Must Batch Records be signed by Quality personnel?

evan_kim90

Involved In Discussions
Hi,

I am new to this industry and am learning a lot from it.
Recently, I got a question regarding some of our processes.

1. Does each batch record have to be signed by quality personnel? Or is it okay to be signed by a supervisor or manager in production? If we have to sign by quality personnel, which standards are based on? (ISO13485, MDR, or FDA)

2. How can we decide on sampling for verification? The FDA or ISO now want us to decide the sample number based on risk. But how exactly can we set the sampling number during verification or other processes?

Thank you and I hope I can get great idea from this discussion.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
We have QA sign to release batch records. Having production employees sign off creates a conflict of interest in my opinion.

Does your company have a statistical control SOP?
 

evan_kim90

Involved In Discussions
We have QA sign to release batch records. Having production employees sign off creates a conflict of interest in my opinion.

Does your company have a statistical control SOP?
Hi, thanks for your response.
Does the decision put QA sign in the batch record was related on standards requirements?
What does statistical control mean, like data analysis? We have a similar SOP that explains how we decide sampling for suppliers or how our data can be analyzed. But it is difficult to apply that SOP for setting the sampling amount for verification.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
7.3.6 Design and development verification
Design and development verification shall be performed in accordance with planned and documented
arrangements to ensure that the design and development outputs have met the design and development
input requirements.
The organization shall document verification plans that include methods, acceptance criteria and, as
appropriate, statistical techniques with rationale for sample size.
If the intended use requires that the medical device be connected to, or have an interface with, other
medical device(s), verification shall include confirmation that the design outputs meet design inputs
when so connected or interfaced.
 

yodon

Leader
Super Moderator
For question 1, what is the purpose of the signature? 13485 requires that a (batch) record be verified and approved. It's not prescriptive as to who is required to approve. There's a similar requirement in 21 CFR 820 for acceptance records (but again is not prescriptive as to who is required to sign). Also, what do your procedures say as to who signs off (and what the signature means)?

@Ed Panek covered question 2.
 

evan_kim90

Involved In Discussions
For question 1, what is the purpose of the signature? 13485 requires that a (batch) record be verified and approved. It's not prescriptive as to who is required to approve. There's a similar requirement in 21 CFR 820 for acceptance records (but again is not prescriptive as to who is required to sign). Also, what do your procedures say as to who signs off (and what the signature means)?

@Ed Panek covered question 2.
Hi, Thanks for the knowledge you shared.

Just for clarification, our batch record (each process) requires signatures from the assembly and supervisor. But the final release has to be done by QA.
I just want to know if any standards require QA signatures in the batch record or not for quality purposes. So, as per your advice, there is no clarification that QA should sign in batch record.
 

Philip B

Quite Involved in Discussions
Quality don't sign off our batch records. They do sign off final product release however, which includes a review of the batch record.
 
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