8.5.2 Identification and traceability
This week we are transitioning from the draft version to the new final publication of ISO9001:2015. Please download your copy today!
ID and traceability is a very basic but very critical requirement. There are only 3 sentences, but they are important and broadly sweeping (depending on the organization and nature of the product).
Each organization should decide and define its identification and traceability requirements. This may be based on industry standards, customer requirements, regulations or nature and status of the product or service. Once this is defined, the standard requires:
“The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services.” As stated above, the definition of “suitable” is really the only question. “Suitable means” will vary from company to company, so the organization should be able to clearly articulate the method and logical justification.
“The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.” As a product or service is being produced and processed, the status should always clearly be known at each step along the way. However the process has been identified, and its measurement points defined, the status of the product/service should be easily discernible to indicate whether the product/service is ready to move to the next step.
“The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability.” This requirement indicates that where traceability is required, the product/service should not only be labeled in some way, but the label should be traceable to some sort of record that means something. This is, of course, important where positive recall is required. But in less significant conditions, it is important to know what each product/service’s identification actually means.
THIS WEEK’S HOMEWORK
Review your ID and traceability policy and process. Is it defined as required above? Do you have clearly defined ways of identifying status of your product/service as it is in process? Now, check the actual output of the process. Is it easy to identify what the status of the product/service is throughout production? Can you clearly and easily determine its status in all cases? If there are any discrepancies, make the necessary adjustments or take advantage of improvement opportunities.
