7.5.3 Identification and traceability

You must identify product status (e.g. is it good or bad).

Where traceability is required then serial numbers or batch numbers must be recorded.

This requirement is often the most misunderstood, notice that this clause starts with the words "where appropriate", it is up to the organisation to decide how far this needs to be taken, but you are generally required to:

  • Establish the identity and status of products
  • Maintain the identity and status of products
  • Maintain records of serial or batch numbers

Your identification system

Where appropriate, the identification system should allow for traceability from the finished product back to incoming material records and customer specifications.

Products must be suitably identified by a part number or job number corresponding to applicable drawings, specifications and other technical documents related to the product. 

Should I document our Production and Service Validation Process?

It is not a mandatory requirement to document your identification and traceability processes. However, you should always look to adequately define and control any operational processes that directly impact upon product quality. Therefore, the implementation of an identification and traceability procedure will be appropriate to most businesses where such activities are undertaken.

How's best to document Production and Service Validation Process?

Develop and implement a procedure that defines:

  • How to identify the status of the product
  • How to ensure traceability
  • What records are kept

Looking for help documenting this process?

We provide an Identification and Traceability Procedure template to help you manage this process in many of our ISO Templates.

Measuring Production and Service Validation Process effectiveness

 The effectiveness of the identification and traceability process may be evaluated by reviewing all elements of process and by looking for evidence that all activities are planned and conducted under controlled conditions.