Why Configuration Item Traceability Matters in PLM Systems

Don’t Erase the Past to Reuse a Number

Introduction: Configuration Item Traceability in PLM (#1)

In product lifecycle management (PLM), effective configuration item traceability is not just a best practice—it’s a critical requirement, particularly for regulated industries such as medical devices, aerospace, and rail. Drawing on the principles and works of Jon M. Quigley, a recognized authority in configuration and project management, this post examines why reusing configuration item identifiers poses more than just a paperwork headache. It can jeopardize your compliance, audit trail, and organizational integrity.

Configuration Management book.

The Hidden Dangers of Reusing Configuration IDs (#2)

Deleting a configuration item (CI) solely to reuse its identifier may appear to simplify your PLM system. In reality, it undermines configuration item traceability and the very story that each CI tells—tying together design intent, validation records (IQ/OQ/PQ), change logs, Device History Records (DHRs), and release decisions. Once you overwrite a CI’s ID, you potentially erase critical historical context.

Industry expert Jon M. Quigley has long emphasized that configuration item traceability is essential for maintaining integrity within the product lifecycle. In his writing, he emphasizes that robust traceability preserves not only technical decisions but also the regulatory evidence required for audits and compliance reviews.

Compliance Risks in Regulated Industries (#2)

In heavily regulated fields, traceability requirements stretch beyond internal benefits:

Breaking Audit Trails: When you reuse configuration IDs, you break links to acceptance criteria, corrupt the bill of materials (BOM), and invalidate historical records.
Legal & Regulatory Consequences: As Quigley highlights, regulatory frameworks demand end-to-end traceability. Failing to provide a clear audit trail can result in non-conformities, hefty fines, or even legal prosecution, depending on the industry.
PLM System Safeguards: Most PLM systems are designed to make deleting CIs difficult. Overriding these controls is not only cumbersome, but a red flag for process integrity.

Preserve, Don’t Delete (#2)

As Jon M. Quigley advocates, consider these best practices adapted for your PLM environment:

Archive, never delete. Keep the original CI and its history intact, even if rendered obsolete.
Create new, unique IDs when a new configuration item arises.
Maintain comprehensive configuration item traceability to ensure each story remains intact for compliance and product improvement.

If you wouldn’t reuse a serial number, don’t reuse a configuration ID.

Conclusion: Always Prioritize Configuration Item Traceability (#2)

Configuring your PLM system to safeguard configuration item traceability isn’t just for internal efficiency; it’s essential for regulatory success and organizational trust. Streamlining your processes at the cost of traceability can lead to compliance risks and expensive setbacks. As Jon M. Quigley shows, a culture of meticulous record-keeping and respect for historical data will always outweigh the perceived benefits of “cleanup” through deletion.

References

Quigley, J. M., & Gargini, K. “Configuration Management: Theory, Practice, and Application,” including discussions on regulated environments and traceability requirements.