Can Regulatory Head Initiate/Trigger the Change Control for Quality Procedures

v9991

Trusted Information Resource
#1
Considering that roles of head of quality & regulatory functions are with separate persons.
can head of RA, initiate the change control for modifying/updating a quality procedure. (viz., change control)

my opinioin is Yes, "initiating/triggering quality procedure ( change control or for that matter any procedure" can be done by any one. (especially at head of function role)

the counter opinion is that, change control SOP belongs to QA, hence RA cannot initiatie/review the change control initiated for modifying the CC-procedure.

your thoughts plz
 
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T

t.PoN

#2
I think anyone can suggest a change or even draft a procedure, but the not anyone can authorize the change.

I think he can submit a feedback, but the final review and authorization will rest with QA as per your procedure I assume.

However, Initiating a change in a procedure may require the assembly of multi-functional team or technical experts. in this case you need someone with authority to summon these expert. It goes in enterprise managment of resources and time. which might not be within the ability of RA
 

Marc

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#3
Considering that roles of head of quality & regulatory functions are with separate persons.
can head of RA, initiate the change control for modifying/updating a quality procedure. (viz., change control) <snip>
Typically companies have their internal system(s) (e.g.: document control) define who can actually make a change to a document. As to who can initiate a change, it is common for any employee to suggest or request a change. In a well run company their internal system(s) define the process for an employee to request or suggest a document change. This is usualy done through some type of "Change Request" system.

It is common for different people to have control over documents their functional area covers ("local" document control) so it's not unusual for different people in a company to be responsible for actually making a change to documents they have a responsibility for.

In your case (depending on how your procedures are written) if you have "local" document control (such as by department) if the regulatory person wants the QA department to change a document QA is responsible for, the regulatory person would probably have to request that QA make a change.
 

v9991

Trusted Information Resource
#4
I agree with t.PoN and Marc, QA;s role/authority(responsiblity) to carry-out/own the changes (...for a QA procedure, in this case Change control procedure)

However, Initiating a change in a procedure may require the assembly of multi-functional team or technical experts. in this case you need someone with authority to summon these expert. It goes in enterprise managment of resources and time. which might not be within the ability of RA
I believe that, RAs ability about initiating a change is not in question, in fact they can dictate/recommend changes to meet respective regulatory requirements/directions. when RA can influence the change through appropriate feedback, whey cant they intiate the change?

In your case (depending on how your procedures are written) if you have "local" document control (such as by department) if the regulatory person wants the QA department to change a document QA is responsible for, the regulatory person would probably have to request that QA make a change.
now there is a section of team who thinks that RA has a recommendation, but still they cannot initiate the change control form? they might provide feedback/review comments....and QA has to initiate the change control form, because CC is QA procedure? :confused:
 
#5
There is the need for the macro understanding of the organization requirements, when many times this gets camouflaged by petty departmental issues. There is always the inner focus that blurs the bigger focus and this must be broken as and when it arises .....
 

Marc

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Leader
#6
<snip> now there is a section of team who thinks that RA has a recommendation, but still they cannot initiate the change control form? they might provide feedback/review comments....and QA has to initiate the change control form, because CC is QA procedure? :confused:
If I am QA and there is a QA procedure that the RA department wants change, the RA department *requests* a change. How you define the word "initiate" is the key. If your definition of "initiate" is a "Request for Change", then the RA person can do that.

It really depends upon how the company's document control procedure is worded.
 
K

kgott

#7
Typically companies have their internal system(s) (e.g.: document control) define who can actually make a change to a document. As to who can initiate a change, it is common for any employee to suggest or request a change. In a well run company their internal system(s) define the process for an employee to request or suggest a document change. This is usualy done through some type of "Change Request" system.

It is common for different people to have control over documents their functional area covers ("local" document control) so it's not unusual for different people in a company to be responsible for actually making a change to documents they have a responsibility for.

In your case (depending on how your procedures are written) if you have "local" document control (such as by department) if the regulatory person wants the QA department to change a document QA is responsible for, the regulatory person would probably have to request that QA make a change.
Change requests are fine in as far as they go but management rarely issue change requests, they tend to issue instructions.

I think what the OP is asking is where does the QA person sit regarding the ability to say no relative to where the RA person sits in the power structure.
 

Marc

Fully vaccinated are you?
Leader
#8
Doesn't matter where they are in the org chart. Their document control procedure should define who can do what and how.

I once worked at a place where there was one big document control department. Every document went through it no matter who the owner. It even controlled every "document of external origin" including customer prints, specifications - You name it, you had to go through them and it had to be in their system. They, of course, had a system/procedure for handling all requests for new documents, document revisions, etc.

That is one of the problems when questions like this come up. Every company has their own way of controlling documents and records. Their relevant system/procedure(s)/process map(s) should define responsibilities and authorities.
 
#9
change control SOP belongs to QA, hence RA cannot initiatie/review the change control initiated for modifying the CC-procedure.
Any SOP is the company's SOP. If a learned person in a corner reviews and initiates a change, it is always worth looking into.
 
T

t.PoN

#10
I think requesting a change is different from revising a document.
It happens all the time that an employee or external party think they may found a problem with a document. so they request a change with specific recommendation. but when the suggested changes are reviewed by QA a better or different approach to solve the problem was adopted.

the different approach could be a different revised text from the suggested or even having the document stays the same and the QA took the full responsibility after getting a third opinion.
 
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