Set-Up of a Functional Safety Management System (FSMS)


Turnkey Contractor (chemical / pharmaceutical plant), Germany



Key Project Data:

A medium-sized Turnkey Contractor  (annual turnover 25 Mio. EUR) requested assistance to set up a Functional Safety Management System in accordance with IEC 61511-1.

Scope of Services:

PSC provided consultancy services to set-up a FSMS that was tailormade to the engineering, fabrication and installation activities of the Turnkey Contractor.

The project comprised three stages:

1.Gap Analysis acc. IEC 61508/61511 Checklists

  • Desk-top-Review of existing FSM-, QM-Procedures
  • Compliance-Review and Interviews acc. to Checklist at Contractor premises
  • Management Report, Presentation/Discussion of Recommendations

2.Preparation of the FSMP

  • FSM-Plan: Table of Contents, Scope
  • Preparation of SLC Responsibility Matrix and Activities
  • Pragmatic way forward, cross-reference / integration of existing QM-Procedures
  • Define Priorities for the next steps: training requirements, preparation of missing documentation/procedures
  • “Road-Map” for phased Compliance

3.Preparation of FSM-Templates

  • Preparation of 24 templates
  • Intensive comment / review sessions to adapt templates to Turnkey Contractor scope and responsibilities as per IEC 61511
FSMS Gap Analysis
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