Development
of your quality management system

With Beatrice Schroetter QM Consulting from Hagenbach your strategic targets are being implemented and existing processes optimised. Revising complaint management, CAPA, document management, change control, risk management or meeting the requirements of new markets and/or in-house key performance indicators have to be met (…) the palette is big and colourful… Besides the day-to-day business you have a great deal to do when you want to develop your quality management system according to ISO 9001 and ISO 13485.

Dynamic Business TeamDefine: Beatrice Schroetter QM Consulting supports you to clearly articulate the business problem, goal, potential resources, project scope and high level project timelines by involving all concerned parties. Consistent communication between all team members and status reporting of the project for the executive management team is a crucial part of the project’s success.

Measure: The target process in consideration is documented, validated how it is measured and the baseline performance is assessed. This is prerequisite to objectively establish current baselines as the groundwork for improvements.

Analysis: In the stage of analysis the top causes behind the metric will be isolated. In most cases there will be no more than three causes that must be controlled in order to achieve success – if too many causes are identified, then the team has either not isolated the primary causes or the project goal is too ambitious to achieve success with a single project.  There are always exceptions, but projects should be customised to assure team success and project closure inside reasonable time limits.

Improve: This phase focusses on fully understanding the top causes detected during the analyse phase. Together with the team members creative solutions will be identified to either control or eliminate those causes to achieve breakthrough performance.

Control: The final phase is about the changes achieved in the improvement phase to guarantee lasting results. The best control is that requires no monitoring. But often times there are process settings, setup procedure etc., that require employees to follow specific requirements in daily operations – such as control plan.

Whether DMAIC or PDCA-Cycle the in-house resources nearly always need backing. An external support for this kind of temporary and time consuming projects makes good sense.