Proposed Quality Workflow (QW) user guide - release 1

The Quality Workflow tool (QW) aims to help reduce the friction in creating and maintaining traceability matrices (later release could target hazards and risks).

Background and use-case

Within medical device software there are several design and development stages that should be tracked, versioned and a traceability matrix is a standard way of presenting this information. The Quality Management System used in WEISS is document based, which requires substantial manual effort in tracking linkages, updating of versions and ensuring that all approvals are current.

The QW allows users to track the different changes in design and development requirements, outputs, verification and validations. These different stages are linked together using github or gitlab as part of the normal development process. QW also will ensure that versioning of items are updated if their contents have changed, and notify when manual verification should be rerun due to changes in requirements or outputs.

Actual and Potential Features

• Manage project on hosted service
  • github.com
  • gitlab anywhere
• Issues as regulated objects
  • User Needs
  • Requirements
  • Hazardous Situation
  • Risk Mitigation
  • Anomaly (bug) template
    • Risk analysis in comment
• Pull Requests as regulated objects
  • Design Objects
  • Automated workflow
    • Cannot merge without review
    • Cannot merge without traceability to User Needs
    • User configurability of checks
• Automated test gathering?
  • Ensure automated tests pass before PR merge?
• Extra information (in CSV files?)
  • Manual test script description
  • Manual test run results
  • Risk class of each component
  • Risk likelihood, impact, matrix
  • Decision for each risk not entered as a Hazardous Situation issue
• Produce documents from data in repo and service
  • MS Word document
  • Markdown document production
  • Excel document production
  • "database file" production to allow users to make their own document templates with MS word or LibreOffice
  • Built-in standards documents
    • ISO13485
    • DCB0129
  • Inserting data into documents
    • Data produces repeated, nested paragraphs
    • Data produces repeated rows in tables
    • Data produces charts
  • Management documentation
    • Burndown charts
      • Or burnup charts
      • Requirements satisfied with Design Object (PR)
      • User Needs covered with Requirements
      • User Needs satisfied with Design Objects
      • Anomalies remaining in different risk categories
    • Remaining items report
      • Anomalies
      • Requirements
      • User Needs
      • Risk decisions made/yet to be made
      • Unmet risks

Setup

Installation

Using pipx

Install the latest version from github:

pipx install git+https://github.com/UCL-ARC/qw

Install a particular version from github:

pipx install git+https://github.com/UCL-ARC/qw@v1.0

Install from the source code directory:

pipx install .

Using conda

After creating and activating your conda environment (with conda create and conda activate), install qw into that environment with:

conda install pip git
pip install git+https://github.com/UCL-ARC/qw

Using venv

The qw tool requires python 3.9 or greater, if your project is in python then we suggest adding it to the developer requirements. If not, you may want to create a virtual environment for your python, one option is the venv module.

For Unix:

python -m venv venv --prompt qw # create virtual environment directory called `venv`
source venv/bin/activate  # use the virtual environment
pip install git+https://github.com/UCL-ARC/qw.git#egg=qw  # install qw
echo "venv" >> .gitignore. # ensure git ignores the `venv` directory

Configuration using Github

Initial setup and adding to repository

The qw tool creates a .qw directory that allows versions of each design and development stage to be tracked at release time. Add this directory to your version control, so that there is a shared baseline at each release. In the first step it also creates a set of GitHub actions and templates to ensure the tool can work correctly. To allow the qw to interact with GitHub you will need to create a fine-grained personal access token. The final step of configuration then updates your GitHub repository with rules, and add templates for each stage of the quality workflow (and another template if there is an issue or pull request that doesn't relate to the quality management documentation).

Initialise qw

At the top level of your git repository, run the intialisation step for github

qw init --repo github.com:username/reponame --service github

INFO: A ".qw" directory has been created

INFO: Github actions for qw have been added to your ".github" directory

INFO: Please commit the files after you have finished your setup

INFO: Rulesets and branch protection added for branches matching "main" to "stefpiatek/dummy-medical-software"

If you have a different development flow than pull requests into main/master then edit the qw ruleset for the repository, adding extra branches to the ruleset (e.g. develop)

You can omit --service github if the repo is at github.com (as in this case) and you can omit --repo <url> if you have the desired repository configured as the git remote named upstream (or origin if you have no upstream remote set).

Setup Personal Access Token

• Follow the GitHub instructions we suggest the following configuration options:

  field	value, user defined values defined by ${...}
  Token name	qw-${repository_name}
  Expiration	custom... then choose 364 days from today
  Description	QW tool for ${repository_name}
  Repository access	Only select repositories -> Select the project repository
  Permissions	Only add repository permissions, see next table

  repository permissions	value
  Actions	Read and write
  Administration	Read and write
  Contents	Read-only
  Issues	Read and write
  Metadata	Read-only
  Pull Requests	Read and write

  Then click the Generate token button and copy the token (you can't get its value again if you close the page).

• Add the personal access token to your machine's keychain (uses keyring)

  qw login

  Please copy the personal access token and hit enter:

  After you've done this, the system will check the personal access token. If you've configured for the remote URL https://github.com/stefpiatek/dummy-medical-software you would see:

  INFO there are currently 27 issues and PRs

  Can connect to remote repository 🎉

Setup for a new user, on an existing project that uses QW

The local and GitHub repository have already been configured to work with qw, you'll just need to add the personal access token

Customising configuration for identifiers

QW initialises with a System component for requirements (used for generating a unique identifier, short code value is X). You can add extra components to the configuration by editing the /.qw/components.csv

name,short-code,description
System,X,Whole system requirements.
Drug dosage,D,Drug dosage calculation module.

You set up the workflow files and the release templates files like this:

qw configure --workflow
qw configure --release-templates basic

At the moment basic is the only option for release templates at the moment. In the future we should have options such as iso13485, dbc0129 and management to allow you to produce regulatory documents and management documents without having to build them yourself.

Configuration using Gitlab

Gitlab is not supported yet. When it is, it will work both on gitlab.com and on instances hosted elsewhere.

Using QW with github

QW uses existing issues and pull requests to track the different design and development stages along with managing risks and their mitigations.

Creating QW items

User needs

• In your github repository, Add a new issue, selecting the User needs template
• Fill out the required fields and any other information if it exists
• Hit Submit new issue and the issue will be rendered like this:
• The first comment of this issue will be used by qw for tracking, but you can edit anything manually after the Other information header and this will not interfere with the tool

Requirements

• In your github repository, Add a new issue, selecting the User needs template
• Fill out the required fields and any other information that may be useful
  • The options for requirements type are:
    • Functional
    • System inputs and outputs
    • Application programming interface
    • Alarms and warnings
    • Security
    • User interface
    • Data definition and database
    • Installation and acceptance
    • Operation methods and maintenance
    • Networking
    • User maintenance
    • Regulatory
• Hit Submit new issue and theissue will be rendered like this:
  • Note that the design-component-d has been added as "Drug dosage" was added as a component type with a short code of D.
• The first comment of this issue will be used by qw for tracking, but you can edit anything manually after the Other information header and this will not interfere with the tool
• The parent issue will have been updated with this issue number

Design outputs and design verification

• Create a pull request from github and follow the instructions on the template
  • If the qw-ignore tag is added, then this PR does is not related to the medical device aspect of the software
• In this example, the pull request contains the design outputs and design verification. These can be added separately, where the design verification would also be linked to the requirement.
• QW will check that the chain of design items are able to be processed and fully signed off, when this is successful the github action will pass
• QW requires a pull request that is labelled as a design-validation or design-verification to have at least one automated test that targets a specific design-output, requirement or user-need
  • Tests are tracked manually in .qw/test_mapping.csv where multiple issues are separated by ;, in the following structure

    test name	issue(s) targeted
    InputVerifierTests::testWeightIsNegative	40
    InputVerifierTests::testConversionOfWeightUnits	4;23
    acceptance_test_user_entry.docx	2

  • The development team may want to write a script that allows them to get the names of all tests run and ensure that automated tests listed in the csv still exist, bonus points if you make this an automated test that fails if a test doesn't exist
  • Adding the manual verification test scripts to version control is ideal, but you may also list the name
  • the QW CI task will fail if:
    • No parent issue is given for a PR
    • A test doesn't exist which is mapped to the parent issue
    • The structure of the test_mapping.csv has been altered, or ; has not been used to separate targeted issues
    • A test name is duplicated in test_mapping.csv

Design validation

• QW does not require design validation documentation to be added to the repository, but you may add the test script. Ideally this would be in a plain text format. We suggest creating a validation directory and storing the validation information there
• As with Design outputs and design verification, update the .qw/test_mapping.csv with the test script(s) that fulfill the user need.
• Create a pull request from github and follow the instructions on the template
  • A validation links to a user need, so link this type of issue in the PR
  • Assign the pull request to the team member who will authorise the validation. Once they have validated it and signed any required paperwork, they should approve the PR.

Non-QW items

• If you'd like to create an issue that doesn't relate to the medical device then use the Non QW item issue template. This tags the issue with qw-ignore so that QW does not parse the issue.
• If you'd like to create a pull request that doesn't relate to the medical device then tag the pull request with qw-ignore.

Closing QW items when they are not resolved by a PR

Note: this functionality has not yet been completed.

• There may be times when a QW-tracked issue is required to be closed not by a PR.

• You may close the issue as either completed or not planned

• Then please add another section to QW information in the issue in the form:

  ### Closure reason
  
  #### type
  
  <!-- allowed types: duplicate, cannot replicate, not a defect, won't fix -->
  
  duplicate
  
  #### explanation
  
  Duplicate of #5

Checking QW items for consistency

You can check that all the closing issues of all PRs (not marked with qw-ignore) are requirements, that all Requirements have User Needs links and that all these User Needs links are marked with qw-user-need:

qw check --remote

There are clearly many more checks that we could run in this stage.

The --remote flag tells qw to examine the PRs and issues as they currently exist on the server. The alternative is:

qw check --local

This checks the PRs and issues as they were gathered by the last invocation of the qw freeze command, described next.

Versioning of QW items

The qw freeze function is used to save the current state of the qw items in github, and to ensure that the versions of items are updated if their information has changed. This should be run regularly, which will update or add to the .qw directory. These changes should be committed and added to the main development branch by a pull request as a Non QW item.

qw freeze

An example incrementing a tag upon update:

Running WQ freeze Found 47 QW items

INFO: Requirement stefpiatek/dummy-medical-software#6 has been updated since last saved

Previous data:

• Description : Warfarin dosage should be calculated using based on patient age, gender and weight
• Parent User need: stefpiatek/dummy-medical-software#5

Current Data:

• Description : Warfarin dosage in mg/kg should be calculated using based on patient age, gender and weight
• Parent User need: stefpiatek/dummy-medical-software#5

Would you like to increment the version? (y/n): <prompt response from user - y>

INFO: Updated tag to "qw-v2"

INFO: There are 2 design outputs that link to this Requirement, please ensure one of them has the "qw-v2" tag if it resolves the updated information

• stefpiatek/dummy-medical-software#7
• stefpiatek/dummy-medical-software#12

...

INFO: ✔️ 12 new QW items added to state

INFO: ✔️ 47 QW items checked

INFO: Please commit the changes in the ".qw" directory

Example response when the change is trivial and does not warrant a change in the version of the QW item:

...

Would you like to increment the version? (y/n): <prompt response from user - n>

INFO: Tag kept at "qw-v1", data for the Requirement has been updated to the current state

...

Creating a documentation release

When you're ready to update the documentation in your Quality Management System (QMS), you can use the QW tool's release command. Running this will create word documents based on the QW template for export

qw release

This turns the files in the qw_release_templates directory into the same named files (within the same named subdirectories) into correctly filled-in documents in the qw_release_out directory. Any paragraphs containing mailmerge fields will be repeated however many times they need to be to be filled in with all the data qw knows about. Also, dependent paragraphs below those repeated paragraphs (at "higher" outline level) will be repeated. The mailmerge fields in these dependent paragraphs will be filled with dependent data from qw.

If you want to write your own document template, or update them, you need to be able to add these mailmerge fields to your document. For this you need a "database file". Get that from the qw generate-merge-fields command. This produces a file called fields.csv.

What do we do with this fields.csv file? In MS Word you choose "Select Recipients|Use Existing List..." from the "Mailings" ribbon, then select the fields.csv file. Now the "Insert Merge Field" button lets you add fields. In LibreOffice you select "Insert|Field|More Fields...". In the dialog that pops up, select the "Database" tab, highlight the "Mail Merge Fields" type. In the "Add database file" box click the "Browse..." button and select the fields.csv file. Now the fields appear in the right hand box. You can select the one you want and click "Insert". You can keep the dialog open as you type if you like.

Now, as long as you save this new file within the qw_release_templates directory, qw release will fill in your document and output the result to the qw_release_out directory.

You probably want to add qw_release_out to your .gitignore file, especially if you are adding the documents inside it to some other QMS tool.

Tab completion of commands

You can use tab to complete the subcommands of qw, for example you can type qw gen then press tab, and qw generate-merge-fields will appear, but only if you have installed the tab completions. Do this with the following on Windows:

qw --install-completion powershell

to get tab completion in PowerShell. Similarly on Linux, Mac or WSL use:

qw --install-completion bash

or use the zsh or fish options if you use those shells.

FAQ and common issues

• Can I import an existing project into QW
  • There's nothing stopping this, though each issue and pull request would need to match the required format, and be tagged appropriately by the time you'd like to run a release. This may be a reasonable amount of work and we expect issues may need to be created.