ISO9001 in 2021 Week by Week - Week 39 – 8.5.2 Identification and traceability

This is a 52 week discussion of ISO9001:2015. Each week, we discuss a specific clause of the ISO9001:2015 standard in detail and look for ways to trim the fat. (As a member of TAG/TC176, the committee responsible for review and revision of ISO9001, (possible revision in 2023), I’ll keep you posted on what I learn all year!)

(It is strongly recommended that you purchase a copy of ISO9001:2015  for reference).  And, be sure to do your homework!

8.5.2 Identification and traceability

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 the nature and status of the product or service.  Once this is defined, ISO9001 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.  In the simplest terms, work-in-process (WIP) might be contained in designated locations or colored bins that would make its status easily identified – at step one awaiting inspection, at step two (inspected) and ready to move on, final inspected, released, on hold, etc.  Slightly more advanced might include special labeling.  And even more specific practices might include inventory management which includes the step and status of each item in process, and workflows within the software that will not allow anything to move onto next steps without completing the required steps.  Further still, there could be positive recall lot control or piece-by-piece laser (or other) labeling.  ISO9001 does not determine what is “appropriate”.  That’s for the organization to decide based on the criteria described above.

“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.

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Watch this 3-minute video about another great resource to accompany this series.   Get the self-directed, on demand, online learning series  ISO9001 in Plain English, today and you'll get:

• A clear understanding of the requirements of ISO9001:2015
• Proven tips to build a robust quality system that's easy to use
• Ways to reduce documentation and paperwork (yes, really!!)

Each video is about 15 minutes and targets a specific element of ISO9001, (with over 6 hours of total content!).  We translate all the gobbledegoop into Plain English you can understand and leverage the requirements to get maximum VALUE from your quality efforts. 

For a deeper dive into the process side of your quality system, get Tribal Knowledge - The Practical Use of ISO, Lean and Six Sigma Together, a simple guide to UNITE ISO9001, lean and Six Sigma to create a robust quality system with better results.  Read what ASQ American Society for Quality – Quality Progress Magazine  had to say about it. 

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