Set up suspect-product investigations

Odoo Enterprise: Quality app For: Administrator, Compliance manager Checked on 18.0.0.2.0, 18.0.1.0.0

Before the first suspect product turns up, decide whether a lot quarantine opens an investigation by itself, record the company's D-U-N-S number for Form FDA 3911, check the records the form's data sheet is filled from, and give staff the access they need. Optionally, add a receiving check in Odoo's Quality app so that warehouse staff look for suspect-product red flags on every receipt.

Note

Without Odoo Enterprise, the Quality app and this add-on aren't available. See Suspect and illegitimate product without Odoo Enterprise.

Set up investigations: D-U-N-S number, automatic investigations, Form 3911 data

Set the two company settings the add-on adds to the DSCSA (Rx Tracking) block, then check the records that the Form FDA 3911 data sheet reads, so that an investigation opens with the right values. Background: the modules follow the reading that suspect product is quarantined and investigated, and that a product determined illegitimate is reported to FDA on Form FDA 3911 (FD&C Act § 582(c)(4); FDA suspect-product guidance (June 2021); Form FDA 3911; see Compliance background).

Your procedure decides whether every quarantine is treated as a suspect-product case; the software opens an investigation for each new quarantine while Open an investigation on quarantine is selected.

Who: Administrator with Administration: Settings, who is also Inventory Administrator and Rx Tracking Manager

Requires: Odoo Enterprise with the Quality app, and Rx Tracking (DSCSA) - Suspect Product Investigations.

Before you start:

• The add-on is installed. See Install the modules.
• Your user has the three rights above: without Rx Tracking Manager, the settings page shows no DSCSA (Rx Tracking) block. See Give staff the right Rx Tracking access.
• You have the company's D-U-N-S number (the Unique Facility Identifier of this location).

1. Go to Inventory ‣ Configuration ‣ Settings.

2. In the Search... box at the top, enter DSCSA.

   Result: the DSCSA (Rx Tracking) block shows. Its last two settings come from this add-on: Open an investigation on quarantine ("Quarantining a DSCSA lot that has no open investigation opens a suspect-product investigation (quality alert).") and D-U-N-S number ("Unique Facility Identifier printed on Form FDA 3911 (item 23).").

3. Leave Open an investigation on quarantine selected (the default), or clear it if a quarantine must not open an investigation.

4. In D-U-N-S number, enter the number, for example 123456789.

   

5. Select Save.

   Result: the page reloads with the new values. Both settings belong to the company you are working in (the building icon next to their names); set them again in each of your companies.

Result: the settings are saved. Records: the company (its Open an investigation on quarantine option and D-U-N-S number). From now on, every lot of a DSCSA product that enters quarantine in this company gets an investigation, unless it already has an open one. See Follow the investigation a lot quarantine opens automatically.

If it doesn't work

• The DSCSA (Rx Tracking) block isn't shown: your user isn't an Rx Tracking Manager. Ask an administrator to give you the right. See Give staff access to investigations.
• The two settings aren't in the block: the add-on isn't installed in this database. See An Enterprise add-on won't install.

Important

The setting acts only when a lot enters quarantine. Lots that were already quarantined when the add-on was installed get no investigation; open one by hand (Open a suspect-product investigation for a lot).

Check the records the Form FDA 3911 data sheet is filled from

An investigation copies these values when it is created, and the data sheet prints them. A missing value prints as a blank, without a warning. Check them once, before the first investigation.

Form FDA 3911 item	Filled from	Where to set it
21 Company name and address	the company	Settings ‣ Users & Companies ‣ Companies
22 Company Category	the DSCSA Role of the company's contact: Manufacturer, Repackager or Dispenser give the same category; any other role (or none) gives Wholesale distributor	Onboard a trading partner: DSCSA role, GLN and address (open the company's contact; GLN: Global Location Number)
23 D-U-N-S number	the D-U-N-S number setting	step 4 above
24 Contact Person	the investigation's Responsible (at creation, the user who opens it): the person's name, phone and email; without a phone, the company's phone	each user's contact
7, 11, 12, 14 Name of Product (as on Label), Strength, Dosage Form, NDC	the product. Dosage Form is chosen from keywords of the product's free-text dosage form (tablet, capsule, sublingual, inject or vial, cream or gel, suspension or syrup, and so on); anything else gives Other	Set up a DSCSA product
16, 17, 13, 15 Lot Number(s), Expiration Date(s), Quantity (Number and Unit), Serial Number(s)	the lot: its number, expiry date, quantity on hand, and the serials of its units in your custody (In Stock, Returned or Quarantined), when there are 200 or fewer	received with the supplier's file

The deadline activity of an illegitimate product is due on the deadline's day in the Timezone of the investigation's Responsible (user form, Preferences tab); without a time zone, in UTC. The data sheet itself and the 24-hour deadline are described in Handle illegitimate product and Form FDA 3911.

Keep a Quality team that every company can use

Every investigation belongs to a Quality team. The Quality app creates Main Quality Team with no Company, so every company can use it. Keep at least one team whose Company is empty or is the company that quarantines (Quality ‣ Configuration ‣ Quality Teams).

Known issue

Known issue (PF-A11-09): when no team can be used by the lot's company, every quarantine in that company fails with "No quality team found for this company. Please go to configuration and create one first.", including the automatic holds when a receipt is validated. Clear the Company of a team, or create one for that company. See Error: "No quality team found for this company.".

Give staff access to investigations

Investigations are quality alerts of Odoo's Quality app with DSCSA fields. The Rx Tracking right decides who sees and changes those fields; the Quality right decides who sees the alerts at all.

Who: Administrator (Administration: Settings)

Requires: Odoo Enterprise with the Quality app, and Rx Tracking (DSCSA) - Suspect Product Investigations.

Before you start:

• The user exists. See Give staff the right Rx Tracking access.

• You know which role each person needs:

  Person	Rx Tracking	Quality	What they can do with investigations
  Warehouse or compliance staff	User	User (comes with the Rx Tracking right)	see Inventory ‣ Rx Tracking ‣ Suspect Investigations; open investigations and change every DSCSA field; Find Trading Partners; print Form FDA 3911. Not: Quarantine Lot, Release Lot, delete
  Compliance manager	Manager	User or Administrator	all of the above, plus Quarantine Lot, Release Lot and deleting investigations
  Quality staff without an Rx Tracking right	none	User	see every quality alert, investigations included, in Quality ‣ Quality Control ‣ Quality Alerts, without the DSCSA fields, tabs and buttons; change the Odoo fields and the stage
  Other staff	none	none	no access to investigations

1. Go to Settings ‣ Users & Companies ‣ Users and open the user.

   Result: the user form opens on the Access Rights tab.

2. In the Other section, set Rx Tracking to User or Manager.

   

3. For a compliance manager who also manages Quality teams and control points, set Quality (in the Manufacturing section) to Administrator.

4. Select the ☁ (Save manually) icon next to the user's name at the top.

   Result: the user is saved. Quality shows User at least: the Rx Tracking right includes it, and it can't be removed while the Rx Tracking right is set.

Result: after reloading the page or signing in again, the user sees Suspect Investigations in the Inventory ‣ Rx Tracking menu and the Quality app on the home screen. Records: the user (its groups).

If it doesn't work

• The user doesn't see Suspect Investigations: the user has no Rx Tracking right, or hasn't reloaded the page.
• "Only DSCSA users can change the DSCSA investigation of a quality alert.": a user without an Rx Tracking right imported or wrote a DSCSA field. Give the user an Rx Tracking right, or have an Rx Tracking User make the change. See Error: "Only DSCSA users can …".

Known issue

Known issue (PF-A11-01): Quality staff without an Rx Tracking right see investigations in the Quality app and can move them to Solved (which closes them) or change their lot; an import by them that empties a DSCSA field is accepted and turns the investigation into a plain quality alert. Give the Quality right only to people your procedure allows to work on suspect-product cases.

Known issue (PF-A11-02): an Rx Tracking Manager or a Quality Administrator can delete an investigation, and no retention export or legal hold covers investigations. The modules follow the reading that investigation records are kept at least six years after the case concludes (FD&C Act § 582, record-keeping provisions; see Compliance background). Your procedure decides how investigation records are kept; don't delete investigations in the software.

Use Quality Control checks alongside DSCSA operations

Odoo's Quality app can add a check to every receipt, so that staff look for suspect-product red flags before they receive. A failed check leads to a quality alert that you turn into a DSCSA investigation. Background: FDA's red flags (unknown source, pricing that is too good, packaging anomalies, a lot or expiry that doesn't match, incomplete transaction information or statement) are worth building into a receiving checklist (FD&C Act § 582(c)(4); FDA suspect-product guidance (June 2021); Form FDA 3911; see Compliance background).

For everything a control point can do (measures, worksheets, failure locations, frequencies), see Odoo's Quality control points documentation.

Who: Administrator, or a user with Quality Administrator, to create the control point; the warehouse staff (Rx Tracking User) do the checks

Requires: Odoo Enterprise with the Quality app, and Rx Tracking (DSCSA) - Suspect Product Investigations.

Before you start:

• The products are DSCSA products. See Set up a DSCSA product.

Create the receiving check

1. Go to Quality ‣ Quality Control ‣ Control Points and select New.

2. Fill in:

   • Title: for example Suspect-product red flags at receiving
   • Products: the DSCSA products to check, for example [DEMO-DPZ-20] Demoprazole 20 mg Delayed-Release Capsules, 30 count (leave it empty to check every product)
   • Operations: your receipts operation, for example Chico Distribution Center: Receipts
   • Type: Pass - Fail (the default)
   • Instructions: what to look for, for example Check each case for the red flags: unknown source, packaging or label anomalies, lot or expiry that does not match the paperwork, missing transaction information or statement. Fail the check if you see one.

3. Select the ☁ (Save manually) icon.

   Result: the control point has a reference QCP000NN. Receipts of those products that are confirmed from now on get a check.

Do the check on a receipt

1. As the warehouse user, go to Inventory ‣ Operations ‣ Receipts and open a receipt of a checked product.

   Result: the header shows Quality Checks.

2. Select Quality Checks.

   Result: a dialog shows the check's title, product and instructions, with Pass, Fail and Discard.

3. Select Pass if the goods show no red flag, or Fail if they show one.

   Result: after Fail, the header shows Quality Alert instead of Quality Checks.

Turn a failed check into an investigation

1. Select Quality Alert.

   Result: a new quality alert opens with Product, Product Variant and Picking (the receipt) filled in.

2. Enter a Title that says what was found, and in DSCSA Investigation select Suspect product.

   Result: the DSCSA Investigation and Form FDA 3911 tabs appear. The Form FDA 3911 tab is filled in from the product, except Type of Report, which stays empty (known issue below).

3. Select the Form FDA 3911 tab, and in Type of Report select Initial notification.

4. Select the ☁ (Save manually) icon.

Result: the investigation is saved with its reference QA000NN and is listed in Inventory ‣ Rx Tracking ‣ Suspect Investigations. Records: the control point, a quality check per receipt (passed or failed), and the investigation linked to the receipt. Once the receipt is done, set the investigation's Lot, and quarantine the lot if it must not be shipped: see Quarantine the lot from its investigation.

If it doesn't work

• Validate opens the check's dialog instead of validating: a check of the receipt is still to do. Select Pass or Fail, then select Validate again. The DSCSA serial count comes first: a receipt whose serials aren't all scanned stops with "… can't be validated: scan one DSCSA serial for each unit being validated." before the check's dialog shows. See Troubleshooting: receiving.
• A failed check doesn't hold the lot: a failure location only moves the units. Quarantine the lot so that it can't be reserved or shipped.

Known issue

Known issue (PF-A11-05): Type of Report is filled in only for an investigation started with New in Inventory ‣ Rx Tracking ‣ Suspect Investigations. On a quality alert whose DSCSA Investigation is chosen after the form opened, new (as here) or already saved, it stays empty, although the other Form FDA 3911 items are filled in. Select Initial notification by hand (step 3). The printed data sheet ticks Initial notification even while the field is empty. See Form FDA 3911 items are empty, or show another lot.

Warning

With the 3PL add-on, never add a control point to the Title Transfer operation type: a check on that operation type blocks every title transfer and every just-in-time delivery. Limit Operations to your receipts.

Next: Open a suspect-product investigation for a lot