How to Fail a Lot in LIMS

Handling of non-conforming materials is handled by the sites specific QA process.  LIMS can be used in conjunction with the internal process to help keep track of lots which are rejected or reworked.

1. Failed Sample

Failed sample can be identified by the "Spec Status" field or visually when the text field of the result is highlighted in red.  After a sample is found to be non-conforming, the following can be done:

  • Rework: adjust the lot to bring it into the specification limit window
  • Reject: waster treat or dispose the lot

LIMS sites use the following status to identify what was done to a non-conforming lot:

  • Rw: Rework
  • Rj: Reject

Some LIMS sites have a custom status "F" which means failed, unfortunately this status does not effectively communicate what happened to the lot after it was found non-conforming.

2. Rejecting a Lot

  1. Click on the thumbs up to open approval prompt
  2. Failed samples cannot be validated, click "OK" on this prompt
  3. Click on the drop down to select a different status
  4. Select status "Rejected"
  5. Click save button
  6. The sample shows "Rj" in the Sample Status field

Rj status samples do not generate a CoA, because it is never sent to the customer.  This product is rejected and thus will be waste treated or disposed.

3. Reworking a Lot

  1. Click on the thumbs up to open approval prompt
  2. Failed samples cannot be validated, click "OK" on this prompt
  3. Click on the drop down to select a different status
  4. Select status "Rework"
  5. Click save button
  6. The sample shows "Rw" in the Sample Status field

Rw status samples do not generate a CoA, because they require adjustment and analysis after to confirm specification status.

There should always be a subsequent sample for lots which are reworked to confirm that lot was successfully adjusted and is in specification window.

4. Resample a Lot

This status can be used when operations suspects that original sample taken does not represent the actual lot.  The difference between Resample and Rework, is that a Resample is where another sample is taken from the batch without it being adjusted and Rework is when another sample is taken from the batch after it was adjusted.

  1. Click on the thumbs up to open approval prompt
  2. Failed samples cannot be validated, click "OK" on this prompt
  3. Click on the drop down to select a different status
  4. Select status "Resample"
  5. Click save button
  6. The sample shows "Rs" in the Sample Status field

Rs status samples do not generate a CoA, because they require another sample to be logged into lims after a new sample is analyzed.

5. New Sample

Entering a sample for a batch which was initially marked as a "Rw" Rework or "Rs" Resample, requires special process because LIMS will not let you manually enter a sample with matching item number and lot.

  1. Navigate to the original sample which was marked either as "Rw" or "Rs"
  2. Click on double paper icon
  3. Select "Create Duplicate Sample"
  4. Click "OK"
  5. Enter original Lot number
  6. Press Save
  7. Press "Yes"
  8. Screen will refresh to new sample

5.2. Enter Analytical Results for New Sample

  1. Enter Results
  2. Press Save

5.3. Approving Sample

  1. Click on thumbs up
  2. The "Approved" status is selected by default
  3. Click save to complete approval process
  1. New sample will have a link to it's Original Sample: the one which was marked Rw or Rs and from which you created this new sample.

7. Reviewing Search Results

When you search for this lot in the future you will see that two samples were logged into LIMS with that lot number.  First one was non-conforming with a sample status of "Rs" and a second one which Passed and was with sample status "A".  Only sample status "A" would have a COA link.  

This allows a report to count how many time a lot is actually analyzed before it is sent to the customer.

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