Configuration Management

Configuration management concerns the task to be in control of documents and product configurations.
When a major project is running with full steam ahead, configuration management is a challenge.
However, if safety was a house then configuration management was the foundation.

Interpretation

The quality of the configuration management is an easy parameter to sense for an auditor.
In organizations with strong safety management (high SIL), the configuration management is pedantic and without a hitch: Documents, Minutes of meetings and Changes on the product are controlled in configuration management systems with fields for unique identity, date, responsible, revision, documents to be updated and tests performed etc.

In organizations with a lower safety culture the configuration management is random and uneven: Not all meetings have a minute of meeting or maybe you hear a busy employee stating: "I do not have time for making registrations!"
Such a statement indicates low awareness of the traceability requirements of safety decisions.
It takes commitment from the executives to change a low safety culture into a high concerning the configuration management issue.

Next chapter >> 4.2 Failure Reporting and Corrective Actions (FRACAS)

Focus on the Source

From chapter 3, "Definitions", in EN 50126

Configuration management: A discipline applying technical and administrative direction and surveillance to identify and document the functional and physical characteristics of a configuration item, control change to those characteristics, record and report change processing and implementation status and verify compliance with specified requirements.

From chapter 5.3.5, "Within all applications of this standard, the following requirements are mandatory":
...
e) an adequate and effective configuration management system shall be established and implemented...

From TR50126 Feb 2007, chapter 7.1.2
Change Management is seen as a crucial part of the LC Phases 11-13 [Operation], as emphasized in Table 7, column D: "…strict Configuration Control is THE most important issue…"

The subject is addressed to the maintenance of the QM and SM Systems of all involved perties.