Quality Record Retention Time - ISO 9001 vs. CFR 820.180(b)

I don't directly deal with supplier/customer relationships or contract manufacturing but it might just be a case of "[your] customer is always right." If they define 'life' as seven years, or just demand retention as a part of your service, you probably have to do it.

On the plus side, it's all those medical device requirements that keeps the competition down.

For us it means a lot of cardboard 'banker's boxes' to hold the records.

Alf

I too am intwerested in this thread, extra info. I service amd MFG several medical companies like Inviro, BD here at this plant. We deal with 3-4 more medical companies in our Janpan plants. The more I learn the better off we become as a team.

Dear Monica!!

Take into account that FDA look for legal compliance and productor responsibilities.
In case of liabilities with your product (such defects during use or others) your records are your protection against enforcement. (Look case Johnson with Tylenol).

Again, you must to keep your record during at least the shelf life of your product plus normaly one or two years.
Is on your interest, not in the registration of QMS.

Good luck

Quality Records Retention

As a contract manufacturer of medical devices, we have been 'round and round' on this topic. Our customers have never informed us of the life of the products we manufacture for them, and haven't responded on the subject when we have asked them directly. So, I have sent out a letter stating that we retain records for seven years and asked that they sign if they approve of the policy. I will report back as to how the letter is received.

Q Recordd Retention - Medical Device

Monica,

Intraocular lenses are medical devices that due to the nature of their production process and packaging, contain an expiration date. Expiration dating for these types of devices, by manufacturer can be attained on the FDA's CDRH MAUDE web site by reviewing the regulatory approval letter sent by the FDA to the company in order to market the product. Depending on the device, check either under the PMA or 510K section by company name.

For your part, unless you can demonstrate otherwise, you'll need to use the expiration duration (generally 3 years) from the company you sell to, then add the 2 years beyond that. Most company's use a 3 year expiry because the stability studies (even accelerated) to go longer generally take longer then the product life cycle before it needs to be changed.

The Q records that have to be retained would be anything that demonstrates the the methods of quality and control for the activities that your company provides. Things like raw material receipt and approval, processing records, testing records, calibration records, and relevant employee training on how to do all of the above. Key to this is having a clear specification for shipment that has acceptance limits, test methods, and sampling plans included.

Because IO lenses are implantable devices, the supplier assurance program of your customer should be under pretty tight scrutiny from their compliance department. You may want to draft a list of what you consider to be the documentation and for what duration your company will retain it, and then secure agreement with your customer's QA group. That way there's no confusion should an issue occur downstream.

Dave Gronostajski

Important to read the preamble.

From the preamble:
"181. A few comments on Sec. 820.180(b), ``Record retention period,'' stated that the section should be amended because all quality records may not be tied to a specific device; therefore, such quality records may not need to be maintained over the lifetime of a device. A few comments stated that the retention period requirement is unclear and burdensome, while others stated that the period should be left to the manufacturer to define. One comment suggested the deletion of the requirements related to photocopying records in proposed Sec. 820.180(b) because it is technology that is not necessarily being used.
FDA believes that all records should be retained for a period equivalent to the design and expected life of the device, but in no case less than 2 years, whether the records specifically pertain to a particular device or not. The requirement has been amended to make clear that all records, including quality records, are subject to the requirement. FDA believes this is necessary because manufacturers need all such records when performing any type of investigation. For example, it may be very important to access the wording of a complaint handling procedure at the time a particular complaint came in when investigating a trend or a problem that extends to several products or over an extended period of time. Further, FDA does not believe that allowing the manufacturer to define the retention period will serve the public's best interest with regard to safety concerns and hazard analysis."

Note the regulation states design AND expected life of the device, but in no case less than 2 years.

In addition section Sec. 820.186 Quality system records add additional requirments.

In most cases this means QS record retention beyond shelf life. The regulation is very specific about what records to keep just do a quick search for shall be documented on the attached file.