A
auclairdiana
I'm working in a start up medical device and I'm trying to determine if job descriptions and org. charts are considered to be controlled documents. If so, is it Quality's responsibility to control those..
Thanks
Thanks
Are Job Descriptions and Organizational Charts Controlled Documents?
D
db
Re: Job Descriptions and Org. Charts
Two questions to be answered.
1) Are they mandated? Neither one is required. They might be good ideas, but they are not mandated. So IF you decide they would be necessary or useful, then ask question #2.
2) Does the information have to be accurate? I would think that it would be important that both (or either one if you only have one of them) have the correct information. An outdated org chart or outdated job descriptions are not too useful. So, I would say that if you are going to have them they do need to be controlled documents.
Two questions to be answered.
1) Are they mandated? Neither one is required. They might be good ideas, but they are not mandated. So IF you decide they would be necessary or useful, then ask question #2.
2) Does the information have to be accurate? I would think that it would be important that both (or either one if you only have one of them) have the correct information. An outdated org chart or outdated job descriptions are not too useful. So, I would say that if you are going to have them they do need to be controlled documents.
A
auclairdiana
Re: Job Descriptions and Org. Charts
Our training program states that training requirements are developed from a job description, so I am assuming that would mean they'd be controlled. The Org. chart demonstrates Executive Management and designates the Management Representative. So, would/should that be controlled??? I'm just not clear on how to proceed. I have enough to do to get our quality system in order before our initial assessment for CE marking, so if I don't have to worry about these documents within the quality system I won't. I just don't want to have a hole either...
Our training program states that training requirements are developed from a job description, so I am assuming that would mean they'd be controlled. The Org. chart demonstrates Executive Management and designates the Management Representative. So, would/should that be controlled??? I'm just not clear on how to proceed. I have enough to do to get our quality system in order before our initial assessment for CE marking, so if I don't have to worry about these documents within the quality system I won't. I just don't want to have a hole either...
A
adickerson
Re: Job Descriptions and Org. Charts
If you are using them in they way you describe they should be controlled documents. However, jsut becasue they are controlled there is no need for these to be "quality department" documents. The HR department could be tasked with making these. Not all controlled documents need to be centralized. In fact in many cases it is best if you get other departments to manage their own document control program.
If you are using them in they way you describe they should be controlled documents. However, jsut becasue they are controlled there is no need for these to be "quality department" documents. The HR department could be tasked with making these. Not all controlled documents need to be centralized. In fact in many cases it is best if you get other departments to manage their own document control program.
A
auclairdiana
Re: Job Descriptions and Org. Charts
Great, now I guess I just have to get HR buy-in
Thanks so much!
Great, now I guess I just have to get HR buy-in
Thanks so much!
Re: Job Descriptions and Org. Charts
Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization.
So let the top management ensure that HR knows this and is competent to handle this task.
(read the 5.5.1 in its entirety)
Remember that you are dealing with regulatory requirements in medical devices, and must respect any such as said in the NOTE of 5.5.1
It will be a good point if you extend this to the organization chart as well. They just compliment each other.
Just remember that ISO13485 at 5.5.1 states in the opening para:Great, now I guess I just have to get HR buy-in
Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization.
So let the top management ensure that HR knows this and is competent to handle this task.
(read the 5.5.1 in its entirety)
Remember that you are dealing with regulatory requirements in medical devices, and must respect any such as said in the NOTE of 5.5.1
It will be a good point if you extend this to the organization chart as well. They just compliment each other.
G
gholland
I believe job descriptions are not explicitly mandated but reading Section 6.2:
[FONT=Arial,Bold][FONT=Arial,Bold]
[FONT=Arial,Bold][FONT=Arial,Bold]6.2.2 Competence, awareness and training
[/FONT][/FONT]
I believe job descriptions would fulfill these requirements. They should be controlled by your doc control system. They aren't Quality's responsibility to create/maintain but if they don't exist Quality should be throwing the flag.
Org charts are required by FDA (21CFR 820.20) but 'establishing and maintaing an orgazational structure' doesn't appear in 13485 that I can see.
[FONT=Arial,Bold][FONT=Arial,Bold]
6.2.1 General
[/FONT][/FONT]Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.
[FONT=Arial,Bold][FONT=Arial,Bold]6.2.2 Competence, awareness and training
[/FONT][/FONT]
The organization shall
a) determine the necessary competence for personnel performing work affecting product quality,
a) determine the necessary competence for personnel performing work affecting product quality,
I believe job descriptions would fulfill these requirements. They should be controlled by your doc control system. They aren't Quality's responsibility to create/maintain but if they don't exist Quality should be throwing the flag.
Org charts are required by FDA (21CFR 820.20) but 'establishing and maintaing an orgazational structure' doesn't appear in 13485 that I can see.
sagai
Quite Involved in Discussions
There was a warning letter item I remember about the company was not selected the employee according to the position's description, it was the reason I consider it as a mandatory document.
There is also statement, I would not recall exactly, about that the organization shall ensure the necessary resources, and how would it do if there is no definition for them.
Org Chart also was requested from us on the course of external audit. I think we have had a nice minor finding based on that, I shall admit, I agree.
br
Sz.
There is also statement, I would not recall exactly, about that the organization shall ensure the necessary resources, and how would it do if there is no definition for them.
Org Chart also was requested from us on the course of external audit. I think we have had a nice minor finding based on that, I shall admit, I agree.
br
Sz.
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