Troubleshooting: suspect-product investigations
Odoo Enterprise: Quality app 3PL add-on For: Administrator, Compliance manager, Warehouse staff Checked on 18.0.0.2.0, 18.0.1.0.0
What to do when an investigation doesn't open, can't be changed, or refuses to quarantine, release or split, in Odoo Enterprise's Quality app with Rx Tracking (DSCSA) - Suspect Product Investigations. Entries are ordered from the most frequent; the entries for investigations of 3PL owners' units come last.
Elsewhere:
- "Only DSCSA users can change the DSCSA investigation of a quality alert." and "Only DSCSA users can change the investigated owner or split an investigation.": see Error: "Only DSCSA users can …".
- "Only a DSCSA manager can quarantine or release a lot.": see Error: "Only a DSCSA manager can …".
- The Release Lot dialog ("Give a reason for the release.", "These lots are not quarantined."): see Troubleshooting: quarantine, scrap and trace requests.
- The determination, notification and termination dates, the 24-hour deadline and Form FDA 3911: see Troubleshooting: illegitimate product and Form FDA 3911.
A quarantine opened no investigation
What you see: a lot was quarantined, but no new investigation is listed in Inventory ‣ Rx Tracking ‣ Suspect Investigations, and the lot's chatter has no "Suspect-product investigation … opened." line.
When: after a lot quarantine, in Follow the investigation a lot quarantine opens automatically.
Cause: one of these:
| What you find | Cause |
|---|---|
| An open investigation of the lot (stage other than Solved) has the line "Lot LOT quarantined: REASON" in its chatter | The lot already had an open investigation: the new reason was logged on it instead |
| The lot's investigation has "Lot LOT quarantined." in its chatter | The lot was quarantined from that investigation (Quarantine Lot) |
| Open an investigation on quarantine is cleared in the settings | Automatic investigations are off for this company |
| The lot was quarantined before the add-on was installed, or it was already Quarantined when a reason was added | Only a lot that enters quarantine gets an investigation |
| The list is filtered on In Progress and the investigation is Solved | It exists, but is closed |
Remedy: a resolution. Work on the open investigation you found, or open one by hand (Open a suspect-product investigation for a lot). To turn automatic investigations on, see Set up investigations: D-U-N-S number, automatic investigations, Form 3911 data.
Who can fix it: Rx Tracking User or Manager to open an investigation; an administrator who is Rx Tracking Manager for the setting.
The Quarantine Lot or Release Lot button isn't shown
What you see: the investigation's header has Form FDA 3911 (and, with 3PL owners, Split per Owner), but no Quarantine Lot or Release Lot.
When: in Quarantine the lot from its investigation or Release the lot from its investigation.
Cause:
| What the form shows | Cause | What to do |
|---|---|---|
| Neither button, whatever the lot's state | You aren't an Rx Tracking Manager | Ask an Rx Tracking Manager |
| Lot is empty | The investigation has no lot | Select the lot, save, then quarantine |
| Release Lot, not Quarantine Lot | The lot is already Quarantined | Nothing: the lot is on hold |
| Quarantine Lot, not Release Lot | The lot is Not Quarantined or Released | Nothing to release |
| No DSCSA Investigation field, no Form FDA 3911 button | You have no Rx Tracking right, or the alert isn't an investigation | See The DSCSA fields and tabs aren't shown |
Remedy: as the table says.
Who can fix it: Rx Tracking Manager; an administrator (Administration: Settings) for the right.
The Lot list offers only "Create"
What you see: on a new investigation, typing a lot number in Lot offers only Create "LOT" and Create and edit....
When: in Open a suspect-product investigation for a lot.
Cause: the Lot list only offers lots of the selected Product. No product is selected yet, or the lot belongs to another product.
Remedy: a resolution. Press Esc, select the Product first, then the Lot. Don't select Create: it creates a new, empty lot
with no units.
Who can fix it: the user opening the investigation.
The DSCSA fields and tabs aren't shown
What you see: a quality alert has no DSCSA Investigation field, no DSCSA Investigation or Form FDA 3911 tab, and no Form FDA 3911 button.
When: opening an investigation from Quality ‣ Quality Control ‣ Quality Alerts, or any alert.
Cause: one of these:
- your user has no Rx Tracking right: the DSCSA parts are shown only to Rx Tracking users;
- the alert is a plain quality alert (DSCSA Investigation is empty): the two tabs appear only once it is set.
Remedy: a resolution. Ask an administrator for the Rx Tracking User right (Give staff access to investigations), or select a value in DSCSA Investigation.
Who can fix it: an administrator (Administration: Settings); an Rx Tracking User to turn an alert into an investigation.
The investigation stays open after the lot is released
What you see: the lot is Released, but its investigation is still in Suspect Investigations (stage New, Confirmed or Action Proposed), with no line about the release in its chatter.
When: after Release the lot from its investigation, after a release from the lot form, or after the software released a lot held for a missing Transaction Statement once the statement was recorded.
Cause: releasing a lot and closing its investigation are separate steps. The release writes nothing on the investigation (known issue PF-A11-08). Receiving holds open investigations too, even for a missing Transaction Statement (known issue PF-A02-02).
Remedy: a resolution. Log a note on the investigation with the release reason, then close it when the case is over: Close an investigation.
Who can fix it: Rx Tracking User or Manager.
Form FDA 3911 items are empty, or show another lot
What you see: on the Form FDA 3911 tab, one of these:
- Lot Number(s), Expiration Date(s), Quantity (Number and Unit) or Serial Number(s) still show the lot the investigation had before;
- Serial Number(s) or Quantity (Number and Unit) is empty;
- Type of Report is empty.
When: after changing the Lot or Product of a saved investigation; on the lot of an investigation opened in Open a suspect-product investigation for a lot; on any quality alert whose DSCSA Investigation was chosen after its form opened, for example after a failed receiving check (Use Quality Control checks alongside DSCSA operations).
Cause:
| Symptom | Cause |
|---|---|
| The previous lot's values stay | The prefill only fills empty items (known issue PF-A11-04) |
| Serial Number(s) empty, Quantity (Number and Unit) filled | The lot has more than 200 units in your custody (known issue PF-A11-10) |
| Both empty | You hold none of the lot's units: it was fully shipped |
| Type of Report empty | The DSCSA Investigation type was chosen after the form opened, on a new alert (for example from a receipt's Quality Alert button, or New in the Quality app) or on a saved one. Only New in Inventory ‣ Rx Tracking ‣ Suspect Investigations, which opens the form with the type already set, fills it (known issue PF-A11-05). The printed data sheet still ticks Initial notification |
Remedy: a workaround. Correct the items by hand: clear the old values and save, then select the lot again to refill them; list more than 200 serials from the lot's Packages smart button in an attachment; for a fully shipped lot, take the serials from the deliveries; select Initial notification in Type of Report (or the type you are about to submit).
Who can fix it: Rx Tracking User or Manager.
Error: "Only lots of DSCSA products can be quarantined"
What you see: an Invalid Operation dialog when you select Quarantine Lot:
Only lots of DSCSA products can be quarantined: LOT.
When: in Quarantine the lot from its investigation, on an investigation of a product that
isn't a DSCSA product (for example Placebrin, lot BPPLB2507A).
Cause: only lots of DSCSA products can be quarantined. The investigation itself is accepted for any product.
Remedy: a resolution. Select Close. Hold the units by Odoo's own means (a separate location), or, if the product should be a DSCSA product, set it up as one first: Set up a DSCSA product.
Who can fix it: Rx Tracking Manager to quarantine; the product's DSCSA setting as that procedure says.
Error: "Lot … is already quarantined."
What you see: an Invalid Operation dialog when you select Quarantine Lot:
Lot LOT is already quarantined.
When: in Quarantine the lot from its investigation, on a page opened before someone quarantined the lot from the lot form or from another investigation of the same lot.
Cause: the lot is on hold already; your page still shows Quarantine Lot.
Remedy: a resolution. Select Close and reload the page (press F5): Lot Quarantine shows Quarantined. The lot's
Quarantine tab and chatter say who quarantined it, and why.
Who can fix it: Rx Tracking Manager.
Error: "No quality team found for this company."
What you see: an Invalid Operation dialog:
No quality team found for this company.
Please go to configuration and create one first.
When: quarantining a lot (from the lot form, from a receipt validation that holds a lot, or from any other hold), or saving a new investigation, in a company that can use no Quality team.
Cause: every investigation belongs to a Quality team. The only teams have another company in their Company field. The quarantine opens an investigation inside the same step, so the quarantine (or the receipt validation) is refused with it: nothing is quarantined (known issue PF-A11-09).
Remedy: a resolution.
- Go to Quality ‣ Configuration ‣ Quality Teams and open a team, for example Main Quality Team.
- Clear its Company, or create a team for your company, and save.
- Repeat the action that failed.
As a workaround, an Rx Tracking Manager can clear Open an investigation on quarantine for the company, quarantine, and select it again (Set up investigations: D-U-N-S number, automatic investigations, Form 3911 data).
Who can fix it: a Quality Administrator. Warehouse staff who meet it at a receipt can't: ask one.
Errors when investigations are changed through an import or the API
What you see: one of these, from an import or a script (the forms hide the buttons that would raise them):
INVESTIGATION is not a DSCSA investigation.
INVESTIGATION: set the lot to quarantine first.
INVESTIGATION: set the lot first.
Form FDA 3911 is only for DSCSA investigations.
Unsupported search on the notification overdue flag.
When:
| Message | Action |
|---|---|
| "… is not a DSCSA investigation." | quarantining the lot of a plain quality alert |
| "… set the lot to quarantine first." | quarantining from an investigation without a Lot |
| "… set the lot first." | Find Trading Partners on an investigation without a Lot |
| "Form FDA 3911 is only for DSCSA investigations." | printing Form FDA 3911 for a plain quality alert |
| "Unsupported search on the notification overdue flag." | a custom filter on Notification Overdue with another operator than "is set" or "is not set" |
Cause: the same rules as in the forms: quarantine, Find Trading Partners and Form FDA 3911 are for DSCSA investigations with a lot.
Remedy: a resolution. Set DSCSA Investigation and Lot first, or use the forms. For the filter, use the Notification Overdue filter of the search options.
Who can fix it: Rx Tracking User (Rx Tracking Manager to quarantine).
Error: "… is not an owner (3PL client) of …: it has no owner profile."
What you see:
INVESTIGATION: PARTNER is not an owner (3PL client) of COMPANY: it has no owner profile.
For example: "QA00008: Riverside Community Pharmacy is not an owner (3PL client) of Demo Rx Distribution LLC: it has no owner profile."
When: an import or a script sets Investigated Owner to a partner that isn't one of your owners, in Open an investigation of an owner's units or Change the investigated owner. The form's list offers only owners.
Cause: the investigated owner must be an owner of the company: a company contact with an owner profile (archived profiles count).
Remedy: a resolution. Use the owner's company (not one of its contacts), or leave the field empty for your own stock.
Who can fix it: Rx Tracking User.
Error: "… leave the investigated owner empty for our own stock."
What you see:
INVESTIGATION: leave the investigated owner empty for our own stock.
When: an import or a script sets Investigated Owner to your own company.
Cause: your own stock is an empty Investigated Owner ("Our own stock"), never your company.
Remedy: a resolution. Clear Investigated Owner.
Who can fix it: Rx Tracking User.
Error: "… only a DSCSA investigation has an investigated owner."
What you see: on saving, a dialog "Oh snap!" with Stay here and Discard changes (or an import error):
INVESTIGATION: only a DSCSA investigation has an investigated owner.
When: clearing DSCSA Investigation on an investigation that has an Investigated Owner, or giving a plain quality alert an owner.
Cause: only DSCSA investigations have an investigated owner, and an owner's investigation stays one.
Remedy: a resolution. Select Discard changes. To stop investigating an owner's units, close the investigation instead (Close an investigation).
Who can fix it: Rx Tracking User.
Error: "… FDA was notified for this investigation, so its investigated owner can't change."
What you see: the Investigated Owner field is read-only in the form; an import or a script that changes it is refused with:
INVESTIGATION: FDA was notified for this investigation, so its investigated owner can't change. Use "Split per Owner" to open the investigation of another owner.
When: changing the owner of an investigation whose FDA Notified On is set, in Change the investigated owner.
Cause: once FDA was notified, the filer of the notification is fixed.
Remedy: a resolution. Open the other owner's investigation with Split per Owner (Split an investigation per owner).
Who can fix it: Rx Tracking User.
Error: "Every owner holding units of lot … already has an open investigation of it."
What you see: an Invalid Operation dialog when you select Split per Owner:
Every owner holding units of lot LOT in our custody already has an open investigation of it.
When: in Split an investigation per owner, on a lot of your own stock only (for example
BPSMS2509K), or after the lot was already split.
Cause: there is no holder of the lot's units without an open investigation of it: nothing to split.
Remedy: nothing to do. Select Close; the investigations of the lot are in Suspect Investigations (search the lot).
Who can fix it: nobody needs to.
Error: "… is closed." when you split
What you see: an Invalid Operation dialog when you select Split per Owner:
INVESTIGATION is closed.
When: in Split an investigation per owner, on an investigation in the stage Solved (the button stays visible).
Cause: only open investigations can be split.
Remedy: a resolution. Split an open investigation of the lot, or move this one back to an open stage first if your procedure allows it.
Who can fix it: Rx Tracking User.
Errors when an investigation is split through the API
What you see: one of these, from a script (the button is hidden in these cases):
INVESTIGATION: only a DSCSA investigation of a lot can be split per owner.
Third-party logistics is off for COMPANY: there is no owner to split for.
When: Split per Owner on a plain alert or an investigation without a Lot; or in a company whose 3PL switch is off (for example Demo Rx Distribution East LLC).
Cause: splitting needs a DSCSA investigation with a lot, in a company with 3PL on.
Remedy: a resolution. Set DSCSA Investigation and Lot first; in a company without 3PL there are no owners to split for.
Who can fix it: Rx Tracking User.