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Purchasing Controls

  • 1.  Purchasing Controls

    Posted 15-Dec-2015 16:52

    Hello fellow RAPS members,

    I would like to get your opinion on the interpretation of 21 CFR 820.50 (Purchasing Controls).  The regulation states that the controls apply to "all purchased or otherwise received product and services..."

    Does this really mean ALL products purchased by a manufacturer, regardless of the product's affect on the quality of the medical device?  For example, should our office supply vendor or vendors associated with research be evaluated and added to our Approved supplier list? 

    Thanks in advance for your input.


    Joy Pelfrey
    Director of RA/QA
    Norman OK
    United States

  • 2.  RE: Purchasing Controls

    Posted 16-Dec-2015 07:34

    You ask if 820.50 applies to all products, or just some. The answer starts with the of QSR, which says, “The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.” Note that “finished device” is a technical term that may have a different meaning than colloquial language.

    To properly implement this part you need to ask if the supplier’s product or service has an impact within the scope. The supplier that provides paper for an office copier probably does not. The supplier that prints instructions for use probably does.

    If a cleaning service covers only office areas, probably not. However, if they enter a clean room then they probably should be covered.

    Research is more difficult. If the researcher provides wonderful “pie in the sky” ideas for a new product, then probably not. If the researcher provides technical knowledge to implement a design, such as potential sterilization methods, then they should be covered.

    Dan O'Leary
    Ombu Enterprises, LLC
    Swanzey NH
    United States

  • 3.  RE: Purchasing Controls

    Posted 16-Dec-2015 07:59

    In general your office supply vendors do not need to be approved and added to your ASL. We have a statement in our Supplier Control SOP that excludes them from the scope.

    When it comes to your R&D suppliers I think the line is a little more grey. I don't feel from a compliance point that they need to be on your ASL. however when you are selecting them you should be selecting them with the controls you have for suppliers in mind. You wouldn't want to get to the point where you are ready to transfer to manufacturing and find out that the supplier you have been using for R&D can't fulfill the requirements to be on your ASL.

  • 4.  RE: Purchasing Controls

    Posted 16-Dec-2015 09:03

    Good morning Joy,

    I would think that this requirement pertains to medical devices related services and products and not to general office supplies. However, I don't know what you meant by "vendors associated with research", but if the research relates to the quality and design of the MD, I would believe that it would be wise to have control on who is providing that service as it can have an impact on final product.

    If you have few minutes available, I suggest to watch the webinar on Purchasing Control from Nov. 4,, specially the QA part.  There were interesting questions that may be useful to you.

    Best regards,


    Valeria Sena-Weltin, M.S., RAC(US)
    Regulatory Affairs Specialist
    Gaithersburg, MD

  • 5.  RE: Purchasing Controls

    Posted 16-Dec-2015 09:14


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    The FDA is not interested in your office supplies, or other non-impact items you purchase.  As you indicated the product and services that impact quality are the focus of 21 CFR 820.50.  That does include things like pest control services, and filters for the cleanroom, as well as components that go into the device.  You might want to review the GHTF Guidance on Control of Products and Services from Suppliers:  This document is used by FDA CDRH as part of its interpretation of the regulation.

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    Edwin Bills RAC, MA
    Principal Consultant
    ELB Consulting
    Overland Park KS
    United States

  • 6.  RE: Purchasing Controls

    Posted 16-Dec-2015 12:53

    The FDA has stated, "...the degree of...control...may vary with the type and significance of the product or service purchased and the impact of that product or service on the quality of the finished device..."

    Accordingly, the rule of thumb is that, if a procured product or service has no impact on the quality of the finished device, then a defensible justification can be made for excluding the product or service from the purchasing controls of 820.50.

    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States

  • 7.  RE: Purchasing Controls

    Posted 16-Dec-2015 12:10
    Hi, Joy,

    Always Risk-Based decisions there.  And with the new emphasis by Canada on segregating critical and non-critical suppliers, you can have at least two categories (critical and non-critical).  I recommend at least three, with one of them office supplies, with little or no scrutiny.  But it must be in your supplier/purchasing procedure(s), including how you manage them.  This is not difficult.  Create a flow chart with what you believe would be a good way to manage them, then hold a brief pow-wow with your internal supplier stakeholders.  Show them the regulations/standards areas where supplier management is stated, then go from there as a team to decide how you will make these risk-based decisions.  Pull in representatives from at least your Purchasing, Material Control, Quality, R&D, Manufacturing departments to go over your flow chart proposal for procedures regarding suppliers, materials, incoming QC, etc.  Remember, you will manage them as a team, so create your processes by the same team.

    Barrett C. Craner
    Retired Med Device VP, Stellartech Research Corporation
    1512 Knollwood Street
    Manteca, CA 95336
    (925) 519-9919 (cell)

  • 8.  RE: Purchasing Controls

    Posted 16-Dec-2015 12:40

    This is to provide you with some additional info from different perspectives.  

    First, try to understand FDA's intent behind the purchasing control.
    Then try to understand what the terms "product" or "services" mean.

    Per 1996 Final Rule for cGMP for medical devices, please refer to Preamble #106, showing FDA's intent. 

    As for finished devices, quality cannot be inspected or tested into products or services.

    The term "product" includes components, manufacturing materials, in-process devices, finished devices, and returned devices.  See CFR § 820.3(r)

    As for the term "services," please refer to the above-mentioned 1996 cGMP Final Rule for medical devices, in particular, Preamble comment #102

    If you have any questions, you may email me at David@RegulatoryDoctor.US 

    Thank you.  

    s/ David
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567

    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.

  • 9.  RE: Purchasing Controls

    Posted 16-Dec-2015 19:00


    The short/quick answer is … everything that is used for the entire procurement, manufacturing, QC, testing, and distribution process, … and R & D that is used for validation, test method development and similar stuff. Also for QA such as doc control software and consultants.
    Do not forget services such as calibration, testing, labels, and promotional literature.

    If you have specific items in question, just ask.



  • 10.  RE: Purchasing Controls

    Posted 17-Jan-2016 17:30

    Hello Art and others,

    Thanks for your input. I have a related question. A QA person asked me whether a foreign distributor needed to be qualified. My initial answer was NO. This correlates to a FDA CDRH presentation at Time 24:57 (

    Nevertheless, then the RA person showed me the contract. MDR responsibility, possible servicing, "instruction for use" translation are mentioned in the contract. Then, I think the distributor needs to be qualified. Am I correct here? More importantly, what's the best way to share these responsibilities with a (foreign) supplier? Thanks a lot!

    H. Zhao

  • 11.  RE: Purchasing Controls

    Posted 18-Jan-2016 15:45

    Sorry, need to change a small part of my original question. It is not "MDR reporting", which is not a requirement for a distributor. It should be "informing manufacturer about product quality complaints". Thanks!