Who should document the Design Review Meeting and Design History File?

[regfocus]

Hello,

May I ask who should document the Design Review Meeting and Design History File, Design Master Records in medical device company please?

For example, if one medical device company has plan to design a new medical device product, and it has medical device product manager and QA/RA manager, who should document the Design Review Meeting and Design History File, Design Master Records, etc?

My understanding is QA/RA manager should ask and require the product manager to document these files and provide them to QA/RA manager as records. I am not sure if my understand is right.

 

[George Weiss]

Greeting thread poster,
.
Having a chain of signatures, from the design department, where the technical skills develop the design, and then later the QA/QC department, would be a conventional course, all written in your QMS procedure right?. Just like all processes, procedures, SOPs etc.
This should be reflected in your ISO 13485 QMS in the area of interest. Sub-clause 7.3.4 design review
Don’t forget the Risk Management ISO 14971
For the meeting, there is no requirement, but a list of attendees and signatures. See page 46 @
http://www.ghtf.org/meetings/conferences/4thapec/4_APEC_SG3_ISO13485%20Introduction%20KL%202008-Gunter%20Frey-Hideki%20Asai.pdf
FDA 21 CFR 820.30 requires formal reviews, suggesting meetings
ISO13485:2003 and FDA 21CFR820 cross references @
http://www.compliance-alliance.com/wp-content/uploads/2010/05/Kimmelman-Chart.pdf

 

[maxenix]

In my company:
The Product Manager bears overall responsibility for successful management of the development program and establishing and maintaining the Design History File.

QA/RA manager is responsible for assuring the quality of the product design process, the manufacturing process, the product, and all phases of the Product Development Cycle. QA/RA manager is responsible for maintaining required hard copies of Design History File documents and design history archives of completed product development programs.

 

[regfocus]

Maxenix, thank you so much! BUT I am still unclear.

In a product development phase, which task QA/RA should do and which task product manager should do? It's a headache!

For example, who should draft the design plan, validation and verification report, DHF and DMR? Keep document is easy but draft the document is time consumable.

In my company:
The Product Manager bears overall responsibility for successful management of the development program and establishing and maintaining the Design History File.

QA/RA manager is responsible for assuring the quality of the product design process, the manufacturing process, the product, and all phases of the Product Development Cycle. QA/RA manager is responsible for maintaining required hard copies of Design History File documents and design history archives of completed product development programs.

 

[George Weiss]

The question of who should will very from org to org. You are the quality gate keeper, and knowing you are not responsible for generating all of these documents is the first step. Your involvement is not excluded. You are an interested facilitator. Getting agreement after the fact is harder than before. This will encourage that in future plans, to have these responsibilities listed in your QMS. It sounds like "meeting time" with the boss, and asking for before-meeting plea-bargain option(s) with likely suspects.
The design manager knows the in-n-outs of the product so should clearly he should be involved in the process, process validation, and verification planning. Where this crosses into quality methods and regulations the QA/QC department should be involved. It is a group/team effort.
An idea:

Develop a procedure for this process:

1. QA/QC generates/provides required generic process, procedure, validation, verification templates, and time lines to complete.
2. Design manager has to refine and fill out the specifics.
3. Performing design analysis, (risk, sustainability, etc), is to be decided.
4. QA/QC has to review

 

[maxenix]

I agree with george1weiss: it is a group/team effort, and the Product Manager bears overall responsibility about design plan, validation and verification report, DHF and DMR, but the QA/QC department should be involved in those phases.

The question of who should draft those documents is very from org to org, in my company : QA/QC is responsible for design review, and only responsible for validation and verification report drafting.

 

[sreenu927]

The design review meeting minutes, in general, will be authored by product manager, where by QA/RA person will be one of the attendees.

Once completed the report, it will be reviewed by QA/RA and to release the document, RA is one of the approvers, following the documentation procedures(SOP) or project phase procedures.

DHF and DMR, depending upon the formats (either just index and referencing the document numbers or the complete DHF and DMR), it will be written by product quality team member (PQ) or RA person. It is less frequent by the product manager.

Regards,
Sreenu

 

[sagai]

Anything is okay, if it fulfills the requirement according to cGMP.
for DR, 21cfr820.30(e)
"
The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed.
"
and also 820.25(b) can come into picture in general:
"
(b)Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.
"

br
Sz.

 

[gholland]

The short answer might be 'what do your procedures say?'

We are moving to a system where the attendees review the meeting minutes and then any changes to the minutes are documented by the Quality representative. The minutes then get submitted to the document control folks for approval, the Quality Rep and the Project Manager at a minimum are required for approval. The number of 'approvers' is small while the number of 'reviewers' includes everyone that attended the meeting or their delegates. Other folks can be added as needed.