Functional safety assessment is a mandatory 3rd party review/audit for functional safety work, and is required by most reliability standards. In line with good auditing practice, the FSA leader should be independent of the project development. Exactly what does this mean? Practice varies from company to company, from sector to sector and even from project to project. It seems reasonable to require a greater degree of independence for projects where the risks managed through the SIS are more serious. IEC 61511 requires (Clause 18.104.22.168.2) that functional safety assessments are conducted with “at least one senior competent person not involved in the project design team”. In a note to this clause the standard remarks that the planner should consider the independence of the assessment team (among other things). This is hardly conclusive.
If we go to the mother standard IEC 61508, requirements are slightly more explicit, as given by Clause 8.2.15 of IEC 61508-1:2010, which states that the level of independence shall be linked to perceived consequence class and required SILs. For major accident hazards, two categories are used in IEC 61508:
- Class C: death to several people
- Class D: very many people killed
For class C the standard accepts the use of an FSA team from “independent department”, whereas for class D only an “independent organization” is acceptable. Further, also for class C, an independent organization should be used if the degree of complexity is high, the design is novel or the design organization is lacking experience with this particular type of design. There are also requirements based on systematic capability in terms of SIL but those are normally less stringent in the context of industrial processes than the consequence based requirements to FSA team independence. The standard also specifies that compliance to sector specific standards, such as IEC 61511, would make a different basis for consideration of independence acceptable.
In this context, the definitions of “independent department” and “independent department” are given in Part 4 of the standard. An independent department is separate from and distinct from departments responsible for activities which take place during the specified phase of the overall system or software lifecycle subject to the validation activity. This means also, that the line managers of those departments should not be the same person. An independent organization is separate by management and other resources from the organizations responsible for activities that take place during the lifecycle phase. This means, in practice, that the organization leading a HAZOP or LOPA should not perform the FSA for the same project if there are potential major accident hazards within the scope, and preferably also not if there are any significant fatal accident risks in the project. Considering the requirement of separate management and resource access, it is not a non-conformity if two different legal entities within the same corporate structure perform the different activities, provided they have separate budgets and leadership teams.
If we consider another sector specific standard, EN 50129 for RAMS management in the European railway sector, we see that similar independence requirements exist for third-party validation activities. Figure 6 in that standard seemingly allows the assessor to be a part of the same organization as an organization involved in SIS development, but further requires for this situation that the assessor has an authorization from the national safety authority, is completely independent form the project team and shall report directly to the safety authorities. In practice the independent assessor is in most cases from an independent organization.
It is thus highly recommended to have an FSA team from a separate organization for all major SIS developments intended to handle serious risks to personnel; this is in line with common auditing practice in other fields.
Why is this important? Because we are all humans. If we feel ownership to a certain process, product or affiliation with an organization, it will inevitably be more difficult for us to point out what is not so good. We do not want to hurt people we work with by stating that their work is not good enough – even if we know that inferior quality in a safety instrumented system may actually lead to workers getting killed at work later. If we look to another field with the same type of challenges but potentially more guidance on independence, we can refer to the Sarbanes-Oxley act of 2002 from the United States. The SEC has issued guidelines about auditor independence and what should be assessed. Specifically they include:
- Will a relationship with the auditor create a mutual or conflicting interest with their audit client?
- Will the relationship place the auditor in the position of auditing his/her own work?
- Will the relationship result in the auditor acting as management or an employee of the audit client?
- Will the relationship result in the auditor being put in a position where he/she will act as an advocate for the audit client?
It would be prudent to consider at least these questions if considering using an organization that is already involved in the lifecycle phase subject to the FSA.