8.5.2 identification and traceability nghĩa là như thế nào
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[This series of articles tries to emphasize the benefits of ISO 9001, and how to yield results from each major clause of the standard.]
Show Overview Clause 8.5.2 is a tiny sub-clause that has big implications. Essentially, “Identification and Traceability” requires that you ensure your product is properly identified at all times, so that quality problems are not caused due to loss, damage, commingling or other mistakes. The clause is essentially two requirements lumped together in one clause, so let’s take them separately. Identification Production identification is mandatory under ISO 9001. It also applies not only to your finished product, but work in process (WIP) and any received goods or raw materials. Because the standard also requires that identification include the “status of with respect to monitoring and measurement requirements” (meaning inspection and test status), we can reasonably extrapolate this to mean both conforming and nonconforming product. (The later clause on control of nonconforming product is going to repeat this later, so it’s best to confront it now.) Things get trickier if your product looks a lot like your tooling or other objects in use. Metal shops often have finished parts that look just like the setup tools, jigs or fixtures they used to makethe product. In such cases, you have to go one step further and ensure you identify product in a way that ensures it can’t be confused for the other items. This often means identifying those other objects, too, even if the standard doesn’t literally require it. Traceability The second part of the clause deals with “traceability,” which often confuses people. What ISO 9001 is asking for is batch or lot numbering, or part serial numbering. The standard recognizes that this may not apply to everyone, so the “traceability” portion of 8.5.2 is optional, whereas the “identification” portion is not. The purpose here is to ensure that if you do part serialization, that each part’s serial number is unique, and they can’t be replicated. Likewise, batch or lot numbers need to be unique, too. Shipping two different products or batches with the same number is a huge mistake, and can lead to massive problems, including a recall of everything. You don’t want that. Benefits When implemented properly, Clause 8.5.2 should result in the following tangible benefits for your company:
Click here for the full series of articles on The Benefits of ISO 9001:2015. About Christopher ParisChristopher Paris is the founder and VP Operations of Oxebridge. He has over 30 years' experience implementing ISO 9001 and AS9100 systems, and is a vocal advocate for the development and use of standards from the point of view of actual users. He is the author of Surviving ISO 9001 and Surviving AS9100. He reviews wines for the irreverent wine blog, Winepisser. Advertisements
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8.5.2 Identification and traceability« Previous | Next » This requirement is comparable to the requirements from ISO 9001:2008 Clause 7.5.3 - Identification and traceability. You should seek and record evidence that product is identified (as appropriate) and its status with regards to monitoring and measuring (conforming or not) is identified throughout the manufacturing processes. Where traceability is a requirement, you should expect to see that your organization is controlling and recording the unique identity of the product throughout the production process to ensure that only products that have passed the required inspections and tests are utilised. Your organization must have a process in place for the identification and traceability of outputs, in terms of the monitoring and measurement requirements at all stages of production, to enable the demonstration of conformity to requirements, e.g. physical part marking, labeling, tags, bar codes, signage, visual indicators, part segregation, lay down areas, storage racks. There are several ways of identifying products to prevent them becoming mixed with other parts, components, or orders. The most obvious is using tags or stickers with a unique traceability identifier, such as a lot or batch number included on the product labels. The identification may be engraved in the product itself, or the product may simply be marked by a colour. Establish and implement a procedure to identify the product through the design, development, manufacture and delivery stages. The established a traceability system should track components from raw material through inspection, test, and final release operations, including rework:
The auditor will expect to see that product is identified (as appropriate) and its status with regards to monitoring and measuring (conforming or not) is identified throughout the product realization processes. Where traceability is a requirement, the auditor will expect to see that the organization is controlling and recording the unique identification of the product. If you need a procedure and forms to help control your business's product and service provision process, click here. « Previous | Next » More information on PDCAPlanningContext
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