings us back to traceability, lack of which can lead to recall of product due to failure in the field or during production and testing. The costs of such failures to a manufacturer break down into direct and indirect costs as indicated in table 1 below:
It is expected there will be an increase in the level of automation of DIRECT COSTS TO BUSINESS
• The cost of product recall from the market • The costs involved in contacting all customers • The cost of recovering product and repairing or destroying it • The cost of re-purchasing correct components • Potential legal costs depending on the nature of the product • Regulatory compliance costs
INDIRECT COSTS TO BUSINESS
• Damage to brand and reputation • Losses due to market-place reaction • Increased marketing to recover the company reputation • More regulatory compliance testing • Permanent costs due to new procedures to prevent recurrence
It is clear that traceability is vital for some sectors of the industry
and the associated costs for not having robust systems in place can be significant at best and ruinous at worst. A typical traceability system is shown in figure 1 above. Approved suppliers and franchised distributors will be able to
provide accurate traceability information, whereas an unofficial source of supply may not. The International traceability standard is IPC-1782, which breaks
traceability down into four levels as follows: Level 1: Basic traceability – Entry-level traceability that is the
minimum level expected for responsible manufacturing where any degree of traceability is required. It indicates the materials used for a work-order of products and requirements at this level should not be a significant challenge for professionally managed operations. Assemblies are grouped and identified under
production lot/date code/work order/batch code, while materials are identified using their part number and incoming order information. However, use of predominantly manual data collection limits level 1 traceability in terms of its ability to identify the scope of an issue or to ensure conformance to operational standards. The storage of traceability data at basic level
may comprise a mix of computerised and manual record keeping, across various locations/sites.
Level 2: Standard traceability – Builds on level 1
by adding the unique identification of both materials and assemblies. This allows the ability to show the materials that were available for use during the period when each sub-assembly was being processed. Materials should gain a unique ID as early as practicable after entering the manufacturing site.
data capture with level 2 traceability, as computerised systems will typically be required to provide the serialisation process, manage the database of individual material and product elements and provide the work-order management required. This reduces the amount of manual data management as well as increasing the accuracy and timeliness of data capture. Data capture built into operating procedures yields additional
assurance of compliance thereby balancing the cost of implementing level 2 against operational benefits. The ability of level 2 to diminish the likelihood of product recall and rework is significantly superior to level 1 traceability.
Level 3: Advanced traceability – This is a tightened specification of
level 2 in which more detailed information about processes and materials are defined and retained. Level 3 also promotes a higher degree of data gathering automation with an associated reduction in data errors and an increase in the speed of operation. As such, level 3 traceability delivers significant additional value from quality and assurance perspectives to the process.
Level 4: Comprehensive traceability – This the gold standard of
traceability, representing an achievable goal that demonstrates maximum benefits in terms of the precise definition of the complete production build record of any product and assembly. In level 4, data for both materials and traceability are collected in precise detail. Material information is detailed, leaving no doubts about where materials are exchanged or replenished during the execution of placement, for example. In level 4 traceability, process data collates results in a
comprehensive set of data. In all cases, the intent is that data captured automatically by way of integration or interfacing with operational and supporting systems, ensures no loss of information or delay. The use of level 4 traceability data, therefore, is compatible with updates and maintenance of live dashboards showing various key performance indicators (KPIs). IPC-1782 forms an essential buffer in
counterfeit prevention and works to lock potential rogue parts out of the supply chain. In conclusion, considering current global
Product marking – letters denote date codes, batch codes etc.
supply chain struggles, traceability is now more important than ever. Ignoring the fundamental principles of full traceability is an extremely high-risk strategy and careful consideration of this risk is vital to avoid problems in the field.
Euroquartz
www.euroquartz.co.uk DECEMBER/JANUARY 2022 | ELECTRONICS TODAY 29
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