Let’s Talk About Compliance – Part 4: Are the Appropriate Actions Being Taken When an Issue is Found?

Heewon Kim
By Heewon Kim | January 3, 2022

Fact checked by Stephen O'Reilly

So, here we are at the fourth article in our Compliance blog series. To quickly recap, InfinityQS VP of Product Management, Eric Weisbrod, laid out the plan for this series in the Introduction. Senior Product Analyst, Matt Ryan, discussed collecting good quality data to help ensure that the products you’re creating are compliant with set specifications and that your processes are performing well in Part 2. And Product Operations Manager, Natalia Ochoa, talked about how the compliance efforts in your organization relate to how you manage your operators’ day-to-day jobs and responsibilities in Part 3.
 
Here, in Part 4, our discussion of compliance switches to what you do when an issue is found. As Eric mentioned in the intro, “when something is determined to be out-of-spec, are we recording our solution to the problem? We put the lot on hold, or we called the supervisor...or we contacted maintenance.” That is, are the appropriate actions being taken when an issue is found? To quote Eric one more time: “I think we can all agree that compliance is important stuff…in lots of different ways. And that we all need to remain compliant to stay in business. To do so, we’ve got to take care of all three of [these] aspects of compliance.” So, let’s dive in…
Compliance is Essential

Exception-based Triggers and Reporting

It’s obviously very important to respond when an issue is found. You certainly don’t want to continue to create bad product, send out bad product, damage your organization’s reputation, or cause any harm. One issue can lead to another before you know it, so responding—and recording that response—is crucial.
 
Exception-based reporting in Enact® takes place on the dashboards. In Eric’s blog, The Power of Dashboards in Enact, he goes into detail about these powerful tools, including the following:
 
“With control charts, you’re supposed to be in the details, in the weeds. With dashboards, you float above. Dashboards enable the kind of analysis that manufacturers can really appreciate. Rather than take an exorbitant amount of time with paper and pencil, you can make the kind of comparisons you need to make with a dashboard in a few clicks of the mouse. And that can only be better for your operations; rather than slogging through compilations and calculations once a quarter to see how everyone is doing, isn’t it better to just keep an eye on things all the time and know how everyone is doing at all times?”
Enact Work Dashboard 
“Your dashboard in Enact can show you statistical violations, or missed data checks—two very different things, with different actions to take, but they can reside side-by-side on your dashboard.  A one-stop-shop, one place to look, big time savings, greater efficiency.”
 
One important thing I notice in this quote is, “actions to take.” That’s what we’re focusing on here. Your operators are probably not statisticians or math majors; their focus is really on operating the manufacturing equipment. With Enact, the operator works throughout the day, accomplishing their myriad tasks, and when a violation occurs—or a data collection is due—the system notifies them (these types of notifications appear on the left side of the dashboard depicted above). No need to study control charts or keep one eye on the software. The system lets them know when something is amiss. Then they can quickly jump into action.
Success Through Quality

Heads Up

When something unexpected happens, Enact immediately alerts the appropriate people—the operator of the line in question, a manager or supervisor, perhaps quality personnel—in multiple ways. Enact uses color-coded alerts on the dashboard for the operator, and emails for management and other employees who need to know what’s going on.
Sample Enact Email Notification
Sample Enact Email Notification 

And Enact keeps changing and improving. Soon Enact will also be able to send event notifications to outside sources. For instance, if an organization uses a business intelligence system, they will receive notifications within that system as well. The important thing is that everyone who needs to know is informed of an issue right away.
Enact on the Production Line

Workflows

When an issue occurs, as mentioned, Enact will notify the operator and other appropriate personnel. When an issue has a corrective action associated with it, workflows can help ensure that the right procedure is followed for the issue in question.
 
Eric wrote extensively about workflows in his blog, Enact Workflow: for Compliance, Clarity, and Consistency:
 
“An important aspect of event workflows in Enact is its adherence to accountability; hence, it is important for compliance purposes.” Sometimes a workflow requires a team effort, in which an operator is responsible for one thing, a supervisor for another task, and the quality manager for yet another task. To help with these different situations, “event workflows can be assigned to specific roles. These assignments can be mandatory or not. For example, a worker may be required to take an action like enter a reason code, while another worker may add a comment based on an observation” …and a photo (as in the example below). Then the supervisor may be required to enter a resolution.

Workflow with Photo 
Sample Workflow with Photo

Users can create their own sets of event codes to fit the organization’s needs. “Appropriate event codes are then assigned to a workflow. This reduces the number of event codes from which a user must make a selection, keeping things efficient [and consistent] for the operator, technician, or manager.” 

Workflow Configuration 
Sample Workflow Configuration

“Event workflows then can be assigned to a static or dynamic list of manufacturing processes. Enact continuously scans for possible events and sends out appropriate notifications of the event. Events with assigned workflows will also send out additional notifications to those workers or managers assigned to the workflow.” By sending appropriate notifications and showing what needs to be done, the operators, supervisors, or quality managers can easily see what actions need to be taken and where.
Event Review 
“The point is that you control who is accountable for certain event codes. And from a compliance standpoint, accountability is crucial.”
 

For Example

Here’s an example of how a workflow can be used:
  • At 10:27am, there is a statistical violation on Line 1. At this time the following roles are immediately assigned actions:
    • The operator is notified immediately regarding the violation.
    • The operator is assigned to select an appropriate action taken.
    • A process engineer is assigned to select an appropriate assignable cause.
    • A supervisor is assigned to enter a comment.
  • At 10:30am, the operator selects the action taken and enters a comment.
  • At 10:32am, the operator takes a photo related to the issue.
  • At 10:35am, one of the process engineers reviews the event and selects the cause of the violation.
  • At 10:44am, a supervisor reviews the event timeline and leaves a comment.
All of those steps look pretty involved, right? Enact makes all of that activity easy to understand when we look at the event timeline, like in the image below.

Sample Event Timeline 

All of the information is captured in time order and the individual who responded to the workflow is documented. This is important because the workflow is assigned to a role (e.g., supervisor), but the actions are taken by individuals. With Enact workflows, you have the flexibility to assign them to a role that should complete the task, and the traceability of the individual who actually completed it.
 
To summarize: workflows are there to make sure that the operators know what to do when issues occur. They don't have to memorize what they have to do for each specific event. The system stores and tracks all that information for them. Then, the next time an operator runs into a similar issue, information is at their fingertips about what another operator did to resolve it, and management has a running record of how events were handled.
Workflow on the Shop Floor

In Closing

So, in closing I’d say that Enact’s workflows and exception-based triggers and reporting are available to help your operators not only keep their focus on what they do best—keep their manufacturing lines rolling and product quality high, instead of worrying about control charts—but also provide a measure of accountability, adherence to best practices, and (of course) compliance along the way.
 
After all, as we’ve stated, manufacturing compliance is essential to making sure we are all meeting the operational standards expected of us, so we can continue doing business and serving our customers.

InfinityQS quality management software is there for every step of your compliance efforts. Our software just makes it all so much easier, so much better. 

To read previous blogs in this series:
Take advantage of the technology at your fingertips today: contact one of our account managers (1.800.772.7978 or via our website) for more information.
 
 

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