Step 1: Record a new exception

In the dashboard select “record new exception” icon.

Step 2: Enter information

Enter information in the fields as applicable. Fields marked with an asterisk are required.

(Some header information relating to the RMP operator will be prepopulated with the information registered to AsureQuality). The AsureQuality XAQ Exception number is already assigned.

• For the RMP/ULI detail, select in the drop-down which site is applicable. Once this has been selected the remainder of the information will populate.
• The notification date is the date the AsureQuality AP was first notified of the event as per the regulatory notification requirements.
• RMP operator reference field is free text; this could be used to populate with your own internal company NCR number for example.

Step 3: Enter subsequent information

Enter information into the fields to describe the event, what has been done, and what is still yet to be done.

Important note: please use text only in the description fields, no pictures or snippets, as these will not be captured on a pdf document generated by the Recognised Agency.

Step 4: Enter CAPA

Select if corrective or preventative actions (CAPA) are needed. If no CAPA are required, then select “No”, then enter a reason description in the free text field below.

If CAPA are required, then select “yes”, then select the “Add” button. This will open a new box to enter CAPA individually with supporting information.

Each corrective and preventative action is entered individually. Enter the information associated into the required fields (marked with asterisk), and then either his “save” to save this action and go back to the exception page, or hit “save & new”, to save and move to entering another CAPA.

CAPA will then show in a table style format on the front page of the exception, as per the below example.

Note: Each can be managed, amended, closed etc. separately.

Step 5: Enter product affected information

If no product is affected by this exception event, select “No”, then enter a reason description in the free text field below.

If product is affected, select “yes”, you can then either manually add product information using the “Add” button, or import data electronically.

Using the Mass upload template

You can also click on the hyper link “click here to download the mass upload template for product affected”. This will allow you to use the standardised excel template and is recommended. This will download to your downloads folder where you can then save and then “import”.

See below snip for template. Note: there is a guidance tab within the excel sheet which explains what information can be populated into the cells.

Justification for sublotting: if required, you can enter a detailed description here of how, and why sublotting is to be applied (if applicable).

Note: if the affected product will be managed under an operator managed event please select this option.

To manually enter product information

• Select “add”.  The below box will appear, requiring information relating to the affected product. All fields are required to be populated. Make sure all fields are checked as completed.  
• Then select “save” to save and return to the exception page, or “save & new” to move to another page of additional affected product.

Note: Description* means the product description.

To import an excel file or template excel file as mentioned above, select “import”.

Select browse to import your file.

Note: “Column name row number “can be left at “1” provided that you have used the product upload template (tab 1 not tab 2 of the excel workbook) and have not altered the column names and locations.

Leave the details as is, in the “match import columns” table.

A sense check on the product affected table is suggested to ensure data looks correct against fields.

Once upload is complete, there is an option to export the information into an excel spreadsheet as per above snippet, printing is also an option.

Editing, adding or changing product information

You can still edit the product affected information at this stage, without uploading a new template.

To add more product after exception submission it is recommended to use the manual “add” product line. However, you can re-upload product affected using the template.

Note:  A new template upload will overwrite the current uploaded product information.

Please add a note into the amendment details section justifying amendments made.

Note: Once the exception has been submitted to the Recognised Agency, to change any product affected information you will have to put the exception into amendment. (see step 8).

Operator Managed Event

Select the tick box if product will be operator managed, even if only a portion of the product will be operator managed.  

If you are unsure at this stage, you can go back into the exception at any time later and select operator managed and use the sublot justification field to indicate what product and why, will be disposed of via operator management.

Evidence of disposal will need to be uploaded into the documents and notes (as per step 6).

Step 6: Documents and Notes

This is an optional field to attach/import from your files any supporting information such as risk assessments, investigation notes, photos.  The system will accept word, pdf, excel, email msg and jpeg images.

Select “Add”, then “browse” adding any additional information as context. 

Step 7: Submitting the exception to AsureQuality

If you select the “Save” button
This will save the exception to your dashboard (status “new”), allowing you to go back and amend it at any stage.  In this instance, the exception has not yet been sent to the AsureQuality AP (Accountable Person) for the site and will be in “Draft”.  

If you select the “Submit” button
This will send an email notification to the AsureQuality AP that an exception has been submitted by the Operator and will move it into showing as “In Progress” under the Process Step column.  

An email will also be sent back to the Operator notifying them the exception has been received by the AsureQuality site AP.

Step 8: Amending the exception

Note: if you are making a change to an exception (for example adding in documents) that will not necessitate a version change, you can do so at any stage. 
If you want to specifically notify the site AP of these sorts of changes you will need to manually email them.

Otherwise, to make any significant changes to the exception, such as adding product, open it via the dashboard, scroll to the bottom and select “Amend Exception”. A box will pop up requiring a reason description.

You will be reverted to your dashboard noting the exception is now in “02 Amendment” status. This allows you to open the exception and make any changes necessary.

At the bottom of the screen you will be required to then summarise the amendments made.

Confirming changes

You can either again select “Save”, saving the information and reverting to the dashboard, without notifying the AsureQuality AP of any changes made. Or select “Submit” which will send an email notification that the exception has been amended.  

Record of changes:

The” Exception history” tab at the top of the screen will show the exception version numbers and short details of changes.

Email

This functionality is there for your use, and is the preferred method of communication as then everything is contained within the system.

Note: this email recipient will default to the allocated site and acting AP as the receiver.

MPI CER number 

This will be notified to the AQ AP and entered into the system for you by the AQ AP. No action is necessary by the Operator.

Accepted Exceptions

Once the site AP has reviewed and accepted the exception, it will then show as in “Accepted” status on your dashboard, and you will also receive an email from the system stating so.

To check the status of an exception, check in the system on your dashboard.

Exception types/statuses:

• New (when a new exception is raised but not yet progressed)
• Accepted (when the AP has reviewed and accepted the information and can send the exception onto MPI)
• Amended (this is the status the exception sits in once the changes have been made and ready for review by the AP)
• More info required (this is the status that allows the Operator to make necessary changes to the exception information)
• Cancelled (the exception has been cancelled as no longer required)
• Closed (an exception can be closed once all CAPA and follow up has been completed)

Step 9: Deleting exceptions

If you raise an exception in error and it is in draft state, this can easily be deleted. 
Open the exception number and on the right-hand side of the screen you can select delete, giving a reason.