fbpx

Quality management and improving your CAPA SOP.

This post outlines the steps involved in setting up a quality management system (QMS) process in JIRA Core. QMS standard operating procedures (SOPs) are all about process management, which is JIRA Core’s strong suit. Read on, and I’ll guide you through the key steps in improving your CAPA SOP. If you’re looking for more information on what CAPAs are or how to process them in Jira, check out our article ‘Managing CAPAs in Jira: key questions answered.’

To make things more concrete, I’ll focus here just on the corrective and preventive actions (CAPA) SOP, within the context of life sciences. In fact, the relative complexity of this process means it’s often the first process clients ask us to help them transfer to JIRA Core.
 
A couple of notes before we dive into the details.
  1. Most of the functionality described is available both on the Atlassian Cloud and the server version. Some functions are currently only available on the server version.
  2. Requires some prerequisite knowledge of JIRA Core configuration.

Step 1: Establish your verification and validation (V&V) strategy

A CAPA process set up in JIRA will be part of your quality management system. It will be subject to the relevant validation and verification (V&V) procedures. If you don’t yet have a V&V strategy in place for automated processes, it’s a good idea to invest some time in developing one.
 
Bear in mind that the extent and depth of V&V activities required will depend on the regulatory framework in which you’re operating. For example, if you’re a medical technology company operating within the framework of FDA QSR 820, you will find the applicable rules in Section 70, Article i. These stipulate that the V&V activities for automated processes must cover the intended use of the software in your specific context. This means that you will need to create and execute a test plan to ensure that your CAPA implementation works as it should.
 
If you rely on other software for other aspects of your business, you may take inspiration from the practices and tools you use there. Before applying similar methods when improving your CAPA SOP process, consider the level of risk associated. For example, if your device is a heart pacemaker. Obviously a CAPA process in JIRA will carry less patient risk than the software controlling your device, so may need less stringent V&V efforts.
 

Step 2: Outline your project structure, issue types and subtasks when improving your CAPA SOP

The most straightforward strategy at this point is to map each quality assurance (QA) process to a dedicated project in JIRA Core. Each instance of that process to a particular issue type in JIRA Core. For example:
  • Manage CAPAs within the CAPA management project and each CAPA instance will be a CAPA issue.
  • Manage training activities within the Training management project. Each training activity (i.e. one person trained on one subject) will be a training activity issue.
  • Manage non-conformities within the non-conformities management project. Each nonconformity will be a nonconformity issue.
You will then define these new issue types in JIRA Core.
 
Some procedures require multiple actions to happen in parallel. Imagine you’re a pharmaceutical company. You open a CAPA due to a series of complaints about medicines arriving at hospitals with damaged packaging. You plan for an investigation into the root cause and decide on two courses of actions. First, a redesign of the packaging and a change in transportation arrangements. Assign those to two different people and will progress in two parallel timelines. You can’t complete the CAPA before hand. This type of process calls for the creation of subtasks, so you would need to define both a CAPA issue type and CAPA subtask issue types.
 
At this stage it’s also worth identifying which processes are related to each other. This can provide valuable contextual information. For example, a nonconformity issue may trigger a CAPA issue. You can indicate this in JIRA Core using issue links.
 

Step 3: Translate your SOP into a workflow

CAPA SOPs are often written using process language. This lends itself easily to producing a workflow description. Here are a few hints on how to break your process into distinct statuses:
 
  1. When completing one set of actions is a prerequisite to another set of actions. It’s usually best to break those up into two separate status steps in the workflow. In the case of CAPAs, identifying the root cause should occur before planning the preventive and corrective actions. So you should separate those into two consecutive statuses.
  2. If a person in a specific role has to take action at a specific stage of the process, this is also a good indication that the status should change. For CAPAs, if the QA manager needs to review the CAPA before you take any further action. Then it makes sense to create a dedicated ‘Review by QA’ status.
  3. If there should be a time delay between actions, a ‘Waiting’ status should be introduced. If an effectiveness check is due six months after a CAPA has been implemented, it should move to ‘Waiting for effectiveness check’ status (see Figure 1.)

Figure 1: An example of a JIRA workflow for CAPAs

Step 4: Map your data fields

Typically, the existing CAPA form is a good starting point for the list of data fields you should define in your CAPA screens. Having a field on a screen can serve a few purposes beyond merely recording relevant information:
 
  1. It can serve as guidance to the person executing the CAPA. We often see phrases within a CAPA SOP like ‘Check if the risk management file could be affected.’ Or ‘notify the management representative if this might be related to the QMS.’ These are actions that need to occur during the CAPA process. It might be useful to add fields that will not only remind people of what they need to do but also record their decisions about it. A checkbox field with the title ‘Could risk management be affected?’ will enforce consideration of this question.
  2. Data fields may influence the workflow of a CAPA. For example, if your organisation can avoid the ‘Effectiveness check.’ Then a field that allows users to indicates that you can avoid that the effectiveness check should be avoided can help you skip the stage. And take the CAPA directly to the final status.
  3. Data fields provide structured information which can be used to filter reports, facilitate analysis of long term trends and statistics. It provides meaningful information for dashboards (see Figure 2).

Figure 2: The CAPA source is an example for a data field. A pie chart can be displayed on the Dashboard, which shows what is the distribution of sources for our CAPAs.
Along with identifying the list of fields you will need, you should associate each field with the corresponding workflow status. For example, the field ‘Was this CAPA effective?’ should occur during the ‘Effectiveness check’ status. Because you could easily have many fields in a CAPA issue – a couple of dozens is typical – it’s good to split the fields into separate tabs. Such as a tab for each workflow status. You should keep the layout of tabs and fields consistent across the different screens you use. For example using the same layout for the View and Edit screens.
 
Another design paradigm for creating a good user experience is to make the transition screen between workflow statuses present all the fields that need to fill in for the current status. If ‘Root cause’ is a field that has to be filled in during the ‘Root cause analysis’ status, then the transition screen between ‘Root cause analysis’ and ‘Action’ will display the ‘Root cause’ field. Along with all the other fields that have to be filled in before you can move forward. This is then coupled with a workflow validator, which will block the transition and display an error message if a user tries to move to the next stage without that field being filled in.

Step 5: Improving your CAPA SOP using electronic signatures

In life sciences, you need to consider the FDA CFR 21 part 11 if you want to use your JIRA Core Server CAPA implementation as your evidence for compliance. Intenso’s Electronic Signature plugin does a good job of providing an easy and compliant way to integrate electronic signatures into the workflow. You need to decide during which workflow transitions you need an electronic signature. Then add an electronic signature field to those transition screens.

 
The other major requirement from FDA CFR 21 part 11 is the need to have an audit trail. JIRA Core has an audit trail facility built in. The trail for each issue can be found in the ‘History’ tab at the bottom of the View screen (see Figure 3).

Figure 3: The History tab shows for each CAPA, the modifications of data alongside with user and time information.

Step 6: Improving your CAPA SOP workflow with a bit of ‘behind the scenes’ automation

In many cases steps 1-5 are all you need to get going using JIRA Core when improving your CAPA SOP.

However, you can add plugins to streamline the workflow, making users’ lives easier. Check out our article on the various plugins you can use to streamline your process. For example by using the right plugins you can:

  • Prevent users from making errors or performing the CAPA in a non-compliant way
  • Avoid people having to guess exactly what is expected of them
  • Reduce the number of clicks needed to complete the task.

You can use workflow mechanisms powered by plugins to achieve some very cool effects in JIRA Core. Here are a few examples of ways they can play a role in improving your CAPA implementation:

  1. Opening CAPA subtasks automatically, such as a subtask to evaluate the risk management file when transitioning from ‘Root cause investigation’ status to ‘Action’ status. Several predefined subtasks may be created, depending on the fields filled in during the investigation. For example, if it was indicated that ‘Risk management may be affected’, then a CAPA subtask titled ‘Evaluate potential impact on risk management file’ will automatically be created and assigned to the right engineer.
  2. Blocking the progress of the CAPA until all relevant subtasks have been completed.
  3. Moving the CAPA from ‘Waiting for effectiveness check’ to ‘Effectiveness check’ status when the effectiveness check due date has elapsed.
  4. Automatically assigning a CAPA to the quality assurance officer responsible for CAPA validation when it transitions to validation and verification.

Step 7: Run your CAPA implementation past the end users

Although you may think your process is very easy and logical, it’s always good practice to allow some of your end users to try it out. You will often discover quirks that will be easy to iron out but which could make a big difference to the user experience. Simply changing the name of a field, the options within a particular field or even the name of a transition could make the whole process more intuitive.

Before launching the new system it’s very important to get the quality assurance team to validate that the implementation accurately reflects your CAPA SOP. As a matter of fact, this stage often reveals not just problems in the implementation but also issues with the original SOP that should be addressed, such as an overcomplicated or incomplete description.

This step will give you a good feeling for how your CAPA meets the following awesomeness criteria:

  1. Easy – a person who is familiar with JIRA (ie uses JIRA for other purposes) needs less than 15 minutes of training to be able to contribute to a CAPA issue.
  2. Self-explanatory – a compliant execution of the CAPA process does not require the person to read the SOP.

If your CAPA doesn’t meet these two criteria, use this step to discover what you could do to improve it.

Step 8: Define public filters and create a CAPA dashboard

Reports and dashboards are the gateway to some of the key advantages to be gained from using JIRA Core.

It’s important to give people access to meaningful reports and dashboards from the very start. This helps to keep users motivated during the adjustment period and can help them realise some very quick wins.

My go-to set of CAPA-related gadgets for dashboards is:

  1. Two dimensional filter statistics that shown all CAPAs split into their status (one axis of the table) and assignee (second axis).
  2. List of all CAPAs for which effectiveness check is due.
  3. Pie charts to view distribution of all our CAPAs per: CAPA source, status, assignee, etc.

Step 9: Finalise your V&V process.

Before signing off the implementation you’ll need to complete the V&V activities you defined in Step 1.

Step 10: Rollout

Follow through on this advice on improving your CAPA SOP and you’ll be ready to roll out your new implementation.

Let’s check out a few tips to guide you through the planning of the rollout.

  1. Depending on the size of your organisation the rollout may be done in one go or gradually spread across teams and departments. By its very nature the CAPA process requires cross-team collaboration, so it’s not always easy to do a stepped rollout.
  2. Teams that are already working with JIRA will have a much easier time getting accustomed to managing CAPAs in JIRA. They may act as champions for the new way of working and support other users. So, if possible, it makes sense to roll out the new CAPA process first in areas where some of the people already know JIRA. For example you could start the rollout on a product line that involves a big software team that already uses JIRA to manage their development work.
  3. Create a JIRA project (or even a JIRA Service Desk project) where users can log tickets relating to the CAPA process implementation in JIRA. This will help you provide support where it’s needed and gather feedback to focus on improving your CAPA SOP implementation.


I hope you will have found the guidance here useful for improving your CAPA SOP or other key procedures to JIRA Core. Remember, if you need help at any stage, that’s what we’re here for, so please
get in touch

For more information on improving your CAPA or Jira performance, visit our website. 

 

Blog posts in this series:

  1. Managing CAPAs in Jira: key questions answered
  2. How triaging customer issues helps streamline CAPA
  3. Compliance, usability and culture in quality management
  4. Use Jira to Document Meetings, So You Can Focus on What Matters