Search the Elsmar Cove!
**Search ALL of** with DuckDuckGo Especially for content not in the forum
Such as files in the Cove "Members" Directory

8.1.3 Management of change - Evidence of HIRA and related things


Involved In Discussions
In 8.1.3 Management of change the standard says -

The objective of a management of change process is to enhance occupational health and safety at work, by minimizing the introduction of new hazards and OH&S risks into the work environment as changes occur (e.g. with technology, equipment, facilities, work practices and procedures, design specifications, raw materials, staffing, standards or regulations). Depending on the nature of an expected change, the organization can use an appropriate methodology(ies) (e.g. design review), for assessing the OH&S risks and the OH&S opportunities of the change. The need to manage change can be an outcome of planning (see 6.1.4).

Basically if we have covered the safety related points in DFMEA at design stage , still the evidence of HIRA and related things are required?

I feel it is adding to documentation part if we have already considered it in core tool of IATF16949 i.e DFMEA ?


Jen Kirley

Quality and Auditing Expert
Staff member
Since the standard does not specify what sort of documented information to use, I would be happy to see it whatever form. I am not used to seeing safety and health risk assessments in design FMEAs, but if you put it there, so be it. Machine guarding, new chemical introduction and potential personnel protective equipment (PPE) needs, training, signage and energy isolation (LOTO) are expected to be considered. I additionally look for high voltage program inclusion (Arc Flash) for power sources 480V and higher, which may have been added to operate the equipment for making the product.

I do, however find missing pieces when planning to changes in infrastructure: evecuation maps updates, needs to add fire extinguishers, exit signage and eyewash/safety shower stations etc. Additionally, I would be interested to know how you plan to direct risk planning personnel to individual design FMEAs for risk analyses that are usually done for processes.
since we are talking about the safety shower, is there any requirement on how many times you need to do PM or inspection to your safety showerand eyewash equipment? is it weekly basis? thanks


OSH Officer
Hello !

My idea : Rajendrak, If you carried out a HIRA during the design phase to choose different OSH risk management options accordingly (in such a way and at such an "acceptable" level in principle), you produced a HIRA whose results remain "virtual" at design stage. But now you have applied the change according to the design finally chosen, so you can proceed to a "real" HIRA (in real work situation) to validate or adjust your virtual HIRA (and you document this new HIRA as you want).

Top Bottom