CAPA Quality Management
Systematic and efficient quality management
- Respond to any deviation with an appropriate measure.
- Develop the optimal solution for each quality problem.
- Track the progress and budget of each investigation, action or implementation project.
- Provide an audit trail for all incl. external stakeholders.
- Overlook all activities with a transparent reporting.
- Provide assurance by monitoring and examining the implemented measures.
Embedded issue tracking and project management
- Based on modern Web technology
- Efficient Workflow with seggregation of duties among project manager, action owner, approver and examiner
- Progress-, effort- and budget monitor
- Automated on current (over-)due tasks
- Refceting your organisation
- Easy to customise project types.
CAPA: Corrective Action – Preventative Action
Systematic quality management responds to any deviation analysing the root cause and implementing appropriate measures. Deviations from the accepted quality standard can trigger corrections adapting existing procedures, running production or manufacturing processes or design changes to products and services. The preventative measures avoid a repetition by modifying the set up to make the occurrence of the same deviation impossible.
All signs possibly leading to deviations or areas must be collected and analysed down to the root cause. The input channels include own measurements and observations, audits or reports of regulatory bodies, user/customer claims or complaints..
All deviations are permanently monitored, evaluated and prioritised.
The analysis must be documented with a proper audit trail to create reliable, reproducible and for stakeholders accessible results. Guideline can be an FMEA (Failure Mode and Effects Analysis) performed beforehand: the sequence of analytic tasks can depend on the risk of failure and cost associated with the investigated object.
Once the corrections and preventions are planned, they must be examined of their effectiveness, budgeted/financed and approved. Only then, the implementation starts under close monitoring. The importance, complexity and/or cost of the measure might require another authorisation of the project results at closure or even a revisit of the project some given period after closure providing assurance on the effectivity of the implemented measures.
The web-based co_issues modul of C.O.S supports all of these workflow steps in a single system including a documented audit trail proving systematic due diligence during the collection, analysis and implementation phases.
Each organisational member has a role-based access on a „need to know“ basis and is informed and reminded by the system automatically. Comments, work results, temporary analysis are traceable from the very first indication of a quality deviation to the effectiveness control after the implementation project.
Gant-charts illustrate the project plan and progress. Cost, time and effort can be planned and their actual values registered. Hence, project and quality manager can have an eye on the efficiency of a project or the quality management as a whole.
A tagging function allows to associate certain key words or characteristics to certain tasks, observations, results, … These can be evaluated in statistics and searched for to identify patterns among the data in the reporting.
A detailed logging provides the unchangeable audit trail.
Multi-Factor authentication and role-based concept prevents from un-authorised system access.
Different security classes are customised by confidentiality and encryption.
An Ishikawa diagram visualises the (interim) results during an investigation and provides a basis for discussing the next steps.
Each deviation stays on the radar of the quality management down to the implementation of CAPA and the control of their effectiveness. Third parties can track the appropriateness of the deviation handling completely in the system.
Statistics on reported deviations, their input channel and the identified root causes and implemented CAPAs provide you a current and historic view to the situation of your quality management.
All reports include functions to filter, group, sort and export the results. Graphical or textual representation can be downloaded in the common formats like PDF, Word or Excel, Text.
Cloud or on-premise
You can run the application on your own premises or select a cloud service provider to host it. We will then take care of the entire operating from support, backup, IT-security.