Identification and traceability requirements
Could you please help me with a question I have with the requirements for identification & traceability,
The new General Manager wants to change our current process for cost reduction on labeling; Currently we package product into totes (48 to a pallet) labeling each tote, then a master label for inventory as bulk packaging to the customer.
He wants to eliminate the labeling for each individual tote and only use the master label, which we would then have totes without identification on each, only the pallet.
Our inventory system would have traceability from incoming to outgoing with this process for lot control, but would I still meet the requirement for product identification if each tote was not individually labeled?
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ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
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ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
The last paragraph of ISO 9001:2015 clause 8.5.2 states that traceability only is a requirement when requested by the organization, by the regulation, or by a customer. With the changes that you describe you will lose traceability for each tote. Do customers or regulation require it? If so, you have a problem. If there is no requirement, adjust your internal rules to the new practice. Determine and evaluate the risks that can come out of this change.
The following material will provide you more information about traceability:
- Article – ISO 9001:2015 clause 8.5 Product realization – Practical examples for compliance - https://advisera.com/9001academy/blog/2015/11/03/iso-90012015-clause-8-5-product-realization-practical-examples-for-compliance/
- Record of Traceability [ISO 9001:2015] - https://advisera.com/9001academy/documentation/record-traceability/
- Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
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Jan 14, 2020