We’re evaluating our regulatory compliance approach in Windchill and trying to determine the optimal balance between automated checks and manual review workflows. Our current setup uses automated validation for basic compliance attributes (material declarations, RoHS status, REACH substances), but everything still routes through manual approval queues.
The challenge is determining which compliance checks genuinely need human oversight versus which can be fully automated. For industry-specific regulations like medical device 21 CFR Part 820 or automotive IATF 16949, we’re concerned about over-automation missing nuanced requirements. However, manual reviews create bottlenecks-our compliance team spends 60% of their time on routine validations that could potentially be automated.
We’re particularly interested in risk-based workflow routing strategies and how others maintain comprehensive audit trails when mixing automated and manual processes. What criteria do you use to decide automation boundaries? How do you handle edge cases where automated checks pass but human review might catch contextual issues?
IATF 16949 compliance is heavily process-focused, which actually makes some aspects easier to automate than you’d think. We automated our PPAP documentation validation-the system checks for all required elements, proper approval signatures, and revision consistency. Where we keep manual review is in the supplier quality assessment and special characteristics verification. These require engineering judgment about manufacturing capability and process control adequacy.
One tip: build escalation paths into your automated workflows. If automated checks detect anomalies or conflicting data, they should automatically route to specialists rather than just blocking the process.
For medical devices under 21 CFR Part 820, we found that automated checks work well for objective criteria but you need human oversight for design controls and risk management documentation. Our rule: if the regulation uses words like ‘appropriate’, ‘adequate’, or ‘where applicable’, it needs manual review. Automated systems can’t interpret subjective requirements. We use risk-based routing where automated checks assign a compliance confidence score, and anything below 95% confidence routes to our regulatory affairs team.
These perspectives are really helpful. The tiered risk approach and confidence scoring make sense. How do you handle the situation where regulations change? We’ve had cases where an automated check was configured for an older regulation version, and the change wasn’t caught until a manual audit.