Approving Failed Samples
Capturing data regarding non conforming lots is an important function for a QC laboratory. Keeping track of this data in LIMS allows for an effortless reporting ability that is standard across all sites which use LIMS.
1. Failed Sample
LIMS immediately notifies you of a failed parameter and product in two ways:
1. The Box for data entry will turn Red, indicating a failed parameters
2. The Spec Status Box will read "FAIL" to indicate a failed product in testing.
If you have data that you know is out of spec, but LIMS is not indicating the correct status, hit the Save icon to refresh, and it will now show the correct status.
Approval of a failed lot requires documentation that an exception is accepted by internal and external QA teams (often external means the customer). Site that have a formal "Waiver" process which allows them to properly document this exceptions will need to obtain a waiver ID because it will need to be entered into LIMS. Sites that do not follow a formal process, can use an email reference, such as date and time of an email, or name of the document.
ISO 9000 Process
You will need to go to your management system of failed products. In this example, we will use the ISO 9000 Quality Management Portal.
Click on "Nonconformance Reports" to access the product waiver page.
Here you can view completed and in process Product waivers and other non-conformance reports.
Typically, a failed product will have to go through several departments, such as QA, Engineering and Production as well as receive a Customer Approval for a Process Waiver.
The Product Waiver
Here is an example of an ISO 9000 version of the Product Waiver. Note the Product number shown here. To approve your product in winLIMS, you will need to take note of this product number and enter it into lims.
This screen shot shows an American product waiver "EAM". You will probably use ETJ or a similar code for your product waivers.
Take note of the following information:
1. Discusses the issue with the Product.
2. Attaches the signed agreement from the customer showing proof of their approval.
3. List of people who have approved this Product Waiver.
This is typically listed for all product waivers.
Approving the Sample
Go back to the LIMS interface, and click on the approve of "Thumbs up" button.
Select "Yes" in the resulting pop up window to continue.
Enter your Waiver ID in the box to approve the sample. In this tutorial example, we are using the code: ETJ-PW-0000 (Enthone Tianjin - Product Waiver - Waiver #)./ Leave the Status as the default value "Approved"
Once you are done entering the ID#, you should hit the save icon at the top left of the box.
Approved Sample with Waiver ID#
Now the sample is approved. Note that it has a Waiver ID attached to it, signifiying that it has gone through the Product Waiver process successfully, ans is ready to ship.
COA Highlight
The Resulting COA will highlight the out-of-spec parameters.