Pest Control and Monitoring Required?

RCW

Quite Involved in Discussions
First, some background:
My company manufactures medical devices for several customers. One customer sends us sterilized, packaged components to include with the non-sterilized units we produce. These are kept in cardboard boxes on shelves until they are required for use. At that time, the box is brought out and placed on the floor while product is pulled from the box.

We do not manufacture sterile products or have an internal sterilization lab.

This customer came in with his registration auditor to monitor our manufacturing processes. He saw the box on the floor and started to go crazy. I could see his point to a degree. The box should be off the floor during use, either placed on the work table or on a skid off the floor. Then he goes on to question our pest control methods.

Here is the question / problem: We do not have a pest control service come in as we have not found any evidence of pest problems, be it droppings or other infestation. Should we have a service come in annually to get an official thumbs up? Management doesn't want to spend the money if there isn't a problem. Unfortunately this could be the "ounce of prevention is worth a pound of cure". Any comments on this matter?
 
A

arios

I believe you client is who can better indicate if you need pest control, they buy your products and use them in theirs so they may know better what it implies not to have it.

One good thing to remember, do not apply pesticides into your manufacturing area and, if you want to use electric bug zappers (the ones that electrocute the insects) it is not good to have them inside the mfg. area either because they can throw into your product pieces of dead insects.
 

DanteCaspian

Quite Involved in Discussions
Here is the question / problem: We do not have a pest control service come in as we have not found any evidence of pest problems, be it droppings or other infestation. Should we have a service come in annually to get an official thumbs up? Management doesn't want to spend the money if there isn't a problem. Unfortunately this could be the "ounce of prevention is worth a pound of cure". Any comments on this matter?

There is a problem! The customer is not satisfied!

Look, if your going to run medical equipment and are not in a clean room, you need to satisfy the customer to prove your competencies.
Can you show audits of housekeeping? What are your house keeping standards? What of quality checks on their parts? Contamination and air quality results? Can you prove there is no problem?

Pets control service is not that expensive. We have a guy come in every 6 months. and check the traps. This shows due diligence and proof.

Your housekeeping standards need to support the ability to provide a product to any customer with excellence. If that to too much for management to make efforts to move towards, then they are not working to customer satisfaction and are in the wrong business.
 

rob73

looking for answers
We have found from bitter experience, our CB will specifically look for a pest control certificate to show that we have proper control of the working environment, we manufacture non-sterile, non-invasive class 1 medical devices. As you say "prevention is better than cure"

Rob
 

ScottK

Not out of the crisis
Leader
Super Moderator
We manufacture secondary packaging for drug and device and every auditor we host looks at our pest control program.

Just saying that you've never had a problem is not going to be enough for 99% of device and pharma clients.
If you want their business you pretty much need to have a proactive pest control program.

I would start getting prices. Look at companies that will give you a turnkey operation - they provide MSDS's, maps, monthly (or more) visits, traps, bait, etc.
 

RCW

Quite Involved in Discussions
There is a problem! The customer is not satisfied!

Not entirely correct. It was the customer's registration auditor, an independent service, that brought this up. For some reason, my customer was quiet on the matter and he never came forward to say, "Yes, here are my requirements. Please do something to improve on this." or "No, I don't consider this a problem."


Look, if your going to run medical equipment and are not in a clean room, you need to satisfy the customer to prove your competencies.
Can you show audits of housekeeping? What are your house keeping standards? What of quality checks on their parts? Contamination and air quality results? Can you prove there is no problem?

Pets control service is not that expensive. We have a guy come in every 6 months. and check the traps. This shows due diligence and proof.

Your housekeeping standards need to support the ability to provide a product to any customer with excellence. If that to too much for management to make efforts to move towards, then they are not working to customer satisfaction and are in the wrong business.

I definitely agree with this. There are no records to show or no proof of any actions taken. As far as people being in the wrong business, is there a business where they can get paid big bucks for sitting around all day and doing nothing? (Strike that - better not go there.)
 

RCW

Quite Involved in Discussions
Just saying that you've never had a problem is not going to be enough for 99% of device and pharma clients.
If you want their business you pretty much need to have a proactive pest control program.

After I told the auditor that we never previously had a problem, I felt stupid because I was simply repeating what management always says.

This is definitely an action item!
 

Deli88

Involved In Discussions
Hi RCW,

I would most definitely insist that you MD authorise an accredited pest controller. I'm surprised your customer hasn't asked about pest control measures. You need at least 8 annual inspections by a pest controller.

Ensure they set out a full bait map with number baits and record actual activity.

You may need to look at insect control as well for the industry you are serving.
 
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