2014.1 Summary

We are excited to continue our aggressive roll out of features that many of our members have been asking for and deliver on a product road map that delivers solutions that enhance process and data visibility while taking advantage of the connection between members and their suppliers/contractors/customers.  

Usability was a major theme here, starting with an all-new dashboard that is built to be easier to use and with actionable data.  Users are literally one-click away from most anything they want to do.  All the new pages also include a simpler vertical style with built in instructions on the right side.  You will see the rest of the app conform to this new style as we go.

The major part of this release is the Issues/CAPAs functionality.  Now any member can log issues for any internal site or one of their external suppliers.  The module is extensive, including a traditional investigation lifecycle, automatic workflow execution with built in notifications, and dead simple notification and sharing feature.  The latter is particularly valuable in eliminating the wasted energy in reviewing/managing deviations between a supplier/customer—the supplier can now simply log the issue/investigation, share it with the customer and even make them a required signatory to the workflow.  All functions are part-11 compliant and paperless. 

Lastly, power users will be happy to see that we are starting to also roll out some terrific new features,, including:

  • File Uploads: Users can now upload files of any type. You can test this in Observation Review window or in the Issues/CAPAs section. In the latter, you will notice that you can even create on demand PDFs that include any uploaded file converted to PDF.
  • File Import: Users can now easily import MS Word (.docx) files right into any of our editors, meaning giving everyone true offline capabilitythat cost nothing to implement. 
  • File Export: Users that want to be able to download a copy of a written report or observation in MS Word to send for commentary can do so now with a single click from any of our HTML editors.


Thanks for your great feedback and ideas, please keep it coming!

-The QAB.




This page was completely re-worked to make it more actionable and easy to understand.  The 'tiles' are organized around key items or activities, and in each case the # values click through to a new window that brings up the selected items in a pre-filtered view.  Users are truly one-click away from exactly what they want to see.

  • Workflows: will work similarly, though the interface has changed
  • Overdue Items: we added a distinction between 'due in 7 days' vs. 'Overdue' items, including Observations, Issues and CAPAs.
  • Activity Monitor: a real focus was put into defining what the key trigger points should be for alerts. Did someone respond to an observation? Did someone assign me something new? Have any of my projects had activity recently? (note the screen cap below is being adjusted this week to include specific items for Issues & CAPAs.)
  • Audits: Users have one click access to all of their audits by state. A second version of this tile is being added for Issues/CAPAs.
  • QAB Inbox & Subscriptions: These two items work the same way as before.


As a bonus: users that receive a daily summary when something new has happened will see this new tile format in their email going forward.


Workflow Approval

This process remains the same, however managing and approving workflows got a much easier.


  1. Users click on the Workflows tile value if it's greater than zero to see a list of workflows. The workflow titles have been simplified.



  1. Opening a workflow item shows the completely reworked approval window, which retains the same functional elements. Our design emphasis is on making pages easier to navigate and understand. So as with many of the other new pages you will see a vertical orientation to the page AND a gray sidebar for instructions, comments and video tutorials right on the page.  Functionally, nothing is different here.



Observation Review—Auditor View

Creating/Publishing audits remains the same, as does finding observations.  The difference is in how you interact with observations for both Auditors and Auditees.  Some highlights for auditors

  • Note the same simplified vertical orientation and instructions side bar. We also added the Observation ID and status at the top.
  • Resolving observations is a one-button click operation with no signatures involved. This page will be read only for users who are not the Auditor Assignee or have special permissions. 
  • We added autosave to this page
  • Once an observation has been marked as RESOLVED, it is locked for editing unless the Auditor resets status to Unresolved.
  • File uploads now allow for files of most types (everyone will like this).
  • Auditees now have the ability to create responses in DRAFT format, meaning the Auditor will only see final responses when the Auditee marks the response as such.
  • Issues/CAPAs: We added a major piece of functionality with full-featured Issue/CAPAs. Any observation that requires more than a straightforward response, including full assessment, investigation, action plans and CAPAs can now be linked to a separate Issue by the Auditee with a single click. If the auditee chooses to share the Issue with your company, then you would see read only links to the full Issue and all related CAPAs.  You could also be listed as a required approval signature prior to implementation.  Pretty fantastic.


Observation Review—Auditee View

Auditees have the same items on their view, however most items are read only for obvious reasons. 

  • Note the "Submit Final to Auditor" button which takes the response out of DRAFT
  • Note the Issues/CAPA section that has links to the Issue and related CAPAs, including current status of each. You can see why this would be helpful—auditors (or your designated assignee) could have full access to the status of a complex response without ever touching an email.



Issues / CAPAs

We have added a robust capability to manage Issues and related CAPAs for both internal sites as well as to log issues with external suppliers/contractors and maintain visibility to any investigations and CAPAs.  Key highlights listed here (and see pictures):

  • Approach includes enhanced design philosophy for ease of use, instructions side bar
  • Relies on traditional CAPA methodology, though flexible enough to work within any quality system
  • Simple configuration options for Issue types, Root Cause categories or CAPA categories.
  • File uploads at most stages including files of most any type that can be converted and included as part of the PDF Export.
  • Notifications section allows investigators to identify internal users or external partners (including those not on the QAB) who need to be notified of activity. Issue owners are able to instantly share the Issue and related CAPAs with any clients who are QAB users with a single click. They can also be set as required signatories to he final action plan.
  • Use custom templates in Root Cause or Action Plan sections.
  • Elegant workflow engine relies on a single button click to launch all workflow from Implementation approval to Close to Verification.


Issues / CAPAs: Logging an Issue

  • Users with subscription accounts can log issues to any site's Qsheet, whether it's one of their sites or a contractor site, so long as the site is Green/registered.
  • Upload files of any type
  • Submitted issues result in immediate notifications to Site Managers, Site QA Leaders and Site Default Messaging Contacts
  • Users can only see issues they have access to (e.g. issues from their sites or issues that another QAB member has explicitly shared with a user from their member).


Issues / CAPAs: Assessment

  • Traditional Risk Assessment and methodology
  • Ability to add unlimited Corrective actions
  • Autosave



Issues / CAPAs: Notifications

  • Simple listing of key internal personnel that should be notified of key events and/or required to review/approve of investigation and action plan
  • Simple listing of key external clients that need to be notified, including one-click sharing for those companies that are also QAB members.
  • All messaging is logged in audit trail.


Issues / CAPAs: Root Cause Analysis

  • Root cause analysis includes configurable category tags
  • Insert standard form templates
  • File uploads of any type


Issues / CAPAs: Action Plan

  • Action Plan allows templates and file upload similar to Root Cause Analysis
  • Create unlimited Preventive Actions



Issues / CAPAs: Workflow

  • True 'set it and forget it' workflow engine carries Issue from Implementation approval to Verification with a single click.
  • Initial approval of the investigation and proposed action plan must run through following a linear sequence: 1) Investigator and CAPA assignee review/approval; 2) the site's custom defined workflow for Issues; and 3) any required internal/external clients.
  • Verification workflow will run automatically once the last CAPA is completed.



Other minor updates/bug fixes

  • Fixed a bug with location data for sites in certain countries
  • Implementing detection/logging of data conflicts for recurring audits and Qsheet Custom Fields when merging sites
  • Fixed a bug that appeared when unlocking a scorecard that had two workflows completed already.
  • Improved the HTML Editor for speed and to allow import of common file types, including RTF and .DOC files.
  • Improved site merge capability, including forum notices.
  • Implemented speed improvements throughout
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