Document approvers by role or by name

[DocCtrller]

My company requires document approvers to be assigned by a combination of role (e.g., regulatory, quality engineer) and document type (e.g., work instruction, validation protocol). How common is that approach?

I think approvers should be known subject matter experts. That would mean assigning approvers by their actual names. Would that cause problems with auditors/inspectors?

Thanks!

 

[Ronen E]

Hello and welcome to the Cove!

The first part means that specific functions in the organization are authorised to approve specific types of documents.

The second means that individuals are qualified to approve specific types of documents based on their qualifications, knowledge, experience etc.

Both arrangements are quite common through the industry, either together or alone. I think you shouldn't have any issues as long as your practice is captured in your QMS and you follow it consistently.

Usually personal qualifications are captured in the individula's training record or in a qualifications matrix.

Cheers,
Ronen.

 

[Ajit Basrur]

Ronen is on the dot

Another info to be noted is to have a Delegation of authority to perform managerial transactions in case of leave or away from office and could be defined either upwards, downwards or lateral.

 

[somashekar]

My company requires document approvers to be assigned by a combination of role (e.g., regulatory, quality engineer) and document type (e.g., work instruction, validation protocol). How common is that approach?

I think approvers should be known subject matter experts. That would mean assigning approvers by their actual names. Would that cause problems with auditors/inspectors?

Thanks!

Competency is the key. Personnel identification is to keep a good track on long term as well as to meet certain regulatory requirements. Both are required to be on record. A good system I have seen is to have a log of signature to person that is established every year or as and when changes are made. This log is maintained. Your clarity of purpose is most important and from there the auditor / inspector would have no problem .....

 

[Ronen E]

A signature log is a useful thing, but what I find even more useful is supporting and promoting the habit of noting the full name of the individual wherever it's practical. Initials are a sort of compromise that I personally dislike due to potential ambiguity. It can be useful to include the person's initials as well (in their own handwriting) in the signature record.

 

[DocCtrller]

Thank you all for your replies!

I think our approach came from an internal audit finding from years ago, before I came on board. The approach we've been using (combination of roles and document types) is complicated by documents that don't fit into one of the predetermined types.

I haven't seen anything in the regulations requiring the approach we use. Thanks for confirming that FDA auditers don't seem to care either, as long as we follow our own documented procedures

Thanks again!

 

[notemadres]

Thank you from me as well - had a similar question!

 

[normzone]

Using names requires you to update your documents whenever somebody leaves or joins the organization, or if duties change.

Using titles requires you to update your documents whenever your organizational structure changes.

I prefer the latter. It's not a panacea - we do mostly the second and some of the first.

 

[Ronen E]

The approach we've been using (combination of roles and document types) is complicated by documents that don't fit into one of the predetermined types.

Maybe I previously misunderstood your question.

In that sense, the regulatory expectation is - apart from not contradicting your own documented rules - that the person reviewing / approving a document has the relevant subject-matter expertise / knowledge / experience. In some cases it's obvious, for example an R&D manager signing off a verification protocol or a production line manager approving a work instruction within that line. Where the situation becomes more vague or sensitive, some orgs choose to formally qualify individulas for certain levels of "approval power".

Generally, the FDA expects that the approving individuals be competent. Whether such competence is demonstrated through the position they hold or otherwise is not a clear cut.