URS AND CHANGE in system

Validation
1

Hi dear experts,

Should URS be updated if a change is made to a validated equipment?
I mean a new requirement should be added to the URS of a validated system commensurate with the change?

Regards,

2

Hi Saeed!

If I understood your question, the answer is yes

Part of what it means for an equipment to be qualified, is that it is demonstrated that the equipment complies with URS. Changes to qualified (validated) equipment need to be manged by the Change Control System, since there are two scenarios that could potentially impact product quality:

  1. The change is originated because the equipment will change its intended use or add new use (e.g. adding larger punches to an existing validated tablet machine to be able to manufacture tablets of greater size)

  2. To recover a qualified (validated) state of the equipment which was previously lost due to break or lack of maintenance or other failures.

In the first scenario, you need to update URS so that it fits the new intended use of the equipment so that validation activities are aimed to demonstrate compliance with new URS (i.e. new intended use). In the second scenario, since the equipment’s intended use is not changed, same URS apply for requalification activities.

I hope this helps :slight_smile:

3

Thanks a lot for your valuable reply,

The change is because of a mistake in first design of a part that needs to be lower weight than the current state
Something that is a bit vague for me is , adding a requirement in URS with the text as”the part should have a weight lower than 2 kg”
but other requirements in the URS are related to time before constructing the machine

It it true if I add the new mentioned requirement in the URS? I believe I should since I require to update traceability matrix and then refer the new design to the requirement.

Looking forward to hear from you

Thanks

4

As a quick observation from your post: It looks to me as if that URS is not an actual URS, but a Design Sepcification (DSP) needed to meet a URS. URS are usually written in such a way that if met, they will enable the intended use of the equipment. You can try asking, “why does the equipment need that component to weight less than 2 kg?” The answer must likely lead you to a URS or a functional spec.

Putting this comment aside; since URS are written to reflect the intended use of the equipment these would change only when this intended use is changed; which has to be managed by a change control. And most likely lead to qualification/validation activities.

From your post:

It it true if I add the new mentioned requirement in the URS? I believe I should since I require to update traceability matrix and then refer the new design to the requirement.

You are absolutely correct. Whenever the URS change, you have to update traceability matrix to see if existing design meets URS or if it needs to be redeisgned, with all activities that entails that change (i.e. engineering, validation, qualification, etc.). All of this must be handled via change control system in compliance with the quality management system of your site.

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