Verification and Validation Report Writing

D

DaisyMae

#1
How important is the audience when wrtiting a design verification/validation report?

My responsibility is to review reports from a regulatory compliance perspective and I get alot of push back when I request a change specifically if the change will make the document read easier and the flow more logical. Some of it is simply poor grammer, some of it is overuse of engineering terminology and some of it is them thinking that everyone thnks the same way they do or that the information is implied/assumed. i.e. For each acceptance criterian I expect a corresponding result.

They are not very happy with me at the moment. How can I help them to at least appreciate, at some level, the audience without further frustration on all our parts? Thanks
 
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S

Sarge

#2
Re: Verification/Validation report writing

Hello DaisyMae,

Please correct me if I’m wrong but it sounds like you are writing a report for internal use based on information provided by another source. Is that correct?

I work in the validation/verification of our company’s product and when faced with a situation like this, we write a report based on the audience, attaching and referencing the findings of the other source. In that case we are not changing the findings or the initial report. We are just interpreting the data.

Regards,

Sarge
 
D

DaisyMae

#3
Re: Verification/Validation report writing

Thank you for the prompt response it is much appreciated :D. You are correct it is an internal report but the data it is based on is also internally generated. Specifically, these are Design verification/validation reports for a medical device. They are written by the engineers based on data derived from tests they have performed. I am one of many reviewers.
 

yodon

Staff member
Super Moderator
#4
Re: Verification/Validation report writing

Poor grammar and overly-techie verbiage won't get you a 483. Having acceptance criteria without objective data showing it was met will. I would suggest you not push too hard on the minors and stand firm on meeting regulations.
 
T

torre

#5
Just write a detailed check list with the acceptance criteria for those V&V reports. After being published as part of your QMS , it will help them to understands what your expectactions are regarding the contents of those reports.
 
B

brahmaiah

#6
How important is the audience when wrtiting a design verification/validation report?

My responsibility is to review reports from a regulatory compliance perspective and I get alot of push back when I request a change specifically if the change will make the document read easier and the flow more logical. Some of it is simply poor grammer, some of it is overuse of engineering terminology and some of it is them thinking that everyone thnks the same way they do or that the information is implied/assumed. i.e. For each acceptance criterian I expect a corresponding result.

They are not very happy with me at the moment. How can I help them to at least appreciate, at some level, the audience without further frustration on all our parts? Thanks
Your problem indicates one or both of the following reasons;
No.1 :You have not been fully entrusted with the requisit authority to perform your duties.
No.2;You have not been trained and sufficiently experienced in the job.
You have to find suitable remedy in the circumstances.
These are not personal remarks against you but purely academic analysis of your problem.
V.J.Brahmaiah
 

Stijloor

Staff member
Super Moderator
#7
Your problem indicates one or both of the following reasons;
No.1 :You have not been fully entrusted with the requisit authority to perform your duties.
No.2;You have not been trained and sufficiently experienced in the job.
You have to find suitable remedy in the circumstances.
These are not personal remarks against you but purely academic analysis of your problem.
V.J.Brahmaiah
What would you suggest to remedy this issue?

Stijloor.
 
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