[This series of articles tries to emphasize the benefits of ISO 9001, and how to yield results from each major clause of the standard.]
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.
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 make the 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.
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.
When implemented properly, Clause 8.5.2 should result in the following tangible benefits for your company:
- Quality problems due to commingling of parts or lots should be eliminated, since everything will be easily identified.
- You won’t accidentally process or ship the wrong products.
- You’ll have excellent records on what exactly was shipped, so that if problems are reported later, you can track back to the appropriate production or service records.
- Good parts will be identified differently from bad parts, reducing the likelihood of accidentally shipping defective product.
- Your shop will be more organized, reducing errors due to confusion or sloppiness.
Click here for the full series of articles on The Benefits of ISO 9001:2015.