LEAN SIX SIMGA BLOG- DMAIC Extension Requests from Internal Deviations in EDMS

BACKGROUND

Currently there is no restrictions or guidelines on the number of extension requests permitted on Corrective or Preventative Actions raised from Internal deviation investigations within the Electronic Document Management System (EDMS) . The aim of this project was to use the DMAIC tool to ascertain the reason for extensions, the volume of extensions and why there can be multiple extension requests for the same action.  

DEFINE

The business driver for this project was to look at resources from a quality perspective, drive quality culture and improve quality metrics. External Deviations are out of scope, due to the fact they do not accurately reflect the state of our QMS, but that of our vendors/third parties. Internal Actions have been identified as an area of concern from Quality Management Review. The high number of extension requests also indicates an issue with Quality Culture. Quality approve every extension request, and the quality group have limited resources to support.

MEASURE

	o   220 Extensions requests from Jan-Oct 2017, ranging from 1 up to 5 extensions
	o   44% requested additional 30 days to complete their action
o  32% justification for extension was original due date was not enough time
Measure of Success: o  Reduce overall  number of 1st time extensions             (and therefore reduce the approval activity for QA) o  Improve users familiarity with the EDMS, and drive Quality Culture.

ANALYSIS

	The points were users have decision points in the workflow are circled in red Owners should not accept actions they are not happy to execute on or feel that the due date is unreasonable. If this was followed we should not need ANY extension requests. QA also review the actions and proposed due dates prior to approval. Do due dates have value? YES! They drive quality culture and ensure activities are actually done. The system has checks to prevent the need for extensions, so why do we need so many?
	Cause/Effect: Analysis conducted to identify root cause for the high number of extension requests Reasons for extensions: o Priorities o Workload o Unclear actions o Lack of awareness of workflow and ability to edit/ change before
Root causes transferred to Effort/impact Matrix

 

IMPROVE

Actions	Status	Due Date
Focused Training to be rolled out to all EQMS users		Q4 2018
Training to all Quality Approvers to be rolled out		Q4 2018
Update WI to give more detail and guidelines around drafting , reviewing and approving actions	Complete	Complete

CONTROL

-         Focused training on extension requests

-         Present Metrics at management review , but also at weekly dashboard so issues can be identified prior to management review

-         Email blasts to remind users regularly

-         Limit the number of requests system allows ( workflow update required

CONCLUSION

Within QA it can be harder to find quick wins within a continuous improvement environment.
We can use lean tools to deep dive into a system based problem to identify contributing factors that have the potential to  cause the issue.

REFERENCES

https://goleansixsigma.com/dmaic-five-basic-phases-of-lean-six-sigma/