The ISO 9001 requirement for product identification and traceability was included in the first edition of the standard and, apart from replacing the word "product" with "output," which represents a broader concept, has not changed much over the years.
Secure identification of output is vital in many situations to prevent unintentional exchange of references, to allow for eventual reordering of certain parts from suppliers, to match outputs to the documents that describe them, and to communicate any updates related to them. Often the names we give things to describe them are enough to immediately let us know what is being talked about, but sometimes we need more detailed information, especially when our outputs are similar to each other.
In this article, we will examine the three requirements of section 8.5.2 of the standard, namely:
- Identification of process outputs
- Identification of the status of process outputs
- Maintaining traceability
Identification of Process Outputs
The requirement regarding the identification of process outputs aims to equip the outputs with a set of characteristics capable of objectively distinguishing them from those defined by another set of characteristics. The requirement applies, of course, only to outputs that need to be distinguishable from each other or to those that are planned in advance to be incorporated into well-defined products and services.
Why is such a requirement necessary? Simple: because without codes, numbers, labels, names, and other forms of unique identification, we cannot adequately describe a product or service to anyone else or be certain that we are all talking about the right product. The output must be identified in one way or another, otherwise it cannot be matched to its specifications in any way.
Certain identification is necessary where it is not inherently obvious. If, in fact, the outputs are so dissimilar that it would be quite unlikely for an unintentional exchange to occur, it is most likely not necessary because the physical differences are large enough to be visible to an untrained eye. In the case, however, that there are only functional differences and slight differences in physical characteristics such as shades of color, minimal differences in size or weight, or in appearance, it is necessary to proceed with the creation of documented identification procedures.
The identification of the product and its components should begin in the design phase, that is, when the product itself is conceived. The design should be given a unique identity, a name or a number, and this should be used on all information related to it. When the product enters production, it should bear the same number or name, in addition to, possibly, a serial number or other type of identification (lot, date, etc.) to allow for the recording of product characteristics with respect to specific products.
This identification system should be reported on all records relating to the product. Products should bear a label or markings with this type of information in an accessible location or bear a unique code number that can lead back to such information. If you do not have any documents describing, for example, a purchased product, you must affix to the product itself or its container a code that can lead exactly to the purchase and related information. The method of identification to be used depends, of course, on the type, size, quantity, or fragility of the product.
It is possible to mark the product directly (provided that the surface is not visible to the end user, unless, of course, the identification is part of the brand), tie a label to it or its container, use remote records, etc., provided that they bear a unique identity that can lead back to all product information.
The unique identification of services is slightly different. Many are not identified except by the nature of what the organization does for generic categories; in the case of a bank, for example, we could have the following categories:
- Investments
- Mortgages
- Financial planning
- General banking services
- etc.
Where there are differences within the same service provided, the names should be different. The results that derive from processes that lead to the provision of a service should be uniquely identifiable with documented information that should contain at least a reference to a distinctive name and date.
To demonstrate that adequate means have been used for identifying changes to product output, it is possible to:
- present evidence of the existence of a product identification process and the conventions that have been established for identification;
- select a representative sample of process outputs and produce proof that they have been uniquely identified according to the indications of the established conventions;
- search the database of registered non-conformities, including customer complaints, to demonstrate that none are attributable to an output lacking identity or with an uncertain identity.