Quality Plan for Gene Sequencing Operation

J

JackD

#1
I work for an orginization that is building a device for gene sequencing. We expect to one day attain certification to ISO 13485 but at this point our quality system is in the earliest stages of development. Hence very few procedures have been developed thus far. I'm tasked with trying to write a very general, high level Quality Plan to satisfy a requirement to get a UL label. Can anyone provide an example of what such a Quality Plan would like like?? Thanks!

Jack
 
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BradM

Staff member
Admin
#2
Re: Quality Plan

Hello Jack!

Welcome to the Cove!:bigwave:I'm glad you found us.

The first thing that comes to mind is ISO 9001. The framework provided by the standard would be a great place to start. Making sure each of the components are addressed will get you on down the road a bit.

You will probably want to address developing a validation master plan covering the facility, equipment, and processes. If you are not familiar with validation, You will find a lot of excellent information on validation among the Covers here. The search function will help.

It might help us to give us an idea regarding your level of experience/expertise with quality systems and the pharmaceutical industry. That way we're not talking down to you, nor confusing you on terminology.

Look forward to hearing more from you.

Added: Jack, I relabeled the title. Let me or another moderator know if it does not work for you.
 
Last edited:

Ajit Basrur

Staff member
Admin
#3
I work for an orginization that is building a device for gene sequencing. We expect to one day attain certification to ISO 13485 but at this point our quality system is in the earliest stages of development. Hence very few procedures have been developed thus far. I'm tasked with trying to write a very general, high level Quality Plan to satisfy a requirement to get a UL label. Can anyone provide an example of what such a Quality Plan would like like?? Thanks!

Jack
Hi Jack,

Welcome to the Cove :bigwave:

Brad has rightly guided you on the right track. To add on to Brad's point, the requirement for Quality Plan is defined in 21 CFR Part 820 under section 820.20 (d) titled Quality Planning which reads as "Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met."

Refer to this post for more info - http://elsmar.com/Forums/showpost.php?p=160488&postcount=7
 
J

JackD

#4
Re: Quality Plan

Brad

I have a pretty fair amount of experience in quality (17 years) that covers pharmaceuticals, biologics and medical devices. I've been through two ISO audits the most recent of which was under ISO 13485. The type of Quality Plan I'm more familiar with could almost be referred to as a project plan that's more product specific in the sense that it would call out many documents that have been approved (or at least drafted). But we're so early in the process of building our quality system that very few documents have been created. Hence I've been told to try and keep it as general (and high level) as possible. It's needed because we are building a next generation gene sequencer we want a UL label for. I've been told that UL will want to audit us before allowing us to use their seal of approval and one of the things they'll be looking for is a Quality Plan. That's the conundrum I find myself in!

Jack

P.S. It's a pleasure to be here!
 

Jim Wynne

Staff member
Admin
#5
Re: Quality Plan

Brad

I have a pretty fair amount of experience in quality (17 years) that covers pharmaceuticals, biologics and medical devices. I've been through two ISO audits the most recent of which was under ISO 13485. The type of Quality Plan I'm more familiar with could almost be referred to as a project plan that's more product specific in the sense that it would call out many documents that have been approved (or at least drafted). But we're so early in the process of building our quality system that very few documents have been created. Hence I've been told to try and keep it as general (and high level) as possible. It's needed because we are building a next generation gene sequencer we want a UL label for. I've been told that UL will want to audit us before allowing us to use their seal of approval and one of the things they'll be looking for is a Quality Plan. That's the conundrum I find myself in!
By definition, a quality plan is a high-level document, whether the target is a particular product or a company strategy. It might be helpful to disregard the UL bit and think in simple terms of the system you need. Start at the beginning, and work your way to the end by way of the middle. For example:
  • Design control
  • Basic infrastructure requirements (machines, people, space, etc.)
  • Supplier selection and development
  • Test requirements
  • Inspection requirements
  • Customer interfaces
The list isn't intended to be exhaustive, but in short you need to consider and have a plan for all of the elements of design, manufacture, testing, etc. that might contribute to product quality.
 
R

Roland Cooke

#6
I'll preface this first by saying that electromedical devices is not my specialist area, other more experienced Covers can correct me if I go offtrack at any point.

The global requirement is to demonstrate compliance to IEC601-x / IEC60601-x.

The "UL Mark" is pretty much set in the public conscious as evidence of compliance. I have no idea of the history here, but clearly there was eventually an issue with a commercial company having a virtual monopoly over the provision of a testing service.

So other organisations can also offer testing to those standards, and I believe that they can also offer the UL mark.

So you should definitely shop around for the testing organisation that best meets your requirements.


But the requirement to demonstrate electromedical safety is of course different to the additional requirement to have an ISO13485 (and/or FDAQSR) compliant quality system in place. After all a DNA sequencer can be perfectly safe, whilst failing to actually sequence correctly!


So as the electromedical testing will be additional in any event, the bottom line is not to get solely fixated on achieving evidence of electromedical safety, it is only part of what you will need to do.

Thus your ISO13485-compliant system should include the plans and processes required to create and maintain a design control system that includes achieving evidence of electromedical safety, as one part of the overall design programme.

I would advise starting at the very top, flow-mapping a strategic overview of the key processes within the organisation, and then cascading flowmaps downwards as things start to take shape within the organisation.

You should be able to map your critical design control flowpath at a relatively early stage, to get you off to the best possible start.

Of course if the machine is already built, (i.e. without having design control procedures in place) it is possible you will have some sizeable holes in your quality systems evidence. You should definitely create the procedures anyway, and do a Gap Analysis to ensure that the design programme (as was) can be justified as having been adequate. If it can't, then you will be able to do some corrective action to patch any holes.

Obviously any design work that is going on at the moment, especially design validation and design transfer operations, should certainly be done against robust procedures .

Design transfer would include the various quality plans required to manufacture the device on a routine basis.
 

Manix

Get Involved!!!
Trusted Information Resource
#8
ISO10005:2005 is an invaluable piece of guidance on the preparation of Quality Plans, especially in the sense of product realisation.

I would reccomend getting a copy of this to help you develop a standard format that can grow as your QMS does.

It's also a great way of ensuring you consider all the aspects that ISO9001 considers in it's process approach.

Hope that helps, I am currently looking at Quality plans as part of an assignment I am doing, so I maybe able to help with any questions you may have!
 
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