Checklists

Introduction

New for v5.9, the Checklists module allows users to create checklists or groups of checklists which can then be triggered at various points throughout the production facility to ensure that processes are compliant with their company SoPs.

Responses to these checks can be set at varying severity levels in order to generate deviations which can then be carried forwards to the new CAPA module (coming soon!) for risk assessment and further action.

1. Checklist Setup
   1. Checklist Templates
   2. Checks
   3. Responses
2. Executing Checklists
   1. Scheduling in Control Center
   2. Ad Hoc in Terminal
   3. Executing a Check
3. Reviewing Checklists
4. Deviation Reporting
5. Template Groups and Event Triggers

To begin to set up a checklist within Control Center, we first need to head to the checklist ‘Templates’ page, which can be found under the QMS menu > Checklists > Templates.

We will now see the checklist template setup window, which is broken up into 3 sections:

Checklist Templates – This is where we can create the checklist template, and assign its name, type etc.

Checks – This is where we can add the checks to the checklist template that we created in the top panel.

Responses – Here we can create responses to the individual check that we have selected in the middle panel.

Column definitions for this Control Center page can be found here.

So let’s set up a checklist here for facilities cleanliness. We would start by clicking the green + associated with the top, checklist templates, panel:

The reference code will automatically be created here, but can be renamed to whatever is desired to match any naming conventions within a customers SoP. The checklist can be named via the next freetext box, after which we have a few different options for how we would want the checklist to function within the system:

• Job – Additional functionality coming soon.
• Schedule type – this controls how the checklist can be run within the system:
  • Ad hoc – Allows the checklist to be run at any time from Terminal, as well as allowing the checklist to be scheduled via the Checklist schedule (more on this below).
  • Formula – Prevents this checklist from being run from the Terminal or from being scheduled in the ‘Schedule’ window. Intended for checklists that can be run via event triggers in the ‘Template Groups’ (LINKDOWN)
• Recur Days – Additional functionality coming soon.
• Frequency – Additional functionality coming soon.
• Start Date – Additional functionality coming soon.
• Last Run – Not used in setup, but this column will automatically update to show when the checklist was last executed.
• Approvals Template – Sets the approvals workflow (MODLINK) for this checklist. These workflows can feature individual or groups of authorised QA/QC personnel who would be responsible for signing off/approving checklist responses each time the checklist is completed. This is optional.
• Location – Sets the production location where this checklist would take place. If left blank this will apply to all production locations.
• Site – As with locations, this can be used to set the site where the checklist would take place. Again leaving this blank will allow the checklist to be run across all sites present in the system.
• Specification – Opens a freetext box that can be used to enter a specification/further information about the checklist.

• Specification Image – Allows for an image to be uploaded against the checklist.
  • Both of these specification information boxes will appear on the Terminal when the checklist is run.

Once we have set up the template for our checklist in this top panel:

We can then start adding ‘Checks’ to it.

With our newly created checklist template created in the top panel, and with this selected, we can use the green + in the middle, ‘Checks’, panel to add a check to our checklist.

These checks are essentially questions that the system will ask when the checklist is run. The first check we will add here is ‘Floors in all production areas are visibly clean and free from dust, spills, or contaminants.’

We then have additional options here to add more information/functionality to each individual check.

• Specification – Similar to the column of the same name above, this opens a freetext dialogue box to add more detailed information to a Check that can be viewed by the operators undertaking the check on the Terminal. This can be used to add instructions or guidance for the operator to determine how they should answer the check questions.

• Specification Image – Allows upload of an image which can then be displayed alongside the text entered in ‘Specification’. This can be used to add visual guidance or examples that the operator can use to guide their responses to the check. So in this example we can upload images with examples to further guide the operator.

• Type of Check. We have 3 options here:
  • Standard – The default option, this provides the standard ‘Question and Answer’ functionality whereby the operator chooses a text based answer to the check.
  • Range – Allows the use of the ‘Target’ and ‘Lower/Upper Tolerance’ columns to define a numerical range of answers that can be selected in response to a check.
  • Date – Selecting this option changes the check into a date input in order to record the date that the check was performed
• Target – Allows entry of a target figure, if using the ‘Range’ type of check.
• Lower/Upper Tolerance – Allows entry of a lower and upper tolerance in relation to the ‘Target’ entered above. Note that this does not work the same as tolerances do for formula steps, here the tolerances don’t represent a +/- value from the target but rather what the lowest/highest answer can be, so for example this setup will accept answers of 3-5 as valid answers.:

• Date Offset (Days) – Works together with the ‘Date’ check type to give a +/- value of acceptable date inputs from today’s date, i.e. if today’s date is the 10^th and an offset value of 1 is entered, the date input will accept input of the 9^th – 11^th. If this check is scheduled against a specific formula then this offset will be overridden by the ‘Expiry Days’ of the formula.

Once we have set up the check in the ‘Checks’ section that we have just looked at, we can then, with this check selected in the middle panel, enter our desired responses to the check in this bottom, ‘Responses’, panel.

This is where we can set severity levels against each response, which the system will then use to generate deviations if these responses are chosen. So let’s go ahead and add 4 responses with varying levels of severity. We would use the green ‘+’ associated with this lower panel to do this.

So here we have the following options available when creating ‘Responses’:

• Answer – Freetext box to create the responses that the operator will choose between at the Terminal when undertaking the check. These can be numerical if using the ‘Range’ type of check that we discussed above.
• Severity – Assign a severity level to the response. Here we can assign:
  • Pass – The check passes – no further action needed.
  • Minor – The lowest level of deviation response.
  • Major – A higher level of deviation response.
  • Critical – The highest level of deviation response, usually requiring immediate escalation and subsequent corrective action.

These severity levels can be assigned to responses depending on individual companies’ SoPs.

• Require Picture – This box can be checked if it is required for the operator to capture a photo as visual evidence using a camera attached to the Terminal they are undertaking the check on.
• Require Additional Comments – This box can be checked if we require the operator to provide additional details (for example in this case they might enter the room cleaning log date/number etc.)
• Notifies Group – We can select an ‘Operator Group’ that selecting this response will subsequently notify.

To complete the setup for this checklist, we can add 2 more ‘Standard’ type checks for the remainder of the cleanliness checks, along with similar Responses for each.

We will also add 2 additional checks of the ‘Range’ and ‘Date’ type to see how these are processed at the Terminal.

When it comes to executing the checklist we have just created, since this is an ‘Ad Hoc’ type checklist, we can do this in a couple of different ways:

• We can schedule the checklist. This can be done in the ‘Schedule’ section of the ‘Checklists’ menu in Control Center.

• We can manually run the checklist from the Terminal without scheduling it.

Let’s take a look at both of these options.

To schedule a checklist in Control Center this is simply a case of navigating to the ‘Schedule’ window shown above. Here we will see our newly created checklist in the list over to the right.

Note that any ‘Ad Hoc’ Checklist will appear here once created. Other types of Checklists cannot be scheduled here. Here we can simply highlight our Facilities Cleanliness Checklist and click ‘Add To Schedule’ to add the checklist to the schedule.

Once added to the schedule we can adjust the ‘Due’ date for the Checklist by using the drop-down calendar in that column.

The second way we can run this type of check is directly from the Terminal. If we head to our Terminal (remembering that the Terminal must be in the appropriate Site/Production Location as in the Checklist setup), and head to the ‘Quality (QMS)’ section.

And then to ‘Checks’, where we will see the checklist that we just scheduled. We need to ensure that we have the ‘Not Started’ view selected at the bottom of the screen here.

However, if we had not scheduled the checklist previously and wanted to run it, this is simply a case of hitting the green + button in the bottom left of the screen:

Here we will see a complete list of the ‘Ad Hoc’ type of Checklist, and we can choose one here and hit the green check to initiate the Checklist.

So let’s run through the checklist via this method and see how it looks within the Terminal software.

Once the Checklist had been started we will see the checks and responses that we set up in Control Center.

We can use the ‘Specification’ and ‘Approval Stages’ buttons at the top here to inform the operator of the additional information that we entered during setup.

As well as informing the operator of the checklist approval stages under ‘Approval Stages’.

Returning to performing the checks, the operator begin to carry out the prescribed checks. If we select one of the checks to perform we will be able to view additional information about each check by hitting the ‘i’ button in the bottom left with a check selected.

This will show the individual check specification that we added during setup, which can be used to further guide the operator for that individual check.

When selecting a response, Terminal indicates the level of severity of that response when it is selected via a simple traffic light system of green/yellow/orange/red to reflect pass/minor/major/critical.

The operator would then move through the various checks that form part of the checklist and provide responses based on their observances.

So let’s imagine the first 2 checks pass, but there is a major deviation for the 3^rd question:

So if we remember the setup that we used for this check, this answer requires both additional comments and a picture. The operator will be prompted for their additional comments once they select this answer (if they selected the answer in error they can back out with the ‘ESC’ key on the virtual keyboard).

And since we also require a picture they will be informed of this.

Note that this is not required immediately, but the check cannot be completed without performing this action.

The operator can take a picture using a camera connected to the device by hitting the camera icon in the bottom right with the relevant check highlighted above.

This will open the capture interface where the operator can use the white button to take a photo. The operator can take as many photos as they want here before hitting the green check to confirm.

Since we have 5 checks here, the operator can use the arrows at the bottom of the screen to move down to see the final check.

When answering the ‘Range’ check here, the operator will be asked to enter a value, so here they might rate a 3, as the floor and walls were clean, despite the door issue.

And this would show as a green indicator, showing that the answer falls within the limits we set on setup.

Answering the date check presents an input for the date.

Entering today’s date here clears this check since we are within the 2-day range that we set when we added this check.

And once the operator has answered all the checks, they can use the green check to submit the checklist results.

Once the checklist has been completed, it is then set to the status of ‘Pending Review’ in the ‘Schedule’ in Control Center. Note that if the checklist does not have an approval workflow set against it then it will just complete at this stage.

As we just saw above, once checks have been undertaken by the Terminal operator, and if the checklist has an approval workflow assigned to it, then a further step is required from a user who is part of the approval workflow template that is assigned to the checklist.

So to complete the check we executed above, we can log back in to Terminal as one of these users.

Checks awaiting approval can then be viewed in the ‘Checks’ section by using the ‘Pending Approval’ filter.

The reviewing user can then select the relevant checklist and hit the green check. This will take them to the review screen.

The reviewing user can then use the ‘Review’ button to review the responses from the operator, select a reason (set in ‘Reasons’ under the ‘Approvals’ type), and add additional comments. They would then enter their system credentials and sign off the checklist by using the button in the bottom right.

The checklist will then be marked as complete.

Once checklists are complete, any deviations reported will be assigned a unique number and can be viewed in Control Center.

Deviations will automatically be added to the ‘Deviations’ page in Control Center, which can be found under the ‘Quality Issues’ menu.

This functionality is currently being developed further and more functionality will be released soon.

We have seen above how we can create and run individual checklists on our Terminal. However, we can also group checklists and create event triggers for them, much like we can with the existing ‘Q&A’ line checks. Let’s see how we can do this with our checklists.

So if we take the checklist we created above for our ‘Facilities Cleanliness’, we might want to run this check at the start of every batch of a specific formula within our dispensing production area. But we might also want to run another checklist at the same time, in this case one that checks PPE compliance for dispensing operators. So we can create a new checklist for this purpose.

So with these 2 checklists created, we can proceed to the ‘Template Groups’ area of the ‘Checklists’ section of Control Center to create our groups and event triggers.

Here we can use the 3 available windows to facilitate our new setup for these 2 checklists:

• Top Panel – We can create template groups here, giving them a unique code and a description to more clearly label the purpose of the group.

• Middle Panel – With the newly created group selected in the top panel, we can then add/remove checklists from our created templates in the middle panel. So here we can add our 2 desired checklists here.

• Bottom Panel – With our group created and checklist(s) assigned, we can then use the bottom panel here to create appropriate event triggers. This works in largely the same way as event triggers for Q&A, but simplified to only reference a Commodity (ingredient/formula), and Event (such as ‘Batch Start’) and a production location.So we can set this group up to always trigger at ‘Batch Start’ for our ‘Dispensary’ production location for an Ibuprofen formulation.

So if we then go ahead and schedule a batch for production at our Dispensary Terminal:

Once we start the highlighted job, the 2 assigned checklists will be run before the batch can proceed.