How is Process Auditing Different from Internal, Supplier, and System audits?
It focuses on work cycle and deliverables (outputs) instead of on isolated elements or requirements. A process audit is used to verify that processes are operating within specified limits and achieving specified targets (objectives).
Process Audits are audits that verify processes are operating within specified limits and achieving specified targets and objectives. It is an evaluation of the sequential steps and interactions of a process within a system.
Process audits can be conducted for simple processes such as filling, stamping, kitting, etc. Process audits can also be conducted for more complex processes such as design processes, management review, and various other projects.
Process audits are a very important tool for high-risk processes such as aircraft engine repair techniques, construction, healthcare treatments, pharmaceutical testing and medical services, and nuclear device construction.
Process audits can be conducted for simple processes such as filling, stamping, kitting, etc. Process audits can also be conducted for more complex processes such as design processes, management review, and various other projects.
Process audits are a very important tool for high-risk processes such as aircraft engine repair techniques, construction, healthcare treatments, pharmaceutical testing and medical services, and nuclear device construction.
Example
Below are the metrics from a process audit of a Class II breast pump device captured in a Pareto Chart. This device had continual issues and numerous complaints. A process audit was conducted to identify bottlenecks, gaps, and decrease risks.
Conclusion
The process audit concluded:
- There were unacceptable risks and work processes that must be restructured.
- Design Control processes were out of compliance
- There were unavoidable risks, but a contingency plan should be in place to minimize those risks.
- SOP’s were not being followed and retraining must be completed.