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  • 1.  Pest Control Procedure

    This message was posted by a user wishing to remain anonymous
    Posted 21-Jun-2021 08:14
    This message was posted by a user wishing to remain anonymous

    Can anyone direct me to the source of the requirement for pest control?
    This is a very specific requirement that would likely be audited. 

    Thanks.


  • 2.  RE: Pest Control Procedure

    Posted 21-Jun-2021 15:35
    The source of the requirement for pest control is determined by the type of product, and by the applicable jurisdiction.  I'll get the conversation going by addressing medical devices in the U.S.A., Canada, and Europe.

    U.S.A: FDA considers pest control for medical device manufacturing facilities to be governed under 21 CFR 820.70(e) (Contamination control).

    Canada: Health Canada for class II, III, and IV devices considers pest control for medical device manufacturing facilities to be governed by the corresponding aspect of ISO 13485, specifically, clause 6.3 (Infrastructure) and/or 6.4.2 (Contamination Control).  For importers or distributors of class II, III, and IV devices, pest control should be governed by CMDR Sec. 45(i) (handling and storage procedures).  Pest control for Class I devices would generally be governed by section 19 of the Food and Drugs Act.

    Europe: EU MDR Article 10(9) third paragraph indent (d) (resource management).

    Hope this helps.

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    Kevin Randall, ASQ CQA, RAC (Canada, Europe, U.S.)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 3.  RE: Pest Control Procedure

    Posted 22-Jun-2021 18:33
    Good survey of the main areas of applicability Kevin, though I don't think that any of them explicitly mention pest control.

    Of course there is the Brazilian requirement found within MDSAP Chapter 6, Task 4: "Confirm that a pest control program has been established and where chemicals are used as part of the pest control program, the company must ensure that they do not affect product quality.  Verify that the manufacturer has established and maintains housekeeping procedures and schedules for production areas and warehouses, in conformance with production specifications." (ANVISA Resolution  RDC #155 16/2013: 5.1.3.4;16/2013: 5.1.3.1)

    Seriously, though, I've thought making more explicit that the pest control program not affect product quality should be a natural inclusion in most countries' requirements.​  I've been sadly surprised when auditees haven't considered that element.

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    Rem Siekmann BSE, MBA, ASQ CBA
    Senior Principal Engineer
    Bellaire MI
    United States
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    Original Message


  • 4.  RE: Pest Control Procedure

    Posted 23-Jun-2021 11:16
    Anon raised the question in the right way by asking what is "the source of" the requirement for pest control.  Had the question been, "Which regulations explicitly mention pest control?", then the answer would need to be framed differently.  Anon seems to understand that it is a sure recipe for compliance problems and/or safety problems to focus only on what a regulation explicitly states.  Indeed, emphasizing that a regulation doesn't explicitly mention pest control is generally moot, and contrary to the fundamental intent of the good manufacturing practices requirements embodied by applicable regulatory requirements.  And although many regulations don't directly mention pest control, make no mistake about it:  Those regulations, and the agencies who interpret them, nonetheless require pest control.  The U.S.A., Canadian, and European medical device authorities do so under the clauses that I mentioned.  Thus, effective practitioners need to focus on the intent and interpretation of regulations; not just the letter.

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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 5.  RE: Pest Control Procedure

    Posted 23-Jun-2021 12:04
    Good day....

    During our ISO 13485:2016 audit we were required to show how we controlled pest, bugs, rodents, snakes, etc.  We provided our contract with our pest company and that they were on our AVL.

    I had always been asked this question during FDA inspections, customer audits, and third party audits such as the LNE from France.  I could never find where it was specifically stated that we must have a pest control procedure so I asked our auditor from Bsi.

    He explained that since medical devices are expected to be produced in a clean environment and rodent droppings can be hazardous it is inferred that one is required wherever it states in any regulation that cleaning procedures are required.

    I did not press anymore since I can't imagine any manufacturing facility of any type of product not controlling pests, and all we needed was the contract and the approved vendor.  It was one of the simplest compliance issues for us as we viewed it as standard business practice.

    Best regards,



    Original Message


  • 6.  RE: Pest Control Procedure

    Posted 24-Jun-2021 02:22
    In audits I also request maps of where the traps, etc are located, I ask how often they are serviced, and how connected to the contract.  I have noticed in multiple audits that many companies have not had their pest control company on their AVL or ASL, the contract they showed me was not the actual signed contract but an initial bid that didn't line up with the actual pest control program of the site or set of buildings at the location.  So, their is more than just having a contract and the pest control company on the AVL.

    I have had one company successfully. justify not requiring pest control within their site just external and controlled by the management company for the type of product they made as not a sterile product and safety of the product would not be impacted by pests dropping on the product other than inconvenience.  But this is a rare occasion. Not the norm.

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    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


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