Are People Dependent Processes Causing Problems?
If the organization’s processes depend too much on people to remember:
- what procedures to follow,
- how to document the execution of them,
- what records to approve,
- where to put the records,
- what to do with the data, etc.,
there is a significant probability that nonconformances against documented processes and quality system regulations and requirements will occur.
Automate Control Where Possible
There are many off-the-shelf options available today to control the flow of quality system processes, procedures and records and . The cost of appropriate systems will, in the long run, be a value add to the organization, relative to the cost of noncompliance and potential product safety and efficacy issues.
Whatever can be done to remove the people variable from business and quality management systems, the more effective, consistent, controlled and compliant the systems are likely to be. Trained, competent and experienced people should be doing the work, not be the process!