I wanted to make sure that others have "heard" or actually made a Kaizen SOP. The people I am working with seem quite put off on the idea.
Thank you for your help!
the question was towards, 'intent'of making the 'kaizen' as a tool
for implementation of NC-CAPA ==> would obviously lead to 'integrating same into SOP' an obvious step and appreciable.
this is to enable
* a harmonized and sustainable practice
* retaining the spirit of "doing as it is written and writing as you do it" ; and the level of details could be differed to an annexure which broadly entails the framework, to a 'format' which enables you to evolve a template for implementation steps.
* traceable - audit-able - compliant practice.
IF you meant otherwise, '
feasibility of adopting kaizen as a tool for CAPA system implementation ' without affecting the 'compliance; aspect to regulations/auditability ....==> it can very well be done,
viz., SOP deals with the auditable-minimum-criteria (viz., follow up for completion-timelines, trending of NC, CAPA etc)
and process of kaizen-implementation would be driven outside SOP, with "minimum or even no-reference" to it.
however, personally, the SOP has to have representation to the implementation process/steps. (viz., if the tracking is through SAP or any other software tool, it is required to add an reference in SOP!)
in this case, if we use kaizen! as an improvement tool, it ought to have minimal reference.
true, SOP for kaizen, or integrating kaizen into QMS would not only raise eye brows, but when implemented in a 'compliant' manner, it would also turn heads;
integration of QMS tool into QMS-systems&processes would really shift the definition from 'compliance to standards' to 'quality_improvement'.
kaizen integration would boost the "continuous improvement" (read preventive actions" process; today this is more or less tightly coupled with the QMS-CAPA, however there is a opportunity ( not long before it becomes a regulatory requirement wrt expectation of Continuous improvement.)