Before

Dear Malvern Panalytical customer,

As part of our on-going commitment to quality, we regularly evaluate our products to ensure they meet our high standards. During manufacturing process checks of the Insitec instrument, we identified a component quality issue that may affect the life expectancy of the laser module within the instrument. Please be rest assured, there are no safety implications regarding this component. Any degradation is readily detectable, can be resolved and perhaps more importantly will not produce incorrect results. We took the decision to pause shipments, begin a robust problem solving and resolution process to investigate the occurrence, and we are making good progress on understanding and resolving the issues. We have reached the point where we have an understanding of how to manage and resolve the issue. This has enabled us to resume shipments under a set of interim control measures, provided you accept such measures.

What is the impact on your installation?
We are confident that the instrument once installed will operate within the required specification and provide value to your business. However there is a greater than normal risk that the instrument can show sudden reduction of the laser power. This can be resolved by intervention by Malvern Panalytical or one of our representatives. In order to avoid the uncertainty we have put in place interim control measures, this will require your input (see below). By providing us with monitoring data from your instrument, we are able to guarantee fast reaction times from our team in the event of a premature failure of the laser module.

What action is required by you?
We require you to provide the background readings from your instrument on a weekly basis, so that we can monitor the performance and predict if laser failure is imminent. These readings will be handled in confidence. In that unlikely event that a failure is detected, you will be contacted by our customer service team and a new laser will be installed free of charge under the instrument’s warranty. Full instructions on how to send this data will be provided on installation.

After

Dear [name],

We are sorry to tell you that our quality control checks recently identified a possible issue with the laser module in the Insitec instrument we were due to ship to you. As a precaution, we paused shipment.

However, I’m pleased to say we now clearly understand the issue, there are no safety or accuracy implications, and we are confident we will soon have a permanent fix. So, if you are happy to accept our interim control measures, we can ship your instrument.

What’s the problem?
There’s a component issue that could affect the life expectancy of the laser module, potentially leading to a reduction in power. This poses no safety issues and does not affect the accuracy of results in any way.

What if my instrument is affected?
We are confident that your instrument will work as expected. In the unlikely event of a problem, we will replace the module free of charge.

Interim measures: monitoring your instrument’s performance
If you send us weekly background readings, we’ll be able to predict any potential issues and react quickly. (We’ll show you how to take these readings on installation.) We will treat all your data confidentially.

• Yes, I am happy for you to monitor our unit
  That’s great. We will ship your instrument straight away.

• No, I do not want you to monitor our unit.
  That’s fine. We will ship your unit as soon as we have fully resolved the issue.