People often ask me about the specific roles different Atlassian tools play in supporting quality management processes.
Here I’ve put together a few examples of which tools are best to support each aspect of certain quality management processes and why.
While the Atlassian tools can be used to support quality management, they are not compliant with regulations by default. However using specific configurations, settings and add-ons will enable you to create a compliant set-up.
You can read more about this in these in our other posts.
So, here are my best practice recommendations…
Design controls, or systems development life cycle (SDLC)
If you’re involved in medical device design you will probably use the ISO 13485 term design controls, and if you’re part of a software team, you might know it as SDLC. Either way, this process is about demonstrating control over what went into your product. Whether you work in Agile or Waterfall, regulators will expect you to deliver a set of artefacts that will demonstrate that control.
User requirements, technical specifications, risk analysis, test reports, design reviews and code should all be aligned in a set of traceability matrices. Ideally you will have your development process set up so these artefacts are generated in a streamlined way. For software teams, the holy grail of that approach is implementing a continuous integration (CI) cycle. In CI, these artefacts are generated as part of the software building process.
JIRA Software is the key tool to support design controls or SDLC, with Bitbucket and Confluence playing supporting roles:
- I recommend using JIRA Software to maintain your requirements and technical specifications. Requirements can be created as epics or stories. For the traceability matrices, each element of traceability is put in a separate JIRA issue type. So design elements should be put in specific ‘Design’ issues (you will need to define this as a new issue type), and test scripts in ‘Test’ issues. Creating links between these JIRA issues enables automatic generation of traceability matrices.
- Bitbucket can be used to control your code. Thanks to its powerful integration with JIRA, you can link code changes with the JIRA issue that triggered them. Bitbucket has a great framework for design reviews and helps to make these an integral part of the way you code.
- Confluence will bring all your artefacts together into a unified release dossier. Some of these, like the validation plan, will be written in Confluence. Others will be generated in JIRA or Bitbucket and brought into Confluence.
In a life sciences environment, some documents must be treated as controlled documents. These include:
- standard operating procedures (SOPs), quality manuals and work instructions
- patient information leaflets and brochures
- quality plans
- and meeting minutes.
Confluence is the place to author, review, sign and share them.
Customer issues are best handled in JIRA Service Desk. This is easy to set up and will give your customer issues procedure an instant boost.
JIRA Service Desk can be set up to support both great customer support and meeting regulatory requirements. It also integrates with other quality processes, such as nonconformities and development.
Other quality management processes that generate quality records
A quality management system (QMS) consists of several recurring processes. These might include:
- Nonconformities and CAPAs
- training management
- engineering change orders (ECOs)
- and supplier management.
JIRA Core is the best place to manage these processes, as it readily supports these common requirements:
- Each occurrence is expected to follow a certain process, the steps of which are explained in a SOP or work instruction. These can be mirrored in a JIRA workflow.
- Each occurrence has to be uniquely identified and recorded in a separate record. In JIRA each occurrence will trigger a new issue with its own unique key.
- A prescribed set of data items should be registered in the record. For example, for supplier management, the information for each approved supplier is registered in a JIRA issue. It captures their contact information, quality certificates and other pertinent information.
- The process requires a team effort. For example, when managing a nonconformity, different people will need to be involved at different stages. In JIRA, this is achieved by assigning the nonconformity to the right person each stage.
- Records are subject to records controls, which mean they need to be signed off and you must keep them for a specified length of time. JIRA can be configured to support this.
If you currently spend a lot of time preparing statistical data for quality reviews, try switching to Confluence.
Confluence will automatically merge data across your eQMS and display it in one place. This page will be available continuously and will always show the latest information. To prepare for quality reviews in the future, all you will need to do is analyse the stats to identify trends and opportunities for improvement.
I hope this helps to clarify the roles of the different Atlassian tools in quality management. However, if you have any specific questions about using them to maximum effect within your organisation, please get in touch.