Where to begin - creating a Quality Plan for Class I Medical Device

If there is an existing thread that addresses this, I must have missed it somewhere. I did find a draft of a quality plan in the Post Attachments List, though, and think I can use it as a guide.

What I need is some advice and direction in developing this quality plan. I've never done one before (previous life it was done at the corporate office by someone else) and don't really know how much info should be included. What information goes into one? How detailed does it need to be?

Here's a little bit of background info on our device: it's not a "finished product", as the customer adds another layer to it and our name is not anywhere on it. This product is not advertised in our marketing literature, and sales are strictly word of mouth.

If anyone has done one of these before and can offer some suggestions, I would be most appreciative.

Thanks!

Hello Gidget!

As you well know, weekends are a bit slow here at the Cove. So hopefully, on Monday the input will increase.

Are you required to perform any validation on the product?

Will you be doing design verification/design review? Exactly what will be the scope of the quality plan and will it include any submissions/testing/etc.?

Will you be subject to FDA audit/scrutiny, or will that come through the customer that you are making the WIP for?

I don't have expertise in this, but I'll at least try to help!

BradM said:

Hello Gidget!

As you well know, weekends are a bit slow here at the Cove. So hopefully, on Monday the input will increase.

Are you required to perform any validation on the product?

Will you be doing design verification/design review? Exactly what will be the scope of the quality plan and will it include any submissions/testing/etc.?

Will you be subject to FDA audit/scrutiny, or will that come through the customer that you are making the WIP for?

I don't have expertise in this, but I'll at least try to help!

Click to expand...

Hi Brad!

Well, I thought that since I was working this morning, maybe some other Covers might also be doing the same.

Let's see if I can answer your questions...Validation on the product? No, not to my knowledge.

Verification/design review? Nope. We make the product on an "as needed" basis and periodically send it off for testing. I'm not sure if a 501(k) submission was done since this is not a finished product and our name is not on it anywhere (not sure if a submission is required, that is). However, I can find out for sure on Monday.

As for FDA scrutiny, I would think that this product is pretty low on the radar screen of the FDA. We do maintain a Device Master Record and Device History Files on this product, though, as well as meeting the other requirements of ISO 9001:2000 and ISO 13485:2003.

Does this help? If you need additional details, please PM me and I'll try to answer as best I can.

Thanks!

Since you are a component manufacturer, you will not do 510(k) nor are "oficially" covered by 21 CFR 820. FDA puts your customer (the maker of the finished device) as the responsible party. If the device is sold in US only, ISO 13485 is a reference but not a requirement to FDA. Your customer will have a lot to say about your product which is part of their finished device. I would have a good dicussion wih my customer if i were you. My guess is you might end up largely doing the "standard" quality plan, which is to build it within the scope of ISO 13485 or 21 CFR 820 with levels of ducments, but exempted from irrelevant sections such as design control.

I would start from drafting a level 1 quality document and getting the customer's input.

GStough said:

If there is an existing thread that addresses this, I must have missed it somewhere. I did find a draft of a quality plan in the Post Attachments List, though, and think I can use it as a guide.

What I need is some advice and direction in developing this quality plan. I've never done one before (previous life it was done at the corporate office by someone else) and don't really know how much info should be included. What information goes into one? How detailed does it need to be?

Here's a little bit of background info on our device: it's not a "finished product", as the customer adds another layer to it and our name is not anywhere on it. This product is not advertised in our marketing literature, and sales are strictly word of mouth.

If anyone has done one of these before and can offer some suggestions, I would be most appreciative.

Thanks!

Click to expand...

To my way of thinking a quality plan is a structured way of showing how you intend to comply with your customers requirements. I would take a good look at the requirements (make a simple matrix) and then I would see where in your quality system you adress the points of the requirements. Most of them will normally be covered by what you already do. If there are any outstanding issues when you have finished the matrix - ie. issues that are not covered by your system - then all you have to do is determine how you will adress the issues. All of this should be formalized and presented to the customer + your management in case there are requirements that are new to your organization.

That's what I would do

GStough said:

Here's a little bit of background info on our device: it's not a "finished product", as the customer adds another layer to it and our name is not anywhere on it. This product is not advertised in our marketing literature, and sales are strictly word of mouth.

Click to expand...

If its not a finished device, you should not be calling as "Class I". The classification comes only for a finished device.

Gert Sorensen said:

To my way of thinking a quality plan is a structured way of showing how you intend to comply with your customers requirements.

Click to expand...

Yes, Gert. I totally endorse your views. Quality Plan lays a good foundation for defining various quality requirements.

Gidget,

I don't think I was much help at all here, but the others were excellent. Did you get the resolution to developing a quality plan, or do you still have some questions?

BradM said:

Gidget,

I don't think I was much help at all here, but the others were excellent. Did you get the resolution to developing a quality plan, or do you still have some questions?

Click to expand...

Hi Brad!

Yes, I meant to post on this thread today in follow-up. After reading the other suggestions/advice posted by fellow Covers, I realize that this may not be a necessary document for our product at this time. And, as our annual surveillance audit is quickly approaching, I can spend this chunk of time working on something else instead!

Thanks, everyone, for your help!