Overly broad training requirements block engineers from essential PLM access, creating shadow processes

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Engineers in regulated industries are often blocked from accessing Product Lifecycle Management systems due to expired training on irrelevant safety modules. This stems from companies assigning all training courses to all employees as a defensive compliance measure, rather than tailoring them to specific roles. For example, a software engineer can be locked out for missing a forklift safety course they will never need. This practice contradicts ISO 13485, which requires competence training to be appropriate to an employee's specific activities. The resulting delays and workarounds create shadow processes that can actually increase operational risk.

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