QMS, another layer of management or smart management.
If you’re thinking that a QMS system would be just another layer of management, think again!
It’s true that most QMS systems are form-driven. Do an action, fill-a-form. Make a meeting, fill-a-form? The list is endless and if you forget, which is easy to do when deadlines are knocking on the door, then your QMS system has holes. Don’t worry, nobody’s perfect! But does a simple capture and sign form-based system, i.e. PDF-based forms, meet the requirements of a complete QMS system?
In a recent FDA Law Blog related to QSR/cGMP compliance, Mark Schwartz makes a compelling case for “failure to document” when he quotes a line by Tom Cruise from the movie A Few Good Men… …” it doesn’t matter what you believe, it only matters what I can prove, so… don’t tell me what I know, or don’t know; I know the law!”
And for the FDA, the law is clear in 21 CFR 820.100 which states that “all activities required … and their results, shall be documented”. This is not a “should be” but a “shall be” requirement. FYI, it’s not optional. It is not enough to complete a signed QMS form saying the action was completed, any lack of documentation of QSR related activities or remedial actions, means that they never happened, signed form or not.
In this particular case, a management PDF form signed off by the participants involved attesting to the review and approved by management was found by the FDA but they concluded that it was inadequate proof as to the activities and their results were not documents. It does not mean you didn’t perform the QSR activities themselves, it means you didn’t document them and as such to the FDA it is like these activities never happened.
Simply having a signed document is no longer the standard of proof. Most PDF-based QMS systems capture signatures, not the activities or related actions leading to them.
When QMS systems are Form driven, as most PDF systems are, the activities that lead to those signatures on a form are lost or buried deep in unconnected paperwork, e.g. timesheets, or project tasks, support tickets… In this case, a QMS system can fail with good intentions.
This level of QMS is not only incomplete it also imposes an additional, and all too often burdensome, layer of management oversight! Or is it?
For teams already reeling from deadline pressures adding an additional layer of paperwork and reporting at each step, stopping after each task to fill-in a PDF form, will create more delays and reticence. It’s another layer of management outside the current project management. How to get things done!
That’s where managing through quality can help.
The concept of managing through quality is not to make the quality endpoints the issue but rather the process of creating quality endpoints. This means integrating project management through quality management and insert reporting points throughout the process and linking them to the QMS form, the endpoint. Tagged as a QMS process, the various tasks can be followed and backtracked to show what tasks were undertaken to resolve QMS related issues within the context of the Project itself. A CAPA (corrective and preventative action) can be traced back to its origins, yet is reported through the QMS process – i.e. the activities get documented.
Managing through quality means as team members complete their tasks, they trigger QMS events that get automatically reported to the QMS system where managers can oversee the progress – not just the project management but any QMS management without them interfering or imposing upon the routine.
For example, in the above incident, a CAPA process can be dropped into the project, thereby triggering a special sequence of events required to resolve the QMS issue. All tasks and activities would be tracked, not only as regular project management but also as duplicated in the QMS management. Any and all related documentation is now tagged and this particular CAPA can be followed back to its origin. Resolution with a signed document, electronic or otherwise, now has a date stamped electronic trail, that, if required, can be printed.
Management through quality is smart management that effectively avoids adding another layer of management by encouraging team-based collaboration compliance.
For more on management through quality click here.