Design Review Participants - Medical Devices - Question

[Jim-S]

Hello,

My company is new to the medical device field. I've drafted a Design Review SOP to comply with 21 CFR 820 section 820.30(e). However, I've received some objections to the part of the requirement regarding "an individual (s) who does not have direct responsibility for the design stage being reviewed". - The party object to this requirement could not understand why they needed to have some unrelated person attend their meetings & suggested that they simply write an exception to this requirement in their Design Review minutes. They further stated that everyone in the company has a direct responsibility, so there is no way to really comply.

How do you handle this requirement? Can the attendance of Quality Assurance satisfy this requirement?

Thanks,
Jim

 

[MIREGMGR]

Re: Question Regarding Design Review Participants

We interpret "direct responsibility" to mean the individual engineer(s) who are specifically responsible for the aspects of the design that are being reviewed.

Lots of people have a share of overall responsibility for the device, but in our operations, only one person (typically) has direct responsibility for a given device aspect.

 

[Al Rosen]

It's good to have another engineer as part of the review to bring in an additional perspective. They can't just write an exception to the requirement. It's like saying that I'm going to exceed the speed limit because I think the limit is unreasonable.

They're both legal requirements.

 

[MIREGMGR]

Re: Question Regarding Design Review Participants

We interpret "direct responsibility" to mean the individual engineer(s) who are specifically responsible for the aspects of the design that are being reviewed.

Lots of people have a share of overall responsibility for the device, but in our operations, only one person (typically) has direct responsibility for a given device aspect.

Sorry to be unclear...my attempted point was that even in a company with a small staff and all the engineers having some involvement in every project, we (usually) define only one engineer as having "direct" responsibility for a given device element, per 21CFR820.30.

Thus the other engineers are unable to claim that loophole as an excuse to not participate in that design review...which has the effect that the engineering culture has much more technical critiquing participation, which improves our designs.

 

[Jim-S]

I was finally able to get the SOPs approved. However, this executive still doesn't want include anyone who is not directly responsible in the design reviews.

We had our first design review meeting yesterday, so I brought up the issue again. The executive argued that it didn't make sense for us to include some untrained "idiot" in the meeting who would have nothing to add & who might later get grilled by the FDA about the design. His argument went on for quite awhile & was all over the place, at one point even stating that he would rather take the issue to court than comply. – The end result is that we are kicking it up a level. He wants our Legal department to confirm the requirement before he will agree to comply.

 

[Stijloor]

I was finally able to get the SOPs approved. However, this executive still doesn't want include anyone who is not directly responsible in the design reviews.

We had our first design review meeting yesterday, so I brought up the issue again. The executive argued that it didn't make sense for us to include some untrained "idiot" in the meeting who would have nothing to add & who might later get grilled by the FDA about the design. His argument went on for quite awhile & was all over the place, at one point even stating that he would rather take the issue to court than comply. – The end result is that we are kicking it up a level. He wants our Legal department to confirm the requirement before he will agree to comply.

Is this "executive" responsible/involved in design reviews?

Stijloor.

 

[MIREGMGR]

What's the stance of the VP with supervisory responsibility for the engineering manager you're describing?

In your organization, are the engineers the subject matter experts regarding clinical product application? If not, does the individual in question regard those subject matter experts as "untrained idiots" as well? How about Quality/Regulatory, Sales and Production...more "untrained idiots"? How about when the customer/end user get involved during Validation...more "untrained idiots"?

Sounds like the individual in question has an ego problem.

 

[Al Rosen]

(e)Design review. Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. 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. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).

What part of that does he need a lawyer to interpret for him?

 

[Jim-S]

Unfortunately for me, this individual is the head of the department that owns our design control/design review processes. I agree that it seems like one of the simplest line in the regulations. I'm not sure exactly what his concern is and I have to question why exactly he would be trying so hard to limit the participants in the review. I guess that it must be an ego issue for him, because there would be no other reason to view the rest of the company as idiots who would have nothing to contribute. - The issue hasn't been resolved yet, but I am confident that one of the other executives will set him straight...I hope so.

 

[Jim-S]

Just to recap, this issue seems to have been resolved. We had a consultant on-site for some training on Friday and the executive brought the question up to the consultant. Of course, the consultant backed up what I had told him. I guess the consultant had the appropriate status to get his point across. The executive still was not happy, but he was no longer objecting to the requirement.