As the world gets more technologically advanced, so do we. Receive articles, videos, and other content about new FedEx services and technology solutions to keep your company ahead of the curve. Additionally, we know that small businesses are the backbone of the world's economy, and we will provide content that spurs conversation on their unique needs.
Syndicate content

Validation versus Qualification in Shipping

pic2.jpg

Many healthcare shippers ask us at FedEx Express whether our cold chain transportation solutions are validated.

Validation means that processes will lead to consistent, reproducible results under highly controlled environmental conditions. However, in the shipping industry, transportation providers cannot control every factor during transport due to external variables (weather, capacity constraints, mechanical failures, missed connections, clearance delays, etc.). So in transportation, we are really talking about qualification rather than validation, and while it is not possible to validate transportation processes, they can in fact be qualified.

The International Conference on Harmonization (ICH) Q7 guideline defines qualification as the “action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results”.

At FedEx Express, we can deliver qualification very well. Our qualification process uses a data-driven approach unique in the shipping industry. We combine quality-focused science and engineering to design and test innovative transportation solutions. Confidential internal documents report hypotheses, experimental details, results, analyses and conclusions, and we also address risk management when developing cold chain shipping solutions.

We often offer trial shipments to potential shippers as part of our business development efforts. For example, we conducted many initial tests in close collaboration with interested shippers in specific transportation lanes to qualify the passive FedEx® thermal blanket solution that keeps freight in a controlled room-temperature range during transit.

Shipping results from those proofs of concept allow healthcare companies to share actual data with their internal decision makers by collecting evidence required for verification and business approval. Once the lane has been officially qualified, if actual data shows that temperatures did not stay within the expected temperature range, then FedEx engineers take post-shipping corrective actions.

It is possible to validate packaging materials and containers in environmental chambers using well-defined temperature profiles. However, once validated systems move through the supply chain, they experience environmental variability such as temperature changes.  So unfortunately, validated packaging systems can fail, as many shippers experienced this year under severe winter weather conditions. Temperature monitoring during transit is essential to rule out product degradation due to temperature spikes. To address this, many shippers use multi-sensor SenseAware® devices to qualify packaging and transportation routes, in addition to using their near-real time temperature monitoring features.

Comments (2) 

* Required fields

Thank you. Its a very good explanation of a complex process.

Great article and excellent explanation of the process. Thanks Christelle!

All comments are moderated. Comments will appear as soon as they are approved by the moderator. We will not post comments if they are defamatory, spam, off-topic If you do submit a comment, you warrant that it is your own original work, that it is not defamatory or offensive and does not infringe any law.
* Required fields
  • You may embed videos from the following providers . Just add the video URL to your textarea in the place where you would like the video to appear, i.e. http://www.youtube.com/watch?v=pw0jmvdh.
  • You may use <swf file="song.mp3"> to display Flash files inline

Type the characters you see in this picture. (verify using audio)
Type the characters you see in the picture above; if you can't read them, submit the form and a new image will be generated. Not case sensitive.

About This Blogger