Warehouse storage and pest control - include in risk file?

[ThatSinc]

Hi All,

I'm in a situation where I'm being told "that doesn't need to go in the risk file" and whilst it's something I would consider very important, I'd like some opinions.

A sterile product is packaged in its primary packaging and undergoes the sterilization process - it is then stored in its primary packaging in open trays in the controlled warehouse.
The instructions with the product are to clean hands prior to opening the sterile packaging, and then to use the device, which is in contact with a mucosal membrane/body orifice.

The warehouse has a pest control program in place, to ensure no pests can contaminate the product (obviously).

My logic is that this is a risk control, to control the biological hazard of any potential infectious agents that could be present on any pests, that could be transferred to the outside of the sterile barrier, onto the clean hands of the user, onto the device, and then back onto the user, which could cause infection.

I understand that the probability of occurrence of the hazardous situation and harm is low, and further reduced by the pest control program, but to me this seems like an obvious risk that's being controlled and should be recognised as such, particularly in the event that they are making changes to the pest control program for any reason. Am I being "overly cautious" for wanting to include this in the risk file?

Thanks,

TS.

 

[Steve Prevette]

Just as temperature and humidity controls for a warehous may be important to product quality (and thus should be in the risk matrix, if lack of pest control could reasonably cause an issue in safety, quality, or monetary damage, then I'd support including it.

Perhaps it is not a risk - as 4.4 Sterile Fields – Nursing Skills. addresses how to open and handle a sterile package. For example this link says:

• Before dispensing sterile supplies to a sterile field, do not allow sterile items to touch any part of the outer packaging once it is opened, including the former package seal.
• Heavy or irregular items should be opened and held, allowing a second person with sterile gloves to transfer them to the sterile field.

So if you figure that whomever is going to handle these items takes these precautions, perhaps it is not a risk. Still, if a camera crew got in a took pictures of rats running around your warehouse, that would at least be a public preception issue.

 

[ThatSinc]

o if you figure that whomever is going to handle these items takes these precautions, perhaps it is not a risk.

Lay users.


From a public perceptions risk, if there was absolutely no risk to the end product - I may not consider it in the product risk assessment, but I would still have it as a business concern.

 

[johncharles]

You have a pest control program. If there is a potential issue with pests and your product, it doesn't belong in the risk file but shows a need to review and revise your pest control process.

Pest control is a 13485 requirement. Would you include having a CAPA process or management review in your risk file? All QMS activities mitigate risk for the product or processes of the business, and it doesn't make sense to include one but not all of them.

 

[ThatSinc]

Pest control is a 13485 requirement.

you'll have to refresh my memory on which clause says you have to have pest control..

It says you have to control your infrastructure and also have to document requirements for cleanliness of product, but at no point that I can see does it say you have to have pest control.

The implementation of a pest control program is an OUTPUT of a process for controlling the infrastructure and maintaining the cleanliness of product, if you determine as a part of your requirements that the product needs to be maintained in a particular microbial state.

I've worked with a few companies that have sterile products but no pest control program - they still have it in their risk file that there's a risk of infection in the case of the product being contaminated, either inside or outside of the sterile barrier, depending on the process for using the product when removing it from its sterile barrier.
However, these are controlled through third party processing. All primary manufacturing activities occur at the site with no pest control program, and all cleaning, sterilising, packaging, and shipping activities are performed by a third party that has a pest control program and clean room facilities.

The clean room facilities are also an OUTPUT of the infrastructure process.

Would you include having a CAPA process or management review in your risk file?

No, but I would certainly include the OUTPUTS of these processes, where applicable, within the risk control file.
ISO 13485 says you have to document design outputs, as an output of 7.3.4, these are most definitely things I would include in the risk management file.

If there is a potential issue with pests and your product, it doesn't belong in the risk file

TR24971 includes the guidance that risk controls may be applicable in other lifecycle phases, including storage and distribution




i.e. if the product can become contaminated during storage and/or distribution, and the method of use would reasonably expose the user to that contamination, it is a risk to patient health.
As such it is a prime candidate for the risk file.
This is why implants come double, or triple, barriered - the exterior sterile barrier is sanitised by hospital staff prior to an aseptic transfer of the internal sterile barrier into the operating theater's sterile field. This is then opened and transferred to the surgeon for use.
The risk of contamination of the external surface (through storage and distribution) is acknowledged, and controlled by the double/triple barrier.

The devices in question do not need this level of sterility assurance, but there is still a risk related to contamination of the outside surface - so the pest control program to mitigate this risk during storage and prior to secondary packaging is sufficient.


Thanks,

TS.

 

[johncharles]

you'll have to refresh my memory on which clause says you have to have pest control..

6.4 - you need a pest control program. If you don't have one, it will be quickly noticed during an audit.

The companies you worked with that did not have a pest control program, did have a pest control program through a third party.

TR24971 says that the risk management file can be integrated with QMS documentation. You have a pest control procedure as an OUTPUT of your infrastructure process. What value do you have in putting in the risk file? Would your pest control policy be changed to minimize risk? Would it be monitored differently? I'm not arguing that pest control isn't an activity to mitigate risk, but that every QMS activity is risk-mitigating. Embed your risk file in your QMS and let your QMS that has already been laid out do the heavy lifting instead of double documenting all activities.