Product Information Traceability

Document your Product Information Traceability system. Traceability is a basic Quality Assurance system and it is necessary for ISO 9001 registration.

Documenting the Traceability System

Cover these items:

The key traceability number the customer receives with the product
The logic breakdown from the key traceability number
How the key traceability number links to the process steps
How the key traceability number links to the raw material
How the key traceability number links to the employees
How the key traceability number links to the machines
Any other key traceability linkage that is important for your organization
How your organization maintains the key traceability through the production and ensures that this traceability is not lost or mixed
How your organization handles changes to key traceability components
How your organization correlates key traceability number to quality records
How your organization documents the key traceability numbers as the product flows through production.

The key traceability number may be a serial number, lot number, manufacturing number, order number, date code, or whatever term your company has decided upon

Traceability Fishbone

Review the above fishbone diagram. A fishbone diagram is normally used for root cause investigation but in this case we are applying it to traceability. See below on how to create this fishbone for each process step. If possible, create a traceability fishbone for each step in your process and file it for later reference. Later, if problems should arise, this fishbone will speed up your root cause corrective action investigation.

Improving your Traceability

To improve your Product Information Traceability system follow these steps:

Select the process step to review
Print the audit form
List all of the operators working on that process step. Be specific, match the operator to the process.
List all of the machines and identify the machine number.
If the machine tooling has a lot identification, list this in the machine box.
List the name and lot number of the raw material used. Record the quantity of material used and the material’s location.
List the procedure followed by the employee. Be specific, identify the procedure number and / or particular method.
Compare the completed traceability audit form to actual production records being used for the product
If the production records traceability information matches the traceability audit form then no improvement may be necessary.
If the production records traceability is missing any of the audit traceability, then improve the production records to collect the missing traceability.

Product Information Traceability system is a basic QA system. A complete traceability system allows for these items:

Provides a way for you to track back to all critical elements within your company.
Is necessary for ISO 9001 certification and it is a basic QA management system.
Helps your business quickly identify potential root cause failure modes.
Makes it easier to statistically compare the critical elements to each other.

Applications That Drive Improvement
Robert Broughton
(805) 200-7979
USA
email