Any advice on what Subject Matter Experts (SMEs) can be allowed to do?
I appreciate that this is a very broad question - and would appreciate all answers!
However, specifically, is it appropriate to allow the SME to control a part of the validation alone - even for quite a long period of time - and then approve their documentation fully at a later date?
As a hypothetical example of this: what if an approved URS were issued, and the supplier needed to combine documenting their proposal with building sub-assemblies to prove that their ideas worked. The sub-assemblies would then be used on the final equipment if they did work. As the sub-assemblies were developed and altered, so the supplier documents would alter. During this development process, the SME (from the user company) and supplier would work closely with frequent, and maybe lengthy, meetings. The SME would be expected to maintain physical and document control, with approval of the supplier documents only happening in full once the SME and supplier were happy that the URS could be met. The approvers should be able to see how the development happened (via some form of log of document changes, revisions etc) but would not approve each revision specifically.
If the use of an SME in this way isn’t appropriate, are there any other ideas about how to control and document such a process - remaining within expectations of regulators?
[quote=Cat]
However, specifically, is it appropriate to allow the SME to control a part of the validation alone - even for quite a long period of time - and then approve their documentation fully at a later date?[/quote]
Will there be only two sign off’s on this. The SME and you?
QA (overall quality responsibility)
Maintenance (engineering / equipment responsibility)
Technical (product responsibility)
Production (ongoing production responsibility)
Validation (compliance to procedure plus acceptable to validation standards responsibility)
So full approval for initial URS and final documentation (prior to design confirmation / qualification) and SME approval (usually the engineering project manager) in between times.
I’m not sure if I fully understand exactly what you are asking here!
“The SME from the users company” I assume this is the person who has issued the URS. The person who works directly for the company in question. Is this correct.
If this is correct I would advocate that the SME takes full control of the URS with input from the supplier where required. Any changes that occur with the URS should be highlighted to other interested parties aswell.
I’m not sure if I am helping here as I dont fully understand the issue.
We try and follow the path of issuing a URS to a supplier, receiving their response (FS/DS) then doing a design qualification / confirmation. However, the reality is that for many projects, issue 1 of the URS is sketchy and there is a period of process development during which the URS and all the supplier documents are started, reviewed, updated etc. So at the end, when we come to a point of wanting to accept the equipment / process, we may have issue 6 of the URS, issues 2, 4 and 7 of various supplier documents and none of them have any real approval. I think this makes us at least look somehow less in control than we are, and I know it raises questions in audits.
I would like to move to a situation where we fully approve issue 1 of the URS (however sketchy) - full approval being from 5 different functions. Then we hand over control to the SME - who in reality is the project engineer / manager. Typically, they then work closely with the supplier, spending time at their site, using our materials etc to develop the process together. During this period, the only approval of any re-issue of the URS and any issues of supplier documents is by the SME alone. However, they are required to keep a document log or history during the development stage.
When the SME is happy that the URS finally details all our real needs, and the supplier response is developed enough to show that they can supply what we need, the documents are finalised at whatever issue they are. These finalised documents are then fully approved (5 functions) and used for the design confirmation stage. At the point of approval of the final URS and supplier response, the approvers can see through the document history (or equivalent) how the needs and responses have developed over time.
So our validation file then contains issue 1 of the URS - sketchy probably, but approved; and the finalised documents (URS, FS, DS etc) containing the development history of how we got from first URS to end point and also approved. We retain any interim URSs, FSs etc containing SME approval only, but would put them in the project file rather than the validation one. (A minor point, but in audit we offer the validation file - only if the auditor digs into more details would we show the project one.)
I think this is OK - but I am unsure - partly because the idea of an SME is new to me, and I don’t know what kind of scope a regulator expects them to have.
Sorry for the long post! Hope it makes my question clearer.
[quote=Cat]Thanks for engaging with this - much appreciated!
We try and follow the path of issuing a URS to a supplier, receiving their response (FS/DS) then doing a design qualification / confirmation. However, the reality is that for many projects, issue 1 of the URS is sketchy and there is a period of process development during which the URS and all the supplier documents are started, reviewed, updated etc. So at the end, when we come to a point of wanting to accept the equipment / process, we may have issue 6 of the URS, issues 2, 4 and 7 of various supplier documents and none of them have any real approval. I think this makes us at least look somehow less in control than we are, and I know it raises questions in audits.
[/quote]
I know exactly what you are saying here, i dont see this as a major problem, as long as all of the initial URS requirements are addressed, any extra URS input canbe seen as improvements. Maybe you should state in your VP that the URS will remain a living document until all parties are happy with the content
[quote=Cat]
I would like to move to a situation where we fully approve issue 1 of the URS (however sketchy) - full approval being from 5 different functions. Then we hand over control to the SME - who in reality is the project engineer / manager. Typically, they then work closely with the supplier, spending time at their site, using our materials etc to develop the process together. During this period, the only approval of any re-issue of the URS and any issues of supplier documents is by the SME alone. However, they are required to keep a document log or history during the development stage.[/quote]
I dont see anything wrong with this approach either, what you are saying is that at least you will have an initial officical sign-off and any other adjustrments will be approved by the SME. State this in your VP and at least everything is clear in terms of approvals and questions should not be raised then.
[quote=Cat]
When the SME is happy that the URS finally details all our real needs, and the supplier response is developed enough to show that they can supply what we need, the documents are finalised at whatever issue they are. These finalised documents are then fully approved (5 functions) and used for the design confirmation stage. At the point of approval of the final URS and supplier response, the approvers can see through the document history (or equivalent) how the needs and responses have developed over time.[/quote]
Agree
I think this is fine, in my view its better to have a c[FONT=‘Times New Roman’]omprehensive URS that details all requirements rather than one that lacks all your requirements.[/font]
[quote=Cat]
I think this is OK - but I am unsure - partly because the idea of an SME is new to me, and I don’t know what kind of scope a regulator expects them to have.
Sorry for the long post! Hope it makes my question clearer.[/quote]
Make this point clear in your VP and it should be fine. I think your approach makes alot of sense.