Workflows at Austin Water Labs Austin Water Labs biggest issue is tracking. Keeping up with stuff and not having it fall through the cracks.

Corrective Actions and Audits Root Cause Corrective Action Preventative Action Verifications Approvals Training Necessary document updates Documentation! The most difficult items to track were corrective actions and internal audits. Each non-conformance had multiple CA and PA. Each needed to be tracked for completion and verification of effectiveness. Sometimes there were trainings and document updates that needed to be tracked. And of course all of this needed documentation to show it was performed. This was attempted to be performed in a collection of spreadsheets and folders.

Corrective Actions and Audits Manual work Constant emails asking for updates Status reports required opening several tabs in several reports Low visibility of status Little accountability Deadlines missed Issues continued This system created a lot of manual work to update the spreadsheets after sending out many emails asking for updates. There was no quick way to get a status report of what was pending. As a result, there was little accountability and deadlines were always missed.

Qualtrax workflows We started using Qualtrax with a non-conformance workflow, CA workflow, and PA workflow. I am not one to start with the easy stuff. They have been an evolving project.

Initial Non-Conformance Who, What, When, Where CA, PA Reviews Verifications We begin with an initial Non-conformance workflow initiated by QA that captures what happened and the basics of the event. Then the action is assigned to an Investigator to perform root cause analysis and determine CA and PA. The actions are reviewed by the Supervisor and QA with possible routes to be returned for revision. Once approved, the Workflow Launcher creates individual workflows for CA and PA then the workflow goes into a Notification step where staff are notified of the RCCA. After that it goes to a wait step. Notice a shortcut route as well for one-offs or personnel issues.

Corrective and Preventative Actions Reminders for action Upload documentation Updates NC CA and PA are initially assigned to QA for reassignment as the workflow launcher can’t fully fill out the new workflow or assignments since the assignment is made in a sub-form. Then the actions are performed, documentation uploaded, and sent for verifications. Once all is verified, they are closed.

Initial Non-Conformance Notifies when final One final review Finished After the wait step, everything is reviewed one more time before going to close.

What workflow will do Help keep actions visible Increase accountability Make status easy to see Reduce the “I thought you had that” Centralized place for documentation Recall for future issues which are similar Workflows are helpful in making things more visible which can lead to better accountability. It helps with keeping the ball in the right court. It is also helpful for keeping documentation in an easy place to get to and find when you need to look it up again later.

Make people do it! What workflow won’t do No matter your system, people still have to perform the job. But having the accountability puts the pressure back on them instead of on us to constantly remind them.

Next step - Audits The next thing we did was take what we already made and created tracking for our audits. Essentially an audit is just a collection of “non-conformances.” So we created a new workflow that records the audit info including findings and observations and launches the non-conformances for each finding.

Weworkflows Questions/Comments Initial Proficiency MDL/RL validation LIMS issues Color coded diagrams – Free with every workflow! Besides the CA workflows, we have many others that we use to help with tracking lots of other things.

LIMS implementation We even used workflows to help with our LIMS implementation. We created checklists to keep track of what had been accomplished and then used reports of the workflow to generate status updates for management.

Training Chemical Hygiene Plan HAZCOM training Ethics Quality Systems Manual updates We use the training/testing modules to keep track of our annual trainings

Training/Testing Attach documents with “acknowledgement” tests Understanding questions Sometimes we do simple “acknowledgement” tests, other times we ask questions to check for understanding of updated sections or areas of common mistakes.

Ongoing proficiency Required annual renewal of proficiencies can be difficult to track. Spreadsheets Databases Outlook reminders Set schedules Ongoing proficiencies are our next item to tackle. Making sure everyone has done their paperwork for every analysis on a yearly basis is a tracking nightmare. We have multiple ways of attempting to do this but people still fall through the cracks and lapse. Such a problem that we had to add a section addressing lapses to our training SOP.

Ongoing proficiency Training set up for each analysis Groups for proficient analysts Annual expiration Attachments for documentation Visible through reports or personnel file We are creating training groups for all trained analysts which will expire on an annual basis. This will make it easier for staff to submit their forms and also easy to see at a glance what they need to get done.

Document control We use it Began 1.5 years after implementation Multiple locations without maintaining multiple documents Document control was the last piece of Qualtrax we started using recently. We were using a SharePoint system previously and it worked ok and tracking of the CA was priority. The major advantage we found of document control in Qualtrax vs SharePoint is the flexibility in having documents in multiple locations. People use to complain they didn’t know which folder documents were in. Now we have them in multiple places for more natural searching.

Custom Fields Effective date Revision ideas Old tracking info We do use some custom fields on our documents. We use one to keep track of effective dates and another as a place to keep ideas for the next revision of a document. We also keep information on the previous tracking of a document prior to Qualtrax since the revision history is reset to 1 when you upload.

Questions?